CORONA Main Coronavirus thread

[Heliobas Disciple]

Posting here not on the monkeypox thread because this is from Igor Chudov who usually posts about covid and who I read avidly, but if anyone wants to copy it over, please do.

Are "Monkeypox Vaccines" Safe and Effective?

Old vaccine is unsafe and ineffective -- new one had NO effectiveness testing at all!

igorchudov.substack.com

(fair use applies)


Are "Monkeypox Vaccines" Safe and Effective?
Old vaccine is unsafe and ineffective -- new one had NO effectiveness testing at all!
Igor Chudov
6 hr ago

Much noise is currently being made about monkeypox.

Monkeypox is the little brother of smallpox, a terrifying illness of the past, that covered patients with lesions, left scars, left many people blind, and killed 15-30% of infected people. Smallpox has been declared eradicated in the world in 1979.

Monkeypox exceeded 7,000 cases in the United States as of the beginning of Aug 2022, and produces very painful lesions that break out with pus and are contagious. A vaccine is being pushed on people. It is advertised to prevent monkeypox.

https://twitter.com/i/web/status/1530235402157686784

View: https://mobile.twitter.com/CDCgov/status/1530235402157686784
CDC @CDCgov
Monkeypox cases have been reported in many countries where it doesn’t occur naturally, incl. the U.S. Learn more about ACIP’s recommendation for the JYNNEOS vaccine for those at risk for exposure through their jobs, like #HCPs treating monkeypox patients: bit.ly/MMWR7122e1

May 27th 2022
273 Retweets1,646 Likes

I wanted to share what I know about poxvirus vaccines in relation to monkeypox and will discuss whether they will work at all.

There are two main vaccines that are used to target the orthopoxvirus family (smallpox and monkeypox belong to this family). I will describe both.

Old Vaccinia Virus-Based Inoculations

The old-style vaccinia-based inoculations against smallpox were the reason why older people have a scar on their right or left arm. These were live virus infections, done with a “vaccinia” virus that is related to, but different from smallpox.

For a history of smallpox inoculations and anti-smallpox-vaccine protests, please read this article by A Midwestern Doctor:

The Forgotten Side of Medicine​

The smallpox pandemic response was eerily similar to COVID​

If you would like to know more about me, the mission of this substack, or how you can contribute, please read this introductory post. Note: The second part of this article (a more detailed summary of early observations of the effects of the vaccines by holistic doctors of the time) can be found…​

6 months ago · 361 likes · 255 comments · A Midwestern Doctor​

I am not going to delve into a very long history of smallpox inoculations. Anyone with a few hours of spare time is highly advised to explore it. It is fascinating.

What I want to do instead is show that these vaccinia smallpox inoculations, by now over 50 year old in anyone who even had them, are unlikely to work against monkeypox.

Check out this article, “… Failure of Childhood Smallpox Vaccination to Provide Complete Immunity”:



The article discusses the famous 2003 Midwest monkeypox outbreak. It shows that among monkeypox patients, there were those older than 31 years of age (as of 2003), most of whom, like me, were vaccinated against smallpox during childhood.

From the table below, we can see that cases, including “moderate-to-severe cases”, happened among smallpox-vaccinated, as well as unvaccinated people.



It is not possible to conclude, from the data presented in the above article, whether childhood smallpox vaccinations provided any protection against getting infected with monkeypox, at all. The article dealt with people who handled monkeypox-infected imported exotic African animals, where possibly more were young and smallpox-unvaccinated to begin with, and without a wide sample of people properly randomized in a clinical trial.

There were fewer “severe cases” among the vaccinated. So, the smaller number of severe cases gives hope of some effect of vaccination on severity, but this difference did not have any statistical significance.

What is clear is that, at the very least, childhood smallpox vaccinations failed to prevent the vaccinees from getting infected with monkeypox. This Midwest outbreak happened 19 years ago, so the childhood smallpox vaccinations that the over-50-year-old people had, aged by exactly 19 years since 2003, and are unlikely to perform any better!

Be aware that even the most modern Vaccinia-based inoculations are extremely immunogenic and lead to an extremely high rate of myocarditis and pericarditis, eczema, and other severe adverse effects. From CDC:

Because ACAM2000 is replication-competent, there is a risk for serious adverse events (e.g., progressive vaccinia and eczema vaccinatum) with it; myopericarditis also occurs with ACAM2000 (estimated rate of 5.7 per 1,000 primary vaccinees based on clinical trial data), but the underlying mechanism is unknown (7,8).​

We all know how Covid vaccines cause myocarditis among young men at the rate of about 1 in 2,000, right? That’s totally terrible! But the ACAM2000 vaccine causes myopericarditis at the rate of 1 per 175 people, or at a 10-12 times greater rate! Since monkeypox is not particularly deadly, it is better to have monkeypox than be infected with the vaccinia virus, if given a choice, in my opinion.

JYNNEOS Vaccine — No Effectiveness Testing Done at All

The second type of vaccine is a so-called JYNNEOS vaccine, which is based on a live virus (Modified Vaccinia Ankara) that is NOT replication competent in humans. So, an inoculation with JYNNEOS does not give rise to an active infection, unlike a vaccinia-based inoculation that creates a live infection. Usually, such replication-incompetent vaccines also create less immune protection than live vaccines, trading effectiveness for fewer adverse events.

The problem with Jynneos is that there were literally no randomized controlled trials on whether it prevents infection. Not a single trial participant was exposed to any live smallpox or monkeypox virus challenge. That is understandable: the smallpox virus is too dangerous to be used in any kind of trial for ethical and epidemiological reasons, and exposing participants to a challenge with monkeypox may also be unethical. However, the bottom line is that JYNNEOS was not really tested properly.

While I am appreciative of the ethical problems of testing vaccines against contagious diseases that do not circulate, it is important to make it clear: JYNNEOS was never subject to a randomized controlled efficacy trial.

All that the vaccine company-sponsored scientists did, was give test subjects JYNNEOS and then record “antibodies” and other immune reactions.

Note: Pfizer and Moderna do the same with endless “Covid vaxx” proposals that they present to the FDA. They pick a small number of participants like children under 5, give them the covid vaccine shots, and count antibodies. Those covid vaccine antibodies are only good for counting and receiving federal money. They do not prevent infection — instead they promote infections — and no longer even reduce disease severity. FDA calls this “immunobridging”. Are JYNNEOS antibodies different? I have no idea, but I am not optimistic.

The FDA recommendation is also clear that they are shooting in the dark and is the most ridiculous document I have seen after the 0-5-year-old Covid vaccine papers:



They had no certainty about anything, their certainty level bounces from “very low certainty” to “low certainty” and only once “medium certainty”, but they unanimously approved JYNNEOS, anyway. Why? Because science and $$$$.

So, how does JYNNEOS work in real life? It started to be given out only a few weeks ago. This graph gives a glimpse of how “well” it works. Even though the monkeypox vaccination barely started, and most vaccine recipients had not encountered a chance to be infected, some Jynneos-vaccinated persons already got monkeypox. (MVA-BN is the same as Jynneos)



We are fortunate that monkeypox does not seem to be very deadly. I am not convinced that any of the above-described “vaccines” make their recipients better off with respect to monkeypox.

Future of Monkeypox

Many people, when discussing monkeypox, seem to be stuck on gay people a little bit too much. It is spreading among gays, because some gay people like partying and go to certain kinds of “saunas” and have many sex partners and have close unprotected sex. But some non-gay people, for example, prostitutes, also have many sex partners. Condoms may not even protect against monkeypox if the lesions are on the skin.

The prostitutes, for example, can pass monkeypox to their family members. Some of these family members belong to high school wrestling teams and also have close contacts with other school students — without any sex acts involved.
So, if it is contagious and passes via close contact, it will not be a gay-people-only disease.

The good news is that so far, no one in the US died from monkeypox.



Have fun, people, but do not have too much fun!

 

[Zoner]

I'm not sure I understand your question. If you look at your question to me, you posted the link. ???? Do you mean the link to his linkedin article? He said in the substack that article was taken down so I assume no link, he reposed it in full in the substack (again, linked in my original post and in your question). If I'm misunderstanding your question please ask it again!

HD

Thanks HD. I thought it was the article but it didn’t seem much like an article. I mean what is the trigger that’s going to cause 100 million deaths?

 

[psychgirl]

Posting here not on the monkeypox thread because this is from Igor Chudov who usually posts about covid and who I read avidly, but if anyone wants to copy it over, please do.

Are "Monkeypox Vaccines" Safe and Effective?

Old vaccine is unsafe and ineffective -- new one had NO effectiveness testing at all!

igorchudov.substack.com

(fair use applies)


Are "Monkeypox Vaccines" Safe and Effective?
Old vaccine is unsafe and ineffective -- new one had NO effectiveness testing at all!
Igor Chudov
6 hr ago

Much noise is currently being made about monkeypox.

Monkeypox is the little brother of smallpox, a terrifying illness of the past, that covered patients with lesions, left scars, left many people blind, and killed 15-30% of infected people. Smallpox has been declared eradicated in the world in 1979.

Monkeypox exceeded 7,000 cases in the United States as of the beginning of Aug 2022, and produces very painful lesions that break out with pus and are contagious. A vaccine is being pushed on people. It is advertised to prevent monkeypox.

https://twitter.com/i/web/status/1530235402157686784

View: https://mobile.twitter.com/CDCgov/status/1530235402157686784
CDC @CDCgov
Monkeypox cases have been reported in many countries where it doesn’t occur naturally, incl. the U.S. Learn more about ACIP’s recommendation for the JYNNEOS vaccine for those at risk for exposure through their jobs, like #HCPs treating monkeypox patients: bit.ly/MMWR7122e1

May 27th 2022
273 Retweets1,646 Likes

I wanted to share what I know about poxvirus vaccines in relation to monkeypox and will discuss whether they will work at all.

There are two main vaccines that are used to target the orthopoxvirus family (smallpox and monkeypox belong to this family). I will describe both.

Old Vaccinia Virus-Based Inoculations

The old-style vaccinia-based inoculations against smallpox were the reason why older people have a scar on their right or left arm. These were live virus infections, done with a “vaccinia” virus that is related to, but different from smallpox.

For a history of smallpox inoculations and anti-smallpox-vaccine protests, please read this article by A Midwestern Doctor:

The Forgotten Side of Medicine​

The smallpox pandemic response was eerily similar to COVID​

If you would like to know more about me, the mission of this substack, or how you can contribute, please read this introductory post. Note: The second part of this article (a more detailed summary of early observations of the effects of the vaccines by holistic doctors of the time) can be found…​

6 months ago · 361 likes · 255 comments · A Midwestern Doctor​

I am not going to delve into a very long history of smallpox inoculations. Anyone with a few hours of spare time is highly advised to explore it. It is fascinating.

What I want to do instead is show that these vaccinia smallpox inoculations, by now over 50 year old in anyone who even had them, are unlikely to work against monkeypox.

Check out this article, “… Failure of Childhood Smallpox Vaccination to Provide Complete Immunity”:



The article discusses the famous 2003 Midwest monkeypox outbreak. It shows that among monkeypox patients, there were those older than 31 years of age (as of 2003), most of whom, like me, were vaccinated against smallpox during childhood.

From the table below, we can see that cases, including “moderate-to-severe cases”, happened among smallpox-vaccinated, as well as unvaccinated people.



It is not possible to conclude, from the data presented in the above article, whether childhood smallpox vaccinations provided any protection against getting infected with monkeypox, at all. The article dealt with people who handled monkeypox-infected imported exotic African animals, where possibly more were young and smallpox-unvaccinated to begin with, and without a wide sample of people properly randomized in a clinical trial.

There were fewer “severe cases” among the vaccinated. So, the smaller number of severe cases gives hope of some effect of vaccination on severity, but this difference did not have any statistical significance.

What is clear is that, at the very least, childhood smallpox vaccinations failed to prevent the vaccinees from getting infected with monkeypox. This Midwest outbreak happened 19 years ago, so the childhood smallpox vaccinations that the over-50-year-old people had, aged by exactly 19 years since 2003, and are unlikely to perform any better!

Be aware that even the most modern Vaccinia-based inoculations are extremely immunogenic and lead to an extremely high rate of myocarditis and pericarditis, eczema, and other severe adverse effects. From CDC:

Because ACAM2000 is replication-competent, there is a risk for serious adverse events (e.g., progressive vaccinia and eczema vaccinatum) with it; myopericarditis also occurs with ACAM2000 (estimated rate of 5.7 per 1,000 primary vaccinees based on clinical trial data), but the underlying mechanism is unknown (7,8).​

We all know how Covid vaccines cause myocarditis among young men at the rate of about 1 in 2,000, right? That’s totally terrible! But the ACAM2000 vaccine causes myopericarditis at the rate of 1 per 175 people, or at a 10-12 times greater rate! Since monkeypox is not particularly deadly, it is better to have monkeypox than be infected with the vaccinia virus, if given a choice, in my opinion.

JYNNEOS Vaccine — No Effectiveness Testing Done at All

The second type of vaccine is a so-called JYNNEOS vaccine, which is based on a live virus (Modified Vaccinia Ankara) that is NOT replication competent in humans. So, an inoculation with JYNNEOS does not give rise to an active infection, unlike a vaccinia-based inoculation that creates a live infection. Usually, such replication-incompetent vaccines also create less immune protection than live vaccines, trading effectiveness for fewer adverse events.

The problem with Jynneos is that there were literally no randomized controlled trials on whether it prevents infection. Not a single trial participant was exposed to any live smallpox or monkeypox virus challenge. That is understandable: the smallpox virus is too dangerous to be used in any kind of trial for ethical and epidemiological reasons, and exposing participants to a challenge with monkeypox may also be unethical. However, the bottom line is that JYNNEOS was not really tested properly.

While I am appreciative of the ethical problems of testing vaccines against contagious diseases that do not circulate, it is important to make it clear: JYNNEOS was never subject to a randomized controlled efficacy trial.

All that the vaccine company-sponsored scientists did, was give test subjects JYNNEOS and then record “antibodies” and other immune reactions.

Note: Pfizer and Moderna do the same with endless “Covid vaxx” proposals that they present to the FDA. They pick a small number of participants like children under 5, give them the covid vaccine shots, and count antibodies. Those covid vaccine antibodies are only good for counting and receiving federal money. They do not prevent infection — instead they promote infections — and no longer even reduce disease severity. FDA calls this “immunobridging”. Are JYNNEOS antibodies different? I have no idea, but I am not optimistic.

The FDA recommendation is also clear that they are shooting in the dark and is the most ridiculous document I have seen after the 0-5-year-old Covid vaccine papers:



They had no certainty about anything, their certainty level bounces from “very low certainty” to “low certainty” and only once “medium certainty”, but they unanimously approved JYNNEOS, anyway. Why? Because science and $$$$.

So, how does JYNNEOS work in real life? It started to be given out only a few weeks ago. This graph gives a glimpse of how “well” it works. Even though the monkeypox vaccination barely started, and most vaccine recipients had not encountered a chance to be infected, some Jynneos-vaccinated persons already got monkeypox. (MVA-BN is the same as Jynneos)



We are fortunate that monkeypox does not seem to be very deadly. I am not convinced that any of the above-described “vaccines” make their recipients better off with respect to monkeypox.

Future of Monkeypox

Many people, when discussing monkeypox, seem to be stuck on gay people a little bit too much. It is spreading among gays, because some gay people like partying and go to certain kinds of “saunas” and have many sex partners and have close unprotected sex. But some non-gay people, for example, prostitutes, also have many sex partners. Condoms may not even protect against monkeypox if the lesions are on the skin.

The prostitutes, for example, can pass monkeypox to their family members. Some of these family members belong to high school wrestling teams and also have close contacts with other school students — without any sex acts involved.
So, if it is contagious and passes via close contact, it will not be a gay-people-only disease.

The good news is that so far, no one in the US died from monkeypox.



Have fun, people, but do not have too much fun!

Good article.
Brief and simple to understand yet hits on most of the pertinent points. He’s not running with his hair on fire and presents the information calmly.

 

[BUBBAHOTEPT]

San Diego covid deaths 41% double vaxxed and double boosted, and the rest of the stats are bad as well..... Ummmmm... Tis true?

 

[Heliobas Disciple]

Good article.
Brief and simple to understand yet hits on most of the pertinent points. He’s not running with his hair on fire and presents the information calmly.

I agree. Igor may be my favortie of all the substack authors I read. I'm going to be posting another article on monkeypox vaccines by Meryl Nass, another wonderful doctor (whose license was suspended for iirc treating with ivermectin). It will be with the substack articles.

HD

 

[Heliobas Disciple]

Californians are staying infected with the coronavirus for a long time. Here's why

Health officials recommend that anyone infected with the coronavirus isolate for at least 5 days — but for many, that timeline may be overly optimistic.

www.yahoo.com

(fair use applies)


Californians are staying infected with the coronavirus for a long time. Here's why
Rong-Gong Lin II, Luke Money - LA Times
Mon, August 8, 2022, 9:00 AM

Health officials recommend that anyone infected with the coronavirus isolate for at least five days. But for many, that timeline is becoming overly optimistic.

The isolation period, which the U.S. Centers for Disease Control and Prevention shortened in December from 10 days to five, is more a starting point than a hard-and-fast rule in California. According to the state Department of Public Health, exiting isolation after five days requires a negative result from a rapid test on or after the fifth day following the onset of symptoms or first positive test — a step not included in federal guidelines.

But many people don't start testing negative that early.

"If your test turns out to be positive after five days, don’t be upset because the majority of people still test positive until at least Day 7, to Day 10 even," Dr. Clayton Chau, director of the Orange County Health Care Agency, said during a briefing Thursday. "So that’s the majority. That’s the norm."

But even typical, longer isolation periods carry very real effects, such as keeping people away from family and friends and out of work. While it may be disruptive, isolating is intended to stymie the spread of the coronavirus.

Dr. Robert Kosnik, director of UC San Francisco's occupational health program, said at a campus town hall in July that there's an expectation people will test negative on Day 5 and can return to work the next day.

"Don't get your hopes up," Kosnik told his colleagues. "Don't be disappointed if you're one of the group that continues to test positive."

