Prevnar Vaccine Effective Against Invasive Pneumococcal Disease And Ear Infections

PHILADELPHIA, PA -- March 16, 2000 -- A study published in this month's issue of The Pediatric Infectious Disease Journal confirms that a newly approved vaccine is at least 90 percent effective in preventing invasive pneumococcal disease in young children.

The study also shows that the vaccine, Prevnar (TM), reduced common ear infections by 7 percent, multiple ear infections by 23 percent, and the need for ear tubes by 20 percent.

Invasive pneumococcal disease includes bacteremia (bloodstream infection) and bacterial meningitis, a potentially fatal infection in the brain or spinal cord. Children who survive meningitis can be left with life-long disabilities such as deafness, impaired vision, seizures and mental retardation. The pneumococcus bacteria, also known as Streptococcus pneumoniae, is also a major cause of bacterial pneumonia, sinusitis, and otitis media (ear infection).

In the United States, infants and young children are at greatest risk for invasive pneumococcal disease, with more than 16,000 cases of pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis reported annually in children under five. There are more than 5 million cases of otitis media in young children every year, resulting in 27 million doctor visits. Annually, pneumococcal disease in children costs the healthcare system an estimated $1.5 billion.

"These study results are great news for children, parents and pediatricians," said George McCracken, Jr., M.D., Professor of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, and editor of The Pediatric Infectious Disease Journal. "The results indicate that we can now prevent nearly all invasive pneumococcal disease in children and a substantial number of ear infections as well. That's important because many of these infections are becoming resistant to the antibiotics we have traditionally used to treat them."

The three-year, Phase III clinical trial involved nearly 38,000 children at 23 Kaiser Permanente sites throughout Northern California. It was conducted by Steven Black, M.D., and Henry Shinefield, M.D., co-directors of the Kaiser Permanente Vaccine Study Center.

Prevnar, a seven-valent pneumococcal conjugate vaccine, targets the seven serotypes (strains) of pneumococci that cause approximately 80 percent of the pneumococcal disease in U.S. children. In the study, half of the infants received Prevnar and half received a control vaccine. Each child was followed for up to three years. Fifty-two cases of invasive disease caused by vaccine strains were reported. All cases but three were in the control group.

Prevnar was approved by the U.S. Food and Drug Administration in February and is now available in physicians' offices.