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FDA Delays Approval for Moderna's Teen Vaccine, Needs More Time to Study Risk of Fatal Heart Condition

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Fears over the safety of Moderna’s coronavirus vaccine mean that its plan to market a vaccine for adolescents is on hold.

The company announced Sunday that the Food and Drug Administration had notified it that its emergency use authorization request for vaccinating Americans in the 12-17 age range is on hold because the FDA “has notified the Company that it will require additional time to complete its assessment.”

Based on 2019 data, that covers about 25 million Americans.

The age group Moderna sought to vaccinate is partially covered. The FDA has approved an emergency use authorization for a vaccine made by Pfizer-BioNTech in those ages 12 to 15. Pfizer also has FDA support for an emergency use authorization for its vaccine targeting 5- to 11-year-olds, with the final decision expected this week, according to The Washington Post.

The move comes after California announced a vaccine mandate for all public school students and as other districts are making similar moves.

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The big roadblock to FDA approval is the risk of myocarditis, the company said.

Moderna said it was told that the FDA’s review might not be finished this year.

“The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence,” it said in its statement.

“An increased risk of myocarditis has been described for COVID-19 vaccines, including the Moderna COVID-19 vaccine, particularly in young men and following the second dose,” the company said.

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Moderna quoted the Centers for Disease Control and Prevention and the World Health Organization as saying such cases as have taken place were “rare and generally mild.”

However, that is not the way several European countries saw it.

Swedish health officials last month extended indefinitely the county’s moratorium on giving the Moderna vaccine to anyone under 31, according to the Daily Mail. The pause on the Moderna shots had been scheduled to end Dec. 1.

Finland, Iceland and Denmark have taken similar steps. Norway is encouraging men under 30 not to get the Moderna shot but is not banning it.

For months, the Moderna vaccine has been under scrutiny because of data that shows young men who receive it are at increased risk for myocarditis, an inflammation of the heart muscle, or pericarditis, an inflammation of the sac around the heart.

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Although the risk of these diseases is linked to all of the COVID-19 vaccines, it is highest in young men injected with the Moderna vaccine.

The Daily Mail reported that one U.S. study that has not yet been peer-reviewed concluded that “young males under [age] 20 are up to six times more likely to develop myocarditis after contracting COVID-19 than those who have been vaccinated.”

Moderna announced in its statement that while its vaccine for adolescents is being reviewed, it will hold off on seeking an emergency use authorization for the vaccine it has developed for children between the ages of 6 and 11.

This article appeared originally on The Western Journal.

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