Notice to Readers Update: Haemophilus influenzae b
Polysaccharide Vaccine
Since the licensure of the first polysaccharide vaccine against
Haemophilus influenzae b (Hib) in April 1985, over 3 million U.S.
children have been immunized against this bacterial disease. The
vaccine is recommended for all children at the age of 24 months,
and
as early as 18 months of age for children at highest risk of Hib
disease (1). Currently, three manufacturers are licensed to
produce
the vaccine (Praxis: b-Capsa-1; Lederle: Hib-imune; and
Connaught:
Hibvax).
As part of the continuing evaluation of the vaccine, CDC, the
U.S.
Food and Drug Administration (FDA), and the vaccine manufacturers
are
collaborating in gathering information on children who have
developed
invasive Hib disease after vaccination. As with any vaccine, a
certain number of cases of disease may be expected to occur among
vaccinated persons.
To ensure a more complete ascertainment of cases, practitioners
and health departments are requested to report all cases of Hib
disease (e.g., meningitis, bacteremia, epiglottitis) occurring
after
vaccination. Cases from 1985, as well as current cases, are
solicited; complete case ascertainment for this entire time is
important for the most accurate interpretation of these reports.
Reports can be made directly to the manufacturers*; by sending Form
1639 "Adverse Reaction Report," to FDA (the form is available by
calling FDA at 301-443-4580); or by writing or telephoning the
Meningitis and Special Pathogens Branch, Division of Bacterial
Diseases, Center for Infectious Diseases, CDC, Atlanta, Georgia
30333;
telephone (404) 329-3687.
In addition to this request for information on Hib cases, it is
also important to report any serious adverse events that occur
within
28 days of receipt of vaccine. Such events occurring among
recipients
of Hib vaccine purchased with public funds should be reported to
the
appropriate city or state health department, which will complete an
investigation and send a report to CDC. Adverse events occurring
among recipients of privately purchased Hib vaccine should be
reported
directly to the manufacturers or to FDA (Form 1639).
Reference
ACIP. Polysaccharide vaccine for prevention of Haemophilus
influenzae type b disease. MMWR 1985;34:201-5.
*Manufacturers' addresses and telephone numbers are as follows:
Mead-Johnson Nutritional Division, Evansville, Indiana 47721
(distributors of the Praxis vaccine); telephone (812) 429-7480.
Lederle Laboratories, Pearl River, New York 10965; telephone (914)
735-5000. Connaught Laboratories, Inc., Swiftwater, Pennsylvania
18370; telephone (717) 839-7187.
Disclaimer
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**Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.
