Moderna's expects COVID vaccine for kids under 6 ready for FDA June review - CBS
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Moderna's (NASDAQ:MRNA) Chief Medical Officer Paul Burton said the company's COVID vaccine for use in children below six years of age will be ready for review by a panel U.S. Food and Drug Administration (FDA) when it meets in June, CBS reported.
Last week (April 28), the company submitted a request to the FDA for emergency use authorization (EUA) of the COVID-19 vaccine in children aged six months to six years. Moderna had noted that it expects to complete the filing in a week.
"I think the FDA now have, you know, all of the core fundamental data they need to be able to begin that application review," Burton said in an interview on CBS's Face the Nation.
An FDA panel is expected to meet in June.
According to Moderna (MRNA) the vaccine's efficacy was at 51% for children 6 months to <2 years and 37% for 2 years to <6 years.
On the question of efficacy Burton said, "Now the number, 50%, I know is- is often lower than we are used to seeing without our- our vaccine, but it's because this study was conducted during a time of Omicron."
Burton noted that the safety profile seen with this vaccine in these young children was "very reassuring."