© 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 kids underneath 6 years previous can be prepared for overview 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 specialists to the U.S. drug regulator will meet in June to overview the request.
“I feel the FDA now have the entire core elementary information they want to have the ability to start an utility overview. 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 could possibly be the primary to win U.S. approval for kids underneath the age of 5. Pfizer Inc (NYSE:) additionally expects to have its vaccine information for kids underneath 6 prepared by the June overview.
“The security profile we have seen on this vaccine in these very youngest children 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 permitted by the FDA to be used in adults 18 and older. Nevertheless it has but to be permitted for 6- to 17-year-olds in the US 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 information.
Burton mentioned on Sunday the corporate is testing one other booster shot that he believes can 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 massive quantities of a brand new booster vaccine by this fall to guard towards Omicron and different COVID-19 variants, he mentioned.
