Healthcare Industry News: otitis media
News Release - December 16, 2011
Pfizer Broadens and Extends Commitment to Help Prevent Pneumococcal Disease in Infants and Young Children in the World’s Poorest CountriesOn Heels of Historic Anniversary, Pfizer Commits to Supply Up to a Total of 480 Million Doses of Prevenar 13* to Help Prevent Leading Cause of Vaccine-Preventable Death in Young Children
NEW YORK--(Healthcare Sales & Marketing Network)-- Pfizer Inc. (NYSE:PFE ) today announced it has entered into a second supply agreement which will broaden and extend the duration of the Company’s commitment to help protect millions of infants and young children in the developing world from pneumococcal disease – the leading cause of vaccine-preventable death in young children. Pfizer is now committed to supply up to a total of 480 million doses of Prevenar 13* (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]) through 2023 building on its original commitment announced in March 2010 to supply up to 300 million doses of the vaccine under the auspices of the Advance Market Commitment (AMC) for pneumococcal vaccines.
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. For more information on the AMC, please go to www.vaccineamc.org.
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.
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.
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.
Important Safety Information for Prevenar 13
* Prevenar 13 should not be given to anyone with a severe allergic reaction to any component of Prevenar 13, Prevenar, or any diphtheria toxoid–containing vaccine.
* Prevenar 13 may not protect all individuals receiving the vaccine. Protection against ear infections is expected to be less than that for invasive disease. Children with weakened immune systems may have a reduced immune response to Prevenar 13. A temporary pause of breathing following vaccination has been observed in some infants born prematurely.
* The most commonly reported serious adverse events include bronchiolitis (an infection of the lungs; 0.9%, 1.1%), gastroenteritis (inflammation of the stomach and small intestine; 0.9%, 0.9%), and pneumonia (0.9%, 0.5%) for Prevenar 13 and Prevenar, respectively.
* The most common side effects are redness, swelling and tenderness at the injection site, fever, decreased appetite, irritability, increased sleep, and decreased sleep. Only a healthcare provider can decide if Prevenar 13 is appropriate for a given child.
Pfizer Inc.: Working together for a healthier world™
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world’s best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world’s leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us.
DISCLOSURE NOTICE: The information contained in this release is as of December 16, 2011. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.
This release contains forward-looking information that involves substantial risks and uncertainties regarding Prevenar 13 for use in infants and young children in the various countries in which the Company’s regulatory applications are pending or may be submitted; the potential benefits of Prevenar 13; the development of a preserved, multi-dose vial; and the success of the AMC project for vaccines. Such risks and uncertainties include, among other things, the uncertainties inherent in research and development; whether and when regulatory authorities will approve the application that may be submitted for this potential indication and their decisions regarding labeling and other matters that could affect its availability or commercial potential; whether and when regulatory authorities will approve applications that may be submitted for a preserved, multi-dose vial and their decisions regarding labeling and other matters that could affects its availability or commercial potential; and competitive developments.
A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2010, and in its reports on Form 10-Q and Form 8-K.
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