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Federal health officials have authorized a COVID-19 vaccine booster in 16- and 17-year-olds as the omicron variant spreads to more states.
The Pfizer-BioNTech vaccine can be used as a booster for this age group at least six months after a primary series, under an expanded emergency use authorization (EUA) granted by the Food and Drug Administration (FDA) Thursday. The Centers for Disease Control and Prevention (CDC) also signed off on the boosters.
“Since we first authorized the vaccine, new evidence indicates that vaccine effectiveness against COVID-19 is waning after the second dose of the vaccine for all adults and for those in the 16- and 17-year-old age group,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a news release. “A single booster dose of the vaccine for those vaccinated at least six months prior will help provide continued protection against COVID-19 in this and older age groups.”
Last month, the FDA and CDC authorized boosters for all adults. The FDA said in its announcement Thursday it believes the benefits of a booster to protect against SARS-CoV-2 outweigh the small risk of myocarditis in those under 18 years.
Health officials have been urging people to get boosters as soon as they’re eligible to protect them against the omicron variant that is being reported in a growing number of states. The variant contains about 50 mutations, and its molecular characteristics suggest it may be able to spread more easily than the original pandemic virus. Experts are racing to study transmissibility, disease severity and vaccine effectiveness relative to omicron.
Earlier this week, Pfizer released preliminary data from a laboratory study showing a booster dose increases neutralizing antibody titers against the omicron variant by 25-fold compared to two doses.
“Although we don’t have all the answers on the Omicron variant, initial data suggests that COVID-19 boosters help broaden and strengthen the protection against Omicron and other variants,” CDC Director Rochelle P. Walensky, M.D., M.P.H., said in a statement. “We know that COVID-19 vaccines are safe and effective, and I strongly encourage adolescents ages 16 and 17 to get their booster if they are at least 6 months post their initial Pfizer vaccination series.”
Pfizer-BioNTech first received an EUA in December 2020 for its COVID-19 vaccine those ages 16 years and older. It is the only vaccine authorized for use in teens.
“As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic,” Acting FDA Commissioner Janet Woodcock, M.D., said in a press release. “With both the delta and omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
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