After calls from members of the scientific, public health, and medical community—myself included—the Food and Drug Administration finally overcame bureaucratic inertia and granted full approval to the Pfizer-BioNTech mRNA COVID-19 vaccine—ahead of its self-imposed deadline of January 2022. This is good news. Pfizer will now market the vaccine under the brand name Comirnaty.
Hundreds of millions of doses have been administered over the course of nearly a year and the safety profiles of these vaccines have been remarkably good. Now the FDA should move quickly on the other mRNA vaccine made by Moderna. The company submitted its application for full approval in June, a month after Pfizer’s application. Johnson and Johnson, makers of the one-dose adenovirus-based vaccine has not yet applied for full approval.
It is important to stress that, while the vaccine does not prevent 100 percent of infection, it is highly effective against severe disease—severe enough to require hospitalization and/or death. The health care news site MedPage Today reported that Peter Marks, MD, PhD, Director of the FDA’s Center for Biologics and Research issued the following statement:
Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities.
Full approval of the Pfizer vaccine hopefully will reduce vaccine hesitancy. Claims, especially by those in the “anti-vax” community that the vaccine is “experimental” influence many of the vaccine-hesitant. Ironically, many who oppose the so-called “experimental” vaccine instead urge the off-label use of the anti-inflammatory/antimalarial drug hydroxychloroquine or ivermectin, used to treat parasites in animals, to prevent or treat COVID-19 infections. Yet the use of those drugs for COVID-19 is truly experimental.
Hopefully, full approval of the Pfizer vaccine and, before much longer, the Moderna vaccine, will alleviate much of the vaccine hesitancy. While politicians and public health officials have employed various approaches to the pandemic—from lockdowns to stay-at-home orders to elective procedure moratoria to mask mandates—the evidence shows that immunization is clearly the most effective and least damaging form of COVID-19 harm reduction.