In fact, some 60% to 70% of infected people still test positive on a rapid test five days after the onset of symptoms or their first positive test, meaning they should still stay in isolation, Kosnik said.

"It doesn't significantly fall off until Day 8," he said.

A study published by the CDC in February found that 54% of patients had positive antigen tests between five and nine days after an initial diagnosis or the onset of symptoms, though "the proportion of positive results declined over time."

People with symptomatic COVID-19 were more likely to continue testing positive five to nine days after symptoms first appeared. In the study, 64% of symptomatic patients still tested positive in this time frame.

"However," the study noted, "a positive antigen test result does not necessarily mean that a person is infectious. Similarly, a negative test result does not necessarily mean that a person is not infectious. Nonetheless, a positive or negative antigen test might be a useful proxy for the risk for being infectious."

The proportion of positive test results “was lower after asymptomatic than symptomatic infection,” researchers found.
In general, the study said, “lower prevalence of positive test results over time and after asymptomatic infections might reflect lower infectiousness.”

Here's a summary on guidance for isolation from the California Department of Public Health, which are also requirements in Los Angeles County.

Day 0: Start of COVID-19 symptoms or the day of your first positive coronavirus test, if you're asymptomatic. Wear a highly protective mask around others if in the same room as others in your home.

Days 1-5: Remain in isolation.

Day 5: You can take a rapid test. If you test negative, don't have a fever and your symptoms are improving, you can exit isolation on Day 6.

Days 6-10: You can end isolation if your rapid test result — taken on Day 5 or later — is negative, you've been fever-free for 24 hours without taking fever-reducing medicines and your symptoms are improving or you don't have symptoms. The California Department of Public Health strongly recommends still wearing a well-fitting mask around other people until the end of Day 10. In L.A. County, it's a requirement that recently infected people who return to their workplace wear a mask through the end of Day 10.

Day 11: You can generally end isolation without needing a negative rapid test result. But if you still have a fever, stay isolated until 24 hours after the fever ends. And if you are immunocompromised or have had severe COVID-19, you might need to isolate longer.

"If you do not have access to an antigen test, then we feel pretty comfortable that 10 days after your symptoms start, you are no longer infectious," Orange County Deputy Health Officer Dr. Matthew Zahn said.

It's worth noting that the isolation guidance from the state Department of Public Health is stricter than what is issued by the CDC. Federal guidance says people can end isolation — without a negative test result — on Day 6 as long as they are fever-free for 24 hours without using fever-reducing drugs and other symptoms have improved; however, they should wear a well-fitting mask around people through the end of Day 10.

But the CDC guidance has come under criticism from some experts who say it's too lax.

Some people experience a recurrence of coronavirus-related symptoms or may start testing positive again. It can sometimes happen after taking Paxlovid, an anti-COVID oral medication that dramatically reduces the risk of hospitalization. But it also can happen without taking that medication.

The most recent notable example of Paxlovid "rebound" was President Biden, who again tested positive for the coronavirus over the weekend, just days after exiting isolation.

"I've got no symptoms, but I am going to isolate for the safety of everyone around me," he wrote on Twitter after his latest positive test.

Though the rebound issue no longer appears to be as rare as once thought, officials note that Paxlovid remains highly effective.

"Paxlovid still works. The goal of Paxlovid is to keep you from getting seriously ill and ending up in the hospital," Zahn said Thursday. "People who take Paxlovid don’t get as seriously ill and, if they have rebound symptoms, those rebound symptoms aren’t as severe."

If COVID-19 symptoms return, or rapid test results turn back positive after testing negative, the CDC recommends following isolation guidance again to reduce risk of coronavirus transmission to other people.

This story originally appeared in Los Angeles Times.

 

[Heliobas Disciple]

BioNTech expects Omicron-adapted vaccine deliveries as soon as October

BERLIN (Reuters) -BioNTech expects to begin deliveries of two Omicron-adapted vaccines as soon as October, which will help spur demand in the fourth quarter, the German biotech firm said on Monday as it reaffirmed its vaccine-revenue forecast for the year. However, booster campaigns using...

finance.yahoo.com

(fair use applies)


BioNTech expects Omicron-adapted vaccine deliveries as soon as October
by Patricia Weiss and Miranda Murray
Mon, August 8, 2022, 6:22 AM

BERLIN (Reuters) -BioNTech expects to begin deliveries of two Omicron-adapted vaccines as soon as October, which will help spur demand in the fourth quarter, the German biotech firm said on Monday as it reaffirmed its vaccine-revenue forecast for the year.

Demand for the vaccine, 3.6 billion doses of which have been shipped globally, is waning as most people in the Western world have received three or four shots already.

However, booster campaigns using upgraded shots specifically targeting the Omicron variant are expected to increase demand in autumn. Pending regulatory approval, BioNTech said, both of its adapted vaccines would be available in time for the campaigns.

Second-quarter revenue and net profit both dropped by around 40% from a year earlier, to 3.2 billion euros ($3.26 billion) and 1.672 billion euros, respectively.

The company reaffirmed its 2022 vaccine revenue guidance of 13 to 17 billion euros, down from 19 billion last year. Partner Pfizer at the end of last month forecast $32 billion in full-year COVID-19 vaccine sales.

"With our strong performance year to date, we believe to be well on track to achieve our previous financial guidance for the ongoing financial year," said Jens Holstein, chief financial officer of BioNTech.

The company acknowledged some uncertainty about what a severe shortage of natural gas, which it uses for the commercial production of its COVID-19 vaccine, would mean for operations but said it did not expect to be affected by the current shortage and is putting measures in place to mitigate risks.

BioNTech and Pfizer submitted one of the adapted vaccines, which targets the BA.1 subvariant, to the EU drugs regulator EMA last month, with delivery pending approval.

The other, targeting the BA.4 and BA.5 subvariants as recommended by the U.S. drug regulator, will begin clinical trials this month, with initial doses expected to be shipped also from as early as October.

($1 = 0.9817 euros)

 

[Heliobas Disciple]

Scientists Fear We’re Not Ready for Nightmare New COVID Variant

Photo Illustration by The Daily Beast/GettyA wave of COVID infections caused by the BA.5 subvariant has crested. All over the world, daily new cases, hospitalizations and deaths are going down.But the SARS-CoV-2 virus is almost certainly here to stay. Another wave is all but inevitable as new...

www.yahoo.com

(fair use applies)


Scientists Fear We’re Not Ready for Nightmare New COVID Variant
David Axe - Daily Beast
Sun, August 7, 2022, 9:22 PM

A wave of COVID infections caused by the BA.5 subvariant has crested. All over the world, daily new cases, hospitalizations and deaths are going down.

But the SARS-CoV-2 virus is almost certainly here to stay. Another wave is all but inevitable as new variants and subvariants mutate, compete for dominance, and find new transmission pathways.

How fast that wave comes, and how bad it gets, probably comes down to a genetic competition between different mutations of the novel coronavirus. If we get lucky, a mild form of the virus wins out—and buys us time to prepare for a worse form of the virus that’s almost certainly coming, sooner or later.

If we’re unlucky, that worse one comes sooner.

The scientific community is taking nothing for granted. “What we have learned from this pandemic is to expect the unexpected,” Cindy Prins, a University of Florida epidemiologist, told The Daily Beast.

BA.5, an offshoot of the basic Omicron variant, was still dominant when epidemiologists began looking for the version of COVID that might come after BA.5. They’ve identified two main possibilities.

The best of the likely possibilities is yet another form of Omicron, a variant our immune systems recognize and know how to beat. The worst is some brand-new variant that might slip right past our antibodies. A Pi, Rho or Sigma variant, if you will.

Either outcome is possible. The only thing experts don’t expect is for COVID to just… disappear. “The virus always figured out a way to survive,” John Swartzberg, a professor emeritus of infectious diseases and vaccinology at the University of California-Berkeley’s School of Public Health, told The Daily Beast. “I see nothing that suggests it’s not going to continue to do that.”

BA.5 is the third major subvariant of Omicron, itself the third major variant of the virus after Alpha and Delta. BA.1, the baseline Omicron, became dominant late last year, replacing forms of Delta.

BA.1 wasn’t as lethal as Delta was, owing mostly to widespread immunity from vaccines and past infection. The worst day for BA.1 deaths, 13,000 on Feb. 9, was less catastrophic than the worst day for Delta deaths, 18,000 on Jan. 20.

But BA.1 was way more contagious than Delta. Some epidemiologists described it as the most transmissible respiratory virus they’d ever seen. BA.1 drove a record wave of infections that peaked at nearly 4.1 million new cases globally on Jan. 19.

The BA.1 wave led to two smaller surges in cases as new Omicron subvariants took over. BA.1 cases subsided in February; BA.2 drove them back up in March. BA.2 infections eased in May. BA.5 drove them back up in June.

The BA.5 surge peaked with 1.6 million new cases on July 20 and 4,500 deaths on July 27. Now infections and deaths are dropping almost everywhere that isn’t Japan.

The relative decline in COVID belies what is, by our pre-pandemic standards, still widespread suffering. “It is quite a reflection of what we have faced during the past few years that we could be in a situation with more than 120,000 known new infections per day, more than 43,000 hospitalizations per day—with 5,000 in ICUs—and 450 deaths per day [in the U.S.] and be in a mindset where we are thinking, ‘This is not so bad, we have seen worse,’” Anthony Alberg, a University of South Carolina epidemiologist, told The Daily Beast.

And the reprieve is temporary. If the last 32 months are any guide, the next COVID wave will build this winter. The only variable is the form of the virus. Is the next dominant form of SARS-CoV-2 the fourth major Omicron subvariant? Or a totally new variant?

The distinction matters a lot. All the Omicron sublineages share certain key mutations, especially around the virus’ spike protein, the part of the pathogen that helps it grab onto and infect our cells.

By now billions of people have antibodies that recognize those mutations, whether the antibodies are from one of the safe and highly-effective vaccines or from past infection. It’s the steady build-up of immunity over the past two years that’s kept death rates down even as infection rates go up. A lot of people have caught COVID since last winter—some for the second or third time. Most had mild cases.

If yet another offspring of Omicron becomes dominant in the next few months, that trend should continue. There’ll probably be a weeks-long surge in cases. But deaths might increase only slightly.

Our antibodies are ready, said Edwin Michael, an epidemiologist at the Center for Global Health Infectious Disease Research at the University of South Florida who has built sophisticated computer models for simulating the COVID pandemic.

“Naturally acquired immunity is long lasting, estimated to 2.5 years in our models, and new infections mostly therefore arise in those losing their vaccine-induced immunity which decays faster,” Michael told The Daily Beast. “This results in a steady but smaller-sized rise and fall of cases, the fluctuations or oscillations getting progressively smaller in size over time until an apparent endemic steady state is reached.”

But if we get Pi, Rho or Sigma, brace for possible disaster.

New variants of a virus become dominant through radical mutations that significantly change how the pathogen behaves—and give it a leg-up over its predecessors. With every new variant, there’s a chance it’s changed so much that our antibodies no longer recognize it. “A major genetic shift that would greatly increase its ability to infect humans regardless of vaccination status and prior infections,” according to Alberg.

Epidemiologists call that “immune escape.” It’s the nightmare scenario when it comes to viruses.

Michael modeled the surge of a major immune-escape variant. How bad it gets depends on whether the new variant dodges vaccine-induced antibodies, natural antibodies from past infection or both. “If the immune evasiveness acts similarly on both forms of immunity, then you will get significantly large repeat waves forming depending on the exact rate and strength by which escape occurs,” Michael said.

There are reasons to believe another Omicron sublineage is likeliest to come next. Geneticists scrutinizing viral samples have noted four forms of Omicron vying for dominance in recent weeks. BA.5, of course. But also BA.5.2, BA.2.75 and BA.4.6.

BA.5.2 is a slightly mutated form of BA.5 and probably doesn’t have enough advantages to outcompete its predecessor, Kristian Andersen, director of infectious disease genomics at the Scripps Research Translational Institute in California, told The Daily Beast. “So I think we’ll see BA.2.75 or something completely different become dominant.”

That “something completely different” hasn’t showed up yet in viral surveillance, meaning BA.2.75 might have a head start.

If there’s a wild card, it might be BA.4.6, a subvariant of BA.4, which is a close cousin of BA.5. “We don’t know much about .4.6 in terms of structure,” Swartzberg said. It’s possible that BA.4.6 mutated for significant immune escape despite being just another Omicron subvariant. “We could wish for a new subvariant of Omicron that is so successful at evading immunity [that] it could be a serious problem for us.”

“Be careful what you wish for,” Swartzberg quipped.

Still, as long as Omicron and its offspring are dominant, there’s a decent chance the next COVID wave will be a fairly small one. That buys us time to prepare for the wave after that—and the increasing likelihood, over time, that some immune-evasive variant eventually shows up.

No one expects another round of major lockdowns, even with a highly immune-evasive new form of COVID raging across the planet. Instead, our best tool against Pi, Rho or Sigma might be new formulations of the messenger-RNA vaccines from Moderna and Pfizer.

MRNA is inherently flexible. It’s a plug-and-play delivery system for tiny scraps of genetic material that prompt a particular immune response. Change the genetic material and you change the vaccine—and the antibodies it induces.

The current mRNA vaccines were designed for the Alpha variant, although they still work really well against Delta and Omicron. Anticipating that an immune-escape variant is coming, both Pfizer and Moderna are working on new “multivalent” vaccine formulations with broader effectiveness against an even wider range of SARS-CoV-2 variants.

But these new formulations aren’t quite ready. Both Massachusetts-based Moderna and Pfizer in New York have run large-scale trials of their multivalent vaccines, but the U.S. Food and Drug Administration is still scrutinizing the data.

Whether and when the FDA approves new vaccine mixes, a precondition for health agencies in many other countries to do the same, could depend on whether and when an immune-escape variant shows up. Swartzberg said the new jabs could get FDA approval in around a month.

Obviously, regulators would prefer to study the new formulations without the pressure of a major surge in infections and deaths. And they just might get that, if the next wave is a BA.2.75 wave instead of something potentially much worse.

 

[Heliobas Disciple]

What is BA.4.6? The CDC tracks a new Omicron 'variant of concern'

The new COVID subvariant seems to be outperforming earlier Omicron strains in at least four U.S. states.

fortune.com

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What is BA.4.6? The CDC is tracking a new COVID ‘variant of concern’ that’s overtaking earlier Omicron strains in at least 4 U.S. states
BY Nicholas Gordon
August 4, 2022, 7:14 AM UTC


New lineages of the Omicron COVID variant, like BA.4 and BA.5, are helping spark a wave of reinfections, as people who previously caught COVID-19 contract COVID again.

Now the U.S. Centers for Disease Control and Prevention (CDC) is tracking a new “variant of concern”: BA.4.6. This week, the CDC included the BA.4 spinoff in its weekly tracking of COVID cases, with the agency’s chief data officer tweeting that the new subvariant had actually been “circulating for several weeks” in the U.S. The CDC designates strains as “variants of concern” if they display greater transmissibility, reduced effectiveness of treatment, increased severity, or decreased neutralization by antibodies.

According to the CDC, BA.4.6 made up 4.1% of COVID cases for the week ending July 30. The new variant is more prevalent in the region comprising Iowa, Kansas, Missouri, and Nebraska, where it makes up 10.7% of local cases. The mid-Atlantic region and the South are also seeing rates of BA.4.6 above the national average.

The new strain has also been detected in 43 other countries, according to outbreak.info, a community repository of COVID information.

BA.5, which one epidemiologist called “the worst version of the virus that we’ve seen” because of its increased transmissibility and ability to evade existing immunity is still dominant in the U.S., making up 85.5% of all COVID cases as of July 30. BA.4 and BA.5 are responsible for driving a global surge in COVID cases, including in places that had held off the virus until the current wave, like the Chinese city of Macau.

As of now, there isn’t much data as to whether BA.4.6 is better than BA.4 or BA.5 at evading immunity. Dr. Eric Topol, founder and director of the Scripps Research Translational Institute, tweeted on Tuesday that BA.4.6’s mutation “does not appear to be concerning [compared to] BA.4/5,” with only a handful of new mutations compared to the earlier subvariants.

Omicron-specific vaccines

Even if BA.4.6 isn’t significantly worse than existing strains, the speed at which new variants of concern are emerging is alarming public health officials who are planning for new vaccine boosters this fall.

On Friday, the U.S. Food and Drug Administration said that it would seek to approve boosters that directly target the BA.5 variant this autumn, rather than make more Americans eligible for a second booster based on the original 2020 strain of COVID. Currently, only Americans over age 50 are eligible for a second booster.

But new variants might make still-in-development boosters less effective by the time they’re finally ready. Dr. Anthony Fauci, the White House’s chief medical adviser, said the new boosters are trying to hit a “moving target” when it came to determining which variants to tackle.

The White House is now pushing for universal coronavirus vaccines that can target multiple variants at once. “These are vaccines that are going to be far more durable, that are going to provide far longer-lasting protection, no matter what the virus does or how it evolves,” Ashish Jha, the White House COVID-19 response coordinator, told Stat News after a July 25 summit on COVID vaccines.

Yet even with new vaccines on the way, experts say that Americans eligible for another booster should get one now, as opposed to waiting for a more tailored shot to come in the fall. A study published Tuesday found that a second booster cut the rate of breakthrough infections by 65% among Israeli health care workers.

 

[Heliobas Disciple]

BA.4.6: What do we know about the latest subvariant of omicron?

The subvariant is spreading in the Mid-West and has been seen in the South and Mid-Atlantic regions.

www.kiro7.com

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BA.4.6: What do we know about the latest subvariant of omicron?
By Debbie Lord, Cox Media Group National Content Desk
August 05, 2022 at 9:21 am PDT

The Centers for Disease Control and Prevention is tracking a new COVID-19 subvariant of concern that is spreading quickly in the United States.

The CDC began reporting on the omicron subvariant BA.4.6. this week, saying the new subvariant has been “circulating for several weeks” in the U.S., Fortune reported.

The subvariant is currently more prevalent in Iowa, Kansas, Missouri, and Nebraska, according to the CDC. It makes up 10.7% of all local cases in that region.

It is responsible for about 4% of all cases of COVID-19 in the United States.

