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European Union

Merck's VAXNEUVANCE Receives Expanded Indication Approval in the European Union for Prevention of Pneumococcal Disease

Strategic Insights

— 2 min read

The European Commission has approved an expanded indication for Merck's (NYSE: MRK) VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) to include active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae (S. pneumoniae) in infants, children, and adolescents from 6 weeks to less than 18 years of age. This approval facilitates the availability of VAXNEUVANCE for this population in all 27 European Union (EU) Member States, as well as Iceland, Norway, and Liechtenstein. VAXNEUVANCE is also indicated in the EU for active immunization for the prevention of invasive disease and pneumonia caused by S. pneumoniae in individuals 18 years of age and older.

Key Takeaways:

  • The European Commission has approved an expanded indication for VAXNEUVANCE to include active immunization for the prevention of invasive disease, pneumonia, and acute otitis media caused by S. pneumoniae in infants, children, and adolescents from 6 weeks to less than 18 years of age.
  • The approval follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), who reviewed data from eight randomized, double-blind clinical studies enrolling approximately 8,400 individuals.
  • The studies evaluated the use of VAXNEUVANCE in various pediatric populations at risk for pneumococcal disease, including healthy infants, children, and adolescents, pre-term infants, and children living with HIV infection or sickle cell disease.
  • The data supporting the approval included findings from the pivotal PNEU-PED-EU-1 study, which evaluated the safety, tolerability, and immunogenicity of a two-dose infant series followed by a toddler dose of VAXNEUVANCE in healthy infants (n=1,184).
  • Results showed that immune responses for VAXNEUVANCE were noninferior to PCV13 for the 13 serotypes shared between the two vaccines and superior for the two additional serotypes in VAXNEUVANCE, 22F and 33F.
  • Pneumococcal disease is an infection caused by the bacterium S. pneumoniae, responsible for serious and potentially life-threatening infections such as bacteremia, bacteremic pneumonia, and meningitis.
  • The use of VAXNEUVANCE in the EU should be in accordance with official recommendations.

Statistics:

  • The studies involved approximately 8,400 individuals, including 5,400 who received VAXNEUVANCE.
  • The PNEU-PED-EU-1 study enrolled 1,184 healthy infants.
  • Results showed that immune responses for VAXNEUVANCE were noninferior to PCV13 for 13 serotypes and superior for the two additional serotypes in VAXNEUVANCE, 22F and 33F.
  • Pneumococcal disease is responsible for serious and potentially life-threatening infections, such as bacteremia, bacteremic pneumonia, and meningitis.

Sources:

  • Merck (NYSE: MRK) press release, date not specified.
  • European Commission press release, date not specified.
  • European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) opinion, date not specified.
  • PNEU-PED-EU-1 study, date not specified.
  • Contify.com, distributed by Euclid Infotech Pvt. Ltd., date not specified.

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