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The future of research into rotavirus vaccine

BMJ 2000; 321 doi: (Published 02 September 2000) Cite this as: BMJ 2000;321:525

Benefits of vaccine may outweigh risks for children in developing countries

  1. Charles Weijer, bioethicist and assistant professor of medicine (
  1. Department of Bioethics, Dalhousie University, Halifax, NS, Canada B3H 4H7

    The future of a potentially lifesaving vaccine for developing countries has been imperiled by its recent withdrawal from the United States market. In August 1998, tetravalent rhesus rotavirus vaccine was licensed for routine vaccination in the United States on the basis of randomised controlled trials there and in Finland. The trials showed that the vaccine had an efficacy of 49-68% in preventing rotavirus diarrhoea overall and, importantly, 69-91% efficacy in preventing severe disease.14

    In July 1999 the US Centers for Disease Control and Prevention reported a clustering of cases of intussusception in the weeks after vaccination with tetravalent rhesus rotavirus vaccine, representing an additional risk of 1 in 10 000 for this complication.5 On the basis of this finding they recommended “postponing administration of tetravalent rhesus rotavirus vaccine to children,” and in October 1999 the manufacturer voluntarily withdrew the product from the United States market. This leaves researchers with a moral quandary: should randomised controlled trials of tetravalent rhesus rotavirus vaccine proceed in developing countries?

    Firstly, it may be thought that other vaccines in development (for example, human-bovine rotavirus vaccine) …

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