Moderna to seek regulatory approval for COVID shot for very young children

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March 23 (Reuters) – Moderna Inc (MRNA.O) 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.

The Omicron variant of COVID-19 was predominant during Moderna’s pediatric trial, and the drugmaker said two doses were around 38% effective in preventing infections in 2 to 5 year olds and 44% effective for children 6 months to under 2 years old

It said these figures were consistent with the lower effectiveness against Omicron seen in adults who had received two doses of its vaccine.

Moderna’s vaccine could be the first authorized shot for children under the age of 5 in the United States, and many parents of young children have been waiting on a vaccine.

A rival shot made by Pfizer Inc (PFE.N) and Germany’s BioNTech SE (22UAy.DE) 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. read more

“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.


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