Moderna in talks with FDA to expand paediatric trial of COVID-19 vaccine

 


Moderna Inc. is in talks with US regulators to expand the scope of an ongoing trial testing its COVID-19 vaccine in children aged five to 11, the drugmaker said on Monday.


The goal of the discussions with the US Food and Drug Administration (FDA) is to build a larger safety database, which will increase the likelihood of detecting rarer events, the company said.

Moderna expects a package to support approval in the winter of 2021 or early 2022, a company spokesman told Reuters.


Earlier, the New York Times reported that US regulators had asked Pfizer Inc-BioNTech and Moderna to expand the scope of the trial.


They said the strength of the studies was insufficient to detect rare side effects, including myocarditis, an inflammation of the heart muscle, and pericarditis, an inflammation of the lining around the heart,


Pfizer said there has been no update to the previously announced timelines. The company had previously said it expected data in September for children aged five to 11.


The health regulator has asked the companies to include 3,000 children in their trials, nearly double the original number of study participants, according to the NYT report, which cited people familiar with the matter.

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