The purpose of this statement is twofold. It is to report (1) the preliminary data on the efficacy of the first. generation HbPV based on "post-licensing" studies and (2) the occurrence of cases of invasive disease due to Haemophilus influenzae type b (Hib) within one week following immunization with HbPV.

"Post-licensing" surveillance were started soon after the licensure of HbPV in May of 1985. Approximately 10 million doses have been distributed since licensure. These findings were reviewed at a recent meeting at NIH sponsored by the Food and Drug Administration.

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