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Pfizer and BioNTech plan to apply for FDA authorization this week for a booster COVID-19 vaccine for 16- and 17-year-olds.
“We expect to share updates on this soon,” Kit Longley, a Pfizer spokesman, told The Washington Post.
The FDA could authorize the extra dose within a week. If approved, the additional shot would be the first booster approved for those under age 18.
“Given the current overall situation of the pandemic, FDA will evaluate any such [emergency use authorization] request in a very timely manner,” the agency told the newspaper.
As countries around the world move to address the new Omicron variant, health officials have called on people to get vaccinated — and for fully vaccinated people to get their booster shots. On Monday, President Joe Biden called the vaccines “the best protection against this new variant or any of the variants out there.”
The Omicron variant hasn’t yet been detected in the U.S., though Biden administration officials have said in recent days that it’s expected to spread around the globe. As of Tuesday morning, 14 countries had reported more than 180 cases to GISAID, a global database for the genomic sequencing of viruses.
Federal regulators have cited recent data from Israel on booster shots as reassurance for authorizing booster doses for 16- and 17-year-olds, the newspaper reported. The studies have shown that serious side effects for younger people have been uncommon and mild.
Extending the age range for booster shots “before Omicron hits can potentially help and certainly won’t hurt,” Jeanne Marrazzo, MD, an infectious disease doctor at the University of Alabama at Birmingham, told the Post.
On Nov. 19, the FDA authorized booster shots of the Pfizer and Moderna vaccines for people ages 18 and older. All adults who received the one-shot Johnson & Johnson vaccine are also eligible for a booster.
Sources :
The Washington Post: “Pfizer set to request authorization for coronavirus booster for 16- and 17-year-olds.”
GISAID: “Map of tracked variant occurrence: B.1.1.529.”
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