FDA Expands Emergency Use Authorization for Pfizer COVID-19 Booster to Include Individuals 12 Years and Older

Officials with the FDA have expanded the emergency use authorization (EUA) for Pfizer and BioNTech’s COVID-19 booster vaccine for adolescents 12 through 15 years of age, according to a press release.

The booster dose for individuals between the ages of 12 and 15 is the same 30-µg dosage strength as the dose approved in the primary vaccine series. A booster dose was previously authorized for individuals 16 years of age and older, and the vaccine is authorized for eligible individuals 18 years of age and older who have completed primary vaccination with a different FDA-authorized COVID-19 vaccine.

“The recent rise in COVID-19 cases is concerning to all and today’s decision by the FDA to further expand the emergency use authorization of a booster dose of our vaccine is critical to help us ultimately defeat this pandemic,” said Albert Bourla, DVM, PhD, chairman and chief executive officer of Pfizer, in the press release. “We continue to believe that broad use of boosters is essential to preserving a high level of protection against this disease and reducing the rate of hospitalizations.”

Real world evidence from the Ministry of Health of Israel found no new safety concerns in adolescents 12 through 17 years of age. According to the press release, these data came from more than 4.1 million booster doses that were administered at least 5 months after the primary series.

In addition to this change in eligibility, the FDA is also amending the existing EUA to reduce the time for booster dose administration from a minimum of 6 months to at least 5 months following completion of the primary vaccine series for individuals 12 years of age and older. This reduction is supported by data from the Ministry of Health of Israel on booster vaccines administered at least 5 months after the primary series, which found no new safety concerns in adults.

Finally, FDA officials expanded the current EUA to include administration of a third primary series dose at least 28 days following the second dose for individuals 5 through 11 years of age who are immunocompromised. This authorization is based on data extrapolated from an independent report evaluating the safety and efficacy of a third dose in adults who received solid organ transplants. This indication is currently authorized for individuals at least 12 years of age who are immunocompromised.

“The booster vaccination increases the level of immunity and improves protection against COVID-19 across all age groups that have been authorized to receive one,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in the press release. “In the current situation, it is important to offer all eligible individuals a booster, particularly against the backdrop of the newly-emerging variants such as Omicron.”

REFERENCE

Pfizer and BioNTech Receive US FDA Emergency Use Authorization of COVID-19 Vaccine Booster for Individuals 12 Years of Age and Older. News release. Pfizer; January 3, 2022. Accessed January 4, 2022. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-emergency-use-0