{"id":35183,"date":"2022-06-03T16:01:59","date_gmt":"2022-06-03T16:01:59","guid":{"rendered":"https:\/\/harchi90.com\/us-fda-flags-risk-of-heart-inflammation-after-novavax-covid-vaccine\/"},"modified":"2022-06-03T16:01:59","modified_gmt":"2022-06-03T16:01:59","slug":"us-fda-flags-risk-of-heart-inflammation-after-novavax-covid-vaccine","status":"publish","type":"post","link":"https:\/\/harchi90.com\/us-fda-flags-risk-of-heart-inflammation-after-novavax-covid-vaccine\/","title":{"rendered":"US FDA flags risk of heart inflammation after Novavax COVID vaccine"},"content":{"rendered":"<div>\n<p data-testid=\"paragraph-0\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">June 3 (Reuters) &#8211; US Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc&#8217;s (NVAX.O) vaccine, even as the company&#8217;s data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19.<\/p>\n<p data-testid=\"paragraph-1\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">In the company&#8217;s nearly 30,000 patient trial, conducted between December 2020 and September 2021, there were four cases of myocarditis, a type of heart inflammation also associated with mRNA vaccines, detected within 20 days post vaccination.<\/p>\n<p data-testid=\"paragraph-2\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">One patient in the trial reported myocarditis after receiving placebo.<\/p>\n<div class=\"registration-prompt__container__2jf5K registration-prompt__inline__2WDU- article-body__element__2p5pI article-body__inline-registration-prompt__1-N9W\">\n<div class=\"registration-prompt__text-content__o0YET\">\n<h5 data-testid=\"Heading\" class=\"text__text__1FZLe text__white__3r45t text__medium__1kbOh text__heading_5__2krbj heading__base__2T28j heading__heading_5__2A2g- registration-prompt__heading__3fq-h\">Register now for FREE unlimited access to Reuters.com<\/h5>\n<p><button data-testid=\"Button\" class=\"button__button__2Ecqi button__secondary__18moI button__round__1nYLA text-button__container__3q3zX registration-prompt__button-text__3kTtQ\" type=\"button\"><\/p>\n<p><span data-testid=\"Text\" class=\"text__text__1FZLe text__inherit-color__3208F text__bold__2-8Kc text__default__UPMUu text-button__medium__113uZ\">Register<\/span><\/p>\n<p><\/button><\/div>\n<\/div>\n<p data-testid=\"paragraph-3\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">&#8220;These events raise the concern for a causal association with this vaccine, similar to the association documented with mRNA COVID19 vaccines,&#8221; the FDA staff wrote in briefing documents released on Friday.<\/p>\n<p data-testid=\"paragraph-4\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">Shares of the company fell nearly 14% after the FDA&#8217;s analysis of data from the company&#8217;s trial.<\/p>\n<p data-testid=\"paragraph-5\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">The FDA said it had requested Novavax to flag myocarditis and another kind of heart inflammation called pericarditis as an &#8220;important identified risk&#8221; in its materials.  The company had not yet agreed to do so.<\/p>\n<p data-testid=\"paragraph-6\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">Novavax said the number of myocarditis events in its clinical trial was &#8220;within the range of expected background cases.&#8221;<\/p>\n<p data-testid=\"paragraph-7\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">Novavax has said its protein-based shot will play a role in driving vaccination among those who have been hesitant to get immunized and it has started an educational effort on vaccine choices.<\/p>\n<p data-testid=\"paragraph-8\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">&#8220;Despite the wide availability of authorized or approved vaccines, the SARS-CoV-2 pandemic is not well controlled in the US &#8230; there remains a desire for vaccines that have been developed using well-understood technology platforms,&#8221; \u200b\u200bit said.<\/p>\n<p data-testid=\"paragraph-9\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">The FDA analyzed data from Novavax&#8217;s trial before the Omicron and Delta variant became the dominant strains.<\/p>\n<p data-testid=\"paragraph-10\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">&#8220;Based on the efficacy estimate in the clinical trial of this vaccine, it is more likely than not that the vaccine will provide some meaningful level of protection against COVID-19 due to Omicron, in particular against more severe disease,&#8221; the FDA staff said .