- Moderna Inc's (NASDAQ:MRNA) chief medical officer said that its COVID-19 vaccine for children under six years old would be ready for review by the FDA panel when it meets in June.
- "I think the FDA now has all of the core fundamental data they need to be able to begin an application review. So yes, we're very confident," Paul Burton, the company's chief medical officer, said in an interview with CBS' "Face the Nation."
- Related: FDA Sets Review Dates For Pfizer, Moderna COVID-19 Shot For Kids, Plus Novavax EUA.
- Moderna's vaccine could be the first to win FDA approval for children under the age of 5.
- Pfizer Inc (NYSE:PFE) - BioNTech SE (NASDAQ:BNTX) 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 6-year-olds to 12-year-olds, and that's great," Burton said.
- Moderna's vaccine is yet to be approved for 6- to 17-year-olds in the U.S. despite gaining approval for that age group in Australia, Canada, and the European Union.
- FDA has asked the company for more safety data.
- Burton added that Moderna expects to have large amounts of a new booster vaccine by this fall to protect against Omicron and other COVID-19 variants.
- Price Action: MRNA shares are up 5.24% at $141.45 during the market session on the last check Monday.
- Photo by mufidpwt via Pixaby
