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[Heliobas Disciple]

When Africans asked for COVID shots, they didn't get them. Now they don't want them

It's noisy inside the Mamprobi clinic in Accra as kids clamber over their mothers while they wait to get their measles vaccines. The perception that COVID-19 doesn't pose a significant threat is common in Ghana's capital and elsewhere in Africa, whose youthful populace has suffered a fraction...

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When Africans asked for COVID shots, they didn't get them. Now they don't want them
Edward McAllister and Cooper Inveen - Reuters
Wed, May 18, 2022, 3:06 AM

DAKAR/ACCRA (Reuters) - It's noisy inside the Mamprobi clinic in Accra as kids clamber over their mothers while they wait to get their measles vaccines. Outside, an area reserved for COVID-19 shots is empty. A health worker leans back in his chair and scrolls on a tablet.

One woman, waiting to get her daughter inoculated, is fully aware of the dangers of measles: the high fever, the rash, the risk to eyesight. But COVID-19? She has never heard of a single case.

The perception that COVID-19 doesn't pose a significant threat is common in Ghana's capital and elsewhere in Africa, whose youthful populace has suffered a fraction of the casualties that have driven vaccine uptake in places like Europe and America, where the disease tore through elderly populations.

"I mean, Ghana has been spared up until now doing just what we're doing," said Nana Kwaku Addo, a 28-year-old construction worker in Accra. "I've heard people say it's common sense (to get vaccinated), but what about all the other countries that have taken it and still put people in lockdown."

Only 17% of Africa's 1.3 billion population is fully vaccinated against COVID-19 - versus above 70% in some countries - in part because richer nations hoarded supply last year, when global demand was greatest, to the chagrin of African nations desperate for international supplies.

Now though, as doses finally arrive in force in the continent, inoculation rates are falling. The number of shots administered dropped 35% in March, World Health Organization data shows, erasing a 23% rise seen in February. People are less afraid now. Misinformation about vaccines has festered.

"If we had gotten vaccines earlier, this kind of thing wouldn't happen so often," Christina Odei, the COVID-19 team leader at the Mamprobi clinic, said of the low uptake in Accra. "Initially everyone really wanted it, but we didn't have the vaccines."

That worries public health specialists who say that leaving such a large population unvaccinated increases the risk of new variants emerging on the continent before spreading to regions such as Europe just as governments there abandon mask mandates and travel restrictions.

In a sign of possible perils to come, cases of two Omicron subvariants have shot up in recent weeks in South Africa, the continent's worst-hit nation, prompting officials there to warn of a fifth wave of infections.

To boost uptake, countries are focusing on mobile vaccination drives, in which teams visit communities and offer doses onsite.

However many African countries can't afford the vehicles, fuel, cool boxes and salaries needed for a national campaign, according to more than a dozen health officials, workers and experts across several countries. Meanwhile, donor funding has been slow to arrive, they said.

Rahab Mwaniki, the Africa co-ordinator for the People's Vaccine Alliance advocacy group, said it was a "big ask" for Africans to prioritise getting COVID-19 vaccines to help protect others around the world when infection rates at home were low.

"Many people say, 'you didn't help us'. They feel like the West never really supported them," she added, stressing that Africans should still get vaccinated to protect themselves and others from new variants.

REACHING OUT

Many African countries are long familiar with deadly diseases. Millions fall ill each year with tuberculosis. Malaria kills hundreds of thousands annually, mostly children under five. Ebola springs up periodically in Democratic Republic of Congo.

West Africa is facing its worst food crisis on record driven by conflict, drought, and the impact of the war in Ukraine on food prices.

For many people COVID-19, which carries a far greater risk of severe illness and death for the elderly, is not the most pressing concern. The median age in Africa is 20, the lowest of all regions, and about half the 43 in Europe and 39 in North America, according to a Pew Research Center analysis Populations skew older in some of the countries hit hard by COVID-19 of U.N. data.

"Let me ask you one question," said Mawule, a businessman in Accra. "Is COVID the biggest problem in Ghana right now? You think it's a bigger problem than inflation, the way people suffer for fuel?"

Now the continent has too many COVID-19 vaccine doses. Vaccination sites lie empty; millions of unused vials are piling up, and one of Africa's first COVID-19 vaccine producers is still waiting for an order.

At the Mamprobi clinic, health workers in bright yellow vests have resorted to proactive measures.

They fan out across the busy market stalls and stores in the area, one with a cool box slung over his shoulder containing COVID-19 vaccine shots, asking wary shoppers if they would like to receive an injection.

After an hour toiling in the baking sun, the team had administered just four doses.

NO MONEY, NO JINGLES

To boost uptake, countries including Ghana, Gambia, Sierra Leone and Kenya are focusing on mobile vaccination campaigns that visit communities. But finances are stretched.

Misinformation is tough to unglue on a continent where big pharmaceutical companies have in the past run dubious clinical trials resulting in deaths. Health workers say they need funds to counter false rumours.

Ghana, one of Africa's most developed economies and one applauded for its early inoculation surge, has a funding gap of $30 million to carry out another campaign, according to the World Bank. Irregular power supply jeopardises the vaccine cold chain. Doses expire.

"We don't have any problem with the number of vaccines anymore. It's only a problem with uptake and the money to get those vaccines out to people," said Joseph Dwomor Ankrah, who manages the country's COVID-19 vaccine distribution.

Niger, where only 6% of the population is fully vaccinated, lacks enough cold storage for vaccines in its vast rural areas, or motorbikes to distribute them, according to the World Bank.

There have been some successes; Ethiopia has vaccinated 15 million people in a nationwide push since mid-February, for example.

Yet uptake is "abysmally low" in the tiny state of Gambia, said Mustapha Bittaye, director of health services.

The African Union wants Gambia to take delivery of more than 200,000 doses, but the country is still working through an old batch and doesn't need more, Bittaye said.

In Zambia, where coverage is 11%, officials are planning outreach campaigns but worry they won't be able to cover the cost of feeding doctors working far from home or pay for their transport.

In Sierra Leone, where 14% of the population is fully vaccinated, radio stations sometimes refuse to broadcast the government's pro-vaccine messages because of unpaid invoices, said Solomon Jamiru, the country's COVID-19 spokesman

A World Bank fund for vaccine purchases and rollouts has sent $3.6 billion to sub-Saharan Africa. Of that, only $520 million has been spent. Amit Dar, the bank's human development director for Eastern and Southern Africa, said outdated health systems had struggled to absorb the funding.

Health experts say more funding was needed at the start of the pandemic for logistics and training.

"The fact that we didn't invest heavily a year or 18 months ago is a big part of what we are seeing now," said Emily Janoch, a senior director at aid group Care USA. "These are the consequences of earlier failures."

(Reporting by Edward McAllister in Dakar and Cooper Inveen in Accra; Additional reporting by Jennifer Rigby and Josephine Mason in London; Editing by Alexandra Zavis and Pravin Char)

 

[Heliobas Disciple]

U.S. to study whether longer Paxlovid course needed to combat reinfections

The U.S. National Institutes of Health is in talks with Pfizer Inc about studying whether a longer course of the drugmaker's COVID-19 antiviral treatment Paxlovid is needed to prevent reinfections, top U.S. infectious diseases expert Dr. Anthony Fauci said on Wednesday. "We're going to be...

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U.S. to study whether longer Paxlovid course needed to combat reinfections
Michael Erman - Reuters
Wed, May 18, 2022, 12:25 PM

(Reuters) - The U.S. National Institutes of Health is in talks with Pfizer Inc about studying whether a longer course of the drugmaker's COVID-19 antiviral treatment Paxlovid is needed to prevent reinfections, top U.S. infectious diseases expert Dr. Anthony Fauci said on Wednesday.

"We're going to be planning what studies we're going to be doing relatively soon, within the next few days" in order to determine whether or not a longer course is needed, Fauci said during a White House COVID-19 briefing.
Rising COVID-19 cases in the United States are driving up use of therapeutics, with more than 660,000 courses of Paxlovid pills administered in the country so far.

Some patients have reported that COVID symptoms recurred after completing the five-day course of treatment and experiencing improvement, but exactly how many have experienced such a rebound is unclear.

In Pfizer's clinical trial, around 2% of recipients who received the two-drug treatment saw an increase in viral load after completing the standard course, compared with around 1.5% of placebo recipients.

White House COVID-19 response coordinator Dr. Ashish Jha said that data was compiled when Delta was the dominant variant of the coronavirus, and it is unclear whether reinfections are more common with Omicron now predominant.

Jha said that reinfections do not seem to hamper Paxlovid's ability to reduce hospitalizations and deaths from COVID-19.

Pfizer has suggested that a second five-day course of Paxlovid could treat reinfections. The U.S. Food and Drug Administration said there is currently no evidence to support taking a second five-day course or a 10-day course of the pills.

(This story refiles to fix typographical error in third paragraph)
(Reporting by Michael Erman; Editing by Bill Berkrot)

 

[Heliobas Disciple]

How COVID-19 can affect your heart health

When COVID-19 first emerged, it was thought to be a respiratory disease primarily affecting the lungs. But as time went on and its list of symptoms reported grew longer, scientists learned that the disease can also impact other organs, including the heart.

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VIDEO AT LINK

How COVID-19 can affect your heart health

Wed, May 18, 2022, 4:37 PM

Over the course of the coronavirus pandemic, scientists have learned that the virus can affect the heart and cardiovascular health in general in the short and long term, and that this impact is not restricted to people who have had severe COVID-19.

“COVID-19 produces inflammation in our body, like any other viral infection,” Dr. Aeshita Dwivedi, a cardiologist at Lenox Hill Hospital in New York City, told Yahoo News. “This inflammation can impact pretty much any organ in your body, and the heart does not get spared,” she added.

When COVID-19 first emerged, it was thought to be a respiratory disease primarily affecting the lungs. But as time went on and the list of its symptoms reported grew longer, scientists learned that the disease can also affect other organs, including the heart.

A recent study conducted by the U.S. Department of Veterans Affairs found that those who recover from a severe case of the disease face significantly higher risks of developing new heart problems and other serious cardiovascular disorders.

The study compared rates of new cardiovascular problems in over 150,000 people infected with the coronavirus before vaccines were available, with 5.6 million people who were never infected; they were also compared to a group of 5.9 million people whose data was collected before the pandemic. Researchers found that a year after their recovery, people who had suffered a severe COVID-19 infection had a 63% higher risk for developing heart complications, including heart attacks, heart failure, arrhythmias and stroke, compared to people who were not infected.

The study found that even people who had mild COVID-19 and were not hospitalized appear to be at a higher risk of heart problems a year after infection. People who had a milder form of the disease had a 39% higher risk of developing heart problems compared to those who had never been sick.

COVID-19 can affect the heart in various ways. For some people who fall critically ill with the virus and who need hospitalization, a serious complication called a cytokine storm can occur. This is not caused by the virus but by the body’s response to it. It happens when the immune system launches an attack on the virus that is so severe that it can damage healthy tissues in the body.

Dwivedi said such an event causes significant inflammation. “At that point, it can impact pretty much any part of your heart, including the lining, the heart muscle itself, the arteries of the heart and the rhythm of the heart,” she said.

In some people with severe COVID-19, the massive inflammatory response is also accompanied by severe blood clotting.

“It's the most blood clot-causing disease we've ever encountered,” Dr. Alex Spyropoulos, a thrombosis expert and professor at the Feinstein Institutes for Medical Research, told Yahoo News. “It's a truck going at a 100 miles an hour in terms of what we call a system-wide tendency to have blood clots.” Blood clots, he explains, can block blood flow and reduce oxygenation to the heart, which can damage it.

He said the number of patients who are critically ill and develop these blood clots has fallen over time, probably because many people now have immunity, either from the vaccines or a prior infection, or a combination of both. However, everyone should continue to exercise caution, he warned, now that COVID-19 cases are on the rise again in many parts of the country.

“Hospitalizations are going up again,” said Spyropoulos, who practices medicine at Northwell Health System in New York. “Thankfully, fewer people are needing critical care, so that's a good sign, but I think once you're sick enough to be in the hospital, the risk of blood clotting is still there.”

New COVID-19 cases have been on the rise nationwide. On Tuesday, New York City’s COVID-19 risk level was upgraded from medium to high, due to an increase in cases and hospitalizations. City officials said more than 10% of its hospital capacity is now occupied by coronavirus patients.

COVID-19 can impact the heart in many different ways, whether an individual has had a severe case of the virus or not. For individuals with underlying heart conditions, COVID-19 can exacerbate the problems, Dwivedi said. She recommends that after contracting COVID-19, people consult a doctor about heart health if they experience any of these symptoms:

• Ongoing shortness of breath
• Ongoing chest discomfort or pain
• Irregular heartbeat
• Elevated heart rate
• Ongoing fatigue
• Swelling in the legs
• Dizziness or lightheadedness with exertion or when changing positions

Some of these heart issues can be temporary, Dwivedi said, and others longer term, but with the proper medical care, they can be rectified. “We do see that with time and appropriate medical care, these can be tackled, in conjunction with your doctor,” she said.

People who have recovered from severe COVID, and even those with milder cases, can also experience lingering COVID-19 heart problems, Dwivedi explained. “Some people may have inflammation of the lining of the heart, which is the sac that the heart sits in, and this is called pericarditis,” she said, adding that this condition can present with chest discomfort and shortness of breath. She said it is relatively benign and can be easily treated.

In some cases, after this condition heals, Dwivedi said it can result in “scarring of the pericardium,” which she compared to the scar from a cut after it heals. Similarly, the inflammation can cause scarring of the pericardium, she explained. In severe cases, this can be problematic, but the cardiologist said that most pericarditis cases she has seen usually resolve after treatment, which involves anti-inflammatory medications.

Body inflammation caused by COVID-19 can also affect the muscle of the heart responsible for pumping blood to the rest of the body. This “less benign presentation," myocarditis, Dwivedi said, can sometimes lead to weakening of the heart muscle and heart failure, which may require immediate medical attention.

A very few cases of myocarditis have been reported after COVID-19 vaccination. "In very rare cases, less than 0.1%, people can get inflammation of the heart muscle," she said, adding that "The good news is that no one [has] had long-term sequelae from vaccine-induced side effects."

Scientists are still studying the long-term effects of infection, known as “long COVID,” which may include heart issues.

Dwivedi said some of these patients also complain of palpitations and abnormal heart rhythm, and that their heart rate remains elevated, especially after changing position. She told Yahoo News that these symptoms are due in part to “an imbalance in the homeostasis or the regulation of the blood pressure.” Diagnosing and treating this condition is more challenging, she said, and the treatment options usually “rely on a lot of lifestyle modifications.”

 

[Heliobas Disciple]

Missouri Bill Prevents Doctors Being Disciplined If They Prescribe Ivermectin or Hydroxychloroquine

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Missouri Bill Prevents Doctors Being Disciplined If They Prescribe Ivermectin or Hydroxychloroquine
By Naveen Athrappully
May 18, 2022

Missouri lawmakers passed legislation that prevents state licensing boards from disciplining doctors who prescribe ivermectin and hydroxychloroquine.

Sponsored by Rep. Brenda Kay Shields (R-Mo.), HB 2149 also bars pharmacists from questioning doctors or disputing patients regarding the usage of such drugs and their efficacy.

With a convincing 130–4 vote in the House, HB 2149 passed both chambers on May 12 and currently heads to the office of Gov. Mike Parson to be potentially signed into law.

“The board shall not deny, revoke, or suspend, or otherwise take any disciplinary action against, a certificate of registration or authority, permit, or license required by this chapter for any person due to the lawful dispensing, distributing, or selling of ivermectin tablets or hydroxychloroquine sulfate tablets for human use in accordance with prescriber directions,” reads the draft of the bill (pdf).

It adds, “A pharmacist shall not contact the prescribing physician or the patient to dispute the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets for human use unless the physician or patient inquires of the pharmacist about the efficacy of ivermectin tablets or hydroxychloroquine sulfate tablets.”

Critics of the bill have noted that the Food and Drug Administration (FDA) has not given approval for usage of the drugs. Ivermectin and hydroxychloroquine have been divisive drugs and politically polarized throughout the pandemic.

“But, nevertheless, the Missouri legislature has chosen to ‘own the libs’ by issuing a gag order against every pharmacist in this state from offering their medical opinion on taking either one of those medications—even if it could kill their patient,” wrote former Democratic nominee Lindsey Simmons in a May 12 Twitter post.

Although 22 countries across the world have approved the use of ivermectin in treating COVID-19, the FDA maintains that the current data show the drug to be ineffective. Large doses can be dangerous, it says.

A recent study published in the International Journal of Infectious Diseases analyzed a national federated database of adults that compared ivermectin with the FDA-approved COVID-19 medication, remdesivir.

“After using propensity score matching and adjusting for potential confounders, ivermectin was associated with reduced mortality vs remdesivir,” researchers wrote. “To our knowledge, this is the largest association study of patients with COVID-19, mortality, and ivermectin.”

According to The Associated Press, Missouri state Rep. Patty Lewis, a Democrat, agreed to the bill to satisfy a group of conservatives in the Senate. She added that the bill will not change anything significantly as medical boards do not engage in punishing doctors who prescribe drugs legally.

 

[Heliobas Disciple]

EXCLUSIVE: Key NIH Research Executive Received 70 Secret Royalty Payments; Colleague Got 7

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EXCLUSIVE: Key NIH Research Executive Received 70 Secret Royalty Payments; Colleague Got 7
By Mark Tapscott
May 16, 2022 Updated: May 18, 2022

Two key National Institutes for Health (NIH) executives in positions of influence on decisions about who gets grants from the agency received a total of 77 previously undisclosed royalty payments from outside firms between 2010 and 2014.

The secret royalty payments, which were first reported by The Epoch Times, are among thousands estimated to total at least $350 million paid between 2010 and 2020. Former NIH Director Dr. Francis Collins received 14 payments, Anthony Fauci, who heads NIH’s National Institute for Allergies and Infectious Diseases (NIAID), received 23, and Clifford Lane, Fauci’s chief deputy, got eight payments.

Acting NIH Director Lawrence Tabak conceded during questioning last week by Rep. John Moolenaar (R-Mich.) that the undisclosed royalties had the “appearance of a conflict of interest,” but he insisted that the agency has sufficient internal safeguards to prevent such problems. Federal law and ethics regulations bar federal employees from activities that present either the appearance or an actual conflict of interest.

Dr. Michael Gottesman, who has been the NIH’s deputy director for intramural research (DDIR) since 1994, received 70 royalty payments during the five-year period from 2010 to 2014, according to documents recently obtained by the nonprofit government watchdog Open the Books (OTB) as a result of a Freedom of Information Act (FOIA) request for extensive data on all payments from 2o10 to the present.

