Abrupt FDA Resignations in Office of Vaccines Research & Review

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September 20, 2021

Timeline of Recent Events

On August 18, 2021, Joe Biden announced from the Whitehouse they would begin offering Pfizer or Moderna mRNA vaccine boosters for all on September 20, 2021 or eight months after an individual’s second dose.

On August 31, 2021, two top FDA vaccine officials resigned. The Director of the Office of Vaccines Research, Dr. Marion Gruber, PhD and Deputy Director of FDA’s Center for Biologics Evaluation and Research, Phillip Krause, MD will depart no later than November. These losses are another significant setback for the federal agency as no permanent leader has yet been hired.

According to Endpoint News, FDA past chief scientist Luciana Borio tweeted, “FDA is losing two giants who helped bring us many safe and effective vaccines over decades of public service”.

Former whistle bower Rick Bright, head of the Biomedical Advanced Research and Development Authority (BARDA) that resigned during the Trump administration after raising concerns about the ignoring of scientific expertise, overruling public health guidance and disrespect of career scientists during the COVID-19 response. Bright stated, “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 adding, “Dr. Gruber is much more than the Director. She is a global leader. Visionary mastermind behind global clinical regulatory science for flu, Ebola, Mers, Zika, Sars-cov-2, many others.”

Endpoints News reported further, “A former senior FDA leader told Endpoints that they’re departing because they’re frustrated that CDC and their ACIP committee are involved in decisions that they think should be up to the FDA. The former FDA’er also said he’s heard they’re upset with CBER director Peter Marks for not insisting that those decisions should be kept inside FDA. What finally did it for them was the White House getting ahead of FDA on booster shots.”

On September 9, 2021, Biden identified new federal vaccine requirements for 100 million American workers in the private sector, health care and federal contactors. He sharply criticized the tens of millions of unvaccinated Americans stating, “We’ve been patient. But our patience is wearing thin and your refusal has cost all of us.” He further accused the unvaccinated “of causing a lot of damage.”

On September 13, 2021, the British medical journal Lancet Viewpoint published “Considerations in boosting COVID-19 vaccine immune responses” with Gruber and Krause as well as sixteen other noted experts which may be viewed below.

Considerations in boosting COVID-19 vaccine immune responses strongly warns against vaccine boosters writing “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, or Guillain-Barre syndrome, which has been associated with adenovirus-vectored COVID-19 vaccines.”

Jeffery Tucker on September 14, 2021 writing for the Brownstone Institute states, “It’s about more than the boosters. It’s about the whole experience of taking away the control of health management from individuals and medical professionals and handing it over to modelers and government officials with coercive power”.

On September 17, 2021, the FDA Vaccine Advisory Committee met to discuss authorizing a third Pfizer booster shot . The committee voted 16 to 2 AGAINST approving the booster shots but did give approval for people 65 and older.