Notices to Readers
Food and Drug Administration Approval of Use of a Haemophilus b
Conjugate Vaccine for Infants
On December 13, 1990, the Food and Drug Administration (FDA)
approved the Haemophilus b Conjugate Vaccine (Meningococcal
Protein Conjugate) (PRP-OMP) (manufactured by Merck Sharpe and
Dohme and distributed as PedvaxHIB). This vaccine is approved for
use in a two-dose primary immunization schedule for infants at 2
and 4 months of age, with a booster dose at 12 months of age.
Previously unvaccinated infants 5-10 months of age should receive
two doses of PedvaxHIB 2 months apart and a booster dose at 12
months of age. Children 11-14 months of age not previously
vaccinated should receive two doses 2 months apart. Previously
unvaccinated children 15-60 months of age should receive one dose
and do not require a booster. This dosing schedule differs from
that for the Haemophilus b Conjugate Vaccine (Diphtheria CRM
197 Protein Conjugate) (HbOC) licensed for infant use in October
1990 (1).
Haemophilus influenzae type b (Hib) is the major cause of
bacterial meningitis in children less than 5 years of age, with
the peak incidence in children less than 1 year of age (2). The
principal efficacy trial for PRP-OMP was conducted in
approximately 5000 Native American infants in Arizona and New
Mexico, half of whom received the vaccine in a prospective
placebo-controlled study (M. Santosham, personal communication,
1990). A total of 3486 infants completed the primary two-dose
regimen. Fourteen cases of Hib invasive disease occurred in
unvaccinated children, compared with one case in fully vaccinated
children, indicating an efficacy of 93% (95% confidence
interval=53%-99%). The Immunization Practices Advisory Committee
will issue a complete statement on this vaccine.
Reported by: Center for Biologics Evaluation and Research, Food
and Drug Administration. Center for Infectious Diseases; Center
for Prevention Svcs, CDC.
References
CDC. Food and Drug Administration approval of use of
Haemophilus b Conjugate Vaccine for infants. MMWR 1990;39:698-9.
Schlech WF, Ward JI, Band JD, et al. Bacterial meningitis in
the United States, 1978 through 1981: the National Bacterial
Meningitis Surveillance Study. JAMA 1985;253:1749-54.
Disclaimer
All MMWR HTML documents published before January 1993 are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices.
**Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.
