FDA Officials That Are Now Resigning Due To Issue, Say Booster Shot Is Not Necessary
As of Monday, available evidence did not support the use of COVID-19 vaccine booster shots in the general population, according to an international group of scientists, including two senior FDA officials who resigned from their positions following a disagreement with the White House over the administration of booster shots.
Marion Gruber, director of the Food and Drug Administration’s Office of Vaccine Research and Review, and her deputy director, Phil Krause, who are both scheduled to retire in October and November, published a viewpoint in The Lancet on Monday with other experts from around the world arguing that the COVID-19 vaccines are still effective in preventing severe disease, including against the highly transmissible and dominant delta variant of the virus.
Authors stated that “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,” and that “Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”
After Dr. Janet Woodcock, acting commissioner of the FDA, and Dr. Rochelle Walensky, director of the Centers for Disease Control and Prevention, recently advised the White House that regulators require additional time to review necessary data before approving a COVID-19 booster shot plan, the White House expressed concern about the comments. It has been recommended by both the FDA and the Centers for Disease Control and Prevention that certain people who got the Pfizer vaccine should get a booster injection.
Last month, the nation’s top health authorities said that the United States was preparing to begin giving COVID-19 vaccine booster injections to Americans on September 20, pending approval by the Food and Drug Administration. In that statement, which was attributed to Walensky and Woodcock, as well as U.S. Surgeon General Dr. Vivek Murthy, National Institutes of Health Director Dr. Francis Collins, President Biden’s chief medical advisor Dr. Anthony Fauci, and others, had stated that existing information indicated protection starts to die down over time, and “could diminish in the months ahead, especially among those who are higher risk or were vaccinated during the earlier phases of the vaccination rollout.”
In order to guide the country’s booster shot rollout, Gruber, Krause, and other authors cautioned against making conclusions about vaccination effectiveness from early observational studies that may have been influenced by “confounding and selective reporting,” among other things. They advocated for allocating vaccine supplies to unvaccinated people in order to minimize the danger of severe disease and the emergence of new variations as much as possible.
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