US FDA Delays Decision on Moderna's COVID-19 Vaccine for Adolescents: WSJ

By Reuters Staff

October 19, 2021

(Reuters) - The U.S. health regulator is delaying its decision on authorizing Moderna Inc's COVID-19 vaccine for adolescents to check if the shot could increase the risk of heart inflammation, the Wall Street Journal reported on Friday, citing people familiar with the matter.

The U.S. Food and Drug Administration (FDA) has been looking into the risk of myocarditis among younger men vaccinated with Moderna's shot, especially compared with Pfizer's vaccine, after certain Nordic countries limited use of the shot, the Wall Street Journal report said.

The agency has not yet determined whether there is heightened risk, the report added.

Earlier this month, Finland, Sweden and Denmark paused the use of Moderna's COVID-19 shot for younger males due to reports of myocarditis in men.

The Danish Health Agency, however, later said the vaccine was available to under-18s, and that a statement on Wednesday suggesting a suspension had, in fact, been a miscommunication.

The FDA and Moderna did not immediately respond to requests for comment.

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