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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

  1. 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.



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