According to an email sent by Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER), to staff members Tuesday, Dr. Marion Gruber, director of the FDA’s vaccines office, will quit at the end of October, and her deputy, Dr. Philip Krause, will leave in November.
Gruber and Krause were upset about the Biden administration’s recent announcement that adults should get a COVID booster eight months after they received a second shot, people familiar with the decision told The New York Times.
Neither believed there was enough data to justify offering booster shots yet, the sources said, and both viewed the announcement, amplified by President Biden, as pressure on the FDA to quickly authorize them.
Still, the White House has moved forward with its plan to make Americans eligible for a third dose of either Pfizer or Moderna’s vaccines eight months after the date of their second injection, even though that plan requires authorization from the FDA and CDC first.
“With 50% of its overall budget and 75% of its drug-testing budget coming from industry, the FDA long ago won its notoriety as the most corrupt and pliable of all federal agencies,” said Children’s Health Defense Chairman Robert F. Kennedy, Jr.
“Now, the White House has torn away its last shred of integrity by ordering top regulators to put politics before science.”
Kennedy said “it’s ironic” that Biden’s team is now “manhandling” the FDA in exactly the same manner they loudly condemned Trump when he pummeled the CDC into bypassing the process and evidence in order to rush out a mass vaccine drive, “with a partially tested product of dubious efficacy to serve political purposes.”
“Many, many, many” hospitals across the South have already begun administering third doses to their healthcare workers amid an explosion of COVID cases linked to the Delta variant, said Helen Keipp Talbot, an ACIP committee member and associate professor of medicine at Vanderbilt University.
“I think since it was given with a date, many assumed that it was given a blessing by the White House and this was the next step,” Talbot said, adding that those providers have “now put themselves at risk” by immunizing individuals outside FDA and CDC recommendations.2 Top FDA Vaccine Officials Resign, Raising Questions About Pressure From White House to Approve Boosters • Children’s Health Defense