Zoner
Veteran Member
You’re amazing HD. That is great information and so many people don’t know this, not even doctors!
Simply put, the virus never gets weaker but Herd immunity is the only thing that takes it out.
CORONA Main Coronavirus thread
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Simply put, the virus never gets weaker but Herd immunity is the only thing that takes it out.
I saw that, too.
Heliobas Disciple
TB Fanatic
Exactly. People's immune systems get trained to recognize and fight off the virus ,as the naturally immune are beginning to do with Omicron and hopefully future variants. The problem is that there aren't enough naturally immune (vs vaccinated) to achieve herd immunity. The last hope was the kids as a huge reservoir to help achieve herd immunity, and the new vaxx push for kids will deplete that too.
HD
Heliobas Disciple
TB Fanatic
FDA Panel Advisor Admits Agency "LOST" Clinical Trial Data for Placebo Group Before Approving Experimental Vaccine for Babies and Toddlers (Video) | The Gateway Pundit | by Julian Conradson
Earlier this month the Food and Drug Administration (FDA) authorized the mRNA vaccine for emergency use in young children, aged six months to five years old, after its advisory committee voted in favor of the experimental treatment, claiming that it has passed its clinical hurdles and is...
www.thegatewaypundit.com
FDA Panel Advisor Admits Agency “LOST” Clinical Trial Data for Placebo Group Before Approving Experimental Vaccine for Babies and Toddlers (Video)
By Julian Conradson
Published June 29, 2022 at 9:30pm
Earlier this month the Food and Drug Administration (FDA) authorized the mRNA vaccine for emergency use in young children, aged six months to five years old, after its advisory committee voted in favor of the experimental treatment, claiming that it has passed its clinical hurdles and is effective in preventing symptomatic infection without causing worrisome side effects.
However, in addition to ignoring the mountain of evidence showing the vaccines are regularly causing life-threatening injuries – especially in healthy children and young people, the FDA ‘experts’ have routinely skipped crucial steps in the testing process, allowing them to manipulate the data in order to suit their desired outcomes.
This inexcusable act of criminal malpractice was confirmed this month by the team leader of the FDA’s clinical review staff, Rachel Zhang, who explained during an advisory panel zoom call that the agency had lost the results from the placebo group during its clinical trials related to the decision to approve the experimental jab for America’s youngest children.
Without this data from the placebo group, the effectiveness of the vaccine cannot be measured against those who did not receive the treatment. Therefore, the clinical trial is meaningless. But the gaping hole in the results apparently doesn’t matter to the ‘experts’ at the FDA, who went ahead with the EUA approval anyway.
“There is no efficacy data,” Zhang explained. “I guess it will have to come from real-world effectiveness,” she added glibly.
In other words, babies and toddlers are essentially vaccine guinea pigs that will provide the lost data. Remember, Zheng is the team leader of the FDA’s clinical review staff, which oversees the approval of new medical treatments.
From Zheng:
“…We have lost the placebo groups, so we cannot really say anything about the duration of vaccine efficacy after that.
There’s no more efficacy data, basically, after that time point. So, unfortunately, we are limited to – in this study – would be the results that we have shown you in the slide with the data cut off. The latest one [placebo group data] would be the May 31st one, and that still is, unfortunately, very few cases…
…I guess it will have to come from real-world effectiveness.”
How does something like this even happen? They don’t even have to come up with a viable excuse anymore. This is literally on par with the old ‘dog ate my homework’ line. What a joke.
Heliobas Disciple
TB Fanatic
Dangerous and Ineffective: Experimental Pfizer Vaccine Causes Nearly FIVE "SERIOUS Adverse Events" Per Every ONE Person it Kept From Being Hospitalized with Covid, Study Finds | The Gateway Pundit | by Julian Conradson
It has become increasingly clear that the experimental mRNA vaccines are nothing close to ‘safe’ or ‘effective’ as they have been billed to be.
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Vaccine Causes Nearly FIVE “SERIOUS Adverse Events” Per Every ONE Person it Kept From Being Hospitalized with Covid, Study Finds
By Julian Conradson
Published June 29, 2022 at 10:15pm
It has become increasingly clear that the experimental mRNA vaccines are nothing close to ‘safe’ or ‘effective’ as they have been billed to be. For months, data has been emerging that not only shows the vaccines do little in the way of stopping transmission (or are likely spreading the virus) and are causing an untold amount of serious medical complications such as myocarditis, pulmonary embolism, blood clots, immune system failure, and Sudden Adult Death Syndrome, known as the SADS for short (yes, really), among others.
Yet, somehow, the medical ‘experts’ and the tyrannical Biden regime continue advocating that Americans take the toxic jab, promising its safety and effectiveness as if the vaccine had caused no issues whatsoever. And that’s as the US Government’s own Vaccine Adverse Events Reporting System (VAERS), which is notoriously underreported, is showing nearly 30,000 deaths and over 50,000 permanent disabilities related to the vaccine – by far the most of any in history.
So, naturally, Fauci and the ‘experts’ just green-lighted the jab for babies and toddlers.
While it may be obvious to those paying attention that the experimental mRNA treatments have caused profound damage to the health of people across the globe, the extent of the problem is still vague even if we know its widespread. However, thanks to a new research study that was published this week by the Social Science Research Network (SSRN), we are finally starting to see the bigger picture, and the ‘safe and effective’ narrative should finally be able to be destroyed once and for all.
According to the study, mRNA vaccines from both Moderna and Pfizer were more likely to cause a “severe” adverse reaction (vaccine injury like myocarditis, etc.) than prevent covid hospitalizations. And not just a little more either. Moderna’s vaccine was found to cause “15.1 serious adverse events” for every 6.4 people kept out of the hospital.
Pfizer’s mRNA jab was even worse. Clocking in at an astonishing 10.1 serious adverse events per every 2.3 prevented hospitalizations – which is nearly 5 to 1.
Keep in mind that Covid-19 is only moderately more dangerous than the flu in the first place. The serious medical complications linked to the vaccine are much more life-threatening than the virus itself. And yet, Pfizer’s vaccine is 5x more likely to cause a serious adverse event than prevent a serious case of Covid-19, per the study.
From the SSRN study, titled “Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials:”
“Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest, with an absolute risk increase of 10.1 and 15.1 per 10,000 vaccinatedover placebo baselines of 17.6 and 42.2 (95% CI -0.4 to 20.6 and -3.6 to 33.8), respectively.
Combined, the mRNA vaccines were associated with an absolute risk increase of serious adverse events of special interest of 12.5 per 10,000 (95% CI 2.1 to 22.9).
The excess risk of serious adverse events of special interest surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group in both Pfizer and Moderna trials (2.3 and 6.4 per 10,000 participants, respectively).”
In conclusion, the researchers call for a formal, widespread harm-benefit analysis to be conducted – something that should have been done throughout the clinical trials before the widespread rollout to the public. As they have found with minimal research, “serious AE’s outweigh reduction in serious risks mitigated,” so there is no excuse for the ‘experts’ to have missed such an obvious safety signal.
The study concludes:
“The excess risk of serious adverse events found in our study points to the need for 49 formal harm-benefit analyses, particularly those that are stratified according to risk of serious 50 COVID-19 outcomes such as hospitalization or death.”
Talk about killing two birds with one stone. The data is clear: this vaccine is dangerous and ineffective.
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Heliobas Disciple
TB Fanatic
Pfizer, Moderna Shots More Likely to Cause Serious Injury Than Reduce Risk of COVID-Related Hospitalization
A new analysis of Pfizer and Moderna COVID-19 vaccine trial data shows the risk of serious injury following the vaccine is greater than the reduction in COVID-19 hospitalizations, according to a study posted June 23 on Social Science Research Network.
childrenshealthdefense.org
Pfizer, Moderna Shots More Likely to Cause Serious Injury Than Reduce Risk of COVID-Related Hospitalization
A new analysis of Pfizer and Moderna COVID-19 vaccine trial data shows the risk of serious injury following the vaccine is greater than the reduction in COVID-19 hospitalizations, according to a study posted June 23 on Social Science Research Network.
By Suzanne Burdick, Ph.D.
06/29/22
A new analysis of Pfizer and Moderna COVID-19 vaccine trial data shows the risk of serious injury following the vaccine is greater than the reduction in COVID-19 hospitalizations, according to a study posted June 23 on Social Science Research Network.
“Combining the trials, there was a 43% increased risk of serious adverse events of special interest and an absolute risk increase of 12.5 serious adverse events of special interest per 10,000 vaccinated participants,” the authors of the pre-print paper wrote.
Based on their findings, the authors called for a harm-benefit analysis of COVID-19 vaccines.
The researchers — among them Peter Doshi, Ph.D., senior editor at The BMJ and associate professor of pharmaceutical health services research at the University of Maryland School of Pharmacy — concluded:
“A systematic review and meta-analysis using individual participant data should be undertaken to address questions of harm-benefit in various demographic subgroups. Full transparency of the COVID-19 vaccine clinical trial data is needed to properly evaluate these questions. Unfortunately, well over a year after widespread use of COVID-19 vaccines, participant-level data remain inaccessible.”
Doshi leads the Restoring Invisible & Abandoned Trials (RIAT) initiative, which seeks to ensure clinical trial publications are accurate and complete, and data are publicly available.
The study’s other authors are:
- Robert Kaplan, Ph.D., who leads Stanford University’s Clinical Excellence Research Center and previously led the behavioral and social sciences programs at the National Institutes of Health and served as the chief science officer at the U.S. Agency for Health Care Research and Quality.
- Dr. Patrick Whelan, M.D., Ph.D., associate clinical professor of pediatrics in the division of rheumatology at the University of California at Los Angeles (UCLA).
- Sander Greenland, Ph.D., professor emeritus of epidemiology and statistics at UCLA who served as an advisor for the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), the Environmental Protection Agency, the Centers for Disease Control and Prevention and the National Academy of Sciences.
- Mark Jones, Ph.D., associate professor of health sciences and medicine at the Institute for Evidence-Based Healthcare, as well as a biostatistician at Bond University in Robina, Australia.
- Juan Erviti, Ph.D. Pharm. D., qualified hospital pharmacist at Navarre Health Service, Spain.
- Dr. Joseph Fraiman, emergency medicine doctor at Louisiana State University’s Lallie Kemp Regional Medical Center.
“The public, and public health officials, need to immediately consider the implications of these study results,” Hooker added.
What the researchers did, and why
The researchers analyzed data from the clinical trials the FDA used as the basis for granting Emergency Use Authorization of the Pfizer and Moderna vaccines “to investigate the association between FDA-authorized mRNA COVID-19 vaccines and serious adverse events identified by the Brighton Collaboration.”
According to the researchers, the Brighton Collaboration in March 2020 created and later updated a priority list of “potential adverse events of special interest relevant to COVID-19 vaccine trials” in collaboration with the Coalition for Epidemic Preparedness Innovations partnership, Safety Platform for Emergency Vaccines.
The priority list identified serious health events as being “adverse events of special interest for safety monitoring” (AESIs) if they met one or more of the following criteria:
- Known association with immunization or a specific vaccine platform.
- Occurrence during wild-type disease as a result of viral replication and/or immunopathogenesis.
- Theoretical association based on animal models.
The WHO’s Global Advisory Committee on Vaccine Safety endorsed the list as a safety monitoring tool and recommended AESIs be reported based on the list — yet no research using the list was conducted on randomized trial data to determine the association between vaccination and the occurrence of AESIs, according to the study authors.
For this reason, the authors of the study conducted an analysis of SAEs reported in the placebo-controlled, Phase 3 randomized clinical trials of the Pfizer and Moderna mRNA COVID-19 vaccines (NCT04368728 and NCT04470427).
How they conducted the analysis
First, the team searched Pfizer and Moderna trial data on the FDA and Health Canada websites to locate SAE results tables for the trials.
Following regulatory norms, the two pharmaceutical companies used nearly identical definitions for what constituted a “serious” adverse event by deeming any adverse event to be an SAE if it resulted in any of the following conditions:
- Death
- Life-threatening at the time of the event
- Inpatient hospitalization or prolongation of existing hospitalization
- Persistent or significant disability/incapacity
- A congenital anomaly/birth defect
- Medically important event, based on medical judgment
Additionally, participants who initially received the placebo were offered the vaccine.
“These self-selection processes may have introduced nonrandom differences between the vaccine and unvaccinated participants,” wrote the authors, “thus rendering the post-authorization data less reliable.”
To “preserve randomization,” the researchers used “the interim datasets that were the basis for emergency authorization in December 2020, approximately 4 months after trials commenced.”
Next, for each of these dataset trials, the researchers prepared blinded SAE tables — showing types of SAEs but not showing results data.
Then, two clinical reviewers used the tables to independently judge whether each SAE was an AESI.
Using statistical analyses, the team then calculated risk ratios and risk differences between the vaccine and placebo groups for the incidence of SAEs.
Finally, the researchers used a simple harm-benefit framework to place their results in context by comparing the risks of excess AESIs against reductions in serious complications of COVID-19.
What the results showed
The Pfizer trial reported a “36% higher risk of [SAEs] unrelated to COVID-19 in 175 vaccinated participants” compared with placebo recipients, the study’s authors reported.
“The Moderna trial reported a 5% higher risk of SAEs unrelated to COVID-19 in vaccinated individuals compared to those receiving placebo,” they wrote.
The researchers’ blind and independent review determined the majority of SAEs were AESIs — meaning most of these events were the type known to be of particular safety concern related to the COVID-19 vaccine.
The researchers’ findings contrast with Pfizer’s previous claim that nearly all SAEs during the vaccine trials were “not related” to the vaccine.
As The Defender reported, Pfizer-BioNTech COVID-19 vaccine documents released June 1 by the FDA revealed numerous instances of participants who sustained severe adverse events during Phase 3 trials.
Some of these participants withdrew from the trials, some were dropped and some died.
According to the study:
“In the Moderna trial, the excess risk of serious AESIs (15.1 per 10,000 participants) surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group (6.4 per 10,000).
“In the Pfizer trial, the excess risk of serious AESIs (10.1 per 10,000) surpassed the risk reduction for COVID-19 hospitalization relative to the placebo group (2.3 per 10,000 participants).”
The authors noted limitations of their study, such as that their analysis used an existing dataset rather than recent data.
However, they noted, “Our analysis has an advantage over postmarketing observational studies in that the data are from blinded, placebo-controlled randomized trials vetted by the FDA, and uses the Brighton Collaboration AESI list, which was pre-specified, endorsed by WHO, and established well before the availability of the clinical trial results, and designed for use in COVID-19 vaccine trials.”
They also noted their results showing a heightened risk of AESIs in the vaccine group represented an average across the group.
“SAEs may not be distributed equally across the demographic subgroups enrolled in the trial, and the risks may be substantially less in some groups compared to others.”
“Knowing the actual demographics of those who experienced an increase in AESI in the vaccine group is necessary for a proper harm-benefits analysis,” they added.
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Heliobas Disciple
TB Fanatic
FDA Panel Recommends New Booster to Target Omicron Despite Concerns of 'Too Little Data'
The U.S. Food and Drug Administration’s vaccine advisory panel voted 19 to 2 on Tuesday to add an Omicron component to COVID-19 boosters this fall, over objections by panel members and despite a lack of data.
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FDA Panel Votes to Waive Clinical Trials for New COVID Boosters
The U.S. Food and Drug Administration’s vaccine advisory panel voted 19 to 2 on Tuesday to add an Omicron component to COVID-19 boosters this fall, over objections by panel members and despite a lack of data.
By Megan Redshaw
06/29/22
The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel on Tuesday voted 19 to 2 to recommend new COVID-19 booster shots that include the Omicron variant this fall.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not issue guidance on whether additional data would be needed to recommend an updated composition of the primary-series vaccines authorized for emergency use in the U.S., or whether it would be appropriate to continue to use a primary-series vaccine as a booster.
It is the first time VRBPAC has suggested vaccine makers modify their vaccines to target a different variant, according to CNBC, which also reported the FDA will likely accept the committee’s recommendation.
If so, the FDA would be authorizing a vaccine change without requiring additional data showing a bivalent vaccine — containing both the original 2019 Wuhan variant and one of the Omicron variants — is safe and effective for those age groups that are already authorized to receive a booster dose.
The FDA plans to decide by early July whether vaccines will target the now-dominant BA.4 and BA.5 Omicron subvariants or the BA.1 Omicron variant that led to a surge in infections last winter, Reuters reported.
At the beginning of the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, suggested a newly designed shot could begin in October, adding that it takes manufacturers around three months to choose a vaccine design and begin producing doses.
Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, and Dr. Hank Bernstein, professor of pediatrics at Zucker School of Medicine, were the only two members who broke from the panel to vote against the initiative.
Offit acknowledged there’s a benefit to providing a booster in the fall to some age groups, but questioned whether Omicron was the right strain. He said the move to new-variant vaccines was happening too fast, with too little data.
“I think as a new product it should be handled as a new product,” Offit said. “I think we need a higher standard than what we’ve been given. …“I’m not comfortable enough to support the risk of a new product.”
Bernstein expressed concern over the lack of data used to justify changing the strain, and the potential that by the time a subsequent booster is approved, it will contain outdated strains.
“So, in sum, I think including an Omicron strain in the vaccine seems to have some potential, but data especially for BA.4 and BA.5 are limited at this time, and that’s why I’m struggling to even make a strain change at this time,” Bernstein said.
Bernstein also said he didn’t see a need to change the strain as the current vaccine being used is shown to be effective against severe disease — a claim made just two weeks earlier at a prior VRBPAC meeting.
Bernstein said the strain change would need to be supported by data showing improved vaccine effectiveness and he “didn’t think we really have the data to be able to say that” even though the panel looked at the immune response.
Dr. Ofer Levy, VRBPAC member and an infectious disease physician at Boston Children’s Hospital, voted “yes” to change the computation of COVID-19 boosters, despite Pfizer’s admission there is “no established correlate of protection,” referring to the level of antibodies needed to confer protection.
“You have a lot of data now,” Levy told Pfizer. “What is your relative protection?”
“I would say there is no established correlate of protection,” Kena Swanson, Ph.D., vice president of viral vaccines at Pfizer, told Levy.
Levy circled back during the meeting:
“I would like to hear from FDA what their overall approach will be around improving our understanding of correlate protection. We spend a good amount of time reviewing antibody data. We have no doubt antibody data is important. We don’t have a level of antibody that anybody is comfortable stating is correlated [with] protection.
“So yes, the antibodies are important but so are the T cells. We heard from Dr. Weir, yes, T-cell assays are trickier and they’re more diverse, but it’s not going to happen without federal leadership to have a standardization of the T-cell assay and encourage or in fact require the sponsors to gather that information.”
“So what is the effort to standardize the pre-clinical assays?” Levy asked. “This is an effort that’s critical not just now but for future cycles of vaccine revision. If we aren’t able to define a standard for correlate protection we are fighting with one arm behind our back.”
Marks acknowledged the importance of Levy’s question, but said T-cell-mediated immunity was “difficult to study” initially.
“We have been having conversations with our colleagues at the NIH [National Institutes of Health] and throughout government about how we might move forward here,” Marks said. “It is something that we don’t have an answer to yet.”
Marks said as vaccines are developed in the future, it will “become even more important” to define a standard of correlate protection because “we won’t be able to have a large naive population to vaccinate with newer vaccines.”
