Pfizer Inc. announced it has signed a 10-year Provisional Supply Agreement to supply Prevenar 13 (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]), the company’s 13-valent pneumococcal conjugate vaccine, for infants and young children in the world’s poorest countries under the terms of the Advance Market Commitment (AMC) pilot project against pneumococcal disease. The AMC is a novel public-private approach to public health funding designed to create a sustainable marketplace, ensure a stable supply of pneumococcal vaccines and stimulate the development and expansion of manufacturing capacity of vaccines specifically for the world’s poorest countries.

“Pfizer is dedicated to broadening access around the world to our medicines, and public-private partnerships such as the one involving the AMC are critical to achieving true inroads on this front,” says Jeffrey Kindler, chairman and chief executive officer of Pfizer Inc. “Last year, working with GAVI, we contributed the first pneumococcal conjugate vaccine used in a national immunization program in the developing world, and we are proud to extend our commitment even further to young children in the world’s poorest countries by participating in the AMC.”

The agreement is the final step in the AMC procurement process which is administered by the United Nations Children’s Fund (UNICEF) and supported by GAVI. The agreement is subject to prequalification by the World Health Organization and AMC eligibility designation, which are both expected later this year.

Under the terms of the agreement, the price of the pneumococcal conjugate vaccine under the AMC framework is $7.00 for the first several years. The vaccine price will include a $3.50 subsidy to be paid by the AMC donor fund, and $3.50 to be paid by GAVI with a co-financing contribution paid by the developing country governments that introduce the vaccine.

Importantly, under the current AMC framework, participating vaccine manufacturers must make a binding commitment to supply vaccine for 10 years at a maximum “tail” price of $3.50 per dose to meet long-term demand and ensure affordability of the vaccine in developing countries even after the donor contributions are exhausted.

“I applaud the groundbreaking milestone achieved today by vaccine manufacturers, developing country governments, donors, the World Bank, and the GAVI Alliance that has made the most advanced pneumococcal conjugate vaccines available to the world's neediest young children at affordable prices and faster than ever before,” says Orin Levine, executive director, International Vaccine Access Center at Johns Hopkins University. ”This year, the Advance Market Commitment will begin helping to save lives and improve the health of infants and young children in Africa.”

Pfizer Increasing Manufacturing Capability to Help Ensure Supply

Prevenar 13 has been approved for use in infants and young children in more than 40 countries. In addition, regulatory filings for Prevenar 13 for pediatric use are in advanced stages of review in various countries. To meet the growing global demand for Prevenar 13, Pfizer is increasing its manufacturing capabilities to help ensure product supply through a combination of capital investment, process improvements and efficiency measures throughout the supply network.

Prevenar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevenar (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed) – the standard in pneumococcal disease prevention in infants and young children – plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A). Together, these serotypes represent the most prevalent invasive disease-causing strains in young children worldwide. Both Prevenar and Prevenar 13 use CRM197 – a carrier protein that has been used in various approved paediatric conjugate vaccines for more than 20 years.

A new approach to public health funding, AMCs are designed to procure vaccines specifically for least developed countries. The pilot AMC is for vaccines that prevent pneumococcal disease.

In the AMC pneumococcal disease pilot, the governments of Italy, the United Kingdom, Canada, Russia and Norway as well as the Bill and Melinda Gates Foundation, have committed US$1.5 billion, with GAVI promising to allocate US$1.3 billion through 2015. Companies that wish to participate in the AMC must make legally binding long-term commitments to supply these vaccines at affordable and sustainable prices for certain GAVI-eligible countries after the donor funds are spent.

The GAVI Alliance hopes to assist up to 60 of the world’s poorest countries, following required regulatory approvals, to introduce pneumococcal conjugate vaccines that meet a target product profile by 2015. Early estimates suggest this pilot project could prevent more than seven million childhood deaths by 2030.