Wednesday, September 21, 2022

Scientists on alert as new Covid strain tears through ’multiple countries’

A new Covid variant is ripping through “multiple countries”, with experts fearing it could be even more transmissible than the BA. 5 Omicron strain.

Named BF. 7 – short for BA. – the new variant is spreading faster than most other variants of interest that scientists are currently tracking in the US.

While it accounted for 1.7 per cent of sequenced infections in America last week, it now represents 25 per cent of cases in Belgium, while Denmark, Germany and France have each recorded 10 per cent of the world’s identified cases, Fortune reports.

Dr Stuart Ray, vice chair of medicine for data integrity and analytics at Johns Hopkins’ Department of Medicine, told the publication the US Centres of Disease Control (CDC) recently named it as a separate strain after cases hit one per cent, with that figure expected to grow.

“The same growth advantage in multiple countries makes it reasonable to think that BF. 7 is gaining a foothold,” Dr Ray said, adding that it could prove to be more transmissible than parent strain BA.5.

The rise of the new variant is of particular concern as it’s growing steadily compared to other Omicron subvariants, and because the northern hemisphere is heading towards winter, when Covid is most worrying.

And Dr Ray said there was also a chance an entirely new variant could soon emerge. “It’s been a while since we went from Alpha to Beta to Gamma to Delta, then to Omicron,” he said. “We may be complacent. This may be feeding into the notion that this is behind us.”

The news is all the more concerning given US President Joe Biden this week stated that the “pandemic is over” – despite a daily death toll in the hundreds in America. He told CBS’s 60 Minutes on Sunday US time that while Covid was still a concern, the worst had passed.

“We still have a problem with Covid. We’re still doing a lotta work on it. But the pandemic is over,” he said. “If you notice, no one’s wearing masks. Everybody seems to be in pretty good shape. And so I think it’s changing.”

Mr Biden’s surprising comments came after the World Health Organisation declared the end of the pandemic was “in sight” last week, after announcing weekly deaths had dropped to the lowest level since March 2020.

“We have never been in a better position to end the pandemic,” WHO chief Tedros Adhanom Ghebreyesus told reporters. “We are not there yet, but the end is in sight.”

But the world needed to step up to “seize this opportunity”, he added. “If we don’t take this opportunity now, we run the risk of more variants, more deaths, more disruption, and more uncertainty.”

However, that message did not go down well in China, where an aggressive Zero Covid category is still being pursued via mass testing and brutal lockdowns months after the rest of the world moved on.

The WHO announcement was originally reported by some local news outlets and shared on social media, but was then quickly censored, given Covid Zero is inextricably bound to President Xi Jinping’s Covid strategy.

Xi is widely expected to secure a historic third term in power in October, with some speculating the country’s Covid rules might potentially be relaxed after that point.

According to WHO’s latest epidemiological report on Covid-19, the number of reported cases fell 28 per cent to 3.1 million during the week ending September 11, following a 12 per cent drop a week earlier.


Drug Companies Test New Booster on Eight Mice and Zero Humans, FDA Approves It Anyway. With no efficacy or safety data, the agency is enthusiastically promoting a fifth COVID shot

On Aug. 31, 2022, the Food and Drug Administration authorized bivalent boosters reformulated to target the BA.4 and BA.5 omicron subvariants. At the authorization meeting, FDA officials announced the approval of these new boosters for emergency use based on data from eight mice in a Pfizer study. At the same time, the FDA revoked authorization for the original monovalent boosters—meaning anyone subject to a booster or “up-to-date” mandate will have to take the bivalent booster, which has no proven safety or efficacy data in human beings.

While the flu vaccine is also approved on a yearly basis without full trials, the mRNA COVID vaccines do not share the flu shot’s decadeslong track record of observed safety. The population most likely to be mandated to take a bivalent booster consists largely of college students. The young men in this population are the exact demographic that face heightened safety concerns, specifically around myocarditis, as documented in multiple peer-reviewed studies. In fact, during a meeting of the Centers for Disease Control and Prevention to recommend the bivalent boosters, the agency presented updated myocarditis data that confirmed the rates of myocarditis in young men were about 2-to-3.5 times higher (slide 35) than the agency had claimed last year (slide 13). Nevertheless, the FDA and CDC moved to recommend the bivalent boosters for anyone over the age of 12 without human clinical trials.

This is just the latest episode in the FDA’s less-than-thorough approach to new COVID vaccine approvals. For example, in May 2022, the FDA authorized monovalent Pfizer boosters for children ages 5-11 based on laboratory data that showed heightened antibody response levels in just 67 children.

During the opioid crisis, the FDA famously failed to demand adequate research, disregarded safety concerns, and allowed Purdue Pharma to promote oxycodone for uses that were never borne out by testing. Later, it was revealed that the agency had been plagued by ethical issues: When the FDA convened advisers to address mounting oxycodone safety concerns, for instance, five out of 10 of these advisers had received payments from Purdue, and another three had received payments from other opioid manufacturers.