Open the Books is a Chicago-based nonprofit government watchdog that uses federal and state freedom of information laws to obtain and then post on the internet trillions of dollars in spending at all levels of government.

According to his official resume on the NIH website, Gottesman “coordinates activities and facilitates cooperation among the 24 Institute- and Center-based Scientific Directors to achieve the scientific, training, and public health missions of the NIH Intramural Research Program.

“He provides guidance for the entire intramural program and reports to [Acting NIH Director Lawrence Tabak]. He oversees and ultimately approves the hiring of all NIH principal investigators, and he is the institutional official responsible for human subjects research protections, research integrity, technology transfer, and animal care and use at the NIH.

“During his tenure as DDIR, Dr. Gottesman has created the post-baccalaureate training program, the Graduate Partnerships Program (which permits graduate students to conduct thesis research at NIH); implemented loan repayment programs; institutionalized an intramural tenure track and new career tracks for clinical investigators; created the NIH Intramural Database (providing online information about all researchers and research at NIH); and spearheaded multiple other programs in the realm of diversity, equity, research integrity, and leadership.”

Gottesman announced in July 2021 his resignation from the DDIR position, pending the selection of his successor. He plans to remain as chief of the Laboratory of Cell Biology in the NIH’s National Cancer Institute after his DDIR successor is chosen.

The NIH initially ignored OTB’s request until the nonprofit filed a FOIA lawsuit in federal court. At that point, the NIH agreed to begin producing the requested documents in a series of monthly tranches.

But who paid the 70 royalties to Gottesman, the amounts of the payments, and for what purpose the payments were made isn’t known, since the NIH is redacting payment amounts and the payers’ identities from documents the agency is providing to OTB as a result of the FOIA.

The Epoch Times has requested from NIH the names of the payers of the 70 payments to Gottesman, the amounts of each payment, and the purpose for which the payment was made. The NIH hasn’t responded.

An additional seven royalty payments of unknown amounts from unknown payers were made to Roger Glass, the NIH’s associate director for international research. Glass was appointed to the post in 2006.

Congressional Democrats, including Senate Committee on Health, Education, Labor and Pensions Chairwoman Sen. Patty Murray (D-Wash.) and House Energy and Commerce Committee Chairman Rep. Frank Pallone (D-N.J.), were silent when asked last week by The Epoch Times about the secret royalty payments.

Republicans on Capitol Hill, however, ripped the payments as an obvious conflict of interest and called for full disclosure of all the facts.

“NIH receives tens of billions of taxpayer dollars and is entrusted with making unbiased scientific assessments and recommendations,” Sen. Joni Ernst (R-Iowa) told The Epoch Times. “Their top officials, like any public officials, need to be held to the highest standards of transparency and accountability to prevent conflicts of interest and ensure the American people’s health and safety remains the agency’s top priority. The NIH must be held accountable to the American people.”

Sen. Marsha Blackburn (R-Tenn.) called the NIH “a dark money pit.”

“They covered up grants for gain-of-function research in Wuhan, so it is no surprise that they are now refusing to release critical data regarding allegations of millions in royalty fees paid to in-house scientists like Fauci. If the NIH wants to keep spending taxpayer dollars, they have a responsibility to provide transparency.”

Sen. Ted Cruz (R-Texas) said, “This report is disturbing and if it is true that some of our country’s top scientists have conflict of interest problems, the American people deserve to have all the answers.”

Rep. Greg Steube (R-Fla.) called for an investigation, noting: “Of course it’s a direct conflict of interest for scientists like Anthony Fauci to rake in $350 million in royalties from third parties who benefit from federal taxpayer-funded grants.
“Anthony Fauci is a millionaire that has gotten rich off taxpayer dollars. He is a prime example of the bloated federal bureaucracy. This royalty system should be examined to ensure it isn’t making matters worse.”

 

[Heliobas Disciple]

Sealed-in Shanghai Residents Say Reopening Is ‘Far Away’ as Authorities Claim ‘Zero-COVID’ Status Reached

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Sealed-In Shanghai Residents Say Reopening Is ‘Far Away’ as Authorities Claim ‘Zero COVID’ Status Reached
By Dorothy Li
May 18, 2022

Shanghai officials on May 17 said they achieved zero infections outside quarantine zones for three consecutive days, marking a long-awaited milestone for a city that has been in lockdown for over seven weeks, though most residents are still confined to their homes.

Zhao Dandan, a deputy director of the Shanghai health Commission, said at a May 17 press conference that all 16 districts in Shanghai had achieved “social dynamic zero-COVID” for three consecutive days. “Social dynamic Zero-COVID” means all infections were reported in centralized quarantine facilities or residential communities under lockdown.

As of May 18, an estimated 790,000 people are still in sealed-off areas, local officials said, where people are subjected to the strictest form of lockdown. The officials didn’t say how many people were in isolation centers.

Shanghai registered 815 cases in the past 24 hours, Zhao said at the regular press conference on Wednesday. The official count, however, has been disputed by residents and experts, who point to the Chinese regime’s history of downplaying and covering up information about outbreaks across the country.

The commercial hub of 25 million released a timetable for gradually exiting the lockdown that lasted for over seven weeks, saying they planned to reopen from the start of June. Unsurprisingly, the plan was met with skepticism by residents who had seen their hopes being dashed time and again. The initial lockdown was expected to last only eight days when it was introduced in late March.

The authorities have lost credit, said a resident surnamed Wang who is still stuck inside his home. Wang’s residential community has been placed in a “quiet period” since May 15 and given no official explanation. During the ten-day period, no one is allowed to leave home, and deliveries are halted.

Some say they have been given passes to exit their residential complexes. The pass only allows one person per household to leave for a few hours at a time, a local resident told The Epoch Times on May 17.

The pass is valid for three hours, said another resident in the Fengxian district. People need to queue up for one to two hours to get into a supermarket, the man surnamed Chen told The Epoch Times, adding they will lose the pass if they don’t return on time.

Even if people have a pass, they can only venture to within a few streets from their home, according to Chen. He is still unable to visit his daughter living in the Pudong district, about a 45-minute drive from his home.

“Fully reopening or resuming work is still very far away,” said a third resident who has been sealed in a residential community in Minxing district for 60 days.

On the country’s popular microblogging platform Weibo, the Chinese Communist Party’s official media posted some photos that showed breakfast joints, restaurants and hairdressers opening up, sparking anger from seal-off Shanghai residents.

One social media user described the post as “nonsense.”

“We have been locked in at home for two months … This story is meant for anyone else other than people in Shanghai.”
By Tuesday morning, the post had been deleted.

Escaping Shanghai

For many migrant workers in the city, they’re desperate to return to their home cities and towns after enduring the protracted lockdown.

Social media posts have shown long queues of people, mostly migrant workers, outside one of the city’s main railway stations, looking to return home after getting permission to go outside.

Some have been photographed hauling suitcases on rented bikes or trekking on foot from distant corners of the city.
A deliveryman surnamed Liu said it’s “incredibly difficult” to get a train ticket to return to this hometown.

Liu said he heard a worker paid an extra 500 yuan ($74) to get a ticket from a scalper. “It’s a blessing to be able to get a ticket,” Liu told The Epoch Times on May 17. He noted that workers who get to go home would still have to undergo quarantine upon their return.

Sun Wei (alias), who works in social media had been deprived of an income for over two months due to the lockdown, finally got permission from a neighborhood community and left the city on May 17.

“If I had continued to stay in Shanghai, I would have starved to death,” Sun told The Epoch Times from a quarantine hotel in his hometown, Fuyang city of Anhui Province, about a seven-hour drive from Shanghai.

The week-long centralized quarantine cost him about 900 yuan ($133) before he was allowed to be isolated at home for another seven days.

The draconian curbs have inflicted pain on millions of residents in the city and wreaked havoc on the country’s economy.
China’s April economic data was bleak: retail sales and factory production dropped to their worst level since the onset of the pandemic, and the country’s unemployment rate hit a two-year high. The data released by the National Bureau of Statistics on May 16 was worse than economists had expected.

The American Chamber of Commerce in China said on May 17 that the regime’s zero-COVID policy would hamper foreign investment for years to come as travel curbs disrupt projects. Big firms are also exploring alternatives for their supply chains, it said.

“Unfortunately the COVID lockdown this year and the restrictions for the last two years are going to mean three, four, five years from now, we will see investment decline, most likely,” said the chamber president Michael Hart.
Luo Ya, Gu Xiaohua, Zhao Fenghua, Fangxiao, and Reuters contributed to this report.

 

[Heliobas Disciple]

Investigation Underway Following Mysterious Surge in Deaths of Newborn Babies in Scotland

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Investigation Underway Following Mysterious Surge in Deaths of Newborn Babies in Scotland
By Jack Phillips
May 18, 2022

Officials in Scotland are investigating a mystery surge in deaths of newborn babies, the second time the phenomenon has been reported in about six months.

The probe was started after 18 infants died in their first four weeks of life in March, which caused the mortality rate to surpass a set threshold and trigger an investigation, Public Health Scotland (PHS) confirmed to local media outlets. In September 2021, 21 babies died in their first four weeks of life, similarly triggering an investigation.

PHS appeared to rule out COVID-19 as a cause for the mysterious deaths, noting that infections in mothers or infants “[did] not appear to have played a role,” according to The Herald newspaper. In September, the agency also said that COVID-19 infections “did not appear to have played a role” in the deaths at the time.

A spokeswoman for Scotland’s Government confirmed the investigations as well in statements to The Herald.

“We are working with PHS, the Scottish National Neonatal Network, and the Maternity and Children Quality Improvement Collaborative to understand any possible contributing factors to ensure we continue to improve the care of the smallest and sickest babies in Scotland,” the spokesperson said.

There will be individual investigations into each day as part of the agency’s policies, which are intended to “improve approaches to the review of adverse events, such as these, in maternity and neonatal settings,” the statement added.

“Each of the losses reflected in the information reported is a tragedy for those involved,” the statement said “The review processes to identify and mitigate any contributing factors are being led by the responsible agencies, and are ongoing.

Public Health Scotland will continue to monitor data on neonatal health outcomes to inform and support this work.”

Dr. Sarah Stock, an expert in maternal and fetal medicine at Edinburgh University who led a study regarding COVID-19 and pregnancies in her country, told the news outlet that “the numbers are really troubling,” noting that officials don’t know the cause yet.

“What we do know is that it’s not neonatal COVID … the rates of COVID-19 infection in babies are very low and deaths from COVID are thankfully very, very small, so this isn’t COVID affecting babies,” Stock commented.

But, she added, “we can’t forget that it might be other causes altogether, so it’s really important that we investigate.”

The agency did not make any references to COVID-19 vaccinations in either the March or September spate of infant deaths. Scotland has vaccinated 91.8 percent of its population over 18, according to public health data. The Epoch Times has contacted PHS for comment.

 

[Heliobas Disciple]

U.S. Bioethics Chief, Who Happens to be Fauci’s Wife, Published a New Paper Telling Corporates They Can Ethically 'Pressure Employees' And 'Embarrass Vaccine Resistors.' - The National Pulse

Anthony Fauci’s wife – who is also head of the Department of Bioethics at the National Institutes of Health Clinical Center – authored a paper defending the ethics of corporations “pressuring employees to get vaccinated” and “embarrass[ing] vaccine resistors.”The study – “The Ethics of...

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U.S. Bioethics Chief, Who Happens to be Fauci’s Wife, Published a New Paper Telling Corporates They Can Ethically ‘Pressure Employees’ And ‘Embarrass Vaccine Resistors.’
The paper comes hot on the heels of a number of White House losses regarding federal worker vaccination and mask mandates.
by Natalie Winters
May 18, 2022

Anthony Fauci’s wife – who is also head of the Department of Bioethics at the National Institutes of Health Clinical Center – authored a paper defending the ethics of corporations “pressuring employees to get vaccinated” and “embarrass[ing] vaccine resistors.”

The study – “The Ethics of Encouraging Employees to Get the COVID‑19 Vaccination” – was funded by the National Institutes of Health (NIH) Clinical Center and the National Human Genome Research Institute and counted Christine Grady, Fauci’s wife, amongst its authors.

Published in March 2022, the paper followed attempts by the White House as well as Democratic Party politicians across America to mandate COVID-19 vaccination for federal and state workers.

Grady’s paper focuses on the “ethics of encouragement strategies aimed at overcoming vaccine reluctance (which can be due to resistance, hesitance, misinformation, or inertia) to facilitate voluntary employee vaccination.”

Grady and her three co-authors outline how it is “ethically acceptable” to “subtly pressure employees to get vaccinated”:

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While employment-based vaccine encouragement may raise privacy and autonomy concerns, and though some employers might hesitate to encourage employees to get vaccinated, our analysis suggests ethically acceptable ways to inform, encourage, strongly encourage, incentivize, and even subtly pressure employees to get vaccinated. ​

While discussing vaccine mandates, the paper posits they can “be ethically appropriate” if there is “clear articulation about the consequences of not complying with the policy.”

“In that circumstance, employees have a choice between getting vaccinated or accepting the consequences of a choice to remain unvaccinated,” it explains.

Grady outlines other tactics employers could use to boost COVID-19 vaccination rates within their company, such as sharing “targeted statistics (such as 75% of the company or unit have been vaccinated) to spur competition or even implicitly embarrass vaccine resistors.”

“There can be social consequences associated with peer communication about vaccination, such as stigma and ostracization of those not vaccinated,” the paper asserts.

“Individuals who choose to make the workplace less safe for others through their vaccine refusal should be able to foresee the possibility of this kind of social consequence,” it continues, appearing to endorse the aforementioned “stigma and ostracization” of individuals unvaccinated against COVID-19.

“When a policy is tied to group vaccination metrics, unvaccinated employees may feel implicit (or explicit) pressure from peers or supervisors to help the group meet its return-to-work goals,” Grady and her co-authors outlined before describing the approach as “ethically appropriate”:

“Despite worries about a perception of unfairness, we argue that the selective easing of public health restrictions is ethically appropriate when done transparently and tied to objective public health guidance.” ​

The unearthed paper comes amidst controversy over Fauci’s decision to fund research on “killer” bat coronaviruses at the Wuhan Institute of Virology. Additionally, Grady’s prominent role in supervising the ethics of NIH research and policy appear to present a conflict of interest given her husband’s role in shaping America’s COVID-19 response and vaccination guidelines.

 

[Heliobas Disciple]

The WHO Changes Guidelines to Favor Lockdowns ⋆ Brownstone Institute

The report says this recommendation will be incorporated into the WHO’s “normative work," meaning it will be part of official WHO guidance.

brownstone.org

(fair use applies)

The WHO Changes Guidelines to Favor Lockdowns
By Will Jones
May 18, 2022

The World Health Organisation intends to make lockdowns and other non-pharmaceutical interventions intended to curb viral spread part of official pandemic guidance.

The revelation comes in a report scheduled to go to the WHO’s World Health Assembly later this month. This is not part of new pandemic treaty and does not require the endorsement of member states. The report says the implementation is already underway.

Many have raised the alarm about a new WHO pandemic treaty. However, as I’ve noted previously (and as Michael Senger notes here), there isn’t a new pandemic treaty on the table. Rather, there are amendments to the existing treaty, the International Health Regulations 2005, plus other recommendations (131 in all) put forward in a report from the Working Group on Strengthening WHO Preparedness and Response to Health Emergencies.

Most of these amendments and recommendations relate to information and resource sharing and preparation for future pandemics; none of them directly interferes with state sovereignty in the sense of allowing the WHO to impose or lift measures. However, that doesn’t mean they’re not dangerous, as they endorse and codify the awful errors of the last two years, beginning with China’s Hubei lockdown on January 23rd 2020.

The recommendations in the report originate from WHO review panels and committees and were sent out in a survey in December 2021 to member states and stakeholders to seek their views.

Non-pharmaceutical interventions appear three times in the recommendations, once under “equity” and once under “finance,” where states are urged to ensure “adequate investment in” and “rapid development, early availability, effective and equitable access to novel vaccines, therapeutics, diagnostics and non-pharmaceutical interventions for health emergencies, including capacity for testing, scaled manufacturing and distribution”.

While rapid development and early availability of non-pharmaceutical interventions sounds worrying in itself, it could be interpreted in a number of ways by states.

Where it really gets alarming, however, is in the “leadership and governance” section. LPPPR 29 states (emphasis added):

Apply non-pharmaceutical public health measures systematically and rigorously in every country at the scale the epidemiological situation requires. All countries to have an explicit evidence-based strategy agreed at the highest level of government to curb COVID-19 transmission.​

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The requirement that a country’s pandemic strategy must aim to curb viral transmission is a major change from the current guidance. The U.K.’s existing pandemic preparedness strategy, prepared in line with previous WHO recommendations, is completely clear that no attempt should be made to stop viral transmission as it will not be possible and will waste valuable resources:

It will not be possible to halt the spread of a new pandemic influenza virus, and it would be a waste of public health resources and capacity to attempt to do so.​

​

It almost certainly will not be possible to contain or eradicate a new virus in its country of origin or on arrival in the U.K. The expectation must be that the virus will inevitably spread and that any local measures taken to disrupt or reduce the spread are likely to have very limited or partial success at a national level and cannot be relied on as a way to ‘buy time’.​

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It will not be possible to stop the spread of, or to eradicate, the pandemic influenza virus, either in the country of origin or in the U.K., as it will spread too rapidly and too widely.​

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But now the WHO says that curbing viral transmission is to be the aim of pandemic response. This is a disaster.

Worse, the report says this recommendation will be incorporated into the WHO’s “normative work,” meaning it will be part of official WHO guidance to states in responding to a pandemic. Worse still, it says it’s already being implemented – it doesn’t need a treaty or the agreement of member states to do this, it’s already happening.

Expect to see new guidance appearing at the international and national levels over the coming months and years which incorporate this presumption that restrictions should be imposed to curb viral spread. This is despite the last two years only confirming the wisdom of the WHO’s previous guidance that this is not possible and not worth the attempt.

This matter must be raised at the highest levels so that lockdowns and other non-pharmaceutical interventions are kept out of all pandemic planning.

Sign the parliamentary petition against the latest moves by the WHO here – now at over 121,000 signatures.

 

[Heliobas Disciple]

What Happens if You Get COVID While Traveling Abroad? Let Me Tell You—It Happened to Me

Tip: “It won’t happen to me” is not a plan.

www.afar.com

(fair use applies)

What Happens if You Get COVID While Traveling Abroad? Let Me Tell You—It Happened to Me
By Julia Cosgrove
May 13, 2022

If you test positive while abroad, you'll need to isolate and delay your return anywhere from 5 to 10 days.
With the United States still requiring a negative COVID test within one day of traveling to the U.S., countless travelers are faced with the possibility of getting stuck abroad if they test positive.

