US FDA OKs Pfizer-BioNTech boosters for children as young as 12

WASHINGTON

The Food and Drug Administration (FDA) authorized on Monday Pfizer-BioNTech coronavirus booster shots for children between the ages of 12 and 15 as the US grapples with soaring virus cases.

Boosters for Pfizer's jab previously received emergency use authorization for people as young as 16, and the FDA's decision to expand eligibility was accompanied by several actions meant to bolster booster uptake.

That includes shortening the time between an individual's completion of their first round of shots and their booster to five months from six, and allowing for a third dose for some immunocompromised children aged five to 11.

Pfizer-BioNTech's shot remains the only option for children under US authorizations.

“Throughout the pandemic, as the virus that causes COVID-19 has continuously evolved, the need for the FDA to quickly adapt has meant using the best available science to make informed decisions with the health and safety of the American public in mind,” Acting FDA Commissioner Janet Woodcock said in a statement.

“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 to in order to effectively fight COVID-19,” she added.

The Centers for Disease Control and Prevention (CDC) must still sign-off on the FDA's decision.

The effort to expand booster eligibility comes as the US grapples with an unprecedented surge in virus cases caused by the omicron variant. Weekly cases have surpassed 2.8 million while weekly deaths exceed 9,000.

Vaccines continue to offer widespread protection against the worst health outcomes from COVID-19 with hospitalizations and deaths largely being tallied among the unvaccinated.