The number of cases tracked to the BA.4.6 variant is also being seen in the mid-Atlantic region and the South.
Researchers are working to determine if BA.4.6, a mutation of omicron variant BA.4, is more contagious than the original omicron variant.

According to Dr. Eric Topol, founder and director of the Scripps Research Translational Institute, the BA.4.6′s mutation “does not appear to be concerning [compared to] BA.4/5.”

Bailey Glen, an assistant professor in the College of Medicine at the Medical University of South Carolina, said he has seen the BA.4.6 subvariant spreading.

“We see a BA.4.6 that we haven’t seen until now. There’s still lots of change going on. From a genetic perspective, it’s still rapidly adapting. It’s still just kind of wild how much it’s able to change and adapt.”

BA.4.6 has been detected in 43 other countries, according to outbreak.info.

While symptoms can vary, general symptoms of BA.4, of which BA.4.6 is a subvariant, include:

· Runny nose
· Sore throat
· Headache
· Persistent cough
· Fatigue

According to the ZOE COVID Study, fewer than one-third of people surveyed reported fevers with their COVID-19 infection.

 

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Virological characteristics of the SARS-CoV-2 Omicron BA.2.75

SARS-CoV-2 Omicron BA.2.75 emerged in May 2022. BA.2.75 is a BA.2 descendant but is phylogenetically different from BA.5, the currently predominant BA.2 descendant. Here, we showed that the effective reproduction number of BA.2.75 is greater than that of BA.5. While the sensitivity of BA.2.75 to...

www.biorxiv.org

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pdf of full study: https://www.biorxiv.org/content/10.1101/2022.08.07.503115v1.full.pdf


Virological characteristics of the SARS-CoV-2 Omicron BA.2.75
Akatsuki Saito, Tomokazu Tamura, Jiri Zahradnik, Sayaka Deguchi, Koshiro Tabata, Izumi Kimura, Jumpei Ito, Hesham Nasser, Mako Toyoda, Kayoko Nagata, Keiya Uriu, Yusuke Kosugi, Shigeru Fujita, Daichi Yamasoba, Maya Shofa, MST Monira Begum, Yoshitaka Oda, Rigel Suzuki, Hayato Ito, Naganori Nao, Lei Wang, Masumi Tsuda, Kumiko Yoshimatsu, Yuki Yamamoto, Tetsuharu Nagamoto, Hiroyuki Asakura, Mami Nagashima, Kenji Sadamasu, Kazuhisa Yoshimura, Takamasa Ueno, Gideon Schreiber, Akifumi Takaori-Kondo, The Genotype to Phenotype Japan (G2P-Japan) Consortium, Kotaro Shirakawa, Hirofumi Sawa, Takashi Irie, Kazuo Takayama, Keita Matsuno, View ORCID ProfileShinya Tanaka, Terumasa Ikeda, Takasuke Fukuhara, Kei Sato
doi: Virological characteristics of the SARS-CoV-2 Omicron BA.2.75

Abstract

SARS-CoV-2 Omicron BA.2.75 emerged in May 2022. BA.2.75 is a BA.2 descendant but is phylogenetically different from BA.5, the currently predominant BA.2 descendant. Here, we showed that the effective reproduction number of BA.2.75 is greater than that of BA.5. While the sensitivity of BA.2.75 to vaccination- and BA.1/2 breakthrough infection-induced humoral immunity was comparable to that of BA.2, the immunogenicity of BA.2.75 was different from that of BA.2 and BA.5. Three clinically-available antiviral drugs were effective against BA.2.75. BA.2.75 spike exhibited a profound higher affinity to human ACE2 than BA.2 and BA.5 spikes. The fusogenicity, growth efficiency in human alveolar epithelial cells, and intrinsic pathogenicity in hamsters of BA.2.75 were comparable to those of BA.5 but were greater than those of BA.2. Our multiscale investigations suggest that BA.2.75 acquired virological properties independently of BA.5, and the potential risk of BA.2.75 to global health is greater than that of BA.5.

 

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China closes Potala Palace after COVID-19 reported in Tibet

Chinese authorities have closed Tibet’s famed Potala Palace after a minor outbreak of COVID-19 was reported in the Himalayan region. The response underscores China’s continued adherence to its “zero-COVID” policy, mandating lockdowns, routine testing, quarantines and travel restrictions, even...

news.yahoo.com

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China closes Potala Palace after COVID-19 reported in Tibet
Mon, August 8, 2022, 11:32 PM

BEIJING (AP) — Chinese authorities have closed Tibet’s famed Potala Palace after a minor outbreak of COVID-19 was reported in the Himalayan region.

The action underscores China’s continued adherence to its “zero-COVID” policy, mandating lockdowns, routine testing, quarantines and travel restrictions, even while most other countries have reopened.

A notice on the palace’s Weixin social media site said the palace that was the traditional home of Tibet’s Buddhist leaders would be closed from Tuesday, with a reopening date to be announced later.

Tibet’s economy is heavily dependent on tourism and the Potala is a key draw.

China says its hard-line policy has been successful in preventing large-scale hospitalizations and deaths, while critics including the World Health Organization have decried its impact on the economy and society and said it is out of step with the changing nature of the virus and new methods of prevention and treatment.

China announced 828 new cases of domestic transmission on Tuesday, 22 of them in Tibet. The majority of those cases showed no symptoms.

Meanwhile, more than 80,000 travelers remain stranded on the southern resort island of Hainan under requirements that they consistently test negative for the virus in coming days before being allowed to leave.

 

[Heliobas Disciple]

China races to contain COVID outbreaks in tourism hubs Tibet, Hainan

SHANGHAI/BEIJING (Reuters) -China raced on Tuesday to stamp out COVID-19 outbreaks in the tourist hubs of Tibet and Hainan, with the authorities launching more rounds of mass testing and closing venues to contain the highly transmissible Omicron variant. Mainland China reported 828 new...

news.yahoo.com

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Chinese cities in Tibet begin mass COVID testing, Hainan cluster grows
by Roxanne Liu, Ryan Woo and Shanghai newsroom
Tue, August 9, 2022, 12:38 AM

SHANGHAI (Reuters) - Parts of Tibet are running mass COVID-19 testing on Tuesday, including the Chinese autonomous region's two largest cities, to fight a rare flare-up, while clusters were growing in tropical Hainan and in Xinjiang in China's west.

Subvariants of the highly transmissible Omicron are challenging China's strategy of swiftly blocking the spread of each nascent cluster. Regions that have seen relatively few cases for more than two years now battling outbreaks, raising the risk of persistent tight restrictions as the economy weakens.

Mainland China reported 828 new domestically transmitted cases for Aug. 8, official data showed on Tuesday. Over 70% of those cases were found in Hainan, one of the country's most popular tourist destinations, as well as Xinjiang, while the rest were reported across more than a dozen provinces and regions.

In Hainan, millions of residents are under lockdown across several cities and towns, allowed out only for necessary reasons such as COVID tests, grocery shopping and essential job roles. Around 178,000 tourists were also stranded in the southern island province, according to state media reports.

Provincial authorities must adopt all measures to achieve by Friday "COVID zero at the community level" where no new cases emerge in communities outside quarantined areas, Hainan's government said in a statement late on Monday.

Hainan's success in containing smaller clusters in April and July has resulted in complacency among officials and residents, one provincial health official said.

"We still have many shortcomings and weaknesses in COVID epidemiologic investigation, testing and treatment," Zhou Changqiang, the head of Hainan's health commission, told state television in a programme that aired late on Monday.

In Tibet, which had previously found only one symptomatic COVID infection in more than 900 days, local authorities reported one local patient with confirmed symptoms and 21 asymptomatic infections on Aug. 8.

Lhasa, Tibet's biggest city and provincial capital, has suspended large events and closed various entertainment and religious venues.

Tibet's second-largest city Shigatse has entered three days of curbs during which people are banned from entering or leaving, with many businesses suspended.

Lhasa and Shigatse are running a fresh round of mass testing, and the second round would begin on Wednesday, state television said on Tuesday.

In Tibet's Ngari prefecture, three towns have started three rounds of mass testing, while the remaining towns are in their first round, state television said.

As of Aug. 8, mainland China had logged a cumulative 231,665 cases with symptoms, including both local patients and those arriving from outside the mainland.

There were no new deaths reported on Aug. 8, keeping the nation's fatalities at 5,226.

China's capital Beijing, along with financial hub Shanghai and the southern technology centre of Shenzhen reported zero new local cases.

 

[Heliobas Disciple]

https://twitter.com/i/web/status/1556469022740332544

View: https://twitter.com/phuromnee/status/1556469022740332544


Paul Doodly @phuromnee

More died after vax than from virus in Taiwan

[GO TO LINK TO SEE VIDEO - 33 seconds]

10:35 PM · Aug 7, 2022

 

[Heliobas Disciple]

View: https://www.youtube.com/watch?v=NgiU8q_xf3g
SARS-CoV2 Spike Protein Expression in Mice Causes Damage via Innate Immune System (Update 158)
19 min 37 sec
Aug 8, 2022
MedCram - Medical Lectures Explained CLEARLY

Roger Seheult, MD of MedCram examines how SARS-CoV2 spike protein expression in mice causes damage to the heart via the innate immune system. See all Dr. Seheult's videos at: https://www.medcram.com (This video was recorded on August 7, 2022)


LINKS / REFERENCES:


Coronavirus Spike Protein Activated Natural Immune Response, Damaged Heart Muscle Cells (DAIC) | https://www.dicardiology.com/content/...

Toll-Like Receptors in Natural Killer Cells and Their Application for Immunotherapy (Hindawi) | Journal of Immunology Research...

Development of an Adeno-Associated Virus-Vectored SARS-CoV-2 Vaccine and Its Immunogenicity in Mice (Frontiers) | https://www.frontiersin.org/articles/...

View: https://youtu.be/9OZZ6_M4OB0

 

[Heliobas Disciple]

SARS-CoV-2 spike mutation that 'escapes' killer T-cells generated by infection and vaccination

U.K. scientists have highlighted a mutation in the spike protein of SARS-CoV-2 that allows the virus to evade important immune cells induced by infection and vaccines.

medicalxpress.com

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SARS-CoV-2 spike mutation that 'escapes' killer T-cells generated by infection and vaccination
by Cardiff University
August 8, 2022



Credit: Cardiff University

U.K. scientists have highlighted a mutation in the spike protein of SARS-CoV-2 that allows the virus to evade important immune cells induced by infection and vaccines.


The P272L Spike mutation first arose during the U.K.'s second wave of COVID-19, which began in September 2020, and has been pinpointed to the part of the spike protein most frequently recognized by killer T-cells. The SARS spike protein is also the basis for current vaccines.

The "escape mutation" has been found in more than 100 viral lineages to date, including those classed as "variants of concern." It has been seen in strains in the U.K. and Europe, and in Australia and the U.S. between September 2020 and March 2022.

When a mutation arises independently multiple times this raises concerns the virus is evolving for a reason such as immune escape.

Now, a new study led by Cardiff University and published in the journal Cell, has shown that the P272L Spike mutation escaped recognition by killer T-cells in a group of health care workers from south Wales infected with SARS-CoV-2 early in the pandemic. The mutation also evaded all T-cells raised against this part of the virus in donors that had been vaccinated.

The researchers say monitoring for "viral escape" is important—and if mutations like P272L start to dominate then future vaccines may need to be altered to include different viral proteins.

Lead author Professor Andrew Sewell, from Cardiff University's School of Medicine and Systems Immunity Research Institute, said: "We studied more than 175 different types of killer T-cells that could see the part of the virus containing the P272L mutation and were surprised to see that this one mutation resulted in escape in all the donors studied.

"Similar escape mutations have been seen in influenza viruses. It has been estimated the virus that caused the 1968 Hong Kong flu pandemic has mutated to escape from recognition by a type of killer T-cell once every three years."

In this study, P272L escaped from more than 175 T-cell receptors—both in the COVID patients and those who had been vaccinated.

Since the Cardiff study was completed, the mutation has been observed in the original omicron variant (BA.1) in England. This variant was outcompeted by other omicron variants (most recently BA.5) that are more transmissible, but the researchers anticipate that the killer T-cell escape mutant may arise and transmit in BA.5 and any subsequent variants.

Professor Tom Connor, an expert in SARS-CoV-2 genomics from Cardiff University's School of Biosciences and Systems Immunity Research Institute, said, "The P272L mutation has arisen in many different SARS-CoV-2 lineages since the start of the pandemic. The independent evolution of the same mutation in multiple viral lineages is an example of homoplasy, which may be suggestive of a mutation that could confer a selective advantage.

"I anticipate that we may see more occurrences of the P272L variant over time, as the virus continues its evolution into a human pathogen. Our work emphasizes how much we still have to learn about SARS-CoV-2, and the importance of monitoring T-cell escape in future."

Dr. Lucy Jones, clinical research lead from Cwm Taf Morgannwg University Health Board who collected the study samples, said, "Our study looked at recognition of the virus spike protein by the most common sort of killer T-cell across the population. If the P272L mutation comes to predominate in time, it might be advantageous to provide vaccine boosts with this new sequence or to extend vaccination to include other viral proteins.

"Current vaccines work well and should still be taken up by people, but our research suggests vaccines may need altering as we learn more about the virus."

 

[Heliobas Disciple]

New portable diagnostic detects SARS-CoV-2 RNA and antibodies at the same time

As the COVID-19 pandemic has run its course, the questions we have been asking ourselves have evolved: from "How do I know if I'm infected?" to "How strong is my immunity?" to "Which strain of the virus do I have?" And, as new variants continue to emerge, it's likely that we'll keep asking...

medicalxpress.com

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New portable diagnostic detects SARS-CoV-2 RNA and antibodies at the same time
by Harvard University
August 8, 2022

As the COVID-19 pandemic has run its course, the questions we have been asking ourselves have evolved: from "How do I know if I'm infected?" to "How strong is my immunity?" to "Which strain of the virus do I have?" And, as new variants continue to emerge, it's likely that we'll keep asking ourselves those questions, often at the same time.

Now, there's a way to get answers to all of them in a couple of hours, without needing to send samples to a lab. A new point-of-care diagnostic device created by members of the Wyss Institute for Biologically Inspired Engineering at Harvard University combines the Institute's eRapid and SHERLOCK technologies into a single, postcard-sized system that can simultaneously detect the presence of both SARS-CoV-2 RNA and antibodies against the virus in a patient's saliva, and potentially multiple other biomarkers.

"This diagnostic can enable cheaper, multiplexed monitoring of infection and immunity in populations over time, at levels of accuracy that are comparable to expensive lab tests," said co-first author Devora Najjar, a graduate student at the MIT Media Lab and the Wyss Institute. "Such an approach could dramatically improve the global response to future pandemics, and also provide insight into which treatment individuals should receive."

The prototype device is described in a new article published in Nature Biomedical Engineering.

Novel chemistry for a novel virus

The diagnostic was born from a collaboration between the labs of Wyss Core Faculty members Jim Collins, Ph.D., and Don Ingber, M.D., Ph.D., who is also the Institute's Founding Director. The eRapid team led by Ingber and Wyss Senior Staff Scientist Pawan Jolly, Ph.D., together with the SHERLOCK team led by Collins and Helena de Puig, Ph.D., a Wyss Postdoctoral Fellow, recognized that while SHERLOCK-based diagnostics can detect molecules with exquisite sensitivity, they were inherently limited by their fluorescence-based readout system. If they could figure out a way to translate the molecular detection of a CRISPR-based system like SHERLOCK into an electrochemical signal like that produced by eRapid, they could create a diagnostic with lab-level precision that could be used in a non-lab setting. They started building this hybrid device and chose Lyme disease as their target application. Within a few months, they had gotten it to work.

Then the COVID-19 pandemic hit.

"In the early days, everyone was working on developing diagnostics that could detect either the SARS-CoV-2 virus or antibodies against it, but not both. We knew that we could successfully detect the presence of DNA and RNA molecules electrochemically, thanks to our work on Lyme disease. We decided to figure out how to multiplex that with antibody detection in order to create an all-in-one test to help track infections and fight the pandemic," said de Puig, a co-first author of the paper.

But creating a platform that could integrate the detection of viral RNA and human proteins was a challenge. The team had to figure out how to perform two separate and very different types of molecular reactions simultaneously, then integrate them into one reporting system so that the results could be read at the same time.

They chose saliva as their sample material, because viral particles and antibodies can both be found there. For the SHERLOCK portion of the diagnostic, which detects the presence of SARS-CoV-2 RNA, the device needed to be able to extract, concentrate, and amplify viral RNA from a saliva sample, then mix it with CRISPR reagents and deliver the resulting solution to the eRapid chip portion for detection.

The team engineered a microfluidic system consisting of multiple reservoirs, channels and heating elements to automatically mix and transfer substances within the prototype device without needing input from a user. In the first chamber, saliva is combined with an enzyme that breaks open any viruses' outer envelopes to expose their RNA. Then the sample is pumped into a reaction chamber, where it is heated and mixed with loop-mediated isothermal amplification (LAMP) reagents that amplify the viral RNA. After 30 minutes of amplification, a mixture containing SHERLOCK reagents is added to the chamber, and then the sample is pumped onto an eRapid electrode.

In the absence of SARS-CoV-2 genetic material in the mixture, single-stranded (ssDNA) molecules with biotin attached to them bind to a molecule called peptide nucleic acid (PNA) on the electrode's surface. The biotin then binds to another molecule in the mixture called poly-HRP-streptavidin, which causes a third molecule, tetramethylbenzidine (TMB) to precipitate out of the liquid solution as a solid. When the solid TMB lands on the electrode, it changes its electrical conductivity. This change is detected as a difference in the amount of electrical current flowing through the electrode, indicating that the sample is free of the virus.

If any SARS-CoV-2 genetic material is present in the saliva sample, however, the CRISPR enzyme within the SHERLOCK mixture cuts it as well as the ssDNA. This cutting action separates the biotin molecule from the ssDNA, so that when the ssDNA binds to PNA, it does not trigger the series of reactions that causes the TMB to precipitate onto the electrode. Therefore, the conductivity of the electrode is unchanged, indicating a positive test result.

