{"id":2055627,"date":"2023-10-04T16:33:02","date_gmt":"2023-10-04T20:33:02","guid":{"rendered":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-authorizes-novavaxs-updated-covid-jab-based-on-data-from-previous-versions\/"},"modified":"2023-10-04T16:39:40","modified_gmt":"2023-10-04T20:39:40","slug":"fda-authorizes-novavaxs-updated-covid-jab-based-on-data-from-previous-versions","status":"publish","type":"post","link":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-authorizes-novavaxs-updated-covid-jab-based-on-data-from-previous-versions\/","title":{"rendered":"FDA Approves Novavax&#8217;s Updated COVID Vaccine Using Previous Version&#8217;s Data"},"content":{"rendered":"<aside class=\"mashsb-container mashsb-main mashsb-stretched\"><div class=\"mashsb-box\"><div class=\"mashsb-count mash-medium\" style=\"&quot;\"><div class=\"counts mashsbcount\">20<\/div><span class=\"mashsb-sharetext\">SHARES<\/span><\/div><div class=\"mashsb-buttons\"><a class=\"mashicon-facebook mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/www.facebook.com\/sharer.php?u=https%3A%2F%2Fwww.conservativenewsdaily.net%2Fbreaking-news%2Ffda-authorizes-novavaxs-updated-covid-jab-based-on-data-from-previous-versions%2F\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Facebook<\/span><\/a><a class=\"mashicon-twitter mash-medium mash-nomargin mashsb-noshadow\" href=\"https:\/\/twitter.com\/intent\/tweet?text=&amp;url=https:\/\/www.conservativenewsdaily.net\/breaking-news\/?p=2055627&amp;via=ConservNewsDly\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Twitter<\/span><\/a><a class=\"mashicon-subscribe mash-medium mash-nomargin mashsb-noshadow\" href=\"#\" target=\"_top\" rel=\"nofollow\"><span class=\"icon\"><\/span><span class=\"text\">Subscribe<\/span><\/a><div class=\"onoffswitch2 mash-medium mashsb-noshadow\" style=\"display:none\"><\/div><\/div>\n            <\/div>\n                <div style=\"clear:both\"><\/div><\/aside>\n            <!-- Share buttons by mashshare.net - Version: 4.0.47--><blockquote>\n<div data-post-content=\"true\" class=\"post_content\" id=\"post_content\">\n<p>The Food and Drug Administration (FDA) has granted emergency\u2062 use authorization \u200b(EUA) \u2062to an \u200dupdated version of Novavax&#8217;s COVID-19 \u200cvaccine. This exciting development \u200dis based on safety data from previous\u200c versions.<\/p>\n<div class=\"my-5\">\n<p>The \u2062Oct. 3 EUA\u200c allows individuals aged 12 and above to receive a dose of the\u200d new Novavax vaccine, regardless of their prior vaccination history. You can find more information in the <a href=\"https:\/\/www.fda.gov\/vaccines-blood-biologics\/coronavirus-covid-19-cber-regulated-biologics\/novavax-covid-19-vaccine-adjuvanted\" target=\"_blank\" rel=\"noopener\">official\u200c news release<\/a>.<\/p>\n<\/div>\n<p>The FDA&#8217;s\u200d latest authorization is unique because it combines existing safety and effectiveness data with booster studies, rather than relying solely on new clinical trial data \u200cspecific to this particular vaccine formulation. This approach\u200d was outlined in an\u2062 Oct. 3 authorization letter signed by Peter Marks, director of the FDA\u2019s Center \u2063for Biologics Evaluation and Research.<\/p>\n<div class=\"shortcode\">\n<div class=\"border-comp-divider mb-4 mr-4 w-full max-w-[500px] border px-5 py-4 text-[16px] leading-[20px] text-[#262626] md:float-left\" id=\"in_article_related_stories\">\n<h2 class=\"mb-3 font-sans text-[16px] font-semibold uppercase leading-[19px] text-[#2F2F2F]\">Related Stories<\/h2>\n<div class=\"mb-4 flex gap-2\">\n<div class=\"grow\">\n<div class=\"mb-1 line-clamp-2\">\n<a href=\"http:\/\/www.theepochtimes.com\/article\/cdc-journal-and-five-others-rejected-key-paper-on-covid-vaccines-and-heart-inflammation-5496029?ea_src=author_manual&#038;ea_med=related_stories\"><\/p>\n<h3>CDC