Interim Recommendations for the Use of Hib-Containing Vaccines

Board Chair Approved: December 19, 2007

The American Academy of Family Physicians has adopted the following recommendations for use of Hib-containing vaccines which are consistent with those of the Centers for Disease Control and Prevention (CDC) as reported in the December 19, 2007 Morbidity and Mortality Weekly Report (MMWR). (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d1219a1.htm) These recommendations were developed by the CDC, in consultation with the Advisory Committee on Immunization Practices, the American Academy of Family Physicians, and the American Academy of Pediatrics.

On December 13, 2007, Merck & Co., Inc. announced a voluntary recall of certain lots of two Haemophilus influenzae type b (Hib) conjugate vaccines, PedvaxHIB (monovalent Hib vaccine) and Comvax (Hib/Hepatitis B vaccine). Providers should return unused vaccine from these recalled lots using procedures outlined on the Merck website at: http://www.merckvaccines.com/PCHRecall.pdf (3-page PDF file; More information about PDFs). Additional information regarding the affected lots is available online from the Food and Drug Administration at http://www.fda.gov/consumer/updates/hib121307.html. Merck has suspended production of its Hib conjugate vaccines and does not expect to return to the market with these vaccines until the fourth quarter of 2008. The recall of these vaccines and suspension of production are expected to result in short-term disruption to the Hib vaccine supply in the United States.

Because of the short-term reduction in available doses of Hib-containing vaccines, the following recommendations have been issued:

Providers temporarily defer the routine Hib vaccine booster dose administered at age 12-15 months except for specific high-risk groups;
For certain children at increased risk for invasive Hib disease, including children with asplenia, sickle cell disease, human immunodeficiency virus infection, certain other immunodeficiency syndromes, and malignant neoplasms, the 12-15 month booster dose should not be deferred.
For American Indian/Alaska Native (AI/AN) children who are at increased risk for invasive Hib disease, particularly in the first 6 months of life, these children should continue to be immunized with unrecalled vaccine. The CDC has a stockpile of a limited amount of Hib-containing vaccine not affected by the recall and will prioritize distribution of available vaccine for use in AI/AN children.
Hib vaccines are also recommended for use in prophylaxis regimes for susceptible close contacts of invasive Hib disease patients.

For additional information on Hib-containing vaccines and interim recommendations, please see the above noted CDC MMWR statement.

Reference:
1. Notice to Readers: Recall of Haemophilus influenzae Type b (Hib) Conjugate Vaccines PedvaxHIB and Comvax and Interim Recommendations for the Use of Hib-Containing Vaccines: MMWR Weekly, December 19, 2007/Vol. 56.

2008 Childhood Immunization Schedule (1-page PDF file; About PDFs)