Moderna says its vaccine for ages under 6 will be ready for U.S. review in June

cde.news desk 2 May 2022, 12:00 · 1 min read

epa09711225 A health worker prepares a dose of the covid-19 vaccine as a child looks on, during an immunization day for children in Rio de Janeiro, Brazil, 26 January 2022. The advance of the omicron variant of the coronavirus puts pressure on the Brazilian hospital system, which registers its highest levels of covid-19 cases since the start of the pandemic and already has 19 of its 27 states on alert, authorities reported this 26 January. However, despite the sharp rise in cases and the considerable increase in deaths, experts agree that the scenario is still quite far from the most critical moment of the pandemic, something they attribute to the progress of the immunization campaign. EPA-EFE/ANDRE COELHO

Moderna Inc’s chief medical officer said on Sunday the company’s 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.

“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 also expects to have its vaccine data for children under 6 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 6-year-olds to 12-year-olds and that’s great,” Burton said.

Moderna’s vaccine is approved by the FDA for use in adults 18 and older.

via Reuters

Topics Coronavirus Moderna