Pfizer Inc. (NYSE: PFE) announced today that the World Health Organization (WHO) has granted an expansion to the prequalification of Pfizer’s pneumococcal conjugate vaccine, Prevenar 13
(Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]), to include adults 50 years of age and older against pneumonia and invasive disease caused by the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) contained in the vaccine.
Prevenar 13 was previously prequalified for active immunization of infants and children from six weeks through 5 years of age against invasive pneumococcal disease, pneumonia and otitis media in August 2010.
“Prevenar 13 is the first and only pneumococcal vaccine to be granted WHO prequalification in the adult population,” says Luis Jodar, vice president, Vaccines, Global, Medicines Development Group and Scientific Affairs, Pfizer. “This expanded designation will allow for broader global access to the vaccine and provide the opportunity for a new prevention option for adults 50 years of age and older in developing nations.”
The WHO prequalification program aims to make quality, priority medicines available for the benefit of those in need. Consequently, this prequalification allows for the procurement of Prevenar 13 for adults 50 years of age and older, in addition to Prevenar 13 for children under 5 years of age, by United Nations agencies, and is for global use of the vaccine in a single-dose vial. The WHO prequalification process applies unified standards to vaccines and other medicinal products.
“We are committed to developing vaccines that can help people remain healthy through every stage of life,” says Susan Silbermann, president and general manager, Vaccines, Pfizer. “With the WHO prequalification, we are proud to be working with a leader in public health to help bring us one step closer to making this important vaccine accessible to all adults 50 years of age and older around the world.”