“We will need to understand the T-cell response better,” Marks said. “I take your point, it’s just that we haven’t solved the problem yet.“
Dr. Meryl Nass, a member of the Children’s Health Defense scientific advisory committee, told The Defender that in her opinion, Tuesday’s meeting was a “vote to essentially approve a future framework — the future framework being a dearth of evidence required to change the booster, without clinical evidence and without a correlation of protection.”
Nass added:
“They voted on using an Omicron variant in the next booster iteration — which could contain any Omicron variant and could be either mono- or bi-valent.
“But most likely they will keep the current version and add another — which might double the amount of mRNA, or not.”
The new formulation might be for adults alone or adults and children, or only older adults and the immunocompromised, Nass said.
Brian Hooker, Ph.D., Children’s Health Defense chief scientific officer and professor of biology at Simpson University, told The Defender:
“The proposed move by VRBPAC will increase the harm to the U.S. public to unprecedented levels, as this action will further circumvent necessary clinical trials even beyond the slapdash testing of COVID-19 vaccines under Emergency Use Authorization.
“This adds to a foundation of lies used to authorize the original COVID-19 vaccines without anywhere near proper testing.”
Dr. Cody Meissner, VRBPAC panel member and professor of pediatrics at Tufts University, expressed concern about the financial risk pharmaceutical companies “are taking by making these vaccines.”
“If there’s a low likelihood the vaccines will be recommended, then they could incur significant loss,” he said.
Marks responded:
“I guess I would say that I would make recommendations here knowing the vaccine manufacturers will be kept whole by the United States government at least for some vaccines. I could be wrong but I think that’s a reasonable assumption.”
During the meeting, Moderna told the panel it would be ready with a “couple of hundred million” bivalent, or double-targeted, vaccines designed to combat BA.1 by September, but it would be late October or early November if the company needs to design a new vaccine targeting subvariants.
Pfizer said it and partner BioNTech have a significant amount of vaccine doses designed for the BA.1 variant ready and are already preparing to produce a large number of doses targeting BA.4 and BA.5 Omicron subvariants.
Pfizer said either could be ready for an early October rollout.
[continued next post]
Heliobas Disciple
TB Fanatic
[continued from post above this]
Multiple concerns raised during the public comment session
During the public comment session of the meeting, experts raised concerns that were largely ignored by the advisory panel.
Dr. Dustin Bryce, with Interest of Justice, said the FDA, Centers for Disease Control and Prevention (CDC) and the World Health Organization are “usurping Congress’ definition of a vaccine — which is any substance designed for the prevention of one or more disease.”
“FDA actually classifies mRNA as gene therapy, which they say is to treat or cure an existing disease by modifying your genes,” Bryce said. “Gene therapies are still being studied and are experimental at this time.”
Citing FDA documents, Bryce said gene therapy, unlike a vaccine, is so inherently unsafe the FDA says it requires 15 years of research to follow up on safety due to known risks of antibody-dependent enhancement, alteration of DNA and delayed adverse effects, such as cancer.
Bryce said:
“FDA says that gene therapy use in the mass population represents an unreasonable risk and they should limit the number of subjects who might be exposed to risk. We require due process and forbid the FDA from authorizing the proposed changes.
“We are demanding that EUA [Emergency Use Authorization] is promptly revoked because unreasonable risks are inherent in gene therapy products, as evidenced by large numbers of reports of adverse serious events linked to or suspected of being caused by an EUA product, product failure and product ineffectiveness.”
Bryce said COVID-19 vaccines fail to meet the requirements of EUA because not a single mRNA vaccine has been found to be effective for the prevention or treatment of an existing disease.
Michael Briskin pointed out in his public comment that the FDA receives approximately 75% of its budget from pharmaceutical companies, which he believes represents a conflict of interest.
Briskin challenged the use of the phrase “safe and effective” to describe COVID-19 vaccines, given the FDA has done no long-term testing to determine whether these products are safe.
Briskin presented data showing a significant rise in reported deaths among working-age Americans following COVID-19 vaccine mandates.
He said:
“In the short-term, 2021 was a very interesting year. We saw a stark increase [in death] among working-age adults from 18 to 64 and specifically in Q3 and into Q4, so something new for the working-age demographic partly through 2021 would be the clear correlation.
“With comparable trends in BLS [Bureau of Labor Statistics] data, children’s health insurance data, Israeli ambulance data, and of course we have the [Vaccine Adverse Event Reporting System (VAERS)] data — which the CDC tried to minimize but a recent FOIA [Freedom of Information Act] request forced them to reveal that they never once did the PRR calcification that was supposed to be their tool for spotting safety signals, according to their posted documents.”
“And what do we do when people get injured from these vaccines?” Briskin asked the panel. “We leave them in the mud.”
Briskin chastised the panel for authorizing boosters for infants two weeks earlier when data showed two doses weren’t effective and only 10 cases were used to assess efficacy.
“Three-quarters of the severe COVID in the trial was in the vaccine arm, as was the only hospitalization case which was accompanied by a seizure,” Briskin said. “And Moderna is so dangerous in young people Nordic countries won’t allow it to be used in anyone under the age of 30.”
Briskin said:
“In fact, the director of health of Denmark just admitted that vaccinating children was a mistake, whereas our officials only ever doubled down. And now we’re about to double down so hard we are about to lose the pretense of holding these pharmaceutical companies to any statistically meaningful regulatory standards for formula modification.
“For people following at home, what this agency is proposing is not just modifying the genetic code in the vaccine and the structure of the proteins produced to chase variants, but even things like doubling the microgram count for Pfizer — all without doing any statistically powered safety studies.”
“And to be clear,” Briskin added, “the companies we’re giving carte blanche to include Pfizer, the world’s largest criminal organization having paid the world’s largest criminal fine, and Moderna, which never made a safe product before we did away with long-term safety testing.”
Dr. Eric Feintuch, a chiropractor, asked the FDA if the agency knows how long mRNA from COVID-19 vaccines and the spike protein stay in the body, whether they know what the rate of protein production is and whether the FDA is aware of the consequences of the methylpseudouridine substitutions at the codon optimization step.
“For anyone on this panel who says it doesn’t go anywhere, tell me what proof you have of that,” Feintuch said, referring to the spike protein.
Feintuch said COVID-19 vaccines are associated with prion disease, noting 26 people have reported experiencing sudden onset of a severe and fatal brain disorder within one month of the second mRNA vaccine dose.
“This information needs to be researched and seen,” Feintuch said.
“A thousand peer-reviewed studies question the safety of COVID-19 vaccines. Doesn’t anyone see the safety signals? Is there anyone here who will stand up?” he asked. “Some of you know this, you need to stand up and you need to help us.”
Dr. David Wiseman, a research scientist with a background in pharmacy, pharmacology and experimental pathology, said VRBPAC is once again being asked to opine on inadequate information.
Wiseman said the FDA recently waived efficacy requirements for COVID-19 vaccines and has ignored its experts, notably Levy, who “has called for federal efforts to validate and standardize a correlate of protection.”
“Recent vaccine decisions were based on irrelevant Wuhan immunobridging,” Wiseman said. “Omicron assays are unvalidated and unverified by FDA.”
Wiseman said safety questions surrounding COVID-19 vaccines remain unanswered:
“We have shown correlations between vaccination and all-cause mortality. FDA says VAERS is under- and misreported. A FOIA disclosure reveals that CDC has not conducted safety signal analyses, which we have provided to FDA. Neurologic adverse events are finally being acknowledged [but there are] still no cancer studies.”
Wiseman further pointed out that FOIA requests show vital studies involving the spike protein have not been done:
“A Stanford study in [the journal] Cell showed vaccine message and antigen persisting for at least eight weeks. Does spike accumulate? Is this why myocarditis rates after boosting match or best primary series rates for some ages?
“Does spike persistence contribute to immune suppression, imprinting and negative efficacy? What is the toxicity of multiple doses? How will sameness of the manufacturing process be defined? Are the guidelines talking about monovalents or bivalents?”
Pfizer has dismissed concerns about the spike protein as “academic,” Wiseman said, “but it is certainly not.”
Booster formulation should be changed to combat waning efficacy, committee said
During the meeting, which occurred two weeks after the panel signed off on the primary COVID-19 vaccine series for the nation’s youngest children, a change in booster composition was deemed necessary due to waning effectiveness.
Dr. Mahesh Shenai, neurosurgeon and data analyst, said in a tweet:
“After many months of extolling benefits of vax and booster, now they are criticizing its efficacy and durability. . . to set the stage for a new updated booster!?”
In a briefing document published ahead of Tuesday’s meeting, FDA officials predicted a major COVID-19 outbreak will occur in the fall “due to the combination of waning immunity, further evolution of variants and increased indoor activity.”
A similar committee that advises the WHO recently suggested COVID-19 vaccines be reformulated to include both the original SARS-CoV-2 Wuhan variant and the first version of Omicron, BA.1 — although this variant has since been replaced by other strains of BA.4 and BA.5.
Moderna and Pfizer studied Omicron-specific vaccines in preparation for fall boosters, but efforts have been complicated by new subvariants.
If the government decides it wants a booster shot that targets BA.4 and BA.5 — two strains derived from the Omicron variant that are becoming dominant — vaccine manufacturers will have to race to produce the doses by fall, The New York Times reported.
Vaccines produced by Pfizer, Moderna, Novavax and Johnson & Johnson were developed against the original Wuhan COVID strain that emerged in 2019, but as the virus has rapidly evolved, these vaccines have become less effective.
COVID-19 vaccines target the spike protein the SARS-CoV-2 virus uses to invade human cells, but as the virus mutates away from the original strain, it has trouble “recognizing and attacking the spike,” CNBC reported. The Omicron variant has more than 30 mutations.
Marks said during the meeting he hopes changing the booster will “convince people to go get that booster,” adding the FDA plans to begin a booster campaign in October.
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Multiple concerns raised during the public comment session
During the public comment session of the meeting, experts raised concerns that were largely ignored by the advisory panel.
Dr. Dustin Bryce, with Interest of Justice, said the FDA, Centers for Disease Control and Prevention (CDC) and the World Health Organization are “usurping Congress’ definition of a vaccine — which is any substance designed for the prevention of one or more disease.”
“FDA actually classifies mRNA as gene therapy, which they say is to treat or cure an existing disease by modifying your genes,” Bryce said. “Gene therapies are still being studied and are experimental at this time.”
Citing FDA documents, Bryce said gene therapy, unlike a vaccine, is so inherently unsafe the FDA says it requires 15 years of research to follow up on safety due to known risks of antibody-dependent enhancement, alteration of DNA and delayed adverse effects, such as cancer.
Bryce said:
“FDA says that gene therapy use in the mass population represents an unreasonable risk and they should limit the number of subjects who might be exposed to risk. We require due process and forbid the FDA from authorizing the proposed changes.
“We are demanding that EUA [Emergency Use Authorization] is promptly revoked because unreasonable risks are inherent in gene therapy products, as evidenced by large numbers of reports of adverse serious events linked to or suspected of being caused by an EUA product, product failure and product ineffectiveness.”
Bryce said COVID-19 vaccines fail to meet the requirements of EUA because not a single mRNA vaccine has been found to be effective for the prevention or treatment of an existing disease.
Michael Briskin pointed out in his public comment that the FDA receives approximately 75% of its budget from pharmaceutical companies, which he believes represents a conflict of interest.
Briskin challenged the use of the phrase “safe and effective” to describe COVID-19 vaccines, given the FDA has done no long-term testing to determine whether these products are safe.
Briskin presented data showing a significant rise in reported deaths among working-age Americans following COVID-19 vaccine mandates.
He said:
“In the short-term, 2021 was a very interesting year. We saw a stark increase [in death] among working-age adults from 18 to 64 and specifically in Q3 and into Q4, so something new for the working-age demographic partly through 2021 would be the clear correlation.
“With comparable trends in BLS [Bureau of Labor Statistics] data, children’s health insurance data, Israeli ambulance data, and of course we have the [Vaccine Adverse Event Reporting System (VAERS)] data — which the CDC tried to minimize but a recent FOIA [Freedom of Information Act] request forced them to reveal that they never once did the PRR calcification that was supposed to be their tool for spotting safety signals, according to their posted documents.”
“And what do we do when people get injured from these vaccines?” Briskin asked the panel. “We leave them in the mud.”
Briskin chastised the panel for authorizing boosters for infants two weeks earlier when data showed two doses weren’t effective and only 10 cases were used to assess efficacy.
“Three-quarters of the severe COVID in the trial was in the vaccine arm, as was the only hospitalization case which was accompanied by a seizure,” Briskin said. “And Moderna is so dangerous in young people Nordic countries won’t allow it to be used in anyone under the age of 30.”
Briskin said:
“In fact, the director of health of Denmark just admitted that vaccinating children was a mistake, whereas our officials only ever doubled down. And now we’re about to double down so hard we are about to lose the pretense of holding these pharmaceutical companies to any statistically meaningful regulatory standards for formula modification.
“For people following at home, what this agency is proposing is not just modifying the genetic code in the vaccine and the structure of the proteins produced to chase variants, but even things like doubling the microgram count for Pfizer — all without doing any statistically powered safety studies.”
“And to be clear,” Briskin added, “the companies we’re giving carte blanche to include Pfizer, the world’s largest criminal organization having paid the world’s largest criminal fine, and Moderna, which never made a safe product before we did away with long-term safety testing.”
Dr. Eric Feintuch, a chiropractor, asked the FDA if the agency knows how long mRNA from COVID-19 vaccines and the spike protein stay in the body, whether they know what the rate of protein production is and whether the FDA is aware of the consequences of the methylpseudouridine substitutions at the codon optimization step.
“For anyone on this panel who says it doesn’t go anywhere, tell me what proof you have of that,” Feintuch said, referring to the spike protein.
Feintuch said COVID-19 vaccines are associated with prion disease, noting 26 people have reported experiencing sudden onset of a severe and fatal brain disorder within one month of the second mRNA vaccine dose.
“This information needs to be researched and seen,” Feintuch said.
“A thousand peer-reviewed studies question the safety of COVID-19 vaccines. Doesn’t anyone see the safety signals? Is there anyone here who will stand up?” he asked. “Some of you know this, you need to stand up and you need to help us.”
Dr. David Wiseman, a research scientist with a background in pharmacy, pharmacology and experimental pathology, said VRBPAC is once again being asked to opine on inadequate information.
Wiseman said the FDA recently waived efficacy requirements for COVID-19 vaccines and has ignored its experts, notably Levy, who “has called for federal efforts to validate and standardize a correlate of protection.”
“Recent vaccine decisions were based on irrelevant Wuhan immunobridging,” Wiseman said. “Omicron assays are unvalidated and unverified by FDA.”
Wiseman said safety questions surrounding COVID-19 vaccines remain unanswered:
“We have shown correlations between vaccination and all-cause mortality. FDA says VAERS is under- and misreported. A FOIA disclosure reveals that CDC has not conducted safety signal analyses, which we have provided to FDA. Neurologic adverse events are finally being acknowledged [but there are] still no cancer studies.”
Wiseman further pointed out that FOIA requests show vital studies involving the spike protein have not been done:
“A Stanford study in [the journal] Cell showed vaccine message and antigen persisting for at least eight weeks. Does spike accumulate? Is this why myocarditis rates after boosting match or best primary series rates for some ages?
“Does spike persistence contribute to immune suppression, imprinting and negative efficacy? What is the toxicity of multiple doses? How will sameness of the manufacturing process be defined? Are the guidelines talking about monovalents or bivalents?”
Pfizer has dismissed concerns about the spike protein as “academic,” Wiseman said, “but it is certainly not.”
Booster formulation should be changed to combat waning efficacy, committee said
During the meeting, which occurred two weeks after the panel signed off on the primary COVID-19 vaccine series for the nation’s youngest children, a change in booster composition was deemed necessary due to waning effectiveness.
Dr. Mahesh Shenai, neurosurgeon and data analyst, said in a tweet:
“After many months of extolling benefits of vax and booster, now they are criticizing its efficacy and durability. . . to set the stage for a new updated booster!?”
Talk about a PIVOT #vrbpac
After many months extolling benefits of vax and booster, now they are criticizing it’s efficacy and durability . . .
. . .to set the stage for a NEW updated booster !? pic.twitter.com/eZ77XcljpV
— Mahesh Shenai, MD (@mahesh_shenai) June 28, 2022
In a briefing document published ahead of Tuesday’s meeting, FDA officials predicted a major COVID-19 outbreak will occur in the fall “due to the combination of waning immunity, further evolution of variants and increased indoor activity.”
A similar committee that advises the WHO recently suggested COVID-19 vaccines be reformulated to include both the original SARS-CoV-2 Wuhan variant and the first version of Omicron, BA.1 — although this variant has since been replaced by other strains of BA.4 and BA.5.
Moderna and Pfizer studied Omicron-specific vaccines in preparation for fall boosters, but efforts have been complicated by new subvariants.
If the government decides it wants a booster shot that targets BA.4 and BA.5 — two strains derived from the Omicron variant that are becoming dominant — vaccine manufacturers will have to race to produce the doses by fall, The New York Times reported.
Vaccines produced by Pfizer, Moderna, Novavax and Johnson & Johnson were developed against the original Wuhan COVID strain that emerged in 2019, but as the virus has rapidly evolved, these vaccines have become less effective.
COVID-19 vaccines target the spike protein the SARS-CoV-2 virus uses to invade human cells, but as the virus mutates away from the original strain, it has trouble “recognizing and attacking the spike,” CNBC reported. The Omicron variant has more than 30 mutations.
Marks said during the meeting he hopes changing the booster will “convince people to go get that booster,” adding the FDA plans to begin a booster campaign in October.
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FDA: Don't rush a move to change the Covid-19 vaccine composition
A multibillion-dollar decision to launch a vaccine based wholly or in part on the BA.1, BA.4, or BA.5 Omicron sequences need not be rushed. Using an additional week or two to obtain more input seems a prudent step to take.
www.statnews.com
First Opinion
FDA: Don’t rush a move to change the Covid-19 vaccine composition
By John P. Moore and Paul A. Offit
June 29, 2022
On Tuesday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 19-2 to approve the use later this year of Covid-19 vaccines based on an Omicron variant sequence. One of us (P.A.O.) was among those voting “no.” It is possible these vaccines will be two-component designs that also include the current version. Will Americans soon be better protected against Covid-19?
The Covid-19 vaccines currently authorized for use in the U.S. are all based on the sequence of the original SARS-CoV-2 virus, which was obtained early in 2020. The virus has evolved over the past 30 months, creating variants that are either more infectious, or harder to counter by vaccination, or both. In late December 2021, the Omicron variant (BA.1) emerged, becoming the most dominant strain in the U.S. BA.1 has now been almost completely replaced by other Omicron-based variants. The BA.4 and BA.5 viruses currently account for 50% of all circulating strains. Earlier variants, like Alpha and Delta, have essentially vanished.
While vaccines made from the original SARS-CoV-2 strain provided strong protection against SARS-CoV-2 circulating in 2020 and 2021, the Omicron variants have been more problematic. They are highly resistant to neutralizing antibodies, which the human immune system uses to prevent infection. As a result, the Omicron viruses find it easier to break through this protective barrier, causing what are mostly mild infections. That’s true whether the neutralizing antibodies were elicited by vaccination or by earlier infection with Alpha or Delta variants. Fortunately, most people have enough neutralizing antibodies to strongly protect them against severe disease and death — that key task requires immune memory cells and lower neutralizing antibody levels than are needed to completely fend off the virus.
