Prognosis
Pfizer Seeks FDA Clearance for Covid Shot in Children Under Five
- Vaccine partners approach FDA with rolling submission of data
- Pfizer seeks green light for children 6 months to 4 years old
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Pfizer Inc. and partner BioNTech SE said they have begun submitting data to U.S. regulators for authorization of their Covid-19 vaccine in younger children, hastening an effort to get shots to more kids after the omicron wave caused pediatric infections to jump.
The companies said in a statement that they have started a so-called rolling submission with the U.S. Food and Drug Administration seeking an emergency authorization for the vaccine in children 6 months to four years of age. A panel of outside advisers is scheduled to meet Feb. 15 to consider the request, according to a statement from the agency.