Even more shocking than the title of this article, is the salient fact that next to no media sources are reporting it. That is, after pressure from both the White House and Pfizer, 2 senior officials at the FDA in charge of vaccine approval, Drs. Marion Gruber, and Philip Krause have resigned. The reason, they claimed both the White House and Pfizer were putting unjust pressure on them for quick approval of boosters with no supporting data to justify such a massive public health policy change.
In this publication you will learn 2 things:
The chronological sequence of events that transpired, ultimately leading to the resignation of both Drs. Gruber and Krause, and approval of a Pfizer booster dose for all 18+
Why this is bad for public health policy
โ Chronological sequence of events
In April of 2021, CEO of Pfizer Albert Bourla released multiple public statements that boosters will be needed within 12 months
Almost immediately after Albert Bourlaโs statement about boosters, the CDC, FDA, and many public health officials like and Dr. Anthony Fauci, grilled Pfizer on their statement. Most agreed, the data didnโt support Pfizerโs booster recommendation.
In Early July of 2021, Pfizer announced their plan to submit a request for emergency use authorization for boosters during August.
In August of 2021, Pfizer held a meeting with U.S. senior scientists from the White House, and regulators, to press their case for boosters. After that, the narrative began to change.
On August 18th after meeting with White House U.S. science officials, and regulators, the Biden administration announced the rollout of boosters beginning September 20th 2021, based on scant evidence provided by Pfizer.
On September 1st 2021, the FDA announced the resignations of Dr. Marion Gruber and Dr. Philip Krause. That as a result of pressure from the Biden media campaign to approve boosters by then end of the month. Both doctors claimed that political pressure to approve boosters by the end of the month was coercive. Moreover, given the time restriction coupled with political drive, the doctors explained an impartial judgement about boosters couldnโt be made. It is important to note, Dr. Philip Krause would leave the FDA on October 31st 2021, and Dr. Marion Gruber would leave by November 2021.
On September 13th, Marion Gruber and Philip Krause published a peer reviewed article in The Lancet medical journal presenting data against Biden and Pfizerโs booster plan. Considering the data, health officials then advised the White House to scale back their boosters for all campaign.
On September 17th 2021, the FDA panel voted against Pfizers broad EUA booster request and suggested something more targeted.
On, September 22nd 2021, The FDA website listed approval of Pfizer boosters for those 65+ and at high risk. Next, consult from the CDC would be needed.
On November 12th 2021, Reuters reported that the CDC will likely bypass input from two key FDA vaccine approval officials Drs. Marion Gruber and Philip Krause regarding Pfizerโs EUA request. Following that, On November 19th 2021, CDC announced boosters FOR ALL 18+ bypassing input from Marion Gruber and Philip Krause.
Marion Gruber and Philip Krause officially leave the FDA after following Pfizer booster vote
As a final cry to the public regarding the poor health policy just approved by both the CDC and FDA (boosters for all 18+), Drs. Marion Gruber and Philip Krause released an op-ed through the Washington Post that explained how the new policy goes against the science.
โ Why is this bad for public health policy?
You see, thereโs an evidence based vetting process that a prospective public health policy involving a drug needs to go through in order to gain EUA (emergency use authorization) or for guidance on that drug/vaccine to be amended. Essentially, many proposed health policy changes, or products are reviewed and rigorously debated by many medically minded individuals at the FDA and CDC. So, if the data looks good and most parties agree, that policy, guidance, or drug/vaccine gets approved/amended. On the other hand, if the prospective policy, guidance or drug/vaccine is lacking evidence to back up its efficacy, it is then denied EUA approval or amending. The point is, ALL appropriate officials need to be involved in the previously mentioned decision making process, theyโre not supposed to be excluded. So how come guidance from 2 key vaccine approval officials was ignored during the final analysis of the newly proposed booster policy, and also overrode by the CDC director Michelle Walensky who conversely expanded the booster policy TO ALL ALL 18+ INSTEAD OF THE RECOMMENDED 65+ AND HIGH RISK INDIVIDUALS? Of course that question is rhetorical and the implication speaks for itself. Be that as it may, anyone reading this should ask themselves the following question. Who regulates the regulators?
LETS CONNECT:
This year in retrospective: A never-ending train wreck in slow motion.
Did the two folks comment about the recent ... whimsical? ... approval of boosters for the 16-17 age group?