Once it became clear that the Omicron variants resisted neutralizing antibodies, thereby increasing the frequencies of mostly mild infections, vaccine companies began rapidly redesigning their Covid-19 vaccines. The revised vaccines were all based on the initial Omicron BA.1 sequence, which was an appropriate step to take. By now, most Americans already have antibodies against SARS-CoV-2’s spike protein because they were vaccinated or infected or both. As a result, the most frequent use of an Omicron-containing vaccine will be as a booster dose for certain high-risk groups.
What is known about Omicron-based vaccines? BA.1 versions have been tested as boosters in experimental animals and also in small-scale human trials. The goals of the studies were to measure the levels of neutralizing antibodies produced, compared to using the original vaccine as a booster under similar conditions.
The animal data have been around for several months. They are quite similar to what’s recently emerged from various human trials. Two to four weeks after the booster shots, neutralizing antibody levels against Omicron BA.1 were about twofold higher with the Omicron-based vaccine than with the original vaccine. Moderna recently released some information on a two-component Omicron plus original booster vaccine. The Omicron (BA.1) neutralizing antibody levels induced were higher than when the original vaccine was used by itself but, again, by less than two-fold. In contrast, Pfizer showed data at the VRBPAC meeting indicating that its two-component vaccine actually performed less well than an Omicron-only booster. Even allowing for the nature of very early data, the story on two-component vaccines is far from clear.
What do an approximately twofold higher level of neutralizing antibodies mean in practice? Is an Omicron-based booster sufficiently superior to the standard one to justify a switch?
That kind of twofold difference is, for example, similar to the modestly greater peak in neutralizing antibodies triggered by the first two doses of the Moderna vaccine compared with the Pfizer vaccine. Those two vaccines provided almost identical protection against mild and severe Covid-19, although the benefits of the Pfizer vaccine waned a bit quicker over time.
We would all gain from having more insights into the performance of the Omicron-based Covid-19 vaccines. The full datasets from all the variant booster trials should now be analyzed using the best available models to provide an informed judgement about whether — and to what extent — the slightly superior neutralizing antibody response to Omicron-based boosters translates into significantly greater protection against BA.4/BA.5-mediated infections and severe or fatal disease.
Moderna and Pfizer executives have claimed that the Omicron vaccines will be protective for longer. That may be true, but how long is longer? A few weeks? A month or two? Again, detailed modeling of the data might provide important information. It’s important to be sure that changing the booster vaccine to include the Omicron sequence offers enough of an advantage to justify the cost and complexity associated with making the switch.
The reason why the Omicron and earlier variant boosters are little or no better than a standard booster is rooted in immunology. The immune system responds to the first sight of the viral spike protein by making neutralizing antibodies and by starting to lay down memory cells that are an archive of what it is seeing. Those memory cells improve over a multi-month period and are then triggered into action when the immune system reencounters the spike protein, either as an infection or in a booster vaccination. The resulting neutralizing antibody response doesn’t appear to depend very much on whether the boost was with the original sequence, the Beta sequence, the Delta sequence, or the Omicron sequence — all are about equally as good at reawakening immune memory cells. The Omicron vaccines also seem to elicit some neutralizing antibodies that are unique to that variant and that make a minor contribution to the overall response. It’s possible that component could improve over time or after additional boosts, but we have no data to evaluate.
Because no one can predict how SARS-CoV-2 will further evolve, there’s no way to tell whether one or more Omicron-based boosts over the next year would be beneficial against what may emerge. What is known is that the increasingly prevalent BA.4 and BA.5 variants are even more resistant to neutralizing antibodies, typically by three- or four-fold, than the now-vanished BA.1 variant on which the Omicron vaccines are based. The trend toward greater resistance of neutralizing antibodies may well worsen.
Some experts have suggested that a booster should be based not on the BA.1 sequence but on BA.4/BA.5 sequences. To do that in a relevant time frame would mean foregoing clinical trials to obtain immunogenicity data. A reasonable assumption is that a booster based on BA.4/BA.5 would be better tailored to those now dominant strains. Nonetheless, the increase in neutralizing antibodies over the standard vaccine boost may still be only modest — probably on par with what’s being seen with the BA.1 boosters.
If an Omicron-based booster provides little advantage over the vaccine stocks that already exist, is it worth the switch? Making and rolling out an entirely new supply of Covid-19 vaccines on a nationwide basis is no trivial matter, particularly when Congress seems reluctant to provide the funds. Would the country be better off using the available resources to accelerate the creation of next-generation vaccines that can produce neutralizing antibodies in amounts high enough to deal with most variants? Or vaccines that can be delivered into the nose, a route that may provide stronger protection against infection? Strategic decisions of this nature require a deep dive into the immunology of how vaccines work; and the use of sophisticated models on neutralizing antibody actions.
Vaccines remain of critical importance at this stage of the pandemic. We strongly urge that everyone who needs a vaccine dose gets one, particularly never-vaccinated people who have been fooled by distortions about vaccine safety. But it’s important to understand what vaccines can and cannot now do, and what any composition switch really means for protection against Covid-19.
Perhaps researchers will learn that particularly vulnerable people, like those who are older or sicker, might benefit sufficiently to justify the use of an Omicron-based booster, but the wider population would not. Decisions could be tailored to specific sub-populations.
Whatever the decision, Americans will need to receive accurate information about how the new boosters perform against mild infections and virus transmission. It isn’t likely that an Omicron-based booster will be a magic bullet, although it might be perceived that way. It is essential to avoid offering people a false sense of security. Those who recently received an Omicron booster should not think they are now bulletproof against SARS-CoV-2 and increase their infection risk by altering their behavior. There are signs that behavioral changes may already be visible in infection statistics from the Centers for Disease Control and Prevention.
A multibillion-dollar decision to launch a vaccine based wholly or in part on the BA.1, BA.4, or BA.5 sequence that would affect more than 100 million people need not be unduly rushed. A decision of this magnitude should be based on as much expertise and analysis as is reasonably practical. Our joint concern is that this may not be what happens in the coming days, when the FDA will likely accept the majority advice given by its advisory committee without fully weighing what the exact composition of the new vaccine should be, and assessing whether it confers significant advantages over the current vaccine. Using an additional week or two to obtain more input seems a prudent step to take.
John P. Moore is a professor of microbiology and immunology at Weill Cornell Medicine in New York City. Paul A. Offit is a pediatrician, professor of pediatrics, and director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, and a member of the FDA’s Vaccines and Related Biological Products Advisory Committee.
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A viral reprise: When COVID-19 strikes again and again
For New York musician Erica Mancini, COVID-19 made repeat performances. March 2020. Last December. And again this May.
apnews.com
BOLDING MINE (because Geert would have a response for all the bolded parts - unlike the baffled scientitsts in this article)
A viral reprise: When COVID-19 strikes again and again
By LAURA UNGAR
yesterday
For New York musician Erica Mancini, COVID-19 made repeat performances.
March 2020. Last December. And again this May.
“I’m bummed to know that I might forever just get infected,” said the 31-year-old singer, who is vaccinated and boosted. “I don’t want to be getting sick every month or every two months.”
But medical experts warn that repeat infections are getting more likely as the pandemic drags on and the virus evolves – and some people are bound to get hit more than twice. Emerging research suggests that could put them at higher risk for health problems.
There’s no comprehensive data on people getting COVID-19 more than twice, although some states collect information on reinfections in general. New York, for example, reports around 277,000 reinfections out of 5.8 million total infections during the pandemic. Experts say actual numbers are much higher because so many home COVID-19 tests go unreported.
Several public figures have recently been reinfected. U.S. Health and Human Services Secretary Xavier Becerra and Canadian Prime Minister Justin Trudeau said they got COVID-19 for the second time, and U.S. Sen. Roger Wicker of Mississippi said he tested positive a third time. All reported being fully vaccinated, and Trudeau and Becerra said they’d gotten booster shots.
COVID-19
“Until recently, it was almost unheard of, but now it’s becoming more commonplace” to have COVID-19 two, three or even four times, said Dr. Eric Topol, head of Scripps Research Translational Institute. “If we don’t come up with better defenses, we’ll see much more of this.”
Why? Immunity from past infections and vaccination wanes over time, experts say, leaving people vulnerable.
Also, the virus has evolved to be more contagious. The risk of reinfection has been about seven times higher with omicron variants compared with when delta was most common, research out of the United Kingdom shows. Scientists believe the omicron mutants now causing the vast majority of U.S. cases are particularly adept at getting around immunity from vaccination or past infection, especially infection during the original omicron wave. U.S. health officials are mulling whether to modify boosters to better match recent changes in the coronavirus.
The first time Mancini got COVID-19, she and her fiancé spiked fevers and were sick for two weeks. She couldn’t get tested at the time but had an antibody test a couple months later that showed she had been infected.
“It was really scary because it was so new and we just knew that people were dying from it,” said Mancini. “We were really sick. I hadn’t been sick like that in a long time.”
She got vaccinated with Pfizer in the spring of 2021 and thought she was protected from another infection, especially since she was sick before. But though such “hybrid immunity” can provide strong protection, it doesn’t guarantee someone won’t get COVID-19 again.
Mancini’s second bout, which happened during the huge omicron wave, started with a sore throat. She tested negative at first, but still felt sick driving to a gig four hours away. So she ducked into a Walgreens and did a rapid test in her car. It was positive, she said, “so I just turned the car around and drove back to Manhattan.”
This bout proved milder, with “the worst sore throat of my life,” a stuffy nose, sneezing and coughing.
The most recent illness was milder still, causing sinus pressure, brain fog, a woozy feeling and fatigue. That one, positive on a home test and confirmed with a PCR test, hit despite her Moderna booster shot.
Mancini doesn’t have any known health conditions that could put her at risk for COVID-19. She takes precautions like masking in the grocery store and on the subway. But she usually doesn’t wear a mask on stage.
“I’m a singer, and I’m in these crowded bars and I’m in these little clubs, some of which don’t have a lot of ventilation, and I’m just around a lot of people,” said Mancini, who also plays accordion and percussion. “That’s the price that I’ve paid for doing a lot throughout these past few years. It’s how I make my living.”
Scientists don’t know exactly why some people get reinfected and others don’t, but believe several things may be at play: health and biology, exposure to particular variants, how much virus is spreading in a community, vaccination status and behavior. British researchers found people were more likely to be reinfected if they were unvaccinated, younger or had a mild infection the first time.
Scientists also aren’t sure how soon someone can get infected after a previous bout. And there’s no guarantee each infection will be milder than the last.
“I’ve seen it go both ways,” said Dr. Wesley Long, a pathologist at Houston Methodist. In general, though, breakthrough infections that happen after vaccination tend to be milder, he said.
Doctors said getting vaccinated and boosted is the best protection against severe COVID-19 and death, and there’s some evidence it also lessens the odds of reinfection.
At this point, there haven’t been enough documented cases of multiple reinfections “to really know what the long-term consequences are,” said Dr. Peter Hotez, dean of Baylor University’s tropical medicine school.
But a large, new study using data from the U.S. Department of Veterans Affairs, which hasn’t yet been reviewed by scientific peers, provides some insight, finding that reinfection increases the risk for serious outcomes and health problems such as lung issues, heart disorders and diabetes compared with a first infection. The risks were most pronounced when someone was ill with COVID-19, but persisted past the acute illness as well.
After Mancini’s last bout, she dealt with dizziness, headaches, insomnia and sinus issues, though she wondered if that was more due to her busy schedule. In a recent week, she had 16 shows and rehearsals — and has no room for another COVID-19 reprise.
“It was not fun,” she said. “I don’t want to have it again.”
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Health officials plan for updated vaccines with an eye on COVID’s unpredictability
Updated COVID-19 vaccines that could better match the more recent variants are on the way. On Tuesday, the U.S. Food and Drug Administration's committee of independent advisors met and recommended that the vaccines should target the latest omicron variant, kicking off the process for...
Health officials plan for updated vaccines with an eye on COVID’s unpredictability
SONY SALZMAN and CHEYENNE HASLETT - GMA
Wed, June 29, 2022, 8:08 AM·5 min read
Updated COVID-19 vaccines that could better match the more recent variants are on the way.
On Tuesday, the U.S. Food and Drug Administration's committee of independent advisors met and recommended that the vaccines should target the latest omicron variant, kicking off the process for distribution of the new vaccines this fall.
That could be good news for the fight against the virus. But the next few months hold a lot of uncertainty.
Many vaccine scientists agree that as the virus evolves, vaccines should be updated along with it. But scientists caution that planning ahead in this pandemic is challenging. A new variant could emerge by the fall, rendering even new vaccines old by then.
There's also a question of how many people will get the shot -- both because the government doesn't have enough funding to secure vaccines for everyone, and because less than half of eligible Americans have received their first booster shots.
That said, the vaccine companies have been testing different strategies for a new-and-improved booster shot.
On Tuesday, the FDA's advisers reviewed the data and favored a bivalent vaccine -- a type of vaccine that targets two strains of virus in the same shot. They recommended that it include the latest omicron subvariant and the original strain, generally supporting it because it could protect more broadly against future variants.
FDA leadership will announce the final decision sometime in early July, incorporating the advisers' discussion from Tuesday.
Health officials are aiming to roll out the newly designed vaccines in early October, said Dr. Peter Marks, who oversees the FDA's vaccine department.
The goal is to get ahead of a potential surge next winter.
"That combination of waning immunity, combined with the potential emergence of novel variants during a time this winter when we will move inside as a population, increases our risk of a major COVID-19 outbreak," Marks said.
"And for that reason, we have to give serious consideration to a booster campaign this fall to help protect us during this period from another COVID-19 surge," he said.
How much better will the new vaccines be?
Scientists cautioned that existing vaccines are still working well to prevent severe illness.
And while newer shots will help, they might not be significantly better at preventing more mild breakthrough illness.
MORE: Evolution is on omicron subvariants' side
"It will be better than what we have now, but I don't think we are going to see 94% again," said Dr. Paul Goepfert, professor of medicine at the University of Alabama at Birmingham.
The current vaccines, designed to match the original Wuhan virus, initially showed efficacy of 94% -- but that's now thought to be an untenable goal because of rapidly-evolving new variants, Goepfert said.
"It's essentially an arms race," said Dr. Dan Barouch, author on the recent study and director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. "As the population becomes more immune, the virus becomes more and more immune evasive."
Updated vaccines "will be helpful," Barouch said, but are unlikely to be a "game changer" that end the need for future boosters.
The political snag getting in the way
The other major caveat to the rollout of new vaccines this fall is funding -- the battle over which has been stuck in a stalemate on Capitol Hill since the winter.
The White House has since pulled funds out of COVID test manufacturing and put it toward contract negotiations for the newest vaccines, but the decision leaves the US vulnerable to a testing shortage, and still doesn't fully do the job.
"It's very clear we're not going to have enough vaccines for every adult who wants one," Dr. Ashish Jha, the White House's COVID coordinator, said last week.
Jha called the decision to move money away from testing "incredibly painful," but necessary to avoid missing out on orders entirely as other countries placed theirs.
"Contract negotiators on behalf of the US government are going to enter into contract negotiations with Moderna and Pfizer with the resources that we've been able to … cobble together for vaccines for the fall," Jha said.
The government will purchase enough for high-risk Americans to get the latest vaccines, Jha said.
But it's unclear how the rest of the population will get access to the vaccines. On one hand, demand for vaccines has continued to drop since the initial doses. If that trend continues and fewer people want a vaccine, it's possible that the government's smaller order could still cover people who want one.
And some experts don't think everyone will need a booster in the fall, like Dr. Paul Offitt, the director of the Vaccine Education Center at Children's Hospital of Philadelphia, who said he thinks re-upping antibody levels ahead of a likely winter surge would be beneficial for high-risk groups, but not necessary for everybody.
Another option is for insurance companies to step in and cover vaccines, rather than the government distributing them for free. Jha dismissed this option, though, calling it too soon to switch to the private market because there's still too much competition for ordering doses among countries and insurance companies wouldn't have enough leverage.
"There is not a commercialization plan that somehow would be ready in time for this fall and winter," Jha said.
Yet vaccine companies have indicated that they're ready to distribute their vaccines through insurance companies and won't leave the American market behind.
Though it's still months away, both the White House and the vaccine companies have committed to devising a plan as fall draws closer.
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Millions remain unboosted, as scientists say 3rd COVID shot provides 'significant' protection
Older Americans — people over 50 — have proven to be more likely to receive their first COVID-19 booster.
abcnews.go.com
Millions remain unboosted, as scientists say 3rd COVID shot provides 'significant' protection
Older Americans have been more likely to receive their first COVID-19 booster.
By Arielle Mitropoulos
June 28, 2022, 2:12 PM
As advisors to the FDA consider what type of COVID-19 shots should be offered in the fall, new federal data reveals a significant proportion of Americans have yet to receive their first and second boosters.
In May, federal officials authorized the use of COVID-19 boosters for children ages 5 to 11 years-old. However, now, nearly six weeks later, fewer than 10% of those eligible — representing just 1.7% of the age group — have been boosted, according to data from the Centers for Disease Control and Prevention (CDC).
Booster uptake among other young populations also continues to lag, with just 28.7% of eligible adolescents ages 12-17 boosted — representing 16% of the age group — and less than 40% of eligible 18- to 49-year-olds — representing 26.5% of the age group — boosted.
"Despite strong evidence for the value of a booster in providing more complete protection, we are seeing massive confusion on the need for third and fourth shots. The slow uptake has created public health vulnerability as we face a surge from the BA4 and BA5 variants and likely a new variant this coming Fall," said Dr. John Brownstein, an epidemiologist at Boston Children's Hospital and an ABC News contributor.
Older Americans — people over 50 — have proven to be more likely to receive their first COVID-19 booster. Over 55% of the eligible 50- to 64-year-old age group, and 72% of eligible people 65 and older have received their first boost.
However, despite repeated encouragements from federal officials for the immunocompromised, as well as those over 50, to receive their second booster shot, uptake for the supplemental doses has been noticeably slower.
Since the rollout, earlier this spring, fewer than a fifth of eligible people ages 50 to 64 have received their second boost -- only about 8% of the age group. Uptake is a bit higher among the elderly, with 35% of those eligible — representing just 20% of the age group.
In May, the CDC announced that it is "strengthening" its recommendation for Americans over the age of 12 who are immunocompromised and those over the age of 50 receive their second booster shot.
"While older Americans have the highest coverage of any age group of first booster doses, most older Americans received their last dose (either their primary series or their first booster dose) many months ago, leaving many who are vulnerable without the protection they may need to prevent severe disease, hospitalization, and death," the CDC wrote in a press release last month.
Health experts suggest that some booster uptake may increase in the fall, should a new generation of vaccines be made available.
"Muddled booster messaging has placed many Americans into a wait and see category, given the prospects for a more well-matched vaccine. While the current booster campaign has likely stalled out, it doesn’t mean we won’t see higher uptake when a vaccine that targets Omicron variants becomes available," Brownstein said.
https://abcnews.go.com/Health/cdc-urges-2nd-booster-older-high-risk-americans/story?id=84857477
During a presentation to the FDA's independent advisory committee, Vaccines and Related Biological Products Advisory Committee (VRBPAC), scientists outlined data showing that vaccine effectiveness with the current COVID-19 shots continues to wane with the latest variants.
