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US considers authorization of first COVID vaccine for children under 5
A decision is expected as soon as this month.
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A child receives a dose of Pfizer's Covid-19 vaccine at an event launching school vaccinations in Los Angeles, California on November 5, 2021. (AFP/Frederic J. Brown)
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 and BioNTech SE began the regulatory approval process on Tuesday.
A decision is expected as soon as this month.
The companies said they began submitting data for an emergency use authorization even though they did not meet a key target in their clinical trial of 2- to 4- year olds. They are submitting the data at the request of the US Food and Drug Administration in order to address an urgent public health need in the age group, they said.
The arrival of a vaccine for younger children could help harried parents who have had to contend with quarantines and closures of pre-schools and daycare centers.
"Having a safe and effective vaccine available for children in this age group is a priority," acting FDA Commissioner Janet Woodcock said. She said the agency asked for the application because of the recent Omicron surge.
The FDA said an outside committee of expert advisers would meet on Feb. 15 to discuss the authorization. If that goes forward, the US 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.
The drug companies said they are asking the FDA for authorization of the first two doses of a planned three-dose regimen.
