June 11, 2024

COVID-19 vaccine boosters unnecessary for most, say FDA advisers reportedly resigning over issue

FDA’s Marion Gruber and Phil Krause argued current evidence doesn’t indicate a need for booster shots among most Americans

By Kayla Rivas | Fox News | September 13, 2021

Available evidence doesn’t yet indicate a need for COVID-19 vaccine booster shots among the general population, an international group of scientists said Monday, including two senior FDA officials reportedly stepping down from their posts over a disagreement with the White House on the administration of booster shots

Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, set to leave in October and November, published a viewpoint in The Lancet on Monday along with other experts worldwide, arguing that the COVID-19 vaccines remain effective in preventing severe disease, including against the highly transmissible and dominant 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,” authors wrote, adding in part: “Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

The comments come 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 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. 

Last month, the nation’s top health officials said the U.S. was prepared to begin offering COVID-19 vaccine booster shots to Americans beginning Sept. 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 other authors urged caution over drawing conclusions about vaccine efficacy from preliminary observational studies possibly affected by “confounding and selective reporting” to inform the country’s booster shot rollout. Vaccine supply should instead be allocated to unvaccinated populations to best reduce the risk of serious illness and emerging variants, they said.

Fox News’ Peter Aitken contributed to this report.

Kayla Rivas is a Health reporter and joined Fox News in April 2020.

Source: COVID-19 vaccine boosters unnecessary for most, say FDA advisers reportedly resigning over issue | Fox News