Merck`s 21-valent pneumococcal jab gears up for Prevnar 20 rivalry
RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: 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.
Pfizer has followed up the recent success of a U.S. clinical trial of its 20-valent pneumococcal conjugate vaccine in infants with a win in the EU, keeping it on track to advance toward approvals in the population on both sides of the Atlantic.
KENILWORTH, N.J.--(BUSINESS WIRE)-- (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved VAXNEUVANCE™ (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) 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. The approval follows the FDA’s Priority Review of Merck’s application. VAXNEUVANCE is contraindicated for individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid; see additional Select Safety Information below.