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www.fdanews.com/articles/204088-officials-investigate-link-between-modernas-vaccine-and-myocarditis-in-younger-adults

Officials Investigate Link Between Moderna’s Vaccine and Myocarditis in Younger Adults

August 23, 2021

Federal officials are said to be examining whether Moderna’s COVID-19 vaccine is linked with higher risks of heart inflammation in younger people than once thought, possibly delaying the shot receiving authorization for adolescents.

And the Moderna vaccine may have a higher risk of myocarditis than Pfizer/BioNTech’s rival messenger RNA (mRNA)-based vaccine, particularly for young men below 30 years old.

In late June, an expert panel with the Centers for Disease Control and Prevention (CDC) concluded that a probable link exists between heart inflammation and receiving a jab with either the Moderna or Pfizer/BioNTech vaccines, following a review of 1,226 reported cases of mRNA-associated myocarditis or pericarditis, mainly occurring in adolescents and males under 30 years of age (DID, June 24).

Now, the CDC and FDA are looking at that data with fresh eyes to see if the Moderna vaccine’s Emergency Use Authorization should be revised to include teenagers aged 12 to 17, which the company requested on June 10. The drugmaker has also filed a biologics license application seeking full approval of its vaccine in people ages 18 years and older (DID, June 2).

The CDC did not provide comment, while the FDA said it “won’t comment on internal meetings or discussions” but is “absolutely committed to reviewing data as it becomes available to us.”

“We have previously communicated about myocarditis and COVID-19 vaccines and if new information changes the risk/benefit profile, we will update the public accordingly,” said the agency spokesperson Friday. ― Jason Scott