However, a third COVID-19 dose was not only found to provide "significant" additional protection against infection and severe disease, but effectiveness also appeared to wane more slowly.
Although officials said it is still too early to draw conclusions about the protection provided by a second booster, the additional shot has been found to provide "substantial" additional protection among the immunocompromised.
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Evolution is on omicron subvariants’ side
"It's essentially an arms race," one expert said.
By Arielle Mitropoulos and Sony Salzman
June 27, 2022, 4:32 PM
A new study finds that as the coronavirus continues to evolve, each new omicron subvariant is increasingly likely to lead to reinfection or breakthrough infection. However, researchers say current vaccines are still doing a good job of protecting people against severe illness.
Meanwhile, vaccine makers are working on new and improved boosters that will hopefully be a better match against omicron and its subvariants. Food and Drug Administration advisers are slated to meet on June 28 to discuss the new booster shots.
https://abcnews.go.com/Health/find-covid-vaccines-children-age/story?id=85541037
The new study, published in the New England Journal of Medicine, echoes prior studies, and the finding is consistent with what we're seeing in the real world. Working in a laboratory, researchers measured neutralizing antibody response against the original Wuhan variant, compared to the new omicron variant and many of its sub variants.
Antibody levels are one measure of immune response, and often used as a rough indication of a variant's ability cause reinfection or breakthrough infection. Other parts of your immune system, like T-cells, are harder to measure but are a much better indicator of how well protected you are against severe disease.
Researchers found neutralizing antibody levels were six-fold lower against the original omicron variant, fourteen-fold lower against BA.2.12.1, and twenty-fold lower against BA.4/BA.5.
The BA.2.12.1 sub variant is currently dominant in the U.S., but the BA.4/BA.5 sub variants have been growing proportionally and now account for more than a third of estimated cases.
"It's essentially an arms race," said Dr. Dan Barouch, author on the recent study and director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. "As the population becomes more immune, the virus becomes more and more immune evasive."
The good news, said Barouch, is current vaccines are still working to dramatically reduce the risk of severe disease. "That's the most important goal of vaccination."
"It's essentially an arms race," one expert said.
By Arielle Mitropoulos and Sony Salzman
June 27, 2022, 4:32 PM
A new study finds that as the coronavirus continues to evolve, each new omicron subvariant is increasingly likely to lead to reinfection or breakthrough infection. However, researchers say current vaccines are still doing a good job of protecting people against severe illness.
Meanwhile, vaccine makers are working on new and improved boosters that will hopefully be a better match against omicron and its subvariants. Food and Drug Administration advisers are slated to meet on June 28 to discuss the new booster shots.
https://abcnews.go.com/Health/find-covid-vaccines-children-age/story?id=85541037
The new study, published in the New England Journal of Medicine, echoes prior studies, and the finding is consistent with what we're seeing in the real world. Working in a laboratory, researchers measured neutralizing antibody response against the original Wuhan variant, compared to the new omicron variant and many of its sub variants.
Antibody levels are one measure of immune response, and often used as a rough indication of a variant's ability cause reinfection or breakthrough infection. Other parts of your immune system, like T-cells, are harder to measure but are a much better indicator of how well protected you are against severe disease.
Researchers found neutralizing antibody levels were six-fold lower against the original omicron variant, fourteen-fold lower against BA.2.12.1, and twenty-fold lower against BA.4/BA.5.
The BA.2.12.1 sub variant is currently dominant in the U.S., but the BA.4/BA.5 sub variants have been growing proportionally and now account for more than a third of estimated cases.
"It's essentially an arms race," said Dr. Dan Barouch, author on the recent study and director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston. "As the population becomes more immune, the virus becomes more and more immune evasive."
The good news, said Barouch, is current vaccines are still working to dramatically reduce the risk of severe disease. "That's the most important goal of vaccination."
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I just recovered from BA.2. Can I get BA.4/5?
As new omicron variants gain a foothold, here’s what to expect.
abcnews.go.com
I just recovered from BA.2. Can I get BA.4/5?
As new omicron variants gain a foothold, here’s what to expect.
ByKristina Fiore | Medpage Today
June 21, 2022, 5:07 AM
Most people who have been infected with COVID-19 in the U.S. in the past couple of months likely had the BA.2 or BA.2.12.1 variant, both lineages of the original omicron strain of SARS-CoV-2. Now, BA.4 and BA.5 are here, and they're starting to make up a larger proportion of U.S. cases.
So if someone was recently infected with a BA.2 lineage, are they mostly protected against reinfection with BA.4 or BA.5?
Probably not, infectious disease experts say.
"It's expected that there's probably not much cross-protection between them," Amesh Adalja, MD, an infectious disease physician at the Johns Hopkins Center for Health Security in Baltimore, told MedPage Today.
Adalja said it essentially comes down to the number and type of mutations in the receptor binding domain of the spike protein. There's an "abundance" of important mutations, he said, which doesn't bode well for protection against reinfection.
"That's what you expect with this viral family," Adalja said. "The virus is going to be able to continue to evolve to reinfect us at will."
James Lawler, MD, MPH, of the University of Nebraska Medical Center's Global Center for Health Security in Omaha, said predicting reinfection with BA.4 or BA.5 after BA.2 is "mostly educated guesses at this point," but there are "some historical data, data from epidemiological studies, and lab studies of neutralizing antibodies" that help inform what will happen with these two new variants.
It's unlikely that someone who was recently infected by a BA.2 lineage will be reinfected with that lineage, Lawler said.
"Those antibody studies seem to be pretty consistent. We don't have great correlation of immunity between antibody levels and protection, but as a general rule, studies have shown that high titers of neutralizing antibodies generally predict higher levels of protection."
Lawler said it's "quite likely and highly predictable that people who were infected with BA.2 will be susceptible to infection with BA.4 or BA.5, and that susceptibility will grow as time goes on, as you get further away from your prior infection."
Adalja agreed that reinfection with BA.4 or BA.5 likely will be dependent on time since last infection -- though the durability of protection may be getting shorter, he noted.
Earlier in the pandemic, he said, there were "several months where it was unlikely you'd be reinfected. Then omicron occurred and people who had delta recently were able to get omicron within weeks of recovery, and the same is happening now."
"It depends on the variant," he said. Protection against reinfection "would be expected to be months if there are no immune-evasive changes. Now, it's probably a matter of weeks to a month."
He cautioned that there are no definitive studies to pin down the durability of immunity after infection with the BA.2 lineages, and it "probably varies from person to person" -- by age and by the type of immunity, whether it's "natural," hybrid, or vaccine-induced immunity, for instance.
What about getting reinfected with BA.5 after recovering from BA.4, or vice versa? While there are even fewer data to help answer that question, Adalja noted that BA.4 and BA.5 share some key mutations, and they're "more related to each other than they are to the other Omicron sublineages," so there may be less of a chance of reinfection.
Lawler said the differences in the variants within the Omicron lineage are vast, and that some experts argue they should be designated with their own Greek letters.
"BA.2 is as different from BA.1 as delta was from Alpha ... in terms of the number and types of mutations," Lawler said. "I think they're different enough that we need to be treating them as if they're completely distinct variants."
Substantial genetic changes in SARS-CoV-2 shouldn't come as a surprise, Adalja said, because that's just how coronaviruses behave. The key is being able to face new variants with the best possible protection, including vaccination, boosters, and antivirals.
"In general, we should expect reinfection," he said. "It's really about making sure reinfections are mild."
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China will stick to its 'zero Covid' strategy even if it hurts the country's economy, Xi Jinping says
"Our country has a large population. Such strategies as 'herd immunity' and 'lying flat' would lead to consequences that are unimaginable," Xi said.
China will stick to its 'zero Covid' strategy even if it hurts the country's economy, Xi Jinping says
Waiyee Yip - Business Insider
Thu, June 30, 2022, 12:10 AM
- China will continue sticking to its "zero Covid" policy, Chinese President Xi Jinping said Tuesday.
- This is despite the economic risks that come with the strategy, he added during a visit to Wuhan.
- He said taking a "herd immunity" approach in China could lead to "unimaginable" consequences.
"We would rather temporarily affect a little economic development than risk harming people's life safety and physical health, especially the elderly and children," he said during a visit to Wuhan, the city where COVID-19 was first detected, per state news agency Xinhua.
"Our country has a large population. Such strategies as 'herd immunity' and 'lying flat' would lead to consequences that are unimaginable," he continued. Both herd immunity as well as "lying flat" — Chinese slang for doing the bare minimum — refers to strategies that involve living with the virus.
Xi also reaffirmed China's "zero Covid" policy last month, calling it "scientific and effective."
China's strategy, which involves sudden lockdowns and mass testing, was largely successful at the start of the pandemic, with citizens enjoying relatively normal lives while the rest of the world struggled to contain Covid outbreaks.
The country's Covid death toll of 14,625 is also low compared to other countries. The US, for example, has recorded more than 1 million Covid deaths.
However, China's recent attempts to completely stamp out the coronavirus have proven ineffective due to the highly transmissible Omicron variant — and citizens are losing patience.
For instance, the authorities' chaotic handling of Shanghai's Covid outbreak in April and May — including a harsh policy that separated parents from their Covid-positive children — has led to widespread anger and frustration.
Last month, the World Health Organization head, Dr. Tedros Adhanom Ghebreyesus, said China's "zero Covid" strategy was "not sustainable," in a rare criticism of a government's handling of the virus.
Read the original article on Business Insider
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Macau COVID infections rise as spread extends to medics, police
by Farah Master
Wed, June 29, 2022, 9:08 PM
HONG KONG (Reuters) - Authorities in the world's biggest gambling hub Macau are scrambling to contain the city's biggest coronavirus outbreak since the pandemic began, requiring all residents test daily and stay home as much as possible.
Health, police and fire services staff are among the 533 infected cases, the government said on Wednesday night as it urged residents to test daily for the virus using Rapid Antigen kits.
The Chinese special administrative region carried out three city-wide mass coronavirus tests for its more than 600,000 residents in the space of a week. More than 7,000 people are in mandatory quarantine.
Sands China's Sheraton hotel located on Macau's Las Vegas style Cotai strip has allocated 2,000 rooms to asymptomatic patients.
More than 20 zones across the city are locked down as authorities try to cut the chains of transmission for the rapidly spreading BA.5.1 Omicron variant.
Authorities have asked people to remain at home as much as possible with most of the city effectively closed, including bars, hair salons and outdoor parks. Only takeaway is allowed from dining facilities.
Casinos, while mostly deserted, are allowed to stay open, the city's government said, in a move to protect local jobs.
The stringent measures come after Macau has been largely COVID-free since an outbreak in October 2021.
Macau adheres to China's "zero COVID" policy which aims to eradicate all outbreaks, at just about any cost, running counter to a global trend of trying to co-exist with the virus.
Macau's cases are still far below daily infections in other places, including neighbouring Hong Kong where cases have jumped to close to 2,000 a day this month.
Macau only has one public hospital with its services already stretched on a daily basis. The territory has an open border with mainland China, with many residents living and working in the adjoining city of Zhuhai.
by Farah Master
Wed, June 29, 2022, 9:08 PM
HONG KONG (Reuters) - Authorities in the world's biggest gambling hub Macau are scrambling to contain the city's biggest coronavirus outbreak since the pandemic began, requiring all residents test daily and stay home as much as possible.
Health, police and fire services staff are among the 533 infected cases, the government said on Wednesday night as it urged residents to test daily for the virus using Rapid Antigen kits.
The Chinese special administrative region carried out three city-wide mass coronavirus tests for its more than 600,000 residents in the space of a week. More than 7,000 people are in mandatory quarantine.
Sands China's Sheraton hotel located on Macau's Las Vegas style Cotai strip has allocated 2,000 rooms to asymptomatic patients.
More than 20 zones across the city are locked down as authorities try to cut the chains of transmission for the rapidly spreading BA.5.1 Omicron variant.
Authorities have asked people to remain at home as much as possible with most of the city effectively closed, including bars, hair salons and outdoor parks. Only takeaway is allowed from dining facilities.
Casinos, while mostly deserted, are allowed to stay open, the city's government said, in a move to protect local jobs.
The stringent measures come after Macau has been largely COVID-free since an outbreak in October 2021.
Macau adheres to China's "zero COVID" policy which aims to eradicate all outbreaks, at just about any cost, running counter to a global trend of trying to co-exist with the virus.
Macau's cases are still far below daily infections in other places, including neighbouring Hong Kong where cases have jumped to close to 2,000 a day this month.
Macau only has one public hospital with its services already stretched on a daily basis. The territory has an open border with mainland China, with many residents living and working in the adjoining city of Zhuhai.
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Elmo talks about getting COVID vaccine; Ted Cruz has a problem with that
Cruz first thanked Sesame Street for showing a parent asking questions about the vaccine, but then turned his attention to Elmo.
Elmo talks about getting COVID vaccine; Ted Cruz has a problem with that
Christopher Brito - CBS News
Wed, June 29, 2022, 5:47 PM·2 min read
Sesame Street released a public service ad on Tuesday of Elmo talking about getting vaccinated against COVID-19. Texas Republican Senator Ted Cruz was not a fan.
The video shows the beloved children's Muppet chatting with his father, Louie, after receiving the vaccine, saying he felt a "little pinch," but that it was "OK." After wondering himself about Elmo getting the COVID-19 shot, Louie said he talked to their pediatrician so he could "make the right choice."
"I learned that Elmo getting vaccinated is the best way to keep himself, our friends, our neighbors and everyone else healthy and enjoying the things they love," Louie said.
On Wednesday, Cruz first thanked Sesame Street for showing parents asking questions about the vaccine, but then turned his attention to Elmo, a character who is perpetually 3 years old.
"You then have @elmo aggressively advocate for vaccinating children UNDER 5. But you cite ZERO scientific evidence for this," Cruz wrote, adding a link to his website.
Thanks, @sesamestreet for saying parents are allowed to have questions!You then have @elmo aggressively advocate for vaccinating children UNDER 5. But you cite ZERO scientific evidence for this. Learn more:https://t.co/Ss20TmFTSB https://t.co/tr67QyfRyC
— Ted Cruz (@tedcruz) June 28, 2022
Less than two weeks ago, the CDC and FDA cleared the way for some 20 million babies, toddlers and preschoolers — children under the age of 5 — to be eligible for COVID-19 vaccines.
Sesame Workshop, the nonprofit organization that runs Sesame Street, said in a statement that the clip — available in both Spanish and English — was produced in partnership with the CDC and the American Academy of Pediatrics. The video was just the latest in a series of spots that have featured Sesame Street Muppets promoting COVID-19 vaccination.
"Many parents understandably have questions about the COVID-19 vaccines for young children, and we want to encourage them to ask questions and seek out information. With help from Elmo and his dad Louie, we want to model real conversations, encourage parents' questions, and help children know what to expect," said Dr. Jeanette Betancourt, senior vice president of U.S. social impact at Sesame Workshop.
It's not the first time Cruz has had a beef with a Sesame Street Muppet. After Big Bird tweeted in November that he received his COVID-19 shot, Cruz took a swipe at him and called the tweet "propaganda."
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In California, vaccines closed gap in Covid-related deaths for Latinos
A new study found the gap between the number of Latino deaths from Covid compared to whites has been significantly narrowed in California through vaccines.
In California, vaccines closed gap in Covid-related deaths for Latinos
Zachary Schermele - NBC News
Wed, June 29, 2022, 1:08 PM
A new data analysis from the Public Policy Institute of California shows that the major racial and ethnic disparities in Covid-related deaths experienced by Latinos in California at the height of the pandemic have significantly narrowed.
In January 2021, the monthly death rate for Latinos over 18 in California was 55 per 100,000 — the highest of any racial and ethnic group — according to the California Department of Public Health. The death rate for white Californians during the same period was 38 per 100,000.
By this month, as monthly Covid-related death rates had significantly decreased overall due to increased vaccinations, the rate for Latinos had fallen to about 1 per 100,000 — below that of white Californians, whose death rate is about 2.5 per 100,000.
The latest vaccination rate according to the California Centers for Disease Control and Prevention is 62.1% for Hispanics 18 to 49 years old. For Latinos who are 50 and over, the rates are in the 70% range.
Shannon McConville, a research fellow with the policy institute who wrote the analysis, said that as California rolled out its vaccination campaign, an “exacerbation of disparities” would have been possible. Equity gaps narrowed, however, in part thanks to efforts focused on putting equity at the center of the vaccination campaign, she said.
“In terms of accessing vaccines, I think California made efforts to try and prevent that, or to try and have equity be part of the vaccine rollout,” she said.
In December 2020, the California Department of Health released a “health equity playbook” for counties in the state. The 73-page document acknowledged the effects of structural racism on the access of marginalized communities to employment, housing and “quality health care.” It also pointed to the overrepresentation of low-income communities of color, who have less access to paid leave and other forms of virus prevention, in the essential workforce.
The strategy highlighted successful examples of equity-focused mitigation strategies throughout the state. Those examples included Northern California’s Sonoma County, which created a group that contracted with community-based providers to improve Covid and vaccine-related case management and response among Latinos and farming communities. Kings County, in the central part of the state, also set aside federal Covid relief money to pay for hotel rooms so essential workers could isolate during the pandemic.
The equity gap in Covid-related deaths between white and Latino Californians started to close for the first time in July 2021, according to a study published in February the Journal of General Internal Medicine. The researchers who wrote the study, from several California universities, attributed the decline to a number of factors, including immunity from vaccines and previous infection.
The decline in California is consistent with national trends. As of May 21, which shows the latest available CDC data without a six-week reporting delay, the Covid-related death rate for Hispanics of all ages was 0.14 per 100,000 people. The rate for the white population was 0.33.
McConville said she believes it will be important to “continue to focus on ensuring access and understanding how to get more people vaccinated and protected.”
“We really need to continue to keep that equity lens in mind as we continue to have people be boosted, as the virus evolves,” she said.
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Zerohedge
ZeroHedge - On a long enough timeline, the survival rate for everyone drops to zero
www.zerohedge.com
BOLDING IN ORIGINAL (not mine)
Fauci Suffers "Much Worse" COVID Symptoms After 'Paxlovid Rebound'
by Tyler Durden
Wednesday, Jun 29, 2022 - 11:45 AM
Fully-vaxx'd and double-boosted mask-admirer Anthony Fauci is suffering.
Two weeks ago, we reported that President Biden's chief medical adviser had COVID.
The 81-year-old reportedly had 'mild symptoms' and of course he 'said the words'...
Of course, Fauci followed the CDC guidelines and ingested the government-blessed treatment - Paxlovid - due to his age and possible risks from the virus.
So, that should have been it right?
But no. During an event at Foreign Policy’s Global Health Forum, Fauci admitted he had not had a good experience:
“After I finished the five days of Paxlovid, I reverted to negative on an antigen test for three days in a row,” Fauci said Tuesday.
“And then on the fourth day, just to be absolutely certain, I tested myself again. I reverted back to positive.”
Interestingly, Fauci admitted:
"...this is becoming more and more typical based on more clinical studies..."
As Bloomberg reports, large numbers of patients have reported the phenomenon, often called Covid rebound or Paxlovid rebound, of returning symptoms after taking a full course of Pfizer’s drug.
