The US Food and Drug Administration late Wednesday authorized booster doses of the Pfizer/BioNTech COVID-19 vaccine for people ages 65 and up. Also eligible for boosters will be those ages 18 to 64 who are at high risk of severe COVID-19 or at high risk from frequent occupational or institutional exposures to SARS-CoV-2, such as healthcare workers and teachers.
The single booster dose should only be given at least six months after the two initial doses. The approval comes an amendment to an Emergency Use Authorization.
The FDA’s authorization largely follows the recommendations from a committee of independent experts that advises the agency, known as the Vaccines and Related Biological Products Advisory Committee or VRBPAC. The committee met all day Friday to review and deliberate over the data surrounding boosters. The meeting concluded with an 18-0 vote in favor of recommending boosters for people over 65 and high-risk groups. But, prior to that, the committee voted 16-2 against recommending boosters for everyone ages 16 and up, rejecting the Biden administration’s plans to rollout additional doses to nearly all vaccinated people.