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Thread: AstraZeneca COVID-19 Vaccine Study Put on Hold

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    Veteran Member Mr. Wizard's Avatar
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    Default AstraZeneca COVID-19 Vaccine Study Put on Hold

    Rebecca Robbins
    September 8, 2020

    A large, Phase 3 study testing a Covid-19 vaccine being developed by AstraZeneca and the University of Oxford at dozens of sites across the U.S. has been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.
    A spokesperson for AstraZeneca, a frontrunner in the race for a Covid-19 vaccine, said in a statement that the company’s “standard review process triggered a pause to vaccination to allow review of safety data.”
    In a follow-up statement, AstraZeneca said it initiated the study hold. The nature of the adverse reaction and when it happened were not immediately known, though the participant is expected to recover, according to an individual familiar with the matter.


    Keep Reading: https://www.statnews.com/2020/09/08/...6d15-150918637

    Last edited by Islander; 09-11-20 at 08:59 AM.

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    Veteran Member Mr. Wizard's Avatar
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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    This is a real blow and likely to cause the other 8 phase 3 clinical trials to shut down---at least temporarily.

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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    This is discouraging, but as of Tuesday it is uncertain whether the illness was directly related to the vaccine. Knowing the history of the early polio vaccine, developers are keenly aware of the potential for something to go wrong, so I am hopeful that the details around this incident Will be quickly explored and resolved.
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    Veteran Member Mr. Wizard's Avatar
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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    You're right....developers are aware that something could go wrong. However, the problem--as I see it--is now much bigger. The CEO of AstraZeneca failed to notify the public for at least a full 48 hours after learning of this problem. He put out a notice to shareholders, but waited another day to alert the authorities. Given the broad mistrust by the public, in general, of any COVID vaccine emerging before the election, the actions of the CEO only serves to heighten public mistrust!! As the saying goes, "it's not the crime, but the coverup" that really gets the public's dander up.

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    Veteran Member Maurya's Avatar
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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    What Mr Wizard said. I am much more afraid of the alacrity with this incident might be pushed aside and covered up as supposedly being inconsequential. When it comes to the vaccine industry, it seems to be full speed ahead and damn the torpedoes.

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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    Given everything we know about the immense amount of time it takes to produce a vaccine that is both safe and effective (the average period of time is 10 years), it seems to me that the furor over a COVID-19 vaccine is driven more by public pressure and political will than by careful science. And given the number of mutations I've been reading about, I really despair of any company creating a vaccine that will be equally effective for all strains. But time will tell.....
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    Veteran Member Mr. Wizard's Avatar
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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    UPDATE: The participant in the U.K. responsible for causing a pause in AstraZeneca's vaccine trials was identified as a "previously healthy 37 yr. old woman, who experienced difficulty walking, pain and weakness in her arms, pain and reduced sensation in her torso, a headache, and reduced ability to use her hands. This occurred about 14 days after receiving a 2nd dose of the trial vaccine. Her medical condition was called "transverse myelitis." **While AstraZeneca has resumed its trials in the U.K, Brazil, and India, the FDA has not given approval for trials to resume in the U.S.-----as best I can tell.
    Continue Reading: https://www.cnn.com/2020/09/17/healt...c227-150918637

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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    Thanks for this important information, Mr. Wizard. It sounds serious indeed.

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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    We are all aware that vaccines will have side effects. The questions are, how common are they and how serious are they? And knowing the answers, how willing are you to take the risk — for yourself or for your children? I get the sense that so far in the progression of vaccine development for COVID-19, there's a great deal of reluctance.
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    Veteran Member Mr. Wizard's Avatar
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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    Twice, AstraZeneca has had to halt its vaccine trials. In July, the trial was halted because another woman developed neurological symptoms. Upon further examination, the woman was diagnosed with multiple sclerosis, which AstraZeneca officials stated was not related to the dose of vaccine she had been given. I guess we'll just have to take their word for it.

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    Veteran Member Mr. Wizard's Avatar
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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    UPDATE: Johnson & Johnson, on Oct. 12, paused its phase 3 clinical trial, due to an unexplained illness of a participant. This comes exactly 1 month after AstraZeneca paused its trials. Interestingly, AstraZeneca and Johnson & Johnson both use an adenovirus in their vaccine. A viral vector, like the adenovirus, is used to deliver a gene of the SARS-Cov-2 virus, which is suppose to elicit a stronger immune response. The leading Chinese vaccine company and one of the Russian vaccines are the only other vaccines I'm aware of that use another virus to deliver the SARS-Cov-2 virus.
    Last edited by Mr. Wizard; 1 Week Ago at 12:54 PM.

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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    So if they had to be put on hold, does it mean that there are no vaccine in progress????

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    Veteran Member Mr. Wizard's Avatar
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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    No, a pause just means these companies stopped giving participants the vaccine for a few days until they can determine what made the participants sick. AstraZeneca has trials in the U.S., U.K., Brazil, and India. A month ago, it paused trials in all of these countries. But, only after a few days of pause, AstraZeneca restarted its trials in every country, except the U.S. So, the way I would describe this is a vaccine is still in progress, but everything has slowed down a bit.

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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    AstraZeneca is only one of over a dozen pharmaceutical companies who are busily trying to develop an effective and safe vaccine for COVID-19.
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    Veteran Member Mr. Wizard's Avatar
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    Default Re: AstraZeneca COVID-19 Vaccine Study Put on Hold

    Yep. It was also the first of the major 9 leading vaccine makers that had to pause its trials. Now, Johnson & Johnson has joined AstraZeneca as the second major vaccine maker pausing its trial due to unexplained illness of a participant.
    What's interesting about these two is they both use an adenovirus as a vector in their vaccines. A Chinese vaccine maker--CanSino Biologics--also uses an adenovirus, as does a Russian manufacturer. It'll be interesting to see if CanSinoBio and/or the Russian maker will have to pause their trials.
    Last edited by Mr. Wizard; 1 Week Ago at 03:56 PM.

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