EU regulator backs single‑dose Bexsero booster for adolescents and older
On 13 Nov 2026 the EMA’s CHMP issued a positive opinion to add a one‑time booster of GSK’s Bexsero vaccine for people 10 years and older who received the original series at least two years before. The recommendation relies on a Phase IIIb trial of 312 participants aged 10‑20 that met its primary endpoint and showed a strong immune response and safety profile. GSK’s share price moved higher after the news, rising roughly 0.8% to about 1,916 pence.
Why it matters
The regulator’s endorsement could lead to label changes and wider use of the booster, potentially increasing Bexsero sales in Europe. GSK’s stock responded positively, gaining about 0.8% on the day of the announcement.
Key facts
- 1The CHMP issued a positive opinion to add a single booster dose to Bexsero’s label for individuals 10 years and older who were vaccinated at least two years earlier. directorstalkinterviews.com
- 2The opinion is based on the Men‑B‑096 Phase IIIb study that enrolled 312 participants aged 10‑20 across Finland, Italy, Spain and the United Kingdom. asktraders.com
- 3The trial met its primary endpoint, demonstrating a stronger immune response and a safety profile consistent with previous data. asktraders.com
- 4Data indicate that immune memory from infant vaccination can be re‑stimulated up to 19 years later. directorstalkinterviews.com
- 5GSK shares rose about 0.79% to roughly 1,916 pence following the announcement. asktraders.com
- 6The announcement was made on 13 Nov 2026. directorstalkinterviews.com
Summary written by AlphAI AI Desk from 5 of 5 sources. Not investment advice. Figures are as stated by the linked sources.