Moderna’s Covid vaccine for teens awaits OK as regulators review

For months, the authorization of Moderna’s Covid-19 vaccine for teenagers has been on hold as the Food and Drug Administration reviews the risk of a rare but serious form of heart inflammation that’s affected mostly young men who got the company or Pfizer’s shots.

Moderna applied for emergency approval of its Covid vaccine for 12- to 17-year-olds in June, but the FDA told the company in October that its review of the vaccine for kids wouldn’t be finished before January.

The agency said it needed more time to examine the risk of myocarditis in vaccines based on mRNA technology, which is used in both company’s shots. The FDA, in a statement to CNBC on Wednesday, said it is conducting the review as fast as possible, but it cannot predict how long the evaluation will take. The review is intended to ensure the benefits of the vaccine outweigh the risks in adolescents, the agency said.

Messenger RNA, or mRNA vaccines, use genetic code to teach cells how to make a protein that triggers an immune response if someone gets infected with a virus. Traditional vaccines, like Johnson and Johnson’s, put inactivate germs into our bodies.

The FDA granted full approval for Moderna’s two-dose vaccine for adults on Monday, and the Centers for Disease Control and Prevention is expected to soon give its final OK. The CDC’s committee of vaccine experts is meeting Friday to review the latest data on on myocarditis in teens and adults.

Moderna said in October it would wait to ask the FDA to authorize its vaccine for 6- to 11-year-olds until the shot for teenagers gets the green light. The company expects to publish data on its vaccine for kids 2 to 5 years old in March.

Myocarditis is an inflammation of the heart muscle that can lead to serious health problems, according to the National, Heart Lung and Blood Institute. Viral infections are the most common cause of myocarditis. People are much more likely to develop myocarditis from Covid than the vaccines, and the risk to the heart can be more severe, according to the Department of Health and Human Services.

The risk of myocarditis from Covid is 100 times higher than developing the condition after vaccination, according to a recent paper in Nature Reviews Cardiology. Depending on the study, the risk of dying from Covid associated myocarditis is between 20% and 70%, while the risk of death from myocarditis due to vaccination is less than 1%, according to the paper.

Dr. Jose Romero, the former chairman of the CDC’s independent committee of vaccine experts, said myocarditis associated with vaccination is generally mild and resolves quickly.

“Whereas with myocarditis due to Covid, it’s more severe, it lasts longer, and the mortality rate can be significant,” said Romero, who serves as the secretary of health in Arkansas.

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