Wyeth’s Prevenar 13 Receives First Approval
-Chile Grants First Approval of Prevenar 13 for the Prevention of
Pneumococcal Disease in Infants and Children-
Collegeville, Pa. – Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that the Chilean Ministry of Health, MINSAL (Ministerio de Salud), has become the first government agency to approve Prevenar 13* Valent, (Pneumococcal Conjugate Vaccine 13 Valent [Diphtheria CRM197 Protein]) for infants and young children.
Prevenar 13 Valent is approved for active immunization of children aged 6 weeks through 5 years for the prevention of invasive pneumococcal disease, as well as pneumonia and otitis media (middle ear infection) caused by 13 pneumococcal serotypes. Pneumococcal disease (PD) is the leading cause of vaccine-preventable death worldwide in children younger than 5 years of age and is estimated to cause up to one million deaths in children each year.
Prevenar 13, which builds on the scientific foundation of Prevenar* (Pneumococcal Saccharide Conjugated Vaccine, Adsorbed), is designed to provide the broadest serotype coverage of any pneumococcal conjugate vaccine. Prevenar 13 contains 13 serotypes, seven of which (4, 6B, 9V, 14, 18C, 19F and 23F) are included in Prevenar and six additional serotypes (1, 3, 5, 6A, 7F and 19A) associated with the greatest remaining burden of invasive disease. Notably, serotype 19A is prevalent in many regions of the world and is often associated with antibiotic resistance.
“The approval of Prevenar 13 in Chile is the first of many regulatory decisions we anticipate receiving around the world this year,” says Emilio Emini, Ph.D., Executive Vice President, Vaccines Research and Development, Wyeth Pharmaceuticals. "We believe that Prevenar 13 is an important milestone in Wyeth’s ongoing commitment to public health in the fight against serious pneumococcal disease worldwide.”
The routine immunization schedule for Prevenar 13 Valent in Chile is at ages 2, 4, 6, and 12 to 15 months, and the vaccine can be administered at the same time as other regularly administered childhood vaccines. Children who have already initiated a vaccination program with Prevenar can transition to Prevenar 13 Valent at any point in their dosing schedule to help protect them from the six additional disease serotypes included in Prevenar 13 Valent. Children aged 7 months through 5 years should follow the appropriate dosing schedule for their age group. There is no information about the interchangeability of Prevenar or Prevenar 13 Valent with any other pneumococcal conjugate vaccine that does not contain protein carrier CRM197. Wyeth expects Prevenar 13 Valent will be commercially introduced in Chile later this year.
The Company initiated its global pediatric filings in late 2008 and, to date, has submitted regulatory applications for Prevenar 13 in more than 50 countries spanning six continents and has been granted priority review in the U.S., Canada, Australia and South Africa. Prevenar 13 is also being studied in global Phase 3 clinical trials in adults, with regulatory submissions expected in 2010.
About Pneumococcal Disease
Pneumococcal disease is complex and describes a group of illnesses, all caused by the bacterium Streptococcus pneumoniae. Pneumococcal disease affects both children and adults, and includes invasive infections such as bacteremia/sepsis and meningitis, as well as pneumonia and otitis media.
Important Safety Information for Prevenar 13
In clinical studies, the most commonly reported adverse events in children were injection site reactions, fever, irritability, decreased appetite, and increased and/or decreased sleep. Risks are associated with all vaccines, including Prevenar 13. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. As with any vaccine, Prevenar 13 may not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes.
Important Safety Information for Prevenar
In clinical studies (n=18,168), the most frequently reported adverse events included injection site reactions, fever (≥38ºC/100.4ºF), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and rash.
Risks are associated with all vaccines, including Prevenar. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevenar does not provide 100% protection against vaccine serotypes or protect against nonvaccine serotypes. The decision to administer Prevenar should be based on its efficacy in preventing invasive pneumococcal disease.
The frequency of pneumococcal serotypes and serogroups can vary from country to country, which could influence the effectiveness of the vaccine in any given country.
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