ATLANTA - The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the seven-valent pneumococcal conjugate vaccine (Prevenar, Wyeth Lederle Vaccines), for routine use in all healthy children age 5 and younger, with priority use in specific populations.
The recommendation by the committee is contingent upon licensure of the Streptococcus pneumoniae vaccine and an additional review if any new safety or efficacy data become available, and when vaccine cost is known. The Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee recommended the vaccine for licensure in early November; the vaccine is currently under FDA's "priority review."
The vaccine contains the seven serotypes of S. pneumoniae that are most prevalent in the United States, and are also the most resistant to antibiotics.
The committee recommended the vaccine be given in four doses at ages 2 months, 4 months, 6 months, and 12 to 15 months. Children 7 to 11 months should receive two doses, two months apart, with an additional doses at 12-15 months of age. Children who are 12 to 23 months of age should receive two doses, two months apart with no additional dose. Children 2 years and older should receive only one dose.
The ACIP also recommended that children 3-5 years of age in specified high-risk groups for which the 23-valent polysaccharide vaccine is currently recommended receive a dose of this vaccine at least two months after conjugate vaccination.
Preliminary data from the randomized, double-blinded study were presented at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy and indicate the pneumococcal conjugate vaccine resulted in a 73% reduction in pneumonia with a chest X-ray pattern showing consolidation; a 33% reduction in pneumonia with an X-ray showing any infection; and an 11% reduction in clinical visits with a diagnosis of pneumonia.
The study results of the three-year trial were recently presented by the study's lead investigators, Henry Shinefield, MD, and Steven B. Black, MD, who are codirectors of the Kaiser Permanente Vaccine Study Center. Black is also a member of the Infectious Diseases in Children editorial board.
More than 38,000 children at 23 Kaiser Permanente sites in California were involved in the study. Half the participants received pneumococcal conjugate vaccine and half received a control vaccine. Each child was given doses at 2, 4 and 6 months of age, with a fourth dose at 12-15 months.
An updated analysis of other data collected in the trial was also presented and indicated that the investigational vaccine is highly effective in preventing invasive disease, defined as bacteremia and meningitis. The vaccine also was shown to reduce physician visits for otitis media and reduce the need for tympanostomy tubes for children who suffer from frequent ear infections.
Priorities for Pneumococcal Immunization
|The recommendation stated that in the event of resource or logistic constraints, immunizations should be provided based on the above priorities.|
For more information:
- Black S. Efficacy of heptavalent conjugate pneumococcal vaccine (Wyeth Lederle) in 37,000 infants and children: Impact of pneumonia, otitis media, and an update on invasive diseases - results of the Northern California Kaiser Permanente efficacy trial. Session 143.G,L. Presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy. Sept. 26-29. San Francisco.
- Eskola J, Kilpi T. Efficacy of a heptavalent pneumococcal conjugate vaccine (PncCRM) against serotype-specific, culture-confirmed pneumococcal acute otitis media in infants and children. Abstract LB-13. Presented at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy. Sept. 26-29. San Francisco.
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