The Food and Drug Administration authorized Covid-19 booster shots Monday for adolescents ages 12-15, marking the latest step by the U.S. government to green-light more vaccine doses for younger Americans.
Regulators shortened the timeframe between completion of the primary vaccination series with the Pfizer-BioNTech shot — the only one authorized for anyone 12 and older — and when someone can get a booster to at least five months, down from six months. The FDA cited lab studies suggesting boosters improve individuals’ antibody response to the Omicron variant, as well as data of millions of Israeli citizens 16 and older who got boosters after at least five months as justification for tightening the window.
The agency will also allow some immunocompromised children as young as age 5 to get an additional dose.
The decisions come as the more transmissable Omicron variant threatens to disrupt daily life in the country well into the winter and as school districts in Democratic-led states scale back efforts to mandate students get vaccinated to not get ahead of regulators.
“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.”
“In the current situation, it is important to offer all eligible individuals a booster, particularly against the backdrop of the newly-emerging variants such as Omicron,” Ugur Sahin, CEO and co-founder of BioNTech said in a statement.
The Centers for Disease Control and Prevention’s advisory committee on vaccines is expected to evaluate expanded eligibility for the boosters this week before deciding whether to recommend the shots for the youngest teens, according to news reports.
The FDA and CDC expanded booster access to 16- and 17-year-olds on Dec. 9, citing Omicron’s rapid rise.
Boosting teenagers as they return to classrooms in January may increase their protection from Covid infection as winter weather forces most Americans indoors, where the coronavirus spreads more easily. The way Omicron has spread across the country has convinced some experts previously skeptical of the widespread boosting strategy to embrace it as health care systems nationwide are stretched to their limits.
But concerns about exposing otherwise healthy, young people to myocarditis, an inflammatory heart condition and rare side effect of the messenger RNA vaccines like Pfizer’s, have prompted some medical experts to urge caution in permitting additional doses for children with scant safety data. Teens and adults under 30, particularly males, are most at risk of developing the condition.