"The integration of the PNA-based assay with the poly-HRP-streptavidin/TMB reaction chemistry that we created for this device allowed us to detect the presence of SARS-CoV-2 with four times higher sensitivity than our original fluorescence-based SHERLOCK technology, and produced results in about the same amount of time," said co-first author Joshua Rainbow, Ph.D., a former Visiting Graduate Student at the Wyss Institute who is now a doctoral student at the University of Bath. "It was also able to detect the presence of viral RNA with 100% accuracy."

Greater than the sum of its parts

In parallel, the team customized the remaining three eRapid electrodes by studding them with different COVID-related antigens against which patients can develop antibodies: the S1 subunit of the Spike protein (S1), the ribosomal binding domain within that subunit (S1-RBD), and the N protein, which is present in most coronaviruses (N). If a patient's saliva sample contains one or more of these antibodies, they bind to their partner antigens on the electrodes. A secondary antibody that is attached to biotin will then bind to the target antibody, triggering the same poly-HRP-streptavidin/TMB reaction and causing a change in the electrode's conductivity.

The researchers tested these antibody-specific sensors using samples of human plasma from patients who had previously tested positive for SARS-CoV-2. The system was able to distinguish between antibodies against S1, S1-RBD, and N with over 95% accuracy.

"Being able to easily distinguish between different types of antibodies is hugely beneficial for determining whether patients' immunity is due to vaccines versus infection, and tracking the strength of those different immunity levels over time," said Sanjay Sharma Timilsina, Ph.D., a former Postdoctoral Fellow at the Wyss Institute who is now a Lead Scientist at StataDX. "Integrating that with viral RNA detection in a portable, multiplexed diagnostic platform provides a comprehensive view of a patient's health both during and after an infection, which is essential for implementing public policy and vaccination strategies." StataDX is commercializing eRapid for neurological, cardiovascular, and renal applications.

Finally, the team tested the combined viral RNA and antibody electrodes using saliva from SARS-CoV-2 patients. They split the saliva into two portions, adding one portion to the antibody reservoir and the second portion to the RNA reservoir of the device. After two hours, they measured the electrodes' readouts to see if they had correctly registered the presence of the antibodies and RNA.

The team found that the multiplexed chips correctly identified positive and negative RNA and antibody samples with 100% accuracy, at the same time. It was also ultra-sensitive, able to detect the presence of RNA down to 0.8 copies per microliter.

"Currently, there is a lack of low-cost diagnostic platforms that can enable accurate detection of multiple classes of molecules without requiring a trip to a lab. Our system offers the best of both worlds—high accuracy and low cost in a multiplexed platform—and could provide a lot of value to both patients and clinicians at the point of care. Plus, it's easily adaptable to a wide range of applications," said co-first author Jolly.

The prototype device's low cost and compact design is user-friendly and minimizes the number of steps a patient needs to perform, reducing the possibility of user error. Customized cartridges could be easily manufactured to detect antigens and antibodies from different diseases, and could be fit into a reusable housing and readout device that a user would keep in their home.

"What excites me about this diagnostic device is that it combines a high level of accuracy with a flexible design that could make it a major tool in our arsenal for addressing future pandemics," said co-senior author Collins, who is also the Termeer Professor of Medical Engineering & Science at MIT. In addition, Collins is a co-founder of Sherlock Biosciences, which is developing the Wyss Institute's SHERLOCK technology into diagnostics for COVID-19 and other diseases.

"I'm very proud of these teams for coming together during a global crisis that ground most activity to a halt, and creating something new and useful that offers great promise for point-of-care diagnosis and management of a broad range diseases around the world," said co-senior author Ingber, who is also the the Judah Folkman Professor of Vascular Biology at Harvard Medical School and Boston Children's Hospital, as well as the Hansjörg Wyss Professor of Bioinspired Engineering at the Harvard John A. Paulson School of Engineering and Applied Sciences.

Additional authors of the paper include Mohamed Yafia, Nolan Durr, and Hani Sallum from the Wyss Institute; Galit Alter from the Ragon Institute of MGH, MIT, and Harvard; Jonathan Li from Brigham and Women's Hospital (BWH), Xu Yu from the Ragon Institute and BWH, David Walt from the Wyss Institute, HMS, and BWH; Joseph Paradiso from the MIT Media Lab, and Pedro Estrela from the University of Bath.

 

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Identification of effective combination therapies for COVID-19 that may reduce the formation of novel variants

COVID-19 is anticipated to keep causing regular outbreak waves for the foreseeable future. The recent COVID-19 waves have caused fewer hospitalizations and deaths than the initial ones, which is largely due to the immunity provided by vaccines. However, many people have defects in their immune...

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Identification of effective combination therapies for COVID-19 that may reduce the formation of novel variants
by Anke Sauter, Goethe University Frankfurt am Main
August 8, 2022



Antiviral effects of approved anti-SARS-CoV-2 drugs in combination with interferon-β (betaferon) against delta, omicron BA.1, and omicron BA.2 isolates. Betaferon was tested in fixed combinations combination with remdesivir (A), EIDD-1931 (B), or nirmatrelvir (C) in SARS-CoV-2 (MOI 0.01)-infected Caco-2-F03 cells. Values represent mean ± S.D. of three independent experiments. D) Combination indices were calculated at the IC50, IC75, IC90, and IC95 levels following the method of Chou and Talalay. E) The weighted average CI value (CIwt) was calculated according to the formula: CIwt [CI50 + 2CI75 + 3CI90 + 4CI95]/10. A CIwt <1 indicates synergism, a CIwt =1 indicates additive effects, and a CIwt ˃1 suggest antagonism. Credit: Journal of Infection (2022). DOI: 10.1016/j.jinf.2022.07.023

COVID-19 is anticipated to keep causing regular outbreak waves for the foreseeable future. The recent COVID-19 waves have caused fewer hospitalizations and deaths than the initial ones, which is largely due to the immunity provided by vaccines. However, many people have defects in their immune systems and cannot effectively protect themselves from COVID-19 by vaccination. Such individuals depend on effective antiviral therapies when they are infected.


Moreover, resistance formation to antiviral drugs is known to happen quickly in viruses and has, for example, caused major problems with the treatment of HIV. However, more effective combination therapies can reduce or even prevent resistance formation.

The first resistance mutations have already been detected in samples of SARS-CoV-2, the coronavirus that causes COVID-19. Novel and resistant variants seem to predominantly emerge in individuals with immune defects, who suffer from long-term infections because they cannot effectively clear the virus. Thus, effective combination therapies are also needed that suppress the formation of new, resistant SARS-CoV-2 variants.

Currently, there are three approved antiviral drugs for the treatment of COVID-19: remdesivir, molnupiravir, and nirmatrelvir (the active agent in paxlovid). Moreover, aprotinin is an approved drug, whose anti-SARS-CoV-2 activity was discovered by the same research team, and it was recently shown to be beneficial in COVID-19 patients.

To find more effective COVID-19 therapies, an international team led by Professor Jindrich Cinatl (Institute of Medical Virology, Goethe-University), Professor Martin Michaelis, and Professor Mark Wass (both School of Biosciences, University of Kent) tested the sensitivity of different SARS-CoV-2 omicron and delta viruses to combinations of the four antiviral drugs with betaferon, which belongs to the interferons, an additional class of antiviral drugs that are also naturally produced in the body and protect it from virus infections.

The findings revealed that interferon combination with molnupiravir, nirmatrelvir, and aprotinin were much more effective than interferon combinations with remdesivir. This may explain why remdesivir/ interferon combinations have so far shown limited improvement compared to remdesivir alone. Based on the current findings, interferon combinations with the other three drugs are much more promising and should be tested in the clinics.

Professor Jindrich Cinatl (Goethe-University and Dr. Petra Joh Research Institute) added, "If these findings are confirmed in patients, I hope that more effective therapies will help us to reduce the formation of novel dangerous COVID-19 variants."

Professor Martin Michaelis, University of Kent, said, "These are exciting findings that will hopefully help to improve the treatment of vulnerable COVID-19 patients and to avoid the formation of resistant viruses as much as possible."

The study, "Synergism of interferon-beta with antiviral drugs against SARS-CoV-2 variants," has been published in the Journal of Infection.

 

[Heliobas Disciple]

Fatigue, headache among top lingering symptoms months after COVID

Fatigue and headache were the most common symptoms reported by individuals an average of more than four months out from having COVID-19, investigators report.

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Fatigue, headache among top lingering symptoms months after COVID
by Medical College of Georgia at Augusta University
August 8, 2022

Fatigue and headache were the most common symptoms reported by individuals an average of more than four months out from having COVID-19, investigators report.

Muscle aches, cough, changes in smell and taste, fever, chills and nasal congestion were next in the long line of lingering symptoms.

"Our results support the growing evidence that there are chronic neuropsychiatric symptoms following COVID-19 infections," Medical College of Georgia investigators write in the journal Brain, Behavior, & Immunity.

"There are a lot of symptoms that we did not know early on in the pandemic what to make of them, but now it's clear there is a long COVID syndrome and that a lot of people are affected," says Dr. Elizabeth Rutkowski, MCG neurologist and the study's corresponding author.

The published study reports on preliminary findings from the first visit of the first 200 patients enrolled in the COVID-19 Neurological and Molecular Prospective Cohort Study in Georgia, or CONGA, who were recruited on average about 125 days after testing positive for the COVID-19 virus.

CONGA was established at MCG early in the pandemic in 2020 to examine the severity and longevity of neurological problems and began enrolling participants in March 2020 with the ultimate goal of recruiting 500 over five years.

Eighty percent of the first 200 participants reported neurological symptoms with fatigue, the most common symptom, reported by 68.5%, and headache close behind at 66.5%. Just over half reported changes in smell (54.5%) and taste (54%) and nearly half the participants (47%) met the criteria for mild cognitive impairment, with 30% demonstrating impaired vocabulary and 32% having impaired working memory.

Twenty-one percent reported confusion, and hypertension was the most common medical condition reported by participants in addition to their bout with COVID-19.

No participants reported having a stroke, weakness or inability to control muscles involved with speaking, and coordination problems were some of the less frequently reported symptoms.

Twenty-five percent met the criteria for depression, and diabetes, obesity, sleep apnea and a history of depression were associated with those who met the criteria. Anemia and a history of depression were associated with the 18% who met the objective criteria for anxiety.

While the findings to date are not surprising and are consistent with what other investigators are finding, Rutkowski says the fact that symptoms reported by participants often didn't match what objective testing indicated, was surprising. And, it was bidirectional.

For example, the majority of participants reported taste and smell changes, but objective testing of both these senses did not always line up with what they reported. In fact, a higher percentage of those who did not report the changes actually had evidence of impaired function based on objective measures, the investigators write. While the reasons are not certain, part of the discrepancy may be a change in the quality of their taste and smell rather than pure impaired ability, Rutkowski says.

"They eat a chicken sandwich and it tastes like smoke or candles or some weird other thing but our taste strips are trying to depict specific tastes like salty and sweet," Rutkowski says. Others, for example, may rely on these senses more, even when they are preparing the food, and may be apt to notice even a slight change, she says.

Either way, their data and others suggest a persistent loss of taste and smell following COVID-19, Rutkowski and her colleagues write.

Many earlier reports have been based on these kinds of self-reports, and the discrepancies they are finding indicate that approach may not reflect objective dysfunction, the investigators write.

On the other hand, cognitive testing may overestimate impairment in disadvantaged populations, they report.

The first enrollees were largely female, 35.5% were male. They were an average of 44.6 years old, nearly 40% were Black and 7% had been hospitalized because of COVID-19. Black participants were generally disproportionately affected, the investigators say.

Seventy-five percent of Black participants and 23.4% of white participants met criteria for mild cognitive impairment. The findings likely indicate that cognitive tests assess different ethnic groups differently. And, socioeconomic, psychosocial (issues like family problems, depression and sexual abuse) and physical health factors generally may disproportionately affect Black individuals, the investigators write. It also could mean that cognitive testing may overestimate clinical impairment in disadvantaged populations, they write.

Black and Hispanic individuals are considered twice as likely to be hospitalized by COVID-19 and ethnic and racial minorities are more likely to live in areas with higher rates of infection. Genetics also is a likely factor for their increased risk for increased impact from COVID, much like being at higher risk for hypertension and heart disease early and more severely in life.

A focus of CONGA is to try to better understand how increased risk and effects from COVID-19 impact Blacks, who comprise about 33% of the state's population.

A reason fatigue appears to be such a major factor among those who had COVID-19 is potentially because of levels of inflammation, the body's natural response to an infection, remain elevated in some individuals. For example, blood samples taken at the initial visit and again on follow up showed some inflammatory markers were up and stayed up in some individuals.

These findings and others indicate that even though the antibodies to the virus itself may wain, persistent inflammation is contributing to some of the symptoms like fatigue, she says. She notes patients with conditions like multiple sclerosis and rheumatoid arthritis, both considered autoimmune conditions that consequently also have high levels of inflammation, also include fatigue as a top symptom.

"They have body fatigue where they feel short of breath, they go to get the dishes done and they are feeling palpitations, they immediately have to sit down and they feel muscle soreness like they just ran a mile or more," Rutkowski says.

"There is probably some degree of neurologic fatigue as well because patients also have brain fog, they say it hurts to think, to read even a single email and that their brain is just wiped out," she says. Some studies have even shown shrinkage of brain volume as a result of even mild to moderate disease.

These multisystem, ongoing concerns are why some health care facilities have established long COVID clinics where physicians with expertise in the myriad of problems they are experiencing gather to see each patient.

CONGA participants who reported more symptoms and problems tended to have depression and anxiety.

Problems like these as well as mild cognitive impairment and even impaired vocabulary may also reflect the long-term isolation COVID-19 produced for many individuals, Rutkowski says.

"You are not doing what you would normally do, like hanging out with your friends, the things that bring most people joy," Rutkowski says. "On top of that, you may be dealing with physical ailments, lost friends and family members and loss of your job."

For CONGA, participants self-report symptoms and answer questions about their general state of health like whether they smoked, drank alcohol, exercised, and any known preexisting medical conditions. But they also receive an extensive neurological exam that looks at fundamentals like mental status, reflexes and motor function. They also take established tests to assess cognitive function with results being age adjusted. They also do at-home extensive testing where they are asked to identify odors and the ability to taste sweet, sour, bitter, salty, brothy or no taste. They also have blood analysis done to look for indicators of lingering infection like those inflammatory markers and oxidative stress.

Neuropsychiatric symptoms are observed in the acute phase of infection, but there is a need for accurate characterization of how symptoms evolve over time, the investigators write.

And particularly for some individuals, symptoms definitely linger. Even some previously high-functioning individuals, who normally worked 80 hours a week and exercised daily, may find themselves only able to function about an hour a day and be in the bed the remainder, Rutkowski says.

The investigators are searching for answers to why and how, and while Rutkowski says she cannot yet answer all their questions, she can tell them with certainty that they are not alone or "crazy."

One of the best things everyone can do moving forward is to remain diligent about avoiding infection, including getting vaccinated or boosted to help protect your brain and body from long COVID symptoms and help protect others from infection, Rutkowski says. There is evidence that the more times you are infected, the higher the risk of ongoing problems.

Rutkowski notes that their study findings may be somewhat biased toward high percentages of ongoing symptoms because the study likely is attracting a high percentage of individuals with concerns about ongoing problems.

SARS-CoV-2 is thought to have first infected people in late 2019 and is a member of the larger group of coronaviruses, which have been a source of upper respiratory tract infections, like the common cold, in people for years.

At least part of the reason SARS-CoV-2 is believed to have such a wide-ranging impact is that the virus is known to attach to angiotensin-converting enzyme-2, or ACE2, which is pervasive in the body. ACE2 has a key role in functions like regulating blood pressure and inflammation. It's found on neurons, cells lining the nose, mouth, lungs and blood vessels, as well as the heart, kidneys and gastrointestinal tract. The virus attaches directly to the ACE2 receptor on the surface of cells, which functions much like a door to let the virus inside.

Experience and study since COVID-19 started both indicate immediate neurological impact can include loss of taste and smell, brain infection, headaches and, less commonly, seizures, stroke and damage or death of nerves. As time has passed, there is increasing evidence that problems like loss of taste and smell, can become chronic, as well as problems like brain fog, extreme fatigue, depression, anxiety and insomnia, the investigators write. Persistent conditions including these and others are now referenced as "long COVID."

 

[Heliobas Disciple]

Nationwide initiative will monitor wastewater for COVID-19, monkeypox, other diseases

Researchers at Stanford University and Emory University have launched a nationwide initiative to monitor monkeypox, COVID-19, and other infectious diseases in communities by measuring viral genetic material in wastewater. The effort will also provide health officials and the public with free...

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Nationwide initiative will monitor wastewater for COVID-19, monkeypox, other diseases
by Stanford University
August 8, 2022

Researchers at Stanford University and Emory University have launched a nationwide initiative to monitor monkeypox, COVID-19, and other infectious diseases in communities by measuring viral genetic material in wastewater. The effort will also provide health officials and the public with free, high-quality data, which is critical to informing public health decision making. The initiative is already producing data, including the first detections of monkeypox DNA in wastewater in the United States.

This new, Stanford-led effort, called WastewaterSCAN, significantly expands access to the analytical approach and public reporting developed by the scientists and 11 Northern California communities through the Sewer Coronavirus Alert Network (SCAN) that launched in November 2020. Beginning with the SARS-CoV-2 virus that causes COVID-19, SCAN has provided frequent information that is comparable over time and from place to place about the community levels of COVID-19, its variants, monkeypox, influenza A, and RSV to help shape public health responses to those infections.

The scientists leading WastewaterSCAN (Twitter: @WastewaterSCAN) were the first to report detections of genetic markers of the monkeypox virus in wastewater in the United States, which thus far are the only reported detections from wastewater monitoring. They began testing for monkeypox viral DNA at the 11 locations in Northern California on June 19, had the first two positive detections in plants serving parts of San Francisco the next day, and have found monkeypox viral DNA in wastewater from 10 sites.

As of today, 38 treatment plants in eight states are receiving monkeypox results from WastewaterSCAN and SCAN in addition to results for the SARS-CoV-2 virus that causes COVID-19 and its BA.4 and BA.5 variants, influenza A and RSV. In all, the team has detected monkeypox DNA in wastewater in 22 locations.

