U.S. FDA delays decision on Moderna's COVID-19 vaccine for adolescents - WSJ

By Kitco News / October 15, 2021 / www.kitco.com / Article Link

(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.wsj.com/3p3P5Zp on Friday, citing people familiar with the matter.

Moderna's shares fell nearly 2% to $326.25 in midday trading after the report.

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 the side effect, 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.

Reporting by Amruta Khandekar; Editing by Devika Syamnath

Disclaimer: The views expressed in this article are those of the author and may not reflect those of Kitco Metals Inc. The author has made every effort to ensure accuracy of information provided; however, neither Kitco Metals Inc. nor the author can guarantee such accuracy. This article is strictly for informational purposes only. It is not a solicitation to make any exchange in commodities, securities or other financial instruments. Kitco Metals Inc. and the author of this article do not accept culpability for losses and/ or damages arising from the use of this publication.

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