© Reuters. FILE PHOTO: A vial labeled “Vaccine Modern COVID-19” is seen in this illustration made on January 16, 2022. REUTERS / Dado Ruvic / Illustration / File Photo
By Doina Chiacu
WASHINGTON (Reuters) – The medical director of Moderna (NASDAQ:) Inc. said on Sunday that the company’s vaccine for children under 6 will be ready for review by a Food and Drug Administration group when it meets in June.
Moderna applied for emergency use authorization from the FDA on Thursday.
An advisory group of US drug regulators will meet in June to consider the request.
“I think the FDA now has all the basic data they need to be able to start a review of the application. So yes, we’re very confident,” Dr. Paul Burton, the company’s medical director, said in an interview with “Face the Nation ”on CBS.
The Moderna vaccine could be the first to obtain US approval for children under 5 years of age. Pfizer Inc (NYSE:) also expects vaccine data for children under 6 to be ready by the June review.
“The safety profile I’ve seen in this vaccine in these very young children is very reassuring – the actual safety rates are even lower than we’ve seen in 6- to 12-year-olds, and that’s great,” he said. Burton.
The Moderna vaccine is FDA approved for use in adults 18 years of age and older. But it has not yet been approved for young people between the ages of 6 and 17 in the United States, although it has been approved for that age group in Australia, Canada and the European Union. U.S. regulators have asked the company for more safety data.
Burton said Sunday that the company is testing another booster injection, which it believes will be superior to the booster results announced by the company on April 19. Booster injections target Beta plus the original coronavirus.
Moderna expects to have large quantities of a new booster vaccine by this fall to protect against Omicron and other COVID-19 variants, he said.