FDA Outlines Safety Data Needed for COVID-19 Vaccine EUAs for Children and Adolescents

June 11, 2021

The FDA would need to see safety data from at least 3,000 trial participants to grant Emergency Use Authorization or approval for a COVID-19 vaccine for children under age 12, an agency official told members of its vaccine advisory panel yesterday.

The Vaccines and Biological Products Advisory Committee met to consider what COVID-19 vaccine data to require for vaccines to be administered to various pediatric and adolescent age groups.

Doran Fink, deputy director-clinical in the Center for Biologics Evaluation and Research’s vaccines division, said a smaller overall safety database of at least 1,000 participants would be acceptable for younger adolescents, aged 12 to 15 years, and up to several hundred for older adolescents, aged 16 and 17, with a median of six months follow-up.

But some panel members expressed concerns about the length of the required follow-up in trials. Cody Meissner, director of pediatric infectious disease at Tufts University School of Medicine, for example, called for up to two years of safety data.

Meissner also said he didn’t feel either pediatric or adolescent groups should be included under the umbrella of an EUA as “the risk of disease is low for this group” and there are unknown side effects from a vaccination, including a risk of myocarditis.

“I think caution should rule the day here,” Meissner stated, adding he would prefer to wait for these groups to be vaccinated with shots that have secured Biologics License Applications with their more robust safety requirements.

In related vaccines news, Moderna requested a revised Emergency Use Authorization (EUA) from the FDA for use of its COVID-19 vaccine in adolescents aged 12 to 17. The company’s submission was supported by a U.S. phase 2/3 study in which the two-dose vaccine demonstrated 100 percent efficacy in almost 2,500 adolescents.

Earlier this month, Moderna filed a Biologics License Application for the vaccine in individuals aged 18 years and older (DID, June 2), in a bid to advance the shot beyond EUA status to full approval. ― Jason Scott