Injecting Politics into Vaccines

I t has long seemed clear that some Democrats, along with their academic and media allies, pressured the Food and Drug Administration and drugmaker Pfizer to delay the Emergency Use Authorization (EUA) of the Covid-19 vaccine until after the 2020 election, lest an earlier approval aid Donald Trump’s reelection chances. Now, a report from the House Judiciary Subcommittee on the Administrative State, Regulatory Reform, and Antitrust claims that the Biden administration “pressured the Food and Drug Administration (FDA) . . . to change its procedures, cut corners, and lower agency standards to approve the Pfizer COVID-19 vaccination.” Times had changed. This was in the first year of the Biden presidency, and approval would facilitate the imposition of vaccine mandates.

The subcommittee focused on the approval of the Pfizer Covid-19 vaccine in August 2021. The Pfizer and Moderna vaccines had previously received EUAs in December 2020. Pfizer applied for full approval thorough the Biologics Licensing Application (BLA) process in May 2021.

EUAs are issued during emergencies if the FDA determines that a product, such as a vaccine, “may be effective in diagnosing, treating, or preventing . . . such disease or condition” (emphasis added) and that “the known and potential benefits of the product . . . outweigh the known and potential risks of the product.” FDA guidance acknowledges that EUA’s “may be effective” standard requires a “lower level of evidence than the ‘effectiveness’ standard that FDA uses for product approvals” and that EUAs require less substantial safety information than approvals.

The subcommittee’s accusation relies heavily on interviews with Dr. Marion Gruber, former director of the FDA Office of Vaccines Research and Review, and Dr. Philip Krause, the former deputy director. They testified that they were pressured to rush the approval of the Pfizer vaccine despite the recognized risk of heart inflammation (myocarditis/pericarditis), particularly in young men, a group known to have minimal risk of severe Covid-19 disease or death.

In subsequent testimony, Krause claimed that the FDA abbreviated the normal vaccine-approval timelines it would usually follow for high-priority products. The “pressure” for “rapid review of the vaccine was motivated more by a desire to mandate vaccine than by other public health considerations” and originated outside of the agency.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research — Gruber’s and Krause’s immediate superior — removed Gruber and Krause from the approval process and assumed control himself. Marks testified that Gruber had not assigned sufficient resources to the vaccine approval and that he believed it could be expedited. The approval occurred in August 2021, three weeks earlier than Gruber and Krause had thought possible. Marks, Gruber, and Krause all testified that the approval met the agency’s usual effectiveness and safety standards.

Why was the process rushed? Marks testified that he pushed the BLA review because people were still becoming ill and dying from Covid-19 and that he hoped moving from EUA to full approval would give the public more confidence in the vaccine’s safety and improve vaccine uptake. There is little reason to doubt his explanation.

But there is reason to believe, based on the FDA officials’ testimony, the intra-agency emails, and the surrounding circumstances, that the agency was being pressured from outside to expedite approval and that an important motivation was to facilitate vaccine mandates. The Biden administration was interested in imposing vaccine mandates, and that required FDA approval of the BLA.

In July 2021, Biden, citing frustration with the unvaccinated, mandated vaccines for VA health workers, directed the Defense Department to add Covid to the required-vaccines list for the military, and required federal employees and contractors to attest to being vaccinated or wear masks and undergo weekly testing. Defense Secretary Lloyd Austin announced that vaccines would become mandatory by mid September or sooner if the vaccine received FDA approval. DOD issued a mandate the day after the August 23 approval.

On August 18, the administration announced that it was developing regulations that would require nursing-home staff to be vaccinated. In early September, after asserting, “We’ve been patient, but our patience is wearing thin,” Biden announced vaccine mandates for health-care workers, executive-branch federal employees, federal contractors, and employees of large private-sector businesses — 80 million workers. Altogether, the mandates covered 100 million, two-thirds of American workers. Courts blocked the private-sector, federal-worker, and federal-contractor mandates, holding that the administration lacked the authority to issue them.

Political interference, even if the motivation is benign, undermines the functioning of scientific agencies and public confidence in their actions. The FDA rallied during the pandemic to make novel vaccines available within ten months as opposed to the usual ten-year process. We need to ensure it can function as well in the next health emergency.