The Food and Drug
Administration (FDA) issued an Emergency Use Authorization (EUA) for Pfizer/BioNTech's mRNA vaccine against the SARS-CoV-2 virus. The FDA's Vaccines and Related Biological Products Advisory Committee voted on Thursday, December 10, to recommend the FDA issue an EUA, following extensive review of safety and efficacy data on the Pfizer/BioNTech vaccine. The clinical trials of the vaccine included more than 40,000 participants—all over the age of 16—and found high vaccine efficacy in all age groups, genders, races, ethnicity and participants with the presence of comorbidities. Access the FDA briefing materials that provide a comprehensive overview of the safety and efficacy data.
The ACS has reviewed the safety and efficacy data submitted by Pfizer/BioNTech and strongly encourages surgeons to take the vaccine when available to them. Mild systemic side effects are very common with this two-dose vaccine (fatigue, injection site reactions, and fever) but serious adverse side effects were very rare. Doses will be dispensed to individual states, which will control local distribution.
