This Article Extract Full Text (PDF) Submit a response View responses Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Shete, P. B. Articles by Daum, R. S. Search for Related Content PubMed PubMed Citation Articles by Shete, P. B. Articles by Daum, R. S. Related Collections Infectious Disease & Immunity Related AAP Red Book topics: Hepatitis B Social Bookmarking                         What's this?

PEDIATRICS Vol. 109 No. 4 April 2002, pp. 701-703

COMMENTARY

Real Versus Theoretical: Assessing the Risks and Benefits of Postponing the Hepatitis B Vaccine Birth Dose

Abbreviations: ACIP, Advisory Committee on Immunization Practices • IOM, Institute of Medicine • AAP, American Academy of Pediatrics • USPHS, US Public Health Service

The Advisory Committee on Immunization Practices (ACIP) has established the hepatitis B vaccine birth dose as the preferred time for administering the first dose of hepatitis B vaccine in infants (J. Modlin, personal communication, December 2001). This recommendation comes on the heels of the Institute of Medicine’s (IOM) report, "Immunization Safety Review: Thimerosal Containing Vaccines and Neurodevelopmental Disorders," which correctly concluded that there is still no evidence to prove (or disprove) a causal relationship between thimerosal-containing vaccines and adverse neurodevelopmental events.¹ The IOM has further recommended more research not only into the biological controversy regarding thimerosal but into the public health issues surrounding policy-making in the face of uncertainty.¹ This is also the same issue being addressed by the National Vaccine Advisory Committee, which will shortly undertake a "review of how public health policy decisions are made under uncertainty" and a "review of strategies used to communicate rapid changes in vaccine policy" using the disruption of the hepatitis B birth dosing program as an example (G. Peter, personal communication, December 2001).

With ACIP recognition of the many benefits of initiating hepatitis B vaccination at birth and with the availability of hepatitis B vaccines with little or no thimerosal content, it seems instructive to continue to pose this question: did our knowledge of thimerosal in July 1999 and concerns about its theoretical toxicity when delivered in pediatric vaccines call for the emergent disruption of the hepatitis B immunization program recommended at that time by the American Academy of Pediatrics (AAP) and the US Public Health Service (USPHS).² In comments made by one of us (R.S.D.) at a conference sponsored by the National Vaccine Advisory Committee³ and in a previous commentary in Pediatrics,² our view on this issue, that disruption of the hepatitis B vaccination program was unnecessary, has been consistent. The counterpoint commentary by Drs Halsey and Goldman⁴ did not address the central question regarding the role of public health policy-making in the vaccine community, a question that will now get the attention it deserves.

From a public health standpoint, the Ping-Pong 1999 recommendations, reversed only months later, caused confusion in the perinatal and pediatric communities over the appropriateness of administration of the hepatitis B vaccine to children in high-risk populations.⁵ Although the AAP/USPHS guidelines were not intended to delay the hepatitis B vaccine birth dose for infants of hepatitis B-infected mothers or of mothers whose status was unknown, the uncertainty over the new birth dose recommendations led to the inadvertent deferral of hepatitis B vaccine even in these high-risk circumstances.⁶ Two important consequences resulted. First, institutions that had practiced routine administration of the hepatitis B vaccine birth dose apparently did not rapidly put systems into place for efficiently identifying and immunizing infants of HBsAg-positive mothers or of mothers whose hepatitis B status was unknown. In fact, 9% of 977 hospitals surveyed discontinued hepatitis B vaccinations of all newborns including those born to HBsAg-positive mothers.⁷

Second, the number of hospitals that provided routine, universal hepatitis B vaccine birth dose, including many hospitals that treat a large number of high-risk children,⁶ decreased substantially. As a well-integrated part of the childhood immunization schedule, the hepatitis B vaccine birth dose was routinely administered at 74% of hospital nurseries in Cook County, Illinois, before the July 1999 AAP/USPHS recommendation. One year later, despite numerous public health agency recommendations for resumption of the birth dose, in August 2000 only 39% of hospital nurseries were practicing routine birth-dose hepatitis B immunization, and surveyed institutions that had abandoned the birth dose indicated no plans to return to it.⁶ A similar study done in Wisconsin showed that the number of hospitals offering routine hepatitis B vaccine at birth decreased by 38% in the wake of the AAP/USPHS recommendation in July 1999.⁸ Furthermore, many of those same hospitals had no established strategy for reintroducing the birth dose even after the introduction of thimerosal-free vaccines.⁸ (It will be interesting to revisit these institutions to see how the new ACIP preference for the hepatitis B vaccine birth dose affects current vaccination practices by these health care providers.)

