WASHINGTON (AP) — U.S. regulators are urging drugmaker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for...
Early Pfizer data has shown the vaccine — which is administered to younger kids at one-tenth the strength of the adult shot — is safe and produces an immune response.
Now, the Food and Drug Administration is pushing the company to submit its application based on the two-dose data for potential approval in February, and then to return for additional authorization once it has the data from the third dose study, which is expected in March, the person familiar with the matter said.
That would be welcome news for parents of young children, the last remaining age group without approval of COVID-19 shots. Speeding the authorization of pediatric vaccines against COVID-19 has been a priority for more than a year of the Biden administration, which believes them critical to reopening and keeping open schools and day care centers — and for freeing up parents occupied by childcare responsibilities to return to the workforce.
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US Urges Pfizer to Apply for Under-5 COVID Shots: AP SourceU.S. regulators are urging drugmaker Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children 6 months to 5 years old
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AP source: US urges Pfizer to apply for under-5 COVID shotsRegulators are urging Pfizer to apply for emergency authorization for a two-dose regimen of its COVID-19 vaccine for children 6 months-5 years old while awaiting data on a three-dose course, aiming to clear the way for the shots as soon as late February.
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US urges Pfizer to apply for COVID vaccine shots for kids under 5U.S. regulators are urging Pfizer to apply for emergency authorization for its COVID-19 vaccine for children 6 months to 5 years old, aiming to clear the way for the shots as soon as late February.
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Pfizer expected to ask for authorization of under-5 COVID shots as soon as TuesdayChildren as young as 6 months old could be eligible for the COVID-19 vaccine later this month.
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Pfizer expected to ask for authorization of under-5 COVID shots as soon as TuesdayChildren as young as 6 months old could be eligible for the COVID-19 vaccine later this month.
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U.S. urges Pfizer to apply for vaccine for children under 5The company's application was expected to be submitted as soon as Tuesday.
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