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Pfizer and its partner, BioNTech, are expected to ask the Food and Drug Administration as soon as Tuesday to authorize a two-dose coronavirus vaccine for children 6 months to 4 years old while continuing to investigate how well the three doses work.
Federal regulators are concerned about reviewing the data in hopes of allowing shootings to minors in an emergency by the end of February, according to many familiar with the controversy. Had Pfizer waited for data on a three-dose regimen, the data would not be available until the end of March, and the vaccine may not be approved for that age group until weeks later, according to many familiar with the situation.
Federal officials and Pfizer executives have been suggesting for days that an application for the urgent authorization of a vaccine for the youngest children is on the way. Pfizer board member and former Food and Drug Administration commissioner, Scott Gottlieb, told CBS News. He said on Sunday that the vaccine could be approved by March. Development was the first reported by the Washington Post.
As the Omicron variant swept the country, there was a sharp increase in pediatric cases of the virus. according to this the American Academy of Pediatrics, which collects state-level data. While young children tend to cope well with the virus, some can get very sick. Federal officials were worried about starting a vaccination program for the youngest children because research showed there were no safety concerns with the two doses.
Pfizer and BioNTech in mid-December announced Two doses of the vaccine, given at one-tenth of an adult dose, did not produce a strong enough immune response in children aged 2 to 4 years.
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