Regulation

FDA to follow authorization of first COVID vaccine for adolescents with update on data requirements for the age group 

FDA’s authorization on Monday of Pfizer and BioNTech’s COVID-19 vaccine for children ages 12-15 will be followed by an emergency CDC meeting on Wednesday to discuss recommendations for use and a June 10 FDA advisory committee meeting to discuss requirements for emergency authorizations for the age group.

CDC’s Advisory Committee on Immunization Practices (ACIP) posted an agenda for its meeting last week indicating that it would consider recommendations for how to use the Comirnaty vaccine from Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) in adolescents.

In an announcement about the June 10 meeting of FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), the agency stated that the goal is to “provide a status update” on its approach to granting emergency use authorizations for COVID-19 vaccines intended for 12-17 year-olds.

The VRBPAC will also discuss the data needed to support an EUA and a BLA for a COVID-19 vaccine intended for use in children less than 12 years of age.

The next COVID vaccine likely to be up for authorization in adolescents is mRNA-1273 from Moderna Inc. (NASDAQ:MRNA). On May 6, Moderna announced an initial analysis of the Phase II/III TeenCOVE study in volunteers ages 12-17 that suggested the vaccine has an efficacy of 96%.

Moderna is also running a Phase II/III trial in children ages six months to 12 years; data are expected this year.

In a tweet, Acting FDA Commissioner Janet Woodcock wrote: “It’s imperative that we focus on helping to ensure availability of vaccines to our children. This meeting will help manufacturers understand our expectations for data and info needed to support EUAs and biologic license applications.”