Expanded U.S. Emergency Use Authorization for an additional COVID-19 vaccine booster in individuals aged 50 years and older. - Pfizer + BioNTech

The FDA also has authorized a second booster dose for individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and who have received a first booster dose of any authorized COVID-19 vaccine. The additional booster is to be administered at least four months after the first booster and is the same formulation and strength as prior Pfizer-BioNTech COVID-19 vaccine doses.

The expanded EUA is based on the totality of scientific evidence shared by the companies including immunogenicity data from an ongoing, open-label study in 154 healthcare workers 18 years of age and older at a single center in Israel who received two booster doses during a period when Omicron was the predominant variant. Among these individuals, approximately 11-fold increases in geometric mean neutralizing antibody titers against wild-type virus, and Delta and Omicron variants, respectively, were reported at two weeks after the second booster as compared to 5 months after the first booster dose. No new safety concerns were noted among study participants. The companies also shared with the FDA data from the U.S. and elsewhere showing a decline in vaccine effectiveness against COVID-19 3 to 6 months after the initial booster, and evidence from Israel that an additional booster dose can improve protection against severe disease and death.