Wyeth Pharmaceuticals, a division of Wyeth, has announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to the company's investigational 13-valent pneumococcal conjugate vaccine for infants and toddlers. The company is seeking a paediatric indication for active immunisation against invasive pneumococcal disease (IPD) and otitis media caused by serotypes included in the vaccine. The vaccine includes six new serotypes (1, 3, 5, 6A, 7F and 19A) in addition to the seven serotypes (4, 6B, 9V, 14, 18C, 19F and 23F) included in PREVENAR™, Pneumococcal Conjugate Vaccine, 7-valent (Diphtheria CRM197 Protein), also known as PCV7.
“While the incidence of pneumococcal disease has been substantially reduced since our introduction of PREVENAR in the United States, 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.
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. With Fast Track designation, the company plans to submit the biologics licence application on a rolling basis as sections of the application are completed, enabling the FDA to begin review sooner.
The company expects to complete its US filing for paediatric use of the vaccine in the first quarter of 2009. It is also exploring opportunities to accelerate the timing of paediatric filings of the vaccine in the rest of the world from its current target of the first quarter of 2009. Their investigational 13-valent pneumococcal conjugate vaccine is being studied in Phase 3 global clinical trials in both infants and adults.
The company has recently achieved significant success in bringing new products to market. In the first quarter of 2008 alone, it obtained three new product approvals in the US in the following therapeutic areas: major depressive disorder, haemophilia A and opioid-induced constipation.
According to the World Health Organisation (WHO), pneumococcal disease is the number one vaccine-preventable cause of death in children younger than 5 years of age. Due to the significant burden of pneumococcal disease and demonstrated vaccine efficacy, WHO recommends the priority inclusion of PCV7 in national childhood immunisation programs worldwide. WHO notes that once other pneumococcal vaccines offering broader protection become available, countries can assess whether it would be helpful to switch to these vaccines.
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 bacteraemia/sepsis and meningitis, as well as pneumonia and upper respiratory tract infections, including otitis media.
In clinical trials (n=18,168), the most frequently reported adverse events included injection site reactions, fever (>38°C), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhoea, and rash. Risks are associated with all vaccines, including PREVENAR. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contra-indication to its use. PREVENAR does not provide 100% protection against vaccine serotypes or protect against non-vaccine serotypes.