While Pfizer Chief Executive Officer Albert Bourlasaid in May that doctors could prescribe a second course of treatment to such patients, US drug regulators have said there’s no evidence that a repeat will help.
However, Fauci said he started taking a second course of Paxlovid after experiencing symptoms “much worse than in the first go around.”
Now near completion of the five-day oral treatment, he said he was still enduring symptoms but felt “reasonably good.”
Finally, as we reported less than two weeks ago, Pfizer stopped enrolling in a clinical trial for Paxlovid for standard-risk COVID-19 patients after the latest results suggested the drug did not reduce symptoms or hospitalizations and deaths to a statistically significant degree.
Watch the full interview below: (forward to around 5:26:00):
6 hr 03 min 33 sec
Not exactly encouraging news...
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The Simple But Forgotten Open Air Factor in Infection Control
www.theepochtimes.com
The Simple But Forgotten Open Air Factor in Infection Control
By Steve Milne
June 29, 2022
Documented in medical journals for almost two centuries but seemingly forgotten nowadays, breathing fresh outdoor air could be key to defending against airborne bacteria and viruses, including COVID-19, a leading infectious disease expert from the Australian National University (ANU) suggests.
Professor Peter Collignon, a co-author of a paper on the subject, said in a release on Wednesday that outdoor air has germicidal properties that can dilute and limit the spread of pathogens and even kill airborne viruses.
“This is why being outdoors helps protect people from contracting COVID-19,” he said.
The infectious diseases physician and microbiologist said that the pathogen-fighting agent in outdoor air—known as the Open Air Factor—is continually neglected in public health as a form of infection control, despite documented evidence of “open-air therapy” being utilised to treat tuberculosis in the first decade of the 20th century, as well as treat soldiers’ infected wounds during the First World War.
Collignon stressed that from the end of the 19th century to the middle of the 20th century, it was widely believed that outdoor air had disinfecting and therapeutic properties.
“During the First World War, a British surgeon found that putting patients outside and then leaving their infected wounds open to fresh air greatly improved recovery. In two or three days, the wounds lost their odour and began to look clean again,” Collignon said.
In addition, the paper points out that during the 1918-19 influenza pandemic, patients nursed outdoors reportedly recovered in greater numbers than those indoors in hospital wards.
Rediscovering the Benefits of OAF in Infection Control
While it is currently unclear how to preserve the health benefits of outdoor air in indoor spaces like hospitals and public areas, Collignon is calling on medical authorities to commission research into whether it is possible and, if so, how it might be achieved.
“This could potentially include rediscovering open-air wards, such as during the First World War, to help patients and staff in hospitals, or finding new ways to improve indoor ventilation techniques with fresh air from outside,” he said.
“The OAF will likely also help in reducing the transmission of many infections in schools, homes, offices, and larger buildings.”
Collignon went on to say that several decades ago, hospitals and other buildings were designed to prevent infections from spreading, whereas today, they are not.
“For example, windows are smaller, ceilings are lower, cross ventilation can be difficult if not impossible, and balconies and verandas are not as common as they once were,” he said.
“Fresh air is no longer considered to be germicidal or therapeutic for hospital patients or, for that matter, anyone else. It is perhaps time to examine how we used to design and ventilate buildings for health. If this is ignored, just as the OAF continues to be, the costs to society could be large.”
Recommendations for Research
Collignon’s paper outlines a number of recommendations for further investigation into the benefits of OAF, including a program of testing the effect of OAF on established and novel pathogens, experiments to determine if and for how long the OAF can be preserved indoors, and a review of building design, with a focus on increased exposure and access to outside air to improve infection control and patient recovery.
“But we need to also recognise that there is already sufficient evidence to show that public health generally would improve if more emphasis was placed on increased exposure to outdoor air,” the study says.
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Pfizer Vaccine for Kids Under 5 Edging Towards Approval in Australia
www.theepochtimes.com
Pfizer Vaccine for Kids Under 5 Edging Towards Approval in Australia
By Daniel Y. Teng
June 30, 2022
Australia is close to approving COVID-19 vaccinations for children aged between six months to five years after the Therapeutic Goods Administration (TGA) granted provisional determination to Pfizer.
This will be the first step to gaining registration on the Register of Therapeutic Goods for Pfizer, along with Moderna’s SpikeVax.
“Approval and potential supply in Australia would only commence should the vaccine be approved as safe and effective by the TGA and recommended for administration to this age group by the [Australian Technical Advisory Group on Immunisation],” according to a statement from the TGA.
“It does not mean an application for use in this age group has been made, and it does not mean any subsequent application would be approved.”
The body said it would carry out a “rigorous assessment” of the safety and efficacy of the vaccine.
Currently, the Pfizer vaccine has only been approved for Australian children aged five and over.
Australia Adjusting to New COVID-Normal
The country is on track to record its 10,000th death from COVID-19, with the current death toll at 9,886.
Health authorities are also concerned that the winter season could see Australians catch the virus a second time.
Dr. Kerry Chant, the chief health officer of New South Wales, said there was no evidence that new sub-variants of COVID-19 could lead to severe illness, but there was “evidence that they are better at evading the body’s immunity.”
“So it is vital that anyone who is eligible for a booster dose who hasn’t yet received it does so as soon as possible,” she said in comments obtained by AAP.
While the state government of Queensland has discarded vaccine mandates in several industries including hospitals, aged care facilities, prisons, schools, and disability accommodation.
“As we move to the next stage of the pandemic, we will be adjusting our approach in relation to mandatory vaccinations,” according to Yvette D’Ath, the Queensland health minister, in a press release.
While the Northern Territory government will soon close its Howard Springs quarantine facility.
The Howard Springs quarantine camp, also known as the Centre for National Resilience, is Australia’s largest quarantine facility and attracted international controversy when an Australian woman described her time there like being “in prison,” according to an interview with British news site UnHerd.
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Scientists Target a Human Protein To Squash COVID-19 and Other Viruses
More than two years after the COVID-19 pandemic began, people are realizing that the “new normal” will probably involve learning to co-exist with SARS-CoV-2 (the virus that causes COVID-19 disease). Some treatments are available, but with new variants emerging, researchers are looking toward new str
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Scientists Target a Human Protein To Squash COVID-19 and Other Viruses
By American Chemical Society
June 29, 2022
Scientists have discovered that apratoxin S4, an anticancer drug candidate that targets a human protein, can interfere with the replication of many viruses, including SARS-CoV-2 and influenza A, offering a possible pan-viral therapy.
More than two years after the COVID-19 pandemic began, people are realizing that the “new normal” will probably involve learning to co-exist with SARS-CoV-2 (the virus that causes COVID-19 disease). Some treatments are available, but with new variants emerging, researchers are looking toward new strategies. In research published today (June 29, 2022) in the journal ACS Infectious Diseases, scientists report that apratoxin S4, an anticancer drug candidate that targets a human protein, can interfere with the replication of many viruses, including SARS-CoV-2 and influenza A, offering a possible pan-viral therapy.
Although a number of COVID-19 vaccines exist, some people who received the shots have still become sick with the disease, and only a fraction of the world’s population is vaccinated. That means effective treatments are still needed, and a few are now available that target the virus’s RNA polymerase — the enzyme it uses to make more of its own RNA inside human cells. But some of these drugs, such as remdesivir, don’t work unless given at very early stages of infection and can require injections.
Apratoxin S4 (structure shown here) is effective against SARS-CoV-2 in human cells and could be a pan-viral therapeutic. Credit: Adapted from ACS Infectious Diseases 2022, DOI: 10.1021/acsinfecdis.2c00008
In the search for new ways to treat COVID-19, various research teams have revisited drugs that are already known to fight other diseases, a strategy called “repurposing.” One such preclinical stage compound is apratoxin S4 (Apra S4), which is a molecule based on a natural product that has anti-cancer activity. Previous studies have shown that apratoxins can target a human protein called Sec61, which ensures that certain proteins are properly glycosylated and folded correctly. Since viruses don’t have their own machinery to do this, they hijack the process and force human cells to make functional viral proteins. Sec61 is essential for the influenza A, HIV and dengue viruses to cause infection, so Hendrik Luesch and colleagues wondered if apratoxins could be a broadly effective, pan-viral medication that could also combat SARS-CoV-2.
In tests with monkey and human cells exposed to SARS-CoV-2, the researchers discovered that treatment with Apra S4 reduced the number of infected cells compared with remdesivir treatment. The molecule was also effective against influenza A, Zika virus, dengue, and West Nile virus infections. Further testing revealed that Apra S4 didn’t prevent SARS-CoV-2 from entering cells, but it reduced the amount of viral protein that was produced and transported in cells, especially the spike protein, and it decreased viral RNA replication. With electron microscopy, the team observed that Apra S4 also largely blocked the formation of new viruses, with many vesicles in SARS-CoV-2-exposed monkey cells having no or very few brand-new viral particles in them. The researchers say more studies are needed, but these results suggest that Apra S4 and other inhibitors of the human Sec61 protein are broadly acting antivirals that could help in the fight against future pandemics.
Reference: “Sec61 Inhibitor Apratoxin S4 Potently Inhibits SARS-CoV‑2 and Exhibits Broad-Spectrum Antiviral Activity” 29 June 2022, ACS Infectious Diseases.
DOI: 10.1021/acsinfecdis.2c00008
The authors acknowledge funding from the National Institutes of Health, the Debbie and Sylvia DeSantis Chair professorship, the Department of Defense, the Dengue Human Immunology Project Consortium, philanthropic donations, JPB Foundation, the Open Philanthropy Project and the Swiss National Science Foundation.
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New project offers efficient approach when tracking SARS-CoV-2 variants
An interdisciplinary research team has developed a fast, cost-effective method to detect the circulation of SARS-CoV-2 variants. SARS-CoV-2 is the virus that causes COVID-19. The team, funded by the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) Tech program, adopted a...
New project offers efficient approach when tracking SARS-CoV-2 variants
by National Institutes of Health
June 29, 2022
An interdisciplinary research team has developed a fast, cost-effective method to detect the circulation of SARS-CoV-2 variants. SARS-CoV-2 is the virus that causes COVID-19. The team, funded by the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) Tech program, adopted a customizable genotyping approach to identify known variants and subvariants. The approach can augment current surveillance methods that use comprehensive next-generation sequencing of virus samples, helping focus sequencing efforts on samples representing unknown and emerging variants.
In their study, which published in the Journal of Clinical Microbiology, the research team proposed that genotyping could be effectively used for SARS-CoV-2 variant classification. Genotyping is a relatively low-cost, high-volume laboratory technique used by thousands of clinical laboratories across the country with minimal hardware and software requirements. The technique zeroes in on genetic reference points, or markers, and limits the intense process of sequencing a 30,000 base-pair SARS-CoV-2 genome to a focus set of about 45 or less of the relevant alterations that distinguish the variety of subvariants in circulation at a given time. It is performed with polymerase chain reaction (PCR), a technique that already makes up a portion of the laboratory testing for COVID-19. The team showed that known variants can be successfully identified in one to two days, for a fraction of the cost of next-generation sequencing.
The research team is part of the RADx Tech program Variant Task Force (VTF). RADx Tech is led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at NIH. "The work of the task force offers a method that can be widely adopted and improve data gathering and reporting," said NIBIB Director Bruce J. Tromberg, Ph.D. "As variants of SARS-CoV-2 continue to emerge, it is critical to know where they are spreading and how rapidly, so countermeasures can be implemented. With this method we can develop new assays and get them into labs about two weeks after identifying a new variant."
While reported cases of COVID-19 have topped 400 million globally, only a fraction of positive test samples are sequenced—around 5% in the United States. Sequencing a viral genome, while necessary to discern unknown variants that arise, is costly and can take from two to three weeks. Adding to the complexity of sequencing, only about half of the positive samples have sufficiently detectible RNA for quality results and sequencing runs are performed in batches, sometimes delaying timely reporting of results. In summer 2021, when the Alpha variant was in decline and the Delta variant had emerged in the United States, NIH's RADx Tech program took on the challenge of assessing alternative methods for variant tracking that were faster and more efficient.
In a simulation with sample data from prior to September 2021, the RADx Tech VTF team worked closely with a bioinformatics research platform company, Rosalind, Inc of San Diego, to design a panel of markers both for detection of the virus—or positivity—and variant identification. They assigned three markers for determination of positivity and a combination of 45 others for identification of the then top 10 most prevalent variants according to the World Health Organization (WHO): Alpha, Beta, Gamma, Delta, Epsilon, Eta, Iota, Kappa, Lambda, and Mu. The results of genotyping agreed with sequencing in at least 96% of positive-result samples and at least 99% of negative-result samples.
Subsequently, they were able to reduce marker redundancy and condense the number of markers from 48 to 16, with nearly as effective performance for variant identification. With each reduction in markers built into the genotyping panel, the researchers could project a proportionate savings in cost and time. Upon the emergence of Omicron, the team further streamlined the panel to consist of only four markers to cover circulating variants (Delta and Omicron); a positive sample without a variant match could then be proposed for next-generation sequencing.
Next, the team analyzed and monitored thousands of positive samples collected between November 2021 and January 2022, during emergence of the Omicron variant. Their analysis of SARS-CoV-2 positive samples showed that the relative prevalence of the Omicron variant grew from approximately 40% in mid-December 2021 to greater than 90% at the end of the month, while Delta decreased from approximately 60% to less than 10% over the same period. By mid-January 2022, the prevalence of the Omicron variant further increased to greater than 95% and Delta dropped to less than 5%.
"The genotyping platform is commonly available in thousands of clinical and research labs in the country," said Eric Lai, team leader with the RADx Tech VTF. "Potentially, if this testing approach is further developed and authorized for clinical use, a hospital lab could order the reagent, validate the assays and perform genotyping on a single sample within a couple of hours to learn whether a person has COVID-19 and with which variant they are infected." He also noted that the faster turnaround, compared to next-generation sequencing, could help inform decisions, such as tailoring monoclonal antibody treatment.
The team contracted with Rosalind to develop a free, public dashboard that displays state-by-state the positivity rate and percentage of each variant in circulation, illustrating how genotyping and sequencing work hand in hand as part of the surveillance framework. This tracking tool—the ROSALIND Tracker for COVID-19—could become increasingly powerful as more public health and private testing labs adopt this genotyping approach and contribute their data to infectious disease authorities. Under contracts with NIH, testing laboratories at Aegis Sciences Corporation, Nashville; Helix, San Diego; and the University of Washington Medical Center, Seattle, have adopted the genotyping approach and are contributing data to the ROSALIND Tracker. NIH contracted with Thermo Fisher Scientific, South San Francisco, to supply instruments, consumables, reagents, software, and single-nucleotide polymorphism marker assays required to run the genotyping assay.
Since the research reported in the paper was performed, the team has further developed the technology to identify subvariants of Omicron based on the recent variant landscape. Within weeks, genotyping panel markers were updated to distinguish between BA.2, BA.2.12.1, BA.4, and BA.5. "That adaptability and how fast we can reposition our markers is very important," said Lai.
"All the materials that are associated with this genotyping assay are commercially available," said co-author Emily Kennedy, a RADx Tech program facilitator. "Links to those resources are provided in the paper so that we can share this information as a public health tool."
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Online tool allows users to predict their likelihood of severe illness or death from COVID-19
Are you more likely to die from COVID-19 or in a car accident? A new risk assessment tool can help you figure that out.
Online tool allows users to predict their likelihood of severe illness or death from COVID-19
by Kathryn Kao, University of Georgia
June 29, 2022
Are you more likely to die from COVID-19 or in a car accident? A new risk assessment tool can help you figure that out.
Created by Cameron Byerley at the University of Georgia, the online tool is called COVID-Taser, and it allows users to adjust age, vaccine status and health background to predict the risks of the virus.
Byerley, an assistant professor in UGA's Mary Frances Early College of Education, said that most people assess risk based on their experience of the world.
"Like if you're trying to decide how dangerous it is to drive, you might think about how out of all your friends and all your family members, you know two people who died of driving in the past 20 years. So, it's risky enough that you should wear a seatbelt and drive sober, but it's not so risky that you shouldn't drive to a friend's house."
That way of thinking helps people compare unknown risks with known ones they interact with every day. The COVID-Taser capitalizes on those comparisons to give people a better idea of their risks of dying from COVID-19 or having adverse side effects from vaccination. Website visitors can then see how those risks stack up to others like dying in a car crash or being struck by lightning in their lifetime.
The website is part of a larger project that aims to investigate how people interpret media using quantitative data representations like graphs and charts.
Understanding health risks of COVID-19
After conducting surveys in both the U.S. and South Korea, the team created several tools and a series of K-12 lesson plans to help citizens and students use mathematical representations of COVID-19 to make data-informed decisions about their health.
"A big focus of the project is thinking about how to communicate information," said Byerley. "We're really interested in risk communication and providing information so people can make decisions for themselves by comparing COVID risks and vaccination risks to more familiar risks they have a sense of."
People can also use the Relative Risk Tool to toggle between different ages to see how the risk of being hospitalized or dying from COVID-19 changes according to age groups.
Additionally, the tool can be used to compare the risk of dying from the coronavirus for vaccinated people versus unvaccinated people, as well as unvaccinated people with various health conditions like rheumatoid arthritis, lupus, psoriasis and other immunosuppressive conditions.
"My dream goal is that people will see that the risk of vaccination is low compared to other risks that they're willing to take," said Byerley. "They'll see that vaccination is safer than driving, pregnancy, playing professional soccer and just safer than lots of things they're willing to do already. It's also far, far safer than getting a COVID infection … the benefits of vaccination far outweigh the risks."
Byerley is currently working on incorporating information on immunocompromised people who are both vaccinated and unvaccinated into the Relative Risk Tool.
Explaining the impact of masks, social distancing in fighting the coronavirus
COVID-Taser's projection tool, which was designed to explain models from the Institute of Health Metrics and Evaluation (IHME), is an educational resource that teaches people the difference between cumulative deaths, which is the total number of people who have died and a figure that will always increase over time, and average daily deaths, which can increase or decrease over time.
Byerley noted that media outlets cause confusion when they include graphs labeled "total deaths" with numbers decreasing over time when they really should be labeled "average daily deaths" because total deaths cannot decrease.
In addition to showing total deaths and daily deaths separately on the projection tool, IHME models also predict how deaths will either increase or decrease in the U.S. depending on whether mask mandates are implemented.
"We want people to understand what a model is and how it's kind of like what happens on your phone when you're using Google Maps to predict how long a trip will take, which is based on some sort of algorithm," said Byerley. "It's usually pretty good, but it's never perfect and it changes. So we want people to understand that epidemiological modeling is very helpful, even though those estimates aren't perfect. They still help people plan and are helpful tools."
The IHME model predicted that, during the middle of the pandemic, areas without mandates involving masks, large gatherings and shutdowns would likely experience an increase in daily deaths. On the other hand, if mask mandates were implemented across the entire U.S., the model predicted that daily deaths would decrease. These predictions were verified by varying death rates in states and other countries with different public health policies.
Although models are not exact, they still show the impact of masking and vaccination in reducing death from COVID-19, Byerley said.
"I'm hoping these tools can serve as a template for medical communication," said Byerley. "And when numbers are hard for people to understand, it helps them see the relative size of things even if they don't know percentages or place values or information like that from school. I want these tools to help people understand that the risk of COVID infection is worse than the risk of vaccination and that the risk of vaccination is lower than other things they already do."
