December 11, 2020
While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,
- One day after an independent advisory panel recommended the FDA grant special status to a COVID-19 vaccine, the FDA followed suit.
- Emergency use authorization (EUA) allows use of medication, tests, devices etc. during moments of national health emergencies based on preliminary or limited data, though the U.S. gov’t stands by the safety and efficacy for this vaccine.
- From the FDA’s announcement: “The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.”
- The President in an oval office message said vaccine distribution will begin within 24 hours of the EUA.
- Why It Matters: This is the first time a vaccine using mRNA technology has been licensed for human use in the U.S. Some models show the vaccine decreasing the number of expected deaths.
Here’s the FDA’s announcement
by Jenna Lee,