Pfizer and BioNTech announced Tuesday that they have submitted clinical trial data to the Food and Drug Administration for their COVID-19 vaccine in children ages 5 to 11.
Last week, the drugmakers announced that their vaccine is safe and generated "robust neutralizing antibody responses" in that age group.
The data are being shared with the FDA for the agency’s initial review. The companies said they plan to formally request in the coming weeks that regulators expand the vaccine’s emergency use authorization to include children 5 to 11.
The Pfizer-BioNTech vaccine received emergency use authorization for people 16 and older in December and was given full FDA approval in August. The vaccine has been authorized for emergency use in 12- to 15-year-olds since May.
It took the FDA about a month to approve the companies’ request to authorize the vaccine for ages 12 to 15. If the process follows a similar timeline, the shots could be available to children 5 to 11 sometime in November.
Pfizer and BioNTech said the clinical trial has shown that the lower dosage of the vaccine in 5- to 11-year-olds generates antibody levels just as strong as in teenagers and young adults after the second dose.
Side effects — such as fever, achiness or sore arms — were similar to those observed in people ages 16-25.
Nearly 928,000 cases of COVID-19 have been reported in children over the past four weeks, according to the American Academy of Pediatrics. While pediatric cases are on the decline, children and adolescents accounted for 26.7% of reported infections in the week ending on Sept. 23.
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