{"id":70360,"date":"2026-07-21T19:22:05","date_gmt":"2026-07-21T11:22:05","guid":{"rendered":"https:\/\/flcube.com\/?p=70360"},"modified":"2026-07-21T19:22:05","modified_gmt":"2026-07-21T11:22:05","slug":"gsk-submits-bexsero-label-update-to-ema-for-single-dose-booster-in-adolescents-and-adults-previously-vaccinated-in-childhood","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=70360","title":{"rendered":"GSK Submits Bexsero Label Update to EMA for Single-Dose Booster in Adolescents and Adults Previously Vaccinated in Childhood"},"content":{"rendered":"\n

GlaxoSmithKline plc (GSK)<\/strong> (NYSE: GSK<\/a>) announced that the European Medicines Agency (EMA)<\/strong> has accepted a submission to update the label for Bexsero<\/strong>, its meningococcal group B vaccine, to include a single-dose booster<\/strong> for individuals aged 10 years and older<\/strong> who were previously vaccinated with Bexsero during childhood. The proposed label expansion aims to address waning immunity and reduce the overall burden of Invasive Meningococcal Disease (IMD)<\/strong> in countries with established infant MenB vaccination programs.<\/p>\n\n\n\n

Regulatory Submission & Product Background<\/h2>\n\n\n\n
Component<\/th>Detail<\/th><\/tr><\/thead>
Company<\/strong><\/td>GlaxoSmithKline plc (GSK) (NYSE: GSK)<\/td><\/tr>
Regulatory Agency<\/strong><\/td>European Medicines Agency (EMA)<\/td><\/tr>
Submission Status<\/strong><\/td>Accepted for review<\/td><\/tr>
Product<\/strong><\/td>Bexsero (meningococcal group B vaccine)<\/td><\/tr>
Proposed Indication<\/strong><\/td>Single-dose booster for ages 10+ previously vaccinated with Bexsero<\/td><\/tr>
Current Registration<\/strong><\/td>61 countries worldwide<\/td><\/tr>
Target Disease<\/strong><\/td>Invasive Meningococcal Disease (IMD) caused by Neisseria meningitidis serogroup B (MenB)<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Disease Burden & Clinical Rationale<\/h2>\n\n\n\n