Pfizer gets expanded USFDA emergency use nod for additional COVID Vaccine booster in adults aged 50 years and older
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-Biotech COVID-19 vaccine doses.;
New York: Pfizer Inc. and BioNTech SE have announced that the U.S. Food and Drug Administration (USFDA) has expanded the emergency use of their COVID-19 vaccine to include a second booster dose in adults ages 50 years and older who have previously received a first booster of any authorized COVID-19 vaccine.
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.
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