FDA advisors OK Pfizer COVID-19 booster for certain groups

Sept. 20, 2021

Federal vaccine advisors approved a third booster dose of Pfizer-BioNTech's COVID-19 vaccine on an emergency use basis, but only for the most vulnerable groups, which includes those age 65 and older and people at high risk of severe disease, according to a news report from the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.

The final vote passed unanimously on an 18 to 0 vote. An initial vote on broader third doses in those age 16 and older failed 16 to 2, based on questions about safety and whether third doses would do much to decrease transmission.

The nonbinding decision from the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will influence how the White House rolls out booster doses next week, part of stepped-up efforts to tamp down the nation's Delta (B1617.2) variant surge.

The booster dose would be given 6 months after receiving the second dose. In the middle of August, federal health officials approved a third dose of Pfizer-BioNTech COVID-19 vaccine for people who are moderately or severely immunocompromised. Some developed countries such as Israel and the United Kingdom have already launched third doses across broad parts of their populations.

VRBPAC made its decision in a high-pressure setting, not only due to White House policy issues, but also from international efforts to push high-income countries to delay booster doses as a way to free up more supply for developing countries.

Visit CIDRAP for more news