Scientists will still want to minimize risks and ensure the safest possible rollout of a vaccine. “But given the outbreak globally and the impact it’s having, I can imagine there are ways to design trials to accelerate testing,” Lee said.
There could also be an unconventional study design for the coronavirus vaccine, according to a new report published in the Journal of Infectious Diseases. In place of traditional Phase 3 trials, volunteers at low risk of developing a severe form of COVID-19 ― healthy people without chronic conditions in their 20s, for instance ― might opt in for a “human challenge study.” They could be exposed to the coronavirus, monitored closely and given the best care.
This type of study would involve fewer participants and could be done in less time than a traditional Phase 3. Of course, the idea would need to be rigorously discussed beforehand as ethics rules generally forbid deliberately infecting human beings with a serious disease.
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