I knew the minute I woke up groggy with a sore throat that my time had come. After successfully dodging COVID-19 for more than two years, I quickly confirmed I was positive using a rapid antigen test from the front desk of my hotel in Oberammergau, the village in southern Germany where I had come in late April to attend a travel conference.

I was lucky—the conference organizers had a COVID response team with clearly defined protocols about what to do next: Isolate in my hotel room until the on-site testing unit could come to proctor a PCR test. About two hours later, a woman in full PPE knocked on my door and swabbed my throat. Two hours after that, I received an email confirming what my body already knew: I had COVID.

The hotel left breakfast and lunch for me outside my door and I waited for my next steps. Meanwhile, I canceled all my appointments and engagements for the week ahead since I was supposed to depart for home in the San Francisco Bay Area the following day. Germany currently recommends a five-day isolation period for individuals who test positive for COVID. I knew I wasn’t going home for a while, and I tried to make my peace with that.

The next morning the conference organizers transferred me and one other COVID-positive (though asymptomatic) attendee by coach to a quarantine hotel at the Munich Airport. We were both masked and sat in the back of the bus, far from the driver. The hotel had been prepped that we were coming and told that we were both positive, which was a relief to me since I don’t speak German.

When we arrived at the hotel I checked in, hightailed it to my room on the second floor, shut the door behind me, and settled in. I stayed in the room for a total of six nights until my five-day isolation period was complete and I tested negative. (See more below on what happens when travelers continue to test positive for a prolonged time.) It was clear the staff here knew exactly what to do, and they couldn’t have been more helpful: Food was left outside my door twice a day, along with bottles of water. Housekeeping called every day to check if I needed anything.

About me: I’m 41 and fully vaccinated. I received my booster shot last November. I’ve been cautious about wearing masks and avoiding large crowds, and I still wear N95 masks on airplanes, buses, trains, and in theaters, museums, and common indoor areas. My symptoms included a sore throat, fever, night sweats, nasal congestion, nausea, headaches, fatigue, brain fog, loss of sense of smell and taste, and a cough.

My story is not uncommon. And as more and more Americans travel overseas this spring and summer, many will test positive for COVID. Some will get sick; others will be completely asymptomatic.

The reason you might get stuck abroad is that the U.S. still has a pretesting requirement in place, so all travelers entering the country must have proof of a negative COVID antigen, PCR, or CDC-approved self-test within one day of travel, regardless of vaccination status. (All foreign nationals entering the United States must also be vaccinated.)

Thankfully, testing has become easier to access throughout the world. Many airports now have testing facilities that offer travelers rapid tests for a fee, and most destinations throughout the world have testing sites. If you want to find out what the testing options are, check the U.S. State Department’s detailed COVID-19 travel information and country-specific advisories, which include an entire section devoted to the availability of COVID-19 tests within the country or countries you are traveling to. Additionally, the U.S. Centers for Disease Control and Prevention (CDC) has approved several at-home test kits for international travel, the caveat being that the use of these kits must be supervised by a health provider in the form of a telehealth video call (so users need to ensure that they have reliable Internet service to be able to conduct this virtual consultation). We have compiled and reviewed the at-home COVID tests that meet the requirements for international travel.

But everyone should have a plan—most travelers won’t be as fortunate as I was to have a team of native-speaking conference organizers to tell them what to do and take care of them if they test positive. So here are some things to think about and what I wish I’d known before I left the States.

Make a contingency plan before you leave home

If you’re traveling with a group, tour, or on a cruise, ask them or your travel advisor before you depart about testing policies and protocols around positive cases. What costs—if any—will they cover? Do you have travel insurance that covers expenses associated with a COVID infection while you’re out of the country? (These can include both any necessary medical treatment as well as an extended hotel stay.) Can you change your airplane ticket? What kinds of fees will be associated with that should you test positive and need to delay your departure? These are the kinds of details that travel advisors deal with every day. If you haven’t considered booking with one before, think about it as an option, especially as we continue to navigate the ever-evolving patchwork of COVID rules and regulations.

If you’re traveling independently, think about where you’ll spend your last night before returning to the U.S. Is it an accommodation you could comfortably spend a week in, should you test positive or fall ill? Does it have high-speed Wi-Fi if you might need to work, video chat with family or friends, or binge watch The Crown (guilty as charged)? If not, do a little research to determine if there’s a nearby hotel or rental better suited for quarantine. Consider cost and comfort. My room was spacious, equipped with a mini-fridge and full bathroom with a tub and steam shower, and most importantly, a large window I could open to circulate fresh air.

The kid scenario

I was traveling solo, which was a blessing and a curse. On the plus side, I didn’t accidentally bring the virus home to my four-year-old, who’s still not eligible for vaccination. And I didn’t have to worry about anyone else in my family of four and when they might or might not test positive. If I’d had my kids with me and we were all stuck for some amount of time, I would have contacted my elder daughter’s teacher and asked about possible distance learning while we remained isolated. If you’re traveling with kids, think about possible childcare needs in your contingency planning.

If you start feeling sick, test and isolate

Be sure to pack plenty of at-home rapid COVID tests so that the minute you start to feel unwell or suspect a possible exposure, you can administer a test. It’s better to know if you have COVID than to be in the dark. If you test positive on a rapid test, schedule a PCR test immediately to confirm the result. A lab-generated PCR test will mean that your COVID case will be officially documented by the country you are in and can help trigger government-generated instructions on next steps. In some countries, your case will go into the contact tracing system. After the PCR test confirmed my infection, the Bavarian State Ministry of Health and Care was notified and sent me a notice that clearly outlined what I needed to do before I could exit my isolation period:

Your isolation lasts a minimum of 5 days after the positive testing.

For your information: Day 0 always equals the day of your initial positive test.

If you are asymptomatic for a minimum of 48 hours you may leave isolation at the earliest after day 5 of isolating (on day 6).

If your symptoms persist beyond day 3, you must isolate until you don’t show symptoms like coughing, fever, and other cold-like symptoms any longer for at least 48 hours.

In any case, isolation will not last more than 10 days.

If you are unsure what to do, you can always reach out to the U.S. embassy of the country you are in for guidance.

What I wish I’d packed

En route to SFO for my flight to Munich, I realized I forgot my personal stash of rapid antigen tests. After I tested positive and before I was transferred to the Munich Airport hotel, conference organizers gave me a bag of at-home tests so I could monitor my progress through the illness. Don’t be like me—pack a bunch of tests so you aren’t left in the lurch (and remember you can receive free at-home COVID tests from the U.S. government).

During my sickest days (days 2–4), I wished I’d brought a Farenheit thermometer to track my temperature, as well as a pulse oximeter to keep an eye on my blood oxygen levels. I had a bottle of Advil with me that proved very useful the first couple of days of fever and headache. I’d also recommend packing some cough drops and cold medicine (Advil Cold & Sinus worked for me) to have on hand. Bring more high-quality masks, such as N95 or KN95 masks, than you think you need. If you do get sick, you will want to protect others in the event you are required to move from one location to another (such as when I transferred to the quarantine hotel) and you won’t want to reuse them.

By the time I arrived at my quarantine hotel, I had a carry-on suitcase of dirty clothes. After all, I was at the end of my trip (or so I thought) and had spent the prior week hiking in the Alps and attending business meetings. I called the front desk and had a stack of my most comfortable clothes laundered, which was a little luxury I didn’t regret.

Know who to call in an emergency

If you do test positive and fall ill with the virus, it’s a good idea to know how to get help if your symptoms worsen rapidly or become severe. Study up on a few phrasebook terms (“I need a doctor,” “It’s a medical emergency”), especially if you’re traveling to a place where English isn’t widely spoken. If you’re in a hotel room or vacation rental with a landline, find out the number to call in an emergency and write it down. Having local contacts or a travel advisor with in-depth knowledge of the destination on your side can really help. Look into travel risk management services such as Global Rescue and International SOS, which provide travel protections that include 24-hour assistance and medical evacuation.

If you continue to test positive after having recovered

According to the CDC, in order to be able to enter the United States from abroad, you either need a negative COVID test or “if you recently recovered from COVID-19, you may instead travel with documentation of recovery from COVID-19—i.e., your positive COVID-19 viral test result on a sample taken no more than 90 days before the flight’s departure from a foreign country and a letter from a licensed healthcare provider or a public health official stating that you were cleared to travel.”

This second option is important because, “We have people who are testing positive 42 days out from when they first tested and yet they’re completely asymptomatic,” says Dr. Robert Quigley, senior vice president and global medical director at International SOS.

One of the services travel risk management companies like International SOS will provide is connecting travelers to a heathcare provider in the destination who can write a certified “fit to fly” or “fit to travel” letter that can be used to board an airplane to the United States. If you just Google “fit to fly certificate,” you will find an overwhelming patchwork of resources and it’s unclear which are legitimate. It’s best to identify a certified healthcare practioner in the destination from whom you can obtain the necessary documentation.

“If a traveler continues to test positive for COVID they will need to obtain a letter of recovery from a healthcare provider to be able to travel. Each country has their own requirements. Most require the individual to have had COVID for a specific amount of time before they can be seen and evaluated for a letter of recovery. The average is 10 days. The letter of recovery is sufficient for travel,” says Jeff Weinstein, medical operations supervisor at Global Rescue, who has extensive experience in emergency and disaster response, critical care paramedicine, and emergency management.

Don’t get discouraged

If you find yourself reading this and falling into a pit of despair with concern about testing positive while abroad: Take a deep breath. For one, it’s very likely you don’t test positive, especially if you take precautions such as masking up in public spaces and if you are traveling to a destination where COVID cases are low.

If you do test positive, as I did, while there will definitely be some challenging moments, there will also be a light at the end of the tunnel. For me, days 2–4 were the most difficult. I could feel my immune system actively fighting the virus, and my spirits were low. Because of the timing of my sickness, I knew I was going to miss my daughter’s first chorus concert, Mother’s Day, and an important in-person meeting with colleagues. I had to process feeling upset and then focus on getting well. In the grand scheme of the horror of the last two years, I ultimately knew I was going to be fine. My advice if you do test positive while abroad: Drink a lot of water, test frequently, phone a friend to counteract loneliness, and try to distract yourself and rest. The good news? I wrote this during my flight home.

 

[Heliobas Disciple]

Does Paxlovid help people who have been vaccinated against Covid-19? Show us the data!

Doctors frustrated with their unvaccinated patients should stop shaking their fists at them and consider how the medical community has contributed to public distrust of Big Pharma.

www.statnews.com

(fair use applies)


First Opinion
Does Paxlovid help people who have been vaccinated against Covid-19? Show us the data!
By Paul Fenyves
May 18, 2022

As a primary care doctor in New York City, I am grateful to drug companies for providing effective Covid-19 therapies for my patients. But I am also frustrated that these companies appear to be completely running the show, and believe that Americans could get more from Big Pharma if only our regulators dared to ask for it. This dynamic is on display with Paxlovid, which was approved based on a study that seems designed to exaggerate the benefit most Americans can expect from this drug rather than provide us with relevant information about it.

Among antiviral agents for Covid-19, Pfizer’s Paxlovid has emerged as the clear winner for two reasons: First, as a pill, Paxlovid is easy to administer, compared to the infusions required for monoclonal antibodies and remdesivir. Second, Paxlovid appears to be highly effective, with a clinical trial showing an 89% relative reduction in hospitalizations or death among high-risk patients who receive it.

I say “appears to be” because there’s a problem: The single trial supporting the FDA’s emergency use authorization of Paxlovid included only unvaccinated people who had never previously had Covid-19. Since 76% of U.S. adults are now vaccinated, and an estimated 58% of Americans have already had Covid, the trial supporting Paxlovid is not directly applicable to a majority of Americans. This means that doctors treating people with the disease don’t know to what degree — if any — Paxlovid will benefit their vaccinated patients. I am left hoping and guessing, and continue to prescribe Paxlovid to my high-risk Covid-19 patients without being sure if I am helping them.

The current situation with Paxlovid is reminiscent of an older antiviral medication, Tamiflu, which became the subject of controversy during the swine flu pandemic.

Because influenza kills an average of 40,000 Americans a year and hundreds of thousands of people worldwide, efforts have been made to develop antiviral agents that could lessen its severity. Tamiflu (generic name oseltamivir), debuted by Roche in 1999, was purported to be such a medication. Using clinical studies reported by Roche, the available evidence showed that Tamiflu reduced the risk of pneumonia, a common and significant complication of influenza. For years, doctors used Tamiflu under the impression that it reduced the risk of severe disease.

But during the swine-flu pandemic of 2009, researchers in the United Kingdom and Australia decided to reexamine the evidence supporting the drug. During this process, Keiji Hayashi, a curious pediatrician from Japan, noted that the bulk of the data supporting Tamiflu had never been evaluated by anyone outside of the company that developed it. Governments around the world had been stockpiling Tamiflu to protect their citizens based on its manufacturer saying, “Trust us, it works!”

Cochrane, an international organization dedicated to improving medical knowledge, along with the British Medical Journal instituted a protracted campaign to compel Roche to release its “secret studies” of Tamiflu. After four years, Roche finally provided more complete data to reviewers at Cochrane, who evaluated the information and published an updated assessment that found — you know what’s coming here — there is no evidence that Tamiflu reduces the risk of serious influenza complications, like pneumonia or hospitalization.

Tamiflu enthusiasts will counter that a subsequent reevaluation of the evidence — sponsored by Roche — did show that the medication lowered the risk of influenza-associated pneumonia and hospitalizations. Personally, I am skeptical of a review article paid for by a drug company after a public shaming and in need of reputational rehabilitation.

But despite my doubts about Tamiflu, as a primary care doctor it is hard to ignore a medication that might help my patients, especially one the CDC continues to endorse. So I continue to prescribe Tamiflu to my high-risk influenza patients, hoping I am doing more good than harm.

The situation with Paxlovid isn’t identical to what transpired with Tamiflu, but there’s certainly some historical rhyming: doctors have been left to make clinical decisions about an antiviral medication for a respiratory virus based on inadequate data.

There are two noteworthy facts about the people who were allowed to participate in the Paxlovid trial, all of whom were both unvaccinated and had never previously had Covid-19. First, even when the Paxlovid trial began in July 2021, only a minority of Americans fit into the category of unvaccinated and Covid-naive, so the results of the trial have never been directly applicable to most Americans. Second, Paxlovid would be significantly more effective in people who have not been primed by vaccination or prior infection, so the trial supporting its use serves to exaggerate the benefit that most people would see from the medication.

Yes, Pfizer has begun a trial of Paxlovid in high-risk individuals who have been vaccinated, but this trial combines vaccinated and unvaccinated patients, potentially clouding the issue. More importantly, results of the trial will not be made available until November 2022.

I am not surprised that Pfizer’s first trial was designed to overstate the efficacy of Paxlovid because, as a pharmaceutical company, its goal is to maximize sales. But I am surprised that the federal government would buy $5 billion worth of Paxlovid without requiring that Pfizer move quickly to answer this essential question: How does Paxlovid perform in high-risk people who have been vaccinated or previously infected? A five-day course of Paxlovid costs about $500, but without the appropriate data it’s impossible to tell if this is a good buy or a rip-off.

If, for example, 10,000 courses of Paxlovid must be prescribed to vaccinated people over age 65 to prevent one hospitalization, the country might not move so quickly to replenish its stockpile. Conversely, if ten people taking Paxlovid prevented one hospitalization, the rush would be on to buy more.

Without knowing how Paxlovid performs in vaccinated people, it’s impossible to make these sorts of calculations. Also, given Tamiflu’s history, a demand for data transparency and independent review would be prudent.

Some might suggest I am focusing on a small matter. Who cares if we ultimately learn that the benefits of Paxlovid are greatly attenuated in people who have been vaccinated or previously infected? I raise this issue as being emblematic of a larger problem: a lack of much-needed independent review of pharmaceutical clinical trials.

Americans have seen the scandals that have emerged from lax oversight, like Vioxx being sold despite known cardiovascular risks, or OxyContin contributing to the opioid epidemic. When Covid-19 appeared, the pharmaceutical industry performed exceptionally well, delivering safe and effective vaccines in record time. But long before then, many Americans had learned to distrust Big Pharma, and many have tragically declined this life-saving intervention.

The conversation around vaccine hesitancy has largely focused on misinformation, but what is missing is an acknowledgement that the pharmaceutical industry has spent decades squandering the public’s trust. Doctors have been complicit in this breach by not raising our voices to demand greater transparency and independent review of the pharmaceutical industry. Many doctors have been understandably frustrated with their unvaccinated patients, but we should consider how the medical community has contributed to public distrust of Big Pharma.

Rather than continuing to shake our fists at the unvaccinated, we should look in the mirror and then begin the long work of rebuilding public trust.

Paul Fenyves is a primary care physician at Weill Cornell Medicine in New York, where he is the associate director of digital care and innovation for primary care. He acknowledges help in writing this essay from John Abramson, a faculty member at Harvard Medical School and the author of “Sickening: How Big Pharma Broke American Medicine and How We Can Repair It.”

 

[Heliobas Disciple]

Danger of Double Masking Against COVID-19

Proper Fit Crucial for Optimal Mask Protection Face shape influences mask fit, suggests problems with double masking against COVID-19. In its updated guidance at the start of 2022, the U.S. Centers for Disease Control and Prevention (CDC) said loosely woven cloth masks offer the least protectio

scitechdaily.com

(fair use applies)

Danger of Double Masking Against COVID-19
By American Institute of Physics
May 18, 2022

Time evolution of cough while wearing a face mask. Credit: Tomas Solano

Proper Fit Crucial for Optimal Mask Protection

Face shape influences mask fit, suggests problems with double masking against COVID-19.

In its updated guidance at the start of 2022, the U.S. Centers for Disease Control and Prevention (CDC) said loosely woven cloth masks offer the least protection against COVID-19, and N95 and KN95 masks offer the most protection. Still, after more than two years since the pandemic began, there is not a full understanding of mask characteristics for the most optimal protection.

In Physics of Fluids, published by AIP Publishing, researchers at Florida State University and Johns Hopkins University use principal component analysis (PCA) along with fluid dynamics simulation models to show the crucial importance of proper fit for all types of masks and how face shape influences the most ideal fit.

The study suggests double masking with improperly fitted masks may not significantly improve mask efficiency and produces a false sense of security.


Time evolution of cough while wearing a face mask. Credit: Tomas Solano

More layers mean a less porous face covering, leading to more flow forced out of the perimeter gaps (sides, top, and bottom) in masks with a less secure fit. Double layers increase filtering efficiency only with good mask fit but could also lead to breathing difficulties.

The researchers modeled a moderate cough jet from a mouth of an adult male wearing a cloth mask over the nose and mouth with elastic bands wrapped around the ears. They calculated the maximum volume flow rates through the front of mask and peripheral gaps at different material porosity levels.

