FDA might approve coronavirus vaccines before Phase 3 trials are done

[Chris Smith]

• Coronavirus vaccine emergency approval might come before Phase 3 trials are finished, said FDA Commissioner Stephen Hahn.
• The remark came days after a report claimed the FDA might be pressured to issue an emergency use approval for one of the vaccines that are in the final stage of testing before the presidential election.
• Hahn said in his remarks that emergency approval would still be based on scientific merit and would not have anything to do with politics.

No matter how scary the novel coronavirus pandemic might be, the officials who are managing it should not approve drugs and therapies before they're efficacy and safety is proven through rigorous scientific testing. The entire hydroxychloroquine disaster proved that point, yet the US Food and Drug Administration is ready to walk down the same road. The agency did the same thing with blood plasma a few days ago, giving it emergency use approval (EUA) before all the facts are in. Plasma from convalescent COVID-19 patients does work in some cases, though, and plasma doesn't have life-threatening side-effects like hydroxychloroquine.

But giving vaccine candidates emergency approval before Phase 3 trials are completed might be even more hazardous. It's not just about the safety of patients, as these drugs have already shown that they do not elicit severe side-effects in the earlier phases. But the vaccines might not work. Plus, having drugs in circulation before the work is done might motivate vaccine skeptics to avoid COVID-19 vaccines altogether. Not to mention that it could hinder future COVID-19 research, not just by setting a precedent, but by preventing people from volunteering for other projects. Yet FDA Commissioner Stephen Hahn says that a vaccine EUA might be coming before the end of trials anyway.

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FDA might approve coronavirus vaccines before Phase 3 trials are done originally appeared on BGR.com on Mon, 31 Aug 2020 at 16:06:52 EDT. Please see our terms for use of feeds.

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