EARA/EFPIA response to antibody recommendation

Updated: Nov 20



A joint report by the European Animal Research Association (EARA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), has challenged an EU expert group recommendation that calls for an end to the use of animals in antibody research, including Covid-19.


The report, also supported by AnimalhealthEurope, was produced by leading European scientists, who said switching to only non-animal-derived antibodies, ‘would have serious negative implications and impact on research, innovation and discovery of new life-saving drugs’ for patients and in animal health.


And they called for ‘real evidence’ to be produced before the sector could move away from animal-derived antibodies.


In May 2020, the EU Commission’s Reference Laboratory for Alternatives to Animal testing (EURL ECVAM) published a report stating that the use of animal-derived antibodies for research and treatment of diseases, including Covid-19, are no longer fit for purpose, and that relevant funding bodies should avoid financing such projects.


In response, the EARA/EFPIA report noted that many of the current front-running antibody drugs for Covid-19 have been developed using animal-derived antibodies (see Notes to Editors).


The report observed: “At a time when the world is depending on biomedical researchers to find a vaccine to combat the global Covid-19 pandemic, the benefits from animal-derived antibodies have been of critical importance in the global struggle to better understand and rapidly advance therapeutics to combat Covid-19.”


The report also said that: “Premature restrictions on the use of animal-derived antibodies for therapeutic purposes would have widespread socio-economic consequences, and there is a high likelihood that in the future patients worldwide will not have access to the best antibody-based medicines that would have otherwise originated from Europe.”


A survey of EARA and EFPIA member organisations, across Europe, found that 90% used animal-derived antibodies, with half also using non-animal alternatives. Just 15% of those surveyed thought that the replacement of animal-derived antibodies was possible in the near future.


The success of animal-derived antibodies in drug discovery and therapeutics was also highlighted in the report, as 90% of approved therapeutic antibodies in the last five years are animal-derived.

EARA executive director, Kirk Leech, said: “This report is a comprehensive evaluation of the vital importance of animal-derived antibodies and we hope that the Member states of the EU and the EU Commission considers the recommendations very carefully”.

The EARA/EFPIA report covers the fields of research, diagnostics and therapeutics, and includes references to animal health and medicine which was previously overlooked by the EURL ECVAM Recommendation. In particular, it outlines the current issues with non-animal derived antibodies and the places where they cannot compete with animal-derived, offering scientific justification behind the continued need for animal-derived antibodies.


The report also stresses the ways in which animal numbers are already being reduced, thanks to developments in molecular biology technologies which allow the reproduction and development of animal-derived antibodies without the need for further animal use.


EARA/EFPIA has recommended a ‘complementary approach’ between non-animal and animal-derived technologies and the establishment of a multi-stakeholder platform that will address the areas where non-animal antibodies can be used, while protecting the availability of animal-derived antibodies in areas where they are clearly still essential.


Recently, the League of European Research Universities also produced a statement expressing concern about the ECVAM recommendations. The German Society for Immunology also issued a statement this week condemning the EURL ECVAM Recommendation and highlighting the many responses from other scientific societies., including the Spanish Nature Methods paper, supported by EARA.


The report has been submitted to the November meeting of the National Contact Points of EU Directive 2010/63/EU, for consideration in each member state and will be circulated to policymakers and the EURL ECVAM committee.


END

Notes to editors

About EARA The European Animal Research Association (EARA) is an organisation that communicates and advocates on biomedical research using animals and provides accurate, evidence-based information. It has close to 100 member organisations, including private and public research bodies, universities, regional and national biomedical associations and suppliers, in 20 European countries.


EARA’s vision is to enhance the understanding and recognition of research involving animals across Europe, allowing for a more constructive dialogue with all stakeholders and a more efficient climate for research in Europe www.eara.eu

Four examples that have come from Covid-19 research involving animal-derived antibodies

Regeneron isolated an antibody cocktail consisting of two neutralising antibodies from immunised transgenic mice, or infected human donors. The cocktail binds non-overlapping epitopes on RBD and prevents viral escape. The cocktail has advanced into phase 3 clinical trials at an unprecedented speed.


VIB, in Belgium, and the German Primate Research Centre, were able to generate specific antibodies against the virus using camelids, and demonstrated that they were able to neutralise the coronavirus.


● The Karolinska Institute, Sweden, found that alpacas can generate a smaller-sized form of antibody against the virus, and that these are remarkably effective at preventing the virus from entering cells and thus causing infection.


● In a similar manner, a collaboration between the University of Texas at Austin, USA and Ghent University, Belgium, found that llama antibodies could prevent the coronavirus entering cells, and have begun preclinical trials in order to develop this as a potential treatment for Covid-19.


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