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
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 Note:
To print large tables and graphs users may have to change their printer settings to landscape and use a small font size.
TABLE 1. Recommended doses of currently licensed hepatitis B vaccines
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Recombivax HB(R) * Engerix-B(R) *
------------------- --------------------
Group Dose (ug) (mL) Dose (Hg) (mL)
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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) ++
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* 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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