Pfizer and BioNTech have been authorized by the Food and Drug Administration to provide Covid-19 booster shots to people 65 and over and other vulnerable Americans six month after their last two doses. This means that many Americans are now eligible for the shots.
The FDA's decision follows the recommendations of its vaccine advisory committee, which met for more than eight hours Friday. The Vaccines and Related Biological Products Advisory Committee voted 16-2 to not distribute the vaccines to Americans aged 16 and over. They then unanimously adopted an alternative plan to give boosters for older Americans and people at high risk of severe illness if they contract the virus.
Despite the fact that Americans 65 and older account for 17% of the U.S. populace, they are at greatest risk of dying from Covid. According to the Centers for Disease Control and Prevention, 77% of all Covid-related deaths occur in this age group.
The FDA granted an emergency authorization to Pfizer to give shots to people over 65 and those with serious medical conditions. A broad definition was also provided by the FDA for people aged 18-64 who are at high risk of getting serious complications from Covid from their frequent occupational or institutional exposure to the virus. The CDC has enough flexibility to possibly clear third doses for those in nursing homes, prisons, and front-line healthcare workers who were among the first Americans to get the shots in December.
"The FDA took into account the input of the committee and did its own thorough analysis of the submitted data to arrive at today's decision," said Dr. Peter Marks (the agency's top vaccine regulator). We will continue to review the FDA data regarding the use of COVID-19 booster vaccines, and will make any further decisions based on that data.
As the Biden administration stated that it wanted to offer booster shots to the public as soon as possible, the non-binding decision of the vaccine advisory committee was likely to be controversial.
Although the agency may not always follow the recommendations of its committee, they often do. On Friday, Marks reminded panel that federal regulators don't have to accept the recommendation as written.