Issue Number 98            July 20, 1999

CONTENTS OF THIS ISSUE

1. Urgent message! Some hospitals have changed their newborn hepatitis B vaccination policies and are not following new CDC guidelines

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July 20, 1999
URGENT MESSAGE! SOME HOSPITALS HAVE CHANGED THEIR NEWBORN HEPATITIS B VACCINATION POLICIES AND ARE NOT FOLLOWING NEW CDC GUIDELINES

IAC EXPRESS has received news that some hospitals have changed their hepatitis B vaccination policies because of the new American Academy of Pediatrics (AAP) guidelines on the use of thimerosal-containing vaccines. The new AAP guidelines do not address the issue of vaccination of infants born to hepatitis B surface antigen (HBsAg) negative mothers who belong to populations and groups that have high risk of early childhood hepatitis B virus infection. As a result, some hospitals have rewritten their policies and are   recommending that these high-risk infants not receive hepatitis B vaccine until they are six months of age.

While the AAP guidelines have no specific recommendations for these high-risk infants, the new CDC guidelines stress the importance of vaccinating these infants in the hospital.

When asked by IAC staff to clarify the difference between the United States Public Health Service recommendation and the AAP recommendation, Dr. Harold S. Margolis, Chief of the Hepatitis Branch of the Centers of Disease Control and Prevention, made the following comment:

"CDC recommends that infants born to HBsAg negative women who belong to populations and groups that have high risk of early childhood hepatitis B virus infection be vaccinated as newborns. Although routine newborn vaccination is not the current recommendation of the AAP, it is still a recommendation of the Advisory Committee on Immunization Practices. However, if a hospital chooses to follow the AAP recommendation and delay vaccination of these high-risk infants until two to six months, they should make sure these infants receive their first dose by two months of age, even if COMVAX is not available. This is definitely a situation in which the larger risk of not vaccinating children far outweighs the much smaller theoretical risk of cumulative exposure to thimerosal-containing vaccines over the first six months of life."

IAC EDITORS' NOTE: COMVAX is a thimerosal-free hepatitis B vaccine that also contains a Hib component. It is licensed for use beginning at six weeks of age. It is also anticipated that thimerosal-free, single-antigen hepatitis B vaccines will be available during the month of September.

The new CDC guidelines, which were released on July 15, 1999, and appear today on the National Immunization Program's website, stress the importance of continuing to vaccinate infants born to HBsAg negative women who belong to populations and groups that have high risk of hepatitis B virus infection as well as infants born to HBsAg positive mothers and to mothers whose status is not known.

CDC GUIDELINES SAY TO VACCINATE THESE GROUPS OF INFANTS AT BIRTH:

1. INFANTS BORN TO HBsAg POSITIVE MOTHERS
   All infants born to HBsAg positive mothers need hepatitis B vaccine and hepatitis B immune globulin (HBIG) within 12 hours of birth.
      
2. INFANTS BORN TO MOTHERS WHOSE HBsAg STATUS IS UNKNOWN
   All infants born to mothers whose HBsAg status is still unknown 12 hours after birth need hepatitis B vaccine at that time. Draw the mother's blood upon admission and send it to the lab ASAP. If the results cannot be obtained by 12 hours after the infant's birth, the infant should be vaccinated at that time. If the mother is found to be HBsAg positive, administer HBIG to the infant ASAP (no later  than 7 days after birth).
      
3. INFANTS BORN TO HBsAg NEGATIVE MOTHERS BELONGING TO POPULATIONS OR GROUPS THAT HAVE HIGH RISK OF EARLY CHILDHOOD HBV INFECTION
   All infants born to HBsAg negative mothers belonging to populations or groups that have high risk of early childhood HBV infection need hepatitis B vaccine prior to discharge. These high-risk groups include, but are not limited to, Asian Pacific Islanders, immigrant populations from countries in which HBV is of high or intermediate endemicity (see CDC's "Health Information for International Travel, 1999"), and households with persons with chronic HBV.

NOTE: The AAP has no specific recommendation for infants who are born to women belonging to groups or populations at high risk of early childhood hepatitis B virus infection. Because of this, some hospitals are treating these high-risk infants no differently from infants with low risk of infection and have written policies to delay these infants' hepatitis B vaccination until 6 months of age.

CDC recommends that if your hospital chooses to follow the recommendation of the AAP, you should vaccinate all children who are born to HBsAg negative women in high-risk communities at two months of age with thimerosal-free vaccine (COMVAX). However, if thimerosal-free vaccine is not available, you should make sure that these high-risk infants receive hepatitis B vaccine no later than two months of age, even if only thimerosal-containing vaccine is available to you (Recombivax HB and Engerix-B).

Do not wait until these at-risk children are six months old to give dose #1. The need for these infants to receive hepatitis B vaccine by two months of age far outweighs the much smaller theoretical risk of cumulative exposure to thimerosal-containing vaccines.

The complete guidelines, "Implementation Guidance for Immunization Grantees During the Transition Period to Vaccines Without Thimerosal," can be downloaded from CDC's website at http://www.cdc.gov/nip/vacsafe/concerns/thimerosal/thimerosal-guidance.htm

If you are unable to download these guidelines, call the immunization program manager at your state health department. Your state health department received these guidelines on July 15, 1999.

CDC also has other important information on thimerosal and vaccines on its website at http://www.cdc.gov/nip/Q&A/clinqa/Thimerosal-p.htm