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.
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“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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