GSK Plc's (LSE:GSK) meningitis B vaccine Bexsero has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), recommending a single booster dose for people aged 10 and older who were vaccinated with the drug at least two years earlier.
The London-listed drugmaker said the recommendation rests on data showing immune memory from infant vaccination can be boosted with one dose up to 19 years later.
Invasive meningococcal disease is uncommon but can progress rapidly and become life-threatening, with incidence highest in infants and young children before a second peak in adolescents and young adults, according to the European Centre for Disease Prevention and Control.
"As the first generation of children vaccinated against MenB in infancy reaches adolescence, today's positive CHMP opinion supports maintaining protection with a single booster dose during a second period in life of increased disease risk," said Sanjay Gurunathan, GSK's senior vice president for R&D vaccines and infectious diseases.
He added that adolescent boosters, if adopted, "could help reduce the overall burden of Invasive Meningococcal Disease in countries with established infant MenB programmes."
The opinion is based on the Men-B-096 study, a Phase IIIb open-label, multi-centre trial that assessed the immune response and safety of a single Bexsero booster in healthy individuals aged 10 to 20 who had completed their primary Bexsero vaccination series.
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The trial enrolled 312 participants across Finland, Italy, Spain and the UK, including 234 who had received Bexsero in infancy and 78 who had not previously received a meningococcal B vaccine, and met its primary endpoint of showing the booster produced a superior immune response compared with a first dose in previously unvaccinated adolescents.
GSK said the safety and reactogenicity profile of the single booster dose was consistent with Bexsero's known profile in this age group.