FDA to consider COVID-19 vaccines for ‘younger populations’ in June

The Food and Drug Administration (FDA) has set tentative dates “to meet to discuss updates to the Moderna and Pfizer-BioNTech [emergency use authorizations] for their COVID-19 vaccines to include younger populations.” According to a Friday news release from the FDA, its Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss the topic “on June 8, 21 and 22.”

“As we continue to address the ongoing COVID-19 pandemic, there are a number of anticipated submissions and scientific questions that will benefit from discussion with our advisory committee members,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We intend to move quickly with any authorizations that are appropriate once our work is completed.”

Friday’s FDA announcement follows months of frustration from families who have not been able to vaccinate their children. Currently, only children ages 5 or older can be vaccinated in the U.S. with Pfizer’s COVID-19 vaccine, leaving 18 million in the younger populations unprotected.

“I think there is an important unmet medical need here with these youngest kids,” Moderna Chief Medical Officer Dr. Paul Burton said earlier this week. “They don’t have any other vaccine. They don’t have any other treatments.”

On Thursday, Moderna announced it has begun the process of applying for an EUA for its COVID-19 vaccine in kids 6 months to 6 years old. In the announcement, Moderna said its child-sized vaccine dose “showed a robust neutralizing antibody response in the 6 month to under 6 years of age group.”

“I think we now have a safe and effective vaccine to be able to offer them that moms and dads and caregivers and physicians that will safely protect them,” Dr. Burton said. “I think it is likely that over time they will need additional doses. But we’re working on that.”

Moderna has filed FDA applications for older kids, but the FDA hasn’t ruled on them. It’s not clear if that data for older children will be considered at the June meetings.

In addition to Moderna’s request, Pfizer is soon expected to announce if three of its even smaller-dose shots work for the youngest children. The company had discovered that two doses weren’t quite strong enough.