For a more realistic 3D face shape and size, the researchers used PCA that integrated 100 adult male and 100 adult female heads retrieved from head scan data at Basel University in Switzerland. PCA condenses large sets of variables while retaining most of the information.

Their model showed how the slight asymmetry typical in all facial structures can affect proper mask fitting. For example, a mask can have a tighter fit on the left side of the face than on the right side.

“Facial asymmetry is almost imperceivable to the eye but is made obvious by the cough flow through the mask,” said co-author Tomas Solano, from Florida State University. “For this particular case, the only unfiltered leakage observed is through the top. However, for different face shapes, leakage through the bottom and sides of the mask is also possible.”

Creating “designer masks” customized to each person’s face is not practical at scale. Still, PCA-based simulations can be used to design better masks for different populations by revealing general differences between male and female or child versus elderly facial structures and the associated airflow through masks.

Reference: “Perimeter leakage of face masks and its effect on the mask’s efficacy” by Tomas Solano, Chuanxin Ni, Rajat Mittal and Kourosh Shoele, 3 May 2022, Physics of Fluids.

DOI: 10.1063/5.0086320

 

[Heliobas Disciple]

Brensocatib Did Not Help Patients With Severe COVID-19 in Clinical Trial

Brensocatib did not improve the clinical status of patients hospitalized with severe SARS-CoV-2 infection in the double-blind randomized, placebo-controlled STOP-COVID19 multicenter clinical trial, according to research published at the American Thoracic Society's ATS 2022 international conference.

scitechdaily.com

(fair use applies)

Brensocatib Did Not Help Patients With Severe COVID-19 in Clinical Trial
By American Thoracic Society May 18, 2022

Brensocatib did not improve the clinical status of patients hospitalized with severe SARS-CoV-2 infection in the double-blind randomized, placebo-controlled STOP-COVID19 multicenter clinical trial, according to research published at the American Thoracic Society’s ATS 2022 international conference. Brensocatib is an oral medication being developed by Insmed for the treatment of patients with bronchiectasis and other neutrophil-mediated diseases.

The study, which began in June of 2020, took place at 14 hospitals in the UK, where participants were randomized to receive 25 mg daily of brensocatib or a placebo for 28 days. One-hundred ninety patients received brensocatib, while 214 received a placebo.

All patients in the study had confirmed SARS-CoV-2 infection and at least one risk factor for severe COVID-19, such as requiring supplemental oxygen. Individuals on mechanical ventilation were excluded from the study. All participants received standard of care treatment.

“Treatments currently available to treat COVID-19, such as dexamethasone and anti-IL-6 antibodies, reduce inflammation, but their effect is not primarily on neutrophils or neutrophilic inflammation,” said presenting author Holly Keir, PhD, postdoctoral researcher, University of Dundee School of Medicine, Dundee, United Kingdom. “We performed the STOP-COVID trial to test the hypothesis that directly targeting neutrophilic inflammation by inhibiting dipeptidyl peptidase-1 (DPP1) would provide additional benefits to patients with severe COVID-19 on top of standard of care.”

Severe COVID-19 infection is primarily caused by an excessive and damaging immune response to the virus. A number of different immune cells are involved in this response, including neutrophils. Neutrophils release enzymes and other substances that cause severe lung damage. Studies have consistently shown that high levels of neutrophilic inflammation are associated with worse outcomes in COVID-19.

Brensocatib is an investigational oral inhibitor of DPP1, an enzyme responsible for the activation of neutrophil serine proteases.

In STOP-COVID19, time to clinical improvement and time to discharge were not different between groups. Mortality was 10.7 percent and 15.3 percent in the placebo and brensocatib treated groups, respectively. Oxygen and new ventilation use were also numerically greater in the brensocatib treated patients. Prespecified subgroup analyses based on age, sex, baseline severity, co-medications and duration of symptoms supported the primary results. Adverse events were reported in 46.3 percent of placebo treated patients and 44.8 percent of brensocatib treated patients.

The researchers also conducted a sub-study at two study sites to directly measure inflammation in patients receiving DPP1 inhibition or placebo. They observed a strong anti-inflammatory effect of DPP1 inhibition on neutrophil protease enzymes. Active blood neutrophil elastase levels were reduced by day eight in the treatment group and remained significantly lower up to day 29.

“Although we did not find a beneficial effect of treatment in this population, these results are important for future efforts to target neutrophilic inflammation in the lungs. STOP-COVID19 is the largest completed trial of DPP1 inhibition in humans and we have performed extensive characterization of how DPP1 inhibition affects the immune system’s response,” noted Dr. Keir. “Using state-of-the-art proteomics (the study of the structures, functions, and interactions of proteins) we have already seen important changes in neutrophils with DPP1 inhibition that will help us to better understand the potential role of this treatment in other diseases.”

One of these diseases is bronchiectasis, where a phase 2 trial published in 2020 showed that brensocatib reduced the risk of exacerbations.

The STOP-COVID19 study was an investigator-initiated study sponsored by the University of Dundee and funded by Insmed Incorporated.

 

[Heliobas Disciple]

Steroids After COVID-19 Recovery May Cut “Long COVID” Risk of Death by Up to 51%

Prescription of steroids upon discharge from hospital for COVID-19 should become standard, argue authors. Evidence is growing that ‘long Covid’, that is, continued negative health impacts months after apparent recovery from severe Covid-19, is an important risk for some patients. For example, res

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Steroids After COVID-19 Recovery May Cut “Long COVID” Risk of Death by Up to 51%
By Frontiers
May 18, 2022

Prescription of steroids upon discharge from hospital for Covid-19 should become standard, argue authors.

Evidence is growing that ‘long Covid’, that is, continued negative health impacts months after apparent recovery from severe Covid-19, is an important risk for some patients. For example, researchers from the University of Florida Gainesville showed last December that hospitalized patients who seemingly recovered from severe Covid-19 have more than double the risk of dying within the next year, compared to people who experienced only mild or moderate symptoms and who had not been hospitalized, or who never caught the illness.

Now, a team of researchers including some of the same authors shows, for the first time, that among patients hospitalized for Covid-19 who seemingly recovered, severe systemic inflammation during their hospitalization is a risk factor for death within one year. This may seem paradoxical, as inflammation is a natural part of the body’s immunological response, which has evolved to fight infection. However in some illnesses, including Covid-19, this response may overshoot, causing further harm.

“Covid-19 is known to create inflammation, particularly during the first, acute episode. Our study is the first to examine the relationship between inflammation during hospitalization for Covid-19 and mortality after the patient has ‘recovered’,” said first author Prof Arch G Mainous III, vice chair for research in the Department of Community Health and Family Medicine at the University of Florida Gainesville.

“Here we show that the stronger the inflammation during the initial hospitalization, the greater the probability that the patient will die within 12 months after seemingly ‘recovering’ from Covid-19.”

Mainous and colleagues studied the de-identified electronic health records of 1,207 adults hospitalized in 2020 or 2021 after testing positive for Covid-19 within the University of Florida health system, and who had been followed up for at least one year after discharge. As a proxy for the severity of systemic inflammation during hospitalization, they used a common and validated measure, the concentration in blood of the molecule C-reactive protein (CRP), secreted by the liver in response to a signal by active immune cells.

Inflammation in many parts of the body

As expected, the blood concentration of CRP during hospitalization was strongly correlated with the severity of Covid-19: 59.4 mg/L for hospitalized patients who didn’t require supplemental oxygen, 126.9 mg/L for those who needed extra oxygen through non-invasive, non-mechanical ventilation, and 201.2 mg/L for the most severe cases, who required ventilation through a ventilator or through extracorporeal membrane oxygenation.

Covid-19 patients with the highest CRP concentration measured during their hospital stay had a 61% greater hazard – corrected for other risk factors – of dying of any cause within one year of discharge from the hospital than patients with the lowest CRP concentration. These results were published on May 12, 2022, in the journal Frontiers in Medicine.

Mainous said: “Many infectious diseases are accompanied by an increase in inflammation. Most times the inflammation is focused or specific to where the infection is. Covid-19 is different because it creates inflammation in many places besides the airways, for example in the heart, brain, and kidneys. High degrees of inflammation can lead to tissue damage.”

Importantly, the authors showed that the elevated hazard of death from any cause associated with severe inflammation was lowered again by 51% if the patient was prescribed anti-inflammatory steroids after their hospitalization.

These results mean that the severity of inflammation during hospitalization for Covid-19 can predict the risk of subsequent serious health problems, including death, from ‘long Covid’. They also imply that current recommendations for best practice may need to be changed, to include more widespread prescription of orally taken steroids to Covid-19 patients upon their discharge.

Covid-19: a chronic disease?

Covid-19 should be seen as a potentially chronic disease, propose the authors.

“When someone has a cold or even pneumonia, we usually think of the illness being over once the patient recovers. This is different from a chronic disease, like congestive heart failure or diabetes, which continue to affect patients after an acute episode. We may similarly need to start thinking of Covid-19 as having ongoing effects in many parts of the body after patients have recovered from the initial episode,” said Mainous.

“Once we recognize the importance of ‘long Covid’ after seeming ‘recovery’, we need to focus on treatments to prevent later problems, such as strokes, brain dysfunction, and especially premature death.”

Reference: “The Impact of Initial COVID-19 Episode Inflammation Among Adults on Mortality Within 12 Months Post-hospital Discharge” by Arch G. Mainous III, Benjamin J. Rooks and Frank A. Orlando, 12 May 2022, Frontiers in Medicine.

DOI: 10.3389/fmed.2022.891375

 

[Heliobas Disciple]

Vaccination after SARS-CoV-2 infection linked to a decrease in long COVID symptoms

Vaccination after infection with SARS-CoV-2, the virus responsible for COVID-19, is associated with a decrease in the likelihood of long COVID symptoms, finds a large study of UK adults published by The BMJ today.

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Vaccination after SARS-CoV-2 infection linked to a decrease in long COVID symptoms
by British Medical Journal
May 18, 2022

Vaccination after infection with SARS-CoV-2, the virus responsible for COVID-19, is associated with a decrease in the likelihood of long COVID symptoms, finds a large study of UK adults published by The BMJ today.

They stress that causality cannot be inferred from this observational evidence, but say vaccination "may contribute to a reduction in the population health burden of long COVID, at least in the first few months after vaccination."

Vaccines against COVID-19 are effective at reducing rates of coronavirus infection, transmission, hospital admission, and death. Evidence also suggests that long COVID is reduced in those who are infected after vaccination, but the effectiveness of vaccination on pre-existing long COVID is less clear.

The latest survey by the UK's Office for National Statistics (ONS) shows that 44% of people who report long COVID have had symptoms for at least one year, two thirds of whom report symptoms severe enough to limit their day-to-day activities.

So a team of researchers set out to estimate associations between COVID-19 vaccination and long COVID symptoms in adults with SARS-CoV-2 infection before vaccination.

They drew on ONS data for 28,356 adults aged 18-69 years (average age 46; 56% women; 89% white) who received at least one COVID-19 vaccine dose after testing positive for SARS-CoV-2 infection.

They then tracked the presence of long COVID symptoms over a seven month follow-up period (February to September 2021).

Long COVID symptoms of any severity were reported by 6,729 participants (24%) at least once during follow-up.

Before vaccination, the odds of experiencing long COVID changed little over time.

A first vaccine dose was associated with an initial 13% decrease in the odds of long COVID, but it is unclear from the data whether this improvement was sustained over the following 12 weeks, until a second vaccine dose was given.

Receiving a second vaccine dose was associated with a further 9% decrease in the odds of long COVID, and this improvement was sustained at least over an average follow-up of nine weeks.

Similar results were also found when the focus was on long COVID severe enough to result in limitation of day-to-day activities.

Due to the study's observational design, causality cannot be inferred, nor can the researchers rule out the possibility that other unmeasured factors, such as those related to take-up of a second vaccine dose, may have affected their results.

However, results were consistent after taking account of sociodemographic characteristics, health related factors, vaccine type, or duration from infection to vaccination, suggesting that they withstand scrutiny.

As such, the researchers say: "Our results suggest that vaccination of people previously infected may be associated with a reduction in the burden of long COVID on population health, at least in the first few months after vaccination."

They call for further research into the long term relationship between vaccination and long COVID, and studies "to understand the biological mechanisms underpinning any improvements in symptoms after vaccination, which may contribute to the development of therapeutics for long COVID."

Are vaccines a potential treatment for long COVID, ask researchers in a linked editorial?

They acknowledge that benefits are possible in some individuals not all, and say the mechanisms underpinning changes in long COVID symptoms after vaccination are still not fully understood.

Until a clear explanation is found, they say vaccination to reduce risk of reinfection remains important for people with long COVID, and evidence so far suggests that benefits are likely to outweigh any harms.

"Unfortunately, many unknowns remain about the long term prognosis of long COVID, including the effect of booster vaccines or recurrent COVID-19," they write, and they call for more research "before we can hope to predict the effects of vaccination on individuals."

 

[Heliobas Disciple]

COVID booster needed for broad protection against omicron variants

A COVID-19 booster shot will provide strong and broad antibody protection against the range of omicron sublineage variants of the SARS-CoV-2 virus in circulation, two new studies using serum from human blood samples suggest.

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COVID booster needed for broad protection against omicron variants
by Emily Caldwell, The Ohio State University
May 18, 2022



Graphical abstract. Credit: Cell Host & Microbe (2022). DOI: 10.1016/j.chom.2022.04.014

A COVID-19 booster shot will provide strong and broad antibody protection against the range of omicron sublineage variants of the SARS-CoV-2 virus in circulation, two new studies using serum from human blood samples suggest.

Researchers tested neutralizing antibody levels against the BA.2 and BA.3 omicron variants and deltacron, a recombinant variant created by the exchange of genetic material between delta and omicron.

Results showed that a third mRNA vaccine dose was required to generate a high enough concentration of antibodies to neutralize BA.2 and deltacron, as well as other sublineage omicron variants, including the original, known as BA.1, and BA.1.1. Antibodies produced by just the two-dose series of mRNA vaccines were enough to neutralize BA.3—a sign this variant is not likely to produce a new surge of omicron infections, researchers say.

These findings were published today (May 18, 2022) in a letter to the editor of the New England Journal of Medicine (NEJM), and in an article published in Cell Host & Microbe on April 25, by a group of Ohio State University researchers.

"Three doses is better for everything," said Shan-Lu Liu, the senior author of both studies and a virology professor in the Department of Veterinary Biosciences at Ohio State.

Recent national data have suggested that the BA.2 variant constitutes about 90% of COVID-19 cases in the United States.

"People have been asking about the recombinant deltacron and also BA.3, and now we have an answer. And it's good news," said Liu, also associate director of the university's Center for Retrovirus Research and a program co-director of the Viruses and Emerging Pathogens Program in Ohio State's Infectious Diseases Institute.

"Based on the neutralization pattern, one booster shot can protect against BA.2 and deltacron, and we do not suspect that BA.3 will become predominant because it's sensitive to neutralization by even two doses."

In the study published in NEJM, researchers tested antibody levels in serum from 10 health care professionals at Ohio State's Wexner Medical Center. After two vaccine doses, on average, antibody levels were 3.3-fold and 44.7-fold lower against BA.3 and deltacron, respectively, than those that neutralized the parent SARS-CoV-2 virus. After the booster, antibody levels were much higher against all variants tested, and the same antibody level reductions were 2.9-fold and 13.3-fold—showing a dramatic improvement in protection, particularly against deltacron.

Next examining blood samples from 18 patients in the ICU during the delta wave of the pandemic, the researchers found comparable levels of antibodies against the parent virus and BA.3, but 137.8-fold lower concentrations against deltacron compared to the parent virus. Blood samples from 31 hospitalized non-ICU patients during the omicron surge showed much better antibody protection against deltacron.

"The deltacron spike protein is structured similarly to other omicron variants, so people infected with omicron seem to have pretty good protection against deltacron. But people infected with delta had pretty weak protection against deltacron," said John Evans, a Ph.D. candidate in Ohio State's Molecular, Cellular and Developmental Biology Program who works in Liu's lab, and the first author of the new studies. "However, compared to the booster, infection by omicron provides much less protection against deltacron."

The Cell Host & Microbe study tested antibody levels in serum from 48 health care professionals after their second mRNA vaccine dose and from 19 after their third mRNA vaccine doses, as well as 31 COVID-19 patients hospitalized during the omicron surge.

"For two vaccine doses, health care workers had very weak neutralizing antibody concentrations against the omicron variants, but after the booster it evened out," Evans said. "The neutralizing antibody levels were still lower against omicron compared to the parental virus, but much more comparable across variants and much higher. So the booster provides much stronger protection and much broader protection."

Patients with delta or omicron infection were similarly protected against their respective infectious variants, and a vaccine dose on top of infection improved protection. Among all of the health care professionals and infected patients studied, people who had received three vaccine doses had the broadest and strongest antibody protection overall.

The researchers conducted the cell-culture studies using pseudoviruses—a non-infectious viral core decorated with different SARS-CoV-2 spike proteins on the surface structured to match known mutations. The method used to detect neutralizing antibodies in the blood samples accounted for the varying concentrations of antibodies produced by individuals.

Liu and colleagues have completed additional tests of neutralizing antibody responses to the BA.2.12.1, BA.4 and BA.5 omicron sublineages. In a paper posted May 17 on the bioRxiv preprint server, they described similar findings: A booster provided sufficient antibody concentrations against these three additional omicron subvariants, though to a lower extent than protection seen for BA.1 and BA.2, and previous omicron infection did not offer effective antibody protection against these variants.

Liu's lab is continuing this work, investigating how long antibody protection from the third booster shot lasts. Waning antibody levels seen in blood samples collected the furthest out from the third dose suggest there is a limit to the first booster's durability, Liu said.

"The virus is evolving, which is typical for all RNA viruses, and what we have seen is not surprising at all," Liu said. "Especially when we have lots of variants in the population, anything can happen, including recombination between them. That's why we still need to be very cautious. The best preparation is to get the second booster."

 

[Heliobas Disciple]

Study in mice suggests that COVID-19 increases risk of developing Parkinson's disease

Brain fog, headaches, and insomnia are some of the neurological symptoms doctors have observed in COVID-19 patients. Neurological sequelae after a viral infection is not new—in fact, following the 1918 influenza pandemic, it took almost a decade for patients to present with the neurological...

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Study in mice suggests that COVID-19 increases risk of developing Parkinson's disease
by Thomas Jefferson University
May 18, 2022

Brain fog, headaches, and insomnia are some of the neurological symptoms doctors have observed in COVID-19 patients. Neurological sequelae after a viral infection is not new—in fact, following the 1918 influenza pandemic, it took almost a decade for patients to present with the neurological syndrome called "post-encephalic parkinsonism." But, the mechanisms by which viruses impact the brain are poorly understood. Now, Jefferson and collaborators show, in a new study performed in mice, that the SARS-CoV-2 virus responsible for the COVID-19 pandemic could increase the risk of brain degeneration seen in Parkinson's disease.

