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Moderna To Ask FDA To Authorize Vaccine For Children As Young As 6 Months

moderna-to-ask-fda-to-authorize-vaccine-for-children-as-young-as-6-months

Moderna on March 23 said its clinical trial for its COVID-19 vaccine in children aged 6 months to 5 years old successfully met its primary endpoint. The company plans to ask the Food and Drug Administration (FDA) to grant emergency use authorization for the age group, even though the estimated effectiveness is lower than the bar set by the FDA and the World Health Organization. Moderna, a Massachusetts-based biotechnology firm, said the phase 2/3 trial showed the safety profile in young children was similar to that seen in adults and older kids, with no cases of post-vaccination heart inflammation recorded. The company also said the vaccine provided a similar neutralizing antibody response to that seen in adults 18 to 25 years of age, who have been cleared since December 2020 to get a two-dose regimen. “We believe these latest results from the KidCOVE study are good news for parents of …  » Read full article

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