Pfizer Inc. announced today that the World Health Organization (WHO) has granted an expansion to the pre-qualification of its pneumococcal conjugate vaccine, Prevenar 13 to include adults over 50 years against pneumonia and invasive disease caused by the 13 pneumococcal serotypes contained in the vaccine.
Prevenar 13 was previously pre-qualified for active immunization of infants and children from six weeks through five 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 pre-qualification in the adult population,” says Luis Jodar, vice president, Vaccines, Global, Medicines Development Group and Scientific Affairs, Pfizer.
The WHO pre-qualification programme aims to make quality, priority medicines available for the benefit of those in need. Consequently, this pre-qualification allows for the procurement of Prevenar 13 for adults 50 years of age and older, in addition to Prevenar 13 for children under five years of age, by United Nations agencies, and is for global use of the vaccine in a single-dose vial. The WHO pre-qualification 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,” said Susan Silbermann, president and general manager, Vaccines, Pfizer.
Currently, Prevenar 13, or Prevnar 13 as it is called in the United States, Canada and Taiwan, is approved in adults 50 years of age and older in more than 70 countries, including Australia, Canada, the European Union, India, Mexico, Russia, Singapore, Turkey and the United States.
To meet the growing global demand for Prevenar 13, Pfizer is increasing its manufacturing capabilities to help ensure product supply through a combination of capital investment, process improvements and efficiency measures throughout the supply network. The company is also investing in the development of a preserved, multi-dose vial which, subject to WHO pre-qualification, is expected to offer an alternative option for developing countries. This additional investment further underscores the company’s commitment to the prevention of pneumococcal disease through vaccination around the world, including in least developed countries.
To date, Pfizer has agreed to supply a total of up to 480 million doses of Prevenar 13 through 2023 to infants and young children in the poorest countries of the world under the AMC for pneumococcal vaccination.
Prevenar 13 for paediatric use is available in 16 of the 18 countries that have launched national immunization programs with a pneumococcal conjugate vaccine through the AMC.