Pfizer, BioNTech Submit Initial Data for Shot in Young U.S. Kids
(Bloomberg) -- Pfizer Inc. and partner BioNTech SE said they have submitted initial data to U.S. regulators about the use of their Covid-19 vaccine in children ages 5 to 11, one step closer to bringing shots to school-age kids.
The companies said in a statement that they expect to make a formal request for emergency authorization in the coming weeks. Submissions to regulators in Europe and elsewhere are also planned.
On Sept. 20, the companies said their vaccine was safe and had produced strong antibody responses in children ages 5 to 11 in a trial with 2,268 participants. Two doses in school-age kids of 10 micrograms -- one-third the adult shot -- produced antibody levels comparable to those seen in a trial of 16- to 25-year-olds who got the adult dose, the companies said at the time.
Tuesday’s statement didn’t include any additional results about the efficacy and side effects in younger kids.
Clearance in school-age kids would herald a crucial new part of the immunization campaign in the U.S., where the Pfizer vaccine already has full approval for people 16 and older and is authorized on an emergency basis for ages 12 to 15. School reopenings have faltered in recent weeks as the delta variant leads to more cases of Covid-19 among children and teachers.
Even so, the U.S. Food and Drug Administration is likely to take a very careful look at the vaccine’s safety in younger kids. While kids get infected frequently and help spread the virus, they are at much lower risk of developing severe complications than older adults. In rare cases. the messenger RNA vaccines have been linked to heart inflammation and heart-lining inflammation, and the risk appears to be higher in young males.
Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has said that he hopes FDA clearance of Pfizer and BioNTech’s vaccine for young children will come by the end of October.
At the request of regulators, the companies previously have said they plan to add 2,250 more children between the ages of 5 and 11 to their pediatric studies. The trial is also studying even lower doses of the vaccine in kids under five, and Pfizer and BioNTech said in the statement that results from this group could come as soon as the fourth quarter.
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