Children's mRNA COVID-19 Vaccine Review Meeting Scheduled by the U.S. FDA

The U.S. FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC) announced it had scheduled a meeting on October 26, 2021, to discuss a request to amend Pfizer-BioNTech's Emergency Use Authorization (EUA) for the administration of the COVID-19 mRNA vaccine to children 5 through 11 years of age.

Pfizer confirmed on March 25, 2021, they had dosed the first children in a global Phase 1/2/3 clinical study to evaluate further the safety, tolerability, and immunogenicity of the Pfizer-BioNTech (Comirnaty) vaccine in 4,644 children between the ages of 11 years to 6 months.

Children younger than six months of age may subsequently be evaluated once an acceptable safety profile has been established, stated Pfizer's website.

Pfizer and BioNTech announced on September 20, 2021, results from a Phase 2/3 study showing a favorable safety profile and robust neutralizing antibody responses in children 5 to 11 years of age using a two-dose regimen of 10 µg administered 21 days apart.

This dosage is smaller than the 30 µg dose used for people 12 and older. 

The VRBPAC open session meeting will be heard, viewed, captioned, and recorded through an online teleconferencing platform available to the public.

The FDA intends to make background material available to the public no later than two business days before the meeting. In addition, materials for this meeting will be available on the VRBPAC meetings' main page.

Interested persons may present data, information, or views on issues pending before the Committee, orally or in writing. The FDA established docket number FDA-2021-N-1088 for public comment on this meeting. 

The https://www.regulations.gov electronic filing system will accept comments.