Positive CHMP opinion for Vaxneuvance (Pneumococcal 15-valent conjugate vaccine) in infants and children
Merck Inc., has announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to less than 18 years of age
Vaxneuvance is currently authorized for use in the European Union (EU) for individuals 18 years of age and older. The CHMP opinion will now be considered by the European Commission (EC) for amending the marketing authorization in the EU, and a final decision is expected by the end of the year.
Pneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae, or pneumococcus. While there are more than 100 different types of S. pneumoniae, called serotypes, a selected number of serotypes are responsible for the majority of pneumococcal infections. Invasive pneumococcal disease (IPD) can cause serious and potentially life-threatening infections such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord.
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