World Health Organization Grants Prequalification to Prevenar 13*, Pfizer's 13-valent Pneumococcal Conjugate Vaccine for Infants and Young Children

NEW YORK, Aug. 23 /PRNewswire-FirstCall/ -- 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.

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"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.

Additional Information About Prevenar 13*

Prevenar 13 has been approved for use in infants and young children in more than 60 countries, to date. In addition, regulatory filings for Prevenar 13 for pediatric use are in advanced stages of review in various countries.

Prevenar 13, built on the scientific foundation of Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), includes the 7 serotypes (4, 6B, 9V, 14, 18C, 19F, and 23F) in Prevenar plus 6 additional serotypes (1, 3, 5, 6A, 7F, and 19A). Together, these 13 serotypes represent the most prevalent invasive disease-causing serotypes in young children worldwide. Prevenar 13 is the only pneumococcal conjugate vaccine indicated for the prevention of invasive disease caused by serotypes 3, 6A, and 19A. 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.

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.

Important Safety Information for Prevnar 13® in the United States

Prevnar 13 should not be given to anyone with a severe allergic reaction to any component of Prevnar 13, Prevnar, or any diphtheria toxoid–containing vaccine.

Prevnar 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 Prevnar 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 Prevnar 13 and Prevnar, 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 Prevnar 13 is appropriate for a given child.

Indication for Prevnar® in the United States

Prevnar is indicated for active immunization of infants and toddlers against serious invasive disease caused by Streptococcus pneumoniae, including bacteremia (bloodstream infection) and meningitis (infection of the membranes surrounding the brain and spinal cord) caused by the seven serotypes in the vaccine. The seven serotypes (strains) of Streptococcus pneumoniae included in the vaccine (4, 6B, 9V, 14, 18C, 19F, and 23F) were the strains that most commonly caused these serious diseases in children prior to the introduction of the vaccine. The routine schedule is 2, 4, 6, and 12-15 months of age.

Prevnar is also indicated for immunization of infants and toddlers against otitis media (ear infections) caused by the seven serotypes in the vaccine. Protection against ear infections is expected to be less than that for invasive disease.

As with any vaccine, Prevnar may not protect all individuals receiving the vaccine from serious invasive disease caused by Streptococcus pneumoniae. This vaccine should not be used for treatment of active infection.

Important Safety Information for Prevnar® in the United States

In clinical studies, the most frequently reported adverse events included injection site reactions, fever (greater than or equal to 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.

Risks are associated with all vaccines, including Prevnar. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar does not protect 100 percent of children vaccinated. Immunization with Prevnar does not substitute for routine diphtheria immunization.

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.

DISCLOSURE NOTICE: The information contained in this release is as of August 23, 2010. 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; the potential benefits of Prevenar 13; the potential 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 in such countries will approve applications that have been or may be submitted for this potential indication and their decisions regarding labeling and other matters that could affect 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, 2009, and in its reports on Form 10-Q and Form 8-K.

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SOURCE Pfizer Inc.