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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.

Reference

  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.
Table_1
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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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