Moderna has withdrawn its application for FDA approval of its combination flu and COVID-19 vaccine, mRNA-1083, for adults aged 50 and older. The company plans to resubmit the application later this year, incorporating efficacy data from an ongoing Phase 3 trial of its standalone seasonal influenza vaccine, mRNA-10102. Interim results from this trial are expected to be available by summer.<\/p>\n\n\n\n
The decision follows discussions with the FDA, which recently introduced stricter guidelines for COVID-19 vaccine approvals. The agency now requires placebo-controlled studies for any new COVID-19 vaccine seeking approval for healthy adults under 65 years old. Moderna had initially filed for approval last year, aiming for a November 2025 authorization, but the FDA’s request for additional efficacy data pushed the expected approval date to 20262.<\/p>\n\n\n\n
Moderna\u2019s flu\/COVID combination vaccine had previously demonstrated promising results, showing comparable or superior antibody responses against flu strains and the Omicron XBB.1.5 COVID-19 variant compared to existing flu and COVID vaccines. Despite this, the FDA’s requirement for further efficacy data led Moderna to voluntarily withdraw its application rather than amend the existing submission1.<\/p>\n\n\n\n
The withdrawal is a setback for Moderna, which has been facing declining revenue from its COVID-19 and RSV vaccines. Following the announcement, Moderna\u2019s stock initially rose by more than 6% but later lost those gains1. The company remains optimistic about its resubmission later this year, once the necessary efficacy data is available.<\/p>\n","protected":false},"excerpt":{"rendered":"
Moderna has withdrawn its application for FDA approval of its combination flu and COVID-19 vaccine, mRNA-1083, for adults aged 50 and older. The company plans to resubmit the application later […]<\/p>\n","protected":false},"author":2,"featured_media":12194,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[171,877,607,608],"tags":[],"class_list":["post-12191","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-fda","category-moderna-vaccine","category-vaccine-news","category-vaccine-safety"],"_links":{"self":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12191","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=12191"}],"version-history":[{"count":2,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12191\/revisions"}],"predecessor-version":[{"id":12193,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/posts\/12191\/revisions\/12193"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=\/wp\/v2\/media\/12194"}],"wp:attachment":[{"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=12191"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=12191"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/cov19longhaulfoundation.org\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=12191"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}