Prevnar: A New Vaccine for Pneumococcal Infections in Infants and Toddlers
March 13, 2000
Each year in the US, some 16,000 cases of pneumococcal bacteremia (infection of the bloodstream by pneumococcus bacteria) and 1,400 cases of pneumococcal meningitis (bacterial infection of the lining of the brain and spinal cord) occur in children under age 5. Children under the age of 2 are at highest risk for infection. In up to half the cases of meningitis, brain damage and hearing loss occurs, and about 10% die.
Now a new vaccine is available to prevent such pneumococcal disease in infants and toddlers: Prevnar. The vaccine is manufactured by American Home Products Corporation by their Wyeth Lederle Vaccines division. Prevnar targets the seven most common strains of pneumococcus (Streptococcus pneumoniae) that account for approximately 80% of invasive disease in infants. Clinical trials of nearly 38,000 children showed that the vaccine was 100% effective in preventing disease caused by the seven pneumococcus strains in the vaccine, and 90% effective in preventing illness caused by all subtypes of pneumococcus.
"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 [death] from pneumococcal diseases."
On February 16, 2000, the Advisory Committee on Immunization Practices voted to recommend the use of Prevnar for all infants up to age 23 months, and in children ages 24 to 59 months who are immunologically compromised; those who are African-American, Native American, or Alaskan natives; those with certain chronic diseases; children in day care; socioeconomically disadvantaged children; and those with recurrent or frequent ear infections.
Infants can receive the vaccine as a series of four injections given at 2, 4, 6, and 12-15 months of age. For children who cannot receive the vaccine starting at age 2 months, including previously unvaccinated older infants and children, parents should consult their healthcare providers about an alternate dosing schedule.
Side effects reported in the clinical trials were generally mild and included irritation at the injection site, irritability, drowsiness, restless sleep, and decreased appetite. Approximately 21% of the children had fevers over 100.3 degrees F, compared to about 14% in the control group not receiving Prevnar.
1. "American Home Products Receives FDA Approval for Prevnar." Press release, American Home Products, February 17, 2000.
2. "First Pneumococcal Vaccine Approved for Infants and Toddlers." Press release, FDA, February 17, 2000.
3. Prevnar Package insert, 2000.
4. FDA Center for Biologics Evaluation and Research Web site, February 2000.
Source: DRUG Infoline on PharmInfoNet