GSK secures EMA review for single‑dose Bexsero booster

(Sharecast News) - Drugmaker GSK said on Monday that the European Medicines Agency had accepted its submission to update the label for its Bexsero asset, allowing for a single‑dose booster in people aged 10 and over who were previously vaccinated in childhood. GSK said that, if approved, the booster would enable those who received Bexsero as infants to take a single additional dose from age 10 onwards, a move company believes could help reduce the burden of invasive meningococcal disease in countries with established MenB infant programmes.

The FTSE 100-listed firm said the filing was backed by a Phase 3b, open‑label, multi‑centre study assessing immune responses in 10 to 20‑year‑olds who had completed the primary Bexsero series in infancy. The data showed a single booster dose effectively restored immune protection. Full results will be presented at the 25th International Pathogenic Neisseria Conference in September.

As of 0815 BST, GSK shares were down 0.37% at 1,909.50p.







Reporting by Iain Gilbert at Sharecast.com