Immunization Action Coalition

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October 9, 2001

Give the Birth Dose!
Providing all infants with hepatitis B vaccine
at birth saves lives.

An open letter from IAC to the Advisory Committee on Immunization Practices, American Academy of Pediatrics, American Academy of Family Physicians, American College of Obstetrics and Gynecology, National Medical Association, National Asian Pacific Islander Task Force on Hepatitis B Prevention, and the American Hospital Association

The Immunization Action Coalition (IAC) urges each of the organizations listed above to support the establishment of a national policy to protect ALL infants from hepatitis B virus (HBV) infection by requiring that the first dose of hepatitis B vaccine be administered to every infant at birth and no later than hospital discharge.

Approximately 19,000 women with chronic hepatitis B infection give birth in the United States each year. Ninety percent of perinatal infections can be prevented by postexposure prophylaxis given within 12 hours of birth. Tragically, many babies are exposed to HBV at birth but do not receive appropriate postexposure prophylaxis.

Because thimerosal has been removed from all pediatric hepatitis B vaccines in the United States, concerns about thimerosal should no longer be an obstacle for practitioners in enacting a universal birth dose policy.

Why is such a policy necessary? Following are some of the ways infants who are not vaccinated at birth become infected:

  • The pregnant woman is tested and found to be hepatitis B surface antigen (HBsAg)
    positive, but her status is not communicated to the newborn nursery. The infant receives neither hepatitis B vaccine nor HBIG protection at birth.
  • A chronically infected pregnant woman is tested but with the wrong test, HBsAb (antibody to hepatitis B surface antigen), instead of HBsAg. This is a common mistake since these two test abbreviations differ by only one letter. Her incorrectly ordered test result is "negative," so her doctor believes her infant does not need postexposure prophylaxis.
  • The pregnant woman is HBsAg+ but her test results are misinterpreted or mistranscribed into her prenatal record or her infant's chart. Her infant does not receive HBIG or hepatitis B vaccine.
  • The pregnant woman is not tested for HBsAg either prenatally or in the hospital at the time of delivery. Her infant does not receive hepatitis B vaccine in the hospital even though the vaccine is recommended within 12 hours of birth for infants whose mothers' test results are unknown.
  • The woman is tested in early pregnancy for HBsAg and is found to be negative. She develops HBV infection later in pregnancy but it is not detected, even though it is recommended by CDC that high-risk women be retested later in pregnancy. The infection is not clinically detected by her health care provider so her infant does not receive hepatitis B vaccine or HBIG at birth.
  • The mother is HBsAg negative but the infant is exposed to HBV infection postnatally from another family member or caregiver. This occurs in 2/3 of the cases of childhood transmission.

The following table summarizes the arguments for the birth dose vs. a two-month visit dose of hepatitis B vaccine. While there are advantages to giving the first dose at a later well-baby visit, these are advantages of administrative convenience. The primary advantage of giving the first dose at birth is that it saves lives.

Advantages of the Birth Dose vs. Two-Month Visit Dose

Birth Dose Advantages

Two-Month Dose Advantages

  • Hepatitis B vaccine at birth prevents disease and saves lives. It protects:
  • infants whose mothers are HBsAg+ but the information is not communicated to the newborn nursery.
  • infants whose mothers were never tested.
  • infants whose mothers' HBsAg tests were ordered incorrectly, mistranscribed, or misinterpreted.
  • infants whose mothers became HBsAg+ later in pregnancy.
  • infants with limited or no postnatal care.
  • infants exposed to HBV during the first
    2 months of life.
  • Hepatitis B vaccine administration in the hospital increases likelihood that all immunizations as well as the hepatitis B vaccine series will be completed on schedule.
  • Hepatitis B vaccine provides an early opportunity to convey the importance of immunization to parents.
  • Administration in the office setting may cost less than administration in the hospital.
  • Convenience: It is easier to keep track of all doses of vaccine administered in the office. (No need to obtain and review hospital records to determine if previous vaccine doses were given.)
  • A combination vaccine can spare the infant one injection.

IAC recently asked hepatitis coordinators at every state health department as well as at many city/county CDC projects to express their views about providing hepatitis B vaccine in the hospital. Their responses contained many examples of children who were unprotected or inadequately protected due to not ordering, misordering, misinterpreting, mistranscribing, and miscommunicating the hepatitis B test results of their mothers. In order to overcome these failures, the states overwhelmingly endorse providing a birth dose.

These state coordinators’ reports tell us that no matter how well health care providers think they are doing with HBsAg screening of all pregnant women, serious mistakes continue to occur; children are unnecessarily being exposed without the benefit of postexposure prophylaxis, and at least one baby has died. (Survey results)

What is the answer? Vaccinate every baby in the hospital prior to discharge regardless of the HBsAg status of the mother. For those providers who choose to use hepatitis B-containing combination vaccine, i.e., Comvax, they may do so. However, since this vaccine cannot be given at birth, monovalent hepatitis B vaccine must be given at birth and then the hepatitis B vaccine series can be completed with three doses of the combination vaccine. Giving four doses of hepatitis B vaccine has been shown to be safe in several clinical studies.

Hepatitis B vaccine is one of the most effective vaccines available. Studies have shown that infants of the most highly infectious mothers ( HBsAg+ and HBeAg+) who receive postexposure prophylaxis with hepatitis B vaccine alone (without HBIG) at birth are protected in 90-95% of cases, essentially the same level of protection afforded by administering hepatitis B vaccine in addition to HBIG. Even higher rates of protection with postexposure prophylaxis have been demonstrated in infants born to less infectious mothers (HBsAg+ and HBeAg –).

Please read the enclosed examples from statements we have received from hepatitis coordinators describing their experiences with failures of the current system, failures that can be largely prevented by administering hepatitis B vaccine to infants before they go home from the hospital.

Your support for providing a birth dose of hepatitis B vaccine to infants while still in the hospital will protect and save lives that are now being put at risk.

Deborah L. Wexler, MD
Executive Director

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