Report Shows Politics Trumped Science on U.S. Vaccine Mandates

“After Action Review of the COVID-19 Pandemic: The Lessons Learned and a Path Forward” praised the Trump administration’s efforts to speed up vaccine development. By contrast, the report said presidential candidate Joe Biden and vice-presidential candidate Kamala Harris undermined public confidence.

“[W]hy do we think the public is gonna line up to be willing to take the injection?” Joe Biden asked on September 5, 2020. This quote appeared in a Politico article titled “Harris says she wouldn’t trust Trump on any vaccine released before [the] election.”

The House report noted, “These irresponsible statements eventually proved to be outright hypocrisy less than a year later when the Biden-Harris Administration began to boldly decry all individuals who decided to forgo COVID-19 vaccinations for personal, religious, or medical reasons.”

Millions of doses of COVID-19 vaccines were administered beginning in December 2020 under an Emergency Use Authorization. This mechanism allows unapproved medical products to be used in emergency situations under certain criteria, including that there are no alternatives. The only previous EUA was for the 2004 anthrax vaccine, which was only administered to a narrow group of people.

By the time vaccines rolled out, SARS-CoV-2 had already infected 91 million Americans. The original SARS virus some 15 years prior showed that people who recovered had lasting immunity. Later, a January 2021 study of 200 participants by the La Jolla Institute of Immunology found 95 per cent of people who had contracted SARS-CoV-2 (the virus behind COVID-19) had lasting immune responses. A February 16, 2023 article by Caroline Stein in The Lancet (updated March 11, 2023) showed that contracting COVID-19 provided an immune response that was as good or better than two COVID-19 shots.

Correspondence suggests that part of the motivation for full (and not just emergency) vaccine approval was to facilitate vaccine mandates. A July 21, 2021, email from Dr. Marion Gruber, then director of vaccine reviews for the Food and Drug Administration (FDA), recalled that Dr. Janet Woodcock had stated that “absent a license, states cannot require mandatory vaccination.” Woodcock was the FDA’s Principal Deputy Commissioner at the time.

Sure enough, the FDA granted full vaccine approval on August 23, 2021, more than four months sooner than a normal priority process would take. Yet, five days prior, Biden made an announcement that put pressure on regulators.

On August 18, 2021, Biden announced that all Americans would have booster shots available starting the week of September 20, pending final evaluation from the FDA and the U.S. Centers for Disease Control and Prevention (CDC).

Some decision-makers objected. Dr. Marion Gruber and fellow FDA deputy director of vaccine research Dr. Philip Krause had concerns regarding the hasty timelines for approving Pfizer’s primary shots and boosters. On August 31, 2021, they announced their retirements.

According to a contemporary New York Times article, Krause and Gruber were upset about Biden’s booster announcement. The article said that “neither believed there was enough data to justify offering booster shots yet,” and that they “viewed the announcement, amplified by President Biden, as pressure on the F.D.A. to quickly authorize them.”

In The Lancet on September 13, 2021, Gruber, Krause, and 16 other scientists warned that mass boosting risked triggering myocarditis (heart inflammation) for little benefit.

Politicized mandates led to profits for vaccine manufacturers but left “science” with a sullied reputation

“[W]idespread boosting should be undertaken only if there is clear evidence that it is appropriate,” the authors wrote. “Current evidence does not, therefore, appear to show a need for boosting in the general population, in which efficacy against severe disease remains high.”

Regardless, approval for the boosters arrived on schedule on September 24, 2021. CDC Director Dr. Rochelle Walensky granted this approval, but for a wider population than recommended by her advisory panel. This was only the second time in CDC history that a director had defied panel advice.

“[T]his process may have been tainted with political pressure,” the House report found.

Amidst all this, the vaccines were fully licensed. The FDA licensed the Comirnaty (Pfizer-BioNTech) vaccine on August 23, 2021. The very next day, Defense Secretary Lloyd Austin issued a memo announcing a vaccine mandate for the military. Four other federal mandates followed.

“[T]he public’s perception [is] that these vaccines were approved in a hurry to satisfy a political agenda,” the House report found.

The House report condemned the dubious process and basis for these mandates. It said the mandates “ignored natural immunity, … risk of adverse events from the vaccine, as well as the fact that the vaccines don’t prevent the spread of COVID-19.”

The mandates robbed people of their livelihoods, “hollowed out our healthcare and education workforces, reduced our military readiness and recruitment, caused vaccine hesitancy, reduced trust in public health, trampled individual freedoms, deepened political divisions, and interfered in the patient-physician relationship,” the report continued.

The same could be said of Canadian vaccine mandates, as shown by the National Citizen’s Inquiry hearings on COVID-19. Unfortunately, an official federal investigation and a resulting acknowledgement do not seem forthcoming. Politicized mandates led to profits for vaccine manufacturers but left “science” with a sullied reputation.

Lee Harding is a Research Fellow for the Frontier Centre for Public Policy.