This statement is provided in response to the December 1990 US Food and Drug Administration (FDA) approval of labeling for a second Haemophilus influenzae type b conjugate vaccine, PRP-OMP (Table 1), for administration to infants as young as 2 months of age. The following recommendations supercede previous American Academy of Pediatrics (AAP) guidelines for the use of H influenzae type b conjugate vaccines.
In October 1990, the FDA approved labeling for one H influenzae type b conjugate vaccine, HbOC (Table 1), stating that it was safe and effective for administration to infants beginning at 2 months of age. The Academy recommended that all infants be immunized at 2 months of age or as soon as possible thereafter. This and related recommendations were communicated to AAP members in a PedComm in October and published in AAP News (Vol 6, November 1990).
Prior to October 1990, the Academy had recommended that all children receive a dose of an H influenzae type b conjugate vaccine at 15 months of age (AAP News. Vol 6, July 1990). The Academy continues to believe that the safety and efficacy of all three licensed conjugate vaccines—PRP-D, HbOC, and PRP-OMP (Table 1)—are likely to be equivalent when administered to children 15 months of age on older.
The FDA's approval of the new labeling for both HbOC and PRP-OMP for use in infants was based in pant on a review of two recent trials performed in infants in the United States that demonstrated the efficacy of these vaccines. The results of these trials will be published in the near future.
- Copyright © 1991 by the American Academy of Pediatrics