"Because it's population-based and unbiased by access to clinical testing, wastewater helps us understand infectious disease trends in a community. We've seen how valuable this can be as individual testing practices for SARS-CoV-2 have changed," said Alexandria Boehm, professor of civil and environmental engineering at Stanford. "Genetic material of the pathogens we monitor has been documented in excretions from infected people that end up in the wastewater treatment system."

The scientists at Stanford and Emory are working with Verily Life Sciences, which collaborates to optimize methods for high throughput, test samples, and produce data in its lab, and with local wastewater and public health officials to produce actionable data about COVID-19 and other pathogens. Communities in California, Colorado, Florida, Georgia, Idaho, Kentucky, Michigan, and Texas are participating thus far. The analytical approach does not measure infectious viruses in wastewater, but instead detects short pieces of the viral genomes.

"We need to rethink our paradigm for tracking infectious disease and anticipating new threats," said Marlene Wolfe, assistant professor of environmental health at Emory University and co-principal investigator for WastewaterSCAN. "We take the same sample of wastewater solids that we're already collecting—it's less than half a gram that represents up to millions of people in a community—and do a slightly different test for the next variant or the next pathogen."

Bradley White, lead scientist on Verily's public health efforts, including wastewater testing, said that providing rapid turnaround of sample results is critical to helping public health officials understand the community spread of these viruses, enabling more effective mitigation and treatment. "Together with Stanford and Emory scientists, we have created shareable, open-access protocols that enable knowledge transfer between academic, industrial, and government labs—and helps unlock a life-saving, new approach for viral disease surveillance," he said.

WastewaterSCAN is also partnering with the National League of Cities to support a cohort of 50 of its member cities as they implement wastewater monitoring and work to improve public health based on its results.

"As we saw during the COVID-19 pandemic, community leaders play a critically important role in proactively managing health crises—and this public health emergency is no different," said NLC CEO and Executive Director Clarence Anthony. "This partnership's work to expand access to wastewater monitoring tools will help cities, towns, and villages across the country lead their response efforts to the monkeypox outbreak equipped with data and a network of support."

Wastewater plants in participating communities sample three times a week and are provided with materials to ship the containers to Verily's lab for analysis including detection of viral genetic material with PCR-based technology. The results are made available on a public website within 48 hours of the samples' arrival.

The materials and shipping are free to the communities, and stipends are available to defray some labor costs for sampling. WastewaterSCAN's national expansion was made possible thanks to support from the Sergey Brin Family Foundation and Bloomberg Philanthropies. WastewaterSCAN aims to demonstrate the value of a national sentinel system using wastewater to inform public health measures and to support the establishment of publicly funded, durable public health infrastructure to prepare for future pandemics.

 

[Heliobas Disciple]

VSS Scientific Updates During Pandemic Times #32 | Voice for Science and Solidarity

VSS Scientific Updates During Pandemic Times #32 : Is COVID Prematurely Aging our Immune Systems? “The concern is that people will be less a

www.voiceforscienceandsolidarity.org

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VSS Scientific Updates During Pandemic Times #32
By Geert Vanden Bossche
August 8, 2022

1. Is COVID Prematurely Aging our Immune Systems?

“The concern is that people will be less able to hold off future bugs and pathogens like influenza, or that unsettled immune systems could lead to an increase in diabetes and other auto-immune diseases.”

Is COVID prematurely aging our immune systems?

2. Comparative Pathogenicity of SARS-CoV-2 Omicron Subvariants Including BA.1, BA.2, and BA.5

“Although in vitro growth kinetics of BA.5 is comparable among the Omicron subvariants, BA.5 become much more fusogenic than BA.1 and BA.2. The airway-on-a-chip analysis showed that the ability of BA.5 to disrupt the respiratory epithelial and endothelial barriers is enhanced among Omicron subvariants.”

Comparative pathogenicity of SARS-CoV-2 Omicron subvariants including BA.1, BA.2, and BA.5

3. NorthShore Reaches $10.3M Settlement in Vaccine Mandate Case

“As part of the agreement, Liberty Counsel said NorthShore will change its policy to allow unvaccinated employees to work if they have an approved religious exemption. Religious exemptions must now be considered on a case-by-case basis, rather than denied to all employees. In addition, unvaccinated employees who were let go because they claimed religious exemptions are now eligible to be brought back.”

NorthShore reaches $10.3M settlement in vaccine mandate case

4. US Rules out Summer COVID Boosters to Focus on Fall Campaign

“Pfizer and Moderna expect to have updated versions of their shots available as early as September, the Food and Drug Administration said in a statement. That would set the stage for a fall booster campaign to strengthen protection against the latest versions of omicron.”

US rules out summer COVID boosters to focus on fall campaign

5. It May Be Too Late to Stop Monkeypox Becoming Endemic in the U.S. and Europe

“If the pox finds a home in some animal species in North America or Europe—say, squirrels, rats or prairie dogs—it’ll be all but impossible to eradicate regionally. “Game over,” Lawler said. The pox will be all around us, probably forever, just waiting for opportunities to spread from animals to people. Outbreaks will be frequent and big, just like they are now in West and Central Africa.”

It May Be Too Late to Stop Monkeypox Becoming Endemic in the U.S. and Europe

6. More People are Catching Coronavirus a Second Time, Heightening Long COVID Risk

“According to a preprint study examining U.S. veterans, of which Al-Aly was the lead author, getting infected twice or more "contributes to additional risks of all-cause mortality, hospitalization and adverse health outcomes" in various organ systems, and can additionally worsen risk for diabetes, fatigue and mental health disorders.”

More people are catching coronavirus a second time, heightening long COVID risk, experts say

7. Immune Boosting by B.1.1.529 (Omicron) Depends on Previous SARS-CoV-2 Exposure

“Immune protection is boosted by B.1.1.529 (Omicron) infection in the triple-vaccinated, previously infection-naïve individuals, but this boosting is lost with prior Wuhan Hu-1 imprinting. This “hybrid immune damping” indicates substantial subversion of immune recognition and differential modulation through immune imprinting and may be the reason why the B.1.1.529 (Omicron) wave has been characterized by breakthrough infection and frequent reinfection with relatively preserved protection against severe disease in triple-vaccinated individuals.”

https://www.science.org/doi/10.1126/science.abq1841

8. 2022 Detections of Highly Pathogenic Avian Influenza in Wild Birds

USDA APHIS | 2022 Detections of Highly Pathogenic Avian Influenza in Wild Birds

9. Hundreds of New Yorkers May Already be Infected with Polio
“New York officials are warning that hundreds of Empire state residents may already be infected with the devastating polio virus after it was detected in wastewater of a second county in the state.”

'Hundreds' of NYers already infected by polio, health chief warns

 

[Heliobas Disciple]

Another monkeypox substack from someone I highly respect who usually posts about covid. Not posting this to the monkeypox thread but anyone can copy it over if they want to.

Unpleasant truths about the Moneypox vaccine

Very high rates of cardiac effects and HIV worsening compound the problem that there are no efficacy data from humans. Does it even work?

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Unpleasant truths about the Moneypox vaccine
Very high rates of cardiac effects and HIV worsening compound the problem that there are no efficacy data from humans. Does it even work?
Meryl Nass
13 hr ago

At the bottom of this article I have posted excerpts from the label for Jynneos and an FDA review document. In a nutshell:

1) there is no evidence to support using this vaccine in pregnancy, lactation or children. There is no information on male (as well as female) fertility effects or carcinogenicity

2) About 2% of recipients had a serious adverse event

3) According to the label, between 1.3% and 2.1% of recipients had a cardiac event of special interest, compared to 0.2% of placebo subjects. According to the FDA review document, not mentioned in the label, there were 10% and 18% of subjects with troponin elevations in two sub-studies. This suggests that somewhere between 1 in 90 and 1 in 6 people will have a troponin elevation or EKG abnormality, indicating some degree of cardiac damage due to the shot.

4) The monkeypox virus against which the vaccine was tested is probably quite different from the monkeypox virus currently circulating.

5) Now, if you want a scarier picture of what the vaccine does to recipients, it is found in the FDA review of the documents and studies that led to Jynneos' 2019 license, but was not included in the label.

For example on page 191 of the FDA review: 8% of those subjects who were HIV positive could not get their second Jynneos dose due to side effects from the first. 7% of the HIV positive subjects had worsening of HIV parameters. It is likely that Jynneos causes immune suppression.

Thirty-eight SAES [serious adverse events] were reported in HIV-infected subjects (17 vaccinia-naïve, 6 vaccinia-experienced) and none in HIV-uninfected controls. Most of these fell under the Infectious or Respiratory SOCs. One of these SAEs, pneumonia which occurred 2 days after the 2nd dose of MVA-BN in a 39-year-old HIV-infected, vaccinia-naïve woman, was considered possibly related to MVA-BN. [And the rest weren't, even though you withdrew the subjects from further doses?--Nass] Of note, 1.0% of HIV infected subjects (n=6) were withdrawn from the study due to AE and 7% (n=35) of HIV infected subjects did not receive a second dose of MVA-BN due to worsening of HIV parameters (drop in CD4 count or rise in HIV viral load) after the first dose.​

​

Now for the label:

https://www.fda.gov/media/131078/download

5.1 Severe Allergic Reactions

Appropriate medical treatment must be available to manage possible anaphylactic reactions following administration of JYNNEOS.

The risk for a severe allergic reaction should be weighed against the risk for disease due to smallpox or monkeypox.

6. Adverse Reactions

Serious Adverse Events

SAEs were monitored from the day of the first study vaccination
through at least 6 months after the last study vaccination.

Among the smallpox vaccine-naïve subjects, SAEs were reported for 1.5% of JYNNEOS recipients and 1.1% of placebo recipients. Among the smallpox vaccine-experienced subjects enrolled in studies without a placebo comparator, SAEs were reported for 2.3% of JYNNEOS recipients. Across all studies, a causal relationship to JYNNEOS could not be excluded for 4 SAEs, all non-fatal, which included Crohn’s disease, sarcoidosis, extraocular muscle paresis and throat tightness.

Cardiac Adverse Events of Special Interest

Evaluation of cardiac adverse events of special interest (AESIs) included any cardiac signs or symptoms, ECG changes determined to be clinically significant, or troponin-I elevated above 2 times the upper limit of normal. In the 22 studies, subjects were monitored for cardiac-related signs or symptoms through at least 6 months after the last vaccination. The numbers of JYNNEOS and placebo recipients, respectively, with troponin-I data were: baseline level (6,376 and 1,203); level two weeks after first dose (6,279 and 1,166); level two weeks after second dose (1,683 and 193); unscheduled visit, including for clinical evaluation of suspected cardiac adverse events (500 and 60). [What happened to the rest of the people (about 70%) who should have gotten a second dose? Why are they missing followup visits?--Nass]

Cardiac AESIs were reported to occur in 1.3% (95/7,093) of JYNNEOS recipients and 0.2% (3/1,206) of placebo recipients who were smallpox vaccine-naïve. Cardiac AESIs were reported to occur in 2.1% (16/766) of JYNNEOS recipients who were smallpox vaccine-experienced. The higher proportion of JYNNEOS recipients who experienced cardiac AESIs was driven by 28 cases of asymptomatic post-vaccination elevation of troponin-I in two studies: Study 5, which enrolled 482 HIV-infected subjects and 97 healthy subjects, and Study 6, which enrolled 350 subjects with atopic dermatitis and 282 healthy subjects. An additional 127 cases of asymptomatic post-vaccination elevation of troponin-I above the upper limit of normal but not above 2 times the upper limit of normal were documented in JYNNEOS recipients throughout the clinical development program, 124 of which occurred in Study 5 and Study 6. Proportions of subjects with troponin-I elevations were similar between healthy and HIV-infected subjects in Study 5 and between healthy and atopic dermatitis subjects in Study 6. A different troponin assay was used in these two studies compared to the other studies, and these two studies had no placebo controls. The clinical significance of these asymptomatic post-vaccination elevations of troponin-I is unknown. Among the cardiac AESIs reported, 6 cases (0.08%) were considered to be causally related to JYNNEOS vaccination and included tachycardia, electrocardiogram T wave inversion, electrocardiogram abnormal, electrocardiogram ST segment elevation, electrocardiogram T wave abnormal, and palpitations.

None of the cardiac AESIs considered causally related to study vaccination were considered serious. [I guess heart attacks and myocarditis no longer count as serious when there are $Billions at stake--Nass]

8.1 Pregnancy

All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available human data on JYNNEOS administered to pregnant women are insufficient to inform vaccine-associated risks in pregnancy.

8.2 Lactation

It is not known whether JYNNEOS is excreted in human milk. Data are not available to assess the effects of JYNNEOS in the breastfed infant or on milk production/excretion.

8.4 Pediatric Use

Safety and effectiveness of JYNNEOS have not been established in individuals less than 18 years of age.

11. DESCRIPTION

JYNNEOS is a live vaccine produced from the strain Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN), an attenuated, non-replicating orthopoxvirus. MVA-BN is grown in primary Chicken Embryo Fibroblast (CEF) cells suspended in a serum-free medium containing no material of direct animal origin, harvested from the CEF cells, purified and concentrated by several Tangential Flow Filtration (TFF) steps including benzonase digestion. Each 0.5 mL dose is formulated to contain 0.5-3.95 x 10 to the 8th power infectious units of MVA-BN live virus in 10 mM Tris (tromethamine), 140 mM sodium chloride at pH 7.7.

Each 0.5 mL dose may contain residual amounts of host-cell DNA (≤ 20 mcg), protein (≤ 500 mcg), benzonase (≤ 0.0025 mcg), gentamicin (≤ 0.163 mcg) and ciprofloxacin (≤ 0.005 mcg).

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

JYNNEOS has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals.

13.2 Animal Toxicology and/or Pharmacology

The efficacy of JYNNEOS to protect cynomolgus macaques (Macaca fascicularis) against a monkeypox virus (MPXV) challenge was evaluated in several studies. Animals were administered Tris-Buffered Saline (placebo) or JYNNEOS (1 x 108 TCID50 ) sub-cutaneously on day 0 and day 28.

On day 63, animals were challenged with MPXV delivered by aerosol (3 x 105 pfu), intravenous (5 x 107 pfu) or intratracheal (5 x 106 pfu) route. Across all studies, 80-100% of JYNNEOS-vaccinated animals survived compared to 0-40% of control animals

[Hang on, the monkeypox virus against which the Jynneos vaccine was tested killed 60-100% of the unvaccinated monkeys. But the currently circulating monkeypox virus has not killed a single American and causes a mild, self-limited disease according to the CDC. Seems like this vaccine was tested against a very different virus. Does it work against the current strain?--Nass]

 

[Heliobas Disciple]

COVID Vaccine Test Animals Were All Killed Shortly After Vaccination

Can't Find SAFETY CONCERNS If All Animals Are Destroyed

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COVID Vaccine Test Animals Were Destroyed Shortly After Vaccination
Can't Find SAFETY CONCERNS If All Animals Are Destroyed
Igor Chudov
3 hr ago

A fact check, promoted by Twitter, attracted my attention. It said that there were NO SAFETY CONCERNS found in animal tests and trials of Covid vaccines:



I felt like I had to take a closer look. And I found something.

The fact check, fortunately, mentions three animal studies — one for each COVID vaccine — and I read each one closely. It turned out that in all three studies, experimenters killed the test animals shortly after vaccination and the subsequent challenge of animals with Sars-Cov-2. They killed them so as to make it impossible to find “safety signals” that arise in vaccinated beings post-vaccination in the long run.

This means, with all test animals dead, the scientists could not find out

• whether these animals could actually reproduce
• whether these animals had shortened lifespans
• what happens to the test animals upon COVID reinfections
• whether the test animals would be more likely to have cancers or other immune-mediated diseases
• whether the test animals were more likely to suffer from other species-specific illnesses

It is very convenient to kill test animals, because this way, vaccine companies could report that “they identified no safety concerns” — and it is kind of truthful! There are no safety concerns with dead animals!

What are these trials? They were mentioned right in the fact check.



Here are the links from above if you want to follow them:

• Pfizer Bnt162b2 macaque study
• Moderna MRNA-1273 macaque study
• AstraZeneca Ad26 hamster study

Pfizer: 12 Macaques Vaccinated



The three vaccinated sentinel macaques who are reported above to NOT have been necropsied (killed), were kept for a short time to allow for a viral rechallenge, and were necropsied shortly after the study ended.



Moderna: 16 Macaques Vaccinated


The article (and supplemental table S1) show that animals were all killed on the days 7, 8 and 14-15 after “viral challenge”. The goal was, ostensibly, to analyze their lungs. I totally agree with the need to analyze lungs, but why could they not have more macaques and follow their lives post-vaccination?

AstraZeneca: 20 Hamsters Vaccinated

AstraZeneca vaccinated 20 hamsters and necropsied some on day 4 and some on Day 14.



Picture 7C leaves little doubt that the remaining hamsters were also necropsied, as it analyzes tissue samples from hearts, spleens, lungs, kidneys etc.



Cruelty to Humans?

In this article, I am not complaining about cruelty to animals. I am complaining about cruelty to humans, shown in these animal trials. All test animals were killed shortly after vaccination. Nobody was allowed to follow them up and see if they seem happy, if they reproduce, live out their lifespans healthily, etc.

The lab animals were promptly destroyed instead — perhaps to ensure that NO SAFETY SIGNAL EMERGED and so that fact-checkers can tell us that “there is nothing to see here”. I am not even touching the tiny sample sizes and the audacity of giving a novel treatment to thousands of people after testing it on a few hamsters or a dozen macaques.
That’s kind of cruel — and it is cruel to us, the target market for COVID vaccines.

Do you think that they could have followed up their test animals’s health at least until the end of human Covid vaccine trials? Is destroying all test animals trialled with a radically novel vaccine technology, a bit suspicious?

.

