Pfizer Inc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) approved a new four-dose, multi-dose vial (MDV) presentation of Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]). This new MDV presentation was developed to help maximize efficiency for health care workers by helping to significantly reduce storage requirements and shipping costs in communities with health systems that are still developing.

This multi-dose presentation of Prevenar 13 demonstrated a favorable safety profile and immune responses to help protect children from invasive pneumococcal disease due to serotypes contained in the vaccine.

The MDV presentation of Prevenar 13 offers significant benefits to developing countries, including a 75 percent reduction in temperature-controlled supply chain requirements, United Nations International Children’s Education Fund (UNICEF) shipping costs, and Storage requirements at the national, regional, district, and community levels.

“Prevenar 13 is the first approved pneumococcal conjugate vaccine available in a preserved multi-dose vial presentation,” said Luis Jodar, Ph.D., global vice president, Vaccines, Pfizer Global Medicines Development Group and Medical/Scientific Affairs. “With this new presentation, a box that once carried enough vaccine to help protect 50 infants and children will potentially vaccinate 200, helping to ensure Prevenar 13 is accessible in the most remote regions of the world where the greatest burden of invasive pneumococcal disease lies.”

Pfizer plans to submit its Prevenar 13 MDV presentation to the World Health Organization (WHO) for prequalification, which, if and when approved, will allow for the global use of this new presentation of Prevenar 13 by United Nations agencies and countries worldwide that require WHO prequalification. If and when prequalified, the MDV presentation is expected to be introduced under the Advance Market Commitment program in early 2017, for shipment to countries covered by Gavi, the Vaccine Alliance (Gavi). This presentation will be available at a lower price of $3.10 per dose.

“Prevenar 13 formulated in multi-dose vials was studied in collaboration with the Medical Research Council Unit, The Gambia,” said William Gruber, M.D., senior vice president Vaccine Clinical Research and Development. “This multi-dose presentation of Prevenar 13 demonstrated a favorable safety profile and immune responses to help protect children from invasive pneumococcal disease due to serotypes contained in the vaccine.”

Accelerating the availability of potentially life-saving vaccines around the world is a key component of Pfizer’s commitment to making true inroads toward global health care access. Through its participation in international public-private programs, Pfizer provided its 13-valent pneumococcal conjugate vaccine, Prevenar 13, to infants and young children in the developing world to help protect against invasive pneumococcal disease. Since 2010, more than 40 low- and lower middle-income countries have launched pneumococcal immunization programs with Prevenar 13, via the Advance Market Commitment, an innovative program by Gavi, the Vaccine Alliance. With continued investment in research and development, Pfizer has helped meet the challenges of the developing world by providing innovative manufacturing, storage, inventory management, and supply chain solutions. Pfizer also continues to develop and deliver educational materials to aid health care workers in the field and conducts surveillance studies to understand the impact of pneumococcal immunization programmes on reducing the burden of disease.

Prevenar 13 (pneumococcal polysaccharide conjugate vaccine [13 – valent, adsorbed]) was first approved for use in the European Union (EU) in December 2009 for use in infants and young children to help protect against invasive pneumococcal disease. Prevenar 13 is now approved for such use in more than 150 countries worldwide, including the United States, Canada, Australia and Japan. Prevenar 13 is the most widely used pneumococcal conjugate vaccine in the world, and is included in the pediatric National Immunization Programs in 102 countries. In addition, Prevenar 13 is approved for use in adults 50 years of age and older in more than 100 countries. It is also approved in the United States, EU and other countries for use in older children and adolescents aged 6 to 17 years. Prevenar 13 is approved in the EU for use in adults 18 to 49 years of age.

Prevnar 13 is a vaccine approved for children 6 weeks through 17 years of age for the prevention of invasive disease caused by 13 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F), and for children 6 weeks through 5 years for the prevention of otitis media caused by 7 of the 13 strains (4, 6B, 9V, 14, 18C, 19F, and 23F).

Prevnar 13 is also approved for adults 50 years of age and older for the prevention of pneumococcal pneumonia and invasive disease caused by the 13 vaccine strains. Prevnar 13 is not 100 per cent effective and will only help protect against the 13 strains included in the vaccine.