Journal and Five Others Rejected Key \u2062Paper on COVID Vaccines and\u200d Heart Inflammation<\/h3>\n<p><\/a>\n<\/div>\n<div class=\"text-comp-caption text-[14px] leading-[18px]\">10\/3\/2023<\/div>\n<\/div>\n<div class=\"shrink-0 basis-[120px]\">\n<a href=\"http:\/\/www.theepochtimes.com\/article\/cdc-journal-and-five-others-rejected-key-paper-on-covid-vaccines-and-heart-inflammation-5496029?ea_src=author_manual&#038;ea_med=related_stories\"><\/a>\n<\/div>\n<\/div>\n<div class=\"mb-4 flex gap-2\">\n<div class=\"grow\">\n<div class=\"mb-1 line-clamp-2\">\n<a href=\"http:\/\/www.theepochtimes.com\/article\/covid-vaccine-mandates-begin-in-red-state-5502656?ea_src=author_manual&#038;ea_med=related_stories\"><\/p>\n<h3>COVID Vaccine Mandates Begin \u200bin Red State<\/h3>\n<p><\/a>\n<\/div>\n<div class=\"text-comp-caption text-[14px] leading-[18px]\">10\/2\/2023<\/div>\n<\/div>\n<div class=\"shrink-0 basis-[120px]\">\n<a href=\"http:\/\/www.theepochtimes.com\/article\/covid-vaccine-mandates-begin-in-red-state-5502656?ea_src=author_manual&#038;ea_med=related_stories\"><\/a>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<p>This marks a departure from previous EUAs for Novavax, \u200bwhich relied on\u200b ongoing trials. \u2062In the \u200bcase of the\u2064 previous version of the Novavax vaccine,\u2064 authorized in July 2022 for individuals\u200c aged\u2063 18 and above, \u2062the FDA reviewed safety \u2064and efficacy data from an ongoing <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/pfizer-biontech-say-covid-19-vaccine-protects-for-six-months\/\" title=\"Pfizer, BioNTech Say Covid-19 Vaccine Protects for Six Months\">phase 3 trial<\/a>. The following month, the FDA authorized the same vaccine for\u200c individuals aged 12 to 17, using data from an expansion of the phase 3 trial for adolescents.<\/p>\n<p>Unlike the previous version,\u2062 Novavax&#8217;s latest vaccine targets the XBB.1.5 Omicron subvariant, which is closely\u200b related to \u200cthe strains currently in circulation. This\u2063 aligns\u200d with the updated vaccines from Pfizer and Moderna.<\/p>\n<div class=\"shortcode post-related-videos\">\n<div class=\"lazyload-wrapper\">\n<div class=\"lazyload-placeholder\"><\/div>\n<\/div>\n<\/div>\n<p>However, \u2063Novavax&#8217;s vaccine differs from Pfizer&#8217;s and Moderna&#8217;s \u200dby utilizing \u2062a protein-based \u2064approach to instruct the immune system in combating the coronavirus.\u200d Protein-based vaccines\u200d have been the \u2064standard for decades, while \u200bPfizer and Moderna employ mRNA technology.<\/p>\n<p>Dr. Marks, in \u200ba statement, expressed his enthusiasm for the FDA&#8217;s authorization, stating,\u200d &#8220;Today\u2019s authorization\u2063 provides an additional COVID-19 vaccine option that meets the FDA\u2019s standards for safety, effectiveness,\u2062 and <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-authorizes-first-one-shot-covid-19-vaccine-for-emergency-use\/\" title=\"FDA Authorizes First One-Shot COVID-19 Vaccine For Emergency Use\">manufacturing quality needed<\/a> to support emergency use authorization.&#8221;<\/p>\n<div class=\"my-5\">\n<p>&#8220;As we head into the fall\u2063 season and transition into 2024, we strongly\u2064 encourage \u200cthose who are eligible to consider receiving an updated COVID-19 vaccine to provide \u200dbetter protection against currently circulating variants.&#8221;<\/p>\n<h2>FDA Authorization Based on\u200c Trial Data for \u200bPrevious Vaccine<\/h2>\n<p>The FDA has confirmed that the authorization\u200d was based on\u200c trial data from previous versions of the Novavax\u2063 COVID-19 \u200bvaccine, including Original monovalent, Omicron BA.1, Omicron BA.5, \u200cand bivalent variants. Additionally, \u200ddata from booster doses administered \u200bto \u2064different age groups \u2064was taken into account.