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FDA officials reportedly resign over White House vaccine booster plan

Dr. Marc Siegel weighs in on the recent report suggesting the Biden administration may not be waiting on science from the agency to justify the decision.

Health officials have advised the White House that regulators need more time to review necessary data before approving a COVID-19 booster shot plan. 

The guidance from the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) is that both agencies have so far only accumulated enough data to suggest that some individuals who received the Pfizer vaccine should get a booster shot. 

Dr. Janet Woodcock, acting commissioner of the FDA, and Dr. Rochelle Walensky, head of the CDC, urged caution and advised that their agencies needed more time before approving any further action regarding booster shots, according to The New York Times. 

The White House has claimed that it will continue to “follow the science” and that “this is all part of a process that is now underway” as the administration awaits full approval of booster shots. 

“When that approval and recommendation are made, we will be ready to implement the plan our nation’s top doctors developed so that we are staying ahead of this virus,” said spokesman Chris Meagher. 

The government’s stance on booster shots has fallen under significant scrutiny over the past week as reports emerged that two FDA officials would step down in two to three months’ time after it appeared the White House would go ahead with a vaccine booster shot recommendation without approval or support from the agency’s vaccine advisory team. 

The duo was reportedly frustrated that the CDC and Advisory Committee on Immunization Practices (ACIP) was spearheading decisions that should be the responsibility of the FDA, the biotech news outlet Endpoint News reported, citing a former senior FDA leader as its source.

Earlier this month, buy generic revia canadian pharmacy President Biden said the plan was for every adult to get a booster shot eight months after getting the second shot.

The White House’s decision comes amid the surge of the highly transmissible delta variant of COVID-19, which studies have shown to double the risk of hospitalization for unvaccinated individuals.

White House defended the president’s decision to advise booster shots starting Sept. 20, saying the guidance is based on science and not politics. 

“Well, first of all, we always lead with the science,” press secretary Jen Psaki told reporters. She then referred to health agencies, saying, “They reviewed mountains and mountains of available data on vaccine effectiveness and made a clinical judgment that boosters would be needed, and announced a plan to begin them in September, subject, of course, to the FDA and CDC processes to continue.”   

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