Real versus theoretical: assessing the risks and benefits of postponing the hepatitis B vaccine birth dose.

Abstract

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 …