Merck's VAXNEUVANCE Receives Expanded Indication Approval from European Commission

Strategic Insights -

The European Commission has granted an expanded indication approval for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine), developed by Merck, 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. This decision follows a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), which reviewed data from eight randomized, double-blind clinical studies involving approximately 8,400 individuals.

Key Takeaways:

  • The European Commission has approved VAXNEUVANCE 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.
  • The approval is based on data from eight randomized, double-blind clinical studies involving approximately 8,400 individuals.
  • VAXNEUVANCE is also indicated for active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older in the EU.
  • The use of VAXNEUVANCE should be in accordance with official recommendations.
  • Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, stated that VAXNEUVANCE was developed to maintain a strong immune response to serotypes included in currently available pneumococcal conjugate vaccines, while expanding coverage to disease-causing serotypes that can pose substantial risk to infants and children.
  • The EC's decision follows a positive opinion from the CHMP, which reviewed data from eight randomized, double-blind clinical studies.
  • Pneumococcal disease caused by Streptococcus pneumoniae can lead to serious and potentially life-threatening infections such as bacteremia, bacteremic pneumonia, and meningitis.

Statistics:

  • 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).
  • The study 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 Streptococcus pneumoniae, or pneumococcus.
  • More than 100 different types of Streptococcus pneumoniae, called serotypes, are responsible for pneumococcal infections.
  • Invasive pneumococcal disease can cause serious and potentially life-threatening infections such as bacteremia, bacteremic pneumonia, and meningitis.

Sources:

  • European Commission
  • European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)
  • Merck & Co., Inc.
  • U.S. Food and Drug Administration (FDA)