<\/p>\n<p data-testid=\"paragraph-11\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">The comments came in a briefing note initially prepared ahead of a May 7 meeting of the FDA&#8217;s outside advisers.  The FDA staff comments will be used by those advisers to guide their decision on whether or not to recommend authorizing the vaccine on Tuesday.  The FDA is not mandated to follow the advise of its outside experts, but usually does.<\/p>\n<p data-testid=\"paragraph-12\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">In the company&#8217;s study, which enrolled about 30,000 adults in the United States and Mexico, the vaccine had an efficacy of 90.4%.<\/p>\n<div class=\"registration-prompt__container__2jf5K registration-prompt__inline__2WDU- article-body__element__2p5pI\">\n<div class=\"registration-prompt__text-content__o0YET\">\n<h5 data-testid=\"Heading\" class=\"text__text__1FZLe text__white__3r45t text__medium__1kbOh text__heading_5__2krbj heading__base__2T28j heading__heading_5__2A2g- registration-prompt__heading__3fq-h\">Register now for FREE unlimited access to Reuters.com<\/h5>\n<p><button data-testid=\"Button\" class=\"button__button__2Ecqi button__secondary__18moI button__round__1nYLA text-button__container__3q3zX registration-prompt__button-text__3kTtQ\" type=\"button\"><\/p>\n<p><span data-testid=\"Text\" class=\"text__text__1FZLe text__inherit-color__3208F text__bold__2-8Kc text__default__UPMUu text-button__medium__113uZ\">Register<\/span><\/p>\n<p><\/button><\/div>\n<\/div>\n<p><span data-testid=\"Text\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__default__UPMUu sign-off__text__PU3Aj\">Reporting by Manas Mishra and Mrinalika Roy in Bengaluru, and Michael Erman in New Jersey;  Editing by Saumyadeb Chakrabarty and David Holmes<\/span><\/p>\n<p data-testid=\"Body\" class=\"text__text__1FZLe text__dark-grey__3Ml43 text__regular__2N1Xr text__large__nEccO body__base__22dCE body__large_body__FV5_X article-body__element__2p5pI\">Our Standards: The Thomson Reuters Trust Principles.<\/p>\n<\/div>\n<p>    .<\/p>\n","protected":false},"excerpt":{"rendered":"<p>June 3 (Reuters) &#8211; US Food and Drug Administration staff said on Friday they were concerned about a possible risk of heart inflammation from Novavax Inc&#8217;s (NVAX.O) vaccine, even as the company&#8217;s data showed the vaccine was effective in reducing the risk of mild-to-severe COVID-19. In the company&#8217;s nearly 30,000 patient trial, conducted between December &hellip;<\/p>\n<p class=\"read-more\"> <a class=\"\" href=\"https:\/\/harchi90.com\/us-fda-flags-risk-of-heart-inflammation-after-novavax-covid-vaccine\/\"> <span class=\"screen-reader-text\">US FDA flags risk of heart inflammation after Novavax COVID vaccine<\/span> Read More &raquo;<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"default","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","spay_email":"","jetpack_publicize_message":"","jetpack_is_tweetstorm":false,"jetpack_publicize_feature_enabled":true},"categories":[8],"tags":[56,429,430,25,552,736,13395,1838,930,3250,1355,931,932,258,16779,933,6571,6572,735,64,3515,3516,3518,511,1819,48,285,75,57,9822],"jetpack_featured_media_url":"","jetpack_publicize_connections":[],"jetpack_sharing_enabled":true,"fifu_image_url":"https:\/\/www.reuters.com\/resizer\/zwlFhqI4hbDXzzpzCNjGGiO-DAU=\/1200x628\/smart\/filters:quality(80)\/cloudfront-us-east-2.images.arcpublishing.com\/reuters\/BSYGKPNE5ZPRXH2OTG23T4DSYI.jpg","_links":{"self":[{"href":"https:\/\/harchi90.com\/wp-json\/wp\/v2\/posts\/35183"}],"collection":[{"href":"https:\/\/harchi90.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/harchi90.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/harchi90.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/harchi90.com\/wp-json\/wp\/v2\/comments?post=35183"}],"version-history":[{"count":0,"href":"https:\/\/harchi90.com\/wp-json\/wp\/v2\/posts\/35183\/revisions"}],"wp:attachment":[{"href":"https:\/\/harchi90.com\/wp-json\/wp\/v2\/media?parent=35183"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/harchi90.com\/wp-json\/wp\/v2\/categories?post=35183"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/harchi90.com\/wp-json\/wp\/v2\/tags?post=35183"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}