Pfizer Receives Prequalification for Presentation of Prevenar 13

On July 19, 2016, Pfizer announced that the World Health Organization (WHO) has prequalified its four-dose, multi-dose vial (MDV) presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). According to the company, WHO prequalification allows for the global use of Prevenar 13 MDV by the United Nations agencies and countries worldwide that require WHO prequalification.

The MDV presentation of Prevenar 13 offers benefits to developing countries, including a 75% reduction in:

• Temperature-controlled supply chain requirements

• United Nations Children’s Fund (UNICEF) shipping costs

• Storage requirements at the national, regional, district, and community 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 °C. 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.

The prequalified MDV presentation is expected to be introduced under the Advance Market Commitment (AMC) program in early 2017, for shipment to countries supported by Gavi, the Vaccine Alliance. In January 2015, during Gavi’s pledging conference, Pfizer began to prepare for the potential introduction of Prevenar 13 in the MDV presentation by announcing a 20-cent reduction in cost, from $3.30 per-dose to $3.10 per-dose, in its MDV per-dose price 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.

Source: Pfizer