BRIEF—FDA nod for Comirnaty EUA in children ages 5 through 11 years

The US Food and Drug Administration on Friday authorized the emergency use of the Pfizer-BioNTech COVID-19 vaccine, trade name Comirnaty for the prevention of COVID-19 to include children 5 through 11 years of age.

The authorization was based on the FDA’s thorough and transparent evaluation of the data that included input from independent advisory committee experts who overwhelmingly voted in favor of making the vaccine available to children in this age group.

The companies will begin shipping 10µg pediatric doses immediately, as directed by the US government. Eligible US residents will continue to receive the vaccine for free, consistent with the US government’s commitment to free access to COVID-19 vaccines.

As a next step, the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will meet next week to discuss a potential recommendation for the use and rollout of the vaccine to children 5 through 11 years of age.

Pediatric vaccinations are anticipated to start, subject to, and after, CDC endorses the ACIP recommendation.