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Persons using assistive technology might not be able to fully access information in this file. For assistance, please send e-mail to: mmwrq@cdc.gov. Type 508 Accommodation and the title of the report in the subject line of e-mail. New Pediatric Formulation of Recombivax HB RegisteredOn June 8, 1993, the Food and Drug Administration licensed a new formulation of the recombinant hepatitis B vaccine produced by Merck Sharpe & Dohme (West Point, Pennsylvania) (Recombivax HB Registered *). This pediatric formulation is intended specifically for vaccinating infants born to hepatitis B surface antigen (HBsAg)-negative mothers and children aged less than 11 years. It is available in a concentration of 2.5 ug/0.5 mL in single-dose (0.5 mL) and six-dose (3.0 mL) vials both with brown caps. The previously licensed formulation of Recombivax HB Registered, which contains 10 ug/1.0 mL, is now also available in a single-dose vial (5.0 ug/0.5 mL) with a yellow cap. The 5.0-ug dose is for high-risk infants (those born to HBsAg-positive women or to women whose HBsAg status is not known) and for adolescents (aged 11-19 years). The previously licensed formulation (10 ug/1.0 mL) still can be used to provide the recommended microgram dose to infants, children, and adolescents. Engerix-B Registered is the other hepatitis B vaccine available in the United States; it is manufactured by SmithKline Beecham (Pittsburgh, Pennsylvania), and no changes have been made in its formulation. Hepatitis B vaccines are supplied in several different concentrations and sizes of vials and the recommended age-specific dose varies by product (Table_1). Additional details regarding administration of hepatitis B vaccine are available in the recommendations of the Immunization Practices Advisory Committee (1) and the manufacturers' package inserts. Reference
* Use of trade names and commercial sources is for identification
only and does not imply endorsement by the Public Health Service or
the U.S. Department of Health and Human Services.
TABLE 1. Recommended doses of currently licensed hepatitis B vaccines ================================================================================================= Recombivax HB(R) * Engerix-B(R) * ------------------- -------------------- Group Dose (ug) (mL) Dose (Hg) (mL) ---------------------------------------------------------------------------------------------- Infants of HBsAg + -negative mothers and children aged <11 yrs 2.5 (0.5) & 10.0 (0.5) Infants of HBsAg-positive mothers; prevention of perinatal infection 5.0 (0.5) @ 10.0 (0.5) Children and adolescents aged 11-19yrs 5.0 (0.5) @ 20.0 (1.0) Adults aged >=20 yrs 10.0 (1.0) @ 20.0 (1.0) Dialysis patients and other immunocompromised persons 40.0 (1.0) ** 40.0 (2.0) ++ ---------------------------------------------------------------------------------------------- * Both vaccines are routinely administered in a three-dose series. Engerix-B(R) also has been licensed for a four-dose series administered at O, 1, 2, and 12 months. + Hepatitis B surface antigen. & New pediatric formulation. @ Previously licensed formulation; can be used to deliver the appropriate age-specific dose to infants of HBsAg-negative mothers and children aged <11 yrs. ** Special formulation. ++ Two 1.0-mL doses administered at one site in a four-dose schedule at O, 1, 2, and 6 months. ================================================================================================= Return to top. Disclaimer All MMWR HTML versions of articles are electronic conversions from ASCII text into HTML. This conversion may have resulted in character translation or format errors in the HTML version. Users should not rely on this HTML document, but are referred to the electronic PDF version and/or the original MMWR paper copy for the official text, figures, and tables. An original paper copy of this issue can be obtained from the Superintendent of Documents, U.S. Government Printing Office (GPO), Washington, DC 20402-9371; telephone: (202) 512-1800. Contact GPO for current prices. **Questions or messages regarding errors in formatting should be addressed to mmwrq@cdc.gov.Page converted: 09/19/98 |
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