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World Health Organization Grants Prequalification to Prevenar 13*, Pfizer's 13-valent Pneumococcal Conjugate Vaccine for Infants and Young Children

Mon, 08/23/2010 - 1:36pm
Bio-Medicine.Org

NEW YORK, Aug. 23 /PRNewswire-FirstCall/ -- The World Health Organization (WHO) has granted prequalification to Prevenar 13* (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed])for active immunization of infants and children from 6 weeks through five years of age 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. 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.

(Logo: http://photos.prnewswire.com/prnh/20100416/PFIZERLOGO)

(Logo: http://www.newscom.com/cgi-bin/prnh/20100416/PFIZERLOGO)

"We are pleased to receive WHO prequalification as recognition that Prevenar 13 meets the organization's high standards for quality," says Emilio Emini, Ph.D., chief scientific officer, 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.

WHO's prequalification program aims to make quality, priority medicines available for the benefit of those in need. The WHO prequalification process applies unified standards of acceptable quality, safety and efficacy to vaccines and other medicinal products.

To meet the gr

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