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CAMBRIDGE, Mass. (WBZ NewsRadio) — Moderna revealed the Phase 2/3 study of their COVID-19 vaccine in children ages 6 to 11. The vaccine found a strong immune response, Moderna said in a statement, after two doses and with a favorable safety profile.
The study, called “KidCOVE,” administered two 50 microgram doses 28 days apart, about half of the vaccine dose for adults.
There were 4,753 children participants, all of which will be monitored for a year following their second shot. Moderna said they will continue to enroll participants in the younger age group, children ranging from ages 6 months to 5 years old. They plan to submit KidCOVE data to the U.S Food and Drug Administration and a peer-reviewed publication.
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On Tuesday, the FDA will have an advisory committee meeting to inform the public on their decision regarding Pfizer's COVID vaccine for children ages 5 to 11.
The meeting will be live streamed October 26, on the FDA's YouTube channel.
"We know from our vast experience with other pediatric vaccines that children are not small adults," said Acting FDA Commissioner Janet Woodcock, M.D. She said, "We will conduct a comprehensive evaluation of clinical trial data submitted in support of the safety and effectiveness of the vaccine used in a younger pediatric population."
The FDA said that they plan on making background materials for the meetings available to the publics, such as meeting agendas and committee rosters.
WBZ's Jeff Brown (@jeffbrownwbz) reports.
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