Senior FDA leaders stepping down

Two senior officials have resigned from their positions within the US Food and Drug Administration (FDA) over frustrations with the current administration’s plans to move forward with COVID-19 booster shots without their prior approval, according to a report.

32-year veteran of the agency Marion Gruber, director of the FDA’s Office of Vaccines Research & Review (OVRR), will leave at the end of October. OVRR deputy director Phil Krause, who’s been at the FDA for more than a decade, will leave in November. The news is a massive blow to confidence in the agency’s ability to regulate vaccines.

The bombshell announcement comes at a particularly crucial moment, as boosters and children’s shots are being weighed by the regulator. The departures also come as the administration has recently jumped ahead of the FDA’s reviews of booster shots, announcing that they might be available by the week of 20 Sept.

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

Kayla RivasBy Kayla Rivas

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.

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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.

Or, less politely, cherry picking data to further the agenda.

Fox News.com

Category: Biden, Usual Suspects