The Food and Drug Administration (FDA) has authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine as a single booster dose to be administered at least 6 months after completion of the primary 2-dose series in certain populations.

The updated Emergency Use Authorization (EUA) allows for a single booster dose of the Pfizer-BioNTech COVID-19 vaccine for individuals 65 years of age and older, individuals 18 to 64 years of age at high risk of severe COVID-19, and individuals 18 to 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 also remains authorized for individuals 12 years of age and older who have been determined to be immunocompromised. 

The FDA’s decision follows recommendations from the Vaccines and Related Biological Products Advisory Committee. The committee reviewed data from several studies, including a phase 3 trial (ClinicalTrials.gov Identifier: NCT04955626) that evaluated the efficacy, safety and tolerability of a booster dose in participants 18 to 55 years of age who were previously vaccinated with a 2-dose primary regimen.  Results showed that the booster elicited high neutralization titers against SARS-CoV-2.

Additionally, real-world surveillance data presented by the Israel Ministry of Health, showed that among individuals 60 years and older who received a booster dose, the rates of COVID-19 and severe disease were substantially lower.


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“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech COVID-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock, MD.

As for safety, the most common adverse reactions reported with the booster dose were injection site reactions (eg, pain, redness, swelling), fatigue, headache, muscle/joint pain, and chills. Swollen lymph nodes in the underarm were observed more frequently after the booster dose vs after the primary 2-dose series.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) is meeting today to discuss a potential recommendation for the use and rollout of the booster dose. The booster dose is the same formulation and dosage strength as the doses in the primary series.

References

  1. FDA authorizes booster dose of Pfizer-BioNTech COVID-19 Vaccine for certain populations. News release. US Food and Drug Administration. Accessed September 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations
  2. Pfizer and BioNTech receive first US FDA emergency use authorization of a COVID-19 vaccine booster. News release. Pfizer and BioNTech. Accessed September 23, 2021. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-first-us-fda-emergency-use.