Coronavirus: Moderna says vaccine for ages under 6 ready for US review in June
- Moderna sought emergency use authorisation from the FDA on Thursday
- Advisory panel of experts to the US FDA will meet in June to review request
Moderna Inc’s chief medical officer said on Sunday the company’s vaccine for children under six years old will be ready for review by a Food and Drug Administration panel when it meets in June.
Moderna sought emergency use authorisation from the FDA on Thursday.
An advisory panel of experts to the US drug regulator will meet in June to review the request.
“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 US approval for children under the age of six. Pfizer Inc also expects to have its vaccine data for children under six ready by the June review.
“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 six-year-olds to 12-year-olds and that’s great,” Burton said.
