FDA Expands Pfizer COVID-19 Vaccine Booster EUA to All Adults Aged 18 or Older

The FDA has expanded the emergency use authorization (EUA) of a booster dose of the Pfizer COVID-19 vaccine to include all individuals aged 18 or older. This expansion comes 6 months after the completion of the primary series of vaccinations.

“With boosters, more adults will now have the opportunity to help preserve a high-level of protection against this disease. We are grateful to the FDA for their rigorous review, and the action taken today that we hope will help accelerate our path out of this pandemic,” said Albert Bourla, chairman and chief executive officer of Pfizer, in a statement.

The authorization comes after Pfizer and BioNTech announced positive topline results showing that those who received a booster after the primary 2-dose series demonstrated a relative vaccine efficacy of 95% when compared to those who did not receive a booster.

The booster vaccine dose will also be the same strength as the primary series of the Pfizer COVID-19 vaccine. During the investigation, the safety profile of the booster dose remained consistent with other safety data assessing the vaccine’s safety.

The FDA previously authorized the booster dose of the vaccine for emergency use after the completion of a primary vaccine series for individuals 65 years of age of older, individuals 18 through 64 years of age at high risk for severe COVID-19 or have frequent institutional or occupational exposure to COVID-19, as well as individuals who have completed a primary vaccination series with a different authorized COVID-19 vaccine.

Reference

Pfizer and BioNTech Receive Expanded U.S. FDA Emergency Use Authorization of COVID-19 Vaccine Booster to Include Individuals 18 and Older. Business Wire. News release. November 19, 2021. Accessed November 22, 2021. https://www.businesswire.com/news/home/20211119005441/en