The continuation of unchecked conflicts of interest, and several recent authorizations for uses of new medical products that are in many ways unproven, demonstrate that the FDA is essentially unresponsive to public outrage, culminating in the bizarre spectacle of the agency promoting bivalent boosters on social media through unsubstantiated claims of efficacy, acting not as a neutral regulator but actively advertising on behalf of pharmaceutical companies with government purchase contracts. The FDA’s disregard for its congressional mandate is not unique to this moment—it is a symptom of its decadeslong transformation into an agency captured by the corporations it is tasked with regulating.

When Kelley Krohnert, a mother and career IT expert from Georgia, watched the CDC’s Advisory Committee on Immunization Practices meeting held on June 17, 2022, she noted a slide that listed COVID as the fourth-leading cause of death for children under 1 and the fifth-leading cause for children aged 1-4 in the United States. This same slide was originally used at the FDA’s June 15 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting, when FDA advisers voted to authorize vaccines for children under 5. Krohnert immediately recognized that the slide was citing a preprint by researchers in the United Kingdom. This preprint not only used death statistics that included deaths where COVID was not an underlying cause—it also compared a 26-month cumulative total for COVID deaths to a 12-month total for other deaths. In Krohnert’s analysis, COVID fell to ninth place for children under 1 and into a four-way tie for eighth place for children aged 1-4. When the researchers corrected their preprint to adjust for some of the errors Krohnert found, COVID fell below influenza and pneumonia as a cause of death for children under 5.

“I didn’t have to do a complex statistical analysis to find these errors,” Krohnert told me. “If this is the standard for what goes into these presentations, what kind of vetting is going into that data?”

This lack of vetting is a central issue in the FDA’s approval process. The key question for any drug authorization is, “Do the benefits outweigh the risks?” When a disease’s risks are exaggerated, one side of this equation is skewed, and the equation is also affected by exaggerating the benefits of a treatment or ignoring the potential risks of that treatment. The data presented in recent FDA meetings has been consistently nonobjective and skewed to favor drug approval.

For the authorization of vaccines for children under 5, boosters for children 5-11, and the new bivalent boosters, the FDA has relied heavily on measures of antibody levels as the main “benefit” side of the equation. This is despite the fact that Pfizer has admitted that there is “no established correlate of protection” between antibody levels and immunity. Both the CDC and the FDA already advise against the use of antibody testing to determine levels of immunity. Essentially, this metric has been deemed inadequate by the very regulatory agency that is now consistently accepting it as a substitute for clinical trials.

This lack of real efficacy data has been accompanied by a disregard for potential safety issues. European Union regulators have already warned that frequent boosters can weaken the immune system; the FDA is apparently unconcerned. The FDA also disregarded the fact that for pediatric vaccines, Pfizer observed a higher rate of severe COVID in its vaccine group (table 5). Furthermore, the FDA allowed the company to ignore 365 symptomatic cases in its trial, and to use only the last 10 symptomatic cases after the third dose to claim 80% efficacy (tables 19 and 20). This is significant because Pfizer saw negative efficacy between doses 1 and 2. In a vaccine meant to prevent illness for an age group that is already at extremely low risk, this data should have been a red flag for the FDA. Why, then, has the body charged with protecting Americans from inadequately tested products been so eager not just to authorize these products for emergency use, but to enthusiastically recommend them?

Dr. Paul Offit, director of the Vaccine Education Center and attending physician in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, was one of only two advisers who voted against VRBPAC’s recommendation for reformulated boosters in June. I asked him about his vote as an FDA vaccine adviser and longtime advocate for vaccination. He told me he believed the thinking behind the bivalent boosters was sound. “The problem for me,” he said, “was I just didn’t think the data that were presented on June 28th to our committee made that case compellingly.”

I asked Offit if he felt there was political pressure to vote a certain way. “I never feel pressure when I cast my vote,” he answered. “I voted no.” However, he said, “I think the way that they were presented, I think it was clear that the FDA and the World Health Organization wanted to go in this direction.” It was notable that the day after the FDA’s vote, the White House announced its purchase of 171 million bivalent booster doses from Pfizer and Moderna for $4.9 billion. “You felt that the train sort of had left the station,” Offit said.

In 2020, the Trump administration was widely criticized for rushing vaccines and pressuring the FDA. Although the Biden administration has exerted similar, if not more pressure, it has enjoyed a conspicuous absence of criticism. Before the FDA’s expert panel could even meet to discuss vaccines for children under 5, for example, the White House’s COVID czar, Ashish Jha, publicly announced a precise date for when they would become available. In other words, Jha appeared to know the FDA’s decision before it had allegedly made one.

Notably, President Joe Biden’s election campaign reversed a long-standing trend of Republican candidates receiving far more campaign donations from the pharmaceutical industry: In 2020, Biden outraised Trump from Big Pharma by a margin of 2 to 1. Several political appointees in the Biden administration, moreover, have ties to vaccine manufacturers, including the president’s chief campaign strategist, Anita Dunn, who worked for Pfizer before joining his team. Biden also ran his election campaign on the promise to “shut down the virus”; it turned out that there were more U.S. COVID deaths in 2021, when vaccines were widely available, than in 2020, when they were not. Rather than reckon with this fact and readjust its strategy, the administration has doubled down by putting increased political pressure on an already compromised FDA.

If your primary job occupation is to work for the firm across the table, how can you be an effective regulator?




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