Merck 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.
“We are committed to advancing protection for those at increased risk for pneumococcal disease, which includes those under the age of 2 years and children of any age who have certain underlying conditions,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are pleased with the CHMP’s positive opinion as it brings us one step closer to our goal of helping to protect against pneumococcal strains that pose substantial risk to infants and children in Europe.”
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).
The CHMP opinion was based on data from eight randomized, double-blind clinical studies that enrolled approximately 8,400 individuals from a variety of pediatric populations and clinical circumstances; of these, approximately 5,400 received VAXNEUVANCE.
In July 2021, VAXNEUVANCE received approval from the U.S. Food and Drug Administration (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 of age and older, and in June 2022, the FDA approved an expanded indication for VAXNEUVANCE to include individuals 6 weeks through 17 years of age.
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