FDA delays decision on Moderna's COVID-19 vaccine in 12-17 age group because of myocarditis concerns: WSJ

After reports in four Nordic countries of the heart inflammation condition myocarditis, the FDA has delayed a decision on the Moderna COVID-19 shot for kids between the ages of 12 to 17, The Wall Street Journal reports.  

This month the shot was closing in on a nod, the newspaper reports, but now officials are taking a closer look at the vaccine's safety profile.

The move comes after four countries—Denmark, Finland, Norway and Sweden—recommended against use of the Moderna shot by those under the age of 30. Some countries have said that young people should instead get the Pfizer vaccine.

The concerns could lead the Pfizer shot to become the vaccine of choice for kids in that age group in the U.S. The company won FDA authorization for the 12 to 15 age group in May and has steered largely clear of myocarditis concerns in recent weeks. More than 12 million people ages 12 to 17 in the United States have received the Pfizer vaccine, according to the CDC.

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“People can be reassured that the risk of myocarditis with an mRNA vaccine is low, it appears to be balanced between the different products,” Moderna chief medical officer Paul Burton told The WSJ, while also pointing out that there is no significant difference between the myocarditis rates for those in the 18 to 25 age group who have been vaccinated with the Moderna and Pfizer shots.

In a study of 3,700 adolescents who received the Moderna vaccine, there were no reports of myocarditis. The company then followed up in June with a request to the FDA to expand use of its vaccine in teenagers.