CDC Advisory Committee on Immunization Practices Reinstates Recommendation for Administration of Full Four-Dose Series of Prevnar

MADISON, N.J. -- Wyeth announces that the recommendations for administering Prevnar, the first and only vaccine approved to help prevent invasive pneumococcal disease (IPD) in infants and toddlers, has been reinstated to a four-dose series by ACIP. The routine vaccination schedule is 2, 4, 6, and 12-15 months of age for all healthy infants and toddlers. ACIP also recommends that physicians call back those children for whom vaccination was deferred to ensure administration of all age-appropriate doses of Prevnar.

As a result of supply constraints, the ACIP had issued interim recommendations in late 2001 in an effort to conserve vaccine for use in children at the highest risk of contracting IPD. The ACIP is reinstating the 4-dose recommendation based on an understanding of current Prevnar supply, the elimination of the backorder situation, and Wyeth's expectations of future supply.

"With the back orders having been eliminated and our current expectation of continued supply, we are now focused on ensuring that all unvaccinated healthy infants and toddlers receive the complete recommended series of Prevnar," says Geno Germano, executive vice president and GM of Wyeth Vaccines. "We also have procedures in place that will help physicians manage the callback process for children with deferred doses."

The four-dose schedule is associated with high efficacy results. Based on a large-scale multicenter clinical trial (N equals 37,816), Prevnar demonstrated 100 percent efficacy (95 percent CI:75.4-100 percent) against IPD caused by vaccine serotypes when administered as a complete 4-dose series. In pre-approval clinical trials, the most frequently reported adverse events included injection site reactions, fever (greater then 38 degrees C/100.4 degrees F), irritability, drowsiness, restless sleep, decreased appetite, vomiting, diarrhea, and urticaria-like rash.

A recent study published in the New England Journal of Medicine (NEJM) reports that the use of Prevnar in infants and toddlers is helping to prevent IPD. The study showed a 78 percent decline in IPD in children under two caused by the strains targeted by the vaccine. The study also demonstrated that the overall incidence of invasive disease caused by penicillin -- resistant Streptococcus pneumoniae bacteria substantially declined -- by 35 percent in children under two years of age -- since the vaccine's introduction.

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 of age.

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 nonvaccine serotypes.

Source: Wyeth Pharmaceuticals