Senior FDA Officials Step Down Over Booster Dispute

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Two senior FDA officials unex­pectedly stepped down over what they viewed as interference from the White House, which announced a booster schedule before FDA approval has been secured. A CNN source de­scribed the White House’s actions as “prejudging what the FDA would say.”

White House COVID-19 Re­sponse Team coordinator Jeff Zients, attempting to deflect criticisms of ma­nipulation, said, “This is pending FDA conducting an independent evaluation and CDC’s panel of outside experts issuing a booster dose recommenda­tion.”
But the senior FDA officials who resigned stunned the world by co-au­thoring a critical study in one of the most prestigious science journals.

Dr. Marion Gruber, former direc­tor of the Office of Vaccines Research and Review at the FDA’s Center for Bi­ologics Evaluation and Research, and Dr. Philip Krause, deputy director of the office, authored a study with oth­ers to lay out their concerns in The Lancet on September 13. It reads, “[T]here could be risks if boosters are widely introduced too soon, or too frequently, especially with vac­cines that can have immune-mediat­ed side-effects (such as myocarditis, which is more common after the sec­ond dose of some mRNA vaccines,3 or Guillain-Barre syndrome, which has been associated with adenovi­rus-vectored COVID-19 vaccines4). If unnecessary boosting causes sig­nificant adverse reactions, there could be implications for vaccine ac­ceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

The risks are of a serious enough nature to deserve further careful study, they concluded.

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