Recent differing expert opinions regarding the safety profile of hepatitis B vaccines: is there really a controversy? 2003

Robert P Pless
Immunisation Safety Unit, Centre for Infectious Disease Prevention and Control, Health Canada, Health Canada Building #6, PL 0603E1, Tunney's Pasture, Ottawa, Ontario, K1A 0K9, Canada. robert.pless@hc-sc.gc.ca

Recent papers in Expert Opinion on Drug Safety arrived at different conclusions about the safety of hepatitis B vaccines. In one of these, review of the epidemiological literature failed to confirm the serious allegations raised with respect to vaccination. In the other, review of case reports and the authors' analytical method suggested serious adverse events are associated with the vaccine. In particular, they suggested a strong relationship with multiple sclerosis, the adverse event that has been the focus of several epidemiological investigations and has been found not to be related to vaccination. The method, using data from reported cases, attempted to compute relative and attributable risks using adult Td vaccine as a comparator. The authors made errors in assumptions about the data, including inappropriate use of controls and inappropriate application of epidemiology, rendering the conclusions invalid. Passive reporting data should be analysed with care and used only for hypothesis generation - anything more requires robust epidemiological study.

UI MeSH Term Description Entries
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D016907 Adverse Drug Reaction Reporting Systems Systems developed for collecting reports from government agencies, manufacturers, hospitals, physicians, and other sources on adverse drug reactions. Adverse Drug Reaction Reporting System,Drug Reaction Reporting Systems, Adverse
D017325 Hepatitis B Vaccines Vaccines or candidate vaccines containing inactivated hepatitis B or some of its component antigens and designed to prevent hepatitis B. Some vaccines may be recombinantly produced. Hepatitis B Vaccine,Vaccine, Hepatitis B,Vaccines, Hepatitis B

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