NEW YORK & MAINZ, Germany– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. Food and Drug Administration (FDA) 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.1 No new safety concerns were noted among study participants.1 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,2-6 and evidence from Israel that an additional booster dose can improve protection against severe disease and death. 7-9
Together, these data demonstrate the public health need in the most vulnerable individuals and suggest that an additional booster dose of the Pfizer-BioNTech COVID-19 Vaccine administered at least four months after the initial booster may restore antibody levels,1 improve protection in older people,7-9 and provide a similar safety profile to that of previous doses.1 These emerging data underscore the importance of considering an additional booster dose for all individuals included in this EUA.
The Pfizer-BioNTech COVID-19 Vaccine was previously authorized under EUA as a single booster administered to individuals aged 12 and older who have completed the primary vaccination series with the Pfizer-BioNTech COVID-19 Vaccine, as well as to individuals aged 18 and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The second booster authorized today for those age 50 years and older is meant to extend high levels of protection against COVID-19 for the most vulnerable populations in advance of potential future waves.
The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech’s proprietary mRNA technology, was developed by both BioNTech and Pfizer. BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries. Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.
