Pfizer and BioNTech have begun submitting data to U.S. regulators to seek emergency use authorization of their COVID-19 vaccine for children under the age of 5, despite weaker-than-expected immune responses in their clinical trial of 2- to 4-year-olds
A person walks past a Pfizer logo in the Manhattan borough of New York City, New York, U.S., April 1, 2021. REUTERS/Carlo AllegriFeb 1 - U.S. regulators are considering the first COVID-19 vaccine for children under the age of 5, the only age group not yet eligible for the shots, after Pfizer IncA decision is expected as soon as this month.
The FDA said an outside committee of expert advisers would meet on Feb. 15 to discuss the authorization. If that goes forward, the U.S. Center for Disease Control and Prevention also needs to sign off on how the vaccinations will be implemented, following a meeting of its own advisers. Those meetings have tended to follow within a week or so of FDA decisions.
He said the company believes three doses of the vaccine will be needed "to achieve high levels of protection against current and potential future variants." The companies said they expect to have ample supply of the 3-microgram shots should the FDA authorize the vaccine.The move could speed up the inoculation timeline for this age group by months. If a third dose is eventually authorized, many children could already have begun the regimen. Pfizer is currently testing two doses three weeks apart, followed by a third dose at least eight weeks later.
"I cannot think of any example ever where the FDA reached a regulatory decision without knowing the data from the end of the trial," Grabenstein said. "I just can't believe that they would authorize getting started without knowing what the third dose would do."
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