Two senior officials of the U.S. Food and Drug Administration (FDA) have stepped down from the COVID vaccine review team at a critical time in the approval process. While the FDA did not cite a specific reason for the departure of two veteran officials, Endpoints News reports that widespread frustration in the regulatory agency began with the U.S. Centers for Disease Control and Prevention (CDC) and its advisory committee’s involvement in FDA responsibilities.
Marion Gruber, PhD and Phil Krause, MD made the “final straw” decision to officially resign over the White House’s decision to publicly recommend the administration of Pfizer COVID-19 booster shots ahead of the FDA’s formal scientific review of booster shot data1—an action that has brought internal friction and turmoil within the regulatory agency.2
Dr. Gruber has been employed by the FDA for 32 years and has served as director of the FDA’s Office of Vaccines Research and Review (OVRR). Dr. Krause has worked with the FDA for over a decade and serves as OVRR Deputy Director. Both officials will leave the agency in October and November, respectively. As officials with the OVRR, both Gruber and Krause were responsible for reviewing vaccine applications, along with their team of scientists. Former FDA chief scientist Luciana Borio, MD said that the FDA was losing “two giants” in the field.1
Political Pressure on the FDA Interferes with the Agency’s Scientific Expertise and Regulatory Responsibilities
Since taking office in January, President Biden has made it a point to state he would not interfere with the work of the FDA.3 White House officials have defended the President’s plan to roll out booster shots ahead of the FDA staff’s review of the data on booster shot safety and efficacy, stating that the plan was endorsed by several federal health officials including Acting FDA Commissioner Janet Woodcock, MD.
Administration officials have stated that a booster is “urgent in light of growing evidence that the vaccines lose potency over time” reports The New York Times.3 Politico reports that health officials were frustrated by the White House’s interference with the process and that the decision sparked “fear that political pressures will once again override the agency’s expertise.”2
International Researchers Concerned that Booster Recommendations May Increase Side Effects, Vaccine Hesitancy
Drs. Krause and Gruber have not responded to media inquiries regarding their decision to suddenly leave the FDA. However, following announcement of their departure, Krause and Gruber along with 16 other international researchers published an article in The Lancet4 concluding that the evidence shows the average fully vaccinated person does not need a COVID vaccine booster at this time. The article states:
Although the benefits of primary COVID-19 vaccination clearly outweigh the risks, 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…or Guillain-Barre syndrome). If unnecessary boosting causes significant adverse reactions, there could be implications for vaccine acceptance that go beyond COVID-19 vaccines. Thus, widespread boosting should be undertaken only if there is clear evidence that it is appropriate.4
FDA Votes Against Biden’s Vaccine Booster Plan
While the political pressure to push booster shots is in large part due to increased SARS-CoV-2 Delta variant infections, Pfizer’s data on immune responses to the Delta variant was only measured in a study with two dozen participants, according to the FDA’s analysis.5 The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), which met on Sept. 17, 2021, voted against the Biden plan to roll out booster shots for ages 16 and over. Instead, the FDA’s advisory committee endorsed boosters only for individuals ages 65 and older or those who are considered high risk. It is not yet clear who qualifies as high risk under the advisory committee’s decision, but further clarification is expected to be given soon.6
Since President Biden’s Aug. 18, 2021 announcement that booster shots would be available to the general public by Sept. 20, CDC data shows that 955,000 Americans have received additional vaccine doses despite the FDA endorsing the boosters only for certain populations.7
Politico reports that the administration’s decision to announce boosters for all adults “has created an awkward situation for federal regulators, who are now left to chart a path forward despite limited, and sometimes confusing, data on vaccines’ effectiveness over time.”7
CDC Advisers “Perplexed” by Booster Rationale
CDC advisers opened a two-day meeting this week regarding the booster shot recommendations. According to AP News, some CDC experts were so perplexed by the rationale for boosters that they suggested putting off the decision until more science is available. AP News states:
The uncertainties were yet another reminder that the science surrounding boosters is more complicated than the Biden administration suggested when the president and his top aides rolled out their plan at the White House last month.8
Several FDA Officials Step Down due to Controversial Alzheimers Drug Approval Earlier This Year
Earlier this year, three other FDA officials stepped down following the controversial approval of an Alzheimer’s drug known as Biogen—an approval one Harvard Medical School professor called “the worst drug approval decision in recent U.S. history.”9 Harvard Medical School professor Aaron Kesselheim, MD, PhD stated that it was clear to him that the FDA is no longer “capable of adequately integrating VRBPAC’s scientific recommendations into its approval decisions” and that the decision will undermine the public’s trust.9
Market Watch reports that regardless of whether or not Pfizer and Moderna COVID booster shots are approved by the FDA for all age groups, sales agreements between the two companies and the U.S. government have already factored in the initial primary two-dose series together with the booster shots. Pfizer is expected to generate $9.6 billion in sales in the third and fourth quarter of the year for a total of $32.8 billion in COVID-19 vaccine sales for 2021.10
“Science by Press Release” Scrutinized by Experts
On Sept. 21, Johnson & Johnson announced via press release that second doses of its COVID vaccine provided 94 percent protection against asymptomatic COVID-19 disease.11 Pfizer also announced the previous day that researchers found an effective and safe COVID-19 vaccine dose for children ages 5-11. However, the data for either claim has not yet been reviewed by the FDA.
Many scientists are scrutinizing “science by press release” and worry about the public’s expectations for vaccines following news reports. In reality, those press releases mean nothing in terms of affecting the FDA’s decision to give approval.
White House Booster Announcement Placed Pressure on FDA
John P. Moore, PhD, a virologist at Weill Cornell Medicine, stated that White House officials were under pressure after President Biden’s Aug. 18, 2021 announcement that boosters would be readily available soon. Moore stated:
Weeks ago, the administration decided that the public needs cake and deserves cake, and so shall have cake. Now, the public expects cake and would be very annoyed if its cake was taken away at this point.5
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1 Brennan Z. In a major blow to vaccine efforts, senior FDA leaders stepping down. Endpoint News Aug. 31, 2021.
2 Owemohle S. Biden’s top-down booster plan sparks anger at the FDA. Politico Aug. 31, 2021.
3 Weiland, N. & LaFraniere, S. Two top FDA vaccine regulators are set to depart during a crucial period. The New York Times Aug. 31, 2021.
4 Krause P, et al. Considerations in boosting COVID-19 vaccine immune responses. The Lancet Sept. 13, 2021.
5 LaFraniere S, Weiland N. U.S.booster policy is in flux as studies add to dissent. The New York Times Sept. 15, 2021.
6 Feldman L. Here’s what’s next for COVID vaccine booster shots. Yahoo! News Sept. 21, 2021.
7 Gardner L. CDC vaccine panel: Let regulators lead on COVID-19 booster shots. Politico Aug. 30, 2021.
8 Perrone M, Neergaard L, Stobbe M. FDA backs Pfizer COVID-19 boosters for seniors, high risk. AP News Sept. 22, 2021.
9 Lovelace B. Third member of prestigious FDA panel resigns over approval of Biogen’s Alzehimer’s drug. CNBC June 10, 2021.
10 Lee J. Whether the FDA approved a COVID-19 booster shot or not, Pfizer and Moderna have already made their money. Market Watch Sept. 22, 2021.
11 Howell T. ‘Jack up the stock’: vaccine profit PR flusters scientists, inflates public expectations. The Washington Times Sept. 21, 2021.