An open letter to:
 
Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention
Committee on Infectious Diseases, American Academy of Pediatrics (AAP)
American Academy of Family Physicians (AAFP)
American College of Obstetricians and Gynecologists (ACOG)
 
 
Dear Colleagues:

In January, Pediarix joined Comvax in the combination vaccine marketplace for use in infants six weeks of age and older. Because of this addition, the Immunization Action Coalition (IAC) is again receiving emails and phone calls from health professionals and organizations asking if the birth dose of hepatitis B vaccine is still needed or recommended for infants of HBsAg-negative women (just as we did when Comvax became available for use).

IAC's answer is "yes!" But IAC's voice is only one of the voices that communicates vaccine recommendations across the United States. It is important that public and private sector health professionals hear again from ACIP as well as from professional organizations, i.e., AAP, AAFP, and ACOG, that the birth dose for all infants remains a top priority in the medical management of newborns, even with the availability of this second infant combination vaccine.

IAC's commitment to the birth dose is based on the findings of our 2001 and 2002 surveys of all state and federally-funded perinatal hepatitis B prevention programs. Our most recent survey was completed in November 2002. All 50 states responded.

The surveys' most striking finding is that states continue to identify significant numbers of medical errors in clinics and hospitals regarding perinatal hepatitis B prevention practices. From July 1999 to October 2002, hepatitis B coordinators reported more than 500 specific examples of medical errors. While many states reported actual numbers of cases of the various types of errors, other states described types of errors they had seen. Clearly, the errors reported are only the "tip of the iceberg" since most errors remain undiscovered. A summary of the most common types of reported errors follows:

• not giving both hepatitis B vaccine and HBIG to infants born to HBsAg-positive mothers within 12 hours of birth
   
• not giving hepatitis B vaccine to infants born to mothers of unknown HBsAg status within 12 hours of birth
   
• misinterpreting or mistranscribing hepatitis B screening test results, or failing to communicate results to or within the hospital
   
• ordering the wrong hepatitis B screening test

Because of these types of medical errors, many U.S. children are now chronically infected with the hepatitis B virus and at least one infant has died. CDC estimates that every year 20,000 HBsAg-positive mothers give birth in the United States. Unfortunately, half of these cases are not reported to their state's perinatal hepatitis B program, and therefore do not benefit from case management.

Errors occur in hospitals as well as in primary care settings and are made by a broad range of perinatal health care workers, including obstetricians, family physicians, pediatricians, nurses, lab technicians, and clerical staff.

I have attached an article summarizing IAC's birth dose survey results titled "States Report Hundreds of Medical Errors in Perinatal Hepatitis B Prevention," written by Teresa A. Anderson, DDS, MPH, and Deborah L. Wexler, MD. Links to additional articles on the importance of the birth dose are provided at the end of this letter.

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 only hepatitis B vaccine (without HBIG) at birth are protected in 90-95% of cases. This is 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?).

We at IAC believe it is critical that ACIP, AAP, AAFP, and ACOG restate their strong support for the birth dose of hepatitis B vaccine to their constituents/membership in light of Pediarix entering the infant vaccine marketplace. Your continued support for providing a birth dose to infants while still in the hospital will protect and save lives that are now being put at risk.

Sincerely,

Deborah L. Wexler, M.D.
Executive Director

Attachment: "States Report Hundreds of Medical Errors in Perinatal Hepatitis B Prevention" by Teresa A. Anderson, DDS, MPH, and Deborah L. Wexler, MD.
http://www.immunize.org/catg.d/p2062.pdf

To obtain additional information on this topic, including the full reports of IAC's birth dose surveys (2001 and 2002), visit http://www.immunize.org/birthdose

Two additional articles to read include:
"Unprotected Babies: Two more infants chronically infected with hepatitis B virus . . . the medical errors continue"
http://www.immunize.org/catg.d/p2127.pdf

"Hospitals & Doctors Sued for Failing to Protect Newborns from Hepatitis B Virus Transmission"
http://www.immunize.org/catg.d/p2061.pdf