FDA Expands Pfizer Vaccine Booster EUA to Include 12-15 Year Olds

A review of real-world data from Israel didn't show any increase risk of myocardities or pericarditis.

The FDA amended its emergency use authorization (EUA) for a booster of the Pfizer COVID-19 vaccine to include use in individuals ages 12 through 15 years.

In addition, the agency is allowing a third primary series dose for certain immunocompromised children from 5 through 11 years of age, FDA said in a news release.

The agency also shortened the time between the completion of primary vaccination of the Pfizer COVID-19 vaccine and a booster dose to five months.

“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” said Acting FDA Commissioner Janet Woodcock, M.D. “With the current wave of the omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask wearing and social distancing in order to effectively fight COVID-19.”

The FDA reviewed real-world data from Israel, including safety data from more than 6,300 individuals, ages 12 through 15, who received a booster dose of the vaccine at least 5 months following completion of the primary two-dose vaccination series.

“The data shows there are no new safety concerns following a booster in this population. There were no new cases of myocarditis or pericarditis reported to date in these individuals,” the agency said.

As a result, the FDA determined that “the protective health benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death, outweigh the potential risks in individuals 12 through 15 years of age.”

In related news, Novavax completed submission of the its data package to fulfill the prerequisites for its EUA application request to the FDA for NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.

Novavax, which is based in Gaithersburg, Maryland, expects to submit a request for EUA for the vaccine in the U.S. in one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.

"Novavax is committed to delivering our protein-based vaccine in the United States, where the COVID-19 pandemic continues to evolve with the emergence of new variants, ongoing need to ensure primary vaccination for the eligible population, and need for boosting," said Stanley C. Erck, Novavax’s president and CEO, in a news release.