{"id":3203,"date":"2025-05-23T15:11:36","date_gmt":"2025-05-23T15:11:36","guid":{"rendered":"https:\/\/healthyretirementnews.com\/index.php\/2025\/05\/23\/fda-requires-covid-vaccine-makers-to-expand-warning-about-risk-of-rare-heart-inflammation\/"},"modified":"2025-05-23T15:11:36","modified_gmt":"2025-05-23T15:11:36","slug":"fda-requires-covid-vaccine-makers-to-expand-warning-about-risk-of-rare-heart-inflammation","status":"publish","type":"post","link":"https:\/\/healthyretirementnews.com\/index.php\/2025\/05\/23\/fda-requires-covid-vaccine-makers-to-expand-warning-about-risk-of-rare-heart-inflammation\/","title":{"rendered":"FDA requires Covid vaccine makers to expand warning about risk of rare heart inflammation"},"content":{"rendered":"<div data-uri=\"cms.cnn.com\/_components\/action-bar\/instances\/cmaym3loh00dy26p64niz0beu@published\" data-label-id-prefix=\"action-bar-start-of-article\" class=\"action-bar\" 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<button class=\"social-share_labelled-list__share\" data-url=\"https:\/\/twitter.com\/intent\/tweet?text=Check%20out%20this%20article%3A&amp;url=https%3A%2F%2Fwww.cnn.com%2F2025%2F05%2F21%2Fhealth%2Ffda-covid-vaccine-warning-heart-inflammation\" data-type=\"x\" aria-label=\"share with x\" title=\"Share with X\">                                <span class=\"social-share_labelled-list__share-links--label\">Tweet<\/span>        <\/button>                                        <span class=\"social-share_labelled-list__share-links--label\">Email<\/span>                <button class=\"social-share_labelled-list__share\" data-url=\"https:\/\/www.cnn.com\/2025\/05\/21\/health\/fda-covid-vaccine-warning-heart-inflammation\" data-type=\"copy\" aria-label=\"copy link to clipboard\" title=\"Copy link to clipboard\">                                <span class=\"social-share_labelled-list__share-links--label\">Link<\/span>        <\/button>        <\/p>\n<div class=\"social-share_labelled-list__copied\" data-type=\"message\">                        Link Copied!        <\/div>\n<\/p>\n<\/div>\n<p>    <button class=\"social-share_labelled-list__open\" data-type=\"open\" aria-label=\"open social share\" title=\"Open social share\">            <\/button>    <button class=\"social-share_labelled-list__close\" data-type=\"close\" aria-label=\"close social share\" title=\"Close social share\">            <\/button><\/div>\n<\/p>\n<\/div>\n<\/div>\n<div class=\"action-bar__buttons\">            <button class=\"action-bar__button\" data-title=\"follow\">                                        Follow            <\/button>            <button class=\"action-bar__button\" data-title=\"share options\">                                <\/button>    <\/div>\n<\/div>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi00073b6m5yevxeju@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The US Food and Drug Administration will now require Covid-19 vaccines from Pfizer\/BioNTech and Moderna to use expanded warning labels with more information about the risk of a rare heart condition after vaccination.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi00083b6mdo0oyg8a@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The vaccines\u2019 previous labels warned about the risk of a heart condition called myocarditis, inflammation of the heart muscle, and pericarditis, inflammation of the lining outside the heart, which the US Centers for Disease Control and Prevention website says is rare but possible after vaccination. The new labels will expand that warning to certain age groups.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi00093b6mkkqs035y@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Research has consistently shown that the mRNA Covid-19 vaccines are safe and effective, and millions of people have gotten them without serious incident. Some studies have found that Covid-19 infection itself carries a higher risk of myocarditis or pericarditis than the vaccine does.    <\/p>\n<div data-uri=\"cms.cnn.com\/_components\/related-content\/instances\/cmayms1q6000h3b6m6z1yfca6@published\" data-component-name=\"related-content\" class=\"related-content-elevate related-content--article\" data-article-gutter=\"true\">\n<header class=\"related-content__title related-content__title-text\" data-editable=\"content.title\">Related article<\/header>\n<section class=\"related-content__body\">\n<div class=\"related-content__image image__related-content\">\n<div data-uri=\"cms.cnn.com\/_components\/image\/instances\/cmawmeity007d27p3bjvfe4e5@published\" class=\"image-elevate image__hide-placeholder\" data-image-variation=\"image\" data-name=\"GettyImages-1231124292.jpg\" data-component-name=\"image\" data-observe-resizes=\"\" data-breakpoints=\"{&quot;image--eq-extra-small&quot;: 115, &quot;image--eq-small&quot;: 300, &quot;image--eq-large&quot;: 660}\" data-original-ratio=\"0.6665\" data-original-height=\"1333\" data-original-width=\"2000\" data-url=\"https:\/\/media.cnn.com\/api\/v1\/images\/stellar\/prod\/gettyimages-1231124292.jpg?c=original\" data-editable=\"settings\">\n<div class=\"image__container \" data-image-variation=\"image\" data-breakpoints=\"{&quot;image--eq-extra-small&quot;: 115, &quot;image--eq-small&quot;: 300, &quot;image--show-credits&quot;: 525}\">           <\/div>\n<div class=\"image__metadata-container media__metadata-container\">\n<div class=\"image__metadata media__metadata\">\n<div class=\"image__caption attribution\">    <span data-editable=\"metaCaption\" class=\"inline-placeholder\">Changes to the way FDA approves Covid-19 vaccines will limit who can get them in the fall.