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MADISON, N.J. -- Wyeth announced today that a study published in this week's New England Journal of Medicine (NEJM) reports that the use of Prevnar in infants and toddlers was associated with a significant reduction in invasive pneumococcal disease (IPD) in vaccinated children.
The study also demonstrated that the overall incidence of invasive disease caused by penicillin-resistant Streptococcus pneumoniae bacteria substantially declined since the vaccine's introduction.
Approved by the U.S. Food and Drug Administration (FDA) in February 2000, Prevnar remains the first and only vaccine approved to help prevent invasive pneumococcal disease in infants and toddlers. The routine vaccination schedule is 2, 4, 6, and 12-15 months of age.
The study, conducted by the Centers for Disease Control and Prevention (CDC), found a steep downward trend in the incidence of IPD in children under two years of age from the 1998 baseline period through 2001. "This study indicates that Prevnar is helping to prevent pneumococcal disease in young children," says Dr. Peter Paradiso, vice president of scientific affairs and research strategy. Surveillance showed a 78 percent decline in IPD in children under two caused by the strains targeted by the vaccine
"An important additional benefit is the reduction in disease events caused by penicillin-resistant strains," says Dr. Paradiso. Prevnar has also helped reduce disease caused by drug-resistant strains, a 35 percent disease reduction in IPD caused by strains that were not susceptible to penicillin among children under two years of age
"More than 42 million doses of Prevnar have been distributed nationwide and we have already seen a significant reduction in the incidence of potentially life-threatening invasive pneumococcal disease since its licensure," says Geno Germano, executive vice president and general manager of Wyeth Vaccines. "We are excited about the role that Prevnar has played in helping the CDC's "Healthy People 2010" initiative accomplish one of its objectives -- decreasing the incidence of IPD for children -- nine years ahead of schedule."
Prevnar is indicated for active immunization of infants and toddlers against invasive disease caused by S. pneumoniae due to the capsular serotypes included in the vaccine. The routine schedule is 4 doses, given at 2, 4, 6 and 12-15 months.
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 percent protection against vaccine serotypes or protect against non-vaccine serotypes. See the Prescribing Information for indications and usage, dosage and administration, and safety information.