"Parkinson's is a rare disease that affects 2% of the population above 55 years, so the increase in risk is not necessarily a cause for panic," says Richard Smeyne, Ph.D., Director of the Jefferson Comprehensive Parkinson's Disease and Movement Disorder Center at the Vickie and Jack Farber Institute for Neuroscience and first author of the study. "But understanding how coronavirus impacts the brain can help us prepare for the long-term consequences of this pandemic."

The research, published in Movement Disorders on May 17, builds on previous evidence from the Smeyne lab showing that viruses can make brain cells or neurons more susceptible to damage or death. In that earlier study, the researchers found that mice infected with the H1N1 strain of influenza, responsible for the 2009 flu pandemic, were more susceptible to MPTP, a toxin that is known to induce some of the characteristic features of Parkinson's: primarily the loss of neurons expressing the chemical dopamine and increased inflammation in the basal ganglia, a brain region that is critical for movement. The findings in mice were later confirmed in humans by researchers in Denmark, who showed that influenza nearly doubled the risk of developing Parkinson's disease within 10 years after initial infection.

In the current study, the researchers used mice that were genetically engineered to express the human ACE-2 receptor, which the SARS-CoV-2 virus uses to gain access to the cells in our airway. These mice were infected with SARS-CoV-2 and allowed to recover. Importantly, the dose chosen in this study corresponds to moderate COVID-19 infection in humans, with around 80% of the infected mice surviving. Thirty-eight days after the surviving animals recovered, one group was injected with a low dose of MPTP that would not normally cause any loss of neurons. The control group was given saline. Two weeks later, the animals were sacrificed and their brains examined.

The researchers found that COVID-19 infection alone had no effect on the dopaminergic neurons in the basal ganglia. However, mice that were given the low dose of MPTP after recovering from infection exhibited the classic pattern of neuron loss seen in Parkinson's disease. This increased sensitivity after COVID-19 infection was similar to what was seen in the influenza study; this suggests that both viruses could induce an equivalent increase in risk for developing Parkinson's.

"We think about a 'multi-hit' hypothesis for Parkinson's—the virus itself does not kill the neurons, but it does makes them more susceptible to a 'second hit,' such as a toxin or bacteria or even an underlying genetic mutation," explains Dr. Smeyne.

Both influenza and SARS-CoV2 have been found to cause a "cytokine storm" or an overproduction of pro-inflammatory chemicals. These chemicals can cross the blood-brain barrier and activate the brain's immune cells—microglia. Indeed, the researchers found increased numbers of activated microglia in the basal ganglia of mice that recovered from SARS-CoV2 and received MPTP. While the mechanism is not fully understood, the researchers believe the increased microglia inflame the basal ganglia and cause cellular stress. This then lowers the neurons' threshold to withstand subsequent stress.

This study was co-led by collaborator Peter Schmidt, Ph.D., a neuroscientist from New York University. "We were concerned about the long-term consequences of viral infection," Dr. Schmidt said. "Dr. Smeyne is a leader in this area of research and Jefferson was the ideal site to perform the analysis."

The researchers are planning to determine whether vaccines can mitigate the experimental increase in Parkinson's pathology linked to prior SARS-CoV-2 infection. They are also testing other variants of the virus, as well as doses that correspond to milder cases in humans.

While their findings thus far bolster a possible link between the coronavirus and Parkinson's disease, Dr. Smeyne says there are some important caveats. "First of all, this is preclinical work. It is too soon to say whether we would see the same thing in humans, given that there seems to [be] a 5-10 year lag between any changes in clinical manifestation of Parkinson's in humans." This lag, he says however, could be used to our advantage. "If it does turn out that COVID-19 increases the risk of Parkinson's, it will be a major burden on our society and healthcare system. But we can anticipate that challenge by advancing our knowledge of potential 'second hits' and mitigating strategies."

 

[Heliobas Disciple]

'Natural immunity' from omicron is weak and limited, study finds

In unvaccinated people, infection with the omicron variant of SARS-CoV-2 provides little long-term immunity against other variants, according to a new study by researchers at Gladstone Institutes and UC San Francisco (UCSF), published today in the journal Nature.

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'Natural immunity' from omicron is weak and limited, study finds
by Sarah C.p. Williams, Gladstone Institutes
May 18, 2022

In unvaccinated people, infection with the omicron variant of SARS-CoV-2 provides little long-term immunity against other variants, according to a new study by researchers at Gladstone Institutes and UC San Francisco (UCSF), published today in the journal Nature.

In experiments using mice and blood samples from donors who were infected with omicron, the team found that the omicron variant induces only a weak immune response. In vaccinated individuals, this response—while weak—helped strengthen overall protection against a variety of COVID-19 strains. In those without prior vaccination, however, the immune response failed to confer broad, robust protection against other strains.

"In the unvaccinated population, an infection with omicron might be roughly equivalent to getting one shot of a vaccine," says Melanie Ott, MD, Ph.D., director of the Gladstone Institute of Virology and co-senior author of the new work. "It confers a little bit of protection against COVID-19, but it's not very broad."

"This research underscores the importance of staying current with your vaccinations, even if you have previously been infected with the omicron variant, as you are still likely vulnerable to re-infection," says co-senior author Jennifer Doudna, Ph.D., who is a senior investigator at Gladstone, a professor at UC Berkeley, founder of the Innovative Genomics Institute, and an investigator of the Howard Hughes Medical Institute.

A weaker infection

As the omicron variant of SARS-CoV-2 spread around the globe in late 2021 and early 2022, anecdotal evidence quickly mounted that it was causing less severe symptoms than delta and other variants of concern. However, scientists weren't initially sure why that was, or how a weaker infection might impact long-term immunity against COVID-19.

"When the omicron variant first emerged, a lot of people wondered whether it could essentially act as a vaccine for people who didn't want to get vaccinated, eliciting a strong and broad-acting immune response," says Irene Chen, co-first author of the new study and graduate student in Ott's lab. Other first authors are Rahul Suryawanshi, Ph.D., a Gladstone staff research scientist, and Tongcui Ma, Ph.D., scientist in the Roan Lab at Gladstone.

To find the answer, the team of researchers first examined the effect of omicron in mice. Compared to an ancestral strain of SARS-CoV-2 and the delta variant, omicron led to far fewer symptoms in the mice. However, the virus was detected in airway cells, albeit at lower levels. Similarly, omicron was able to infect isolated human cells but replicated less than other variants.

The team then characterized the immune response generated by omicron infections. In mice infected with omicron, despite the milder symptoms, the immune system still generated the T cells and antibodies typically seen in response to other viruses.

"We demonstrated in this study that the lower pathogenicity of omicron is not because the virus cannot take hold," says Nadia Roan, Ph.D., an associate investigator at Gladstone.

That leaves other reasons that might explain why omicron differs from other variants in terms of symptoms and immunity, including the lower replication seen with omicron or the types of antibodies that the immune system generates in response to the virus.

No cross-variant protection

To gauge how the immune response against omicron fared over time, the researchers collected blood samples from mice infected with the ancestral, delta, or omicron variants of SARS-CoV-2 and measured the ability of their immune cells and antibodies to recognize five different viral variants—ancestral (WA1), alpha, beta, delta, and omicron.

Blood from uninfected animals was unable to neutralize any of the viruses—in other words, block the ability of any of the viruses to copy themselves. Samples from WA1-infected animals could neutralize alpha and, to a lesser degree, the beta and delta virus—but not omicron. Samples from delta-infected mice could neutralize delta, alpha and, to a lesser degree, the omicron and beta virus.

However, blood from omicron-infected mice could only neutralize the omicron variant.

The team confirmed these results using blood from ten unvaccinated people who had been infected with omicron—their blood was not able to neutralize other variants. When they tested blood from 11 unvaccinated people who had been infected with delta, the samples could neutralize delta and, as had been seen in mice, the other variants to a lesser extent.

When they repeated the experiments with blood from vaccinated people, the results were different: vaccinated individuals with confirmed omicron or delta breakthrough infections all showed the ability to neutralize all the tested variants, conferring higher protection.

"When it comes to other variants that might evolve in the future, we can't predict exactly what would happen, but based on these results, I'd suspect that unvaccinated people who were infected with omicron will have very little protection," says Ott. "But on the contrary, vaccinated individuals are likely to be more broadly protected against future variants, especially if they had a breakthrough infection."

"Our results may be useful not only to inform individuals' decisions on vaccination, but also for the design of future COVID-19 vaccines that confer broad protection against many variants," says Charles Chiu, MD, Ph.D., a professor of infectious diseases at UCSF and a co-senior author of the work.

The research was published in Nature.

 

[Heliobas Disciple]

COVID long-haulers: Study shows who is most at risk, impact on local communities

A Japanese research team looking at COVID-19's lingering impacts on survivors and local communities found that having a mild case of COVID-19, smoking status, comorbidities, or your sex aren't significant predictors to tell if you are less likely to develop long-term symptoms, but age is.

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COVID long-haulers: Study shows who is most at risk, impact on local communities
by Hiroshima University
May 18, 2022

A Japanese research team looking at COVID-19's lingering impacts on survivors and local communities found that having a mild case of COVID-19, smoking status, comorbidities, or your sex aren't significant predictors to tell if you are less likely to develop long-term symptoms, but age is.

"The prevalence of sequelae did not significantly differ by sex, severity of COVID-19, place of medical care, smoking status, or comorbidities," the research team, led by Hiroshima University Professor and Executive Vice President Junko Tanaka, said in their findings published in Scientific Reports.

The cross-sectional study explored four areas to investigate what recovery and community life are like for COVID-19 survivors. These areas are the persistence of symptoms, psychological distress, impairments in work performance, and experiences of stigma and discrimination. Some 127 patients who recovered from COVID-19 at two hospitals in Hiroshima Prefecture, Japan participated in the study between August 2020 to March 2021.

Although they found that smoking history and comorbidities were not significantly related to the frequency of long-term symptoms in the multivariate analysis, the researchers believe that these factors should be continued to be examined in the future since only 18 were smokers among the study participants. As for comorbidities, hypertension was reported only in 19 of the participants and diabetes in 13.

COVID-19 severity is not a risk factor

Persistent symptoms of COVID-19 were identified in over half of the participants at a median of 29 days after onset. Meanwhile, half of those with mild cases experienced lingering symptoms.

"The most important finding is that the percentage of patients with some sequelae after approximately one month from the onset of COVID-19 was as high as 52%, and even among those with mild disease, the rate was as high as 49.5%," study first-author Aya Sugiyama, assistant professor at Hiroshima University's Graduate School of Biomedical and Health Sciences, said.

Their findings are consistent with previous studies reporting that 53% to 55% of non-hospitalized COVID-19 patients get lingering symptoms.

"Several reports have pointed out that COVID-19 severity is not associated with sequelae. These findings suggest that COVID-19 patients should be followed up for persistent symptoms regardless of the severity of COVID-19," the researchers said.

Older age is a factor

The prevalence of lingering symptoms varied by age group in the study, but the researchers found that older patients are significantly more likely to become long-haulers compared to those aged 40 and below. This is consistent with previous studies showing that long-haul symptoms were more likely with increasing age.

They also discovered age-dependent differences in the prevalence of symptoms. Patients aged 60 and above were more likely than other age groups to report fatigue, palpitations, dry eyes or mouth, dyspnea, and sputum production.

The researchers noted how long-haul symptoms are common in organs with high ACE2 expression. ACE2, the major cell entry receptor for SARS-CoV-2, is extensively expressed in numerous human organs such as the mouth, liver, and lungs.

"COVID-19 affects various tissues and organs, such as those in the respiratory, cardiovascular, and neurological systems," they stated in the paper.

Common symptoms reported by long-haulers in the study included disorders in their sense of smell (15%) and taste (14.2%), cough (14.2%), and fatigue (11%).

Recovery and community life

Their findings also found that sex was not a risk factor for long-haul COVID symptoms, a contrast to another study in the BMJ that pointed out how they are twice as common in females as in males.

Sex and the presence of long-haul symptoms, however, were found to be predictors of psychological distress. Some 45% of females and 17.9% of males scored ≥ 5 on the Kessler Psychological Distress Scale (K6), meaning the risk of psychological distress was higher in women than men.

Stigma and discrimination due to COVID-19 were reported by 43.3% of participants. The most common complaints were being treated as contagious despite being cured (61.8%), harmful rumors (29.1%), and verbal harassment (25.5%).

Meanwhile, 29.1% of study participants had possible impairments in their job performance, suggesting that post–COVID-19 conditions may influence productivity at work to only a limited extent.

The researchers noted how their findings revealed significant health impacts of long-haul COVID symptoms in local communities. They hope to conduct a large-scale and long-term study.

"We would like to elucidate how long the aftereffects last and whether the actual aftereffects differ by viral variant," Sugiyama said.

 

[Heliobas Disciple]

COVID mortality age patterns changed significantly during pandemic

Early in the pandemic, older populations in the United States suffered the greatest death toll from COVID-19. But Penn demographers Irma Elo and Samuel Preston, with Boston University's Andrew Stokes and others, wanted to understand whether this mortality pattern changed as the pandemic continued.

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COVID mortality age patterns changed significantly during pandemic
by Michele W. Berger, University of Pennsylvania
May 18, 2022


Age-Specific Death Rates Due to COVID-19 for Select Periods, March 2020 to October 2021. Credit: JAMA Network Open (2022). DOI: 10.1001/jamanetworkopen.2022.12686

Early in the pandemic, older populations in the United States suffered the greatest death toll from COVID-19. But Penn demographers Irma Elo and Samuel Preston, with Boston University's Andrew Stokes and others, wanted to understand whether this mortality pattern changed as the pandemic continued.

In a paper published in JAMA Network Open, the researchers reveal the results of their latest study. Between March 2020 and October 2021, the age pattern of COVID mortality changed in a striking fashion, with rates significantly dropping for those 80 and older and profoundly increasing for those 25 to 54. The findings held across racial and ethnic groups.

"The main message of the paper is that the age pattern of mortality has shifted over the course of the pandemic," says Elo, lead author and sociology professor in the School of Arts & Sciences.

"This could reflect several factors," she says. "For one, vaccine coverage is much higher among the elderly." In addition, many younger people went back to working in person and to doing other activities that increased their COVID exposure risk, says Preston, also a professor in Penn's Department of Sociology and senior paper author.

To conduct the work, the researchers pulled all death certificates with COVID-19 listed as the underlying or contributing cause of death for three periods of time: an early surge from March to June 2020, a midwinter surge from November 2020 to February 2021, and the delta variant surge from July to October 2021. To account for racial disparities in age-specific COVID-19 mortality rates, the researchers also stratified their analyses by race and ethnicity.

Data for every group showed the same trend; death rates rose for younger people and decreased for older people, leading to more total years of life lost and a substantial decrease in life expectancy overall. "Years of life lost" represents the number of potential years a person might still have lived. In a hypothetical scenario where an 85-year-old can expect to live five additional years and a 35-year-old can expect to live an additional 50 years, the combined total years of life lost would be 55.

"Even as older-age mortality declined, life expectancy continued to drop in 2021 due to the significant years of life lost," says Stokes, an assistant professor in the Department of Global Health at BU's School of Public Health.

None of the findings, however, pointed to a decrease in how COVID-19 disproportionately affected different populations, Elo says. "The age pattern changed in the same way for all groups, but the COVID rates were higher in working ages for Black and Hispanic people than for white people throughout the pandemic."

This study is part of a larger ongoing research agenda for the team. Future work will look at, for instance, why midlife COVID mortality went up so much in 2021, Stokes says. "While differences in vaccination rates were likely an important factor, state policies, occupational risks, and a lack of access to health care may have also contributed."

Beyond that, the team continues to study mortality rates from the virus at the county and state levels, while delving deeper into implications by race and ethnicity. "We also want to study the relationship between COVID mortality and mortality from other causes of death at the state level," Preston says, "to investigate whether places with high COVID death rates also had high rates of death from diabetes, cardiovascular disease, and other similar ailments."

For now, the latest findings point to one important public health solution, according to Elo: "Get those younger people vaccinated," she says.

 

[Heliobas Disciple]

SARS-CoV2 Spike protein is a toxin

Factcheckers were wrong. People continue to suffer the consequences.

rwmalonemd.substack.com

(fair use applies)

SARS-CoV2 Spike protein is a toxin
Factcheckers were wrong. People continue to suffer the consequences.
Robert W Malone MD, MS
8 hr ago

First, a quick overview of the various “factchecking” organization statements. How many people developed brain damages or lost their life or that of a loved one because of accepting a vaccine based on the falsehoods propagated by these grossly unqualified “factcheckers”? Do they have criminal liability for their falsehoods and propaganda?

As you look through this, please keep in mind that the FDA has approved three doses of these mRNA vaccines for administration to all of our 5-11 year old children. Under emergency use authorization, of course. Even though there is no medical emergency.

Factcheck.org
COVID-19 Vaccine-Generated Spike Protein is Safe, Contrary to Viral Claims
By Catalina Jaramillo
Posted on July 1, 2021. Link here.
Catalina Jarmillo’s training is from the Columbia School of Journalism.
Why would anyone place any credence in what she has to say about toxicology and molecular virology? How many excess deaths can be attributed to this lie?

Politifact
No sign that the COVID-19 vaccines’ spike protein is toxic or ‘cytotoxic’
Tom Kertscher
POLITIFACT CONTRIBUTING WRITER
Tom Kertscher is a contributing writer for PolitiFact. Previously, he was a fact-checker for PolitiFact Wisconsin.
You can find this article here.
And why would anyone believe Tom Kertscher, who has no training in medicine or biology, let alone molecular virology? And why is a political fact checking site making assessments about biology and toxicology anyhow?

Associated Press
Spike protein produced by vaccine not toxic
By BEATRICE DUPUY
June 9, 2021
Another doozey. You can find it here.


Now, let us review the actual science.

Not what these wannabe scientists who are actually journalists at best claim to be true.

First off, it is important to understand a little bit about the SARS-CoV-2 Spike protein.