<\/span>  <\/div><figcaption class=\"image__credit\">Jon Cherry\/Getty Images<\/figcaption><\/div>\n<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p class=\"related-content__headline\">        <span class=\"related-content__headline-text\" data-editable=\"content.headline\">FDA may limit future Covid-19 shots to older people and those at risk of serious infection<\/span>      <\/p>\n<\/section>\n<\/div>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000a3b6mi96nli2t@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The CDC last month told its independent vaccine advisers that research showed Covid-19 vaccinations from 2020 through 2022 showed a statistically significant increased risk of myocarditis. The incidents were rare, however, and \u201cthere is no increased risk observed with the doses administered in subsequent years,\u201d the agency said.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000b3b6m0nw5zpjd@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            In the rare case that someone did develop heart inflammation after vaccination, the CDC told the advisers, acute myocarditis typically resolves quickly.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000e3b6mhk8gwi1w@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The vaccines already carried warnings that the highest risk of these heart problems was observed in males between ages 18 and 24 for the Moderna vaccine and 12 to 17 for Pfizer\u2019s; the new warnings for both vaccines will be for males age 16 to 25.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000c3b6mwj18n0hj@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            In letters to Pfizer and Moderna that were dated April 17 and are now posted online, the agency says analysis of commercial health insurance claims data shows that there were eight cases of myocarditis and\/or pericarditis per million vaccine doses given to people ages 6 months through 64 years.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000d3b6miervdssd@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Cases were more common among males ages 16 through 25 within seven days of vaccination, but they were still rare, with about 38 cases of myocarditis and\/or pericarditis per million doses among this group.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000f3b6mkfei0tl6@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            A spokesperson for the US Department of Health and Human Services said Wednesday that the move was intended to increase \u201cradical transparency.\u201d Neither Pfizer nor Moderna responded to requests<strong> <\/strong>for comment.    <\/p>\n<div data-uri=\"cms.cnn.com\/_components\/related-content\/instances\/cmaym7qec00113b6myy7yh0zi@published\" data-component-name=\"related-content\" class=\"related-content-elevate related-content--article\" data-article-gutter=\"true\">\n<header class=\"related-content__title related-content__title-text\" data-editable=\"content.title\">Related article<\/header>\n<section class=\"related-content__body\">\n<div class=\"related-content__image image__related-content\">\n<div data-uri=\"cms.cnn.com\/_components\/image\/instances\/cmat0glr4009726nofemf8avz@published\" class=\"image-elevate image__hide-placeholder\" data-image-variation=\"image\" data-name=\"GettyImages-1242252795.jpg\" data-component-name=\"image\" data-observe-resizes=\"\" data-breakpoints=\"{&quot;image--eq-extra-small&quot;: 115, &quot;image--eq-small&quot;: 300, &quot;image--eq-large&quot;: 660}\" data-original-ratio=\"0.6666666666666666\" data-original-height=\"2000\" data-original-width=\"3000\" data-url=\"https:\/\/media.cnn.com\/api\/v1\/images\/stellar\/prod\/gettyimages-1242252795-20250518015134679.jpg?c=original\" data-editable=\"settings\">\n<div class=\"image__container \" data-image-variation=\"image\" data-breakpoints=\"{&quot;image--eq-extra-small&quot;: 115, &quot;image--eq-small&quot;: 300, &quot;image--show-credits&quot;: 525}\">           <\/div>\n<div class=\"image__metadata-container media__metadata-container\">\n<div class=\"image__metadata media__metadata\">\n<div class=\"image__caption attribution\">    <span data-editable=\"metaCaption\" class=\"inline-placeholder\">Vials of Novavax Covid-19 vaccines arranged at a pharmacy in Schwenksville, Pennsylvania, US, on Monday, Aug. 1, 2022.<\/span>  <\/div><figcaption class=\"image__credit\">Hannah Beier\/Bloomberg\/Getty Images<\/figcaption><\/div>\n<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p class=\"related-content__headline\">        <span class=\"related-content__headline-text\" data-editable=\"content.headline\">After delay, FDA approves Novavax\u2019s Covid-19 vaccine, but only for older people and those at high risk<\/span>      <\/p>\n<\/section>\n<\/div>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000g3b6mhgi7l52c@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The vaccines were developed during the first Trump administration and underwent what the CDC says was \u201cthe most intensive safety analysis in US history,\u201d and the agency continues to monitor vaccine administration data for effectiveness and any potential problems.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000h3b6ms7nol7ij@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, has falsely claimed that the Covid-19 vaccine was \u201cthe deadliest vaccine ever made.\u201d    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000i3b6mmy0sy6ki@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            In a US Senate Homeland Security and Governmental Affairs subcommittee hearing on Wednesday,  Sen. Ron Johnson, R-Wisconsin, claimed that the Biden administration downplayed the risks of the vaccine and delayed getting information about those risks to the public.    <\/p>\n<div data-uri=\"cms.cnn.com\/_components\/related-content\/instances\/cmaymsfgw000j3b6mdnztj2vx@published\" data-component-name=\"related-content\" class=\"related-content-elevate related-content--article\" data-article-gutter=\"true\">\n<header class=\"related-content__title related-content__title-text\" data-editable=\"content.title\">Related article<\/header>\n<section class=\"related-content__body\">\n<div class=\"related-content__image image__related-content\">\n<div data-uri=\"cms.cnn.com\/_components\/image\/instances\/cm9398g0q000q2cql6gr09tof@published\" class=\"image-elevate image__hide-placeholder\" data-image-variation=\"image\" data-name=\"c-JG-Samoa-2019.jpg\" data-component-name=\"image\" data-observe-resizes=\"\" data-breakpoints=\"{&quot;image--eq-extra-small&quot;: 115, &quot;image--eq-small&quot;: 300, &quot;image--eq-large&quot;: 660}\" data-original-ratio=\"0.64375\" data-original-height=\"1030\" data-original-width=\"1600\" data-url=\"https:\/\/media.cnn.com\/api\/v1\/images\/stellar\/prod\/c-jg-samoa-2019.jpg?c=original\" data-editable=\"settings\">\n<div class=\"image__container \" data-image-variation=\"image\" data-breakpoints=\"{&quot;image--eq-extra-small&quot;: 115, &quot;image--eq-small&quot;: 300, &quot;image--show-credits&quot;: 525}\">           <\/div>\n<div class=\"image__metadata-container media__metadata-container\">\n<div class=\"image__metadata media__metadata\">\n<div class=\"image__caption attribution\">    <span data-editable=\"metaCaption\" class=\"inline-placeholder\">This handout photo from Hawaii Gov. Josh Green shows Green and Dr. Nadine Tenn Salle of the Queen&#8217;s Health Systems distribute vaccinations in Samoa.<\/span>  <\/div><figcaption class=\"image__credit\">Courtesy Hawaii Gov. Josh Green<\/figcaption><\/div>\n<\/p>\n<\/div>\n<\/div>\n<\/div>\n<p class=\"related-content__headline\">        <span class=\"related-content__headline-text\" data-editable=\"content.headline\">Hawaii governor: An urgent call to action to protect America\u2019s children from measles<\/span>      <\/p>\n<\/section>\n<\/div>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym4jcp00003b6mxu3ahtkz@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            One witness, Hawaii Gov. Josh Green, a family physician, said in his testimony the US vaccine safety monitoring systems worked \u201cexactly as intended\u201d by detecting rare cases of myocarditis.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaymn9oj000e3b6mndo4jmv0@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            \u201cThe data were made public, warnings were updated, and clinical guidance was revised accordingly,\u201d Green said. \u201cDespite this, some continue to promote misleading interpretations, unverified claims or anecdotes to suggest that vaccines are broadly unsafe.\u201d    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000k3b6menjpd6w2@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The FDA has taken recent steps to limit Covid-19 vaccines for certain groups.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000l3b6m1bggedva@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            On Tuesday, the FDA said it would change the type of evidence it will accept from vaccine manufacturers to approve updated Covid shots, which may limit who is eligible for updated shots. The vaccines are expected to be be available in the fall, but only for adults 65 and older and people with underlying conditions that put them at a higher risk for severe Covid-19 infection.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000m3b6my7yqxg3o@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            In an editorial published in the New England Journal of Medicine, FDA Commissioner Dr. Marty Makary and Dr. Vinay Prasad, the new director of the FDA\u2019s Center for Biologics Evaluation and Research, said there\u2019s not enough evidence that healthy children and adults get clinically meaningful benefit from regular Covid-19 shots, and officials want to see more placebo-controlled trials, particularly in adults 50 to 64, before recommending the shots for other groups.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmaym3zyi000n3b6myayjn64x@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            On Thursday, the FDA\u2019s vaccine advisers \u2013 the Vaccines and Related Biological Products Advisory Committee \u2013 will meet to discuss the coronavirus strain selection for this fall\u2019s Covid-19 vaccines.    <\/p>\n<\/p>\n<div>This post appeared first on cnn.com<\/div>\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Vaccines Respiratory viruses Heart disease Chronic diseases See all topics Facebook Tweet Email Link Link&hellip;<\/p>\n","protected":false},"author":1,"featured_media":3204,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-3203","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-news"],"_links":{"self":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/posts\/3203","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/comments?post=3203"}],"version-history":[{"count":0,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/posts\/3203\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/media\/3204"}],"wp:attachment":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/media?parent=3203"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/categories?post=3203"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/tags?post=3203"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}