 

[Zoner]

Here is Dr. McMillan's thoughts on why there is a Tsunami of death coming.

https://twitter.com/i/web/status/1556894291112431617

View: https://twitter.com/KLMO504/status/1556894291112431617?s=20&t=7jgvRO9u7ObdWYkz1v1Lew

https://twitter.com/i/web/status/1556896070327848960

View: https://twitter.com/philamillan/status/1556896070327848960?s=20&t=7jgvRO9u7ObdWYkz1v1Lew

 

[Heliobas Disciple]

A question and answer document on the subject of VAERS as a pharmacovigilance tool.

Feel free to print and use.

jessicar.substack.com

(fair use applies)


A question and answer document on the subject of VAERS as a pharmacovigilance tool.
Feel free to print and use.
Jessica Rose
1 hr ago

Dr. Jessica Rose - A short Q and A - August 9, 2022

1. "Are the COVID vaccines causing injuries, what kinds, and how do we know?"

Yes. Any human physiological system that you can name, able to be affected in an injurious way, is being affected in an injurious way in a percentage of individuals. We know because VAERS – a pharmacovigilance tool – currently has an extraordinarily high number and range of adverse event reports in the context of the COVID-19 injectable products. We also know because the Yellowcard and EUDRA adverse event (AE) data collection systems are reporting the same things.[1]

2. An introduction to VAERS: what is it, who runs it, what is its history?

VAERS[2] is a pharmacovigilance tool designed to detect safety signals (not detected in pre-market testing) emitted in people following administration of biological or pharmaceutical products. It was originally put into place in 1990 as a solution to non-liability of pharmaceutical companies as per the National Childhood Vaccine Injury Act of 1986 (NCVIA)[3]. In spite of the fact that the NCVIA requires health care providers and vaccine manufacturers to report to the U.S. Department of Health & Human Services (DHHS)[4] specific AEs following the administration of vaccines outlined in the Act, under-reporting is a known imperfection of the VAERS system.[5],[6] VAERS is maintained and monitored by the Centers for Disease Control (CDC)[7] and the Food and Drug Administration (FDA)[8].

3. In fairness to the "other side", what is the distinction between reported injury and confirmed injury?

A reported injury that gets into the front-end downloadable database IS a confirmed injury.[9]

4. What is the reality of submitting an adverse event report to the VAERS system (the difficulty and the time investment involved on front end and in follow up)?

It takes 30 minutes – at least – to file a VAERS report online. It requires a multi-electronic page submission of detailed information and each electronic page is time-restricted. This means that if one does not complete the electronic form fast enough, one must begin the submission process again. The vetting process is long and dealt with by a handful of contracted employees.[10] There is a massive backlog of data in VAERS.[11]

5. What percentage of actual incidents is reflected by the number of reports - and how are we making that guess?

The under-reporting factor represents the percentage of individuals who actually experienced an adverse event in contrast with how many individuals reported an event. Studies have shown that the percentage of incidents reported can be quite low (1–10%). My own study showed an under-reporting factor of 31, which means that each stand-alone adverse event count must be multiplied by a factor of 31.[12],[13],[14] Steve Kirsch also estimated the under-reporting factor to be 41 based on Anaphylaxis data.1

6. What are the top injuries reported with percentages?

Cardiovascular and neurological injuries remain highest with regard to grouped adverse event reporting frequency.[15],[16]


7. How does this injury rate compare to all other vaccines recorded by VAERS?

The injury rates do not compare in any way, shape or form to all other vaccines combined for the past 30 years. For the past 30 years, the VAERS data has housed approximately 39,000 adverse event reports per year for all vaccines combined.
Of these, approximately 155 have been deaths. In 2021, there were 705,985 reports and 12,490 deaths in the context of the Moderna[17], Pfizer/BioNTech[18] and Janssen[19] products, in the VAERS Domestic data set alone, not including all other products on the vaccine list.


Figure 1: Atypical absolute numbers in general and for thousands of stand-alone AEs. This requires investigation by the CDC and the FDA. The signals being thrown off by VAERS now are being downplayed and ignored. VAERS is a pharmacovigilance tool designed to detect safety signals not detected in pre-market testing.

8. Request: Please include the narrative on that amazing CDC ad looking for analysts to cover the 770,000 incidents related to COVID alone.

In reference to a previous article that I wrote on the subject of the VAERS support contract going up for rebid, it was documented that the new VAERS contractor would provide VAERS follow-up activities and enhanced surveillance and quality control for VAERS data.

In the proposal, it is written:

“The contractor shall implement a staffing and operations plan focusing only on vaccine adverse event (VAE) reports after COVID-19 vaccines to help process an estimated 770,000 digital reports per year. Periods of heavier and lighter reporting volume are anticipated throughout the year. Contractor is responsible for maintaining active monitoring and adjusting of the number of reports processed on an annual basis.”

This means one thing: The CDC are well aware of the number of adverse event reports being filed in VAERS in the context of these COVID-19 shots, and how this contrasts starkly to historical report counts.

The CDC know: they are recruiting new employees to deal with the large number of individuals who they anticipate to be submitting adverse event reports in the context of the COVID-19 shots, and they are compensating in this regard without public acknowledgement.


Figure 2: All VAERS reports for all vaccines combined for the past 10 years.

This is a bar graph showing the total number of adverse events reported to VAERS (per year) for all vaccines combined going back 10 years. Notice the mean is 39,218 reports and the peak number of events occurs in 2020 at 49,412.


Figure 3: All VAERS reports for all vaccines combined for the past 10 years plus ONLY COVID-19 injectable product-associated reports for 2021 and 2022. The count is low in 2022 due to the serious backlog.


[1] VAERS - Data Sets
[2] Vaccine Adverse Event Reporting System (VAERS)
[3] H.R.5546 - 99th Congress (1985-1986): National Childhood Vaccine Injury Act of 1986
[4] U.S. Department of Health & Human Services (HHS)
[5] Lazarus, Ross et al. Grant Final Report. Grant ID: R18 HS 017045. Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS). Submitted to The Agency for Healthcare Research and Quality (AHRQ).
[6] Rose, J. 2021, Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System? Science, Public Health Policy & the Law Volume 3:100–129.
[7] CDC Works 24/7
[8] U.S. Food and Drug Administration
[9] https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf
[10] https://www.cdc.gov/vaccinesafety/pdf/VAERS-v2-SOP.pdf
[11] Rose, J. 2021, Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System? Science, Public Health Policy & the Law Volume 3:100–129.
[12] Lazarus, Ross et al. Grant Final Report. Grant ID: R18 HS 017045. Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS). Submitted to The Agency for Healthcare Research and Quality (AHRQ).
[13] Crawford M. 2021. How Underreported Are Post-Vaccination Serious Injuries and Deaths in VAERS? The Chloroquine Wars Part LI. How Underreported Are Post-Vaccination Serious Injuries and Deaths in VAERS?
[14] Rose, J. 2021, Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System? Science, Public Health Policy & the Law Volume 3:100–129.
[15] Rose, J. 2021, Critical Appraisal of VAERS Pharmacovigilance: Is the U.S. Vaccine Adverse Events Reporting System (VAERS) a Functioning Pharmacovigilance System? Science, Public Health Policy & the Law Volume 3:100–129.
[16] Rose, J. 2021. A report on US Vaccine Adverse Events Reporting System (VAERS) of the COVID-19 messenger ribonucleic acid (mRNA) biologicals. Science, Public Health Policy & the Law. 2:59-80.
[17] Pioneering mRNA technology - Moderna
[18] COMIRNATY® | Pfizer
[19] Janssen COVID-19 Vaccine

1 http://www.skirsch.com/covid/Deaths.pdf

 

[Heliobas Disciple]

The CDC's failure to use multivariate analysis shows the total depravity of the vaccine program

Quant genius Mathew Crawford is doing a brilliant series of articles exploring the possibility that vaccine efficacy — for all vaccines — may be zero and that any claimed benefit from shots is actually a wealth effect (said differently, when one controls for wealth any benefit from the vaccine...

tobyrogers.substack.com

(fair use applies)


The CDC's failure to use multivariate analysis shows the total depravity of the vaccine program
Toby Rogers
2 hr ago

Quant genius Mathew Crawford is doing a brilliant series of articles exploring the possibility that vaccine efficacy — for all vaccines — may be zero and that any claimed benefit from shots is actually a wealth effect (said differently, when one controls for wealth any supposed benefit from the vaccine disappears). I would like to add my two cents to this debate.
As many of you know, I got a master of public policy degree from UC Berkeley in 2012. What you may not know is that UC Berkeley is usually the top rated quantitative public policy program in the country. So what that means in this case is that it is heavily focused on econometrics.

Econometrics is beautiful. It usually starts with a large data set for a population. Then one uses sophisticated statistical software (STATA, SPSS) to analyze the data. Econometrics involves massive equations that are looking for the effect of a particular variable, while controlling for a wide range of additional variables.

There is a humility to econometrics as well — so-called “dummy variables” are added to account for factors one may have overlooked and error measures are added to almost every equation to reflect that the data is gathered by humans and there will always be some error.

What’s fascinating about econometrics is that if one really builds the model correctly, the largest effect size that one will ever see for a single variable is about 0.3. This means that X intervention explains 30% of the outcome — the rest of the variables explain the rest. We live in a multivariate world.

Even with all of that complexity, there are still those (such as the great economist Steve Keen) who argue that econometrics, with its 15, 50, or even 100 variables is still completely inadequate and that if one really wants to understand how the world works, one must utilize the tools of physics (and supercomputers) to build models with millions of variables and account for things like chaos theory (this approach is called econophysics).

So that was my background when, in 2015, in the midst of a Ph.D. program in political economy, I started researching autism and decided to read a vaccine safety study for the first time. There are about 20 studies that the CDC points to as showing that there is no relationship between vaccines and autism. I assumed that I would not be able to read or understand these studies at all. Given what I knew about the complexity of econometrics, and knowing that the human body, biology, chemistry, and the immune system are even more complex than economics, I assumed that I would be looking at equations involving calculus, that used advanced statistical software to analyze hundreds or perhaps thousands of variables that impact health and disease.

The reality is quite different. Vaccine safety studies tend to be bivariate — they only look at two variables — the vaccine (independent variable) and whether someone suffered an adverse event (dependent variable). It’s actually even worse than that. Vaccine safety studies almost always look at children who have received the full vaccine schedule as compared with children who have received the full schedule +1 more vaccine. And on that basis, they decide whether the 1 additional vaccine is safe. There is no unvaccinated control group. And they do not control for hundreds of other variables that influence health and disease.

When I read a vaccine safety study for the first time, a sickening panic swept over me — “no, no, no, this cannot possibly be. THIS is what the CDC is relying upon!? THIS is what the CDC is using to claim that vaccines are safe!?” Far from being too advanced, these studies are so crude they would fail any Statistics 101 class in any college in America. Tears streamed down my face.

So I read another, and another, and another “vaccine safety” study (eventually reading all 20). And they were all the same.
These studies are preposterous because they cannot possibly answer the question they are trying to tackle because their methods are too basic. Vaccine safety studies contain no biology, no chemistry, and vanishingly little statistics. These people are doing arithmetic, badly. In fact, they resemble a card trick more than anything having to do with science. I realized that the CDC has no idea what it is doing — the entire field of pediatrics and public health is a Potemkin Village, a Ponzi scheme, the worst intellectual fraud that I have ever seen.

I wept because of the implications (and hoped against hope that I was misunderstanding something). These are some of the most consequential studies ever produced — because their findings impact the health of 95% of the children in the developed world. Yet the field itself is stunted and basic — at least 100 years behind their colleagues in the physical sciences or even the quantitative branches of the social sciences. The vulgarity of vaccine safety studies is covered up by the PR machine for the most ruthless industry in the world (and a web of financial relationships that has become “too big to fail”).

(You can find the full citations and links for all 20 studies in my thesis).

Here’s the point I want to make: The CDC’s failure to use proper statistical tools (multivariate analysis and beyond) is a threat to national security. But the reason why the CDC relies upon crude bivariate analysis (that is categorically rejected by all fields of scholarly endeavor except vaccine safety studies) is because rigging these studies is the only way to hide the fact that these shots do not work and cause catastrophic harms. If the CDC ever used proper statistical methods, the national vaccine program would come to a screeching halt because the entire program is based on fraud.

But here’s what I cannot figure out — why do scholars in these other fields, who actually know their stuff, fail to call the CDC out on their chicanery? Even worse, why do scholars in these other fields — who could spot the errors in these “vaccine safety studies” in about 10 minutes if they did any due diligence — poison their own kids and themselves? We live in the dumbest era in human history — we have the tools to know and do better and yet mainstream society still participates in self-inflicted genocide because they just want to fit in.

Blessings to the warriors.

Prayers for everyone fighting back against the most egregious fraud in human history.

In the comments, please let me know what’s on your mind.

As always, I welcome any corrections.

 

[Heliobas Disciple]

Here is Dr. McMillan's thoughts on why there is a Tsunami of death coming.

https://twitter.com/i/web/status/1556894291112431617

View: https://twitter.com/KLMO504/status/1556894291112431617?s=20&t=7jgvRO9u7ObdWYkz1v1Lew

https://twitter.com/i/web/status/1556896070327848960

View: https://twitter.com/philamillan/status/1556896070327848960?s=20&t=7jgvRO9u7ObdWYkz1v1Lew

Thanks!

I agree, BA2.75 is the one to watch, although there's that other new one I just posted about that is gaining ground too. (but I still think BA2.75 is going to be the one to watch, I'm really surprised Geert hasn't talked about it at all).

HD

 

[Zoner]

Thanks!

I agree, BA2.75 is the one to watch, although there's that other new one I just posted about that is gaining ground too. (but I still think BA2.75 is going to be the one to watch, I'm really surprised Geert hasn't talked about it at all).

HD

I know, right. And he just put out two blog Q&As as well. I think he may be like Dr. McMillan and realizing that the Tsunami wave can now be seen and it's too late to warn. He has already done a lot of that. Still wondering what kind of conversation took place between him and Malone. Maybe he's been threatened. As we see with Trump, these communist globalists are all in right now to take total dominion. Geert is in danger as are all truth tellers.

 

[Zoner]

Dr. McMillan "This could be the one. Remember the name BA 2.75. Similar lung penetration as Delta with the infectiveness of Omicron. Technically DELTACRON!"

 

[Heliobas Disciple]

Older Americans ready for fall COVID-19 boosters, poll finds

Story at a glance Overall, 61 percent of adults over 50 are very likely to get an updated booster. The number is higher among particularly vulnerable groups as 68 percent respectively of people over 65, Black adults over 50 and people with low incomes are very likely to do so. About 17 percent...

www.yahoo.com

(fair use applies)


Older Americans ready for fall COVID-19 boosters, poll finds
Adam Barnes - The Hill
Tue, August 9, 2022, 9:44 AM

Story at a glance

• Overall, 61 percent of adults over 50 are very likely to get an updated booster.
• The number is higher among particularly vulnerable groups as 68 percent respectively of people over 65, Black adults over 50 and people with low incomes are very likely to do so.
• About 17 percent of adults over 50 said they are not likely to get a booster this fall.

Most older adults who have received at least one dose of a COVID-19 vaccine will likely get an updated booster shot when they are available this fall.

Overall, 61 percent of adults over 50 are very likely to do so, according to a new national survey from the University of Michigan.

The number is higher among particularly vulnerable groups as 68 percent of people over 65, Black adults over 50 and people with low incomes are very likely to get a COVID-19 booster.

About 17 percent of adults over 50 said they are not likely to get a booster this fall.

“The vaccines we’ve had since late 2020 have saved countless lives and made COVID-19 much less serious for millions worldwide. We also know that those who got at least one booster dose have done better than others in the Omicron variant era,” the poll’s director and infectious disease physician Preeti Malani said in a media release.

“But if we’re going to drive down deaths, hospitalizations, serious illness and long-term effects even further, we will need to get as many people vaccinated with these new formulations as possible,” Malani added.

The poll also found that doctors play a vital role in patients’ decision making with 77 percent of those surveyed saying their provider’s recommendation is important. This was especially important to individuals over the age of 65, those who are Black and people whose incomes are below $30,000 per year.

Two-thirds of those surveyed who were previously vaccinated but had not test positive for the virus were likely to get a booster. Around 56 percent of vaccinated people who had had COVID-19 once said the same.

The poll results are based on responses in late July from a nationally representative sample of 1,024 adults over 50 from the Foresight 50+ Omnibus panel, which draws from the Foresight 50+ Panel by AARP and NORC at the University of Chicago.

Data from the Centers for Disease Control and Prevention shows more than 70 percent of fully vaccinated individuals over the age of 65 have received at least one booster.

 

[Heliobas Disciple]

EU regulator begins review of Pfizer-BioNTech's variant-adapted COVID shot

LONDON (Reuters) -The European Medicines Agency (EMA) has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, it said on Tuesday. The so-called bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID - the original strain first identified...

news.yahoo.com

(fair use applies)


EU regulator begins review of Pfizer-BioNTech's variant-adapted COVID shot
by Natalie Grover
Tue, August 9, 2022, 6:12 AM

LONDON (Reuters) -The European Medicines Agency (EMA) has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech, it said on Tuesday.

The so-called bivalent vaccine targets two strains of the SARS-CoV-2 virus behind COVID - the original strain first identified in China, and the Omicron offshoots BA.4/5 that are currently behind most cases in Europe.

A rolling review means the EMA assesses the data as it becomes available, and the process continues until there is enough data for a formal marketing application.

Last month, the EMA said it had begun a rolling review of another version of the companies' shot which targets the original SARS-CoV-2 strain and Omicron subvariant BA.1.

While existing coronavirus vaccines continue to provide good protection against hospitalisation and death, vaccine effectiveness has taken a hit as the virus has evolved.

European Union officials plan to use bivalent shots in their autumn vaccination campaign, with most cases in the region now linked to the BA.5 variant.

The EMA expects new COVID variant-adapted vaccines to be approved by September, but has signalled it is open to using shots targeting the older BA.1 variant for that campaign, given the shots targeting the newer BA.4 and BA.5 strains are further behind in clinical development.