<\/p>\n<\/div>\n<p>In\u200b his Oct. 3\u2063 authorization letter,\u2064 Dr. Marks explained\u200d that \u200c&#8221;the data accrued&#8221; from the previous versions of the vaccine &#8220;are relevant to&#8221; the updated version &#8220;because these vaccines are manufactured \u2063using \u200da similar process.&#8221;<\/p>\n<div class=\"my-5\">\n<p>&#8220;FDA determined it \u2064is reasonable to conclude,\u200b based on the totality of\u200b the scientific\u2062 evidence available, that the known and potential benefits of the Novavax COVID\u201119\u2062 Vaccine, Adjuvanted (2023-2024 Formula) outweigh its known\u200b and potential risks for the prevention of COVID-19\u2062 in individuals 12 years\u200b and older when administered in accordance with the authorized dosing regimen and schedule,&#8221; wrote Dr. Marks (<a href=\"https:\/\/www.fda.gov\/media\/159902\/download?attachment\" target=\"_blank\" rel=\"noopener\">pdf<\/a>).<\/p>\n<\/div>\n<p>According\u200d to\u200d the FDA&#8217;s \u2062analysis of clinical \u2062trial \u200bdata, \u200bthe previous version of Novavax was found to be 78.29 percent effective in preventing\u200b &#8220;PCR-confirmed symptomatic mild, moderate, or severe COVID-19&#8221; at least seven \u200ddays after the second dose. \u2064However, Dr. Marks notes in his letter that no cases of \u200bmoderate or\u200c severe COVID-19 were reported \u2064in participants who received either the vaccine or \u2063placebo.<\/p>\n<p>As a result of the\u2064 updated vaccine, the FDA has revoked authorization \u200dfor the \u2063<a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-authorizes-novavaxs-updated-covid-jab-based-on-data-from-previous-versions\/\" title=\"FDA Approves Novavax's Updated COVID Vaccine Using Previous Version's Data\">original monovalent virus jab<\/a> in the United States. Last month, the U.S. Centers for Disease \u2064Control and Prevention (CDC) approved the updated vaccines, \u2063including Novavax&#8217;s.<\/p>\n<p>When the FDA authorized\u2064 Novavax&#8217;s shot last summer, fact sheets indicated that clinical trial\u2063 data suggested an increased\u200c risk of myocarditis and pericarditis after receiving the Novavax vaccine.<\/p>\n<p>In \u200cthe <a href=\"https:\/\/www.conservativenewsdaily.net\/breaking-news\/fda-violated-their-own-standards-in-approving-covid-19-vaccines-for-children\/\" title=\"FDA Violated Their Own Standards in Approving Covid-19 Vaccines For Children\">trial data submitted<\/a> to the regulator, five\u200b cases of one\u2064 or both conditions were \u200dreported among the approximately 26,100 \u2064vaccinated individuals, while zero cases were reported among placebo\u200b recipients. Subsequently, U.S. authorities approved a Novavax booster.<\/p>\n<p>In \u2062Europe, the regulatory agency initially\u2063 did not issue a warning about\u200b inflammation following\u2064 the administration of the Novavax vaccine.\u200c However, it later added \u2062a \u2062warning to its product\u2062 information.<\/p>\n<\/div>\n<\/blockquote>\n<p> <\/p>\n<h2>The vaccine. This includes safety and efficacy data from an\u2063 ongoing phase 3 trial and expansion of the trial for adolescents.\u200b How does the FDA&#8217;s consideration of previous versions of the vaccine enhance our understanding of its safety and effectiveness?<\/h2>\n<p><span>  \u200c Using the same production \u200bprocess and differ only in the \u2062specific antigens they contain.&#8221; This means that the safety and efficacy data from the previous versions can be applied to the updated version of the Novavax vaccine.<\/p>\n<p>The FDA&#8217;s decision to grant emergency use authorization\u2062 to \u200dthe updated Novavax vaccine \u200bis a significant step in combating the ongoing \u2064COVID-19 pandemic. With this authorization, individuals aged 12 and above can now receive a dose\u2063 of the new vaccine, regardless of their prior vaccination history. This broadens the access to vaccinations and enhances our \u200befforts \u2064to achieve widespread immunity.