EC green light for Merck's Vaxneuvance

The European Commission (EC) has approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine), developed by US pharma giant Merck & Co (NYSE: MRK), for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

The approval allows marketing of Vaxneuvance in all 27 European Union member states plus Iceland, Norway and Lichtenstein. The use of Vaxneuvance in the EU should be in accordance with official recommendations.

The EC’s decision follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products on Human Use (CHMP), which reviewed data from seven randomized, double-blind clinical studies evaluating Vaxneuvance in 7,438 individuals from a variety of adult populations and clinical circumstances. These included healthy adults ages 50 years and older, adults ages 18 to 49 with risk factors for pneumococcal disease, and immunocompromised adults living with HIV.