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(Sharecast News) - Pharmaceutical giant GSK said on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use had issued a positive opinion recommending a label update for its Bexsero meningitis B vaccine.
The CHMP backing paves the way for a single booster dose in individuals aged 10 years and older who received their primary vaccination at least two years prior, expanding the commercial reach of the shot into adolescent immunisation programmes across Europe.
GSK noted the recommendation was underpinned by data from its Phase IIIb Men-B-096 study, which met its primary endpoint and demonstrated that immune memory established in infancy can be boosted with a single dose up to 19 years later. Safety and reactogenicity profiles remained consistent with existing data.
While invasive meningococcal disease was said to be uncommon, incidence hits a second peak in adolescents and young adults, with Serogroup B remaining the leading cause of the life-threatening condition in Europeans under 65.
As of 0910 GMT, GSK shares were up 0.39% at 1,908.50p.
Reporting by Iain Gilbert at Sharecast.com
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