Prevenar 13 Helping to Prevent Pneumococcal Disease
in Infants and Young Children Around the World
Pneumococcal disease is a leading cause of death in young children and can result in invasive infections such as meningitis and sepsis, as well as noninvasive infections.
Prevenar 13, which is based on the scientific foundation of Prevnar—the company's 7-valent pneumococcal conjugate vaccine—provides coverage against the 13 most prevalent serotypes associated with pneumococcal disease in infants and young children worldwide. Prevenar 13 includes the seven serotypes in Prevenar (4, 6B, 9V, 14, 18C, 19F and 23F) as well as six additional serotypes (1, 3, 5, 6A, 7F and 19A). Notably, serotype 19A is now the most common invasive-disease-causing serotype in the United States and is increasing in prevalence elsewhere. It is frequently antibiotic resistant.
First introduced in Germany in December 2009, Prevenar 13 had been registered in 80 countries and launched in more than 50 countries around the world by the end of 2010.
Seeking Approval to Expand Prevenar 13 to Adults 50 and Older
Older adults are also at increased risk for pneumococcal disease and its potentially serious consequences. As a result, we announced in December 2010 that we are seeking supplemental indications for Prevenar 13 in both the United States and the European Union in adults 50 years of age and older for the prevention of pneumococcal disease caused by the 13 serotypes contained in the vaccine. Pfizer's applications to the FDA and EMA are based on six Phase III studies involving approximately 6,000 subjects.
Partnering to Bring Prevenar 13 to Children in the Developing World
As a part of our ongoing commitment to accelerate global access to our vaccines and medicines, on December 12, 2010, we made history when Prevenar 13 was introduced into the first childhood immunization program for pneumococcal disease in the developing world, in Nicaragua, under the auspices of the Advance Market Commitment (AMC) program. The AMC is an innovative program which involves private-public partnerships to help make newer vaccines available on a sustainable, affordable and accelerated basis to the least developed countries.
The launch of Prevenar 13 in the developing world within one year of its introduction in industrialized nations was unprecedented, given the average 15-year gap between introduction of new vaccines in developed and developing countries.
In March 2010 we entered into a 10-year agreement to provide Prevenar 13 to infants and young children in the world's poorest countries under the terms of the AMC. The AMC procurement process is administered by the United Nations Children's Fund, piloted by the GAVI Alliance and funded by the Bill & Melinda Gates Foundation and the governments of Italy, the U.K., Canada, Russia and Norway.