Moderna Inc said on Wednesday it will ask regulators to authorize its COVID-19 vaccine in children younger than 6 years old based on data showing it generated a similar immune response to adults in its clinical trial.
is authorized for use in children 5 and older. But their trial results for 2- to 4-year olds showed a weaker immune response than in adults, forcing the trial to be extended to test a third dose. Results are expected in April."Given the need for a vaccine against COVID-19 in infants and young children we are working with the U.S. FDA and regulators globally to submit these data as soon as possible," Moderna Chief Executive Stephane Bancel said in a statement.
The dose size tested was 25 micrograms - a quarter of the dose that adults receive for each of their first two shots. "FDA did ask us to evaluate lower doses and we intend to do so," said Moderna's Miller. "However, we believe that the current data really support the dose selections that we have made in this age group... We are confident in the dose that we've chosen."
U.S. regulators have asked the company for more safety data and the FDA also said it needed additional time to evaluate the risk of a type of heart inflammation called myocarditis after vaccination in the age group, a rare side effect that has primarily affected young males.
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Moderna Will Seek Emergency Use Approval For Low-Dose Covid Vaccine In Kids Under 6I am a London-based reporter for Forbes covering breaking news. Previously, I have worked as a reporter for a specialist legal publication covering big data and as a freelance journalist and policy analyst covering science, tech and health. I have a master’s degree in Biological Natural Sciences and a master’s degree in the History and Philosophy of Science from the University of Cambridge. Follow me on Twitter theroberthart or email me at rhartforbes.com
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