{"id":40619,"date":"2025-09-03T14:51:41","date_gmt":"2025-09-03T06:51:41","guid":{"rendered":"https:\/\/flcube.com\/?p=40619"},"modified":"2025-09-03T14:51:42","modified_gmt":"2025-09-03T06:51:42","slug":"pfizer%e2%80%91biontech-receives-fda-approval-for-new-covid%e2%80%9119-vaccine-indication-for-high%e2%80%91risk-adults","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=40619","title":{"rendered":"Pfizer\u2011BioNTech Receives FDA Approval for New COVID\u201119 Vaccine Indication for High\u2011Risk Adults"},"content":{"rendered":"\n<p>Pfizer Inc. (<a href=\"https:\/\/www.google.com\/finance\/quote\/PFE:NYSE\">NYSE: PFE<\/a>) and BioNTech SE (<a href=\"https:\/\/www.google.com\/finance\/quote\/BNTX:NASDAQ\">NASDAQ: BNTX<\/a>) today announced that the United States Food and Drug Administration (FDA) has approved a new indication for their LP.8.1\u2011adapted monovalent COVID\u201119 vaccine (COMIRNATY\u202fLP.8.1). The product is now authorized for use in adults aged 65\u202fand older and in individuals aged 5\u201164 who have at least one underlying condition that places them at high risk for severe COVID\u201119 outcomes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-fda-guided-sublineage-selection\">FDA\u2011Guided Sublineage Selection<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><strong>LP.8.1<\/strong> was chosen as the preferred sublineage for a JN.1\u2011lineage\u2011based monovalent vaccine, in line with FDA recommendations for the 2025\u2011fall U.S. rollout.<\/li>\n\n\n\n<li>The vaccine will begin shipping immediately, becoming available in pharmacies, hospitals, and clinics nationwide within days.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-global-reach-and-proven-safety\">Global Reach and Proven Safety<\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Over <strong>five\u202fbillion<\/strong> doses of the Pfizer\/BioNTech COVID\u201119 vaccine have been distributed worldwide.<\/li>\n\n\n\n<li>Extensive real\u2011world evidence, clinical trials, non\u2011clinical studies, pharmacovigilance data, and robust manufacturing records continue to support the vaccine\u2019s favorable safety and efficacy profile.<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-product-and-regulatory-overview\">Product and Regulatory Overview<\/h2>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><thead><tr><th>Item<\/th><th>Details<\/th><\/tr><\/thead><tbody><tr><td><strong>Technology<\/strong><\/td><td>BioNTech\u2019s proprietary mRNA platform<\/td><\/tr><tr><td><strong>Co\u2011development<\/strong><\/td><td>Pfizer &amp; BioNTech<\/td><\/tr><tr><td><strong>Marketing Authorization<\/strong><\/td><td>BioNTech holds approval in the U.S., EU, UK, and other markets; emergency use authorizations elsewhere<\/td><\/tr><tr><td><strong>New Indication<\/strong><\/td><td>Adults\u202f\u2265\u202f65 &amp; 5\u201164 with high\u2011risk conditions<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p>The approval underscores the ongoing commitment of Pfizer and BioNTech to adapt their mRNA technology to evolving viral variants and to protect the most vulnerable populations.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pfizer Inc. (NYSE: PFE) and BioNTech SE (NASDAQ: BNTX) today announced that the United States&#8230;<\/p>\n","protected":false},"author":1,"featured_media":40621,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_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}},"categories":[7,11],"tags":[342,13,1124,863,309,15],"class_list":["post-40619","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-company","category-drug","tag-biontech","tag-covid-19","tag-nasdaq-bntx","tag-nyse-pfe","tag-pfizer","tag-product-approvals"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Pfizer\u2011BioNTech Receives FDA Approval for New COVID\u201119 Vaccine Indication for High\u2011Risk Adults - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Pfizer (NYSE:\u202fPFE) and BioNTech (NASDAQ:\u202fBNTX) announce FDA approval of COMIRNATY\u202fLP.8.1 for adults\u202f\u2265\u202f65 and individuals\u202f5\u201164 with high\u2011risk conditions. 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