Young Children In Developing World Receive Accelerated Access to Pfizer's Prevenar 13 Vaccine

Pfizer Inc.Pfizer Inc. (NYSE: PFE) announced that Prevenar 13* (Pneumococcal polysaccharide conjugate vaccine [13-valent, adsorbed]) was introduced into the first childhood immunization program for pneumococcal disease (PD) in the developing world under the auspices of the Advance Market Commitment (AMC) when Nicaragua launched its program. The AMC is an innovative program which involves private-public partnerships to help make newer vaccines available on a sustainable, affordable and accelerated basis to the least developed countries.

"Pfizer remains steadfast in its commitment to accelerate global access to its vaccines and medicines; public-private partnerships such as those that underpin the AMC are a great example of how to make critical progress in that area," says Mark Swindell, president, Pfizer Vaccines. "It truly is historic to see a new vaccine such as Prevenar 13 launched in a developing country within one year of its introduction in the U.S. and Europe, given the previous average 15-year gap between introduction of new vaccines in developed and developing countries."

Prevenar 13 provides coverage against the 13 most prevalent invasive pneumococcal disease-causing strains (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in infants and young children worldwide. Prevenar 13 is the only pneumococcal conjugate vaccine available under the AMC that is prequalified by the World Health Organization (WHO) for use in children through 5 years of age and to help prevent pneumonia caused by the 13 serotypes contained in the vaccine.

About the AMC
In March 2010, Pfizer entered into a 10-year agreement to provide Prevenar 13 to infants and young children in the world's poorest countries under the terms of the AMC for pneumococcal disease.

A new approach to public health funding, the AMC, which is administered by the GAVI Alliance, is designed to procure vaccines specifically for least developed countries. In this pilot AMC for PD, the governments of Italy, the United Kingdom, Canada, the Russian Federation and Norway as well as the Bill and Melinda Gates Foundation, the World Bank, and GAVI have committed financing.

In addition, this novel program is a reflection of the dedication and commitment of organizations such as the GAVI Alliance, the World Bank and other public health organizations.

"This innovative new model is poised to drive accelerated access to potentially lifesaving vaccines for millions of children in the world's poorest countries, where PD exacts its greatest toll," adds Mr. Swindell. "It's a great example of how creative partnerships can result in solutions for some of the most pressing public health issues."

Pneumococcal Disease
PD is complex and describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae (S. pneumoniae). It includes invasive infections such as bacteremia and meningitis, as well as non-invasive disease including pneumonia and acute otitis media.

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 S. 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 seven strains of S. 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
Earlier this year, the World Health Organization (WHO) 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 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. The prequalification is for global use of the vaccine in a single-dose vial.

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

How SARS-CoV-2 mutates to escape antibody binding

In a recurring pattern of evolution, SARS-CoV-2 evades immune responses by selectively deleting small bits of its genetic sequence, according to new research from the Uni...

Anticancer drug may improve outcome for severe COV…

Treating severe COVID-19 patients with the anticancer drug bevacizumab may reduce mortality and speed up recovery, according to a small clinical study in Italy and China ...

Pfizer and BioNTech commence global clinical trial…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the first participants have been dosed in a global Phase 2/3 study to further evaluate the saf...

One dose of COVID-19 vaccine provokes strong immun…

Although clinical trial data are encouraging, real-world evidence with regard to the COVID-19 vaccine remains scarce. In particular, response to the vaccine among those p...

Johnson & Johnson announces submission of appl…

Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting E...

GSK and Vir Biotechnology expand coronavirus colla…

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) have signed a binding agreement to expand their existing collaboration to include the resear...

Could a nasal spray prevent coronavirus transmissi…

A nasal antiviral created by researchers at Columbia University Vagelos College of Physicians and Surgeons blocked transmission of SARS-CoV-2 in ferrets, suggesting the n...

European Commission purchases additional 150 milli…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission purchased an...

Neandertal gene variants both increase and decreas…

Last year, researchers at Karolinska Institutet in Sweden and the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany showed that a major genetic risk ...

CureVac initiates rolling submission with European…

CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today annou...

Pfizer and BioNTech publish data from in vitro stu…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the publication in Nature Medicine of data from in vitro studies that demonstrate that sera from in...

Johnson & Johnson Announces Submission to Worl…

Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen-Cilag International N.V. has submitted for Emergency Use Listing (EUL) to the World Health Organization...