Question

• In healthy children, does the heptavalent pneumococcal conjugate vaccine (PCV7; brand name Prevnar) prevent invasive pneumococcal disease and otitis media?

Clinical Bottom Lines

1. Immunization with the heptavalent pneumococcal conjugate vaccine at 2, 4, 6 and 12 to15 months of age is highly effective in preventing invasive pneumococcal disease, and it has a significant impact in reducing otitis media in young children.¹
2. Fully vaccinating approximately 300 children would prevent one case of invasive disease.
3. Providing at least one dose of vaccine to approximately 400 children would prevent one case of invasive disease.
4. Fully vaccinating approximately 160 children would prevent one case of otitis media.
5. PCV7 is recommended for universal use in children 23 months and younger.

Summary of Key Evidence

1. This study was a randomized, double blind trial involving 37,868 healthy infants who received either the heptavalent pneumococcal conjugate vaccine (study group) or the meningococcus type C conjugate vaccine (control group).  The vaccines were administered at 2, 4, 6 and 12 to 15 months of age, along with the standard immunization schedule.
2. At the time of an interim evaluation, PCV7 demonstrated such high efficacy against invasive pneumococcal disease that termination of the trial was recommended.
3. In the final efficacy analysis, PCV7 was 97.4% effective in reducing invasive disease involving vaccine serotypes in fully immunized children.  It was 89.1% effective in reducing overall invasive disease regardless of serotype.  There was no evidence of increased disease caused by non-vaccine serotypes.
4. PCV7 was 7.0% effective in preventing otitis media episodes in fully immunized children and 8.9% effective in reducing otitis media visits.
5. PCV7 was 9.3% to 22.8% effective in preventing frequent otitis media.  Efficacy increased with increasing frequency of disease.
6. PCV7 was 20.1% effective in reducing ventilatory tube placements.

Additional Comments

• This study was sponsored by the vaccine manufacturer, Wyeth-Lederle.
• Efficacy of PCV7 against pneumonia is to be reported separately.
• PCV7 appears to be safe and may be cost-effective for healthy infants and children.  Please see previous CATs regarding these topics (Ada Lin, 3/23/00; Susan Frangiskakis, 5/8/00).

Citation

1. Black S, Shinefield H, Fireman B, et al.  Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children.  Pediatric Infectious Disease Journal 2000; 19:187-195.
2. AAP Committee on Infectious Diseases.  Policy Statement:  Recommendations for the Prevention of Pneumococcal Infections, Including the Use of Pneumococcal Conjugate Vaccine (Prevnar), Pneumococcal Polysaccharide Vaccine, and Antibiotic Prophylaxis.  Pediatrics 2000; 106:362-366.

CAT Author: Y. Katharine Chang, MD

CAT Appraisers: Katherine Layton, MD

Date appraised: August 21, 2000