Moderna in talks with U.S. regulators to expand COVID-19 vaccine pediatric study | CBC News

Moderna expects to have a package that supports authorization in winter of 2021 or early 2022, a company spokesperson told Reuters.

Earlier in the day, the New York Times reported that U.S. regulators have asked mRNA-based vaccine makers Pfizer-BioNTech and Moderna to expand the size of the trial.

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

Pfizer said it has not provided any updates to its previously stated timelines. It had previously said it expects to have data for children aged between 5 and 11 in September.

The health regulator has asked the companies to include 3,000 children in their trials, almost double the original number of study participants, the report said, citing people familiar with the matter.

The U.S. FDA did not immediately respond to Reuters’ request for comment.