Summary
The authors of this guest editorial argue that novel animal‑free test methods (NAM) can and should be used in all steps of drug and vaccine development, especially for Covid-19, but also beyond. According to the authors the advancement of cell-culture, stem cell techniques and computational research in recent decades have proved to deliver quick and reliable results. Testing for genotoxicity has proven to be especially successful with NAMs. The authors also argue that NAMs are a reliable alternative in situations where no animal disease model is present (like for Covid-19) and testing a high number of substances and parameters is warranted. Some strengths of this editorial are the detailed discussion of every step of drug and vaccine development and the description of legal and historical situations. However, the editorial lacks the detailed description of possible limitations of NAMs. In conclusion, the authors argue that the use of NAMs is mainly limited by official regulations. They express hope that the use of NAMs for the development of Covid-19 drugs and vaccines under time pressure could open the door to general usage of NAMs as common practice in the future.
Note: Although this journal is peer-reviewed, guest editorials are not subject to this review. However, these editorials are expected to be sound and scientifically-founded.
The COVID-19-inducing virus, SARS-CoV2, is likely to remain a threat to human health unless efficient drugs or vaccines become available. Given the extent of the current pandemic (people in over one hundred countries infected) and its disastrous effect on world economy (associated with limitations of human rights), speedy drug discovery is critical. In this situation, past investments into the development of new (animal-free) approach methods (NAM) for drug safety, efficacy, and quality evaluation can be leveraged. For this, we provide an overview of repurposing ideas to shortcut drug development times. Animal-based testing would be too lengthy, and it largely fails, when a pathogen is species-specific or if the desired drug is based on specific features of human biology. Fortunately, industry has already largely shifted to NAM, and some public funding programs have advanced the development of animal-free technologies. For instance, NAM can predict genotoxicity (a major aspect of carcinogenicity) within days, human antibodies targeting virus epitopes can be generated in molecular biology laboratories within weeks, and various human cell-based organoids are available to test virus infectivity and the biological processes controlling them. The European Medicines Agency (EMA) has formed an expert group to pave the way for the use of such approaches for accelerated drug development. This situation illustrates the importance of diversification in drug discovery strategies and clearly shows the shortcomings of an approach that invests 95% of resources into a single technology (animal experimentation) in the face of challenges that require alternative approaches.