Pfizer has obtained European approval for the expanded use of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), in adults between 18 to 49 years of age for the prevention of invasive pneumococcal disease.
The vaccine is indicated for active immunization to prevent the invasive disease caused by vaccine-type Streptococcus pneumoniae (S. pneumoniae).
Prevenar 13 label expansion approval is based on data from a Phase III trial of the vaccine, which met all primary and secondary objectives in healthy adults aged 18 to 49 years.
Pfizer vaccine research chief scientific officer Emilio Emini said, "Prevenar 13 has been administered to millions of individuals around the world, and today's European approval for the expanded use of Prevenar 13 is a testament to Pfizer's continued commitment to developing innovative vaccines that can help prevent serious - and sometimes fatal - disease through every stage of life."
The product, which was earlier approved for use in infants, young children and adolescents aged six weeks to 17 years and adults aged 50 years and more, is now the only pneumococcal vaccine offering protection at all stages of life in the EU.
