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3Rs in Covid-19 debate

Two live webinars on the 3Rs in coronavirus research have highlighted the disagreements over the contribution of animal research in the development of vaccines and treatments.

Organised by the 11th World Congress on Alternatives and Animal Use in the Life Sciences, the webinars heard from a wide range of speakers across the debate.

Dr Penny Hawkins, of RSPCA UK, said that while Covid-19 is raising awareness of animal use, and data sharing and collaboration is helping the 3Rs (replace, reduce, refine) there was a downside.

She was concerned that the ‘covidisation’ of research, with many scientists brought in to assist in lab research, would see a race to develop new animal models and mean a lack of rigour and lead to a failure to look for alternative methods instead.

But in his presentation, Jan Willem van der Laan, of European Medicines Agency, stressed that having the best model possible rather than having a replacement is the best way to achieve success in Covid-19 vaccine development.

He added: "The scientific community is under pressure, pressure from the political parties on how to develop a vaccine without extensive animal testing. This is taken seriously but thus far the process is difficult to do without animals due to complexity of immune system."

At the end of the first day of webinars, the discussion included a question by EARA:

“Are there any case studies of European scientists not conforming with current legislation and overlooking the use of alternatives due to the pressure caused by Covid-19 to get research done quickly? Similarly, are there any case studies where the 3Rs haven’t been properly applied for the same reason?”

All the speakers said they did not know of any case, while Christian Desaintes, policy officer, at the EU Commission, replied saying that all projects funded by the EU must go through strict legislation, where approval for the use of animals in research can only be given if there are no suitable alternative methods.

At the final discussion, the audience asked: Can organoids really replace the need for animals in disease study? Thomas Hartung, Director CAAT, Johns Hopkins University, USA, highlighted that using animal models is a wrong approach to study human disease, because “we show a completely different immune response.”

While Mr van der Laan countered by asking how vaccine studies can be set up with no prediction of what immune response can be expected in humans.

Is there a role for the 3Rs in Covid-19 research?

“The evidence is that the EU has a robust system in place, through laws and regulations such as Directive 2010/63, to ensure that it only allows tests with animals where non-animal alternatives do not yet exist. Researchers are working tirelessly under difficult circumstances to combat this pandemic and EARA believes no public or private research organisation would forego the use of validated non-animal methods where they are the most effective and efficient model to achieve the testing needed in Covid-19 research. In addition, the European Medical Agency (EMA) has set up a formal EU expert group on the application of the 3Rs of animal testing which has made a significant contribution towards the elimination of repetitious and unnecessary animal testing within the EU.
The EMA has also, under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA) of all global medicine regulators, a plan to map out data requirements for phase 1 COVID-19 vaccine trials and to discuss the preclinical data required to support proceeding to first-in-human (FIH) clinical trials, including what animal studies would not need to be conducted prior to proceeding to FIH clinical trials.
EARA also believes that during the global pandemic it would be short-sighted to turn away from such a well-characterised and available research techniques such as animal-derived antibodies. There are already many examples throughout the pandemic of how animal-derived antibodies have pushed forward both basic and therapeutic research for Covid-19. Moving away from this in favour of animal-free techniques that are not yet well established, or readily available throughout the research community, would be premature.”

This is the EARA response to the question Is there a role for the 3Rs in Covid-19 research? which has been posed on the WC11 website. Contributions are being sought from researchers everywhere with the answers posted each week on the website. What is your opinion?

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