FDA expert panel votes against Pfizer booster

Although the vote is not binding, it is likely that it will form the basis of a formal FDA recommendation

The scientific advisory council of the Food and Drug Administration (FDA) has voted against the authorisation of a “booster” shot of Pfizer’s mRNA vaccine to the general public – a move that will likely disappoint some public health experts pushing for a third dose to help slow the spread of COVID-19.

In a 16-2 vote on Sept. 17, 2021, an independent committee of physicians, scientists, and public health experts recommended against full approval of the third dose of the vaccine, which now goes by the brand name “Comirnaty.” However, the panel did recommend the shot for Americans age 65 and older or those at high risk for severe COVID-19. In recommending against the shot for the general public, the committee cited reasons such as lack of sufficient safety data in younger age groups as well as indications that the initial doses still seem to be providing robust protection against severe illness leading to hospitalization and death. The panel also agreed in a poll – but not a formal vote – that boosters would be beneficial for certain populations, such as health care workers and others at high risk for occupational exposure.

Although the vote is not binding, it is likely that it will form the basis of a formal FDA recommendation.