Prevnar, the first and only vaccine available to help prevent invasive pneumococcal disease (IPD) in both infants and young children, is approved to be given in a four-dose series to healthy children at 2, 4, 6 and 12 to 15 months of age. However, a shortage of vaccine earlier this year prompted the CDC to modify their recommendations for administration to healthy children. The CDC recommends that providers resume administration of the vaccine according to the routine schedule.
A catch-up schedule for children who are incompletely vaccinated is provided in the September 17th issue of the Morbidity & Mortality Weekly Report (MMWR) Notice to Readers.
"We are pleased with the CDC's recommendation to return to the full, four- dose schedule for all children," says Joe Mahady, President Wyeth North America and Global Business. Mr. Mahady adds, "Moving forward, we will focus on alerting doctors and parents about the reinstated four-dose recommendation to help ensure that children who may have missed doses during the shortage receive their remaining age-appropriate doses."
One year after vaccine licensure, core surveillance sites of the Centers for Disease Control and Prevention (CDC) noted a 78 percent reduction in invasive pneumococcal disease cases in children younger than two years caused by vaccine serotypes. In 1998 and 1999, there was an average of 156.1 cases per 100,000 of invasive pneumococcal disease caused by vaccine serotypes among children younger than two years of age. In 2001, following routine use of the vaccine, the number of cases fell to 33.6 per 100,000.
About Prevnar
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 to 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. See Prescribing Information for indications and usage, dosage and administration, and safety information.
About Wyeth
Wyeth Pharmaceuticals, a division of Wyeth , has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and nonprescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare, and Fort Dodge Animal Health.
The statements in this press release that are not historical facts are forward-looking statements based on current expectations of future events that involve risks and uncertainties including, without limitation, risks associated with the inherent uncertainty of the timing and success of pharmaceutical research, product development, manufacturing, commercialization, economic conditions including interest and currency exchange rate fluctuations, changes in generally accepted accounting principles, the impact of competitive or generic products, trade-buying patterns, wars or terrorist acts, product liability and other types of lawsuits, the impact of legislation and regulatory compliance and obtaining reimbursement, favorable drug pricing, access and other approvals, environmental liabilities, and patent, and other risks and uncertainties, including those detailed from time to time in the Company's periodic reports, including current reports on Form 8-K, quarterly reports on Form 10-Q and the annual report on Form 10-K, filed with the Securities and Exchange Commission. Actual results may vary materially from the forward-looking statements. The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise.
Wyeth
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