European Commission Expands Merck's VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) Indication to
Merck MRK, known as MSD outside of the United States and Canada, announced today that the European Commission (EC) has approved an expanded indication for 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. The approval facilitates availability of VAXNEUVANCE for this population in all 27 European Union (EU) Member States plus Iceland, Norway and Lichtenstein. 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. The use of VAXNEUVANCE in the EU should be in accordance with official recommendations.
VAXNEUVANCE was developed to maintain a strong immune response to serotypes included in currently available pneumococcal conjugate vaccines, or PCVs, while expanding coverage to disease-causing serotypes that can pose substantial risk to infants and children, said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. With this approval, we are pleased to bring an important new PCV option to a vulnerable population in Europe, including infants less than one year of age, who typically experience the highest rates of disease.
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