"Hands-on" vaccine providers recognize the need for clarity in hepatitis B vaccine policy. A recent survey done by the Immunization Action Coalition, presented at a recent ACIP meeting, documented perceptions of uncertainty in hepatitis B vaccine birth-dose policy.⁹ Furthermore, among hepatitis B vaccine coordinators surveyed by the Immunization Action Coalition in 50 states, providers from 48 states expressed a preference for the administration of hepatitis B vaccine birth dose. Among health care practitioners surveyed, most believe that establishing a clear preference for the hepatitis B vaccine birth dose would eliminate existing confusion about the vaccine’s administration while preventing many missed opportunities for vaccination.⁹

There are clear benefits to administration of the hepatitis B vaccine birth dose that were available in July 1999, yet sacrificed by the hasty changes in policy. Mounting evidence has attested to an important association between immunizing children at risk for hepatitis B at birth and an increased likelihood of on-time compliance with related and even unrelated immunization regimens.¹⁰ Among inner-city children, we found a correlation between receipt of the hepatitis B vaccine birth dose and the likelihood of completion of the hepatitis B vaccine series by 2 years of age compared with children who received their first dose of hepatitis B vaccine at 1 or 2 months of age.¹⁰ Another study by the Centers for Disease Control and Prevention, using data collected by the National Immunization Survey, found that early administration of the hepatitis B vaccine correlated with higher rates of hepatitis B vaccine series completion.¹¹ Children who received the hepatitis B vaccine birth dose also increased the likelihood of completing the so-called 4:3:1 schedule by 19 months of age.¹⁰ Therefore, the hepatitis B vaccine birth dose had an important association in improving immunization rates among those children at high risk for general immunization delay as well as delay in the hepatitis B immunization series.

To render quality health policy decisions and maintain the public trust, vaccine policy decision-makers might have accorded more weight to these positive public health outcomes compared with the theoretical risk of thimerosal toxicity when delivered in routine vaccinations. Had there been compelling evidence regarding the toxicity of thimerosal as administered in vaccines, we would have, of course, supported the "urgent" measures to protect children from thimerosal exposure. However, at the time of the 1999 recommendation (and even now, according to the recent IOM report¹) no conclusive evidence existed to show that ethylmercury, at doses administered with vaccines, was toxic.¹²

We agree, of course, that any potential health risk to children because of the composition of vaccines should be carefully evaluated so that no child is put at unnecessary risk. The removal of thimerosal from vaccines even because of a theoretical concern was reasonable because of everyone’s desire to maintain the public trust regarding the safety of vaccines. But the same public trust implies creating optimal strategies to prevent serious infectious diseases and minimize vulnerability to vaccine-preventable diseases.

We believe that the hepatitis B vaccine birth dose is a convenient and effective introduction for families to the immunization schedule and to the importance of vaccinations. At birth, hepatitis B vaccination provides a safety net to ensure the immunization of children born to mothers whose hepatitis surface antigen status was positive or unknown. Beginning the immunization schedule at birth is associated with increased rates of on-time receipt of other immunizations.¹⁰ The birth dose also prevents vertical transmission of disease and diminishes the risk of horizontal hepatitis B transmission. A recent study done by the National Center for Infectious Diseases and the Centers for Disease Control and Prevention estimated the number of nonperinatal hepatitis B virus infections among US children younger than 10 years to have been 16 000 in 1991 and 18 700 in 1998.¹³ Thus, a substantial burden from hepatitis B exists, even in childhood. Chronic hepatitis B remains a public health threat, affecting 90% of all children infected perinatally, and substantially increases the risk of liver cancer and cirrhosis.⁹ We agree that public health policy should be made in a timely and considerate manner of dialogue, weighing each concern appropriately¹⁴ and, when possible, avoiding unnecessary disruption. By suspending the hepatitis B vaccine birth dose, the AAP and USPHS placed the theoretical risk of thimerosal toxicity above the real public health burden of failing to immunize children at risk for hepatitis B and other vaccine-preventable diseases beginning at birth.