<\/p>\n<p>What sets this authorization apart is the FDA&#8217;s unique approach of combining existing safety and effectiveness data with booster studies. Rather than relying solely on new clinical trial data specific to\u200d the updated vaccine formulation, the FDA considered\u2064 data from previous versions and booster doses. This approach ensures that \u200cthe authorization is based on a \u2063comprehensive understanding of the vaccine&#8217;s performance.<\/p>\n<p>The Novavax vaccine has undergone rigorous evaluation by the FDA. In the case of the previous version \u200cauthorized in July 2022, the FDA\u200b reviewed safety and efficacy \u2063data from \u200can ongoing phase 3 trial. Subsequently, the same vaccine \u2062was authorized for individuals aged 12 to 17 using data from the expansion of the phase 3 trial for adolescents. This demonstrates the FDA&#8217;s commitment to thoroughly assessing the vaccine&#8217;s safety and effectiveness.<\/p>\n<p>The updated Novavax vaccine specifically targets the XBB.1.5 Omicron subvariant, which is closely related to the strains currently in circulation. \u200dThis aligns with the strategies employed by Pfizer\u200b and Moderna in their updated vaccines. \u2064However, Novavax&#8217;s vaccine differs in its use of a protein-based\u200d approach to instruct \u2064the immune system in fighting the coronavirus. Protein-based vaccines have been the standard for decades, while Pfizer and Moderna\u200b utilize mRNA technology.<\/p>\n<p>Dr. Marks, the director of the FDA&#8217;s Center for Biologics \u2062Evaluation and Research,\u200b expressed his enthusiasm for \u200dthe FDA&#8217;s\u2062 authorization and emphasized the importance of considering an updated COVID-19 vaccine. As we head \u200dinto the \u2064fall season and prepare for \u2064the coming year, it is \u200dcrucial\u200b for eligible individuals to receive the updated vaccine to enhance their protection against currently circulating variants.<\/p>\n<p>The FDA&#8217;s authorization of the updated Novavax vaccine is based on trial data from previous versions of<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA has granted emergency use authorization to Novavax&#8217;s updated COVID-19 vaccine. This allows individuals aged 12 and above to receive the new vaccine, regardless of their previous vaccination history. The authorization is based on safety data from previous versions of the vaccine.<\/p>\n","protected":false},"author":618,"featured_media":2055628,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_mo_disable_npp":"","fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","fifu_image_alt":"","footnotes":""},"categories":[543],"tags":[],"class_list":["post-2055627","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-the-epoch-times"],"fifu_image_url":"https:\/\/cndimages.nyc3.digitaloceanspaces.com\/breaking-news\/wp-content\/uploads\/2021\/01\/IMG_2758-scaled-1.jpg","_links":{"self":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2055627","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/users\/618"}],"replies":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/comments?post=2055627"}],"version-history":[{"count":0,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/posts\/2055627\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media\/2055628"}],"wp:attachment":[{"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/media?parent=2055627"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/categories?post=2055627"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.conservativenewsdaily.net\/breaking-news\/wp-json\/wp\/v2\/tags?post=2055627"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}