FDA Authorizes Pfizer Boosters for People 65 and Older and Those at High Risk for Severe Covid-19

FDA Authorizes Pfizer Boosters for People 65 and Older and Those at High Risk for Severe Covid-19
Photo: Francois Monier / AFP, Getty Images

After weeks of wondering who will get covid-19 booster shots and when — and receiving confusing advice from a variety of public officials — the Food and Drug Administration has made a decision.

On Wednesday, regulators at the FDA decided to amend Pfizer-BioNTech’s emergency use authorization and allow for a single booster shot of its covid-19 vaccine to be given to certain population groups. The groups are the following: people 65 years old and older; people between 18 and 64 years old who are at high-risk of developing severe covid-19; and people between 18 and 64 years old in certain institutions or jobs that put them at high-risk of developing severe covid-19 or serious complications.

Although the first two groups are pretty clear cut, the third group is less so, which is perhaps why agency officials decided to provide examples. Acting FDA commissioner Janet Woodcock said that the group included health care workers, teachers, day care staff, grocery workers, people in prisons, and individuals in homeless shelters, among others.

The agency’s decision only applies to Pfizer-BioNTech’s covid-19 vaccine, which is the only vaccine currently approved in the country. It should be noted that the booster is simply a third dose of the Pfizer-BioNTech vaccine. It is not a different shot.

“This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day,” Woodcock said in a statement. “As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

As far as timing goes, the FDA said that the booster shots can be given to individuals in the specific groups at least six months after they receive their 2-dose series and any point after that time.

The safety and side effects of the booster shot were analysed by Pfizer in a 318-person clinical trial. Participants, of which 306 were between the ages of 18 and 55 while 12 were over 65, were monitored for an average time of two months. Side effects from the booster shot were similar to those reported after the first two doses and included pain, redness and swelling at the injection site; fatigue; headache; muscle and joint pain; and chills. The FDA pointed out that participants experienced swollen lymph nodes in their underarms more frequently after the booster shot.

The decision follows a meeting by the Vaccines and Related Biological Products Advisory Committee, the agency’s outside advisory panel, which last week voted against recommending booster shots to Americans over the age of 16. The committee did, however, unanimously agree to recommend boosters to people over 65 years old and others at high risk of covid-19. The decision was ultimately left to the FDA — as well as the Centres for Disease Control and Prevention, which has not released its opinion yet — because the committee’s votes are non-binding.

The FDA’s decision throws a wrench into the Biden administration’s plan to provide booster shots to most Americans. The U.S. is the latest wealthy country to authorise booster shots for its citizens, joining the ranks of Germany, France, Britain, and Israel.