© Reuters. FILE PHOTO: A vial labelled “Moderna COVID-19 Vaccine” is seen on this illustration taken January 16, 2022. REUTERS/Dado Ruvic/Illustration/File Picture
By Doina Chiacu
WASHINGTON (Reuters) – Moderna (NASDAQ:) Inc’s chief medical officer mentioned on Sunday the corporate’s vaccine for youngsters beneath 6 years previous might be prepared for evaluate by a Meals and Drug Administration panel when it meets in June.
Moderna sought emergency use authorization from the FDA on Thursday.
An advisory panel of consultants to the U.S. drug regulator will meet in June to evaluate the request.
“I feel the FDA now have all the core basic knowledge they want to have the ability to start an software evaluate. So sure, we’re very assured,” Dr. Paul Burton, the corporate’s chief medical officer, mentioned in an interview with CBS’ “Face the Nation.”
Moderna’s vaccine might be the primary to win U.S. approval for youngsters beneath the age of 5. Pfizer Inc (NYSE:) additionally expects to have its vaccine knowledge for youngsters beneath 6 prepared by the June evaluate.
“The security profile we have seen on this vaccine in these very youngest youngsters could be very reassuring – precise charges of security occasions even decrease than we have seen within the 6-year-olds to 12-year-olds and that is nice,” Burton mentioned.
Moderna’s vaccine is accepted by the FDA to be used in adults 18 and older. However it has but to be accepted for 6- to 17-year-olds in the USA regardless of gaining approval for that age group in Australia, Canada and the European Union. U.S. regulators have requested the corporate for extra security knowledge.
Burton mentioned on Sunday the corporate is testing one other booster shot that he believes might be superior to booster outcomes the corporate introduced on April 19. The booster pictures goal the Beta variant plus the unique coronavirus.
Moderna expects to have giant quantities of a brand new booster vaccine by this fall to guard towards Omicron and different COVID-19 variants, he mentioned.