“With the current wave of the Omicron variant, it’s critical that we continue to take effective, life-saving preventative measures such as primary vaccination and boosters, mask-wearing and social distancing in order to effectively fight COVID-19.”

-Acting FDA Commissioner Janet Woodcock, M.D.

On Monday, Jan. 3, 2022, the Food and Drug Administration (FDA) updated its emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine, authorizing a booster shot for children ages 12-15.

The Pfizer-BioNTech vaccine is currently the only primary vaccination series authorized for this age group.

The FDA also amended the EUA to shorten the time between the completion of the primary vaccination series of the Pfizer-BioNTech vaccine and a booster dose to at least five months—down from the previous six months. This applies to all individuals over the age of 12.

Further, the FDA authorized a third primary series dose for certain immunocompromised children ages 5-11.

Expanding booster shots to children and teens is intended to help reduce cases of the rapidly spreading coronavirus Omicron variant, according to the FDA.

The agency’s news release states this authorization announcement comes as the FDA reviews real-world data concerning all available vaccines, and it will continue to provide additional updates as appropriate.

What’s Next?

With this change, the FDA allows children aged 12-15 to join 16- and 17-year-olds who were recently authorized to receive booster shots. This means children and teens ages 12 and up can receive a booster at least five months after completing their primary series of the Pfizer-BioNTech vaccine.

Parents of children and teens eligible for COVID-19 vaccines or boosters should speak with their children’s primary care physicians about vaccination.

The content of this News Brief is of general interest and is not intended to apply to specific circumstances. It should not be regarded as legal advice and not be relied upon as such. In relation to any particular problem which they may have, readers are advised to seek specific advice. © 2021 Zywave, Inc. All rights reserved.