Objectif
The exciting promises associated to biotechnology in the 80's have generally been deceived. There are several reasons behind such phenomenon: i.e. difficulties in the transfer of new knowledge from the labs to the market, but also problems of social acceptance of biotechnology processes and products. Indeed, in several European countries and in the US biotechnology often raised controversies and conflicts due mainly to ethical and safety reasons. Such controversies seem to be stronger when the environment and human health are involved (see Eurobarometer 35.1 and 39.1 on Biotechnology). The cultural and social factors able to influence the public perception of biotech may indeed play a stronger role when the concepts of nature and human life are directly called. Instead when therapeutic applications are examined. the social acceptance seems to be wider (see again Eurobarometer). Even in the case of vaccines. the development of recombinant products does not seem to raise particular controversies. Considering that: the use of traditional vaccines meets some social resistance due to ethical and safety reasons; and that the vaccine sector can be viewed as a strategic area for the drug industry (as recently confirmed by the European Commission with the establishment of a special task-force); the apparent paradox of a smooth marketing and a good social acceptance of a recombinant vaccine can be considered as a very interesting case to be studied. We here propose to analyse in detail the case- history of ACELLUVAX, a recombinant vaccine against whooping cough. that has been produced and extensively used in Italy without meeting any problem of acceptance.
Whooping cough is a disease caused by Bordetella pertussis, a bacterium which colonises the upper respiratory trait of humans. The many toxic substances produced by the bacteria cause local and systemic damages responsible for the clinical disease. Mortality is quite common in developing countries and rare, but still present, in Western countries. Each year over 60 million cases and over half a million deaths due to pertussis are reported worldwide. An effective vaccine against whooping cough was developed in the 1940s. It was a cellular vaccine with some side effects. A second generation of a cellular vaccine containing pertussis toxin detoxified through chemical methods was proposed in the 1970s. However, chemical detoxification yields molecules with reduced immunogenic activity, requires the handling of very dangerous materials and involves a risk of reversion to toxicity.
In order to avoid these problems, researchers at Sclavo Research Centre of Sclavo Vaccini (now Immunology Research department of Biocine Spa) modified. with recombinant DNA technologies two crucial codons in the chromosome of Bordetella pertussis obtaining a new strain producing a non-toxic form of pertussis toxin that has lost all its toxic properties while maintaining the antigenic properties of the original antigen. In Italy, where pertussis vaccination rates were very low, a vaccination campaign based on the new vaccine started in winter 1994-95. Until now, 400 000 Italian babies have been vaccinated with the recombinant vaccine produced by Biocine Spa. This case-study is relevant in several ways. First. the observed product is a rare example of successful product of biotechnology developed in a country which is hardly advanced in this area. Second. it is explicitly labelled as 'a product of genetic engineering' but this does not seem to have been a limiting factor. Third. while most early products of biotechnology are suspected to benefit more the industry than the final consumer, it seems to represent an unquestionable improvement for children's health by reducing the risk of possible adverse reactions. The diffusion of this kind of vaccine is mediated by a specific and relatively small social group - paediatrist physicians - who have a privileged contact with the public. This peculiar situation would enable an accurate assessment of the different reactions of the public to the introduction of the new vaccines based on qualified. first-hand information. Moreover, such information would be collected in specific geographical areas and this would also help to identify possible relevant factors. Such unique set of characteristics makes it an ideal research subject in order to understand the socioeconomic impact of specific biotechnological products. with particular regard to specific aspects. such as: how the public opinion may react to the introduction of novel products; which factors and actors may influence this process; and which impact such new product may have on the industry.
Champ scientifique (EuroSciVoc)
CORDIS classe les projets avec EuroSciVoc, une taxonomie multilingue des domaines scientifiques, grâce à un processus semi-automatique basé sur des techniques TLN. Voir: Le vocabulaire scientifique européen.
CORDIS classe les projets avec EuroSciVoc, une taxonomie multilingue des domaines scientifiques, grâce à un processus semi-automatique basé sur des techniques TLN. Voir: Le vocabulaire scientifique européen.
- sciences naturelles sciences biologiques microbiologie bactériologie
- sciences médicales et de la santé biotechnologie médicale génie génétique
- sciences médicales et de la santé médecine fondamentale immunologie
- sciences médicales et de la santé médecine fondamentale pharmacologie et pharmacie produit pharmaceutique vaccins
- sciences naturelles sciences biologiques génétique chromosome
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Italie
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