Development of experimental vaccines to combat the COVID-19 pandemic has been rapidly progressing. In the United States, several Phase I clinical trial participants already received an injection of mRNA-1273, the experimental vaccine developed by the National Institutes of Health (NIH) and a biotechnology firm called Moderna (U.S. National Library of Medicine 2020). The chief medical officer at Moderna, Dr. Tal Zaks, lauded the speed with which his company has provided a potential COVID-19 vaccine: “I think we’ve set a new record here,” (Kelly 2020). However, the usual Food and Drug Administration (FDA) standard for proving safety and efficacy in animal models before moving onto testing in humans, has not been followed (Boodman 2020). Instead, safety and efficacy studies in animals will run concurrently with the Phase I clinical trial in humans. This article highlights the potential implications of this new manner of testing, while placing it in the context of the current pandemic.
https://www.tandfonline.com/doi/full/10.1080/15265161.2020.1763696