BREAKING: Moderna Asks FDA to Authorize COVID Vaccine for Kids Under 6 Years Old
Dr. Peter Marks, who heads the FDA office responsible for vaccines, told the Senate health committee this week that the drug regulator's committee of independent advisors will meet to fully review the data.
"We will proceed with all due speed once we have complete applications," Marks said. He told the committee that the FDA will publish a timeline in the next week for advisory committee meetings on several emergency-use applications. The FDA is in the process of clearing several potential dates for the committee to meet in June, according to a person familiar with matter.
Parents have been waiting for months for a way to protect their children against the virus. During the winter omicron wave, children younger than 5-years-old were hospitalized with Covid at five times the rate of the pandemic's peak, when delta was dominant,About 75% of children under 11 years old had been infected with Covid as of February, according to data released by the CDC this week.
The FDA had originally sought to fast track authorization of Pfizer's Covid vaccine for children under age 5 in February by clearing the first two doses of the three-shot vaccine. However, Pfizer decided to postpone its application and wait for data on the third shot, because the results from the first two doses weren't good enough., said the first two shots only had 30% to 40% efficacy, but he expects the third dose to significantly improve protection.
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