Pfizer should ask the FDA to authorize its Covid vaccine for children under 5.

Pfizer and its partner BioNTech are expected as early as Tuesday to ask the Food and Drug Administration to authorize a coronavirus vacc...


Pfizer and its partner BioNTech are expected as early as Tuesday to ask the Food and Drug Administration to authorize a coronavirus vaccine for children 6 months to 4 years old as a two-dose schedule while continuing to research the effectiveness of three doses. .

Federal regulators are eager to review the data in hopes of authorizing injections for young children on an emergency basis as early as late February, according to several people familiar with the discussions. If Pfizer was expecting data on a three-dose schedule, the data would not be submitted until late March and the vaccine may not be licensed for this age group until weeks later, according to several people familiar with the situation.

Federal officials and Pfizer executives had been suggesting for days that a request for emergency authorization of a vaccine for younger children was in the works. Pfizer board member and former Food and Drug Administration commissioner Scott Gottlieb told CBS News Sunday that the vaccine could be authorized as early as March. The development was first reported by the Washington Post.

As the Omicron variant invaded the country, there was a sharp increase in pediatric cases of the virus, according to the American Academy of Pediatrics, which collects state-level data. Although young children tend to fight the virus well, some can get very sick. Federal officials were eager to begin a vaccination program for younger children because studies showed there were no safety concerns with two doses.

Pfizer and BioNTech in mid-December announcement that two doses of the vaccine, given at one-tenth the amount given to an adult, did not produce a sufficiently strong immune response in children aged 2 to 4 years.

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Newsrust - US Top News: Pfizer should ask the FDA to authorize its Covid vaccine for children under 5.
Pfizer should ask the FDA to authorize its Covid vaccine for children under 5.
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