MANILA, Philippines?According to the World Health Organization, invasive pneumococcal disease is the No. 1 vaccine-preventable cause of death in children younger than 5 years of age.

IPD describes a group of illnesses such as bacteremia/sepsis and meningitis, as well as pneumonia and upper respiratory tract infections, including otitis media.

?Wyeth Pharmaceuticals is curently marketing the 7-valent pneumococcal conjugate vaccine to arrest IPD. While the incidence has been substantially reduced, IPD remains a health threat to children, specifically as emerging strains become more prevalent,? said Emilio Emini, EVP of Wyeth Pharmaceuticals? Vaccine Research and Development.

In the Philippines, pneumonia is one of the leading causes of morbidity and mortality in infants and young children.

?This is why we are very pleased to announced that the United States Food and Drug Administration has granted Fast Track designation to our investigational 13-valent pneumococcal conjugate vaccine (PCV-13) for infants and toddlers.

Expedite the review

A Fast Track designation is designed to expedite the review of products that address serious or potentially life threatening conditions for which there is an unmet medical need.

With Fast Track designation, Wyeth Pharmaceuticals plans to submit the biologics license application on a rolling basis as sections of the application are completed, enabling the FDA to begin review sooner.

The PCV-13 is a candidate vaccine for IPD, which is caused by the bacterium Streptococcus pneumoniae.

The company expects to complete its US filing for pediatric use of the vaccine in the first quarter of 2009 while also exploring opportunities to accelerate the timing of pediatric filings of the vaccine in the rest of the world from its current target of the first quarter of 2009.

The PCV-13 is being studied in Phase 3 global clinical trials in both infants and adults.