CDC Pushed for COVID-19 Boosters Without Clinical Trials

Zachary Stieber

The U.S. Centers for Disease Control and Prevention (CDC) pressured U.S. regulators to clear COVID-19 boosters without clinical trial data, according to newly released emails. CDC officials relayed to counterparts at the Food and Drug Administration (FDA) in early August 2021 that they wanted authorization for Moderna and Pfizer boosters as data began showing that the vaccines weren’t working as well as initially promoted. The conversation took place on a call that was described by Dr. Phil Krause, a top FDA official, to several other FDA workers. “Take a deep breath before reading this next paragraph. On that call, the CDC evidently stated that they will assemble all the data they are aware of on third dosing in this setting and send it to us in the hope that we will (very soon) authorize the third dose for immunocompromised as part of the EUA,” Krause wrote in the Aug. 5, 2021, email (pdf). EUA stands for emergency use authorization..........To Read More.....

The Updated mRNA COVID Boosters Are a Bust, Two New Studies Show By Debra Heine - The new, heavily promoted mRNA booster shots from Pfizer and Moderna are not all they’re cracked up to be, according to two new preprint studies.  The boosters perform no better against Omicron than the fourth jab with the original formulation,” a new study from scientists at Columbia University in New York City found. The updated Covid-19 booster shots have been advertised as “bivalent,” meaning they target the original coronavirus strain as well as the Omicron BA.4/BA.5 subvariants.  However, the Columbia paper found that the newer Omicron variants easily evade both types of boosters, Alex Berenson reported on Substack................

Japanese Surgeon Calls for Suspension of COVID Boosters

By Jennifer Margulis and Joe Wang TIME August 3, 2022

In a letter to the peer-reviewed journal Virology, a Japanese cardiovascular surgeon, Dr. Kenji Yamamoto, has called for the discontinuation of COVID-19 booster shots. “As a safety measure, further booster vaccinations should be discontinued,” Yamamoto wrote. Among his urgent concerns are the fact that the COVID-19 vaccines have been linked to vaccine-induced immune thrombotic thrombocytopenia, which, in some cases, has been lethal to patients.

Yamamoto works at Okamura Memorial Hospital in Shizuoka, Japan. In the letter he explains that he and his colleagues have “encountered cases of infections that are difficult to control,” including some that occurred after open-heart surgery and were still not under control after several weeks of treatment with multiple antibiotics.  These patients, says Yamamoto, showed signs of being immunocompromised, and some of them died.  Yamamoto believes their suppressed immune function is likely to have been caused by COVID-19 vaccination............To Read More.....

Robin's Take - I don't know if concerns along these lines will eventually pan out or not - but there's so much solid research and other evidence pointing to serious problems this way that I think it's well worth noting, being concerned, and there darned well ought to be much more hard core research into these issues going on than there is.  The way the world has handled this pandemic and these vaccines is, unfortunately, deplorable and all too grossly politicized rather than being based on solid science and medicine.

Natural infection versus vaccination: Differences in COVID antibody responses emerge

August 24, 2021 Rockefeller University

This news story has been updated to reflect the publication of the study, previously available on BioRxiv, in a peer-reviewed journal.  

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Hope for a future without fear of COVID-19 comes down to circulating antibodies and memory B cells. Unlike circulating antibodies, which peak soon after vaccination or infection only to fade a few months later, memory B cells can stick around to prevent severe disease for decades. And they evolve over time, learning to produce successively more potent "memory antibodies" that are better at neutralizing the virus and more capable of adapting to variants.

Vaccination produces greater amounts of circulating antibodies than natural infection. But a new study suggests that not all memory B cells are created equal. While vaccination gives rise to memory B cells that evolve over a few weeks, natural infection births memory B cells that continue to evolve over several months, producing highly potent antibodies adept at eliminating even viral variants.

The findings highlight an advantage bestowed by natural infection rather than vaccination, but the authors caution that the benefits of stronger memory B cells do not outweigh the risk of disability and death from COVID-19.......Recent studies have suggested that within five months of receiving a vaccine or recovering from a natural infection, some of us no longer retain sufficient circulating antibodies to keep the novel coronavirus at bay, but our memory B cells stand vigilant. Until now, however, scientists did not know whether the vaccines could be expected to provide the sort of robust memory B cell response seen after natural infection................

Regardless of the cause, the implications are clear. We can expect memory B cells to undergo limited volleys of evolution in response to mRNA vaccines, a finding that may have significant implications for the design and rollout of booster shots. A booster with the currently available mRNA vaccine would be expected to engage memory cells to produce circulating antibodies that are strongly protective against the original virus and somewhat less so against the variants.............

 

FDA panel votes against approving COVID booster shots to general public

OAN Newsroom  Friday, September 17, 2021

A Food and Drug Administration (FDA) advisory committee halted the Biden administration’s push to administer booster shots for Pfizer’s COVID-19 vaccine. On Friday, an advisory panel to the FDA voted not to fully approve the booster shots for the Pfizer vaccine.

Only two committee members voted in favor of adding a jab, but the move was squashed by the remaining 16. The Biden administration initially wanted to get booster shots in the arms of Americans as soon as next week. However, the committee was hesitant to greenlight the added jabs, claiming Pfizer didn’t provide sufficient data showing booster shots were safe or necessary.

Although, the panel did vote unanimously to give the go ahead on the shots for Americans ages 65 and older. Additionally, those at higher risk of contracting COVID-19, including the immunocompromised, were also advised to get the booster.

The vote comes as two senior FDA officials stepped down at the beginning of the month over pressure by the White House to recommend a third injection of the vaccine.

In the meantime, the FDA has the final say as to whether to approve the booster and critics have said the advisory board’s decision shows Biden’s push to add a jab to Americans is out of tune with top health experts..........To Read More....

We Need Complete Transparency in Data on the Need for COVID Booster Shots

by Dr. Li-Meng Yan

As the Delta variant rages, the Biden Administration wants Americans to get a booster shot beginning September 20th. However, there is lingering doubt as CDC advisors called for more data to support the boosters. Compounding the uncertainty, two top FDA vaccine officials—Dr. Marion Gruber, Director, and Dr. Phil Krause, Deputy Director of the Office of Vaccines Research and Review—suddenly resigned.

“These sudden resignations and calls for more data are very troubling,” says Dr. Li-Meng Yan. “It’s very risky to issue a booster without the proper scientific understanding of the virus and its variants.”

The FDA and CDC still need to meet next week to approve the third dose, and even then there is confusion on who gets the shot. FDA’s scientific advisers will publicly debate Pfizer’s evidence on Sept. 17, just three days before the administration’s target. If the FDA approves another dose, then advisers to the Centers for Disease Control and Prevention will recommend who should get one, according to The Associated Press.

Dr. Janet Woodcock, the acting commissioner of the Food and Drug Administration, and Dr. Rochelle P. Walensky, who heads the Centers for Disease Control and Prevention, warned the White House on Thursday that their agencies may be able to determine in the coming weeks whether to recommend boosters only for recipients of the Pfizer-BioNTech vaccine — and possibly just some of them to start. Federal regulators warned on Thursday they may not have enough data to recommend boosters for anyone except certain recipients of the Pfizer vaccine by late September, reports the New York Times..............To Read More.....