The AMC, an innovative program piloted by the GAVI Alliance, is a public-private approach to health funding designed to create a sustainable marketplace, ensure an affordable and stable supply of pneumococcal vaccines at a steeply discounted price and stimulate the development and expansion of manufacturing capacity for vaccines specifically for the world's poorest countries. The agreements for supply of pneumococcal vaccines have been financed by GAVI, five donor countries - Italy, the United Kingdom, Canada, the Russian Federation, Norway - and the Bill and Melinda Gates Foundation.
"Pfizer is proud to broaden and extend access to our vaccine to advance public health," said Mark Swindell, president of Vaccines, Pfizer Inc. "Public-private partnership programs like the AMC are vital to accelerating the availability of affordable vaccines, faster than ever before, to those children who are most vulnerable. We are proud to help protect even more children at risk for the potentially devastating consequences of pneumococcal disease - which claims more young children's lives than any other vaccine-preventable disease."
In December 2010, Pfizer's 13-valent pneumococcal conjugate vaccine was introduced into the childhood immunization program of Nicaragua - the first developing country to launch a program under the auspices of the AMC.
"Prevenar 13 was introduced into the childhood immunization program of a developing country within one year of its launch in the United States and European Union - a historic precedent given the average 10-15 year lag between the introduction of newer vaccines in developed versus developing countries," added Swindell. "One year later, Prevenar 13 is now available in 14 of 16 countries which have launched pneumococcal immunization programs under the AMC. While there is much more work to be done, we are encouraged by this progress."
To date, Prevenar 13 has been introduced into the national childhood immunization programs of the following GAVI-eligible countries: Benin, Burundi, Cameroon, Central African Republic, Democratic Republic of Congo, the Gambia, Guyana, Honduras, Malawi, Mali, Nicaragua, Rwanda, Sierra Leone and Yemen.
To meet the growing global demand for Prevenar 13, Pfizer is increasing its manufacturing capabilities through a combination of capital investment, process improvements and efficiency measures throughout its supply network. Additionally, Pfizer is engaged in the development of a preserved, multi-dose vial which, subject to the required regulatory approval, World Health Organization (WHO) prequalification and AMC eligibility requirements, would provide an alternative option for developing world countries.
Additional Information About Prevenar 13
Prevenar 13 has been approved for use in infants and young children in more than 100 countries, to date. It provides coverage against the 13 most prevalent invasive disease-causing serotypes in young children worldwide. Additionally, Prevenar 13 is the only pneumococcal conjugate vaccine indicated for the prevention of invasive disease caused by serotypes 3, 6A, and 19A. Prevenar 13 uses CRM197 - a carrier protein that has been used in various approved pediatric conjugate vaccines for more than 20 years.
About the Advance Market Commitment (AMC)
A new approach to public health funding, AMCs are designed to procure vaccines specifically for least developed countries. The GAVI Alliance hopes to assist up to nearly 60 of the world’s poorest countries 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.
Every year, up to one million children are estimated to die from pneumococcal disease, the majority of whom are in the developing world.
Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium S. pneumoniae. It affects both children and adults and includes invasive infections such as bacteremia, sepsis and meningitis, as well as non-invasive disease including pneumonia and acute otitis media.
Prevenar 13 is marketed in the United States for pediatric use as Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). In the United States, Prevnar 13 is not indicated for the prevention of pneumonia.
World Health Organization Indication for Prevenar 13
Prevenar 13 is prequalified by the WHO for the active immunization of infants and children from 6 weeks through 5 years of age against invasive disease, pneumonia and otitis media caused by S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
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