FDA Will Limit Approvals for Covid-19 Shots. Moderna Stock Soars. -- Barrons.com

Dow Jones

May 20, 2025

By Josh Nathan-Kazis

The Food and Drug Administration will only stick to its existing process for updating Covid-19 shots for older adults and those at a high risk of severe illness, the agency's head wrote in a medical journal article on Tuesday.

In order to get new Covid-19 shots approved for younger, healthy adults, drugmakers will need to run new randomized clinical trials, FDA commissioner Dr. Marty Makary wrote.

Though the stance would impose new limits on FDA approvals, it's a softer approach than Trump officials had seemed poised to take. Moderna shares were up 9.4% to $28.85 in midday trading.

This is breaking news. Please check back for more analysis soon.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

(END) Dow Jones Newswires

May 20, 2025 11:55 ET (15:55 GMT)

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Please check back for more analysis soon. \n</p>\n<p>\n     Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com \n</p>\n<p>\n     This content was created by Barron's, which is operated by Dow Jones &amp; Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal. \n</p>\n<pre>\n \n</pre>\n<p>\n  (END) Dow Jones Newswires\n</p>\n<p>\n  May 20, 2025 11:55 ET (15:55 GMT)\n</p>\n<p>\n  Copyright (c) 2025 Dow Jones &amp; Company, Inc.\n</p>\n</font>","source":null,"html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>FDA Will Limit Approvals for Covid-19 Shots. 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Moderna Stock Soars. -- Barrons.com\n</h2>\n\n<h4 class=\"meta\">\n\n\n<div class=\"head\" \">\n\n\n<div class=\"h-thumb\" style=\"background-image:url(https://static.tigerbbs.com/150f88aa4d182df19190059f4a365e99);background-size:cover;\"></div>\n\n<div class=\"h-content\">\n<p class=\"h-name\">Dow Jones </p>\n<p class=\"h-time\">2025-05-20 23:55</p>\n</div>\n\n</div>\n\n\n</h4>\n\n</header>\n<article>\n<font class=\"NormalMinus1\" face=\"Arial\">\n<p>\n  By Josh Nathan-Kazis \n</p>\n<p>\n  The Food and Drug Administration will only stick to its existing process for updating Covid-19 shots for older adults and those at a high risk of severe illness, the agency's head wrote in a medical journal article on Tuesday. \n</p>\n<p>\n     In order to get new Covid-19 shots approved for younger, healthy adults, drugmakers will need to run new randomized clinical trials, FDA commissioner Dr. Marty Makary wrote. \n</p>\n<p>\n     Though the stance would impose new limits on FDA approvals, it's a softer approach than Trump officials had seemed poised to take. 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