The House Oversight and Reform Committee is once again investigating the Biden White House seeking answers about its decision-making process surrounding COVID-19 booster shot guidance. The recent announcement of the probe follows an ignored prior request for information and documents related to allegations of improper political interference at the U.S. Food and Drug Administration (FDA) by the Biden administration.
A letter sent Jan. 19, 2022, by ranking member Rep. James Comer, R-KY, to Acting FDA Commissioner Dr. Janet Woodcock accuses the Biden administration—who has consistently pushed for boosters—of putting its preferred COVID-19 vaccination policy outcomes ahead of the scientific work at its agencies. According to Comer, the strategy amounts to inappropriate political influence. The letter to Dr. Woodcock explains:
“On Sept. 14, 2021, Select Subcommittee Ranking Member Scalise and I wrote to you requesting documents and information related to allegations of improper political interference at the U.S. Food and Drug Administration (FDA) by the Biden White House. Since that request, reports continue to surface, raising concerns about White House politicization of the FDA.
Recently, two former high-ranking FDA officials—including one that resigned because of the alleged political interference by the Biden Administration at the FDA—raised concerns about the agency bypassing the standard process for making decisions related to booster shots for Americans. If true, these shortcuts undermine the integrity of our public health system and cause vaccine hesitancy. The President has repeatedly demonized unvaccinated Americans, which is outrageous given these allegations. In addition to the prior questions and requests, we have new requests for information.”
— Rep. James Comer (@RepJamesComer) January 26, 2022
The Concerns & Resignation of Two Career FDA Vaccine Officials
Indeed, following the departure of the FDA’s two career vaccine officials, agencies in the Biden administration made the decision to authorize teenagers to receive a third COVID-19 booster shot. Marion Gruber and Phil Krause were essential participants in establishing the guidelines COVID-19 vaccine makers had to abide by to win emergency clearance for their shots. Shocking to many, the Biden FDA made the determination without convening a standard panel of outside scientific experts (the Panel). As the former FDA officials noted, deviating from the formal process sabotages our public health framework, and “although some may find it convenient to make policy without their [expert] input, the long-term consequences will hurt public health.”
In October 2020, Gruber, then director of the FDA’s Office of Vaccines Research and Review, expressed his concerns about “the risk that the use of a vaccine under an EUA would interfere with long-term assessment of safety and efficacy in ongoing trials and, potentially, even jeopardize product approval for not only the first vaccine but maybe even follow-on vaccines.” Notably, despite the fact that the EUA is the fastest route to get COVID-19 vaccines into the arms of Americans swiftly, these clinical trials (as well as the late-state tests run by others) are essential as they randomly assign participants to either receive the vaccine being studied or a placebo. That critical step in the protocol allows researchers to “conclusively determine a vaccine’s safety and effectiveness.”
"Current evidence does not…appear to show a need for boosting in the general population"
FDA's top two vaccine officials, Philip Krause and Marion Gruber. Both submitted resignations two weeks ago, reportedly over opposition to Biden ordering boosters.https://t.co/scKW98HPAg pic.twitter.com/6CE9VD5MWn
— Phil Kerpen (@kerpen) September 13, 2021
Further, Gruber and others were concerned about how an EUA would impact ongoing vaccine research. An EUA might also “ethically” obligate a vaccine developer (Pfizer, Moderna) to “unblind” the study and offer their vaccine to everyone. While the FDA stated a vaccine authorization is not “necessarily grounds to automatically unblind a placebo-controlled study,” Pfizer informed the FDA on Oct. 15, 2020, of its plans to do just that should its jab receive EUA. Doran Fink, Gruber’s then-deputy at the FDA, clarified further concerns held by several scientists, telling advisors at a meeting on Oct. 22, 2020:
“Once a decision is made to unblind an ongoing placebo-controlled trial, that decision cannot be walked back, and that controlled follow-up is lost forever.”
Biden is asked if the new CDC mask guidance will sow confusion:
"We have a pandemic, because of the unvaccinated and they're sowing enormous confusion… If those other 100 million got vaccinated, we'd be in a very different world." pic.twitter.com/cro35jwyd4
— Daily Caller (@DailyCaller) July 27, 2021
The Biden FDA Made Key Vaccine Decisions Without Consulting Panel
As pointed out in Comer’s letter, Joe Biden’s FDA has previously made three critical vaccination-related decisions without consulting the expert Panel. He repeated this action recently “while authorizing booster shots for all children 12 to 15 years of age.” The letter points out, “This is a deviation from the standard practice and is likely a result of ongoing scientific disagreement on the necessity of booster shots.” Furthermore, Comer remarks Biden’s agencies preempted the FDA and the CDC in their announcements of boosters for all adults. Comer explained:
“When the Panel was convened, there was significant dissension among the experts regarding whether booster shots were advisable for all Americans over the age of 18. Also, in September 2021, the Panel rejected, by a vote of 16 to 2, boosters for teens. Since then, the data have not changed. Teens remain at low risk of serious illness.
