FOR IMMEDIATE RELEASE FOOD AND DRUG ADMINISTRATION
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February 17, 2000
Consumer Inquiries:888-INFO-FDA
The vaccine -- Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197Protein)-- will be marketed as Prevnar by a unit of Wyeth-Ayerst Laboratories, a Division of American Home Products Corporation in Philadelphia, Pennsylvania.
Infants can receive the vaccine as a series of four inoculations administered at 2,4,6, and 12-15 months of age. For children who cannot receive the vaccine starting at age two months, it is recommended that parents see their health care provider for alternative schedules.
Prevnar is the first multivalent conjugate pneumococcal vaccine for children under the age of two. It targets the most common seven strains of pneumococcus that account for approximately 80 percent of invasive disease in infants. It is manufactured by attaching the polysaccharides (purified surface components of the different strains) to a genetically modified nontoxic form of the diphtheria toxin protein called CRM197.
"This new vaccine is great news for parents and their 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." said Dr. Jane Henney, Commissioner of Food and Drugs. "When we prevent these infections, we are also preventing brain damage and mortality from pneumococcal diseases."
It is estimated that each year in the U.S. there are about 16,000 cases of pneumococcal bacteremia and 1400 cases of pneumococcal meningitis among children under age five. Children under the age of two are at highest risk for infection. In up to half the cases of meningitis, brain damage and hearing loss occurs and about 10 percent die.
Clinical trials included a large multicenter safety and efficacy study conducted at Northern California Kaiser Permanente in Oakland, Calif. The controlled, double- blind trial enrolled approximately 38,000 children, about half of whom received Prevnar. The vaccine was given at 2,4, 6 and 12-15 months of age along with routinely recommended vaccines. In this trial, the vaccine was 100 percent effective in preventing invasive pneumococcal disease caused by the seven strains of pneumococcus in the vaccine. The vaccine was approximately 90 percent effective in preventing invasive disease for illnesses caused by all pneumococcal subtypes.
This vaccine is not indicated for use in adults or as a substitute for other approved pneumococcal polysaccharide vaccines approved for high risk children over the age of two.
Side-effects in the trials were generally mild and included local injection site reactions, irritability, drowsiness and decreased appetite. Approximately 21 percent of the children had fevers over 100.3 compared to about 14 percent in the control group not receiving Prevnar.
The vaccine's effectiveness in preventing ear infections, another infection caused by pneumococcus, has not been evaluated by FDA.
Meningitis is usually caused by a viral or bacterial infection. There are different types of bacterial meningitis. Before the approval of the first Haemophilus influenza type b (HIB) conjugate vaccine in 1990 for infants, Hib was the leading cause of bacterial meningitis, but today Streptococcus pneumoniae is one of the leading causes of bacterial meningitis.
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