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Moderna Shares Sink After Report of Delay on Children’s Vaccine

Moderna Shares Sink After Report of Delay on Children’s Vaccine

Moderna Inc. shares fell after a report that U.S. regulators had put a decision on authorization of its Covid-19 shot for younger kids on hold over concerns about heart-related side effects.

Shares of the biotechnology company fell 2.3% to $324.21 at 4 p.m. on Friday in New York.

The Wall Street Journal reported, citing unidentified people familiar with the matter, that the Food and Drug Administration is delaying a decision on allowing younger people to receive the vaccine while it looks into whether it may lead to heightened risk of myocarditis, a rare inflammatory heart condition.

According to the Journal’s report, regulators hadn’t determined yet if there is an elevated risk, and that the extent of the delay wasn’t clear.

Moderna’s vaccine is currently authorized for people 18 years or older in the U.S. The competing messenger RNA vaccine from Pfizer Inc. and BioNTech SE has been fully approved for people 16 and up, and authorized on an emergency basis for ages 12-15.

Moderna’s application for authorization for its vaccine in 12-to-17 year-olds was submitted to the FDA in early June, more than four months ago.

The FDA is evaluating Moderna’s submission and will update the public when it has more information to share, an agency spokesperson said in an email statement.

Representatives for Moderna didn’t respond to a request for comment.

Earlier this month, Sweden and Denmark opted to halt vaccinations with Moderna’s shot for younger people because of potential side effects, recommending the Pfizer-BioNTech shot as an alternative. Iceland and Finland also halted Moderna doses for younger people.

While myocarditis has been recorded in rare instances among mostly young men who received messenger RNA vaccines, it is far more likely that an individual would develop the condition as a result of contracting Covid-19, according to health experts.

Patients with Covid-19 had nearly 16 times the risk for myocarditis compared with patients who didn’t have Covid-19, according to the U.S. Centers for Disease Control and Prevention.

The report of the delay comes less than 24 hours after advisers to the FDA backed a third-dose booster shot for people who received the Moderna vaccine as their initial inoculation. The same panel is weighing a potential Johnson & Johnson booster on Friday.

©2021 Bloomberg L.P.