Singapore, Aug 23, 2010: The World Health Organization (WHO) has granted prequalification to Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine )for active immunization of infants and children from six weeks through five years of age. The vaccine acts  against invasive disease, pneumonia and otitis media caused by the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) contained in the vaccine.

The WHO prequalification allows for the procurement of Prevenar 13 by United Nations agencies, including the United Nations Children's Fund (UNICEF), governments and other organizations for use in national immunization programs. The prequalification is for global use of the vaccine in a single-dose vial.

“We are pleased to receive WHO prequalification as recognition that Prevenar 13 meets the organization's high standards for quality," says Dr Emilio Emini, CSO, Vaccine Research, Pfizer. "This is an important step towards our goal of making Prevenar 13, which offers the broadest serotype coverage of any pneumococcal conjugate vaccine, available to infants and young children globally."

In March 2010, Pfizer entered into a 10-year Provisional Supply Agreement to provide Prevenar 13 to infants and young children in the world's poorest countries under the terms of the Advance Market Commitment (AMC) for pneumococcal disease, an innovative program piloted by the GAVI Alliance. In order to participate in the AMC program, vaccines must receive WHO prequalification.

To meet the growing global demand for Prevenar 13, Pfizer is increasing its manufacturing capabilities through a combination of capital investment, process improvements and efficiency measures throughout its supply network. Additionally, Pfizer is engaged in the development of a preserved, multi-dose vial which, subject to WHO prequalification, is expected to offer an alternative option for developing world countries.

"Now that we have WHO prequalification for Prevenar 13, Pfizer will work with GAVI and UNICEF to finalize arrangements for first orders and shipments under the AMC," said Mr Mark Swindell, president of Vaccines, Pfizer.