Parents hoping to vaccinate their youngest children against COVID-19 may soon get the relief they've been waiting for.
Pfizer-BioNTech announced Monday that testing shows its three-shot COVID-19 vaccine is safe, well-tolerated and 80% effective at preventing illness in children ages 6 months to under 5 years -- the only group in the U.S. not yet eligible for COVID-19 vaccination.
"Our COVID-19 vaccine has been studied in thousands of children and adolescents, and we are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response," Pfizer CEO Albert Bourla said in a statement.
The drug maker plans to submit the test results to the U.S. Food and Drug Administration in a bid to have the vaccine authorized for emergency use in younger children.
"We are preparing the relevant documents and expect completing the submission process to the FDA this week, with submissions to [European Medicines Agency] and other regulatory agencies to follow within the coming weeks," BioNTech CEO Ugur Sahin said in a statement.
Pfizer started the authorization process of the vaccine in younger children in February 2022 at the request of the FDA. At that time, a two-dose series was determined to be well-tolerated in this age group, but not at levels high enough for authorization.
Additional testing of a third dose, administered at a time when Omicron was the predominant variant, suggests that children experience benefits from a "booster" similar to adults that raises efficiency levels to meet all criteria required for Emergency Use Authorization by the FDA, Pfizer said.
Moderna has also submitted data for FDA authorization of its vaccine in the same age group.
The FDA is planning to meet next month to discuss both pediatric COVID vaccines and could possibly authorize them for use as soon as June 16 or 17, The Washington Post reported.
"We know parents are anxious for us to determine if these vaccines are safe & effective," the FDA said on Twitter. "We are working as quickly as possible to carefully review all the data."
The FDA did not provide a timetable for when a decision is expected.
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