Pfizer’s new Prevenar 13 presentation approved by EMA

Pfizer announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has approved a new presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13-valent, absorbed]).

The new presentation, which will be four-dose, multi-dose vial (MDV), is designed to increase the efficiency by considerably decreasing storage requirements and cutting shipping costs in communities where health care systems are still being developed.

The new Prevenar 13 presentation will offer vast benefits to developing countries, which include the reduction of temperature-controlled supply chain requirements, cost of shipping for the United Nations International Children’s Education Fund (UNICEF) and national, regional, district and community storage requirements by 75 percent.

Pfizer will present its MDV presentation for the Prevenar 13 to the World Health Organization (WHO) for prequalification. This would allow the new Prevenar 13 presentation to be used worldwide by United Nations countries and agencies requiring WHO prequalification.

The MDV presentation will be unveiled at the Advance Market Commitment program early next year if it is prequalified. Then, the presentation will be able to be shipped to countries that are currently covered by the Vaccine Alliance (Gavi). It will cost $3.10 per dose.