The only difference in the actual protein sequence between the original “Wuhan” strain Spike protein of the virus, and that coded for by the genetic vaccines, is two amino acids which have been changed in the S2 region of the protein. These were not introduced to make that vaccine version less toxic (as some “factcheckers” have asserted), but rather to make it better able to stimulate an antibody-based immune response. Whether vaccine encoded or virus encoded, the S1 subunit (which includes the receptor binding domain (to which the majority of “neutralizing” antibodies are directed) gets cut free (“proteolytically cleaved’) to yield an S1 subunit which is free to circulate in the blood, bind ACE2 receptors, interact with platelets, neurons, open up vascular endothelial tight junctions etc. THERE IS NO DIFFERENCE BETWEEN THE S1 SUBUNIT RELEASED FROM THE VACCINE SPIKE PROTEIN AND THE S1 SUBUNIT RELEASED FROM THE VIRUS SPIKE PROTEIN. THEY ARE THE SAME DAMN THING!



Now, how much and for how long does this free S1 subunit spike protein, including the receptor binding domain, become produced by the mRNA vaccines, versus how much and for how long by natural infection?

Surely this was well understood and characterized by Pfizer before these vaccines were widely deployed? Surely the FDA required that these studies be performed?

NOPE. WE HAD TO WAIT UNTIL AN ACADEMIC GROUP DID THE STUDIES AND PUBLISHED AT THE END OF JANUARY 2022. AND BURIED THE FINDINGS BY USING AN OBSCURE TITLE.




WELL, ISN’T THAT INTERESTING.

So, the vaccine produces far more spike S1 subunit for far longer than the natural infection does. Hmm. Curiouser and curiouser.

But is the S1 subunit (which is identical between the virus and the vaccine) actually a toxin? Good question. Let’s look into that. One moment…. searching. There.

First question - does spike S1 subunit get into the brain across the blood brain barrier?

Why yes, Virginia, thank you for asking. It does! You are such a good student.


You can find and read the article yourself here.


Next question. Does Spike S1 do any damage to the brain when it hits nerve cells (neurons)? Oops. Looks like it does! Who would have guessed. Well, who among those scientists who are not misinformation spreaders?


Read it for yourself here.


AND THEN THERE IS THIS ONE.

Read this one here.

Highlights

•COVID-19 generates cerebrovascular, sensitive, motor, cognitive and diffuse brain disorders.
•The trigeminal and vagus nerve or the gut-brain axis are the entrance of SARS-CoV-2 in brain.
•SARS-CoV-2 affects brain by neuroinvasion and by the consequences of the systemic infection.
•COVID-19 favors BBB disruption, inflammation, hypoxia, and secondary infections.
•The study of the neurological affectation of COVID-19 raises a new challenge for neuroscience.


For this one, it is important to recognize that there is no significant difference between the symptoms of long COVID (PASC) and post vaccination syndrome.


And you can read all about it here.


And then there is this little issue of demylination of nerve cells. That is sort of like stripping off the insulation on a wire.
Causes short circuits and all sorts of problems.


Yipes. Read here.


And brain endothelial attack. What could possibly go wrong?


Which you can read here.


SO, I ASK YOU, WHO WAS RIGHT? THE SCIENTISTS OR THE FACTCHECKERS?

IS THE SPIKE S1 SUBUNIT PRESENT IN BOTH VIRUS AND THE PRODUCT OF THE GENETIC INOCULATIONS A TOXIN?

Wikipedia-

“A toxin is a harmful substance produced within living cells or organisms;[1][2] synthetic toxicants created by artificial processes are thus excluded.[3] The term was first used by organic chemist Ludwig Brieger (1849–1919)[4] and is derived from the word toxic.”

 

[Heliobas Disciple]

vaccine adverse events data

to say that safety standards have slipped might be the understatement of the pandemic

boriquagato.substack.com

(fair use applies)

vaccine adverse events data
to say that safety standards have slipped might be the understatement of the pandemic

el gato malo
21 hr ago

“these products are safe” has been a consistent claim of covid vaccines, but the numbers do not bear this out. claiming “this is a vaccine so of course, it’s safe because other vaccines were safe what are you some kind of anti-vaxxer?” has been common, but was never a valid framing. it’s a false equivalence akin to claiming that because raspberries and blueberries are safe and lots of people eat them, that baneberries you found in the yard are not poisonous. (pro tip: they are)

most countries have vaccine adverse events reporting systems. they are not intended to catalogue all bad vaccine outcomes but just catch some small subset. by so doing, they serve as sorts of “canaries in coal mines” to generate an alert when things are going wrong.

and these birds have been dropping like flies.

this is FIMEA, finland’s equivalent to VAERS. i have no idea what the reporting percentage is for events but even if we take the serious category at face value, it gets pretty worrying for a vaccine because their definition of serious quite serious. (see highlight)



this can be tricky to eyeball, so let’s run the ratios:



so, we see that the mRNA vaccines actually look safer than astro-zeneca and janssen (i used 3582 as janssen count. it’s likely a bit lower which would make the safety look worse.)

but none of these are good numbers. they are, in fact, terrible.

if we take 2,000 as a ballpark number for mRNA, this means that 1 in 2000 people who got the jab experienced a reaction that was “fatal or life-threatening, requires hospitalisation or prolongs it, causes persistent or significant disability or incapacity or congenital anomaly.”

and that’s per dose, not per person. so, double it to get fully vaxxed and triple it for a booster.

so double dosed is ~ 1 per 1,000 for mRNA, ~900 for janssen (JnJ) which is single dose, and a terrifying ~1 per 300 for astra zeneca.

for a vaccine even 1 per 1000 is a completely outlandish number. it would mean that you would expect to inflict 330,000 serious AE’s like death, hospitalization, or disability to fully vaccinate a country the size of the US, and those are just the ones you catch.

that’s something on the order of 7X the total number of reports (including mild which are the vast majority) VAERS gets in pre covid years.

doing a rough extrapolation from VAERS this last year it’s probably more like a 45-50X rise in serious reports. (deaths, for example, were up 46X and that was just through september.



when we count the full year for deaths, we get this: (note that 2022 is still partial)



the US averaged 166 vaccine deaths a year in the 5 years prior to 2021.

2021 was 61 times that.

2022 so far is 19 times that, 41 X if we extrapolate this rate to a full year.

these are numbers so far above any seen before in every other vaccine program combined as to completely lack precedent.

and keep in mind that VAERS is just a reporting system. it undercounts actual outcomes by something like 90-99% best i can tell. that is to say, actual outcomes are 10-100X higher. some have claimed 40.

According to Mitteldeutscher Rundfunk (MDR), a public broadcaster in Leipzig, "The number of severe complications after vaccination against Sars-CoV-2 is 40 times higher than previously recorded by the Paul Ehrlich Institute (PEI) (germany’s VAERS equivalent).

i suspect it drops somewhat for “serious” as more serious complications are more likely to be reported.

a german insurer estimated underreporting of serious as follows:



that’s ~14X variance which seems reasonably in line.

more HERE.

if we apply that to finland the 1 per 1000 for double vaxxed and 1 per 677 for triple becomes 1 per 71 and 1 per 48 respectively and would imply some sort of serious AE in over 2% of the triple vaxxed.

that’s a horrifying number.

the swine flu vaccine in 1976 was called a “debacle” for killing 25 people and causing guillian barre disease in about 500.

read what the LA times had to say about this back in 2009 prior to the wild departures from age old standards, practices, and mores on vaccines:



it’s amazing how clear eyed their takes were. ms roan sounds like she could be writing for bad cattitude… (bold mine)

The swine flu brush of 1976 -- some call it a debacle -- holds crucial lessons for the government and health officials who must decide how to react to the new swine flu threat in the days and weeks ahead.​

​

For starters, officials must keep the public informed. They must admit what they know and don’t know. They must have a plan ready should the health threat become dangerous. And they must reassure everyone that there is no need to worry in the meantime…​

​

“I think we’re going to have to be cautious,” Wenzel said. “Hopefully, there will be a lot of good, honest public health discussion about what happened in 1976.”​

​

Officials should be prepared for plenty of second-guessing, especially for any decisions regarding vaccination, which was at the core of the 1976 controversy, said Dr. David J. Sencer, the CDC director who led the government’s response to the threat and was later fired.​

​

The question of whether politics overtook science in 1976 has been the fodder of books, articles and discussions for 33 years.​

this vaccine was pulled after 10 weeks once about 25% of the american population had received it. (about 54 million people) it was another rush job vaccine brought to market with little testing and great political pressure amidst a government driven fear surge.

it was pulled off the market for about a 1 in 100,000 severe outcomes figure.

covid vaccine in finalnd are reporting 100X that.

and in the US we see

covid vaccines have this far killed nearly 13,000 in the US.



total severe events (grabbed from these categories and not including urgent care) look at be about 160k from 220mm fully vaxxed people. that’s 1 per 1,375 fully vaxxed and finds pretty good alignment with the 1 per 1000 finnish reporting figures.

apply a 10-15X underreporting range similar to what we see in germany and it’s on the order of 1.6 to 2.4 million predicted actual severe outcomes in the US.

that’s a staggering figure, but one that does not seem at all implausible to me. i do not personally know a single person that has had severe covid/been hospitalized/or died. (though i have a couple of “once removed” friends/relatives of friends.) but i personally know dozens of people who are vaccine injured and have had severe or chronic responses from anaphylaxis to shingles to tinnitus to vertigo to heart issues or palsies. if anything, i’m guessing that the sort of 1 in 100 figure for severe outcomes that a 14X underreporting figure implies is considerably low.

(though my experience based on who i am and what my friends know about my background and opinions on this topic may also make me unrepresentative as people seek me out preferentially to discuss such things. that said, a strongly disproportionate number of my friends are also unvaxxed.)

this severe outcomes safety signal has similarly been on the order of 100-200X the size of those previously required to take a vaccine off the market.

and yet we lacked the societal courage to stop it.

government could not reverse course even when they were obviously wrong about both vaccine efficacy and vaccine safety.

(and do not let anyone tell you they did not claim the vaccines stopped transmission. that’s flatly, provably false and we have an entire file cabinet of receipts.)

bad cattitude​

yes, the vaccines were supposed to stop covid spread. yes, the "experts" told us so.​

the revisionist history around vaccines is getting pretty extreme. let’s be VERY clear: yes, they were promised to stop spread, contagion, and provide herd immunity. yes, those promises were made by t…​

5 months ago · 689 likes · 322 comments · el gato malo​

yet curtailing vaccines not even being discussed in the US.

instead we rubber stamp boosters with obviously negative net expected value for 5-11 year olds.
even as other countries are contra-indicating vaccinating kids for mRNA at all.



such a severe departure from all past standards and policy warrants explication.

as we enter the “pointy questions” portion of this public health collapse, it’s time we got serious about discussing the harms here in open, honest fashion.

these products and mandates were the technocratic centerpieces of 2 administrations. and they have not performed even remotely as promised and their impact even now is being severely misrepresented.

erecting truth ministries and medical board censors to stop such discussion represents vast societal harm.

we must get back to a place like 2009 when the press and people alike were skeptical, not credulous and censorious.

we must ask, in all abashed humility, “how did we, once more, allow politics to completely overtake science and run roughshod over lives and livelihoods, rushing the sort of product that should have 5-10 years of testing to market in 5-10 months and wrapping themselves in oppressive moral raiment as offensive to liberty as it was inaccurate in it’s claims?”

how did we allow the full regulatory capture and subversion of the federal agencies whose theoretical job is to prevent such miscarriages, not to serve as the marketing arms of corrupt crony corporatism?

because the math on that one is always the same.

 

[155 arty]

Is that true?

not in my case !

 

[Zoner]

Dr. Geert Vanden Bossche - ADE, Evolution of the Virus & Expected Excess Deaths | Voice for Science and Solidarity

www.voiceforscienceandsolidarity.org

New interview

 

[psychgirl]

Dr. Geert Vanden Bossche - ADE, Evolution of the Virus & Expected Excess Deaths | Voice for Science and Solidarity

www.voiceforscienceandsolidarity.org

New interview

Please remind me again later! Thank you!

 

[Zoner]

Dr. Geert Vanden Bossche - ADE, Evolution of the Virus & Expected Excess Deaths | Voice for Science and Solidarity

www.voiceforscienceandsolidarity.org

New interview

The summary and good part starts at about the 50 minute mark if you want to skip all the science.

 

[jward]

..almost like they don't trust their science/vaxxes..
Insider Paper
@TheInsiderPaper

White House: "Anyone meeting with Biden, Harris or their spouses must first be tested for the virus. Additionally, aides wear masks when they meet with Biden and stay more than six feet away" - Washington Post reported


1:16 PM · May 19, 2022·Twitter Web App


Replying to
@TheInsiderPaper
MORE:

https://twitter.com/i/web/status/1527353766684479496

View: https://twitter.com/TheInsiderPaper/status/1527353766684479496?s=20&t=RzVMjm86yQGbiJ9ldiRLsA

 

[Heliobas Disciple]

Dr. Geert Vanden Bossche - ADE, Evolution of the Virus & Expected Excess Deaths | Voice for Science and Solidarity

www.voiceforscienceandsolidarity.org

New interview

Thanks! I watched the whole thing. A lot of similar ground covered. The woman interviewer was really stuck on the upcoming WHO treaty, she interrupted him at least twice to complain about it, (annoyingly, because what can Geert do about it, and she interrupted his train of thought more than once). Finally Geert told her it won't matter what the WHO wants to do, the virus is in control, not man and they'll be too busy dealing with what's coming to do anything else. I don't know when the interview was actually conducted, sometimes they're done a few days or even a week before being posted - I was hoping for a question about NK and their possible experiment in herd immunity - and a question about Monkey Pox and whether the now weaker immune system of the vaxxed will contribute to its spread. But neither was asked...

HD

 

[Heliobas Disciple]

..almost like they don't trust their science/vaxxes..
Insider Paper
@TheInsiderPaper

White House: "Anyone meeting with Biden, Harris or their spouses must first be tested for the virus. Additionally, aides wear masks when they meet with Biden and stay more than six feet away" - Washington Post reported


1:16 PM · May 19, 2022·Twitter Web App


Replying to
@TheInsiderPaper
MORE:

https://twitter.com/i/web/status/1527353766684479496

View: https://twitter.com/TheInsiderPaper/status/1527353766684479496?s=20&t=RzVMjm86yQGbiJ9ldiRLsA

almost like they know what's coming....

 

[Heliobas Disciple]

Wuhan Lab Publishes Study Manipulating H7N9 Virus To Be More Lethal. - The National Pulse

A scientific journal published by top Wuhan Institute of Virology researchers shared studies appearing to engage in gain-of-function type research, a controversial method of studying pathogens that can increase their lethality.The Wuhan Institute of Virology is believed to have engaged in the...

thenationalpulse.com

(fair use applies)

Wuhan Lab Publishes Study Manipulating H7N9 Virus To Be More Lethal.
by Natalie Winters
May 19, 2022

A scientific journal published by top Wuhan Institute of Virology researchers shared studies appearing to engage in gain-of-function type research, a controversial method of studying pathogens that can increase their lethality.

The Wuhan Institute of Virology is believed to have engaged in the risky form of research regarding bat coronaviruses, as now-deleted webpages reveal the lab manipulating bat coronaviruses to “replicate efficiently in primary human airway cells and achieve in vitro titers equivalent to epidemic strains of SARS-CoV.”

Now, the latest edition of the lab’s journal, Virologica Sinica, appears to contain a similar style of research with the H7N9 virus in chickens and mice. The publication’s Editor-in-Chief is Wuhan’s infamous “bat lady,” Shi Zhengli, who is the lab’s premier bat coronavirus researcher and a recipient of funds from Anthony Fauci through Peter Daszak’s EcoHealth Alliance.

Virologica Sinica published the study “Combined Insertion of Basic and Non-basic Amino Acids at Hemagglutinin Cleavage Site of Highly Pathogenic H7N9 Virus Promotes Replication and Pathogenicity in Chickens and Mice” in its most recent edition, published February 2022.

Journal Cover.

The paper’s abstract outlines how researchers “generated six H7N9 viruses,” analyzing how various amino acids altered the virus’ virulence and infectivity.

“We characterized the reconstituted viruses in terms of viral replication in avian and mammalian cells, thermostability and acid stability, cleavage efficiency, the virulence in mice, and pathogenicity and transmissibility in chickens,” outlined the study.

“The I335V substitution of H7N9 virus enhanced infectivity and transmission in chickens, suggesting that the combination of mutations and insertions of amino acids at the HACS promoted replication and pathogenicity in chickens and mice,” explained researchers.

In one case study, the H7N9 variant caused a 35 percent mortality rate in mice, with researchers noting that certain amino acids “increased the pathogenicity”:

Surprisingly, the monobasic mutants (i.e., PEIPKGR/G) showed clear symptoms of infection, including shaggy hair and abdominal breathing, after the second day of infection, followed by 15% of weight loss compared to the initial weight and death, with a mortality rate of 35%. In addition, each H7N9 viruses can replicate efficiency in lungs of the infected mice PEVPKRKRTAR/G (P ¼ 0.0109) significantly increased viral titers in the lungs of mice compared to that of the PEVPKGR/G group, indicating that the insertion of KRTA increased the pathogenicity of mice.​

“Notably, we observed that the insertion of non-basic amino acids TA and IA in H7N9 viruses caused death in mice despite having the same viral titer, which suggested that HPAIV H7N9 inserted with a non-basic amino acid posed a potential threat to humans,” added the paper.

The paper follows continued revelations about the Wuhan Institute of Virology engaging in “gain of function” research with U.S. taxpayer funds from Fauci’s National Institutes of Health (NIH) agency.

Virologica Sinica: Research Article | PDF | Virus | Influenza

paper

www.scribd.com

 

[Heliobas Disciple]

Louisiana Governor Reverses ‘Insane Mandate’ Requiring COVID Vaccines for Students

Louisiana’s Democratic Governor, John Bel Edwards, Wednesday reversed the state’s vaccine mandate requiring students to be fully vaccinated beginning the 2022-23 school year.

childrenshealthdefense.org

(fair use applies)

Louisiana Governor Reverses ‘Insane Mandate’ Requiring COVID Vaccines for Students
Louisiana’s Democratic Governor, John Bel Edwards, Wednesday reversed the state’s vaccine mandate requiring students to be fully vaccinated beginning the 2022-23 school year.
By The Defender Staff
05/19/22

Children and students attending daycare, K-12 programs and college in Louisiana, at least for now, will not be required to get the COVID-19 vaccine, Gov. John Bel Edwards announced Wednesday.

The announcement reversed an earlier decision by the governor’s administration and the Louisiana Health Department (LHD) requiring students to be fully vaccinated beginning in the 2022-23 school year.

Edwards said he based the decision on the fact that the U.S. Food and Drug Administration (FDA) has not fully approved the vaccines for people under age 16.

The governor said his administration will continue to recommend all children age 5 and over get the vaccine, a recommendation the LHD endorsed Wednesday in a news release.

In their statements, the governor and the LHD implied COVID-19 vaccines for people over age 16 are fully approved. However, while the FDA did grant full licensing to Pfizer’s Comirnaty and Moderna’s Spikevax COVID-19 vaccines — for people 16 and older and 18 and older, respectively — those vaccines are not available in the U.S.

