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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
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