https://www.scientificamerican.com/article/pfizer-biontech-covid-vaccine-is-first-to-win-u-s-authorization/

After months of intense anticipation, the U.S. Food and Drug Administration has granted an emergency use authorization (EUA) for the COVID-19 vaccine developed by the companies Pfizer and BioNTech—the first to be approved for use in the U.S. The news comes as a devastating surge in cases grips the country, with many hospitals approaching capacity and new records for deaths being set weekly. Immunizations will begin in the next few days and weeks for health care workers and residents of long-term care facilities such as nursing homes. Other groups will get the shot in the coming months as more doses become available. The authorization was first reported by the New York Times and the Washington Post.

An FDA advisory group, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), voted on Thursday to recommend authorization of the vaccine for individuals age 16 and older. The committee reviewed data provided by the FDA’s own analyses and discussed issues including the vaccine’s efficacy in subpopulations, such as the elderly and minority racial groups, and ongoing monitoring of the roughly 44,000 participants in the late-stage clinical trial. The majority of VRBPAC members voted that the benefits of granting an EUA outweighed the risks, with 17 voting yes, four voting no, and one abstaining.