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Determining the ideal COVID-19 vaccine type and timing during pregnancy
Although pregnant individuals and newborns may face elevated risks of developing more severe cases of COVID-19 following SARS-CoV-2 infection, data indicate that COVID-19 vaccination during pregnancy can help to protect both the mother and child. New research collaboratively led by investigators...
Determining the ideal COVID-19 vaccine type and timing during pregnancy
by Massachusetts General Hospital
June 29, 2022
Although pregnant individuals and newborns may face elevated risks of developing more severe cases of COVID-19 following SARS-CoV-2 infection, data indicate that COVID-19 vaccination during pregnancy can help to protect both the mother and child. New research collaboratively led by investigators at Massachusetts General Hospital (MGH) and Brigham and Women's Hospital (BWH) and published in Nature Communications examined how different COVID-19 vaccines and the timing of vaccination during pregnancy impact the extent of this protection.
"Our goal was to compare maternal antibody responses and transplacental transfer of antibody to the neonate with vaccination across all three trimesters of pregnancy, and across different vaccine platforms (Moderna, Pfizer, and Johnson & Johnson). We hope to use this information to better counsel patients wondering about vaccination in the first versus the second or third trimester," says co–senior author Andrea Edlow, MD, MSc, a maternal-fetal medicine specialist at MGH and an assistant professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School.
For the study, Edlow and her colleagues characterized antibody responses after Janssen's adenovirus-based Ad26.COV2.S, Moderna's mRNA-based mRNA-1273, and Pfizer-BioNTech's mRNA-based BNT162b2 vaccines in 158 pregnant individuals. The team also evaluated the transfer of protective SARS-CoV-2 antibodies via the placenta from mother to fetus by analyzing maternal and umbilical cord blood in 175 maternal-neonatal pairs.
The research revealed induction of lower-functioning SARS-CoV-2-specific antibodies after Ad26.COV2.S compared with mRNA vaccination, as well as subtle advantages in antibody levels and function with mRNA-1273 versus BN162b2. mRNA vaccine-induced antibodies had higher levels and functions against SARS-CoV-2 variants of concern, such as Alpha, Beta, Delta, and Gamma. Vaccine-induced antibodies also demonstrated neutralizing activity against Omicron. First and third trimester vaccination led to enhanced maternal immune responses relative to second trimester vaccination. The transfer of SARS-CoV-2-specific antibodies to the fetus through the placenta was most efficient following first and second trimester vaccination.
"These data support the initial vaccine series early in pregnancy if it has not yet been administered, with possible boosting later in pregnancy if eligible, to optimize protective antibody titers for both mother and neonate," says co-senior author Galit Alter, Ph.D., a core member at the Ragon Institute of MGH, MIT and Harvard and a professor of Medicine at Harvard Medical School.
The investigators stressed the need for more research on this topic. "Additional studies are needed to understand how to optimize maternal and neonatal immunity induced by vaccines in general during pregnancy," says co–senior author Kathryn J. Gray, MD, Ph.D., an associate obstetrician at Brigham and Women's Hospital and an assistant professor of Obstetrics, Gynecology, and Reproductive Biology at Harvard Medical School.
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Epigenetic biomarkers predict CVD risk
Epigenetic biomarkers may reflect past cardiovascular health exposures and predict cardiovascular disease in the future, according to a Northwestern Medicine study published in the journal Circulation.
Epigenetic biomarkers predict CVD risk
by Will Doss, Northwestern University
June 29, 2022
Epigenetic biomarkers may reflect past cardiovascular health exposures and predict cardiovascular disease in the future, according to a Northwestern Medicine study published in the journal Circulation.
These biomarkers measured around midlife reveal valuable health information from a patient's past, according to Yinan Zheng, Ph.D., assistant professor of Preventive Medicine in the Division of Cancer Epidemiology and Prevention and lead author of the study.
"Our past exposures to obesity, elevated blood pressure, blood sugar and cholesterol leave 'epigenetic footprints' for us to better inform the development of cardiovascular diseases," Zheng said.
Cardiovascular health from young adulthood is strongly associated with future risk of cardiovascular disease (CVD) and total mortality. In the current study, investigators defined a cumulative cardiovascular health score including body mass index, blood pressure, cholesterol and fasting glucose. They applied this score to more than 1,000 patients in the Coronary Artery Risk Development in Young Adults (CARDIA) study, a long-term study of cardiovascular risk factors which began in 1983.
In addition, the scientists measured DNA methylation —epigenetic changes that regulate gene expression—in patient blood samples at two different time points collected around 40 years of age. DNA methylation can be modified gradually through long-term exposures to cardiovascular risk factors and the investigators hypothesized that it might better capture risk of CVD in conjunction with conventional CVD risk factors.
"These epigenetic markers integrate our exposures over decades to environmental factors like air pollution and to behavioral factors like our diet and physical activity," said Donald Lloyd-Jones, MD, ScM, chair and the Eileen M. Foell Professor of Preventive Medicine and co-senior author of the study. "In some ways, your epigenome is even more important than your inherited DNA code in determining your health."
The scientists found changes in 45 DNA methylation markers that were prospectively associated with 15 to 20 years of cardiovascular health prior to the measurement of the markers. For example, poorer cardiovascular health was associated with less methylation in the gene CPT1A, "switching on" expression of the gene.
The gene CPT1A codes for a lipid metabolism protein that's important for burning fat, but a long-term poor diet can "exhaust" those proteins and contribute to fat buildup and eventual CVD, Zheng said.
Investigators also created a methylation risk score and used it to predict risk of coronary artery calcification (CAC), a condition that often presages later CVD. This methylation score was able to predict future clinical CVD events in the Framingham Heart Study, another large longitudinal cohort.
"Clinicians can use the score just like the CVH metrics by applying thresholds to determine the CVD risk level, such as low, moderate or high," said Lifang Hou, MD, Ph.D., chief of Cancer Epidemiology and Prevention in the Department of Preventive Medicine and co-senior author of the study. "However, future larger population studies are needed to determine such a threshold."
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Researchers simulate coronavirus infection using human lungs and organoids
Researchers across the globe continue their endeavors to improve our understanding of the mechanisms underlying COVID-19 infection and the pneumonia and lung damage occasionally associated with it. As part of these endeavors, researchers from Charité, the Berlin Institute of Health at Charité...
Researchers simulate coronavirus infection using human lungs and organoids
by Charité - Universitätsmedizin Berlin
June 29, 2022
Researchers across the globe continue their endeavors to improve our understanding of the mechanisms underlying COVID-19 infection and the pneumonia and lung damage occasionally associated with it. As part of these endeavors, researchers from Charité, the Berlin Institute of Health at Charité (BIH), the Max Delbrück Center for Molecular Medicine (MDC), the Robert Koch Institute, and Freie Universität Berlin have analyzed the propagation of, and immune activation by, SARS-CoV-2 viruses inside human lungs. Specifically, the researchers focused on cells within the alveoli and alveolar macrophages. The latter are phagocytic cells of the innate immune system which clean the lungs by ingesting and eliminating foreign particles, including infective pathogens such as viruses and bacteria.
Led by Prof. Dr. Andreas Hocke of Charité's Department of Infectious Diseases and Respiratory Medicine, the team of researchers found that SARS-CoV-2 infects very few of the epithelial cells lining the alveolar surface, meaning that it causes very little direct tissue damage. In this respect, the virus differs significantly from both MERS-CoV and influenza viruses. Using comprehensive spectral microscopy-based analyses, the researchers were also able to show that only very few alveolar epithelial cells possess ACE2 receptors, which are required by SARS-CoV-2 to gain entry into host cells.
"Using human lungs and lung organoids—models of human alveoli developed using stem cells harvested from human lung tissue—we were able to show that SARS-CoV-2 is directly dependent on its receptor. By doing so, we were able to exclude other, alternative receptors," explains the study's first author, Dr. Katja Hönzke of Charité's Department of Infectious Diseases and Respiratory Medicine.
When large quantities of SARS-CoV-2 reach the alveoli from the upper respiratory tract, these do not propagate widely within the lungs' epithelial cells, as is often the case in other severe viral infections. Instead, they are subject to ingestion by macrophages.
"Using detailed bioinformatics analyses and COVID-19 autopsy samples, we observed that the macrophages change after ingesting coronaviruses," says co-first author Dr. Benedikt Obermayer-Wasserscheid of the BIH. These changes in turn trigger a range of reactions which are associated with pneumonia. The macrophages release inflammatory messengers and can occasionally set off severe inflammatory cascades. The researchers also observed that the virus does not replicate inside these immune cells.
Explaining the researchers' findings, Prof. Hocke says: "Our study suggests that severe lung injury in COVID-19 is more likely to be due to macrophage-induced immune activation than direct, virus-induced damage to the alveoli. As such, it makes a major contribution to our understanding of disease progress during the early phase of potential COVID-19 pneumonia and shows why, in contrast to MERS coronaviruses, most cases of SARS-CoV-2 infection show relatively moderate disease severity."
It is therefore safe to assume that, in most cases of SARS-CoV-2 infection, local immune mechanisms within human lung tissues are effective at removing the virus and limiting inflammatory response. Where this fails to happen—something which may be affected by individual risk factors—the infection may, in rare cases, prove severe and even fatal. Prof. Hocke continues: "The lung models we used provide an excellent example of how human cell-based alternatives to animal models are particularly useful in zoonotic diseases research. We were able to do this thanks to our close collaboration with Charité 3R, a facility dedicated to developing alternatives to animal-based research."
The study was published in the European Respiratory Journal. Subsequent research will focus on patient-derived organoid models, which will be used for a more detailed study of how general risk factors such as age, gender, concomitant disease and different medicines affect the activation of the immune response. This knowledge may then enable the identification of possible treatment approaches targeting the immune system.
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Q&A with A&V Livestream 6/29/22 8:00 PM
1 hr 53 min 16 sec
Streamed live 7 hours ago
Vincent Racaniello
Virologists Amy Rosenfeld and Vincent Racaniello answer your COVID-19 questions (or any virus questions) on this livestream of 6/29/22 at 8:00 PM eastern US.
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Novavax Vaccine Looked Good During the FDA Committee Meeting
25 min 59 sec
Streamed live 6 hours ago
Drbeen Medical Lectures
Novavax Vaccine Looked Good During the FDA Committee Meeting Novavax COVID Vaccine looked good to me during the FDA's VRBPAC meeting. Let's review their data. Keep an eye on their univalent and bivalent vaccine efficacy. If you like this content and want more, I am doing a special lifetime membership offer. Click here: https://www.drbeen.com/yt-special/
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Rebounds not unique to Paxlovid?
Several Substackers have been on the case of Paxlovid for leading to rebounds — essentially creating a scenario where individuals who may have otherwise stayed home and rested believe they are “cured” increasing transmission potential in the best case scenario. But snake oil is snake oil is...
jestre.substack.com
Rebounds not unique to Paxlovid?
Jestre
7 hr ago
Several Substackers have been on the case of Paxlovid for leading to rebounds — essentially creating a scenario where individuals who may have otherwise stayed home and rested believe they are “cured” increasing transmission potential in the best case scenario. But snake oil is snake oil is snake oil regardless of the packaging. As it turns out, a recent study found that Molnupiravir may cause a similar, albeit more dire, effect.
The pre-print uses health data from the TriNetX research network and compares 13,644 patients over the age of 18 that took either Paxlovid or Molnupiravir, matching them using propensity scores, then looks at a variety of COVID-like symptoms to find out if they had a rebound within 7 and 30 days. The symptoms are probably where the largest chance for error can occur in this study as, in the usual fashion, they include fever, chills, cough, shortness of breath, muscle aches, headache, loss of taste or smell, sore throat, nasal congestion or rhinorrhea, vomiting, diarrhea, and skin rashes. As with most COVID studies, these symptoms seem broad and adverse events being stronger in Molnupiravir than Paxlovid (I have no idea if that is true), for example, could possibly explain the results.
In any case, the researchers found that there was no statistically significant difference in rebound rates between the drugs after propensity score matching. And though the rates were statistically the same, they were actually higher in the Molnupiravir cohort. Before propensity score matching (for those skeptical about the choice of variables included)? Even worse. Rebound rates were much higher in the Molnupiravir cohort.
Here’s the thing that makes Molnupiravir more dire, I would argue. Molnupiravir has very little if any efficacy to begin with.
Let that sink in for a second. If this study is correct and Molnupiravir causes rebounds at the same or with a higher rate than Paxlovid. Plus, Molnupiravir has little or no efficacy in general. Then, individuals who would have otherwise been fine in a few days without taking the drug are not only spreading the virus at a higher rate than they would have, but they are more likely to have a lasting infection and the consequences that come with any virus being in their system for long periods of time. Add in the potential side-effects of the drug and… well… yikes.
Imagine naming a drug so useless after Thor’s hammer.
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The end of Covid-19 vaccine safety science in America
On June 28, the FDA decided that henceforth THEY will choose the variants for reformulated Covid-19 shots and NO clinical trials will be conducted to evaluate safety. Because $cience.
tobyrogers.substack.com
The end of Covid-19 vaccine safety science in America
On June 28, the FDA decided that henceforth THEY will choose the variants for reformulated Covid-19 shots and NO clinical trials will be conducted to evaluate safety. Because $cience.
Toby Rogers
7 hr ago
I. The end of the beginning
Yesterday, the FDA’s Vaccines and Related Biological Products Advisory Committee approved a bivalent Covid-19 shot with the Wuhan strain and the Omicron variant.
The vote was:
19 yes.
2 no.
A few thoughts:
The Wuhan strain is no longer in circulation. So they are vaccinating against a strain that no longer exists.
The Omicron variant that they are going to put into this shot is Omicron BA.4/BA.5:
1. By the time it gets to market in the fall, Omicron BA.4/BA.5 will likely no longer be in circulation.
2. There is no efficacy data whatsoever on vaccines against Omicron BA.4/5.
3. There is no safety data whatsoever on vaccines against Omicron BA.4/5.
4. They do not intend to gather any efficacy or safety data between now and when these shots will be released in the fall:
At the meeting, the manufacturers (Moderna, Pfizer, and Novavax) were asked what their production timelines are… and they said out loud, “So long as we don’t have to provide any clinical data, we’ll have them ready by fall.”
No one had a problem with that.
Ofer Levy said that he was concerned about the lack of safety data (there is none) and asked if the FDA intended to gather any. FDA vaccine head Peter Marks said that he was “comfortable” that the Sentinel BEST Initiative would catch any safety signals after these shots are introduced into the market. No one has ever heard of Sentinel BEST. Meanwhile Dr. Marks disparaged the Vaccine Adverse Events Reporting System (VAERS) that has shown 29,031 reports of death following Covid-19 shots.
So the FDA is going to introduce reformulated shots into the population this autumn with no safety data and then try to spot adverse events in the population after the fact using a safety system no one has ever heard of — while ignoring the system that has existed for 32 years that is showing a massive safety signal right now.
We are the experiment. But it’s not even really an experiment because they do not care about the data. We are the people they want to democide.
The FDA’s Actions yesterday were a violation of the Nuremberg Code, the Declaration of Helsinki, and the Hippocratic Oath.
The FDA has plunged the United States into a pre-scientific dark ages.
II. Wait, hold up, I thought the FDA was voting on the Future Framework yesterday?
The policy question was whether reformulated Covid-19 shots would be treated as new molecular entities (which they are) in which case they should be subject to formal review or whether reformulated shots would be treated as “biologically similar” to existing Covid-19 shots and be allowed to skip clinical trials altogether.
Apparently the FDA did not have the votes to just pass this as a policy question. If you ask anyone whether reformulated mRNA represents a new molecular entity, well of course it is, so that would require formal regulatory review.
What the FDA did instead was to smuggle the policy question in disguised as a vote about reformulated “boosters” for the fall. In essence, the FDA just started doing the Future Framework (picking variants willy nilly, skipping clinical trials) and essentially dared the committee members to turn down a booster dose — knowing that all of the VRBPAC members are hand-picked because they’ve never met a vaccine they did not like. So of course only two people on the committee had the courage to turn down a booster dose — even though it was based on this preposterous process (that was never formally adopted) where there was literally no data at all.
Paul Offit even said prior to the vote, “This is a new product… we need a higher standard of protection.” Offit was one of two VBBPAC members who voted no (the other was Hank Bernstein).
By stealth, the FDA replaced a system based on evidence with a system based entirely on belief.
III. The meeting itself
The meeting was chaos. You can watch the whole thing (here) — in general, the discussion starting at 6:33:23 is where you will find the most damning quotes.
The guy they brought into to model the future of the pandemic, Justin Lessler, who by my count has TWENTY conflicts of interest, presented slide after slide with confidence intervals so wide, the prediction was literally ‘anything can happen.’
Hats off to this grifter for stealing millions of dollars from Bill Gates and Tony Fauci and producing nothing in return.
At one point, Wayne Marasco at Harvard suggested abandoning mRNA shots altogether (yes, good idea) and switching to the Novavax platform because he liked the CEO’s presentation. Then Peter Marks came in and slapped that idea down (Novavax does not have an approved EUA in part because they are now on their third contract manufacturer and their last manufacturer, Emergent BioSolutions, contaminated 400 million Covid-19 vaccine doses).
At the end of the meeting, the chair, 89-year-old Arnold Monto, did not even know what strains were in the proposed fantasy bivalent shot — he thought it included beta but literally no one was proposing that yesterday. Of course Dr. Monto voted yes anyway. Like many members of the committee his attitude is ‘shoot ‘em all up and let God sort ‘em out.’
Dr. Monto did not look well, so I imagine there is a better than zero chance that he just voted for the product that will end his life.
Late stage capitalism is wild.
The representative from the World Heath Organization proposed a monovalent Omicron (BA.1) booster but the committee blew right on by that idea to the latest and greatest variant (BA.4/5) — even though no one knows how to target that.
In the weeks leading up to the meeting, Moderna and Pfizer already started making bivalent Covid-19 shots with Wuhan and Omicron BA.1 variants. But the committee blew right on by that idea as well. Not to worry, at the end of the meeting Peter Marks assured them that the federal government would “make them whole” — i.e. pay Moderna and Pfizer, with our tax dollars, for shots that no one even asked for.
The committee spent a fair amount of time discussing a slide from Pfizer showing antibody response — and apparently no one other than me bothered to look at the note in the bottom left hand corner that read “N = 8 Balb/c mice.” Quite literally, this “immunogenicity data” was based on 8 mice specifically bred to be “exceptional responders to immunization.” That’s how miserable the data were.
Most of the presentations at this meeting were so flawed they would have failed a high school biology class.
FDA, VRBPAC, and the WHO admitted that they have no correlates of protection.
VRBPAC member Bruce Gellin (the new guy) admitted that the flu vaccine is not a good comparator for Covid-19 vaccines.
They all admitted that they have no safety data.
And then they approved this reformulated fantasy shot by a vote of 19 to 2 because they are incapable of critical thinking.
IV. What does this all mean?
Peter Marks and the members of VRBPAC think that they achieved a great victory. Indeed the vote Tuesday was the last piece of their Final Solution for Amerika — shots approved for all ages — with no clinical trials ever again.
