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.