{"id":3193,"date":"2025-05-21T15:15:42","date_gmt":"2025-05-21T15:15:42","guid":{"rendered":"https:\/\/healthyretirementnews.com\/index.php\/2025\/05\/21\/fda-to-limit-future-covid-19-shots-to-older-people-and-those-at-risk-of-serious-infection\/"},"modified":"2025-05-21T15:15:42","modified_gmt":"2025-05-21T15:15:42","slug":"fda-to-limit-future-covid-19-shots-to-older-people-and-those-at-risk-of-serious-infection","status":"publish","type":"post","link":"https:\/\/healthyretirementnews.com\/index.php\/2025\/05\/21\/fda-to-limit-future-covid-19-shots-to-older-people-and-those-at-risk-of-serious-infection\/","title":{"rendered":"FDA to limit future Covid-19 shots to older people and those at risk of serious infection"},"content":{"rendered":"<div data-uri=\"cms.cnn.com\/_components\/action-bar\/instances\/cmawmeity007m27p3gjvxgu5t@published\" data-label-id-prefix=\"action-bar-start-of-article\" class=\"action-bar\" 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class=\"follow-topics-bar_overlay__fade follow-topics-bar_overlay__fade--hide\"><\/div>\n<p>                      See all topics              <\/p><\/div>\n<\/div>\n<\/div>\n<div class=\"action-bar__action-sheet--action\" data-title=\"share options\">\n<div data-uri=\"cms.cnn.com\/_components\/social-share\/instances\/cmawmeity007p27p38cno4nts@published\" class=\"social-share_labelled-list\">\n<div class=\"social-share_labelled-list__share-links vossi-social-share_labelled-list\" data-type=\"share-links\">        <button class=\"social-share_labelled-list__share\" data-url=\"https:\/\/www.facebook.com\/dialog\/share?app_id=80401312489&amp;href=https%3A%2F%2Fwww.cnn.com%2F2025%2F05%2F20%2Fhealth%2Fcovid-vaccine-fda-changes&amp;display=popup\" data-type=\"facebook\" aria-label=\"share with facebook\" title=\"Share with Facebook\">                                <span class=\"social-share_labelled-list__share-links--label\">Facebook<\/span>        <\/button>        <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%2F20%2Fhealth%2Fcovid-vaccine-fda-changes\" 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\/20\/health\/covid-vaccine-fda-changes\" 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\/cmawmeity007o27p382s23eei@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The US Food and Drug Administration is changing the way it approves Covid-19 vaccines for Americans \u2014 a move that will limit future vaccines to older Americans and people at higher risk of serious Covid-19 infection.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000k2e6aywwgretf@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The agency is changing the standard of evidence required for Covid-19 vaccine approval in the US, Dr. Vinay Prasad, the new director of the FDA\u2019s Center for Biologics Evaluation and Research, and FDA Commissioner Dr. Marty Makary, said in an editorial published Tuesday in the New England Journal of Medicine    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000l2e6a20qhp1fy@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The change means that Covid-19 shots will likely be available in the fall for adults ages 65 and older and those with underlying conditions that may put them at higher risk of a Covid-19 infection, but not for everyone who was previously eligible for an updated shot. Nearly three-quarters of Americans age 6 months and older have an underlying medical condition that puts them at higher risk, according to the US Centers for Disease Control and Prevention.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000m2e6apynocswp@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The change, which was already being studied by experts that advise the CDC on its vaccine recommendations, will more closely align the United States with Covid-19 vaccine recommendations in the UK, Canada and Australia.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000n2e6aue4v3apm@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Millions of healthy adults and kids will likely lose access to updated vaccines under the new criteria. Prasad and Makary say there\u2019s not enough evidence that healthy kids and adults get clinically meaningful benefit from regular Covid-19 shots. They want to see placebo-controlled trials, particularly in adults ages 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\/cmawnafz6000o2e6axr59dy8d@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Dr. Noel Brewer, a professor of public health and health behavior at the University of North Carolina at Chapel Hill, said he supports the change.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000p2e6aabxbx2ul@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            \u201cThe proposed policy moves the US in line with other countries. This global view of public health is a welcome development,\u201d said Brewer, who sits on the CDC\u2019s Advisory Committee on Immunization Practices, and was part of the working group mulling the change to Covid vaccine recommendations    <\/p>\n<div data-uri=\"cms.cnn.com\/_components\/related-content\/instances\/cmawo01a3000m3b6mkx2nfn92@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\/cmawnafz6000q2e6aqvh4tg8v@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            But he and other experts say they\u2019re still worried about the youngest children, those under age 2, who have high rates of hospitalization from Covid-19.