 

[Heliobas Disciple]

Novavax does not have a forecast for U.S. orders in 2022: CEO Erck

Novavax missed Wall Street expectations but remains optimistic about the fourth quarter and 2023.

news.yahoo.com

(fair use applies)


Novavax does not have a forecast for U.S. orders in 2022: CEO Erck
Anjalee Khemlani
Tue, August 9, 2022, 1:41 PM

Novavax (NVAX) missed Wall Street expectations Monday after its second quarter earnings showed softer-than-expected demand in global vaccine sales, forcing the company to slash its 2022 outlook by 50% to $2 billion.

While at least $400 million in revenue has come in since July 1, the company has not fulfilled orders for low- and middle-income countries (LMICs) through the global COVAX program and anticipates no further orders from the U.S. this year, according to company executives Monday.

But that does not include anticipated authorizations for boosters and adolescents, CEO Stanley Erck told Yahoo Finance Live Tuesday.

"We're not forecasting something that we don't have. We're talking with the U.S. government, we don't have a forecast right now," he said.

Erck said that a booster market, the adolescent market — and stronger 2023 sales — are expected for the company going forward.

"What we need to do is get a couple indications for boosting and for adolescents, both of which we've applied for, and our expectations are that we'll get those approvals hopefully soon — but we're dependent on the FDA," he said.

However, global demand remains soft.

The problem with COVAX is it supplies LMICs, which are facing an oversupply of vaccines right now, Erck said.

"We've put off any projections of sales to COVAX this year. I don't know what's going to happen next year," he said.

"We're forecasting as conservatively as possible, and I think we're setting the stage for next year," Erck added.

The company had told federal officials that a BA.5 variant-targeting booster would be ready by the fourth quarter, but on Monday the company said that an October deadline was unlikely.

That isn't far off from competitors, however. As the Biden administration has called for a September booster campaign with the newly formulated vaccines, both Pfizer (PFE) and Moderna (MRNA) previously told the FDA they would be able to manufacture the new doses by October at the earliest.

In a recent interview with Yahoo Finance, Moderna CEO Stéphane Bancel said the company was working hard to meet the September deadline.

Erck remains optimistic about a fourth quarter deadline, and about the vaccine's original formula as a booster, which provides broad coverage including protection against the BA.5 variant.

 

[Heliobas Disciple]

Are these furry creatures to blame for the pandemic? Study finds 'reasonable' origin of COVID

An animal sold at a Wuhan wet market, such as a raccoon dog, may have first passed the virus that causes COVID-19 to humans.

news.yahoo.com

(fair use applies)


Are these furry creatures to blame for the pandemic? Study finds 'reasonable' origin of COVID
Karen Weintraub, USA TODAY
Tue, August 9, 2022, 3:30 PM

Raccoon dogs, a spaniel-size canine bred and sold in China both for their meat and luxurious fur, are one of the likeliest sources of the last 2½ years of human misery.

A new study suggests these furry creatures, native to Asia, may have been the intermediary, catching the SARS-CoV-2 virus from bats and passing it on to people at a Chinese market, leading to the global COVID-19 pandemic.

There's no way to know for certain because animals sold at the market were never tested. But samples taken from cages and carts used to house and transport raccoon dogs at the Huanan Seafood Market in Wuhan, China, in late 2019 contained traces of the virus, said Chris Newman, a biologist, ecologist and research associate with Oxford University, and a co-author on the paper.

"As far as the virologists are concerned, looking at the evolutionary strain of the virus itself, it's perfectly reasonable that (SARS-CoV-2) evolved in a bat and then spread through the raccoon dog as the primary intermediary," Newman said.

So-called wet markets, which sell both meat and live animals, have been shuttered across China since the start of the pandemic, Newman said, although they still operate in other countries.

Wet markets often keep animals in what most people would consider appalling conditions, which can foster disease. Newman described cages of raccoon dogs and other mammals such as marmots stacked high, where the urine and feces of the animals in upper cages rain down on the lower ones, potentially passing viruses and bacteria.

The animals are "slaughtered on demand and not in a particularly nice way," Newman said. At fur farms, raccoon dogs and foxes are skinned alive or electrocuted; in markets, the vendor butchers them with a knife, providing what consumers would consider the freshest possible meat.

Although currently available data cannot provide beyond a shadow of a doubt that this is where SARS-CoV-2 made the jump to people, Newman and others said it's a particularly plausible route.

Research shows that raccoon dogs can be infected with and shed the SARS-CoV-2 virus, though they don't become visibly ill, said Thomas Müller, a veterinarian, who was involved in one of the studies.

Was a wet market ground zero?

There were potentially many other locations in Wuhan, a city of 11 million, where the virus could have originated, but the new study, published in the peer-reviewed, well-respected journal "Science," investigated multiple options, all of which home in on that particular market.

In a detailed Twitter thread posted in late July, study co-author Angela Rasmussen, a virologist, wrote that all available data – and there are plenty – points to the seafood market as the origination point, rather than a research laboratory in the same city, as some have speculated.

"Although many questions remain, these provide conclusive evidence that SARS-CoV-2 emerged via at least 2 zoonotic spillovers from animals sold at Huanan," she wrote, referencing a term that describes pathogens jumping from animals to people. "Yes, the data is incomplete and imperfect, but it overwhelmingly shows that the pandemic began at Huanan through zoonosis, not at the WIV (Wuhan Institute of Virology) or any other lab."

The Huanan market has long been suspected as the point of origin for SARS-CoV-2.

W. Ian Lipkin, an epidemiologist and director of the Center for Infection and Immunity at the Mailman School of Public Health at Columbia University, said it was seen as the likeliest site back in January 2020 when he met with colleagues in Beijing to discuss what was then a relatively small outbreak of an as-yet-unnamed new disease.

The study reflects "excellent work," Lipkin said.

"Nonetheless, it does not unequivocally prove a market origin, and won’t convince those who feel the origin was a laboratory leak," he said.

Since long before COVID-19, Lipkin has argued that wild animal markets like Huanan are dangerous and should be shuttered worldwide.

More controls should also be added to laboratory research that involves wildlife, he said.

"Irrespective of the high probability that this or another wild animal market triggered the pandemic, work with materials from wildlife should only be conducted in biocontainment," Lipkin said, referring to lab protocols that reduce the risks of transmitting pathogens.

Any contact wild animals have with humans poses a disease risk that can go either way, said Müller, who specializes in virology and epidemiology at the Friedrich-Loeffler-Institut in Riems, Germany. Pigs can catch the flu from humans and visa versa, he noted.

"The closer the contact, the higher the risk," he said.

Many diseases are known to come from wild animals, including Ebola, Zika, flu, plague, Lyme disease and rabies. The first SARS virus, detected in China in 2002, was believed to have traveled from a bat to a palm civet, a cat-size creature with a long furry tail and a pointed snout, before making the jump to people.

Humans have increased the risk for these zoonotic diseases in recent years, Müller said, by encroaching on territory used by wild animals through logging, hunting and urbanization, as well as attitudes that view all animals as potential pets rather than potential dangers.

"Any kind of risk-mitigating measures in terms of human behavior – that is key to avoiding these cross-species transmission events in the future," Müller said.

Don't bring one of these home

Raccoon dogs were introduced to eastern parts of Europe, particularly Russia, in the 1930s, as a new fur species, Müller said.

Since then, they've spread to central and western Europe.

"It's almost impossible to get rid of these species anymore," said Müller, who has studied them as part of rabies-eradication efforts. "They have well adapted and have established sometimes pretty high population densities, especially in the central European countries."

Raccoon dogs, like raccoons, are generally nocturnal creatures that hide from rather than attack other animals.

"They are not aggressive at all," Müller said. "You would hardly see them in nature."

They are cute and impressive animals, he said, but according to the Royal Society for the Prevention of Cruelty to Animals, the British version of the ASPCA, raccoon dogs make terrible house pets.

They require wide ranges for roaming, far bigger than an urban apartment or suburban yard. Communicating with each other via scent, raccoon dogs also smell horrible to humans, the RSPCA said.

It is illegal to breed raccoon dogs in Europe or sell any but existing stock.

Selling wild raccoon dogs has also long been illegal in China, Newman said, but that regulation was not well enforced before the discovery of SARS-CoV-2.

About 40 million raccoon dogs are bred in China for their fur, roughly 99% of the animal's global population, Müller said. He is not aware of any testing done to look for SARS-CoV-2 among farm-bred raccoon dogs.

Raccoon dogs are not the only potential animal source for SARS-CoV-2, Newman said.

There are a number of animal species that can spread the virus and that humans can spread back into animals. These include minks, which were slaughtered by the millions in Denmark, after they were discovered to carry the virus.

Like mink, other small animals that burrow underground, such as badgers, hog badgers and weasels, "all of these animals that have a subterranean, denning lifestyle seem to be particularly susceptible," Newman said.

Like minks and badgers, raccoon dogs like to live in burrows or caves, where they potentially came into contact with bats, either by eating them or cohabitating with them.

Zoos have had to vaccinate many of their animals, particularly primates and even big cats, against COVID-19, because they are susceptible to catching the virus from their human caretakers, Newman said. Deer, which are prone to respiratory infections, have also been known to contract the virus, and he suggests hunters wear masks when butchering or otherwise coming into close contact with deer.

Pets like cats and dogs can catch COVID-19 from people but do not seem to commonly pass it back, Newman said.

"Sticking with farmed animals, sticking with domesticated animals and sticking with animals that are produced and slaughtered and processed in accordance with the public health service would seem to be the way to go," he said.

 

[Heliobas Disciple]

Former asthma sufferer Biden has cough, but not COVID, White House says

U.S. President Joe Biden continues to test negative for COVID-19 but is suffering its lingering effects, the White House press office said on Tuesday, after he coughed repeatedly through a speech on the South Lawn. Biden spoke to dozens of Congress members, including Republicans, as well as...

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Former asthma sufferer Biden has cough, but not COVID, White House says
by Jeff Mason and Heather Timmons
Tue, August 9, 2022, 1:07 PM

WASHINGTON (Reuters) - U.S. President Joe Biden continues to test negative for COVID-19 but is suffering its lingering effects, the White House press office said on Tuesday, after he coughed repeatedly through a speech on the South Lawn.

Biden spoke to dozens of Congress members, including Republicans, as well as business executives and members of his Cabinet, in sweltering midday heat before signing the a $53 billion bill aimed at boosting the U.S. semiconductor industry.

His persistent congestion forced him to stop the speech at several points to turn aside and cough into his hand or sip water, drawing the attention of supporters and detractors alike on social media. The 79-year-old president recently suffered his second bout of COVID-19, and was isolated for over two weeks in the White House until Sunday.

"The President tested negative for COVID yesterday and this morning," the press office told the White House pool, soon after the speech ended.

Biden used to have asthma, Ashish Jha, the COVID-19 coordinator, told reporters in July, and has "reactive airway disease," which means he is prone to getting "a little bit of bronchospasm," or cough. He relied on an albuterol inhaler to alleviate his cough during his illness, and has previously used an inhaler while he had a cold, he said.

“What he’s experiencing right now is the lingering effects of getting COVID,” White House press secretary Karine Jean-Pierre told reporters later on Tuesday.

 

[Heliobas Disciple]

A 33-year-old runner was hospitalized for heat exhaustion and electrolyte imbalance from a light vacation workout

A runner said she experienced heat exhaustion symptoms like dizziness after an easy beach jog. High humidity and lack of electrolytes may be to blame.

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A 33-year-old runner was hospitalized for heat exhaustion and electrolyte imbalance from a light vacation workout
Gabby Landsverk - INSIDER
Mon, August 8, 2022, 4:48 PM

• Experienced runner Morgan Philpott told Insider she was hospitalized after a light run on vacation.
• High humidity may have led to heat exhaustion, according to a researcher specializing in heat illness.
• Lingering symptoms of nausea may have been electrolyte imbalance from drinking too much water.

A 33-year-old woman from Texas said she was treated for heat exhaustion and electrolyte imbalance after taking a short, easy run.

Morgan Philpott, a 33-year-old Texas resident, has been a runner since high school, with 5K, 10K, and half-marathon races under her belt. She routinely does three-to-five mile runs for training, and 10 to 15 mile runs once a week.

But 30 minutes of early-morning running on the beach on a recent vacation sent her to the ER, Philpott told Insider.

She said she was hospitalized with symptoms like nausea, severe headache, and confusion, which continued after she stopped exercising.

Humidity and drinking too much water without sodium likely contributed to her illness, according to an exercise science researcher specializing in heat safety.

Symptoms like severe vomiting, headache and confusion 'came out of nowhere'

It was the first day of a coastal vacation with her family when Philpot got up before dawn to go for a run, excited to get back to a workout routine after recent illness in June.

"It was the first real day of our vacation and I was still technically on the mend," she said. "I was looking forward to making a daily beach run a pleasurable way to get back on track."

Philpot ran a leisurely 15 or 20 minutes along the beach, stopping to take scenic photos, then ran back to join her family at their condo near the shore.

A few hours later, playing on the beach with her children, she developed a headache, her eyes hurt from the glare of the sun on the water, and she started to feel nauseous.

Over the next two hours, she said symptoms worsened — she was vomiting every few minutes, unable to keep down liquids, and had muscle cramps and jagged lines across her vision. Her husband drove her to the ER where she was treated with IV electrolytes and anti-nausea medication, which resolved the problem. Philpott said it took several days to feel well enough for beach activities again.

Factors like humidity and lack of electrolytes combined to make a 'perfect storm' of risk
Philpott said she's used to exercising in hotter temperatures than the 85 degree morning on the beach, but experienced a "perfect storm" of risks like prior illness, humidity and low electrolytes.

Humidity prevents the body from evaporating sweat to cool down, according to Sean Langan, an associate research director at the University of Connecticut's Korey Stringer Institute who specializes in heat injury prevention.

"Humidity impairs the efficiency of your sweat response because when you're outside in the heat, sweat evaporates the heat into the atmosphere, he said. "If you see sweat just dripping off your body, it's not doing anything to cool you down."

Combined factors of heat stress like temperature and humidity are known as the "wet bulb globe temperature."

Langan said Philpott may have experienced heat exhaustion, when the body gets too hot and is unable to cool itself effectively, causing fatigue and dizziness.

However, symptoms of heat illness can be treated by cooling the body, and don't typically persist hours later. Langan said Philpott's nausea and disorientation may have been hyponatremia, or electrolyte imbalance. Philpott had been drinking lots of water, she said, which can prevent dehydration (and further heat risk), but dilutes electrolytes.

Since her incident, Philpott said she's been adding electrolytes to her water and paying closer attention to minor symptoms like headache, in case they turn out to be warning signs of a more dangerous issue.

"I do not want to end up in the ER again. That was one of the more miserable days of my life," she said.

 

[Heliobas Disciple]

80,000 Tourists Stranded in Hainan as COVID-19 Sweeps China’s Resort Island

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80,000 Tourists Stranded in Hainan as COVID-19 Sweeps China’s Resort Island
By Nicole Hao
August 9, 2022

Chinese authorities locked down at least nine cities on the tourist island of Hainan on Aug. 8 as a COVID-19 outbreak was detected. Over 80,000 tourists and six professional soccer teams are unable to leave the far southern province and are facing higher hotel rates.

The lockdown has left the streets of Hainan’s capital, Haikou, and tourist city Sanya deserted and its beaches havens for sea birds.

All of Hainan’s over 10 million residents and any visiting tourists were ordered to undergo COVID-19 testing on Aug. 7. According to official data, about 8,600 medical personnel from 18 provinces arrived by Aug. 8 to assist with the mass testing.

The communist party’s “zero-tolerance” COVID-19 policies state that travelers can leave the island once they return five negative tests within the previous seven days. But no commercial passenger flights are operating between the island and the mainland. Tourists told China’s state-run media that they have been driven off airplanes after successfully boarding with all the necessary negative tests, right before the lockdown was announced on Aug. 6.

Beijing has plans to transform the 12,800 square mile island province into a massive free trade port. It’s uncertain how much economic harm the lockdown will cause.

An Expanding Lockdown

The Hainan provincial government announced on Aug. 8 that over 1,500 infections had been diagnosed in the province during the outbreak, which began on Aug. 1. On Monday, 77 new infections were diagnosed. Official reports said that more COVID-19 cases were still being detected amid the strict lockdown measures.

To curb the outbreak, the regime announced lockdowns for one city after another on the island. As of Monday afternoon, residents in Sanya, Wuzhishan, Haikou, Zhanzhou, Waning, Qionghai, Dongfang, Lingshui, and Chengmai were prohibited to leave their homes.

“We must firmly prohibit people’s moving out. We must ensure that no one may leave [the island],” Hainan party secretary Shen Xiaoming ordered of the provincial regime on Aug. 6. “We must monitor the people who enter Hainan. Every fisherman must be quarantined for seven days and tested five times during this time.”

Shen then announced that the province will operate under “a wartime mode.”

The epicenter of the Hainan outbreak is Sanya. The city regime announced it would open a second makeshift hospital on Aug. 7. The new facility with a capacity to handle 2,000 COVID-19 patients would open on Aug. 11. The regime said that currently, the island’s makeshift hospital can take 2,876 patients.

The true COVID-19 infection rate in China is questioned by outsiders, due the regime’s history of coverups and non-transparency with uncensored data.

Frustrated Tourists

Because of its beaches and climate, Sanya is referred to as “China’s Hawaii.” On the afternoon of Aug. 6, a few hours after the regime had shut down all public transportation, Mayor He Shigang announced: “We estimated that over 80,000 tourists are stranded in Sanya.”

“334 flights were canceled at Sanya Phoenix Airport on Aug. 6,” State-run Hongxing News reported. “Some passenger flights had to return back to Sanya after take-off.”

Ms. Wang is a Shanghai native. Her family was locked down at home for months this year under the regime’s “zero-tolerance” COVID-19 policies. After the Shanghai lockdown lifted, she quickly arranged the trip to Sanya for her family of five, which includes old parents and a young child.

Wang learned in the early hours of Aug. 6 that Sanya might suspend all public transportation. She bought the earliest flights back to Shanghai immediately.

“I thought I had luckily acquired the last tickets [that could leave Sanya],” Wang, who didn’t provide her first name, told State-run Yicai on Aug. 6. “We hurried to the airport, got through security, boarded the plane, and heard the pilot said the plane’s doors are closed. We believed we could fly back to Shanghai.”

