Moderna Inc’s MRNA.O chief medical officer said on Sunday the company’s COVID-19 vaccine for children under 6 years old will be ready for review by a Food and Drug Administration panel when it meets in June.
Moderna sought emergency use authorization from the FDA on Thursday.
An advisory panel of experts to the U.S. drug regulator will meet in June to review the request.
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“I think the FDA now have all of the core fundamental data they need to be able to begin an application review. So yes, we’re very confident,” Dr. Paul Burton, the company’s chief medical officer, said in an interview with CBS’ “Face the Nation.”
Moderna’s vaccine could be the first to win U.S. approval for children under the age of 5. Pfizer Inc PFE.N also expects to have its vaccine data for children under 6 ready by the June review.
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“The safety profile we’ve seen in this vaccine in these very youngest kids is very reassuring – actual rates of safety events even lower than we’ve seen in the 6-year-olds to 12-year-olds and that’s great,” Burton said.
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Moderna’s vaccine is approved by the FDA for use in adults 18 and older. But it has yet to be approved for 6- to 17-year-olds in the United States despite gaining approval for that age group in Australia, Canada and the European Union. U.S. regulators have asked the company for more safety data.
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Burton said on Sunday the company is testing another booster shot that he believes will be superior to booster results the company announced on April 19. The booster shots target the Beta variant plus the original coronavirus.
Moderna expects to have large amounts of a new booster vaccine by this fall to protect against Omicron and other COVID-19 variants, he said.
— Reporting by Doina Chiacu