Pneumococcal Vaccine Approved by FDA

WASHINGTON, DC-The Food and Drug Administration (FDA) has approved Prevnar, manufactured by American Home Products Corporation, as a vaccine to prevent pneumococcal diseases in infants and toddlers. The vaccine would be issued as a series of four inoculations given at 2, 4, 6, and 12-15 months of age to prevent invasive diseases caused by Streptococcus pneumoniae including bacteremia and meningitis. Prevnar has not been approved for preventing ear infections, another product of pneumococcus, however American Home Products Corporation hopes it will soon be able to submit conclusive data to the FDA for approval.

The Commissioner of Food and Drugs, Dr. Jane Henney, states, "This new vaccine is great news for parents and children because now, for the first time, we have a highly effective way to prevent a major cause of meningitis and serious blood infections in the most susceptible children-those under two years of age. When we prevent these infections, we are also preventing brain damage and mortality from pneumococcal diseases."

The Advisory Committee on Immunization Practices (ACIP), an advisory committee for the Centers for Disease Control and Prevention, voted to recommend the use of Prevnar for all children up to age 23 months. APIC also recommended some older children ages 24-59 months be vaccinated with Prevnar, including African Americans, Native Americans, Alaskan Natives, or children who have sickle cell anemia, HIV, chronic diseases, or are immunocompromised.