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Pfizer Receives World Health Organization Prequalification for Multi-Dose Vial Presentation of Prevenar 13®

Pfizer Receives World Health Organization Prequalification for Multi-Dose Vial Presentation of Prevenar 13®


The World Health Organization (WHO) has prequalified Pfizer’s four-dose, multi-dose vial (MDV) presentation of Prevenar 13®* (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). WHO prequalification allows for the global use of Prevenar 13® MDV by United Nations agencies, GAVI, Expanded Program for Immunization (EPI) and countries worldwide that require WHO pre-qualification.

“We are pleased that the WHO has prequalified the MDV presentation of Prevenar 13®, another crucial step in providing broader global access to this important vaccine for those who need it,” said Susan Silbermann, President and General Manager, Pfizer Vaccines. “Pfizer is committed to continued innovation aimed at meeting the challenges of the developing world and helping to prevent invasive pneumococcal disease by providing a path for children in resource-limited countries to access a reliable supply of Prevenar 13®.”

“The WHO MDV approval is very encouraging for Pakistan and will greatly support our Expanded Program for Immunization in maintaining a perfect balance between efficacy (broadest coverage vaccine), efficiency (reduced wastage, increased outreach) and Value (price),” said Dr. Farid Khan, Country Manager, Pfizer Pakistan Limited.

The MDV presentation of Prevenar 13 ® offers significant benefits to developing countries, including but not limited to Pakistan: Vial usage over a 28-day period leading to reduced wastage; 40% reduction in supply chain requirements; Reduction in shipping costs, and 50% reduction in storage requirements at the national, regional and municipal council levels.

The Prevenar 13® MDV presentation includes the preservative 2-Phenoxyethanol, which enables use of the vaccine over a 28-day period following its first use, provided it is stored at 2-8 degrees Celsius. This presentation has been approved in the European Union following the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in April 2016

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