FDA Authorizes Pfizer COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the COVID-19 vaccine created by Pfizer in collaboration with BioNTech, as initially reported by The New York Times on Friday evening, with subsequent confirmation from The Wall Street Journal. This EUA was granted after an independent expert panel, assembled by the FDA to assess Pfizer’s application, delivered a unanimous recommendation in favor of authorization earlier this week.

With this authorization in place, vaccine distribution is anticipated to commence promptly, beginning with an initial shipment of 2.9 million doses. Individuals identified as most at risk, encompassing healthcare professionals and elderly residents of long-term care facilities, are projected to start receiving vaccinations within several days of the EUA being granted.

It’s important to note that this is not a complete approval from the U.S. regulatory body for therapeutics, but rather an emergency authorization. This still necessitates a thorough evaluation of all data provided by Pfizer from its Phase 3 clinical trial, which involved approximately 44,000 volunteer participants. Pfizer’s analysis of the trial data revealed a 95% efficacy rate for its mRNA-based vaccine, and safety data showed no major safety concerns among vaccinated individuals.

Beyond the initial order of 2.9 million doses, the U.S. plans to allocate roughly 25 million doses before the close of 2020. However, the number of people fully vaccinated may be lower, as the Pfizer vaccine regimen requires two doses to achieve optimal effectiveness. The majority of Americans should not anticipate vaccine availability until at least the latter part of the first or second quarter of 2021, considering Pfizer’s production rate and the size of the U.S. order.

Despite this, this represents a significant initial advancement and a remarkable accomplishment in the speed of vaccine development, having taken approximately eight months from the start of work on the Pfizer vaccine candidate. Moderna has also requested an EUA for its vaccine candidate, which, like Pfizer’s, utilizes mRNA technology to instruct the body’s cells to generate protective responses against the virus. Approval of Moderna’s vaccine could follow soon, potentially making two vaccines available under EUA in the U.S. before the year’s end.