Top FDA vaccine regulators rush after exits, resign positions while Biden jumps gun on booster stick

Two senior FDA vaccine officials have stopped and raised eyebrows about the agency’s future. In addition to failing to appoint an FDA commissioner seven months into his tenure, Biden promoted a booster shot without the agency’s review.

Two of the top executives involved in vaccine research and testing at the Food and Drug Administration are leaving the agency, according to a Tuesday letter from Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research. Marion Gruber and Phil Krause were the Director and Deputy Director of the Agency’s Office of Vaccines Research & Review, respectively.

A 32-year-old FDA veteran is leaving the agency because of WH political strongmen arming their decision-making. If this does not raise red flags among some of you, nothing will. https://t.co/om5VcnpxhC

- Jordan Schachtel @ dossier.substack.com (@JordanSchachtel) August 31, 2021

Although there was no official reason for their departure, a former FDA bigwig told biotech outlet Endpoints that the couple complained that the CDC and specifically its Advisory Committee on Immunization (ACIP) had taken the right to make decisions that had previously been left up to the FDA. The researchers were also reportedly upset by Marks for not standing up for them against the CDC. The Biden administration’s decision to announce a third round of mRNA “Booster” shots without consulting them was just the last straw.

After finally providing its evidence for the Pfizer BioNTech vaccine eight months after it was approved in an emergency, the FDA indicated last week that it would make a boost shot of the mRNA-based drugs available on September 20. to those who had received their second dose eight months before.

Gruber spent over 30 years with the agency and plans to retire in late October, while Krause has worked for the FDA for over a decade. Despite the departure of the top two officials in her vaccine division, FDA spokeswoman Stephanie Caccomo insisted in a announcement emailed that the agency remained “Assured of the expertise and ability of our staff to continue our critical public health work, including the evaluation of COVID-19 vaccines." The agency is about to be closely monitored as Americans await permission to vaccinate their children under the age of 12 who remain outside the age group for existing provocateurs.

Despite the FDA and CDC’s joint announcement last week promising a third shot for those in need of an mRNA booster, the FDA’s seal for proval was shown to have been affixed prematurely. In a presentation on Monday, ACIP called for a more targeted and cautious approach to the booster, arguing that fully vaccinated individuals remained protected from “The most serious disease” indicates that there was little data to show the usefulness of booster shots in the general population. Instead, the committee suggested that medical authorities focus on vaccinating those who had not yet received the shot - including people in countries where the vaccine is scarce.

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