All COVID-19 vaccines being administered in the U.S. are still available only under Emergency Use Authorization.
Commenting on the governor’s announcement, Robert F. Kennedy, Jr., chairman and chief legal counsel for Children’s Health Defense (CHD), said:

“The science shows this age group is at zero risk from COVID-19 and at high risk of debilitating and sometimes deadly vaccine injury.

“The only thing driving these mandates is the deceptive campaign of orchestrated fear and deliberately induced confusion carried out by reckless and incompetent health officials, their Big Pharma overlords and the gullible politicians who do what they are told rather than conduct their own independent research.”

Kennedy added, “Hats off to Louisiana Attorney General Jeff Landry, who forced Gov. Edwards to back off this insane mandate.”

Landry in December 2021 sued the governor in a bid to block the addition of the COVID-19 vaccine to Louisiana’s immunization schedule for schools and colleges.

CHD on March 16 filed an amicus brief in the lawsuit, arguing the data do not support mandatory COVID-19 vaccines and it is scientifically unjustifiable to impose the requirement on children.

About 4,700 Louisana parents joined CHD in filing the brief.

According to the brief:

“Simply put, the COVID vaccines have not been shown to be either effective or safe for children. The benefits to children are minuscule, while the risks — including the risk of potentially fatal heart damage — are ‘known’ and ‘serious,’ as the [FDA] itself has acknowledged.

“Moreover, it is undisputed that the existing COVID vaccines do not prevent COVID — at best they reduce the incidence of severe disease outcomes — and hence COVID is not a ‘vaccine-preventable’ disease; as a result, COVID vaccines cannot be made mandatory for school attendance under express Louisiana statutory law.”

Landry wasn’t alone in trying to block the mandate — Louisiana’s House Health and Welfare Committee in April filed a resolution to repeal it.

However, in a 4-3 vote, the committee on May 11 rejected the resolution, allowing the mandate to stand until Wednesday’s announcement by the governor.

According to WWNO – New Orleans Public Radio, only 24% of children ages 5 to 17 are fully vaccinated, according to the state.

New Orleans Public Schools is the only district in the state that already requires students to be vaccinated against COVID-19. Because the district doesn’t need state permission to mandate such a policy, the state health department’s announcement isn’t likely to impact the requirement already in place in New Orleans schools, WWNO reported.

 

[Heliobas Disciple]

CDC urges Pfizer booster for children ages 5 to 11

U.S. health advisers are urging a booster dose of Pfizer's COVID-19 vaccine for kids ages 5 to 11. The Centers for Disease Control and Prevention quickly signed off on the advice.

apnews.com

(fair use applies)

CDC urges Pfizer booster for children ages 5 to 11
By LAURAN NEERGAARD
May 19 2022

Kids ages 5 to 11 should get a booster dose of Pfizer’s COVID-19 vaccine, advisers to the U.S. government said Thursday.
The Center for Disease Control and Prevention quickly adopted the panel’s recommendation, opening a third COVID-19 shot to healthy elementary-age kids — just like what is already recommended for everybody 12 and older.

The hope is that an extra shot will shore up protection for kids ages 5 to 11 as infections once again are on the rise.
“Vaccination with a primary series among this age group has lagged behind other age groups leaving them vulnerable to serious illness,” said CDC Director Dr. Rochelle Walensky, in a statement.

“We know that these vaccines are safe, and we must continue to increase the number of children who are protected,” she said.

Earlier this week, the Food and Drug Administration authorized Pfizer’s kid-sized booster, to be offered at least five months after the youngsters’ last shot.

The CDC takes the next step of recommending who actually needs vaccinations. Its advisers debated if all otherwise healthy 5- to 11-year-olds need an extra dose, especially since so many children were infected during the huge winter surge of the omicron variant.

But the U.S. now is averaging 100,000 new cases a day for the first time since February. And ultimately, the CDC’s advisers pointed to growing evidence from older kids and adults that two primary vaccinations plus a booster are providing the best protection against the newest coronavirus variants.

“This always perhaps should have been a three-dose vaccine,” said Dr. Grace Lee of Stanford University, who chairs the CDC’s advisory panel.

The booster question isn’t the hottest vaccine topic: Parents still are anxiously awaiting a chance to vaccinate kids under 5 — the only group not yet eligible in the U.S.

Dr. Doran Fink of the Food and Drug Administration said the agency is working “as rapidly as we can” to evaluate an application from vaccine maker Moderna, and is awaiting final data on the littlest kids from rival Pfizer. The FDA’s own advisers are expected to publicly debate data from one or both companies next month.

For the 5- to 11-year-olds, it’s not clear how much booster demand there will be. Only about 30% of that age group have had the initial two Pfizer doses since vaccinations opened to them in November.

CDC adviser Dr. Helen Keipp Talbot of Vanderbilt University said health authorities must put more effort into getting youngsters their initial shots.

“That needs to be a priority,” she said.

Thursday’s decision also means that 5- to 11-year-olds with severely weakened immune systems, who are supposed to get three initial shots, would be eligible for a fourth dose.

Pfizer and its partner BioNTech currently make the only COVID-19 vaccine available for children of any age in the U.S. Those ages 5 to 11 receive a dose that’s one-third the amount given to everyone 12 and older.

In a small study, Pfizer found a booster revved up those kids’ levels of virus-fighting antibodies — including those able to fight the super-contagious omicron variant — the same kind of jump adults get from an extra shot.

Vaccines may not always prevent milder infections, and the omicron variant proved especially able to slip past their defenses. But CDC cited data during the omicron surge that showed unvaccinated 5- to 11-year-olds had twice the rate of hospitalization as youngsters who got their first two doses.

Health authorities say for all ages, the vaccines are still offering strong protection against COVID-19′s worst outcomes, especially after a third dose.

Some especially high-risk people, including those 50 and older, have been offered the choice of a second booster, or fourth shot — and the CDC on Thursday strengthened that recommendation, too, urging anyone who’s eligible to go ahead and get the extra dose.

Still to be decided is whether everyone will need additional shots in the fall, possibly reformulated to offer better protection against newer coronavirus variants.

 

[Heliobas Disciple]

Tea and infomercials: N. Korea fights COVID with few tools

North Korean propaganda describes an all-out effort to fight a suspected COVID-19 outbreak that has sickened nearly 2 million people.

apnews.com

(fair use applies)

Tea and infomercials: N. Korea fights COVID with few tools
By HYUNG-JIN KIM and KIM TONG-HYUNG
May 19 2022

SEOUL, South Korea (AP) — On a recent nighttime visit to a drugstore, a double-masked Kim Jong Un lamented the slow delivery of medicine. Separately, the North Korean leader’s lieutenants have quarantined hundreds of thousands of suspected COVID-19 patients and urged people with mild symptoms to take willow leaf or honeysuckle tea.

Despite what the North’s propaganda is describing as an all-out effort, the fear is palpable among citizens, according to defectors in South Korea with contacts in the North, and some outside observers worry the outbreak may get much worse, with much of an impoverished, unvaccinated population left without enough hospital care and struggling to afford even simple medicine.

“North Koreans know so many people around the world have died because of COVID-19, so they have fear that some of them could die, too,” said Kang Mi-jin, a North Korean defector, citing her phone calls with contacts in the northern North Korean city of Hyesan. She said people who can afford it are buying traditional medicine to deal with their anxieties.

Since admitting what it called its first domestic COVID-19 outbreak one week ago, North Korea has been fighting to handle a soaring health crisis that has intensified public anxiety over a virus it previously claimed to have kept at bay.

The country’s pandemic response appears largely focused on isolating suspected patients. That may be all it can really do, as it lacks vaccines, antiviral pills, intensive care units and other medical assets that ensured millions of sick people in other countries survived.

North Korean health authorities said Thursday that a fast-spreading fever has killed 63 people and sickened about 2 million others since late April, while about 740,000 remain quarantined. Earlier this week, North Korea said its total COVID-19 caseload stood at 168 despite rising fever cases. Many foreign experts doubt the figures and believe the scale of the outbreak is being underreported to prevent public unrest that could hurt Kim’s leadership.

State media said a million public workers were mobilized to identify suspected patients. Kim Jong Un also ordered army medics deployed to support the delivery of medicines to pharmacies, just before he visited drugstores in Pyongyang at dawn Sunday.

North Korea also uses state media outlets — newspapers, state TV and radio — to offer tips on how to deal with the virus to citizens, most of whom have no access to the internet and foreign news.

“It is crucial that we find every person with fever symptoms so that they can be isolated and treated, to fundamentally block the spaces where the infectious disease could spread,” Ryu Yong Chol, an official at Pyongyang’s anti-virus headquarters, said on state TV Wednesday.

State TV aired infomercials showing animated characters advising people to see doctors if they have breathing problems, spit up blood or faint. They also explain what medicines patients can take, including home remedies such as honey tea.

The country’s main newspaper, Rodong Sinmun, advised people with mild symptoms to brew 4 to 5 grams of willow or honeysuckle leaves in hot water and drink that three times a day.

“Their guidelines don’t make a sense at all. It’s like the government is asking people to contact doctors only if they have breathing difficulties, which means just before they die,” said former North Korean agriculture official Cho Chung Hui, who fled to South Korea in 2011. “My heart aches when I think about my brother and sister in North Korea and their suffering.”

Kang, who runs a company analyzing the North Korean economy, said her contacts in Hyesan told her that North Korean residents are being asked to thoroughly read Rodong Sinmun’s reports on how the country is working to stem the outbreak.

Since May 12, North Korea has banned travel between regions, but it hasn’t attempted to impose more severe lockdowns in imitation of China. North Korea’s economy is fragile due to pandemic border closures and decades of mismanagement, so the country has encouraged farming, construction and other industrial activities be accelerated. Kang said people in Hyesan still go to work.

The office of the U.N. High Commissioner for Human Rights expressed worry this week about the consequences of North Korea’s quarantine measures, saying isolation and traveling restrictions will have dire consequences for people already struggling to meet their basic needs, including getting enough food to eat.

“Children, lactating mothers, older people, the homeless and those living in more isolated rural and border areas are especially vulnerable,” the office said in a statement.

Defectors in South Korea say they worry about their loved ones in North Korea. They also suspect COVID-19 had already spread to North Korea even before its formal admission of the outbreak.

“My father and sibling are still in North Korea and I’m worrying about them a lot because they weren’t inoculated and there aren’t many medicines there,” said Kang Na-ra, who fled to South Korea in late 2014. She said a sibling told her during recent phone calls that their grandmother died of pneumonia, which she believes was caused by COVID-19, last September.

Defector Choi Song-juk said that when her farmer sister in North Korea last called her in February, she said that her daughter and many neighbors had been sick with coronavirus-like symptoms such as a high fever, coughing and sore throat. Choi said her sister pays brokers to arrange phone calls, but she hasn’t called recently, even though it’s around the time of year when she runs short of food and needs money transfers via a network of brokers. Choi said the disconnection is likely related to anti-virus restrictions on movements.

“I feel so sad. I must connect with her again because she must be without food and picking wild greens,” said Choi, who left North Korea in 2015.

In recent years, Kim Jong Un has built some modern hospitals and improved medical systems, but critics say it’s mostly for the country’s ruling elite and that the free socialist medical service is in shambles. Recent defectors say there are lots of domestically produced drugs at markets now but they have quality issues so people prefer South Korean, Chinese and Russian medicines. But foreign medications are typically expensive, so poor people, who are a majority of the North’s population, cannot afford them.

“If you are sick in North Korea, we often say you will die,” Choi said.

Despite the outbreak, North Korea hasn’t publicly responded to South Korean and U.S. offers of medical aid. World Health Organization Director-General Tedros Adhanom Ghebreyesus said Tuesday that the world body “is deeply concerned at the risk of further spread” in North Korea and the lack of information about the outbreak.

Choi Jung Hun, a former North Korean doctor who resettled in South Korea, suspects North Korea is using its pandemic response as a tool to promote Kim’s image as a leader who cares about the public and to solidify internal unity. He says the country’s understated fatalities could also be exploited as a propaganda tool.

“One day, they’ll say they’ve contained COVID-19. By comparing its death toll with that of the U.S. and South Korea, they’ll say they’ve done a really good job and their anti-epidemic system is the world’s best,” said Choi, now a researcher at a Korea University-affiliated institute in South Korea.

 

[Heliobas Disciple]

Newstream | KCNA Watch

kcnawatch.org

(fair use applies)

Epidemic Spread and Treatment Results in DPRK
Date: 20/05/2022 | Source: KCNA.kp (En) | Read original version at source

Pyongyang, May 20 (KCNA) -- According to information of the state emergency epidemic prevention headquarters, more than 263,370 persons with fever, over 248,720 recoveries and two deaths were reported from 18:00 of May 18 to 18:00 of May 19 throughout the country.

As of 18:00 of May 19 since late April, the total number of persons with fever is over 2,241,610, of which more than 1,486,730 have recovered and at least 754,810 are under medical treatment.

The death toll stands at 65. -0-

www.kcna.kp (Juche111.5.20.)

 

[Heliobas Disciple]

US Regulators Reject Request to Clear Cheap Drug for Treatment of COVID-19
(fair use applies)

US Regulators Reject Request to Clear Cheap Drug for Treatment of COVID-19
By Zachary Stieber
May 19, 2022

U.S. regulators have rejected a request to grant emergency authorization to a cheap drug for the treatment of COVID-19, drawing criticism from one of the doctors that asked for the clearance.

The Food and Drug Administration (FDA), in a 27-page memorandum explaining its decision, said that the benefit of fluvoxamine was “not persuasive when focusing on clinically meaningful outcomes such as proportion of patients experiencing hospitalizations or hospitalizations and deaths.”

A review of clinical trials that have examined fluvoxamine, a widely used antidepressant, against COVID-19 led to the conclusion that the data at this time are insufficient for emergency clearance, the FDA added.

Dr. David Boulware, who drew up the request because he believes more COVID-19 treatments are needed, said that the FDA erred because it used different criteria when analyzing fluvoxamine than when it analyzed drugs from major pharmaceutical companies, such as a pill from Pfizer called paxlovid.

Hospitalization was defined in the trials for those drugs as receiving over 24 hours of acute care, whether in a hospital or similar facility. But it analyzed hospitalization in the case of fluvoxamine only in hospitals, excluding similar facilities.

“FDA should evaluate clinical trials using the same endpoint definitions for generic drugs as for big pharma. The deliberate creation of two-tiered system is inappropriate,” Boulware, a professor of medicine at the University of Minnesota, said in a letter to Dr. Peter Stein, who is the director of the FDA’s Office of New Drugs.

Asked for a comment on Boulware’s letter, an FDA spokesperson told The Epoch Times in an email that the agency after its review “was unable to reasonably conclude that fluvoxamine may be effective for the treatment of outpatient adults with COVID-19 to prevent severe disease progression and/or hospitalization.”

The COVID-19 Treatment Guidelines Panel, convened by the National Institutes of Health, says that it cannot recommend for or against fluvoxamine against COVID-19 due to “insufficient evidence.”

Supporters, though, note that some trials have shown efficacy against COVID-19.

A meta-analysis of three clinical trials, for instance, found a high probability that fluvoxamine was linked with reducing the risk of hospitalization among COVID-19 patients.

Researchers who conducted one of the trials said they discovered “a clinically important absolute risk reduction” of hospitalization.

Taken together, the research indicates “fairly conclusively” a benefit, Boulware told The Epoch Times. “It has about 25 percent reduction in hospitalization, has about a one-third reduction preventing progression of severe disease. The data comes from multiple randomized, double-blind, placebo-controlled trials. And so the data is pretty good.”

Dr. Todd Lee, a scientist at McGill University, and colleagues recently estimated that a COVID-19 hospitalization prevented through fluvoxamine cost $908. Drugs authorized or approved by the FDA for treating COVID-19 cost much more per hospitalization averted, including some $45,479 for molnupiravir, Merck’s pill, Lee and his colleagues said.

Major companies that develop drugs are more likely to invest money in large trials, Boulware said, which is one reason none of the cheaper alternatives have yet received U.S. emergency authorization. Drug companies do not have a financial incentive to support trials for generic drugs.

Depending on results from future trials, the doctor may resubmit the request to the FDA.

 

[Heliobas Disciple]

COVID-19 Cases, Hospitalizations Linger in Ohio

www.theepochtimes.com

(fair use applies)

Covid Cases, Hospitalizations Linger in Ohio But Vaccines Working, Say Health Officials
By Michael Sakal
May 19, 2022

With the lifting of most pandemic restrictions, cases of COVID-19 have slightly increased across Ohio and throughout the nation.

On May 19, Ohio’s director of health Bruce Vanderhoff said the increase in early-to-mid May was due to virus variants lingering around.

The rise was around the time the Centers for Disease Control and Prevention (CDC) pandemic’s U.S. death toll reached 1 million people.

In Ohio, the weekly average of deaths has declined by 16 percent.

Vanderhoff said there were 582 people hospitalized throughout Ohio with the virus; a substantial drop compared to the more than 6,700 being treated in hospitals on Jan. 11 during the height of the pandemic.

Despite those numbers, Vanderhoff said Ohio is still doing well in comparison to the case spikes experienced in the winter months, and in surrounding states.

Across the country, 4.6 million people were hospitalized between April 1 and May 17.

At Premier Health’s Miami Valley Hospital in Dayton, Ohio, just 12 people were hospitalized, and it was down to one COVID-19 patient about a month ago, according to figures from the healthcare network.

There has not been a COVID-related death reported from Miami Valley Hospital in about a month.

Unlike early on in the pandemic—when many older people or seniors were diagnosed with the virus—now a wider age range of people are getting it.

Of Ohio’s 88 counties only one remains yellow, or on a higher alert level. The rest of the counties are green meaning the number of transmissions is low, according to the ODH.

Lawrence County is the only one not yet in the green category. It is Ohio’s southernmost county, is situated along the Ohio River, and has a population of slightly more than 58,000.

“This tells us that immunity, especially from vaccines, is making a difference,” Vanderhoff said.

“This is good news as we head into warmer weather, but we need to take this opportunity to prepare for the fall when more of us are indoors or to prepare for unanticipated changes in viral activity,” he added.

Nationally, 81 percent of counties throughout the United States are green, and four percent are orange or on a higher alert, Vanderhoff said.

Vaccination (two shots with one booster) remains the best mode of defense, Vanderhoff said, but he also alluded to therapeutic methods such as intravenous monoclonal antibodies or Paxlovid being vital tools.

However, Vanderhoff stressed that therapeutic methods should not be used as a sole alternative, but could be used in addition to the vaccines, and to consult a doctor before using therapeutic antibodies.

