The World Health Organization (WHO) has granted prequalification to Prevenar 13 (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed])for active immunization of infants and children from 6 weeks through five years of age against invasive disease, pneumonia and otitis media caused by the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) contained in the vaccine. WHO prequalification allows for the procurement of Prevenar 13 by United Nations agencies, including the United Nations Children's Fund (UNICEF), governments and other organizations for use in national immunization programs. The prequalification is for global use of the vaccine in a single-dose vial.
"We are pleased to receive WHO prequalification as recognition that Prevenar 13 meets the organization's high standards for quality," says Emilio Emini, Ph.D., chief scientific officer, Vaccine Research, Pfizer. "This is an important step towards our goal of making Prevenar 13, which offers the broadest serotype coverage of any pneumococcal conjugate vaccine, available to infants and young children globally."
In March 2010, Pfizer entered into a 10-year Provisional Supply Agreement to provide Prevenar 13 to infants and young children in the world's poorest countries under the terms of the Advance Market Commitment (AMC) for pneumococcal disease, an innovative program piloted by the GAVI Alliance. In order to participate in the AMC program, vaccines must receive WHO prequalification.
WHO's prequalification program aims to make quality, priority medicines available for the benefit of those in need. The WHO prequalification process applies unified standards of acceptable quality, safety and efficacy to vaccines and other medicinal products.
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 WHO prequalification, is expected to offer an alternative option for developing world countries.
"Now that we have WHO prequalification for Prevenar 13, Pfizer will work with GAVI and UNICEF to finalize arrangements for first orders and shipments under the AMC," says Mark Swindell, president of Vaccines, Pfizer.
On May 21, 2010, the World Health Assembly adopted a resolution that called on the WHO and its 193 Member States to implement the interventions outlined in the WHO/UNICEF Global Action Plan for the prevention and control of pneumonia. These interventions include widespread vaccination against pneumococcal bacterium, a leading cause of the disease.
"WHO prequalification of Prevenar 13 is an important step towards universal access to pneumococcal conjugate vaccines for infants and young children worldwide," says Orin Levine, Ph.D., executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health. "Under the AMC, pneumococcal conjugate vaccines can be made available to the highest risk children in the world faster than ever before."
Prevenar 13 is marketed in the United States 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.
Indication for Prevnar 13® in the United States
In the United States, Prevnar 13 is a vaccine approved for use in children 6 weeks through 5 years of age (prior to the sixth birthday). Prevnar 13 is indicated for active immunization for the prevention of invasive disease caused by 13 strains of Streptococcus pneumoniae (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F).
Prevnar 13 is also indicated for the prevention of otitis media (ear infection) caused by 7 strains of Streptococcus pneumoniae (4, 6B, 9V, 14, 18C, 19F, and 23F). No efficacy data for ear infections are available for strains 1, 3, 5, 6A, 7F, and 19A.
Indication for Prevenar 13 in Most Countries Outside the United States
Prevenar 13 is indicated for the prevention of invasive disease, pneumonia, and otitis media caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in infants and children from 6 weeks to 5 years of age.
Pneumococcal Disease
According to the World Health Organization, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than five. Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae. It includes infections such as bacteremia/sepsis and meningitis, as well as pneumonia and acute otitis media.
About Advance Market Commitments
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. For more formation on AMCs, please go to www.vaccineamc.org.
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