BREAKING: FDA Advisory Committee Explains Reason They’ve Voted To NOT Recommend Approval of COVID Booster Shots

Posted by on September 18, 2021 3:03 am
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Categories: NATIONAL HEADLINES

Last week, we reported about two senior FDA officials Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, who announced they are leaving the FDA later this Fall over their disagreement with the Biden administration’s announcement about COVID booster shots.

Endpoints News, a biotech industry outlet, reported that Gruber and Krause were frustrated that the CDC was making decisions that should be made by the FDA. The final straw was reportedly the Biden administration’s announcement that COVID booster shots would be made available—before the FDA had finished evaluating data on the need for a third jab.

The resignation of the two senior officials at the FDA is a huge loss according to the FDA’s former acting chief scientist Luciana Borio:  “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service. These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave.” 

Now an international group of scientists, including the two senior FDA officials, are saying the COVID booster isn’t necessary.

The group’s opinion argued that COVID vaccines are effective enough to prevent severe disease, including the delta variant”

“Careful and public scrutiny of the evolving data will be needed to assure that decisions about boosting are informed by reliable science more than by politics. Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

The group warns:

“There could be risks if boosters are widely introduced too soon, or too frequently, especially with vaccines that can have immune-mediated side-effects (such as myocarditis, which is more common after the second dose of some mRNA vaccines,3 or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines4).”

Now, an independent panel at the U.S. Food and Drug Administration (FDA) has voted to recommend approval of booster doses for the Pfizer-BioNTech COVID-19 vaccine only for specific at-risk groups.

The Daily Mail reports – These groups include older adults above age 65 and those who are at an increased risk of developing a severe case of the virus.

It comes after a first vote Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 16-2 against boosters for those aged 16 and older and said there was not enough evidence that a third dose was safe and effective for use in all Americans.

The FDA is not bound to follow the advisory group’s recommendations but the agency rarely goes against the guidance of VRBPAC.

Pfizer had previously submitted data that the company claims show its vaccine’s efficacy falls by about six percent every two months following the second and final dose.

But many scientists, including senior officials at the FDA, disagree and argue that the vaccines are still highly effective at preventing severe illness and death.

Last month, boosters were approved for immunocompromised Americans who had received either the Pfizer or Moderna vaccine after data showed they were less likely to develop high antibody levels after two doses.

At least 2.04 million people in the U.S. have received booster doses as of Friday, according to data from the Centers for Disease Control and Prevention (CDC).

The White House also announced that booster shots would become available for all Americans starting on September 20 due to data suggesting waning efficacy of the initial shots.

During the VRBPC meeting, members pushed back against these data.

Dr Phil Krause, deputy director of the FDA’s Office of Vaccines Research and Review, said that Pfizer’s data had yet to be independently reviewed by experts.

‘One of the issues in this is that much of the data that’s been presented and being discussed today is not peer-reviewed and has not been reviewed by FDA,’ he said.

FDA and CDC officials have previously expressed to their doubts to the White House about the need for extra doses.

In a separate briefing document also published Wednesday, FDA scientists wrote with a skeptical tone about the need for booster shots.

‘Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,’ the scientists wrote.

They added that studies on booster doses have presented conflicting findings and that ‘known and unknown biases that can affect their reliability.’