WHO grants prequalification status to pneumococcal vaccine, paving way for U.N. procurement

The WHO "has granted prequalification status to Pfizer Inc.'s children's pneumococcal vaccine, Prevenar 13, paving the way for United Nations agencies and governments to start ordering the product," the Associated Press reports (8/23).

The WHO decision comes after Pfizer in March 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," according to a Pfizer press release. A vaccine must be prequalified by the WHO in order to be included in the AMC.

"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," Emilio Emini, chief scientific officer of vaccine research at Pfizer, said, according to the press release (8/23). This version of the vaccine, which "protects against 13 different disease-causing strains, is an advanced version of the original Prevenar, which only protected against 7 strains," the AP adds (8/23).

"According to the WHO, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5," the Daily Finance reports. Prevnar 13 "has already been approved in over 60 countries, including the U.S. and the European Union" (Alazraki, 8/23).

"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 Pfizer release continues.

"WHO prequalification of Prevenar 13 is an important step towards universal access to pneumococcal conjugate vaccines for infants and young children worldwide," Orin Levine, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health, said, according to the release. "Under the AMC, pneumococcal conjugate vaccines can be made available to the highest risk children in the world faster than ever before."

"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," the release adds. "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" (8/23).