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New Pediatric Formulation of Recombivax HB Registered

On 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.


  1. CDC. Hepatitis B virus: a comprehensive strategy for eliminating transmission in the United States through universal childhood vaccination -- recommendations of the Immunization Practices Advisory Committee (ACIP). MMWR 1991;40(no. RR-13).

* 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.
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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.

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