Hepatitis B Vaccination for Newborns  
http://jama.ama-assn.org/issues/current/ffull/jlt0801-3.html   August 1, 2001

To the Editor: In their article on the impact of recommendations regarding the birth dose of hepatitis B virus (HBV) vaccine, Dr Daum and colleagues1 concluded that "special efforts may be required to make at-birth administration of HBV vaccination universal." However, since HBV vaccination of newborns has never been shown to be better than vaccination after the maturation of the immune system, this worry about missing the birth dose seems misplaced.

There is no scientific evidence to justify HBV vaccination before the age when those risk factors associated with the HBV transmission (sex, needles, etc) become relevant. Recent risk-benefit analyses show HBV vaccination among children carries one of the largest unjustified risks and substantial financial costs, second only to the new controversial conjugate pneumococcal vaccine.2, 3 Specifically, HBV immunization has been associated with 53 deaths and 828 serious injuries, but for 38 million children younger than age 10 years, the total yearly incidence of HBV infection is 191. For children younger than age 14 years, the estimated total mortality secondary to HBV disease is only 11.2 With such statistics, it is difficult to rationalize HBV vaccination for newborns.
Erdem I. Cantekin, PhD
Department of Otolaryngology
University of Pittsburgh School of Medicine
Children's Hospital of Pittsburgh
Pittsburgh, Pa

Michael Belkin
Bainbridge Island, Wash

1. Oram RJ, Daum RS, Seal JB, Lauderdale DS. Impact of recommendations to suspend the birth dose of hepatitis B virus vaccine. JAMA. 2001;285:1874-1879. ABSTRACT  |  FULL TEXT   |  PDF   |  MEDLINE

2. Horwin M. Ensuring safe, effective and necessary vaccines for children. Calif West Law Rev. 2001;37:101-148.

3. Orient J. Statement by the AAPS in "Vaccines: Public Safety and Personal Choices" before the Government Reform Committee of the House of Representatives." Presented to: 106th Cong, August 3, 1999; Washington, DC.


"Oh, I acknowledge the 4 benefits listed in the JAMA reply. 1. it is too confusing to just vaccinate those who need it.  2. there are some (very rare) cases of young kids at risk. 3. it gets all the kids on the vaccine schedule right away, so they'll be more likely to get the other vaccines on schedule. 4. it is easier to get to babies than adolescents. I just don't think that these justify the risk associated with HBV vaccine for most babies, and I don't think it justifies the coercion used."---Roger Schlafly

In Reply: Dr Cantekin and Mr Belkin question the importance of initiating routine HBV vaccination at birth, a practice whose benefits we described recently.1 They are correct that some behaviors rendering people at high risk for HBV do not begin until adolescence or adulthood. However, a lower but nevertheless substantial incidence of HBV infection affects individuals, including adults and children, who do not engage in these high-risk behaviors.2 Furthermore, there are at least 4 benefits to newborns of HBV-infected mothers. First, it eliminates confusion in birthing units regarding the need for immediate immunization of newborns of mothers whose hepatitis surface antigen status is positive or unknown, thereby avoiding irretrievable missed opportunities to interrupt vertical transmission, which can have tragic consequences.3, 4 Second, rendering children immune to HBV in early infancy provides protection against the small but measurable incidence of HBV infection that is acquired horizontally during childhood. Third, initiation of the 3-dose series at birth has been associated with a higher likelihood of on-time receipt of the entire series of HBV vaccinations,5, 6 and of unrelated immunizations, such as diphtheria, tetanus, pertussis vaccine; inactivated poliovirus vaccine; and measles, mumps, rubella vaccine.5 Fourth, immunization during infancy with integration into a schedule with other vaccinations has the best chance for high coverage and protection for most US children when the burden of disease increases sharply beginning in adolescence. Such a strategy has paid great dividend in the case of rubella immunization.

Risks of this simple neonatal intervention are few. Cantekin and Belkin cite data abstracted from the US Food and Drug Administration/Centers for Disease Control and Prevention, the Vaccine Adverse Events Reporting System (VAERS) reports,7 which passively report data regarding putative adverse events temporally associated with vaccine administration, to indicate that the HBV vaccine has been temporally associated with 53 deaths/y. However, analysis of VAERS data obtained only from newborns immunized with HBV vaccine tells a different story. From 1991 to 1998, 18 reports were submitted to VAERS regarding death in infants who recently had received the HBV vaccine.7 Seventeen of these infants had another plausible diagnosis and had no recognizable syndrome that might have resulted from the HBV vaccine.

We do share the implied view of Cantekin and Belkin that vaccine safety is a great concern and must be an area of constant vigilance. However, we also believe that protection against HBV infection is of great benefit to all members of our society. Initiating the vaccination series with an initial dose of HBV vaccine during the newborn period is the best strategy to ensure the highest level of protection.

Ronda J. Oram, MD
Diane S. Lauderdale, PhD
John B. Seal, MA
Robert S. Daum, MD
Departments of Pediatrics and Health Studies
Pediatric Immunization Program
University of Chicago
Chicago, Ill

1. Oram RJ, Daum RS, Seal JB, Lauderdale DS. Impact of recommendations to suspend the birth dose of hepatitis B virus vaccine. JAMA. 2001;285:1874-1879. ABSTRACT  |  FULL TEXT   |  PDF   |  MEDLINE

2. Alter MJ, Hadler SC, Margolis HS, et al. The changing epidemiology of hepatitis B in the United States. JAMA. 1990;263:1218-1222. MEDLINE

3. Centers for Disease Control and Prevention. Impact of the 1999 AAP/PHS joint statement on thimerosal in vaccines on infant hepatitis B vaccination practices. MMWR Morb Mortal Wkly Rep. 2001;50:94-97. MEDLINE

4. Watson B. Comment. In: Transcript of the National Vaccine Advisory Committee Workshop on Thimerosal in Vaccines. Washington, DC: Government Printing Office; August 12, 1999.

5. Lauderdale DS, Oram RJ, Goldstein KP, Daum RS. Hepatitis B vaccination among children in inner-city housing, 1991-1997. JAMA. 1999;282:1725-1730. ABSTRACT  |  FULL TEXT   |  PDF   |  MEDLINE

6. Yusef HR, Daniels D, Smith P, Coronado V, Rodewald L. Association between administration of the hepatitis B vaccine at birth and completion of the hepatitis B and 4:3:1:3 vaccine series. JAMA. 2000;284:978-983. ABSTRACT   |  FULL TEXT  |  PDF   |  MEDLINE

7. Niu MT, Salive ME, Ellenberg SS. Neonatal deaths after hepatitis B vaccine. Arch Pediatr Adolesc Med. 1999;153:1279-1282. ABSTRACT   |  FULL TEXT  |  PDF  |  MEDLINE