The purposes of this statement are twofold. They are to report (1) the preliminary data on the "postlicensing" efficacy studies of the first generation Haemophilus b Polysaccharide Vaccine and (2) the occurrence of cases of invasive disease due to Haemophilus influenzae type b within 1 week following immunization with the Haemophilus b Polysaccharide Vaccines. These findings were reviewed at a recent meeting at the National Institutes of Health sponsored by the FDA1 and/or were presented at a recent meeting of the Interscience Conference on Antimicrobial Agents and Chemotherapy.
Postlicensing surveillance was started in 1985 after the licensure of Haemophilus b Polysaccharide Vaccine. Over 10 million doses have been distributed since licensure.