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In February 2000, the Food and Drug Administration approved the new heptavalent pneumococcal conjugate vaccine (Prevnar) for use in the USA. This approval was based on a number of studies, the most prominent of which was the Northern Kaiser Permanente Vaccine trial involving 37 868 children.1 In this study, children were randomised to receive either the heptavalent pneumococcal vaccine or an experimental vaccine of meningococcal C at 2, 4, 6, and 12 to 15 months of age. Children were followed for up to 24 months after vaccination. There were three cases of vaccine serotype-specific invasive disease in the children randomised to receive the pneumococcal vaccine, and 49 cases in the children randomised to receive the meningococcal vaccine (94% efficacy). Against bacteraemic pneumonia, the estimated efficacy was at least 85% against serotype-specific disease and there were 10% less cases of acute otitis media in the group that received the pneumococcal vaccine. More importantly, the use of tympanostomy tubes was decreased by 20% in children who had received the pneumococcal vaccine.
Based predominantly on the Kaiser data, the American Academy of Pediatrics has made the following recommendations2:
All children 23 months and younger should receive the vaccine at 2, 4, 6, and 15 months
Doses of the vaccine may be administered concurrently with other childhood immunisations
All children 23 months and younger who have not received doses of the vaccine should be given catch-up doses
Children 24 to 59 months old who are at high risk and presumed high risk for invasive pneumococcal infection should receive the vaccine (high risk is defined as an attack rate of invasive pneumococcal disease >150/ 100 000 cases/year and includes children with sickle cell disease, splenic abnormalities, human immunodeficiency infection, primary immunodeficiency, and children receiving immunosuppressive treatment)
Currently available data are inadequate to recommend use of the vaccine in children at moderate risk for invasive pneumococcal disease (moderate risk is defined as an attack rate of pneumococcal disease >20 cases/100 000 per year, and includes all children 24 to 25 months old; children 36 to 59 months old who attend out of home care; and children 36 to 59 months old who are Native American or African American.
Where do these recommendations leave clinicians in the USA? Essentially, it is recommended that the current birth cohort be immunised with the new pneumococcal vaccine and that practitioners provide catch-up doses to all children less than two years old, and those between two and five years old who are at high risk of pneumococcal disease. Each vaccination costs approximately $50–80, and thus the cost to vaccinate the 4 000 000 children born in the USA this year will be between $800 000 000 and $1 280 000 000.