BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - GSK plc (GSK, GSK.L) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended updating the Bexsero label to include a single booster dose for individuals aged 10 years and older who were previously vaccinated at least two years earlier with Bexsero. The company said, once approved, the single-dose Meningitis B booster could help vaccination programmes maintain protection into adolescence, when disease incidence reaches a second peak.
The opinion is based on data from Men-B-096, a Phase IIIb study which assessed the immune response and safety of a single booster dose of Bexsero in healthy individuals aged 10-20 years.
GSK shares are trading at 1,905.50 pence on LSE, up 0.24%.
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