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000r2e6ax9rbit9d@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Dr. Paul Offit, director of the Vaccine Education Center at the Children\u2019s Hospital of Philadelphia and a member of FDA\u2019s independent advisory group on vaccines, says he disagrees with the underlying premise of the new framework, which is that our Covid-19 vaccine recommendations haven\u2019t been based on good evidence.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000s2e6amcojjmog@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            \u201cWe have been using an evidence-based approach to Covid-19 vaccination, but they kind of swoop in and believe that for the first time, we\u2019re going to get, as they say, \u2018gold standard\u2019 data, robust data, for the first time, because according to them, we don\u2019t have that, but we do have that,\u201d Offit said.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000t2e6ajokcfm88@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            \u201cThat\u2019s why we\u2019ve made good decisions about the vaccine. That\u2019s why that vaccine is remarkably safe. I mean, the mRNA vaccines are remarkably safe.\u201d    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000u2e6akthr6lrx@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The editorial says that going forward, Covid-19 vaccines for people ages 65 and older and those 6 months of age and older with underlying health conditions that put them at higher risk from Covid-19 infections will be approved after pharmaceutical companies can demonstrate that they create protective antibody concentrations in people.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000v2e6a90bssvmb@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            These types of studies are called immunobridging studies.  They\u2019re typically done in a smaller number of people, and importantly, they can be done quickly so vaccine manufacturing can ramp up in time to have large numbers of shots ready for an expected wave of illness, usually over the fall and winter.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000w2e6aewkaaf3b@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            This is largely how seasonal flu vaccinations are approved each year in the US, and it\u2019s the way FDA has been approving Covid-19 vaccines for the past few years.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000x2e6anm1kn5xu@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            For everyone else, the FDA will only approve vaccines after studies that prove the shots can prevent symptomatic Covid-19 better than a placebo.  The FDA will also consider several secondary outcomes, including severe illness, hospitalization and death.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000y2e6a0mp835zs@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The new plan doesn\u2019t consider other impacts of Covid-19 infections, such as long Covid. Studies have shown that vaccination may cut the risk of developing long Covid by somewhere between 25 %to 60%.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz6000z2e6aqqq5yp98@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Prasad and Makary say the new policy balances the need to swiftly approve vaccines to have them ready by the fall for the most vulnerable adults and children, with the need for more evidence before offering them to others.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz600102e6a51muywfr@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            What\u2019s more, they say millions of Americans under the age of 65 will still qualify to get a Covid-19 vaccine if they want one if they have any of a broad range of health conditions identified by the CDC as putting a person at high risk of severe disease from Covid-19.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz600112e6a8fxin8kx@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            \u201cEstimates suggest that 100 million to 200 million Americans will have access to vaccines in this manner,\u201d the FDA officials wrote.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz600122e6akoklf28l@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Prasad and Makary say their goal in requiring more evidence for other groups is to restore public trust in vaccines.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz600132e6aaqqpo2c2@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            They point out that for the past two seasons, less than 25% of Americans have received a Covid-19 shot, including less than 10% of kids and less than 50% of adults over the age of 75.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawnafz600142e6azx6uuu9u@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            They say broad Covid-19 vaccine recommendations and mandates during the pandemic eroded public trust and caused falling rates for other types of vaccines, too, such as the measles, mumps and rubella vaccine.    <\/p>\n<p class=\"paragraph-elevate inline-placeholder vossi-paragraph\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cmawni5qm00003b6mi2c6fdpc@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            <em>This is a breaking news story and will be updated.<\/em>    <\/p>\n<\/p>\n<div>This post appeared first on cnn.com<\/div>\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Respiratory viruses Vaccines Federal agencies New in medicine See all topics Facebook Tweet Email 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