Wyeth is informing its customers that due to temporary supply limitations of Prevnar, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein), the company is continuing its allocation program to optimize access to available doses. All monthly supplies of Prevnar will be allocated to the CDC and private physicians based on historical monthly allocations to help ensure the equitable distribution of available vaccine.
Wyeth is experiencing temporary supply limitations due to a recent shutdown of the Prevnar filling line. Although manufacturing enhancements have been done and product is currently being manufactured and shipped to customers in accordance with the allocation programme, production issues are not resolved and supply will remain limited through first half of 2004. Due to the supply limitations, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) issued new interim recommendations temporarily deferring the administration of the fourth dose of Prevnar for healthy children.
In 2003, Wyeth supplied over 18 million doses of Prevnar, an increase of 33 per cent over the previous year. Overall supply in 2004 is expected to exceed last year's supply. Wyeth realizes the medical importance of this vaccine and is committed to optimizing product availability in the months to come.
Prevnar is the only vaccine available to help prevent pneumococcal meningitis, otitis media, and bacteremia among infants and young children. Since its licensure by the FDA in February 2000, Prevnar has become an important vaccine for children's health - recommended by the CDC's ACIP, the American Academy of Pediatrics (AAP), and the American Academy of Family Physicians (AAFP), and covered by virtually every health insurance plan in the United States.
Risks are associated with all vaccines, including Prevnar. Hypersensitivity to any vaccine component, including diphtheria toxoid, is a contraindication to its use. Prevnar does not provide 100 per cent protection against vaccine serotypes or protect against nonvaccine serotypes.