The US Food and Drug Administration has authorized the Pfizer/BioNTech Covid-19 vaccine, the first Covid-19 vaccine for emergency use in the United States. Millions of doses will be soon shipped around the country so vaccinations can begin within days. Pfizer would have to file a separate application for its vaccine to be fully licensed by the FDA. “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,” a FDA statement said.
Before vaccinations can begin, a US Centers for Disease Control and Prevention immunization advisory committee still must vote to recommend the vaccine, and the CDC must accept that recommendation. About 20 million people could be vaccinated in the U.S. in the next few weeks. A two-dose regimen of the vaccine has an efficacy of 95% in people ages 16 and older. FDA briefing documents also note that the vaccine appears to provide “some protection” against Covid-19 following just one dose. The most common adverse reactions to the vaccine have been reactions at the injection site, fatigue, headache, muscle pain, chills, joint pain and fever.