Pfizer Signs Long-Term Agreement to Supply Prevenar 13 to The World's Poorest Countries

Pfizer Inc.Pfizer Inc. (NYSE:PFE) has signed a 10-year Provisional Supply Agreement to supply Prevenar 13* (Pneumococcal Polysaccharide Conjugate Vaccine [13-valent, adsorbed]), the company's 13-valent pneumococcal conjugate vaccine, for infants and young children in the world's poorest countries under the terms of the Advance Market Commitment (AMC) pilot project against pneumococcal disease. The AMC is a novel public-private approach to public health funding designed to create a sustainable marketplace, ensure a stable supply of pneumococcal vaccines and stimulate the development and expansion of manufacturing capacity of vaccines specifically for the world's poorest countries.

"Pfizer is dedicated to broadening access around the world to our medicines, and public-private partnerships such as the one involving the AMC are critical to achieving true inroads on this front," says Jeffrey Kindler, chairman and chief executive officer of Pfizer Inc. "Last year, working with GAVI, we contributed the first pneumococcal conjugate vaccine used in a national immunization program in the developing world, and we are proud to extend our commitment even further to young children in the world's poorest countries by participating in the AMC."

The agreement is the final step in the AMC procurement process which is administered by the United Nations Children's Fund (UNICEF) and supported by GAVI. The agreement is subject to prequalification by the World Health Organization and AMC eligibility designation, which are both expected later this year.

Under the terms of the agreement, the price of the pneumococcal conjugate vaccine under the AMC framework is $7.00 for the first several years. The vaccine price will include a $3.50 subsidy to be paid by the AMC donor fund, and $3.50 to be paid by GAVI with a co-financing contribution paid by the developing country governments that introduce the vaccine.

Importantly, under the current AMC framework, participating vaccine manufacturers must make a binding commitment to supply vaccine for 10 years at a maximum "tail" price of $3.50 per dose to meet long-term demand and ensure affordability of the vaccine in developing countries even after the donor contributions are exhausted.

"I applaud the groundbreaking milestone achieved today by vaccine manufacturers, developing country governments, donors, the World Bank, and the GAVI Alliance that has made the most advanced pneumococcal conjugate vaccines available to the world's neediest young children at affordable prices and faster than ever before," says Orin Levine, executive director, International Vaccine Access Center at Johns Hopkins University. "This year, the Advance Market Commitment will begin helping to save lives and improve the health of infants and young children in Africa."

Pfizer Increasing Manufacturing Capability to Help Ensure Supply
Prevenar 13 has been approved for use in infants and young children in more than 40 countries. In addition, regulatory filings for Prevenar 13 for pediatric use are in advanced stages of review in various countries. To meet the growing global demand for Prevenar 13, Pfizer is increasing its manufacturing capabilities to help ensure product supply through a combination of capital investment, process improvements and efficiency measures throughout the supply network.

Prevenar 13 includes the seven serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed) – the standard in pneumococcal disease prevention in infants and young children – plus six additional serotypes (1, 3, 5, 6A, 7F, and 19A). Together, these serotypes represent the most prevalent invasive disease-causing strains in young children worldwide. Both Prevenar and Prevenar 13 use CRM197 – a carrier protein that has been used in various approved pediatric conjugate vaccines for more than 20 years.

About Advance Market Commitments (AMCs)
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. Early estimates suggest this pilot project could prevent more than seven million childhood deaths by 2030. For more formation on AMCs, please go to www.vaccineamc.org.

Pneumococcal Disease
According to a World Health Organization (WHO) 2002 estimate, pneumococcal disease is the leading cause of vaccine-preventable death worldwide in children younger than 5 years. 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.

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. To learn more about our commitments, please visit us at www.pfizer.com.

Most Popular Now

Imfinzi is the first immunotherapy to demonstrate …

AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi durin...

Sandoz Healthcare Access Challenge #SandozHACk ret…

Sandoz, the Novartis generics and biosimilars division, today announces the launch of the second Sandoz Healthcare Access Challenge (HACk). The #SandozHACk is a global co...

Global survey reveals that physicians need more in…

Results from a new global survey revealed that more than one-third (36%) of the 310 physicians surveyed do not think they have sufficient information required to make inf...

In clinical trials, new antibody therapy controls …

Thanks to improvements in antiretroviral therapy, HIV is now a manageable condition. Yet even the best drugs do not entirely eliminate the virus, which latently lingers i...

Novartis licenses three novel anti-infective progr…

Novartis announced today that it has entered into a licensing and equity agreement with Boston Pharmaceuticals for the development of three novel anti-infective drug cand...

The Nobel Prize in Physiology or Medicine 2018 was…

Cancer kills millions of people every year and is one of humanity's greatest health challenges. By stimulating the inherent ability of our immune system to attack tumor c...

Pfizer to award more than $3 million in grants to …

Pfizer Inc. today announced the recipients of the Advancing Science through Pfizer Investigator Research Exchange (ASPIRE) Breast Cancer Research Awards. Four grants tota...

FDA approves first treatment for advanced form of …

The U.S. Food and Drug Administration today approved Libtayo (cemiplimab-rwlc) injection for intravenous use for the treatment of patients with metastatic cutaneous squam...

DNA islands effective as 'anti-bacterial drones'

Genomic "islands" that evolved from viruses can be converted into "drones" that disable Staphylococcus aureus, bacteria that are often resistant to antibiotics and pose a...

FDA awards 12 grants to fund new clinical trials t…

The U.S. Food and Drug Administration today announced that it has awarded 12 new clinical trial research grants totaling more than $18 million over the next four years to...

Addressing social and cultural drivers of type 2 d…

New research shows healthcare services and public health strategies aimed at reducing the burden of type 2 diabetes may prove ineffective, unless they address social and ...

Evidence mounts linking aspirin to lower risk of o…

Taking a low-dose aspirin daily may help women lower their risk of developing ovarian cancer. A new study co-led by Moffitt Cancer Center found that women who reported ta...