The reality is that FDA/VRBPAC and CDC/ACIP with their reckless votes across 8 meetings during the month of June, guaranteed the collapse in our lifetime of these regulatory agencies, allopathic medicine, and the vaccine program.
Think about it: going forward, only about 25% of the population — the hypochondriacs — are going to want these dangerous shots with no clinical safety data. It’s an unnatural experiment. The people who receive the most shots will develop Covid-19 at higher rates and experience side effects including heart attacks, strokes, infertility, and death at higher rates than the population that is not vaccinated. There will also be a dose-response relationship — the more shots, the worse the health outcomes (thereby confirming one of the Bradford Hill criteria). This is already happening, and lots of people are starting to notice.
The FDA’s decision to authorize this junk is the most effective plan ever devised to completely discredit and destroy the FDA/CDC, mainstream allopathic medicine, and vaccines in general. The harms are heartbreaking and they will get worse.
But we just have to keep the faith, stand back, and the other side will destroy itself.
Before Covid-19 shots were introduced, I imagine it would have taken us another 50 years to bring down the Pharma cartel. Now we can do it in less than 10 years. If we work hard, perhaps we can get there in 5?
V. Where do we go from here?
I spent 5 months of my life trying to stop the FDA from committing these crimes against humanity. Between all of the medical freedom groups working on this issue we generated tens of thousands of comments and over a million emails to politicians and FDA officials. In the end, we only picked off 2 votes — Hank Bernstein and Paul Offit of all people.
Was it worth it? Absolutely.
When we started this fight back in January, 30% of parents said they were going to rush out to get their kids vaccinated right away. In April that number was down to 18%. By today I imagine it’s even smaller.
Only half of Americans have gotten “boosters”. With these new crazy shots that will have no safety data, that number will come down even further.
When we get loud to educate the FDA/CDC, we also end up educating the public. And that saves lives.
The other thing is that we forced the FDA to reveal who they truly are. This is extremely valuable because it helps us to update our strategy. Before this fight, the FDA pretended to be a regulatory agency. Well, we removed that mask and showed that the FDA absolutely does not care about science nor health. Furthermore we discovered that the FDA has been laundering Moderna and Pfizer’s data for them throughout the Emergency Use Authorization process. And now the FDA is abandoning clinical trials altogether in connection with Covid-19 shots. What an extraordinary admission of failure on their part. We now know that the FDA is NOT a regulatory agency. The FDA is the data laundering branch of the Pharma cartel. Our challenge is no longer to educate these fascist clowns but rather to replace them with people who actually care about science and health.
Going forward, there are a few things I want to do:
I intend to launch a campaign through my Substack called “This Is On You.” Lots of Americans are going to be maimed and killed by these shots in the coming months. It’s going to be heartbreaking. And what I want to encourage people to do is, every time you see a heartbreaking story of vaccine injury online I want you to print it and mail it to the members of VRBPAC who approved these toxic shots — along with a note that says, “This is on you!” All of their mailing addresses are (here). There is no reason we should carry the emotional burden for their crimes.
But over the long term, we absolutely have to take power. Every non-profit that works on medical freedom needs to set up a 501(C)(4) to do political work. When you go to see your heroes speak at these medical freedom conferences, ask them when they are going to set up a 501(C)(4) and see what they say.
Attorney Jeff Childers at Covid & Coffee does these wonderful targeted fundraising operations called Operation Multiplier. Anytime a politician stands up and fights for us, he encourages all of his readers to send small donations as a token of appreciation. “He says, donate ANY AMOUNT that you can easily afford ending in the number ‘2’.” That way the campaign can track the contributions that come from his appeal. We should all amplify this effort because it is one of the best things going in the movement.
In the comments, I’m interested to read your thoughts on the steps we should take going forward to right these egregious wrongs.
Warriors, I am more grateful than you will ever know for the community we have built and the extraordinary actions you have taken over the last many months.
Today is a sad day for America. But keep your chin up because we are absolutely going to win this war.
Blessings to the warriors!
Hugs and prayers for everyone in the movement.
In the comments please let me know what’s on your mind.
As always, I welcome any corrections.
p.s. for those who are interested, I went on Bannon and CHD.TV after the vote to share my thoughts. The Bannon clip is raw and angry and the CHD clip from this morning is more forward-focused.
Update: June 29, 2022
Well, well, well, Paul Offit just published an Op Ed in StatNews titled, “FDA: Don’t rush a move to change the Covid-19 vaccine composition.” Reading between the lines, it appears the Offit is backing a rival product and is somehow trying to clear a path for its approval:
Would the country be better off using the available resources to accelerate the creation of next-generation vaccines that can produce neutralizing antibodies in amounts high enough to deal with most variants? Or vaccines that can be delivered into the nose, a route that may provide stronger protection against infection?
Offit is the biggest name on the VRBPAC and if he’s publicly pouring cold water on the FDA’s decision there’s a chance it ain’t over yet. Stay tuned.
Heliobas Disciple
TB Fanatic
just how much are covid cases up in the US?
when you adjust for testing levels (which have been dropping rapidly) the US data look ominous
boriquagato.substack.com
just how much are covid cases up in the US?
when you adjust for testing levels (which have been dropping rapidly) the US data look ominous
el gato malo
21 hr ago
PCR testing for covid is an iffy process. it’s nearly always far too sensitive and we do not sort by clinical presentation. but, the thing about such errors is that they at least stay fairly consistent so even if it provides a difficult metric for accurate prevalence counts, we can generally at least compare the data to itself.
the problem with doing this in “cases” is that testing levels vary so widely. if you have 1000 people 100 of whom have covid and you test 200, you find 20 cases. if you test 400 people, you find 40. this has not made covid more prevalent.
reporting that “covid doubled” would be wrong. you just looked for it harder. this is called “sample rate” and to get real case data, we need to control for it because, to bang on a favorite drum of mine: reporting incidence without controlling for sample rate is tantamount to lying.
sure, such adjustment is never exact, but it’s a helluva lot better than raw cases.
for much of early covid, testing levels were constantly rising. this made raw case counts overstate the rise in prevalence. in many cases, it literally inverted the slope of the series (for example making winter of 2020-21 look higher than peak from spring 2020. it wasn’t.)
now, testing levels are dropping. and this is understating case counts by wide margins.
that which is, in reality, much higher than the past looks lower.
and this is masking the impact of OAS and inflating relative CFR both of which have profound implications.
let’s look:
this is raw cases in the US and testing numbers.
to look at this, you’d think case counts are flat from mid may at a level about 25% below the peak from last summer. but this is a sample rate illusion.
the reality is very different.
i normalized the testing rate on this series to 5 per day per 1000 people and adjusted all case data to reflect this. this means that the absolute numbers no longer really map to anything (as current testing rate is about 1.5) but it does make the whole series comparable to itself in a manner that it was not previously.
as can be seen, LOTS of things change.
we can now see that winter peak 2020-1 was lower than the april 2020 peak.
we can also see that current case levels are rising fast and early this summer.
the absolute level is VERY high and has already eclipsed the summer seasonal peak from last year by ~100%.
we’re not “down 25%” we’re “up 100%” and rising fast.
we’re already above the 2020-21 seasonal peak for winter and look to have a real shot at reaching/exceeding the seasonal peak from winter 2021-22, a peak that was over 3X as high as the prior year’s.
that’s deeply aberrant and it’s being masked by a plummeting testing rate.
US case counts are exploding.
this next one gets a little busy, but it’s also quite revelatory.
green lines are peak to peak or peak to current. red are from 6/27/22 to the same date a year and 2 years before so you can see where we are in expected seasonal cycle.
the peak of winter in 2020-1 dropped about 25% from prior year.
then vaccination started. the next winter peak was 2.29X.
the summer peak in 2021 was over 1.5X the size of the prior unvaxxed year.
and this year, in the post booster omicron age, is going absolutely wild.
it’s over 10X the same day last year.
it’s ~2X last year’s summer PEAK and peak cases are a solid 6 weeks away, maybe 8 if seasonality holds.
it looks to have a real shot at making new all time highs.
prior to vaccination, peaks were lower than prior year.
since vaccination, they have ALL been higher.
and the extent to which they are higher is increasing with each peak.
you can see the wild expansion of multiples of last year here. this is the same sample rate adjusted series but divided by the same day last year to show the multiple of cases now vs then. a number below 1 indicates contraction vs last year. a 2 means twice the cases, etc.
the trend here gets deeply ominous. each successive peak is getting higher. the waves are getting bigger, not smaller.
2.2X, then 3.4X, then 11.6X each new seasonal peak of acceleration vs prior year is blowing out.
(note that this year’s surge is considerably earlier than last year’s and so this 10-11X rate is likely inflated and ought to compress some as it starts to comp against the surge from 2021 instead of the trough, but even if it halves, 5-6X is terrifying.)
this is not herd immunity, it’s the herd getting more and more vulnerable.
and that does not happen like this in the wild. not at this magnitude.
we’re watching water flow uphill. and when you see this, you need to start looking for an external driver.
many keep trying to call this a change in the intrinsic infectivity of covid, but i suspect this is probably wrong or, at least, mostly wrong. i know i keep posting this chart like some sort of broken record, but that’s because i think it’s REALLY important.
because the chart you just saw looks a lot like this chart but with the next surge added onto the end.
it shows you that as omicron hit, the risk ratios for the vaxxed and especially for the boosted blew out. they were not only far above the unvaxxed, but were rising higher and higher by the month. the confluence here is past provocative.
the UK stopped reporting this series. look at the US prevalence data and perhaps you’ll get some intuition as to why. relative risk ratios doubled from ~2 to ~4 over an 8 week span despite (or perhaps because) their switching to reporting triple dosed instead of double.
this shatters the “more intrinsically infectious” narrative. it might be a little bit so, but mostly, it’s the vaccines. it’s not 3.4X, much less 11X as infective.
no way. no how.
and the vaxxed vs unvaxxed data was laying out the driver clearly until they stopped reporting it.
the data is flat out telling us that the huge genetic jump to omicron was a sharp selection for an OAS variant advantaged by the vaccine driven herd antigenic fixation stemming from leaky vaccines. omi is not a descendant of delta, it’s a throwback to a far earlier common ancestor. it got plucked off the “failed variant” pile by a powerful new evolutionary selector.
that’s what leaky vaccines do: they select for OAS and ADE.
it’s WHY we don’t use them.
and these vaccines look to induce strong antigenic fixation rendering your immune system a one trick pony unable to adapt to new variants of this pathogen.
to my knowledge, herd antigenic fixation has never happened before in humans. if this is what’s happening now, things are going to get pretty dramatic.
the math around this and how milder variants (and omi is much less virulent which is probably a part of why it spreads better) can get really sinister and can make vaccines that are causing more overall death than would have otherwise occurred (even in the vaxxed) look like they are working because relative effect ignores a rise in incidence rate.
and we’re starting to see signs of this. the highly vaxxed US northeast saw more old people in hospital this winter than the year before despite a milder variant and sky-high vaxx rates.
many saw second spikes this spring that exceeded winter.
this is omicron jumping the vaccinated and rapidly rarifying into new and increasingly optimized sub-lineages to infect the vaccinated.
and it’s starting to become a summer issue as well.
looks what’s happening to over 70’s in the US. nearly all vaxxed, mostly boosted.
it’s 2.3X the number as on the same day last year and rising rapidly. season should barely be beginning but counts have been rising for months. it’s at 10.5. last summer’s peak was 14.4
i would not advise taking the under on peak to peak seasonal counts. if this exceeds the feb peak, then you know we’re into serious failure.
this could be mostly a “hospitalization with” vs “for” signal or a sign of high nosocomial transmission. whether it winds up leading to a rise in deaths vs last year (not yet occurring) is hard to call. omi is much intrinsically milder and CFR is being elevated by lower cases count capture due to lower sample rate.
gatopal™ and fellow substacker eugyppius is finding the same issues by doing a clever analysis of germany where the low vaxx and boosted east is not seeing the surge the high vaxxed west is.
this is all leading to some strong conclusions.
omicron is much milder than prior strains, more so even than appears in the data. intrinsic CFR is likely down about a full log. (90%)
but omi is spreading like wildfire because it’s optimized to infect the vaccinated. their antigenic fixation has frozen their immune response and it’s clear that variant based boosters are not going to help. fixated is fixated.
and this is getting worse over time likely due to continuing selective pressure in an immune fixated herd. (how bad it can get is anyone’s guess. i’m not sure we even have a valid past model for this process)
prevalence is swamping declines in virulence and this is starting to show up in hospitalization data. whether that’s scary or incidental is not yet clear.
whether it makes it into deaths eventually is hard to predict with any confidence. it would likely take a huge jump in infectivity to counteract the drop in CFR, but when we start talking about 10X jumps in prevalence, this becomes possible, at least mathematically. (whether and to what extent that 10-11X is amplified by seasonal shift remains to be seen)
bottom line:
it is the vaccines driving covid evolution and superspread and they are failing faster by the day.
the reported cases data is masking this, but the magnitude of what’s starting to happen will be too big to hide from the general public much longer.
when you’re quad vaxxed and on your fifth round of covid and it feels worse than your fourth, even the stalwart “trust the experts” crowd starts to notice…
this may be a bumpier summer than many were planning.
.
Heliobas Disciple
TB Fanatic
data suppression and adulteration or just simple incompetence?
a data series of unfortunate events
boriquagato.substack.com
data suppression and adulteration or just simple incompetence?
a data series of unfortunate events
el gato malo
14 hr ago
a couple weeks ago, i wrote about data adulteration becoming a mainstream process in order to rein in and manipulate both public perception and our ability to have any valid basis whatsoever from which to validate or refute public narrative.
there has been such an intense recent run of this that i wanted to highlight some specific examples because either data is being suppressed and altered to lie to us, or we’re facing an unprecedented epidemic of fundamental incompetence in government agencies. neither instills much confidence.
the EIA has been having “server problems” for weeks. the hilarity of this in the age of cloud computing speaks to either archaic architecture or outright absurdity on the order of “the dog ate my homework.”
this, of course, comes at a time of both great strain, dislocation, and political relevance to oil and energy data.
(and of silly attempts at price suppression by tapping reserves while suppressing supply)
and apparently this disease is going around.
the CDC has been out of whack for 3 weeks.
i wonder what THEY might be trying to hide or change?
to be clear, i have no proof that this is malfeasance and manipulation and not just incompetence but given the number of times the CDC has been caught lying to us and making up and slanting data over the last two years, call me mr cynical paws but it feels like the high probability bet.
how do you trust the people who did THIS:
and then literally ran the same trick again.
and got caught. again.
“Replicating the CDC study shows similar results; however, incorporating a larger sample and longer period showed no significant relationship between mask mandates and case rates,” the authors state.
so there is really no basis for trust here.
and the FDA may be even worse.
look what they are doing for variant based boosters, an idea already known not to work:
they are going to approve them (and move to a system of approving all such products in the future) based on a biomarker, not clinical efficacy. it’s just antibody count. but pfizer has flat out told them “there is no established correlate of protection.”
that means they have no idea if it has any clinical effect.
they did not even check to see if it actually works. (this is probably because they know it doesn’t. see study linked above)
reaching the “we know the data will be bad so let’s not collect it” stage of pharma regulation is not a good thing.
they did the same for remdesivir, which failed its clinical trial. they changed the endpoint post-results to p hack it.
and they have done the same thing for paxlovid which probably never worked at all and was run through rigged trials that did not include vaccinated people.
gatopal™ igor has been on top of this for ages and has a great compilation of data here:
this is worth reading in detail, especially this piece by brian mowrey who nailed the MOA on the fail 10 weeks ago.
paxlovid does not seem to clear covid. it’s just a “pause” button and it’s not a pause the refreshes, it’s the pause that sets you up for a nasty rebound that was worse than your initial infection.
certain snarky cats were heard to crack wise about this. (but just because they are “malo” does not mean they are wrong)
the UK killed the data series that showed expanding risk ratios in the vaxxed and boosted vs the unvaxxed.
isreal, same.
canada, same.
when the data goes against the narrative, the data goes away.
either this is widespread and willful, or there sure are a lot of coincidences around here…
.
Heliobas Disciple
TB Fanatic
San Francisco is Another Portugal -- Worst Covid Wave Ever
Never-ending Chronic Covid grips city
igorchudov.substack.com
San Francisco is Another Portugal -- Worst Covid Wave Ever
Never-ending Chronic Covid grips city
Igor Chudov
17 hr ago
The icon of liberalism, as well as a bastion of “support for science” San Francisco, believes in vaccines. It is over 90% vaccinated. The city is not even reporting the exact percentage vaccinated, possibly out of embarrassment or incompetence.
The graph of Covid cases shows that Covid is well under control in the city, thanks to the safe and effective vaccines and mRNA boosters.
This is, of course, a mirage.
San Francisco, like most other US locales, stopped counting Covid cases after moving to home-based RAT testing around Jan 2022. The tests are done at home and are not reported. The poorer people probably do not even bother testing, they just get sick again and again without a diagnosis.
However, San Francisco also monitors wastewater — the municipal stream of water from showers, toilet flushes, and everything else. The viral RNA that is shed in fecal matter is a reliable indicator of how many San Franciscans are having Covid right now (ignoring that some of them defecate on sidewalks instead of toilets).
The city is actually doing a decent job measuring wastewater virus levels and is measuring concentrations of different segments of viral RNA. This way it can know what variants predominate, without doing any genetic testing of individual residents.
Things look very bad if you look at wastewater measurements. Here’s the concentration of viral RNA in San Francisco wastewater:
We can see that SF is having a record amount of COVID, which follows a record amount of COVID just a month ago, that follows a record amount of COVID in January.
Let’s do simple math comparing Jan 2022 to May 2022:
Based on wastewater levels, the number of cases in May 2022, if measured the same way as Jan 2022, would be estimated as 3,091 cases per day instead of the reported 500 PCR cases. This means that cases are underreported by about 6 times compared to January. This calculation is by its nature quite imprecise, however, you can see that underreporting is very significant and the number of sick people is grossly understated.
San Francisco's COVID situation is replicated in thousands of highly vaccinated places. I wrote about Portugal, showing how the country with “no one left to vaccinate” is gripped by endless waves of Covid.
Ba.5 is just starting to become predominant in San Francisco, unlike in Portugal where it dominated since a month ago, and that is not a good sign for a beautiful coastal city whose residents keep catching endless cases of Covid.
Do you feel sorry for San Franciscans, who get ill so often? I do.
.
Heliobas Disciple
TB Fanatic
I feel I need to post this reminder before I post this substack: it's best to not take medical advice from the internet without first discussing what you want to do with your doctor, who has your records, is trained in medicine, and knows you and your medical history.
~~~~~~~~~~~~~~~~~~~~
palexander.substack.com
(fair use applies)
URGENT: BA.4 & BA.5 omicron driven by VACCINE warrants nasal-oral washes with povidone iodine (PI) or hydrogen peroxide (no swallow); Flavio & Rapiti offers aggressive treatment for this BA.4/.5
I re-provide PI protocol & suggested treatments for BA 4 & BA 5 omicron; emerging reports indicate these are more symptomatic & stronger; talk to your doctor with the FLCCC program; VAX causing this
Dr. Paul Alexander
6 hr ago
BA.5 is reported as being more stronger. It appears BA.4 and BA.5 are worse for vaccinated persons. BA.2.12.1 appears to account for 50% of infections at this time.
