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Chris Smith
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- A volunteer in the largest Phase 3 trial for a coronavirus vaccine has developed an “unexplained illness,” prompting the company to halt the trial so it can investigate.
- Johnson & Johnson did not disclose details about the patient or the illness, nor did it say whether the volunteer was on the experimental drug or a placebo.
- The company said that temporary pauses are standard for vaccine trials, and the FDA has not placed a regulatory hold on the study.
There has been plenty of talk about coronavirus vaccine safety in the past few months, as COVID-19 vaccines have become a major political topic ahead of the November 3rd presidential elections. Just as Trump increased his vaccine rhetoric on the campaign trail, a new survey showed that more Americans are reluctant to get a vaccine when it becomes available. Top health officials including Dr. Anthony Fauci have made it clear that vaccines won’t get emergency approval unless they’re safe. On top of that, the FDA has just released new guidelines that make it practically impossible for pharmaceutical companies to apply for authorization before the election. Most of the Phase 3 vaccines require two shots that are administered several weeks apart. The FDA wants volunteers to be observed for two months after that, which makes an approval in late October impossible. However, Fauci did say that at least a vaccine might be approved by the end of the year. At that point, certain at-risk categories of people could qualify for immunization, including healthcare professionals and the elderly.
Of course, there are no guarantees that any of the coronavirus vaccine frontrunners will end up being approved. Some drugs fail Phase 3 trials, and we already saw it happen with several therapies like hydroxychloroquine, tocilizumab, and an anti-HIV combo that was being tested. Also, the final phase of testing often isn't without problems. AstraZeneca had to pause its Oxford vaccine Phase 3 trial in early December after a volunteer experienced an unexpected neurological complication. The study was resumed after a brief investigation, but not in America, where AstraZeneca's experimental drug trial is still on hold. Now, another vaccine maker has announced that it had to pause its Phase 3 trial after one volunteer developed an “unexplained illness.”
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The largest coronavirus vaccine trial was halted due to an ‘unexplained illness’ originally appeared on BGR.com on Tue, 13 Oct 2020 at 10:13:43 EDT. Please see our terms for use of feeds.
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