To achieve the White House’s desired outcome this time around, the FDA dispensed with convening the Panel when it made the Dec. 9, 2021, decision to allow boosters for ages 16 and 17, and the Jan. 3, 2022, decision to allow boosters for ages 12-15.10 The Panel was not going to do the White House’s bidding so instead of engaging in a robust scientific dialogue, the Biden Administration made the calculated political decision to entirely cast aside the Panel. This has become a pattern with the Biden Administration—the Administration that repeatedly promised to follow the science.”
It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board… FDA is quietly doing this because their experts previously voted it down, voicing concerns about medical harms. @POTUS @DrWoodcockFDAhttps://t.co/tFk3jRkzg5
— Marty Makary MD, MPH (@MartyMakary) January 2, 2022
Undoubtedly, Comer maintains the Biden White House and the agencies it controls “have pushed forward without following the normal course.” The letter highlights observations made on Jan. 10, 2021, by Dr. Marty Makary that further emphasized ongoing vaccine transparency concerns. According to Makary, “the CDC informed its Advisory Committee on Immunization Practices members that because it asked for 24 days of their time last year, the CDC will do most of the work internally.” Calling out the agency for its alleged misgivings, a frustrated Comer wrote:
“The agency claims to be looking for a ‘feasible and sustainable’ approach to meetings. Of course, this is a red herring since zoom has become ubiquitous through the course of the ongoing pandemic. Instead of being thorough and transparent, this Administration is shortcutting the standard vaccine recommendation process, and in lieu, Dr. Walensky is determining, ‘what we thought people would be able to tolerate.’“
Comer’s Request for Initial & New Documents and Information
Stressing the obligation by the Committee on Oversight and Reform to “understand whether there is a valid reason the Biden Administration is circumventing the standard vaccine recommendation process,” Comer reiterated to Woodcock his prior requests and added new ones. He asks for the following information (from period Jan. 21, 2021, to present, unless noted) as soon as possible but no later than Feb. 2, 2022:
All documents and communications relating to the study and implementation of a booster shot option for mRNA vaccine recipients.
All documents and communications between the FDA and the White House relating to booster shots.
All documents and communications related to President Biden’s Aug. 18, 2021, announcement that booster shots would be available for Americans beginning Sept. 20, 2021.
All documents and communications relating to any effort by political appointees or White House personnel to review, revise, edit, delay, or prohibit publication of information related to booster shots.
All documents and communications related to the departure of FDA scientist Marion Gruber.
All documents and communications related to the departure of FDA scientist Phil Krause.
All documents and communications relating to any adverse employment action taken or considered against any employee, official, or contractor of the federal government for actions taken in the course of their employment related to the science of Americans receiving booster shots.
All documents and communications between or among employees at the White House, FDA, and/or CDC referring or relating to the decision not to convene additional meetings of the Vaccines and Related Biological Products Advisory Committee after Sept. 17, 2021.
All documents and communications between or among FDA employees and experts on the Vaccines and Related Biological Products Advisory Committee since Sept. 17, 2021.
All documents and communications between any FDA employee and Dr. David Kessler at the White House.
There Must Be a Trustworthy Process Behind Forced Vaccines
It is worth noting that, despite Biden’s recent creation of a Scientific Integrity Task Force designed to ensure “a trustworthy science system to serve the American people,” many current and former employees assert “the administration is flouting civil service protections—and its own promises.” Also underwhelmed is PEERS executive director Tim Whitehouse, who remarked, “The [Office of Science and Technology Policy] report lacks specificity, all but ensuring the Biden administration will fall short on its effort to strengthen federal scientific integrity policies.”
In the noticeable absence of a trustworthy system to serve the American people, Comer—who is also pressing the FDA for answers explaining the delays for alternative COVID-19 treatments—emphasized the critical need to understand and investigate the steps behind the evolution of Biden’s mass vaccination campaign. He reminded Woodcock that the Committee on Oversight and Reform is the principal oversight committee of the U.S. House of Representatives and has broad authority to investigate “any matter” at “any time.”
Additionally, Comer emphasized that the Select Subcommittee on the Coronavirus Crisis is empowered to scrutinize “preparedness for and response to the coronavirus crisis, including the planning for and implementation of testing, containment, mitigation, and surveillance activities.” Recapping the President’s ongoing mandatory “vaccine” narrative, Comer’s letter spotlighted Biden’s persistent mischaracterization of the pandemic. He wrote:
“President Biden has called the ongoing pandemic, ‘a pandemic of the unvaccinated’ and intimated that those who are not vaccinated are unpatriotic. Instead of playing the blame game, President Biden should ensure the federal government is not cutting corners in the vaccine recommendations process.”