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World Health Organization Grants Prequalification to Prevenar 13*, Pfizer's 13-valent Pneumococcal Conjugate Vaccine for Infants and Young Children
Date:8/23/2010

owing 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," says Mark Swindell, president of Vaccines, Pfizer.

On May 21, 2010, the World Health Assembly adopted a resolution that called on the WHO and its 193 Member States to implement the interventions outlined in the WHO/UNICEF Global Action Plan for the prevention and control of pneumonia. These interventions include widespread vaccination against pneumococcal bacterium, a leading cause of the disease.

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

Prevenar 13 is marketed in the United States as Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). In the United States, Prevnar 13 is not indicated for the prevention of pneumonia.

Indication for Prevnar 13® in the United States

In the United States, Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the sixth birthday). Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused
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SOURCE Pfizer Inc.
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