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Participants in clinical trials are inoculated with a candidate for a COVID-19 vaccine developed jointly by the Jenner Institute at the University of Oxford in the UK and AstraZeneca. Based on preliminary results from phase 1 and 2 clinical trials published on day 20, side effects were not significant and the antibody-forming effect was confirmed, indicating that a large phase 3 clinical trial is worth conducting. scale. Zener Lab video capture
Clinical trials for a new vaccine candidate for coronavirus infection (COVID-19, Corona 19) being developed by AstraZeneca and the University of Oxford in the United Kingdom will resume. AstraZeneca suspended the trial on day 8 due to side effects in one of the trial participants. The side effects of the company’s vaccines were analyzed for various external causes, but the company ultimately did not disclose the specific names of the diseases or the symptoms of the side effects when testing was resumed.
On the 12th (local time), Reuters reported that AstraZeneca and Oxford were reopening clinical trials after obtaining approval from the UK’s Medicines Management Products Regulatory Authority (MHRA) for safety reasons.
AstraZeneca said: “We voluntarily suspended global trials for safe data review by independent committees and international regulators.” “Instead, all researchers and study participants will receive relevant information, which will be released in accordance with clinical trials and regulatory standards.”
Phase 2 of the clinical trial is the final clinical trial in which hundreds of healthy participants are given vaccines and placebo (placebo) respectively, and then efficacy and side effects are checked in large numbers of personnel. Phase 3 clinical trials target thousands to tens of thousands of people. AstraZeneca completed the phase 2 clinical trial of this candidate in July and is currently conducting phase 2/3 concurrently in the UK and India, and phase 3 in Brazil, the UK and the US. Phase 2 clinical trial results published in the Lancet medical journal in July, the safety and antibody-forming effects were confirmed throughout, and the side effects were not seen much except mild.
On day 8, AstraZeneca stopped clinical trials related to candidate substances due to side effects. Content related to side effects has not been accurately disclosed. According to the New York Times (NYT), a participant in one trial had symptoms of transverse myelitis, which caused inflammation of the spine, but it was not confirmed to be related to the discontinuation of the trial. No relevant information was disclosed in the announcement of clinical resumption. AstraZeneca said: “All researchers and study participants will receive relevant information, which will be released in accordance with clinical trials and regulatory standards.”
Clinical trials resume once in the UK and Brazil only. AstraZeneca did not provide any explanation regarding clinical trials in the United States, India, and South Africa. Brazilian health authorities announced directly that they allowed the resumption of phase 3 vaccine trials.
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