GSK plc (LON: GSK) said in an announcement on the London Stock Exchange today that a European Medicines Agency committee has recommended adding a single booster dose to the label of its MenB vaccine, Bexsero. The committee is the CHMP.
The booster would be for people aged 10 and older who had Bexsero at least two years earlier. A CHMP opinion is a recommendation rather than an approval, and GSK’s release refers to the booster as something to be adopted.
The recommendation rests on Men-B-096, a Phase IIIb trial in 312 10- to 20-year-olds across Finland, Italy, Spain and the UK. Of those, 234 were vaccinated in infancy and 78 had never had a MenB vaccine.
The study met its main goal: a single booster in the previously vaccinated group produced a stronger immune response than a first dose did in adolescents with no prior MenB vaccination. GSK said the data show immune memory from infant vaccination can be boosted up to 19 years later, with safety consistent with the known profile.
Sanjay Gurunathan, SVP R&D Vaccines & Infectious Diseases at GSK, framed it around the first infant-vaccinated generation reaching adolescence.
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.
Sanjay Gurunathan, SVP R&D Vaccines & Infectious Diseases, GSK
Invasive meningococcal disease is uncommon but can progress rapidly and be life-threatening. Incidence peaks in infants and again in adolescents and young adults, and in Europe serogroup B is the leading cause under 65. Bexsero is registered in 61 countries, with around 140 million doses distributed globally since 2015.
GSK shares were up 0.79% at 1,916p by 9.38am, against yesterday’s close of 1,901p, within a range of 1,895.5p to 1,919p. The gain is modest, and no link between it and the vaccine news has been established.
The wider picture is a recovery from lows. Yesterday’s close was 8.44% above the 1,753p of the 13th of October, the 52-week closing low, and 4.19% up on the year. The shares fell 4.78% on the 28th of October, the day of third-quarter results, but remain 16.18% below the 2,268p closing high of the 18th of February.
For Bexsero, the next step is whether the booster is adopted. The release says that if it is, adolescent boosters could reduce the overall burden of the disease in countries with established infant MenB programmes.