Pfizer-BioNTech Covid vaccine receives long-awaited FDA approval

August 23, 2021, saw the FDA approval of the Pfizer vaccine for COVID-19. This action is expected to result in numerous mandates by institutions, companies, and state/local governments to require vaccination that can only result in a positive impact on the viral pandemic. Many individuals had been postponing vaccinations pending this approval, by perhaps up to 30% as polled by the Kaiser Family Foundation. Up to now, the various COVID-19 vaccines have been administered on an emergency basis.

The approval, which is the first among the available vaccines, was based on data gleaned from 44,000 clinical trial participants in the US, EU, Turkey, South Africa, and South America. Pfizer’s data indicated that the vaccine was 91% effective in preventing infection, which was down 4% from the efficacy rate initially reported when the vaccine was granted approval for emergency use in late 2020. That decrease according to Pfizer, reflected the fact that researchers had more time to catch people who became infected.

This approval is critical, because the skepticism about the vaccines has stalled the progress against the virus and facilitated the development of more dangerous COVID-19 variants. The Delta variant currently predominates in the US.

Dr. Janet Woodcock, the acting F.D.A. commissioner commented, “While millions of people have already safely received Covid-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The Pfizer vaccine will continue to be authorized for emergency use in children 12 to 15 years of age until sufficient data are available to achieve full approval for this age group.

The next critical step for the FDA is the determination of whether or not to authorize booster shots. If this is approved, individuals who received the Pfizer or Moderna vaccines can receive a booster 8 months after the second injections beginning September 20. This timing is important because of the waning potency of the vaccines and the presence of the Delta variant.

The application for full approval of the Moderna’s vaccine is ongoing and may following today’s action in a few week. Johnson & Johnson should be applying soon for full approval.