Wyeth's Prevenar vaccine for pneumococcal disease registered in Russia

Mar 2 2009

Wyeth announced today that its 7-valent pneumococcal conjugate vaccine, Prevenar (Pneumococcal saccharide conjugated vaccine, Adsorbed), has been registered by the Russian Ministry of Health and Social Development (Roszdravnadzor) and is expected to be commercially available later this year.

Prevenar (also referred to as PCV7), the global standard in pneumococcal disease prevention for infants and young children, helps protect against the seven pneumococcal serotypes contained in the vaccine that cause the majority of pneumococcal disease worldwide.

"This important decision by Roszdravnadzor to register Prevenar is an important step forward in helping to protect the more than 1.5 million Russian children born every year from the potentially serious consequences of pneumococcal disease," says Dr. E. David McIntosh, paediatrician and Wyeth's Medical Director for Infectious Disease and Vaccines in Europe, the Middle East and Africa. "Given the public health benefits that have been documented where Prevenar is routinely used, Wyeth looks forward to engaging in discussions with the Ministry of Health with a view toward including Prevenar in the national childhood immunisation schedule in Russia."

According to the World Health Organization (WHO), pneumococcal disease causes up to 1 million deaths in children each year and is the leading vaccine-preventable cause of death in children younger than five years of age worldwide.

The WHO recommends priority inclusion of PCV7 in national childhood immunisation programs worldwide due to the significant burden of pneumococcal disease and demonstrated vaccine efficacy.

Following inclusion of Prevenar into the routine U.S. paediatric immunization schedule, there has been a 98 percent (95% CI: 97-99) reduction in vaccine-type pneumococcal disease among infants and toddlers younger than 5 years of age compared with a prelicensure baseline. In addition, incidence of disease caused by the seven conjugate vaccine serotypes declined 55 percent (95% CI: 51-58) among adults 50 years of age and older, an unvaccinated group.

Prevenar is now available in more than 90 countries around the world, and 34 of those countries include Prevenar in their national childhood immunisation programme.

Pneumococcal disease affects both children and adults and is a leading cause of illness and death worldwide. Pneumococcal disease is caused by the bacterium Streptococcus pneumoniae and describes a group of illnesses, including invasive infections, such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media.