Two senior FDA officials are in disagreement with the Biden administration over COVID booster shots. They plan on leaving the FDA later this Fall and announced their departure last month after reported frustration with the Biden administration.

Endpoints News, a biotech industry outlet, reported that Gruber and Krause were frustrated that the CDC was making decisions that should be made by the FDA. The final straw was reportedly the Biden administration’s announcement that COVID booster shots would be made available—before the FDA had finished evaluating data on the need for a third jab.

The resignation of the two senior officials at the FDA is a huge loss, according to the FDA’s former acting chief scientist Luciana Borio:  “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service. These two are the leaders for Biologic (vaccine) review in the US. They have a great team, but these two are the true leaders of CBER. A huge global loss if they both leave.” 

Now an international group of scientists, including the two senior FDA officials, are saying the COVID booster isn’t necessary.

The two FDA officials, Marion Gruber, director of the FDA’s Office of Vaccines Research and Review, and her deputy director, Phil Krause, published an opinion piece in The Lancet with other experts.

Marion Gruber and Phil Krause are pictured below:

 

The Hill reports that the two scientists are the most senior vaccine regulators at the agency and both helped review the COVID-19 vaccines. Gruber, who has spent 32 years at FDA, will leave at the end of October. Krause, who’s worked at FDA for more than a decade, will leave in November.

The group’s opinion argued that COVID vaccines are effective enough to prevent severe disease, including the 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. Widespread boosting should be undertaken only if there is clear evidence that it is appropriate.”

The group warns:

“There 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).”