In the end, Wang said, the plane wasn’t allowed to take off, and her family and the other passengers were forced to exit the aircraft along with the flight crew.

Businesswoman Yang Jing told Reuters that she decided to take her family on vacation to Sanya because the island had reported only two COVID-19 infections in 2021. Now, her family is stuck on the island and facing high hotels rates, leaving them eating pot noodles to save money.

Yang and other tourists worry that the lockdown in Sanya will mirror the one in Shanghai, which was initially scheduled to last for five days but ended up lasting three months.

Stranded Soccer Teams

The China national football team and six Chinese Super League soccer teams are also stranded in Haikou, state-run Beijing Youth reported on Aug. 8. The teams won’t be able to attend their scheduled matches.

The national team traveled to Haikou after finishing the EAFF E-1 Football Championship in Japan on July 28. Following the policy at the time, the players were quarantined in a hotel for ten days, to be released on Aug. 8. Now, they’re facing more time in lockdown.

Six super league teams are stuck in Haikou: Chengdu Rongcheng, Jinmen Tigers, Shandong Taishan, Hebei, Cangzhou Lions, and Guangzhou. They were there for round 12 of the league’s competition.

The Chinese Football Association (CFA) has postponed the matches involving these six teams.

 

[Heliobas Disciple]

New test may predict COVID immunity

Most people in the United States have some degree of immune protection against COVID-19, either from vaccination, infection, or a combination of the two. But, just how much protection does any individual person have?

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New test may predict COVID immunity
by Anne Trafton, Massachusetts Institute of Technology
August 9, 2022



The test, which uses the same type of lateral flow technology as most rapid antigen tests for COVID-19, measures the level of neutralizing antibodies that target the SARS-CoV-2 virus in a blood sample. Results can be interpreted qualitatively or quantitatively. Credit: Courtesy of the researchers.

Most people in the United States have some degree of immune protection against COVID-19, either from vaccination, infection, or a combination of the two. But, just how much protection does any individual person have?

MIT researchers have now developed an easy-to-use test that may be able to answer that question. Their test, which uses the same type of "lateral flow" technology as most rapid antigen tests for COVID-19, measures the level of neutralizing antibodies that target the SARS-CoV-2 virus in a blood sample.

Easy access to this kind of test could help people determine what kind of precautions they should take against COVID infection, such as getting an additional booster shot, the researchers say. They have filed for a patent on the technology and are now hoping to partner with a diagnostic company that could manufacture the devices and seek FDA approval.

"Among the general population, many people probably want to know how well protected they are," says Hojun Li, the Charles W. and Jennifer C. Johnson Clinical Investigator at MIT's Koch Institute for Integrative Cancer Research. "But I think where this test might make the biggest difference is for anybody who is receiving chemotherapy, anybody who's on immunosuppressive drugs for rheumatologic disorders or autoimmune diseases, and for anybody who's elderly or doesn't mount good immune responses in general. These are all people who might need to be boosted sooner or receive more doses to achieve adequate protection."

The test is designed so that different viral spike proteins can be swapped in, allowing it to be modified to detect immunity against any existing or future variant of SARS-CoV-2, the researchers say.

Li, who is also an attending physician at the Dana-Farber/Boston Children's Cancer and Blood Disorders Center, is the senior author of the study, which appears online today in Cell Reports Methods. Guinevere Connelly, a former Koch Institute research technician who is now a graduate student at Duke University, and Orville Kirkland, a research support associate at the Koch Institute, are the lead authors of the paper.

A simple test

Li, who joined the Koch Institute in the fall of 2019, studies blood cell development and how blood cells become cancerous. When SARS-CoV-2 emerged, he started thinking about ways to help combat the pandemic. Many other researchers were already working on diagnostic tests for infection, so he turned his attention to developing a test that would reveal how much immune protection someone has against COVID-19.

Currently, the gold standard approach to measuring immunity involves mixing a blood sample with live virus and measuring how many cells in the sample are killed by the virus. That procedure is too hazardous to perform in most labs, so the more commonly used approaches involve noninfectious modified "pseudoviral" particles, or they are based on a test called ELISA (enzyme-linked immunosorbent assay), which can detect antibodies that neutralize a fragment of a viral protein.

However, these approaches still require trained personnel working in a lab with specialized equipment, so they aren't practical for use in a doctor's office to get immediate results. Li wanted to come up with something that could be easily used by a health care provider or even by people at home. He drew inspiration from at-home pregnancy tests, which are based on a type of test called a lateral flow assay.

Lateral flow assays generally consist of paper strips embedded with test lines that bind to a particular target molecule if it is present in a sample. This technology is also the basis of most at-home rapid tests for COVID-19.

Li did not have experience working with this type of test, so he reached out to two MIT faculty members with expertise in devising diagnostics based on lateral flow assays: Hadley Sikes, an associate professor of chemical engineering, and Sangeeta Bhatia, the John and Dorothy Wilson Professor of Health Sciences and Technology and of Electrical Engineering and Computer Science, and a member of the Koch Institute.

With their help, his lab developed a device that can detect the presence of antibodies that block the SARS-CoV-2 receptor binding domain (RBD) from binding to ACE2, the human receptor that the virus uses to infect cells.

The first step in the test is to mix human blood samples with viral RBD protein that has been labeled with tiny gold particles that can be visualized when bound to a paper strip. After allowing time for antibodies in the sample to interact with the viral protein, a few drops of the sample are placed on a test strip embedded with two test lines.

One of these lines attracts free viral RBD proteins, while the other attracts any RBD that has been captured by neutralizing antibodies. A strong signal from the second line indicates a high level of neutralizing antibodies in the sample. There is also a control line that detects free gold particles, confirming that the solution flowed across the entire strip.

To develop the reagents needed for the test, members of Li's lab worked with the labs of Angela Koehler, an associate professor of biological engineering, and Michael Yaffe, a David H. Koch Professor in Science, who are both members of the Koch Institute.

Predicting immunity

Along with a testing cartridge, which contains the paper test strip, the testing kit also includes a finger prick lancet that can be used to obtain a small blood sample, less than 10 microliters. This sample is then mixed with the reagents needed for the test. After about 10 minutes, the sample is exposed to the test cartridge, and the results are revealed in 10 minutes.

The output can be read two different ways: One, by simply looking at the lines, which indicate whether neutralizing antibodies are present or not. Or, the device can be used to obtain a more precise measurement of antibody levels, using a smartphone app that can measure the intensity of each line and calculate the ratio of neutralized RBD protein to infectious RBD protein. When this ratio is low, it might suggest that another booster shot is needed, or that the individual should take extra precautions to prevent infection.

The researchers tested their device with blood samples collected in December 2020 from about 60 people who had been infected with SARS-CoV-2 and 30 people who had not. They were able to detect neutralizing antibodies in the samples from people previously infected to the virus, with accuracy similar to that of existing laboratory tests. They also tested 30 serial samples from two people before they received an mRNA COVID-19 vaccine and at several time points after vaccination. The level of neutralizing antibodies in the vaccinated individuals peaked around seven weeks after the first dose, then began to slowly decline.

Previous studies of SARS-CoV-2 and other viruses have shown a strong correlation between the amount of neutralizing antibody circulating in an individual's bloodstream and their likelihood of infection.

The test could be easily adapted to different variants of SARS-CoV-2 by swapping in a reagent that is specific to the RBD from the variant of interest, Li says. The researchers now hope to partner with a diagnostics company that could manufacture large quantities of the tests and obtain FDA approval for their use.

 

[Heliobas Disciple]

New inhaled COVID-19 therapeutic blocks viral replication in the lungs

Scientists at the University of California, Berkeley, have created a new COVID-19 therapeutic that could one day make treating SARS-CoV-2 infections as easy as using a nasal spray for allergies.

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New inhaled COVID-19 therapeutic blocks viral replication in the lungs
by Kara Manke, University of California - Berkeley
August 9, 2022

Scientists at the University of California, Berkeley, have created a new COVID-19 therapeutic that could one day make treating SARS-CoV-2 infections as easy as using a nasal spray for allergies.

The therapeutic uses short snippets of synthetic DNA to gum up the genetic machinery that allows SARS-CoV-2 to replicate within the body.

In a new study published online in the journal Nature Communications, the team shows that these short snippets, called antisense oligonucleotides (ASOs), are highly effective at preventing the virus from replicating in human cells. When administered in the nose, these ASOs are also effective at preventing and treating COVID-19 infection in mice and hamsters.

"Vaccines are making a huge difference, but vaccines are not universal, and there is still a tremendous need for other approaches," said Anders Näär, a professor of metabolic biology in the Department of Nutritional Sciences and Toxicology (NST) at UC Berkeley and senior author of the paper. "A nasal spray that is cheaply available everywhere and that could prevent someone from getting infected or prevent serious disease could be immensely helpful."

Because the ASO treatment targets a portion of the viral genome that is highly conserved among different variants, it is effective against all SARS-CoV-2 "variants of concern" in human cells and in animal models. It is also chemically stable and relatively inexpensive to produce at large scale, making it ideal for treating COVID-19 infections in areas of the world that do not have access to electricity or refrigeration.

If the treatment proves to be safe and effective in humans, the ASO technology could be readily modified to target other RNA viruses. The research team is already searching for a way to use this to disrupt influenza viruses, which also have pandemic potential.

"If we can design ASOs that target entire viral families, then when a new pandemic emerges, as long as we know which family the virus belongs to, we could use the nasally delivered ASOs to suppress the pandemic in its early stages," said study first author Chi Zhu, a postdoctoral scholar in NST at UC Berkeley. "That's the beauty of this new therapeutic."

Hacking the viral copy machine

Like DNA, RNA carries genetic information coded in a sequence of bases—but unlike DNA, RNA usually comes in a single strand, without a second, complementary strand to form a double helix. However, RNA still readily binds to complementary base pair sequences. ASOs are short strands of lab-made, DNA-like molecules that, like molecular Velcro, are programmed to stick to specific sequences of RNA in viruses and cells.

For more than a decade, Näär and his team have been studying how these molecules might be used to modify the activity of messenger RNA and microRNA in the human body, potentially reversing conditions like obesity, Type 2 diabetes, fatty liver diseases and Duchenne muscular dystrophy. When the COVID-19 pandemic hit, his team quickly mobilized to study whether ASOs could also be used to interfere with SARS-CoV-2.

View: https://www.youtube.com/watch?v=KPvW1xlWpV4
Credit: University of California - Berkeley
3 min

"The SARS-CoV-2 genome is single-stranded RNA, similar to messenger RNA or microRNA," Näär said. "We thought perhaps we could use these ASOs to stick onto the viral RNA and prevent it from working."

In collaboration with associate professor Sarah Stanley's lab at UC Berkeley's School of Public Health and Department of Molecular and Cell Biology, and scientists at the Innovative Genomics Institute, the team began pitting the SARS-CoV-2 virus against hundreds of different ASOs. Each of these ASOs was designed to disrupt a different region of the viral RNA, including the region that codes for the infamous "spike" protein that helps the SARS-CoV-2 virus hijack host cells.

Out of all these targets, they identified one that was far and above the most effective at disrupting the virus. This target was a non-coding sequence of viral RNA that forms a hairpin loop structure and that appears to play a key role in helping SARS-CoV-2 replicate.

"We showed that if you bind an ASO to this hairpin, it dissolves the hairpin, and the RNA forms a straight line instead of a bubble structure," Näär said. "We think that this prevents the virus from effectively translating and replicating, and we found that it was incredibly effective at preventing viral replication in human cells."

When they administered ASOs into the noses of infected hamsters and mice, the team found that they were also highly effective at both preventing and treating COVID-19 infections. Importantly, these experiments also showed that the ASOs did not appear to stimulate any significant immune response, indicating that ASOs are not likely to produce toxic side effects in humans.

Because the hairpin loop structure is found in all known variants of SARS-CoV-2, ASOs should be effective against all of them. To prove that this is the case, the team repeated their experiments against all of the major variants of concern, including delta and the highly-infectious omicron.

"[SARS-CoV-2] enters the body and hijacks our own machinery to become a copy machine to produce tons of virus copies for more infection and spread," said study author and UC Berkeley NST graduate student Justin Lee in a winning UC Grad Slam talk. "We were able to find the key code in the viral RNA that allows the copy machine to run, and all the variants, including delta and omicron, share the same key code."

According to Näär, the team has already identified an additional ASO target that is found in the genetic code of all SARS-family viruses, including the SARS-CoV-1 virus that caused the 2002 SARS outbreak. A "cocktail" of these two ASOs could be even more effective at suppressing the virus—and would be nearly impossible for a new variant to evade.

The team has additional experiments to conduct before the ASO treatment will be cleared for clinical trials in humans. However, Näär is optimistic that the therapeutic could one day be used as part of a spectrum of treatments for COVID-19 and other viral illnesses.

"It's very clear that this virus is not going away," Näär said. "We need a lot of different avenues to tackle it, and therapeutics like ours that are agnostic to the variants could play a major role."

 

[Heliobas Disciple]

Study shows PPE was highly effective against COVID-19 in emergency department workers

Workers in America's emergency departments were more likely to contract COVID-19 in the early days of the pandemic in community settings or at home rather than when providing patient care in a hospital setting, according to new research conducted at emergency departments across the nation.

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Study shows PPE was highly effective against COVID-19 in emergency department workers
by Bob Shepard, University of Alabama at Birmingham
August 9, 2022

Workers in America's emergency departments were more likely to contract COVID-19 in the early days of the pandemic in community settings or at home rather than when providing patient care in a hospital setting, according to new research conducted at emergency departments across the nation.

The study, part of the COVID-19 Evaluation of Risks in Emergency Departments, known as the Project COVERED study, found that personal protective equipment, including masks, gloves and protective gowns, helped keep emergency health care workers shielded from infection while caring for patients. The study was published July 22 in the journal PLOS ONE.

"From the start of the pandemic, emergency department personnel served as the initial hospital caregivers for the majority of critically ill patients with known or suspected COVID-19 infection," said Walter Schrading, M.D., professor in the Department of Emergency Medicine in the Heersink School of Medicine at the University of Alabama at Birmingham. Schrading is a co-author on the study.

Between May and December 2020, prior to the COVID-19 vaccine availability, emergency department staff at 20 medical centers across the country were followed with surveys, COVID-19 tests and serology testing. The study included 1,673 emergency department physicians, advanced practice providers, nurses and non-clinical staff who were observed over 20 weeks and 30,000 person-weeks in total. During this surveillance, more than 4,400 high-risk aerosolizing intubations were performed.

"At the beginning of the pandemic, the risk of providing emergency patient care was not understood. Emergency care staff were committed to their role in responding to the crisis, but they were understandably anxious," said Nicholas Mohr, M.D., lead author and co-principal investigator of the study, at the University of Iowa Hospitals and Clinics. "Even though emergency care workers felt vulnerable performing procedures and providing clinical care for COVID-19 patients during this time, our findings support that it was really when they were outside the hospital and at home, with their families and friends, and in their community that people were at risk of infection."

The study found that only 4.5% of emergency personnel became infected with COVID-19, and the most prominent factors associated with those infections were community exposures, hospital case counts and mask use in public.

"This study does provide reassurance to health care professionals that, with the proper precautions, they can be relatively safe while treating patients in the emergency medicine setting," Schrading said. "PPE is effective at preventing COVID-19 transmission during clinical care, so when case counts are high in the community, health care personnel should take precautions outside the hospital just as they do inside the hospital when they are working."

 

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Increase in non-COVID-19 respiratory infections predicted this winter

An increase in the number of non-COVID-19 respiratory infections should be expected this winter, say scientists. The warning comes following the results of a new study, published in The Lancet Regional Health—Europe, which found that over 55% of respiratory disease hospitalizations during the...

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Increase in non-COVID-19 respiratory infections predicted this winter
by University of Bristol
August 9, 2022

An increase in the number of non-COVID-19 respiratory infections should be expected this winter, say scientists. The warning comes following the results of a new study, published in The Lancet Regional Health—Europe, which found that over 55% of respiratory disease hospitalizations during the pandemic's peak were caused by non-SARS-CoV-2 infections.

The University Bristol-led study funded and conducted in collaboration with Pfizer Inc., as part of AvonCAP, is the first to compare the number of hospitalizations from respiratory disease infections caused by COVID-19 and non-SARS-CoV-2 infections.

Using data from 135,014 hospitalizations from two large hospitals in Bristol between August 2020 and November 2021, researchers identified 12,557 admissions attributable to acute Lower Respiratory Tract Disease (aLRTD) with patients admitted with signs or symptoms of respiratory infections including cough, fever, pleurisy, or a clinical or radiological aLRTD diagnosis. Of these, 12,248 (98%) patients, comprising mainly older adults, consented to participate in the study.

Following further analysis, the team show that of the 12,248 aLRTD hospitalizations, 55% (6,909) were due to infection with no evidence of SARS-CoV-2, while confirmed SARS-CoV-2 infection only accounted for 26% (3,178) of respiratory infections. The remaining 17% (2,161) were due to infection with no infective cause.

Adam Finn, Professor of Paediatrics at the University of Bristol, Director of the Bristol Vaccine Centre at Bristol Medical School and lead of Bristol UNCOVER (Bristol COVID Emergency Research Group), says that "what is really surprising from our results is just how much other non-COVID respiratory infections there was during this time, other infections clearly didn't just disappear and despite significant public health measures, including both vaccination and non-pharmaceutical intervention such as masks, our findings show there was still a high incidence of non-COVID-19 disease causing hospitalizations alongside COVID-19 patients."

Dr. Catherine Hyams, Post-Doctoral Clinical Research Fellow, Principal Investigator for the AvonCAP study and one of the study's lead authors at the University of Bristol, added that their "results really highlight not only the huge burden of respiratory infection on the NHS and other healthcare systems, but also how bad things may get this winter. It is therefore essential that appropriate healthcare planning and resource allocation is undertaken to care for patients with respiratory conditions, in addition to implementation of public health measures to reduce respiratory disease burden and improve patient outcomes."

The study is part of AvonCAP, an ongoing collaborative surveillance project funded by Pfizer Inc., which records detailed information on every adult patient admitted to Bristol's two large NHS hospitals with symptoms, signs and/or X-ray evidence of acute disease in the lungs.