{"id":74959,"date":"2026-08-17T12:54:27","date_gmt":"2026-08-17T04:54:27","guid":{"rendered":"https:\/\/flcube.com\/?p=74959"},"modified":"2026-08-17T12:54:28","modified_gmt":"2026-08-17T04:54:28","slug":"pfizer-and-valneva-see-ema-validate-maa-for-pf-07307405-the-first-potential-blockbuster-lyme-disease-vaccine","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=74959","title":{"rendered":"Pfizer and Valneva See EMA Validate MAA for PF\u201107307405, the First\u2011Potential Blockbuster Lyme Disease Vaccine"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\"><strong>Pfizer Inc.<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/PFE:NYSE\">NYSE: PFE<\/a>) and <strong>Valneva SE<\/strong> (<a href=\"https:\/\/www.google.com\/finance\/beta\/quote\/VALN:NASDAQ\">NASDAQ: VALN<\/a>) announced that the <strong>European Medicines Agency (EMA)<\/strong> has <strong>validated the Marketing Authorization Application (MAA)<\/strong> for <strong>PF\u201107307405<\/strong>, the companies&#8217; <strong>6\u2011valent outer surface protein A (OspA)\u2011based Lyme disease vaccine candidate<\/strong>. EMA validation confirms the submission is administratively complete and formally starts the centralized review procedure.<\/p>\n\n\n\n<h2 id=\"h-regulatory-milestone\" class=\"wp-block-heading\">Regulatory Milestone<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Agency<\/strong><\/td><td>European Medicines Agency (EMA)<\/td><\/tr><tr><td><strong>Submission Type<\/strong><\/td><td>Marketing Authorization Application (MAA) \u2013 validated<\/td><\/tr><tr><td><strong>Product<\/strong><\/td><td>PF\u201107307405, 6\u2011valent OspA\u2011based Lyme disease vaccine candidate<\/td><\/tr><tr><td><strong>Target Population<\/strong><\/td><td>Individuals aged 5 years and older<\/td><\/tr><tr><td><strong>Announcement Date<\/strong><\/td><td>14 Aug 2026<\/td><\/tr><tr><td><strong>Next Steps<\/strong><\/td><td>Centralized EMA scientific review; potential CHMP opinion<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<h2 id=\"h-vaccine-profile-amp-mechanism-of-action\" class=\"wp-block-heading\">Vaccine Profile &amp; Mechanism of Action<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>Molecule:<\/strong> <strong>PF\u201107307405<\/strong>, a <strong>6\u2011valent vaccine<\/strong> based on <strong>outer surface protein A (OspA)<\/strong> of <em>Borrelia burgdorferi<\/em> sensu lato, the causative pathogen of Lyme disease<\/li>\n\n\n\n<li><strong>Design:<\/strong> Targets six OspA serotypes, designed to provide broad coverage against the <em>Borrelia<\/em> strains most prevalent in both North America and Europe<\/li>\n\n\n\n<li><strong>Partnership Structure:<\/strong> Under an April 2020 collaboration and license agreement, <strong>Pfizer<\/strong> and <strong>Valneva<\/strong> co\u2011develop PF\u201107307405; assuming regulatory success, <strong>Pfizer<\/strong> will exclusively manufacture and commercialize the vaccine<\/li>\n\n\n\n<li><strong>Unmet Need:<\/strong> No Lyme disease vaccine is currently approved for humans, making PF\u201107307405 a potential first\u2011in\u2011class preventive option<\/li>\n<\/ul>\n\n\n\n<h2 id=\"h-clinical-evidence-phase-3-valor-trial\" class=\"wp-block-heading\">Clinical Evidence \u2013 Phase 3 VALOR Trial<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Element<\/th><th>Detail<\/th><\/tr><\/thead><tbody><tr><td><strong>Trial Name<\/strong><\/td><td>VALOR \u2013 &#8220;Vaccine Against Lyme for Outdoor Recreationists&#8221;<\/td><\/tr><tr><td><strong>Identifier<\/strong><\/td><td>NCT05477524<\/td><\/tr><tr><td><strong>Primary Readout<\/strong><\/td><td>Efficacy of <strong>more than 70 %<\/strong> observed against Lyme disease cases<\/td><\/tr><tr><td><strong>Population<\/strong><\/td><td>Individuals aged <strong>5 years and older<\/strong><\/td><\/tr><tr><td><strong>Safety<\/strong><\/td><td>Well tolerated; no safety concerns identified<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p class=\"wp-block-paragraph\">The Phase 3 VALOR study investigated whether <strong>PF\u201107307405<\/strong> prevents Lyme disease cases in a broad at\u2011risk population. The observed efficacy of more than 70 % combined with a clean tolerability profile forms the core of the MAA dossier.<\/p>\n\n\n\n<h2 id=\"h-market-impact-amp-outlook\" class=\"wp-block-heading\">Market Impact &amp; Outlook<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>First\u2011Mover Potential:<\/strong> With no licensed human Lyme disease vaccine on the market, a successful approval would create a new preventive category, with demand concentrated in endemic regions across North America and Europe.<\/li>\n\n\n\n<li><strong>Addressable Population:<\/strong> The 5\u2011plus age indication and outdoor\u2011recreation positioning open a broad target cohort, from children in endemic areas to adult hikers, hunters, and forestry workers.<\/li>\n\n\n\n<li><strong>Commercial Leverage:<\/strong> <strong>Pfizer&#8217;s<\/strong> exclusive manufacturing and commercialization rights give it direct control over launch execution, building on its established global vaccine infrastructure.<\/li>\n\n\n\n<li><strong>Strategic Significance:<\/strong> Validation by the <strong>EMA<\/strong> moves the program closer to a potential first approval, while parallel regulatory pathways in the United States would further expand the commercial opportunity for the <strong>Pfizer\u2013Valneva<\/strong> partnership.<\/li>\n<\/ul>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Forward\u2011Looking Statements<\/strong><br>This brief contains forward\u2011looking statements regarding regulatory review timelines, clinical outcomes, and commercial expectations for PF\u201107307405. Actual results may differ due to risks including regulatory decisions, market adoption, and competitive dynamics.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pfizer Inc. (NYSE: PFE) and Valneva SE (NASDAQ: VALN) announced that the European Medicines Agency&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_feature_clip_id":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2},"jetpack_post_was_ever_published":false},"categories":[7,11],"tags":[38,2255,863,309,12,2256],"class_list":["post-74959","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-market-approval-filings","tag-nasdaq-valn","tag-nyse-pfe","tag-pfizer","tag-vaccine","tag-valneva"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.5 (Yoast SEO v28.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pfizer and Valneva See EMA Validate MAA for PF\u201107307405, the First\u2011Potential Blockbuster Lyme Disease Vaccine - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Pfizer Inc. (NYSE: PFE) and Valneva SE (NASDAQ: VALN) announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF\u201107307405, the companies&#039; 6\u2011valent outer surface protein A (OspA)\u2011based Lyme disease vaccine candidate. EMA validation confirms the submission is administratively complete and formally starts the centralized review procedure.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/flcube.com\/?p=74959\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pfizer and Valneva See EMA Validate MAA for PF\u201107307405, the First\u2011Potential Blockbuster Lyme Disease Vaccine\" \/>\n<meta property=\"og:description\" content=\"Pfizer Inc. (NYSE: PFE) and Valneva SE (NASDAQ: VALN) announced that the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for PF\u201107307405, the companies&#039; 6\u2011valent outer surface protein A (OspA)\u2011based Lyme disease vaccine candidate. 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