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Article
February 26, 1997

FDA Approval for Infants of a Haemophilus influenzae Type b Conjugate and Hepatitis B (Recombinant) Combined Vaccine

JAMA. 1997;277(8):620-621. doi:10.1001/jama.1997.03540320022013
Abstract

THE ADVISORY Committee on Immunization Practices (ACIP); the Committee on Infectious Diseases, American Academy of Pediatrics; and the American Academy of Family Physicians recommend that all infants receive Haemophilus influenzae type b (Hib) conjugate vaccine and hepatitis B vaccine.1-4 On October 2,1996, the Food and Drug Administration (FDA) licensed a combined Hib conjugate and hepatitis B (recombinant) vaccine (COMVAXTM)* for infants. Since 1991, the antigenic components of COMVAXTM have been used routinely in separate vaccines and have contributed to the declining incidence of infant Hib disease and hepatitis B virus (HBV) infection in the United States.5,6

Vaccine Description  COMVAXTM is made of the antigenic components used in PedvaxHIB® and RECOMBIVAX HB® manufactured and distributed by Merck & Co., Inc. (West Point, Pennsylvania). Each 0.5-mL dose of COMVAXTM contains 7.5 ug of Haemophilus influenzae type b polyribosylribitol phosphate (PRP), 125 ug

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