Pfizer and BioNTech announced that the FDA has authorized for emergency use a booster dose of the Pfizer-BioNTech COVID-19 Vaccine for individuals 65 years of age and older, individuals 18 through 64 years of age at high risk of severe COVID-19, and individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19. The booster dose is to be administered at least six months after completion of the primary series, and is the same formulation and dosage strength as the doses in the primary series.
“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “Over the last year and a half, we have aimed to stay vigilant as the pandemic has evolved – including evaluating the impact of a booster dose. We believe boosters have an important role to play in addressing the continued threat of this disease, alongside efforts to increase global access and uptake among the unvaccinated. Today’s FDA action is an important step in helping the most vulnerable among us remain protected from COVID-19.”
“Today’s emergency use authorization is supported by clinical data underlining that a booster induces a strong immune response against tested variants of concern and can address a current public health need. We will continue to monitor new SARS-CoV-2 strains, to be prepared for potential emerging escape variants,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “We and our collaboration partner have submitted booster data to other regulatory agencies around the world. We are simultaneously working to expand access to our vaccines globally.”
The FDA based this EUA on the totality of scientific evidence shared by the companies and reviewed by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), including data from the Pfizer-BioNTech clinical program evaluating the safety, tolerability and immunogenicity of a booster dose of the COVID-19 vaccine. A booster dose of the vaccine elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild type), as well as the Beta and Delta variants, when compared with the levels observed after the two-dose primary series. The reactogenicity profile within seven days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after dose two. The adverse event profile was generally consistent with other clinical safety data for the vaccine.
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