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    Home > Medical News > Medical World News > Clinical trials of the suspended Oxford-AstraZeneta vaccine will resume

    Clinical trials of the suspended Oxford-AstraZeneta vaccine will resume

    • Last Update: 2020-11-12
    • Source: Internet
    • Author: User
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    On September 12th it learned from Oxford University's vaccine research and development team that the new crown vaccine, developed in partnership with AstraZeneta, would resume clinical trials.
    clinical trials of the new crown vaccine will continue at all clinical trial sites in the UK, the Oxford University vaccine team said in an email to the news agency.
    said in a statement on its website that it had resumed clinical trials of the Oxford-AstraZeneta vaccine AZD1222 in the UK.
    On September 8th Local time, AstraZene announced that it would suspend an ongoing trial of a new coronavirus vaccine because of a suspected serious adverse reaction in a volunteer, the first new crown candidate vaccine to be suspended from Phase III clinical trials, and an Oxford University spokesman said the disease may or may not be related to the vaccine.
    Shares in AstraZeneca fell 8.1 per cent after an independent commission was set to review its security data, sparking immediate industry concerns.
    did not give further details about the suspected serious adverse reactions in the volunteers, but according to US media STAT, the ASTRAC CEO revealed in a private meeting with investors that the suspension stemmed from symptoms in a British female subject, consistent with a rare neurological disease called transverse spinal corditis, which is improving and could be discharged as early as Wednesday.
    transverse spinal corditis, a rare disease that causes inflammation on both sides of the spinal cord, symptoms including severe physical pain, quadriplegia, urinary incontinence, sexual dysfunction, and in severe cases can lead to complete paralysis of the limbs.
    the American medical journal Neurology, the cause of 60 percent of transverse spinal cord cases remains unclear, with the remaining 40 percent linked to autoimmune diseases.
    in rare cases, vaccines can cause transverse spinal corditis, but the disease can also be caused by viral infections.
    the conference call also revealed that the subject was using a vaccine, not a placebo.
    STAT report also said it was the second case of the nervous system in the trial, in which a subject developed neurological symptoms in July but was later diagnosed with multiple sclerosis, unrelated to the vaccine trial.
    , AstraZenecom said in a statement that reports confirming that volunteers in clinical trials were suffering from transverse spinal corditis were inaccurate and that no final diagnosis had been made.
    Since the outbreak, the adenovirus vector vaccine, code-named AZD1222 (a.k.a. ChaAdOx1 nCoV-19), has been the subject of much attention since the outbreak, based on a modified version of the common cold virus (adenovirus) that replicates defective chimpanzee virus vectors and carries genetically modified proteins that encode the new coronavirus pyridze protein.
    , it produces a prickly protein, triggering the immune system to produce antibodies against the new coronavirus.
    July 20, The Lancet published the interim results of the 1/2 clinical trial COV001 of AZD1222, which showed that AZD1222 was resistant to and produced antibodies and cellular immune responses to the new coronavirus in all the participants assessed.
    In terms of safety, the AZD1222 group experienced a one-time local and systemic reaction comparable to previous trials and other adenovirus vector vaccines, including temporary injection site pain and pain, mild to moderate headache, fatigue, chills, fever, discomfort, and muscle pain, and AZD1222 did not report serious adverse events.
    August 31, AstraZeneta announced on its official website that it would begin a Phase III trial in the United States, which will include 30,000 adults over the age of 18 to verify the safety, effectiveness and immunogenicity of the vaccine.
    September 3rd, AstraZenecom's website take stock of the current progress of clinical trials of the vaccine: current clinical trials include Phase III trials in the United States, post-phase I/II trials in the United Kingdom and Brazil, and Phase I/II clinical trials in South Africa.
    also has plans to conduct clinical trials in Japan and Russia in the near future.
    the trials will include a total of 50,000 volunteers from around the world.
    five days later, clinical trials triggered a pause.
    also announced the suspension of clinical trials on the same day as AstraZeneta, together with GlaxoSmithKline, Johnson and Johnson, Mercedon, Moderna, Sanofi, BioNTech, Pfizer, Novavax and nine other pharmaceutical CEOs issued a joint pledge, declaring: "Always inoculation of human safety and health as a top priority." The design and conduct of Phase III clinical trials will be conducted in accordance with the requirements of professional regulatory bodies such as the FDA, and approval or emergency use authorization will only be applied for after the results of Phase III clinical trials have shown sufficient safety and effectiveness, and efforts will be made to ensure that vaccines are adequately available and available, including vaccines suitable for widespread global use.
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