FDA authorizes first COVID-19 vaccine
The U.S. Food and Drug Administration (FDA) issued the first emergency use authorization for a vaccine to prevent the novel coronavirus (COVID-19), the agency announced late Friday evening.
The Pfizer and BioNTech messenger RNA (mRNA)-based vaccine candidate, BNT162b2, met the statutory criteria for issuance of an emergency use authorization, FDA officials said, and may now be distributed in the United States. As of Monday morning, doses were already being administered to healthcare professionals in key regions, including New York City.
The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive spike protein, officials said. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but rather triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2, the virus that causes COVID-19.
According to the FDA, the totality of the available data provides evidence the vaccine may be effective in preventing COVID-19. The data also supports that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in people 16 years of age and older, including healthy individuals, they said.
Biotechnology company, Moderna, is currently awaiting review by the FDA for emergency use authorization of its COVID-19 vaccination, mRNA-1273. A decision is expected later this month.