In a first for the U.S., the FDA has authorized the use of Pfizer's BioNTech-partnered COVID-19 vaccine for use in adolescents between the ages of 12 and 15—months ahead of the upcoming school year in the fall.
The FDA will amend the existing emergency authorization for the vaccine, which was first issued in December, the agency said. Pfizer’s vaccine is currently the only shot allowed in the U.S. for Americans as young as the age 16. The vaccine's two-dose regimen will be the same for adolescents as it is for adults, the agency said.
“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement.
The action will bring the country "closer to returning to a sense of normalcy and to ending the pandemic" while protecting adolescents, Woodcock added. As of the end of April, roughly 1.5 million COVID-19 cases in people between the ages of 11 to 17 have been reported to the CDC, according to the FDA.
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The agency based its decision on the positive data Pfizer reported in late March from a trial of 2,260 adolescents. In that phase 3 trial, the vaccine posted a perfect 100% efficacy in children ages 12 to 15. The U.S. emergency nod in the age group follows a similar move by Canada last week.
Meanwhile, agency vaccine advisers are set to meet next month to discuss the potential use of COVID-19 vaccines in children under 12.
The news comes as the U.S. pushes ahead with President Joe Biden's goal to vaccinate at least 70% of adults with at least one dose by July 4. After a fast start to the rollout, adult vaccinations have slowed in recent weeks. Experts say vaccinating children is an important step to potentially reaching herd immunity in the U.S.
So far, the U.S. has administered 261 million COVID-19 vaccine doses, and more than 115 million Americans are fully vaccinated. Pfizer doses account for nearly 140 million doses of the total administered.