C
Chris Smith
Guest
- Dr. Anthony Fauci explained in an interview that Phase 3 trials for novel coronavirus vaccines can end early in two different scenarios, but politics wouldn't play a role.
- If the independent Data and Safety Monitoring Board finds that the drug is effective, it could stop the trial so the group of volunteers who gets placebos will also receive the real vaccine.
- The other reason a trial might end early would be if a drug has side effects so severe that the safety board decides to terminate the research early.
- Fauci's comments came in response to recent COVID-19 vaccine controversies, from the early use of Russian and Chinese vaccines to the rumors that say Trump wants to have a vaccine approved before the November election.
All the toxic coronavirus vaccine chatter from the past few weeks isn't really going to help the initiative to speed up COVID-19 immunization campaigns. On one hand, we have Russia and China that are already using vaccines before Phase 3 trials are completed. Of those, the Russian vaccine is the most disturbing, considering there's no scientific evidence at all to back up the emergency use authorization. China, on the other hand, has published several papers that prove the efficacy and safety of some of the vaccines it's testing.
On the other hand, some people believe that President Trump will attempt to pressure officials into speeding up the emergency use authorization (EUA) for at least one vaccine candidate that's currently in the works to help his reelection bid. Dr. Anthony Fauci explained why such a decision would be dangerous for the entire vaccine research effort, saying that clear scientific evidence is needed before emergency approvals are given. He did concede that we might have an answer in November. FDA Commissioner Stephen Hahn, who faced plenty of criticism for the way he promoted plasma therapy during a White House briefing last week, said that some companies might seek EUAs before Phase 3 trials are ready. The FDA will have to analyze the request and issue a decision, the official added, explaining that politics will not play any role in such determinations.
It turns out there are two scenarios where a Phase 3 trial may end earlier than expected, and they have nothing to do with politics or election schedules. Both can apply to any of the coronavirus vaccines that are currently in the final stage of testing, or to any other drugs that are being developed.
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Dr. Fauci explained the only way we’ll get a coronavirus vaccine early originally appeared on BGR.com on Wed, 2 Sep 2020 at 11:06:23 EDT. Please see our terms for use of feeds.
Via BRG - Boy Genius Report