The company's application was expected to be submitted as soon as Tuesday.
U.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 while awaiting data on a three-dose course, aiming to clear the way for the shots as soon as late February, a person familiar with the matter told the Associated Press on Monday.
That would be welcome news for parents of young children, the last remaining age group without approval of COVID-19 shots.The decision was bolstered by real-world evidence from the more than 200 million doses administered in the U.S. since the FDA cleared the shot in December 2020. 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 child-care 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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Pfizer vaccine for children under 5 may be available in U.S. by end-Feb - reportPfizer Inc and Germany's BioNTech SE are expected to submit an emergency use authorization request as early as Tuesday to the U.S. Food and Drug Administration (FDA) for vaccines for children aged six months to 5 years, the Washington Post reported on Monday.
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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
続きを読む »
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.
続きを読む »
Pfizer vaccine for children under 5 may be available in U.S. by end-Feb - reportPfizer Inc and Germany's BioNTech SE are expected to submit an emergency use authorization request as early as Tuesday to the U.S. Food and Drug Administration (FDA) for vaccines for children aged six months to 5 years, the Washington Post reported on Monday.
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