U.S. approves use of Moderna vaccine for children: EU rejects idea due to risk of heart inflammation

Advisors to the U.S. Food and Drug Administration (FDA) unanimously recommended on June 14 that the agency approve Moderna Inc.'s (MRNA.O) vaccine for children and teens aged 6 to 17 years Reuters.

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About 77 million people in the United States have received at least two doses of the Moderna vaccine, which has long been available to people aged 18 and over.

A committee of outside experts is due June 15 to review the Moderna vaccine for children under 6 years of age, as well as the Pfizer (PFE.N) and BioNTech (22UAy.DE) COVID vaccine for children under 5 years of age - and in both cases from the age of 6 months.

It is unlikely that there will be significant demand for the Moderna vaccine for children aged 6 to 17 years. The Pfizer/BioNTech vaccine was approved for children aged 5 to 11 years in October, and approval for teenagers preceded it by several months.

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However, according to the US Centers for Disease Control and Prevention (CDC), only about 30% of children aged 5 to 11 and 60% of children aged 12 to 17 are fully vaccinated in the United States.

“I would like to give parents as many choices as possible and let them make the decisions for their children,” committee member and UC Berkeley professor Dr. Arthur Reingold said at the meeting.

The FDA, which normally follows the advice of its advisors but is not required to do so, will likely soon approve the Moderna vaccine for children ages 6 to 17. The CDC must also recommend the use of the vaccine. Meetings of the committee of its advisers are scheduled for June 17 and 18.

There has long been concern that the Moderna vaccine, which is given at a higher dose than the Pfizer/BioNTech vaccine, could cause inflammation of the heart known as myocarditis and pericarditis to a higher degree, primarily in young men.

Some countries in Europe have restricted use of the Moderna vaccine to younger age groups after observations showed it was associated with a higher risk of heart inflammation and the FDA delayed review of the vaccine to assess the risk of myocarditis.

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U.S. regulators presented data at a June 14 meeting suggesting the Moderna vaccine may have a higher risk of heart inflammation in young men, but said the results are inconsistent across different safety databases and are not statistically significant, meaning they may be random.

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