At the end of August, Charliekirk.com reported two of the Food and Drug Administration’s “most senior vaccine leaders” were resigning from their posts due to disagreements with the Biden administration, particularly over booster shots. Marion Gruber, director of the FDA’s Office of Vaccines Research & Review, as well as deputy director Phil Krause, stepped down from their positions reportedly due to the “White House getting ahead of FDA on booster shots.” Gruber and Krause are set to leave the FDA in October and November.
On Monday, Gruber and Krause joined experts worldwide in publishing a viewpoint piece in The Lancet. The paper argues that the COVID-19 vaccines remain effective in preventing severe illness, including against highly transmissible and dominant delta variants.
“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,” the authors wrote. “Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”
The authors urged caution over preliminary studies possibly affected by “confounding and selective reporting” which could draw conclusions about vaccine efficacy in an attempt to aid in the rollout of booster shots.
Fox News reports 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 need more time to review necessary data before approving a COVID-19 booster shot plan.
“The guidance from the FDA and 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” adds Fox News.
Last month, top U.S. health officials stated booster shots could be available as early as September 20, pending FDA review. “That statement, attributed to Walensky Woodcock, U.S. Surgeon General Dr. Vivek Murthy, NIH Director Dr. Francis Collins, President Biden’s chief medical advisor Dr. Anthony Fauci and others, had said available data indicated protection begins to wane 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.”
Gruber, Krause and the other authors who urged caution on “selective reporting” to draw efficacy conclusions, say vaccine supply should instead be allocated to unvaccinated populations to best reduce the risk of serious illness and emerging variants.