Hospital Infection Prevention-Strep pneumo vaccine for children near release

May fight resistant bugs, cut day-care infections

The first vaccine designed specifically to prevent Streptococcus pneumoniae infections in children is nearing final federal approval, providing a much-needed new weapon against drug-resistant strains and invasive disease. The vaccine also should help cool down hotbeds of transmission like day-care centers, where strep pneumo infections are difficult to prevent.

"One of the strongest predictors of increased risk among healthy kids is day-care attendance," says Stephen Black, MD, co-director of the Kaiser Permanente Vaccine Center in Oakland, CA. "There are two possible ways the vaccine would help with that. One would be to reduce the risk of invasive disease, which I think it will clearly do. The second possibility is that it might reduce carriage of the organism in the day-care centers, especially of the antibiotic-resistant organisms."

Strep pneumo kills 1 million children per year

Penicillin-resistant strep pneumo continues to increase in the United States, climbing from 14% of tested isolates at sentinel hospitals in 1993-1994 to 25% of isolates in 1997.¹ The pathogen can cause invasive disease, including bacteremia and meningitis. In the United States, there are approximately 16,000 cases of invasive pneumococcal disease each year among children under age 5. Pneumococcal disease in children costs the U.S. health care system an estimated $1.5 billion annually. Worldwide, more than 1 million children die each year as a result of pneumococcal disease.

The vaccine recently was recommended for licensure by the Food and Drug Administration's Vaccines and Related Biological Products Advi sory Committee. In making its decision, the FDA Advisory Committee reviewed safety and efficacy data from numerous clinical trials involving approximately 38,000 children. Children in the trial were monitored for up to three years after receiving the vaccine. The most frequently reported adverse events included injection site reactions, fever, irritability, drowsiness, restless sleep, and decreased appetite.

While the committee's recommendation is not binding, the vaccine also has drawn the endorsement of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices. While the vaccine is expected to be recommended for all children 5 and under, the CDC committee cited some initial priority groups. The recommendation stated that in the event of resource or logistic constraints, immunizations should be provided in the following order: to all children 2 years old and under; children age 24 to 59 months with sickle cell disease, functional or anatomic asplenia, or HIV infection; and children age 24 to 59 months who are immunocompromised, who have chronic illness, or who are Alaskan natives or American Indians.

"We will have to see what will happen when a large cohort of children are immunized," Black says. "We're hopeful that it will reduce [strep pneumo] circulation among these kids. That will have an effect both on them and potentially on adults that are in contact with them."

In that regard, the new pediatric vaccine is not to be confused with an existing strep pneumo vaccine that has been aimed primarily at adults. That vaccine is recommended for all adults over 65 years old, including those in long-term care settings. Revaccination is recommended for those 65 and over if the person was immunized before age 65 and if more than five years have elapsed since the first dose. That vaccine had not been recommended for children less than 2 years of age.

Reference

1. Centers for Disease Control and Prevention. Geographic variation in penicillin resistance in Streptococcus pneumoniae — selected sites, United States, 1997. MMWR 1999; 48:657.