Wyeth submits marketing authorization application for its 13-Valent vaccine

PCV13 covers the broadest range (13 serotypes) of the various forms of pneumococcal diseases.

The pneumococcal vaccine Prevenar has immunized tens of millions of children and saved tens of thousands of lives in a time when the World Health Organization (WHO) had raised the spotlight on pneumococcal disease as the current number one cause of vaccine-preventable deaths in children under 5, globally. According to the WHO, up to 1 million children die every year because of pneumococcal diseases.

Prevenar is the first and only vaccine against pneumococcal disease, which is a group of illnesses, all caused by the bacterium Streptococcus pneumoniae, that include invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media (inner ear infection). Most recently, the pneumococcal serotype 19A, which is included in the 13 valent pneumococcal conjugate vaccine, has been increasing in prevalence in many regions of the world and is frequently resistant to antibiotics.

"While the incidence of pneumococcal disease has been substantially reduced since our introduction of Prevenar, pneumococcal disease remains a health threat to children, specifically as emerging strains, such as 19A, become more prevalent,"

says Emilio Emini, Ph.D., Executive Vice President, Vaccine Research and Development, Wyeth Pharmaceuticals.

According to a study conducted in Abu Dhabi, the incidence was much as 102 cases of pneumococcal diseases in every 100,000 children under five years of age. Studies in Bahrain, the UAE, Oman and Saudi Arabia have shown that occurrences of invasive pneumococcal disease are higher than in many western countries.

From January 2009, Prevenar will be available in all six Gulf Countries. Bahrain, Oman and KSA are adding Prevenar to their National Immunization Programs (NIP) joining other GCC nations like Qatar, Kuwait and the Health Authorities in Abu Dhabi and Dubai to included Prevenar on their NIP's for the safety and health of their new generations.

"Like polio and tuberculosis before, children today are at their greatest risk from pneumococcal diseases, like pneumonia and meningitis. Now that the vaccine is available; a significant drop in registered cases is expected" said Dr. Baher Masoud Medical Director of Wyeth Pharmaceuticals Middle East and North Africa. "Since its introduction, Prevenar has had a substantial impact on public health, dramatically reducing the rate of invasive pneumococcal disease, with the potential to prevent up to 92 percent of invasive pneumococcal disease in infants and young children worldwide."

Earlier this year, the U.S. Food and Drug Administration (FDA) granted Fast Track designation to PCV13 for infants and toddlers. Fast Track designation is designed to facilitate review of products that address serious or potentially life threatening conditions for which there is an unmet medical need.

A total of 31 countries worldwide now include Prevenar on their Immunization Schedule of which 24 are in Europe and Middle East. The vaccine is available for free to all nationals from government hospitals and clinics.

Pneumococcal Disease

Pneumococcal disease affects both children and adults, and is a leading cause of illness and death worldwide. Pneumococcal disease describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae, that include invaive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media. Most recently, the pneumococcal serotype 19A, which is included in the candidate vaccine, has been increasing in prevalence in many regions of the world and is frequently resistant to antibiotics.

Due to the significant burden of pneumococcal disease and demonstrated vaccine efficacy, the World Health Organization (WHO) recommends the priority inclusion of PCV7 in national childhood immunization programs worldwide.

Wyeth Pharmaceuticals

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.

Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.