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Excerpts below; full text is at http://www.sciencedirect.com/science/article/pii/S1369848617300857
Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences, Volume 64, August 2017, Pages 11–21
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https://doi.org/10.1016/j.shpsc.2017.05.004
Open Access funded by Wellcome Trust
Under a Creative Commons license
•The recombinant hepatitis B vaccines rehabilitated vaccines as commercially interesting pharmaceutical products.
•The recombinant hepatitis B vaccines helped substantially to establish the commercial viability of the biotech sector.
•The commercial success of the recombinant hepatitis B vaccines was largely unanticipated.
•The recombinant hepatitis vaccines helped establish a two-tier global vaccine innovation system.
The approval, from 1986, of a series of recombinant hepatitis B vaccines was a landmark both in the growth of biotechnology and in the development of the vaccine innovation system. In this paper, we show how the early development of the hepatitis B vaccines was shaped by a political and economic context that newly favoured commercialisation of academic research, including the appropriation and management of intellectual property; we elucidate the contingent interests and motivations that led new biotechnology companies and established pharmaceutical businesses to invest in developing recombinant vaccines specifically against hepatitis B; and we show how these and other factors combined to make those vaccines an unexpected commercial success. Broadening the scope of our analysis to include not just North America and Europe but also low- and middle-income countries, we show how the development of the hepatitis B vaccines facilitated the emergence of a two-tier innovation system structured by tensions between the demands for commercial profitability on the one hand, and the expectation of public health benefit for low- and middle-income countries on the other.
In May 1986 the vaccine Recombivax HB, which protects against hepatitis B infection, was approved for marketing in West Germany; approval by the United States Food and Drug Administration followed two months later. Recombivax HB marked a milestone in the development of medical biotechnology. Manufactured by Merck Sharp & Dohme, it was the first vaccine to be produced using recombinant DNA technology, and only the third recombinant product to be licensed for human use (following human insulin in 1982 and human growth hormone in 1985 and just preceding alpha interferon in June 1986). Two similar recombinant hepatitis B vaccines quickly followed: Engerix-B, marketed by SmithKline Biologicals, was approved in Belgium in December 1986 and in the US in September 1989; while GenHevac-B by Pasteur Vaccins was approved in France in May 1989.
Historians have paid little attention to the development of the hepatitis B vaccines – perhaps because the early biotechnology companies themselves tended to see them as scientifically and commercially less exciting than other first-wave recombinant medicines such as human insulin and interferon. As Nicholas Rasmussen notes in Gene Jockeys, these were high-profile medical molecules – insulin for its iconic position in the history of human physiology and medicine, and interferon because it was widely seen as a potential cure for cancer. As such, they were strong candidates with which to demonstrate the technical and commercial possibilities of the new recombinant biotechnology ( Rasmussen, 2014). By contrast, the hepatitis B vaccines targeted a disease that at that time attracted little attention in North America and Europe. Accordingly, the vaccines ranked low among the priorities of the young biotech companies.
Seen in wider historical perspective, however, the recombinant hepatitis B vaccines turned out to be more consequential than the early biotechnologists and their business partners initially envisaged. Stuart Blume has argued that, between the 1960s and the 1990s, the “vaccine innovation system” underwent a major shift, from a predominantly publicly-funded, public-health-oriented enterprise in the years after the Second World War, to one dominated by private industry, including the new biotechnology sector, by the end of the century (Blume, 2008). Blume and Ingrid Geesink see the advent of the recombinant hepatitis B vaccines as symbolic of that shift (Blume & Geesink, 2000, pp. 50–51, 55–57). In the present paper, we show that it was not just symbolic; it was instrumental.
Drawing on a mixture of historical sources including published scientific literature, legal and policy documents, archives and oral history interviews, we construct an explanatory narrative of the development and commercialisation of the recombinant hepatitis B vaccines and the plasma vaccines that preceded them. We show how the early development of the vaccines was shaped by a political and economic context that strongly favoured commercialisation of academic research, including the appropriation and management of intellectual property (IP); we elucidate the contingent interests and motivations that led new biotechnology companies and established pharmaceutical businesses to invest in developing recombinant vaccines specifically against hepatitis B; and we show how these and other factors acted together to make those vaccines into an unexpected commercial success.
We go on to argue that this success served to embed vaccine development within a larger biopharmaceutical innovation system that increasingly involved collaborations between academia, new biotech start-ups and established pharmaceutical companies, mediated by strict control and licensing of IP. Finally, broadening the scope of our analysis to include not just North America and Europe but also low- and middle-income countries, we note how the development of the hepatitis B vaccines ultimately resulted in a distinctly two-tier innovation process, with the first tier, on which the present paper focuses, geared towards producing vaccines for sale at a substantial profit to rich-country markets, while a very different set of institutions developed to manufacture cheaper vaccines for use in poorer countries.
In telling this story, we contribute to the history of biotechnology as well as of the vaccine innovation system. As a number of analysts have emphasised, the growth of biotechnology involved significant reconfiguration of university-industry relationships, as university scientists and resources were increasingly engaged to supply the research expertise needed to realise commercial possibilities (e.g. Kenney 1986, Orsenigo, 1989; Vallas and Kleinman, 2008 ; Rasmussen, 2014). The story of the hepatitis B vaccines provides a case study of how that reconfiguration occurred around one particular set of products, highlighting the interaction of local contingencies with wider socio-technical factors which led to the institutionalisation of a particular field of biotechnological innovation. But focusing on vaccines also alerts us to the global dimensions of innovation, highlighting how, in this instance at least, the growth of biotechnology has tended to privilege the interests of wealthy countries and international businesses over the public health needs of low- and middle-income countries.