ERRATUM

In the letter to the editor entitled "Resuscitation—Air Versus 100% Oxygen," which appeared on pages 347–349 in the February 2002 issue of Pediatrics, the name of one of the authors who contributed to the letter was inadvertently omitted. The author’s name, Myra Wyckoff, MD, should have appeared after the name Jeffrey M. Perlman, MD. Dr Wyckoff’s affiliation (Department of Pediatrics, University of Texas, Southwestern Medical Center, Dallas, TX 75235-9063) is the same as Dr Perlman’s

Priya B. Shete, BA and Robert S. Daum, MD, CM

University of Chicago
Department of Pediatrics
Section of Pediatric Infectious Diseases
Chicago, IL 60637-1470

-->

FOOTNOTES

Received for publication Dec 18, 2001; Accepted Jan 30, 2002.

Address correspondence to Robert S. Daum, MD, University of Chicago, Department of Pediatrics, Section of Pediatric Infectious Diseases; MC 6054, 5841 S Maryland Ave, Chicago, IL 60637-1470. E-mail: rsd2{at}midway.uchicago.edu

REFERENCES

1. Institute of Medicine. Immunization Safety Review: Thimerosal Containing Vaccines and Neurodevelopmental Disorders. Washington, DC: Institute of Medicine; 2001
2. Seal JB, Daum RS. What happened to primum non nocere? Pediatrics.2001; 107 :1177 –1179[Full Text]
3. Daum RS. Comment. In: Transcript of the National Vaccine Advisory Committee Workshop on Thimerosal in Vaccines; August 12, 1999; Bethesda, MD
4. Halsey NA, Goldman L. Balancing risks and benefits: primum non nocere is too simplistic. Pediatrics.2001; 108 :466 –467[Full Text]
5. Halsey NA. Limiting infant exposure to thimerosal in vaccines and other sources of mercury. JAMA.1999; 282 :1763 –1766[Medline]
6. 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[Medline]
7. Centers for Disease Control and Prevention. Availability of hepatitis B vaccine that does not contain thimerosal as a preservative. MMWR Morb Mortal Wkly Rep.1999; 48 :780 –782[Medline]
8. Hurie MB, Saari TN, Davis JP. Impact of the joint statement by the American Academy of Pediatrics/US Public Health Service on thimerosal in vaccines on hospital infant hepatitis B vaccination practices. Pediatrics.2001; 107 :755 –758[Abstract/Full Text]
9. Immunization Action Coalition. Results from IAC hepatitis B vaccine birth dose survey October 9, 2001. Available at: http://www.immunize.org. Accessed November 2001
10. Lauderdale DS, Oram RJ, Goldstein KP, Daum RS. Hepatitis B vaccination among children in inner-city public housing, 1991–1997. JAMA.1999; 282 :1725 –1730[Medline]
11. Yusuf HR, Daniels D, Smith P, Coronado V, Rodewald L. Association between administration of hepatitis B vaccine at birth and completion of the hepatitis B and 4:3:1:3 vaccine series. JAMA.2000; 284 :978 –983[Medline]
12. Ball LK, Ball R, Pratt RD. An assessment of thimerosal use in childhood vaccines. Pediatrics.2001; 107 :1147 –1154[Abstract/Full Text]
13. Armstrong GL, Mast EE, Wojczynski M, Margolis HS. Childhood hepatitis B virus infections in the United States before hepatitis B immunization. Pediatrics.2001; 108 :1123 –1128[Abstract/Full Text]
14. Feudtner C, Marcuse EK. Ethics and immunization policy: promoting dialogue to sustain consensus. Pediatrics.2001; 107 :1158 –1164[Abstract/Full Text]

---

PEDIATRICS (ISSN 1098-4275). ©2002 by the American Academy of Pediatrics

CiteULike    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

This article has been cited by other articles:

				G. A. Weinberg Question From the Clinician: Hepatitis B Vaccine Birth Dose Pediatr. Rev., June 1, 2005; 26(6): 226 - 227. [Full Text] [PDF]

				E. Coleman Ethylmercury in Vaccines Pediatrics, April 1, 2003; 111(4): 922 - 923. [Full Text] [PDF]

eLetters:

Read all eLetters

Thimerosal risk

Eric C Colman

Pediatrics Online, 4 Apr 2002 [Full text]

This Article Extract Full Text (PDF) Submit a response View responses Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services E-mail this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My File Cabinet Download to citation manager Request Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Shete, P. B. Articles by Daum, R. S. Search for Related Content PubMed PubMed Citation Articles by Shete, P. B. Articles by Daum, R. S. Related Collections Infectious Disease & Immunity Related AAP Red Book topics: Hepatitis B Social Bookmarking                         What's this?