CDC, AAFP, Others Release Interim Hib Vaccine Recommendations

By News Staff
12/19/2007

In response to a looming shortage of Haemophilus influenzae type b, or Hib, conjugate vaccine, the CDC, in consultation with its Advisory Committee on Immunization Practices, or ACIP; the AAFP; and the American Academy of Pediatrics, is recommending that physicians and other vaccine providers temporarily defer the routine Hib vaccine booster dose typically administered at age 12-15 months except for children in specific high-risk groups. CDC officials are encouraging health care professionals to track children in whom the booster dose is deferred so they can be recalled for immunization when the current Hib vaccine supply disruption improves.

The interim recommendations are outlined in a Morbidity and Mortality Weekly Report, or MMWR, Dispatch, issued today. Read a summary of the key recommendations in a statement posted on the AAFP's Immunization Resources Web page.

The shortage can be traced to a voluntary recall Merck & Co. Inc. announced (3-page Word file; About Downloading) on Dec. 13 involving two of its Hib-containing vaccine products. Specifically, the company recalled 10 lots of its monovalent Hib conjugate vaccine, sold as PedvaxHIB, and two lots of its combination Hib/hepatitis B vaccine, COMVAX, because it could not assure the sterility of manufacturing equipment used to produce these lots and had concerns about potential product contamination. In all, about 1 million doses of vaccine were recalled, including about one-half of the doses contained in the CDC national stockpile.

According to the dispatch, Merck has suspended production of its Hib conjugate vaccines and does not expect to resume distribution of these vaccines until the fourth quarter of 2008.

Two Hib vaccine products manufactured by sanofi pasteur -- its monovalent Hib vaccine, ActHIB, and its diphtheria and tetanus toxoids and acellular pertussis/Hib vaccine, TriHIBit -- are unaffected by the recall. However, sanofi pasteur likely will not be able to immediately provide adequate Hib vaccine to vaccinate fully all children for whom the vaccine is recommended, says the dispatch.

Briefly, the CDC, the AAFP and other groups are recommending the following changes to best utilize available Hib vaccine supplies:

providers should temporarily defer the routine Hib vaccine booster dose administered at age 12-15 months except for children in specific high-risk groups;
the 12-15 month booster dose should not be deferred in certain children at increased risk for invasive Hib disease, including children with asplenia, sickle cell disease or HIV infection and certain other immunodeficiency syndromes, as well as those who have malignant neoplasms.
American Indian/Alaska Native children, who are at increased risk for invasive Hib disease -- particularly during their first 6 months of life -- should continue to be immunized with unrecalled Merck vaccine. The CDC will prioritize distribution of available vaccine from its stockpile for use in these children.
administration of Hib vaccine continues to be recommended for use in prophylaxis regimes for susceptible close contacts of patients with invasive Hib disease.

Finally, the CDC is urging health care professionals left with little or no useable Hib vaccine to order only the number of doses required to fulfill the needs of their patients. Physicians can order vaccine from sanofi pasteur via the company's VaccineShoppe Web site.

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