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by akiselev
2290 days ago
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It might not take that long. If the vaccine candidate is viable, Stage 1 trials could be completed in a few months since there's already tons of patients with COVID-19 going to hospitals where they can be monitored for a maximum safe dose trial. The FDA might be able to waive most of Phase 1 similar to some oncology drugs and once it hits Phase 2, they just needs enough data about efficacy and safety to declare it a breakthrough therapy. The reality is that many clinical trials take time because of how long it takes to set up the infrastructure, get patients, and coordinate with an understaffed and underfunded FDA. If the entire agency is ordered to focus on COVID-19, I think it could happen a lot faster. That's only if the vaccine works though. If do that process and it turns out it doesn't, it could make the situation a whole lot worse. |
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