{"id":9668,"date":"2025-02-18T10:44:06","date_gmt":"2025-02-18T15:44:06","guid":{"rendered":"https:\/\/lifescivoice.com\/?p=9668"},"modified":"2025-02-18T10:44:06","modified_gmt":"2025-02-18T15:44:06","slug":"fda-approves-penmenvy-vaccine-for-meningococcal-disease-prevention","status":"publish","type":"post","link":"https:\/\/lifescivoice.com\/fda-approves-penmenvy-vaccine-for-meningococcal-disease-prevention\/","title":{"rendered":"FDA Approves Penmenvy Vaccine for Meningococcal Disease Prevention"},"content":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) has approved Penmenvy, a vaccine for meningococcal groups A, B, C, W, and Y, for use in individuals aged 10 to 25 years. The vaccine targets five major serogroups of Neisseria meningitidis, the bacteria responsible for invasive meningococcal disease (IMD).<br \/>\nThe approval is based on data from two phase 3 clinical trials (NCT04502693; NCT04707391) that assessed the vaccine\u2019s safety, tolerability, and immune response in more than 4,800 participants. Penmenvy combines elements from two existing GSK meningococcal vaccines, Bexsero and Menveo, to enhance immune protection against multiple strains.<br \/>\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script> <ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins> <script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script><br \/>\nOne study (NCT04502693) examined the effectiveness of two or three doses of Bexsero along with two doses of Penmenvy in healthy adolescents and young adults. The trial included 3,651 individuals, with primary endpoints focusing on safety and immune response. Researchers reported immune response rates of 78.7% for a 0-to-2-month schedule, 81.8% for a 0-to-6-month schedule, and 83.2% for a 0-to-2-to-6-month schedule. No significant differences in immunogenicity were observed between the dosing schedules, and the vaccine was well tolerated.<br \/>\nThe second trial (NCT04707391) evaluated the vaccine\u2019s safety and immunogenicity in individuals aged 15 to 25 years who had previously received the MenACWY vaccine. The primary endpoint assessed the noninferiority of MenABCWY compared with the MenACWY-CRM197-glycoconjugate vaccine. Secondary endpoints included the percentage of participants with human serum bactericidal antibody (hSBA) titers above the lower limit of quantification (\u2265 LLOQ) for serogroups ACWY. The results showed noninferiority of MenABCWY, with hSBA titers \u2265 LLOQ ranging from 97.9% to 98.9% following one dose and 99.5% to 100% after two doses. The MenACWY-CRM group had response rates between 96.8% and 99%. The vaccine was well tolerated.<br \/>\n<script async=\"\" src=\"https:\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js?client=ca-pub-3812572458252831\" crossorigin=\"anonymous\"><\/script> <ins class=\"adsbygoogle\" style=\"display: block; text-align: center;\" data-ad-layout=\"in-article\" data-ad-format=\"fluid\" data-ad-client=\"ca-pub-3812572458252831\" data-ad-slot=\"7669348015\"><\/ins> <script>\n     (adsbygoogle = window.adsbygoogle || []).push({});\n<\/script><br \/>\nAccording to the U.S. Centers for Disease Control and Prevention (CDC), cases of meningococcal disease have increased significantly since 2021, surpassing pre-pandemic levels. In 2023, 438 confirmed and probable cases were reported in the United States.<br \/>\nThe CDC\u2019s Advisory Committee on Immunization Practices is expected to vote on recommendations regarding the vaccine\u2019s use in adolescents and young adults.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration (FDA) has approved Penmenvy, a vaccine for meningococcal groups A, B, C, W, and Y, for use in individuals aged 10 to 25 years. The vaccine targets five major serogroups of Neisseria meningitidis, the bacteria responsible for invasive meningococcal disease (IMD). The approval is based on data from two [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":9669,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36],"tags":[],"class_list":{"0":"post-9668","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-regulatory"},"_links":{"self":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/9668","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/comments?post=9668"}],"version-history":[{"count":1,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/9668\/revisions"}],"predecessor-version":[{"id":9670,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/posts\/9668\/revisions\/9670"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media\/9669"}],"wp:attachment":[{"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/media?parent=9668"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/categories?post=9668"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lifescivoice.com\/wp-json\/wp\/v2\/tags?post=9668"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}