Pfizer will supply up to 480 million doses of Prevenar 13 under the AMC to help expand immunization programs against pneumococcal disease by 2023. 7
About the Advance Market Commitment (AMC)
Pfizer has been a long-standing partner of the GAVI Alliance, since March 2010, when the Company entered into the first 10-year agreement to provide Prevenar 13 to infants and young children in the world’s poorest countries under the AMC framework. Pneumococcal vaccines are expected to reach more than 50 GAVI-supported countries by 2015.
In December 2010, Nicaragua became the first GAVI-eligible country to launch a pneumococcal conjugate vaccine, Prevenar 13, through the AMC. To date, Prevenar 13 has been introduced into the national immunization programs of the following GAVI-eligible countries: Benin, Burundi, Cameroon, Central African Republic, Congo, Democratic Republic of Congo, Djibouti, Gambia, Ghana, Guyana, Honduras, Malawi, Mali, Nicaragua, Rwanda, Sao Tome, Sierra Leone, Tanzania, Yemen and Zimbabwe. 7To meet the growing global need 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 prequalification and AMC eligibility requirements, would provide an alternative option for developing world countries. 7 About Prevenar 13 Prevenar 13 was first introduced for use in infants and young children in December 2009 in Europe and is now approved for such use in more than 120 countries worldwide. It is already the most widely used pneumococcal conjugate vaccine in the world, and more than 500 million doses of Prevenar/Prevenar 13 have already been distributed worldwide. 7 Currently, Prevenar 13 is included as part of a national immunization program in more than 60 countries, offering coverage against invasive pneumococcal disease to more than 30 million children per year. 7 Prevenar 13 offers the broadest serotype coverage of any currently available pneumococcal conjugate vaccine for prevention of pneumococcal disease including invasive pneumococcal disease, pneumonia and otitis media. 8 The 13 pneumococcal serotypes in Prevenar 13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) are among the most prevalent invasive-disease causing strains in children worldwide. 8,9 Prevenar 13 is also approved for use in adults 50 years of age and older in more than 100 countries, and is the first and only pneumococcal vaccine to be granted World Health Organization prequalification in the adult population. 7 Prevenar 13 is marketed in the United States as Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM 197 Protein]). 10 In the United States, Prevnar 13 is not indicated for the prevention of pneumococcal pneumonia in the pediatric population. 10 Pneumococcal Disease Pneumococcal disease is a group of illnesses caused by the bacterium Streptococcus pneumoniae ( S. pneumoniae), also known as pneumococcus. 11 It includes invasive infections such as bacteremia and meningitis, as well as non-invasive disease such as pneumonia and acute otitis media. 11 While pneumococcus can infect people of all ages, infants and young children and the elderly are at heightened risk. 12 The World Health Organization estimates that more than 1.6 million people – including more than 800,000 children under 5 years of age – die every year from pneumococcal infections. Nearly all these deaths occur in the world’s poorest countries. 13 Indications for Prevnar 13 in the United States In the United States, Prevnar 13 is indicated for use in children six weeks through 5 years of age for the prevention of invasive disease (e.g., meningitis, bacteremia) caused by 13 Streptococcus pneumoniae serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F). The vaccine is also indicated in adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F). Indication is based on immune responses. World Health Organization Indication for Prevenar 13 The World Health Organization prequalified Prevenar 13 for active immunization of infants and children from 6 weeks through five years of age against invasive disease, pneumonia and otitis media and for active immunization of adults 50 years of age and older against pneumonia and invasive disease caused by the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) contained in the vaccine. The World Health Organization prequalification allows for the procurement of Prevenar 13 by United Nations agencies. The prequalification is for global use of the vaccine in a single-dose vial.