State numbers show that about two-thirds of eligible Ohio residents have started the vaccine process. Vanderhoff said the state’s vaccination rate combined with those who have already recovered from the virus has made for a “substantial level of protection against severe illness.”

Dr. Joe Gastaldo, director of infectious diseases with the OhioHealth Physicians Group, was present at the press conference with Vanderhoff.

Vanderhoff had Gastaldo speak on the effectiveness of the vaccines, and with cases slightly increasing earlier in May, Vanderhoff asked him if that meant the vaccines were no longer working or weren’t as effective as they were early on.
Gastaldo said that the vaccines were continuing to do what they were supposed to do.

“The vaccines are continuing to work well and are performing extremely well,” Gastaldo said. “They were never intended to stop all infections but to prevent severe illnesses resulting in hospitalizations and death.”

The Food and Drug Administration authorized the use of Pfizer’s COVID-19 vaccine for children ages 5 and older on May 16. The next step in that process is to await approval from the CDC.

“I feel confident that that process is going forward and that we will likely have that vaccine available sometime this summer, or late summer,” Gastaldo said.

 

[Heliobas Disciple]

COVID Vaccine Blood Clot Issue ‘May Be in the Hundreds,’ but ‘Heart Issue Is in the Thousands’: Cardiologist

www.theepochtimes.com

(fair use applies)

COVID Vaccine Blood Clot Issue ‘May Be in the Hundreds,’ but ‘Heart Issue Is in the Thousands’: Cardiologist
Heart specialist sees many more cases of heart inflammation since COVID vaccine roll out
By Enrico Trigoso
May 19, 2022

Dr. Sanjay Verma, an adult cardiologist practicing in Coachella Valley, California, sees a few hundred patients a month, and since last summer, he has seen “possibly a dozen” patients whose heart conditions might be connected to the COVID vaccines.

“I can only say possibly—not definitively—because we do not yet have any diagnostic test that 100 percent says ‘this caused this.’ What we do is what’s called a process of exclusion. We look for common associations like coronavirus, influenza virus, other infections, atherosclerosis or coronary artery disease, alcohol, recreational drugs, and if everything keeps coming back negative or normal, then by default and process of exclusion, vaccine-associated heart injury is a probability.

“Usually we don’t even see that many [heart problems] in a year,” Verma said.

Adding that prior to the pandemic it would be “much less than that per year.”

Verma is puzzled as to why the media has given more attention to COVID vaccine blood clot issues when there have been many more cases of myocarditis, according to his observation.

“I cannot, with confidence, conclude why one is getting more attention. And by attention, it’s not just news reports, it’s to the extent that they’ve basically put a caution to only use the Johnson and Johnson if there’s no other choice. So that’s a pretty strong caution. Whereas for the mRNA vaccines and heart issues, the warning is there on the FDA factsheet. But the number of people affected is far greater,” Verma said.

“The blood clot issue with Johnson & Johnson may be in the hundreds, but the heart issue is in the thousands. It’s a different level of patient exposure.”

In June of last year, the FDA announced a revision to the fact sheets of Pfizer and Moderna COVID vaccines, warning that there is a “low” risk of myocarditis—inflammation of the heart muscle, and pericarditis—inflammation of the lining outside the heart.

A study published in October of last year by the New England Journal of Medicine inferred that the risk of myocarditis was greater from COVID-19 than from the vaccines, but according to Verma’s research, the study was flawed.

“This analysis was imperfect because it combined all age groups in its analysis. It is well established that COVID-19 hospitalizations are predominantly comprised of those older than 65 years (this cohort outnumbers all other age groups combined for COVID hospitalizations). CDC’s own analysis reveals that 91% of all COVID-19 hospitalizations occurred in people with underlying medical conditions and most recently CDC Director Rochelle Walensky has stated that 75% of COVID deaths were in people with at least 4 underlying medical conditions. Therefore, the myocarditis cases after COVID infection likely occur in older people with underlying medical conditions,” Verma wrote.

“This was confirmed in a more recent study that demonstrated for those less than 40 years-old, the risk of myocarditis after COVID-vaccination is far greater than after COVID-19 infection. The study found that compared to background rate in general population there was a 3.4x increased risk for Pfizer COVID vaccine and 20.71x increased risk after Moderna vaccine whereas the risk after COVID infection was 4.06x the background rate in the general population. When this group is further risk stratified, the 16–29-year-old group had an even greater risk of myocarditis after vaccination, especially for Moderna mRNA vaccine (COVID infection yielded 2.83x increased risk, Moderna vaccine yielded 74.39x increased risk, and Pfizer vaccine yielded 2.88x increased risk compared to background rate in general population). The authors of this study recently performed an urgent updated analysis to include the effect of boosters. Their analysis found that the risk of myocarditis was further exacerbated after boosters, especially for the Pfizer mRNA vaccine. In another recent study on myocarditis after vaccination, the authors found only 17% of cases had any underlying medical conditions (in contrast to the 91% of COVID hospitalizations having underlying medical conditions). This group of young healthy people is at very low risk of severe COVID complications themselves.”

When asked if the reactions were caused by autoimmune responses from spike protein expressions originating from the vaccine, Verma said that it was one hypothesized mechanism that could cause blood clots, but there is no defined mechanism for cases of myocarditis or pericarditis.

“It could be autoantibodies to the spike protein. It could be spike protein direct damage. It could be a combination of both,” he said, “And obviously, being a cardiologist, I acknowledge it may appear that I’m biased [by] focusing on the heart issues, but because the heart issues are greater in numbers [it] has a bigger impact on ‘vaccine hesitancy.'”

The Epoch Times recently reported that a pediatric cardiologist had to stop working and was punished by his board for not wanting to recommend a vaccine to a young patient that had already contracted COVID previously.

Reports to VAERS of myocarditis and pericarditis jumped dramatically in 2021 to 24,084 cases, and 16,417 as of May 6, 2022.

Most of these reactions (31,501) are connected to Pfizer vaccines.

According to OpenVAERS, “VAERS is the Vaccine Adverse Event Reporting System put in place in 1990. It is a voluntary reporting system that has been estimated to account for only 1% of vaccine injuries.”

The VAERS official disclaimer, however, states: “While very important in monitoring vaccine safety, VAERS reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.”

The FDA had asked a judge in December 2021 to give it 75 years to produce safety data concerning the Pfizer and BioNTech vaccine, but at the beginning of January of this year, the FDA was ordered to release its related documents in about 8 months.

It was revealed that 1,223 deaths and 42,086 adverse events were reported to Pfizer from the first day of the Pfizer-BioNTech vaccine rollout on Dec. 1, 2020, to Feb. 28, 2021.

Also worth noting is that the vaccines were not immediately injected into people from Dec. 1, 2020, but were slowly rolled out, so the adverse events occurred in less than the 3-month time period.

 

[Heliobas Disciple]

Aviation Associations Highlight Concerns of COVID-19 Vaccine Injuries Among Pilots and Cabin Crew

www.theepochtimes.com

(fair use applies)

Aviation Associations Highlight Concerns of COVID-19 Vaccine Injuries Among Pilots and Cabin Crew
By Naveen Athrappully
May 19, 2022

An international coalition of aviation and medical professionals from countries like the United States, United Kingdom, France, and Switzerland have published a statement raising serious concerns about the compromise in aviation safety due to COVID-19 vaccine injuries among the flight crew.

Advocacy groups, scientists, and doctors are receiving reports of COVID-19 vaccine-injured airline pilots on a daily basis, claimed the signatories in the statement. Harms suffered by pilots include blood clots, cardiovascular issues, auditory and neurological issues, and more.

“Many of our pilots have lost medical certification to fly and may not recover the same. Others are continuing to pilot aircraft while carrying symptoms that should be declared and investigated, creating a human factors hazard of unprecedented breadth. The very foundation of our just safety culture—non-punitive reporting—no longer exists,” according to the May 18 statement.

“Pilots have suffered and are suffering medical issues that at least correlate to receiving COVID-19 vaccinations. Their spectrum of symptoms is broad, ranging up to death. Pilots who report their injury face possible loss of licensing, income, and career while receiving little to no support from their unions, and a prosecutorial invective from employing airlines.”
The statement represents more than 30 airlines, thousands of pilots, and over 17,000 physicians and medical scientists. Signatories of the document include Free to Fly from Canada, US Freedom Flyers, UK Medical Freedom Alliance, Airliners for Humanity from Switzerland, and more.

Pilots who have been let go have resorted to working in a variety of industries to generate income, including manufacturing and processing plants, truck driving, furniture moving, and graphic design, said Greg Hill, Director of Free to Fly.

“It’s really about control,” Hill told The Epoch Times, referring to the Canadian government’s vaccine mandate policy. “Why are the Canadian airlines not raising their voices to demand that these mandates be dropped?”

According to the policy, all citizens over 12 years old need to be fully vaccinated in order to board domestic or international flights, as well as trains.

Regarding alternate modes of transportation, Canada has a breadth of 5,500 kilometers (3,418 miles). “We have people from Quebec whose parents are dying and they can’t get to see them without driving for 4–5 days. It’s absolute cruelty and makes no sense.”

Indifferent Stance of Corporations

Many airlines have indemnified themselves from liability against damages suffered by airline staff who have taken COVID-19 jabs, mentioning it in the same documents that forced vaccine mandates on employees.

Documents from Pfizer as well as regulatory documents from organizations like the U.S. Food and Drug Administration (FDA), Health Canada, European Medicines Agency (EMA), and the UK’s Medicines Healthcare Regulatory Agency (MHRA) show that they have withheld “essential safety and efficacy information” from the public, the groups claimed.

To make matters worse, airlines, aviation regulators, or unions seem to have not performed any of their due diligence on COVID-19 vaccines and their impact on pilot performance and health, which is at “complete odds with existing aviation medical standards,” according to the statement.

Failure to address these matters brings harm to the traditional aviation mantra of “safety first, always,” the groups argued.
Airlines and unions have been repeatedly warned of dire repercussions by several signatories of the statement. Yet, “little meaningful action” has been taken; instead, there has been silence and “stone-walling,” the statement said.

The joint statement lists some of the airlines that have allegedly had pilots injured due to COVID-19 vaccines, which includes eight from the United States, two from the Netherlands, one from Germany, and three each from Australia, Canada, and France. The U.S. airlines include American, JetBlue, Delta, Southwest, Spirit, United, Frontier, and Alaska.

The signatories called on the aviation regulatory bodies in the United States, United Kingdom, Canada, Australia, and the European Union to begin fulfilling their obligations.

The statement asks that: COVID-19 vaccination mandates are discontinued; a permissive environment for self-reporting is emphasized by both airlines and regulators; pilots and cabin crew be subjected to “thorough and objective aviation medical screenings;” and airline and regulators retain data regarding “sickness and medical certificate suspension,” with the data being analyzed by independent third parties either to establish or rule out COVID-19 vaccination as a possible cause.

The public statement from the coalition comes as multiple stories of COVID-19 vaccines ruining the lives of pilots are coming to the fore.

Multiple Adverse Events

Bob Snow, a captain with a major U.S. airline, received a Johnson & Johnson COVID-19 shot on Nov. 4, 2021, due to the vaccine mandate of his employer. A little over two months after taking the vaccine, he began to experience medical issues.

On April 9, after landing at Dallas-Forth Worth International Airport, Snow suffered a cardiac arrest. He was diagnosed as having suffered a sudden cardiac arrest (SCA). Before the incident, he had no history of prior significant cardiac issues, as shown by two electrocardiograms he has taken every year for the previous 10 years.

Snow has been recuperating from home since April 15 and does not believe he will fly again. “[F]or now, it appears my flying career—indeed, likely all flying as a pilot—has come to a rapid and unexpected conclusion as SCA is a red flag to FAA medical certification,” he said to The Defender. This has resulted in “a significant loss of income and lifestyle.”

According to data from the Vaccine Adverse Event Reporting System (VAERS), which is the primary government-funded system for reporting adverse vaccine reactions in the United States, there were 1,498,159 cases of adverse reactions as of May 6 among individuals who had taken COVID-19 vaccines.

This includes 27,968 deaths and 51,996 cases of permanent disabilities.

According to the VAERS disclaimer, “reports alone cannot be used to determine if a vaccine caused or contributed to an adverse event or illness.”

Dr. Robert Jackson, a physician who has been working in the field for 35 years, vaccinated roughly 3,000 people with COVID-19 jabs. He found out that 40 percent of his vaccinated patients had suffered a vaccine injury while 5 percent continue to remain injured.

“It’s very difficult for these pilots who were coerced into taking the jab in exchange for their job to now go against the airlines who think they’ve absolved themselves of all the liabilities for these harms,” said Hill.

 

[Heliobas Disciple]

COVID cases up 76% among kids in recent weeks

It's not just among kids — infections are on the rise nationwide.

news.yahoo.com

(fair use applies)

COVID cases up 76% among kids in recent weeks
Nikki Battiste CBS News
Thu, May 19, 2022, 7:16 PM

COVID-19 cases among kids have climbed 76% in recent weeks, according to the American Academy of Pediatrics.
The increase comes as Pfizer's booster shot for kids ages 5 to 11 was recommended by the Centers for Disease Control and Prevention — even though only 28% of children in that age group have received their two doses.

"This current wave of infections among kids could well land a lot of kids in the hospital," Kaiser Health News' Dr. Celine Gounder told CBS News.

It's not just among kids — infections are on the rise nationwide. In the past month alone, COVID cases have soared more than 168%. New cases are nearing 100,000 per day. Nationwide, hospitalizations are on the rise in 40 states and cases are increasing in 41 states.

"The reality is much worse because we're undercounting COVID cases," Gounder said. "Many people are testing at home, using at-home rapid tests and many people are not testing at all."

Some health officials are concerned it could be the beginning of a fifth wave.

About one-third of the nation lives in areas where COVID infections are at medium or high risk levels. Public health officials are urging some communities with rising cases to return to stricter pandemic measures, including indoor masks.

In Connecticut, COVID cases are up nearly 118% in the past month. That's where Bridget Tichar is raising two young, immunocompromised kids. Five-year-old Teddy and 3-year-old Liza have type 1 diabetes.

"Vaccine is so important to us because it's basically another tool, another weapon in our arsenal to keep them safe," she told CBS News. "It's been wildly stressful the way that I think all parents are dealing with the unknown. That is doubled or maybe even tripled for us."

Her son got his first dose on his fifth birthday two weeks ago.

But Tichar said she feels like parents are only thinking about their own children in making the decision whether or not to get them vaccinated.

"The vaccine really does save lives and protects lives," she said.

 

[Heliobas Disciple]

Possible discovery of mechanism behind mysterious COVID-19 symptoms

In patients with serious and long-term COVID-19, disturbed blood coagulation has often been observed. Now, researchers at Linköping University (LiU), Sweden, have discovered that the body's immune system can affect the spike protein on the surface of the SARS-CoV-2 virus, leading to the...

medicalxpress.com

(fair use applies)


Possible discovery of mechanism behind mysterious COVID-19 symptoms
by Karin Söderlund Leifler, Linköping University
May 19, 2022

In patients with serious and long-term COVID-19, disturbed blood coagulation has often been observed. Now, researchers at Linköping University (LiU), Sweden, have discovered that the body's immune system can affect the spike protein on the surface of the SARS-CoV-2 virus, leading to the production of a misfolded spike protein called amyloid. The discovery of a possible connection between harmful amyloid production and symptoms of COVID-19 has been published in the Journal of American Chemical Society.

In those who have serious and long-term COVID-19, organs other than the lungs can be gravely affected. Complex symptoms and damage in, for example, the heart, kidneys, eyes, nose, and brain, as well as disturbed blood coagulation, can persist. Why the illness affects the body in this way is largely a mystery. Now, researchers at LiU have found a biological mechanism which has never been described before, and which can be a part of the explanation.

The research team studies illnesses which are caused by misfolded proteins, of which Alzheimer's disease in the brain is the most well-known example. The researchers noted that there are many similarities between COVID-19-related symptoms and those which are observed in illnesses caused by misfolded proteins.

The functions of proteins are strongly affected by the fact that proteins are folded in specific ways that give rise to a specific three-dimensional structure. As well as this shape, a protein can also assume an alternative form. Over 30 different proteins are known to have this kind of alternative shape, which is associated with illness. This alternative folded protein is called amyloid. The LiU researchers wondered whether the virus which causes COVID-19, SARS-CoV-2, contains a protein that can create amyloid. They were specifically interested in the spike protein on the surface of the virus, which the virus uses to interact with the body's cells and infect them.

Using computer simulation, the researchers discovered that the coronavirus' spike protein contained seven different sequences which potentially could produce amyloid. Three of the seven sequences met the researchers' criteria for being counted as amyloid-producing sequences when experimentally tested. They produced, among other things, so-called fibrils, which look like long threads when examined under an electron microscope.

But do these fibrils arise spontaneously? It is well known that many illnesses, such as Alzheimer's, are preceded by a process where the body cuts up large proteins into smaller pieces, which can in turn produce the harmful amyloid. In their study, the researchers show that an enzyme from immune system's white blood cells can cut up coronavirus' spike protein. When the spike protein is cut up, it produces the exact piece of protein which, according to the researchers' analysis, is most likely to produce amyloid. This enzyme is released in large quantities from one type of white blood cells, neutrophils, which are released early on during infections such as COVID-19. When the researchers mixed pure spike protein with this enzyme, called neutrophil elastase, unusual fibrils were produced.

"We have never seen such perfect, but scary, fibrils as these ones from the amyloid-producing SARS-CoV-2 spike protein and pieces thereof. The fibrils starting from the full-sized spike protein branched out like limbs on a body. Amyloids don't usually branch out like that. We believe that it is due to the characteristics of the spike protein," says Per Hammarström, professor at the Department of Physics, Chemistry and Biology (IFM) at Linköping University.

Previous research, including a study by South African researchers, has indicated that the spike protein may be involved in the production of small blood clots. The blood contains the fibrin protein, which helps the blood to coagulate when a vessel is damaged, so that the hole seals again and stops bleeding. When the injury has begun to heal, the coagulate is supposed to be broken up by plasmin, which is also found in blood. The researchers at LiU mixed amyloid-producing protein pieces from the spike protein together with these bodily substances in test tubes, and saw that the fibrin coagulate which was then produced could not be broken down in the usual way by plasmin. This newly discovered mechanism may lie behind the production of similar micro blood clots that have been observed in both serious and long-term COVID-19. Disturbed blood coagulation is also seen in many amyloid-related illnesses.

"We can see that the spike protein, when affected by our own immune system, can produce amyloid structures, and that this can potentially affect our blood coagulation. We believe that this discovery is significant for many fields of research, and we hope that other researchers will examine the questions that it raises," says Sofie Nyström, who is an associate professor at IFM and the other author on the study.