What we feared is happening, or beginning to, I have written about this after consulting with Geert Vanden Bossche. Geert is the most incredible mind I have realized. The argument is that the blocking of severe infection in the lower respiratory tract would disappear (and soon) and severe illness could emerge with future variants. Early treatment can work as before and you have to consult your doctor and devise a plan.
Early treatment clinicians (e.g. Dr. Marik) are advising that BA 4 & BA 5 must be treated more aggressively with antibiotics and STEROIDS on day 1-3 (at the latest) with anti coagulants (anti-blood clotting drugs) added if the D-dimer elevated as replication appears far greater than for SARS Delta and the lungs are involved with viral inflammation and clotting in the initial few days.
Other clinicians indicate that in places like Brazil, treatment is as below as BA.5 is increasing. They use clinical signs of lung involvement by looking at SOB as the patient is talking, or walking 10 paces in the office or if they indicate that they have some dyspnea (SOB) on engaging in some effort. They are not relying on PCR or CT. Initial reports are that BA.4 & BA.5 are spreading more rapidly (maybe 50% of cases in US), and is driving increases in hospitalization.
Again, we told them to stop the COVID failed shots and they have caused this by pushing a failed non-neutralizing injection with non-neutralizing vaccinal antibodies pressuring the antigen (spike) during a pandemic with massive infectious pressure.
Povidone iodine program to kill the virus in the nostrils and oral cavity:
Remember POVIDONE-IODINE (PI) (aka Betadine), it is a simple program & nips COVID virus, all/most respiratory viruses in the nose, mouth, nasopharynx; 1/2 teaspoon of betadine mixed with 1.5 ounces of water
put that in a bulb syringe, stick it up your nose & washout each nostril 2x. Swish and spit orally, twice a day, and when you go outside and return; No swallowing; use hydrogen peroxide diluted if no PI or you cannot stand the bitter taste
Research suggests that PI or HP will kill most viruses we are in contact with…again, no swallow, and you dilute to taste.
swish and spit orally, and Q tip bulb cleaning out nostrils etc. as far as can go.
We have added PI to the early treatment regimen at the top box if you look carefully for in some sense, if this is done routinely, one can argue there may be no need for early treatment and you can effectively stave off COVID and cold virus etc. routinely. Completely. Hydrogen peroxide (and there are oral versions too I have seen at least one) is used by some who find PI too bitter, but remember, no swallow and you dilute it.
This can be purchased OTC. Oral dental surgeons etc. came forward and informed us they use similar programs before COVID to clean nostrils and mouths as they are inside people mouths daily in surgery and they use this as their own protection. Keeps them safe. We then dug further and studied it and boy, had we known earlier, this would have been out there to help protect more, even before early treatment. It defies logic why public health will not tell people these solutions that saves lives including for vitamin D.
“Can povidone iodine gargle/mouthrinse inactivate SARS-CoV-2 and decrease the risk of nosocomial and community transmission during the COVID-19 pandemic? An evidence-based update”
Aditi Chopra 1, Karthik Sivaraman 2, Raghu Radhakrishnan 3, Dhanasekar Balakrishnan 2, Aparna Narayana 2
Enhanced treatment on FLCCC for BA.4 & BA.5 variants:
~~~~~~~~~~~~~~~~~~~~
URGENT: BA.4 & BA.5 omicron driven by VACCINE warrants nasal-oral washes with povidone iodine (PI) or hydrogen peroxide (no swallow); Flavio & Rapiti offers aggressive treatment for this BA.4/.5
I re-provide PI protocol & suggested treatments for BA 4 & BA 5 omicron; emerging reports indicate these are more symptomatic & stronger; talk to your doctor with the FLCCC program; VAX causing this
palexander.substack.com
URGENT: BA.4 & BA.5 omicron driven by VACCINE warrants nasal-oral washes with povidone iodine (PI) or hydrogen peroxide (no swallow); Flavio & Rapiti offers aggressive treatment for this BA.4/.5
I re-provide PI protocol & suggested treatments for BA 4 & BA 5 omicron; emerging reports indicate these are more symptomatic & stronger; talk to your doctor with the FLCCC program; VAX causing this
Dr. Paul Alexander
6 hr ago
BA.5 is reported as being more stronger. It appears BA.4 and BA.5 are worse for vaccinated persons. BA.2.12.1 appears to account for 50% of infections at this time.
What we feared is happening, or beginning to, I have written about this after consulting with Geert Vanden Bossche. Geert is the most incredible mind I have realized. The argument is that the blocking of severe infection in the lower respiratory tract would disappear (and soon) and severe illness could emerge with future variants. Early treatment can work as before and you have to consult your doctor and devise a plan.
Early treatment clinicians (e.g. Dr. Marik) are advising that BA 4 & BA 5 must be treated more aggressively with antibiotics and STEROIDS on day 1-3 (at the latest) with anti coagulants (anti-blood clotting drugs) added if the D-dimer elevated as replication appears far greater than for SARS Delta and the lungs are involved with viral inflammation and clotting in the initial few days.
Other clinicians indicate that in places like Brazil, treatment is as below as BA.5 is increasing. They use clinical signs of lung involvement by looking at SOB as the patient is talking, or walking 10 paces in the office or if they indicate that they have some dyspnea (SOB) on engaging in some effort. They are not relying on PCR or CT. Initial reports are that BA.4 & BA.5 are spreading more rapidly (maybe 50% of cases in US), and is driving increases in hospitalization.
Again, we told them to stop the COVID failed shots and they have caused this by pushing a failed non-neutralizing injection with non-neutralizing vaccinal antibodies pressuring the antigen (spike) during a pandemic with massive infectious pressure.
Povidone iodine program to kill the virus in the nostrils and oral cavity:
Remember POVIDONE-IODINE (PI) (aka Betadine), it is a simple program & nips COVID virus, all/most respiratory viruses in the nose, mouth, nasopharynx; 1/2 teaspoon of betadine mixed with 1.5 ounces of water
put that in a bulb syringe, stick it up your nose & washout each nostril 2x. Swish and spit orally, twice a day, and when you go outside and return; No swallowing; use hydrogen peroxide diluted if no PI or you cannot stand the bitter taste
Research suggests that PI or HP will kill most viruses we are in contact with…again, no swallow, and you dilute to taste.
swish and spit orally, and Q tip bulb cleaning out nostrils etc. as far as can go.
We have added PI to the early treatment regimen at the top box if you look carefully for in some sense, if this is done routinely, one can argue there may be no need for early treatment and you can effectively stave off COVID and cold virus etc. routinely. Completely. Hydrogen peroxide (and there are oral versions too I have seen at least one) is used by some who find PI too bitter, but remember, no swallow and you dilute it.
This can be purchased OTC. Oral dental surgeons etc. came forward and informed us they use similar programs before COVID to clean nostrils and mouths as they are inside people mouths daily in surgery and they use this as their own protection. Keeps them safe. We then dug further and studied it and boy, had we known earlier, this would have been out there to help protect more, even before early treatment. It defies logic why public health will not tell people these solutions that saves lives including for vitamin D.
“Can povidone iodine gargle/mouthrinse inactivate SARS-CoV-2 and decrease the risk of nosocomial and community transmission during the COVID-19 pandemic? An evidence-based update”
Aditi Chopra 1, Karthik Sivaraman 2, Raghu Radhakrishnan 3, Dhanasekar Balakrishnan 2, Aparna Narayana 2
Enhanced treatment on FLCCC for BA.4 & BA.5 variants:
Heliobas Disciple
TB Fanatic
It is a 'pandemic of the VACCINATED', we told you this! Geert Vanden Bosche said this, Mike Yeadon said this, I, Dr. Paul Alexander said this, bad cattitude (el gato malo) leaned in hard (eloquent)...
gatopal, eugyppius; issue we argued is simple, the COVID vaxx damages innate/adaptive immunity, drives enhanced infection in vaxxed; see the Germany, UK, and Israel cases as of today; BA.5 problem!
palexander.substack.com
It is a 'pandemic of the VACCINATED', we told you this! Geert Vanden Bosche said this, Mike Yeadon said this, I, Dr. Paul Alexander said this, bad cattitude (el gato malo) leaned in hard (eloquent)...gatopal, eugyppius;
issue we argued is simple, the COVID vaxx damages innate/adaptive immunity, drives enhanced infection in vaxxed; see the Germany, UK, and Israel cases as of today; BA.5 problem!
Dr. Paul Alexander
7 hr ago
What am I saying?
If our immune response is subverted and damaged by these COVID injections as they have been with repeat boosting, then we run the risk of this pandemic going on for 100 years with infectious variant after infectious variant and potentially a lethal virulent one that could devastate humanity. COVID will never ever end and I am beginning to sound conspiracy by saying I do think these people like Fauci and Bourla cannot be that stupid and inept. This is being done deliberately at some level. We see that sub-variant after sub-variant is posing escalating infection risk in those vaccinated (whether mRNA or adenoviral vector injections). Seems like this will go on in perpetuity. Long-term, no end in sight.
Mass vaccination has made things devastatingly worse. We told them to stop, over and over! You never ever mass vaccinate while there is circulating pathogen.
We devastatingly underestimated the evolutionary capacity of the COVID virus to evolve and adapt to the sub-optimal immune pressure on the spike. We have underestimated the viral-host immune ecosystem, the complex interplay. You cannot study or debate or assess the devastation of these fraud COVID injections without considering the virus-host ecosystem. It is not simply properties intrinsic to the virus that is causing the immune escape and infection in the vaccinated. These idiots like Fauci and Bourla and Njoo and Tam and Walensky must not exclude the definitive impact of the non-neutralizing antibodies on the target antigen.
Moreover, we have to consider that recent omicron sub-variants such as BA.4 and BA.5 may be completely novel COVID viruses and not necessarily variants of the omicron. It is evading immunity massively so we need to consider this. This then will limit natural immunity yet prior infection and recovery may offer some level of protection. We need to quickly consider and assess this. The key issue as we have said day one, is that these sub-optimal flawed failed fraud of COVID vaccines is driving this. This is why we called, one year now, to stop these COVID vaccines. Immediately!
I will remind what Geert Vanden Bossche is developing and saying, that currently, while sub-optimal vaccine induced antibodies (Abs) to omicron enhances infection in the upper respiratory tract (URT), and at the same time reduces severity in the lower respiratory tract (LRT) (blocks transfection or transmission of infection from infected cells to non-infected cells in the LRT), this ‘nature’s gift’ we thought we had will not go on much longer. Severe disease is coming soon in the LRT, deep inside the lungs. The very same vaccinal Abs to omicron that is blocking severe disease in the LRT, is subjected to sub-optimal immune pressure that will drive variants to overcome this pressure. Geert explains (based on published research) that these non-neutralizing Abs in the LRT are linked to the formation of syncytia that is correlated to severe illness.
I will say it again (standing on shoulders of GVB): it is the mass vaccination into a pandemic as we did here in February 2021, using a non-sterilizing vaccine (vaccinal antibodies that do not neutralize/sterilize the virus where the virus became largely resistant to the vaccinal antibodies) that pressures the spike (infectiousness of the virus) as there is massive infectious pressure. This mounting ‘immature’ host immune pressure on the spike via a non-neutralizing injection is the key devastating issue. This drives selection pressure to select the most infectious fittest variants that would become enriched in the environment and proliferate and be the new dominate variant/clade/sub-variant e.g. Omicron BA.5.
There is consequent antibody-dependent enhancement of infection (ADEI) where the vaccinated gets massively infected post vaccine, and original antigenic sin (OAS) that I renamed mortal antigenic sin (MAS) as the initial imprinting, priming, exposure prejudices the immune response life-long to the initial antigen/exposure or similar. The recall antibodies are to the initial Wuhan legacy strain and not the current omicron clade.
Yahi et al. has presented intriguing research showing that the vaccinal antibodies bind to the virus’s spike receptor binding domain and/or N-terminal domain (binding sites) yet cannot sterilize the virus (eliminate it, stopping infection or transmission). This binding was shown to actually facilitate and enhance infection in the vaccinated (ADEI).
SOURCE:
Yahi et al.: Infection-enhancing anti-SARS-CoV-2 antibodies recognize both the original Wuhan/D614G strain and Delta variants. A potential risk for mass vaccination?
Updated case graphs:
I have included the case data for UK up to week 13 this year (below), March 2022, in which the data was so bad, that the UK government stopped reporting the double and boosted vaccinated persons. The data was catastrophic showing how vulnerable the vaccinated were.
COVID-19 vaccine surveillance report Week 13 31 March 2022
Week 13 Infection:
Week 12 infections
Week 11 infections
Week 10 infections
Week 9 infections
Week 8 infections
Week 7 infections
Week 6 infections
Week 5 infection
Week 4 infections
Week 3 infections
psychgirl
Has No Life - Lives on TB
A friend of mine lives in the San Antonio area of Texas. Our in the boonies on a huge, private ranch.
Yeah, they’re wealthy lol. (Rancher type, with their own vineyard and heliport)
Anyway she’s sick with Covid now for the first time and I’m almost 95% sure they’re vaccinated but I’ve not gotten nosy enough to ask her.
She said she’s the sickest she’s ever been, but yet has tested three times negative for Covid. One was a PCR.
Shes now lost her taste and smell and they think, her negatives were “false results” due to her symptoms.
But the big thing she did say was that this next wave of Covid is really getting bad in area; they have 900 reported cases so far.
I’m wondering if this new variant is also able to escape detection on the tests we’ve been using?
Yeah, they’re wealthy lol. (Rancher type, with their own vineyard and heliport)
Anyway she’s sick with Covid now for the first time and I’m almost 95% sure they’re vaccinated but I’ve not gotten nosy enough to ask her.
She said she’s the sickest she’s ever been, but yet has tested three times negative for Covid. One was a PCR.
Shes now lost her taste and smell and they think, her negatives were “false results” due to her symptoms.
But the big thing she did say was that this next wave of Covid is really getting bad in area; they have 900 reported cases so far.
I’m wondering if this new variant is also able to escape detection on the tests we’ve been using?
Zoner
Veteran Member
Parents aren't running to have their infants and kids jabbed from what I'm reading. That's good news. But too many are running with the herd.Exactly. People's immune systems get trained to recognize and fight off the virus ,as the naturally immune are beginning to do with Omicron and hopefully future variants. The problem is that there aren't enough naturally immune (vs vaccinated) to achieve herd immunity. The last hope was the kids as a huge reservoir to help achieve herd immunity, and the new vaxx push for kids will deplete that too.
HD
I believe Geert is aware of the data that is being produced in regard to BA 5 and variants that are even now breaking out and have not hit the media yet. I think that is what has enabled him to say in his last interview - 4 weeks and then to be safe said 2 months. He knows something imho. That is why in that last interview he said he is now getting his family ready and prepared. A virulent strain of Covid PLUS a Flu Epidemic is going to rage in our world in the very near future. Combine this with war drums getting louder with China, Russia, Iran and S. Korea ..... well we just need to enjoy and thank God for the day we have today.
He said, "Therefore do not worry, saying, ‘What shall we eat?’ or ‘What shall we drink?’ ... For your heavenly Father knows that you need all these things. But seek first the kingdom of God and His righteousness, and all these things shall be provided for you. Therefore do not worry about tomorrow ... sufficient for the day is its own trouble." Matthew 6:31
Zoner
Veteran Member
No matter what they discover that could help, prevent or cure, tptb will not allow it, just like they did with Ivermectin.(fair use applies)Scientists Target a Human Protein To Squash COVID-19 and Other Viruses
More than two years after the COVID-19 pandemic began, people are realizing that the “new normal” will probably involve learning to co-exist with SARS-CoV-2 (the virus that causes COVID-19 disease). Some treatments are available, but with new variants emerging, researchers are looking toward new strscitechdaily.com
Scientists Target a Human Protein To Squash COVID-19 and Other Viruses
By American Chemical Society
June 29, 2022
Scientists have discovered that apratoxin S4, an anticancer drug candidate that targets a human protein, can interfere with the replication of many viruses, including SARS-CoV-2 and influenza A, offering a possible pan-viral therapy.
More than two years after the COVID-19 pandemic began, people are realizing that the “new normal” will probably involve learning to co-exist with SARS-CoV-2 (the virus that causes COVID-19 disease). Some treatments are available, but with new variants emerging, researchers are looking toward new strategies. In research published today (June 29, 2022) in the journal ACS Infectious Diseases, scientists report that apratoxin S4, an anticancer drug candidate that targets a human protein, can interfere with the replication of many viruses, including SARS-CoV-2 and influenza A, offering a possible pan-viral therapy.
Although a number of COVID-19 vaccines exist, some people who received the shots have still become sick with the disease, and only a fraction of the world’s population is vaccinated. That means effective treatments are still needed, and a few are now available that target the virus’s RNA polymerase — the enzyme it uses to make more of its own RNA inside human cells. But some of these drugs, such as remdesivir, don’t work unless given at very early stages of infection and can require injections.
Apratoxin S4 (structure shown here) is effective against SARS-CoV-2 in human cells and could be a pan-viral therapeutic. Credit: Adapted from ACS Infectious Diseases 2022, DOI: 10.1021/acsinfecdis.2c00008
In the search for new ways to treat COVID-19, various research teams have revisited drugs that are already known to fight other diseases, a strategy called “repurposing.” One such preclinical stage compound is apratoxin S4 (Apra S4), which is a molecule based on a natural product that has anti-cancer activity. Previous studies have shown that apratoxins can target a human protein called Sec61, which ensures that certain proteins are properly glycosylated and folded correctly. Since viruses don’t have their own machinery to do this, they hijack the process and force human cells to make functional viral proteins. Sec61 is essential for the influenza A, HIV and dengue viruses to cause infection, so Hendrik Luesch and colleagues wondered if apratoxins could be a broadly effective, pan-viral medication that could also combat SARS-CoV-2.
In tests with monkey and human cells exposed to SARS-CoV-2, the researchers discovered that treatment with Apra S4 reduced the number of infected cells compared with remdesivir treatment. The molecule was also effective against influenza A, Zika virus, dengue, and West Nile virus infections. Further testing revealed that Apra S4 didn’t prevent SARS-CoV-2 from entering cells, but it reduced the amount of viral protein that was produced and transported in cells, especially the spike protein, and it decreased viral RNA replication. With electron microscopy, the team observed that Apra S4 also largely blocked the formation of new viruses, with many vesicles in SARS-CoV-2-exposed monkey cells having no or very few brand-new viral particles in them. The researchers say more studies are needed, but these results suggest that Apra S4 and other inhibitors of the human Sec61 protein are broadly acting antivirals that could help in the fight against future pandemics.
Reference: “Sec61 Inhibitor Apratoxin S4 Potently Inhibits SARS-CoV‑2 and Exhibits Broad-Spectrum Antiviral Activity” 29 June 2022, ACS Infectious Diseases.
DOI: 10.1021/acsinfecdis.2c00008
The authors acknowledge funding from the National Institutes of Health, the Debbie and Sylvia DeSantis Chair professorship, the Department of Defense, the Dengue Human Immunology Project Consortium, philanthropic donations, JPB Foundation, the Open Philanthropy Project and the Swiss National Science Foundation.
Zoner
Veteran Member
These tests are a joke. In Geert's last interview he was talking to a Dr. who does testing and they both said there is only one sure test but I can't remember what it is. I'll go see if I can find it.