Pfizer’s Pneumococcal Vaccine Gets WHO PrequalificationBy
The World Health Organization (WHO) has prequalified a four-dose, multi-dose vial (MDV) presentation of Pfizer's Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13â€“valent, adsorbed]). The prequalification allows for the global use of Prevenar 13 MDV by United Nations agencies and countries worldwide that require WHO prequalification.
The MDV presentation is expected to be introduced in early 2017 under the advance market commitment (AMC) program for shipment to countries supported by Gavi, a global public-private vaccine alliance. During Gavi's pledging conference in January 2015, Pfizer began preparation for the potential introduction of Prevenar 13 MDV by announcing a 20-cent reduction in cost, from $3.30 per-dose to $3.10 per-dose for Gavi-eligible countries. Once the MDV presentation is introduced under the AMC, this pricing is expected to be available to all Gavi-eligible countries. In addition, expanded availability will enable Gavi-graduated countries to access the same pricing until 2025.
This 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. It has been approved in the European Union (EU) following a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in April 2016.
Prevenar 13 was first approved in the EU in December 2009 for use in infants and young children to help protect against invasive pneumococcal disease and is approved for such use in more than 150 countries worldwide, including the United States (US), Canada, Australia and Japan. The vaccine is included in the pediatric national immunization programs in 102 countries. It is also approved in the US, EU and other countries for use in infants, older children and adolescents aged 6-17 years and for use in adults 50 years of age and older in more than 100 countries. The vaccine is now approved in the US, the EU, and 44 other countries for use in adults 18-49 years of age.