The U.S. Food and Drug Administration approved the emergency use of Pfizer-BioNTech’s COVID-19 vaccine, Friday.
After reporting a 95% efficacy rate in its Phase 3 trials, the Pfizer vaccine was evaluated by the FDA’s Vaccines and Related Biological Products Advisory Committee on Thursday and recommended for emergency approval Friday morning.
The final step was to get it authorized by the administration, for which they announced the vaccine met the criteria for emergency use.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” FDA Commissioner Stephen M. Hahn, M.D. said. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization.”
California regions are expected to receive an initial batch on Tuesday, Dec. 15, with L.A. County expected to receive 83,000 doses, according to Los Angeles Mayor Eric Garcetti.
The vaccine approval announcement comes on the heels of L.A. County’s highest single-day recording of positive COVID-19 cases (13,815) and a three-week stay-at-home order that was applied to Southern California.