FDA approves pneumococcal vaccine for children

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FDA approves pneumococcal vaccine for children

Posted 2-21-2000
Reuters Health

Rockville, Md. The Food and Drug Administration (FDA) approved the first vaccine to prevent pneumococcal disease in infants and toddlers, Wyeth Lederle Vaccines’ Prevenar.

The agency approved the vaccine to prevent pneumococcal meningitis and pneumococcal bacteremia, the spread of the bacteria in the bloodstream, both caused by Streptococcus pneumoniae (S. pneumoniae). It was approved for infants in a series of four shots given at 2, 4, 6, and 12-15 months.

"This new vaccine is great news for parents and their children because 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 2 years of age," said Jane Henney, FDA commissioner.

In Wyeth’s pivotal trial, conducted at Kaiser Permanente of Northern California, Prevenar was 100 percent effective in preventing pneumococcal disease caused by the seven S. pneumoniae strains included in the vaccine. It was 90 percent effective in blocking disease caused by all S. pneumoniae strains.

Officials estimate there are 16,000 cases of pneumococcal bacteremia and 1,400 cases of pneumococcal meningitis in the United States each year. Children under 2 are at highest risk, which means the vaccine, if given to all those children, might wipe out most pneumococcal disease.

Children from ages 2 to 5 also are at risk. But the national Centers for Disease Control and Prevention’s Advisory Committee on Immunization Policy urged physicians to restrict administration of the vaccine in 2- to 5-year-olds, citing cost concerns.

According to Wyeth Lederle spokesperson Doug Petkus, the vaccine will list for $58 per dose.

The CDC advisers said only high-risk 2- to 5-year-olds—those with sickle cell anemia, HIV, or other immunodeficiencies—should receive Prevenar. African American, Native American, and Native Alaskan 2-to 5-year-olds should also receive it, the advisers said, noting higher infection rates in these ethnic groups.