Moderna Plans to Expand its Covid Vaccine Trial for Younger Children

Drug maker Moderna has announced plans to expand its COVID-19 vaccine trial of kids 5 to 11 of age and will be seeking clearance with the Food and Drug Administration (FDA) as early as year-end.

The company confirmed to CNBC on Monday it plans to expand the size of its clinical trial.

Moderna is expanding the trial, which began in late March, to increase the likelihood of detecting potential rare side effects, the company said.

It was in June that the FDA had added a warning label to the Pfizer and Moderna Covid-19 vaccines to list a rare risk of heart inflammation, which was reported in young people, as a potentially rare side effect.

Last month health officials said there had been more than 1,200 cases of a myocarditis (inflammation of the heart muscle) or pericarditis (inflammation of the tissue surrounding the heart) mostly in people age 30 and under who received the shots.

There have been just 12.6 heart inflammation cases per million doses for both vaccines combined, officials said at the time. They added the benefits still outweighed the risks.

“It is our intent to expand the trial and we are actively discussing a proposal with the FDA,” the company told CNBC. “At this point, we expect to have a package that supports authorization in winter 2021/early 2022, should the FDA choose to use the authorization avenue.”

The NY Times had also reported on Monday that the FDA has asked both Moderna as well as pharma giant Pfizer to include 3,000 children in the 5-11 year old trials, citing unnamed sources.

According to one of the sources, this number was double the original number of study participants that the company had planned.

In a statement to CNBC, Pfizer said it has not provided any updates to the previously stated timelines or details for its trial.

Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.