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Positive CHMP opinion for Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) in individuals 18 years of age and older.- Merck Inc.

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Last updated:17th Oct 2021
Published:17th Oct 2021
Merck Inc., 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) for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. The CHMP recommendation will now be reviewed by the European Commission for marketing authorization in the European Union, and a final decision is expected by the end of the year.

The CHMP opinion was based on data from seven randomized, double-blind clinical studies evaluating Vaxneuvance in 7,438 individuals FDA for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years and older.

The benefits of Vaxneuvance are the presumed protection against pneumococcal disease (based on immunobridging data). The most common side effects are injection site pain, fatigue and headache.

Condition: Pneumococcal Disease
Type: drug

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