FDA Issues Emergency Use Authorization for Pfizer, BioNTech COVID-19 Booster Vaccine

Pfizer and BioNTech have received the first FDA Emergency Use Authorization (EUA) for a COVID-19 booster shot, indicated for individuals 65 years of age and older, as well as for individuals of all ages who are at high risk of contracting severe COVID-19.

Individuals at high risk of severe COVID-19 include those whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at an elevated risk of serious complications from COVID-19, according to a Pfizer press release. The booster doses are to be administered at least 6 months after completion of the primary 2-dose series and are the same formulation and dosage strength as the original doses.

“This first FDA authorization of a COVID-19 vaccine booster is a critical milestone in the ongoing fight against this disease,” said Albert Bourla, DVM, PhD, chairman and CEO of Pfizer, in the press release. “Over the last year and a half, we have aimed to stay vigilant as the pandemic as 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.”

This EUA aligns with a recommendation last week from an FDA advisory committee, which did not recommend the booster shots for the broader public because they said more data are needed. However, the panel voted unanimously to recommend booster shots for adults over 65 years of age and those at high risk of severe COVID-19.

The EUA is based on data evaluating the safety, tolerability, and immunogenicity of a booster dose of the COVID-19 vaccine. According to the press release, clinical trials found that the booster dose elicited significantly higher neutralizing antibody titers against the wild-type SARS-CoV-2 virus, as well as the Beta and Delta variants, compared with titers observed after the initial 2-dose series.

These findings are from a phase 3 trial with 306 participants between 18 and 55 years of age who received a third dose of the vaccine between 4.8 months and 8 months after the primary 2-dose regimen. Researchers had a median follow-up time of 2.6 months post-booster and the neutralizing titers after the third dose met a prespecified 1.5-fold non-inferiority criterion of success and were statistically superior.

The reactogenicity profile within 7 days after the booster dose was typically mild to moderate, and the frequency of reactions was similar to or lower than after the second dose. The adverse event profile was generally consistent with earlier clinical safety data for the vaccine.

A third dose was previously authorized under the EUA for individuals at least 12 years of age who have undergone solid organ transplant or who have conditions resulting in an equivalent level of immunocompromise. This authorization is for a third dose administered at least 28 days following the second dose and is separate from the newly authorized booster dose.

“Today’s emergency use authorization is supported by clinical data underlining that a booster induced a strong immune response against tested variants of concern and can address a current public health need,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “We will continue to monitor new SARS-CoV-2 strains, to be prepared for potential emerging escape variants.”

REFERENCE

Pfizer and BioNTech Receive First US FDA Emergency Use Authorization of a COVID-19 Vaccine Booster. News release. Pfizer; September 22, 2021. Accessed September 23, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-fda-emergency-use