Notice to Readers
FDA Approval of Change in Pediatric Formulation for Recombivax
HB{Registered}
Effective August 27, 1998, the Merck Vaccine Division (Merck &
Co.,
Inc., West Point, Pennsylvania) discontinued distribution and
production of
the 2.5-ug dose of Recombivax HB{Registered} * pediatric hepatitis
B
vaccine, which was licensed by the Food and Drug Administration for
infants
of hepatitis B surface antigen (HBsAg)-negative mothers and
children aged
less than or equal to 10 years. The 2.5-ug dose was replaced with a
5.0-ug
dose previously used for vaccination of adolescents and infants of
HBsAg-positive mothers. To simplify the vaccination schedule for
infants
and children, the Advisory Committee on Immunization Practices
recommends
use of the 5.0-ug dose for all children and adolescents aged 0-19
years.
Either the 2.5-ug dose or the 5.0-ug dose may be used to complete
any
vaccine series already started for children aged less than or equal
to 10
years, regardless of the initiating dose of vaccine. Children who
have
completed the hepatitis B vaccination series with the 2.5-ug dose
do not
need to be revaccinated.
Use of trade names and commercial sources is for identification
only and
does not imply endorsement by CDC or the U.S. Department of Health
and
Human Services.
Disclaimer
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