Prevent Pneumococcal Disease in Infants and Young Children in the World's Poorest Countries

PfizerPfizer Inc. (NYSE:PFE) 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.

Pneumococcal Disease
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.

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.

Most Popular Now

Delivering insulin in a pill

Given the choice of taking a pill or injecting oneself with a needle, most of us would opt to regulate a chronic health condition by swallowing a pill. But for millions o...

Probiotics can protect the skeletons of older wome…

For the first time in the world, researchers at the University of Gothenburg, Sweden, have demonstrated that probiotics, dietary supplements with health-promoting bacteri...

Alzheimer's breakthrough: Brain metals that may dr…

Alzheimer's disease could be better treated, thanks to a breakthrough discovery of the properties of the metals in the brain involved in the progression of the neurodegen...

FDA approves first drug comprised of an active ing…

The U.S. Food and Drug Administration today approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with two rare and severe forms o...

In mice, stem cells seem to work in fighting obesi…

Obesity is an increasing global health problem associated with several comorbidities and a high risk of mortality. A wide spectrum of interventions has been proposed for ...

Can aspirin treat Alzheimer's?

A regimen of low-dose aspirin potentially may reduce plaques in the brain, which will reduce Alzheimer's disease pathology and protect memory, according to neurological r...

FDA takes steps to foster greater efficiency in bi…

Today, the agency withdrew the draft guidance, "Statistical Approaches to Evaluate Analytical Similarity," issued in September 2017. The draft guidance, if finalized as w...

Research shows how a moderate dose of alcohol prot…

For at least 20 years, research has shown that for many people, moderate consumption of alcohol can protect the heart, but the reason for this is poorly understood. A stu...

'Kiss of death' cancer

It's called the 'kiss of death'. Triple negative breast cancer has no targeted drug therapy and, as such, the only hope for these patients is chemotherapy. Triple negativ...

Novartis Clear about Psoriasis survey data highlig…

Novartis announced today the publication of global Clear about Psoriasis survey data in the Journal of the European Academy of Dermatology and Venereology[1]. The publica...

Some existing anti-cancer drugs may act in part by…

Bolstering the notion that RNA should be considered an important drug-discovery target, scientists at Scripps Research have found that several existing, FDA-approved anti...

Poliovirus therapy for recurrent glioblastoma has …

A genetically modified poliovirus therapy developed at Duke Cancer Institute shows significantly improved long-term survival for patients with recurrent glioblastoma, wit...