GSK (LSE:GSK) has announced that the European Medicines Agency has accepted its application to update the prescribing information for Bexsero, seeking approval for a single booster dose for people aged 10 years and older who received the meningococcal B vaccine during infancy. The proposed label expansion is intended to extend protection into adolescence and early adulthood, when cases of invasive meningococcal disease experience a second peak.
The submission is supported by data from a Phase 3b clinical trial demonstrating that a single booster dose successfully restores protective immune responses in individuals aged between 10 and 20 who completed the original vaccination schedule as infants. If the application is approved and adopted by countries with existing meningococcal B immunisation programmes, the booster could help reduce the incidence of invasive meningococcal disease while strengthening GSK’s position in the global vaccine market.
GSK continues to benefit from strong underlying financial performance, supported by healthy operating margins, improving earnings and an attractive valuation, including a relatively low price-to-earnings ratio and a dividend yield of around 3.47%. However, these strengths are partly offset by weaker technical indicators, with the shares trading below key moving averages, as well as financial considerations including leverage and variable free cash flow generation.
More about GSK
GSK is a global biopharmaceutical company focused on developing innovative vaccines and medicines to prevent and treat disease. The company combines scientific research, advanced technology and global manufacturing capabilities to address a broad range of infectious diseases and chronic health conditions.
Its vaccine portfolio includes Bexsero, a meningococcal B vaccine approved in 61 countries and incorporated into several national immunisation programmes across Europe. Since its launch in 2015, approximately 138 million doses of Bexsero have been distributed worldwide, making it one of the leading vaccines for the prevention of meningococcal B disease.
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