FDA Authorizes COVID-19 Boosters of Pfizer for Seniors and Those at High Risk

A vial of Pfizer-BioNTech COVID-19 vaccine in Los Angeles, Calif., on Aug. 23, 2021. (Robyn Beck/AFP via Getty Images)

The Food and Drug Administration on Wednesday authorized for emergency use a booster dose of the Pfizer-BioNTech vaccine for those aged 65 and older, as well as those aged 18–64 who are at high risk of severe COVID-19.

The third dose of the mRNA-based shot is authorized to be administered at least six months after the first two doses of the vaccine.

A third population eligible for the dose under the amended FDA emergency use authorization (EUA) are those aged 18-64 “whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.”

This third category includes “health care workers, teachers, and day care staff, grocery workers, and those in homeless shelters or prisons,” among others, Acting FDA Commissioner Janet Woodcock said in a statement.

The Centers for Disease Control and Prevention (CDC) is expected to issue guidance on the distribution of the Pfizer boosters, after the CDC’s Advisory Committee on Immunization Practices (ACIP) meets for a vote on the boosters, which is scheduled for Thursday.

The latest development comes after an FDA advisory panel last week recommended boosters for people 65 and older, and those aged 18-64 at high risk of getting COVID-19, including those with frequent occupational exposure.  That same advisory panel overwhelmingly voted against a blanket authorization of the COVID-19 Pfizer booster for those 18–64 in the general population.

COVID-19 is caused by the CCP (Chinese Communist Party) virus, also known as the novel coronavirus.

Woodcock said that the FDA “we will continue to evaluate the rapidly changing science and keep the public informed” as it learns more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose.