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Pharmaceutical company AstraZeneca on September 8 said that it had "voluntarily paused" a clinical trial of its coronavirus vaccine after a volunteer developed an unexplained illness.
The volunteer whose illness stopped the clinical trials has shown symptoms of a neurological disorder that affects the spinal cord. The details about the woman were released by AstraZeneca CEO Pascal Soriot in a "private conference call" with company investors.
The CEO had informed the investors that the woman had symptoms of a rare disease called 'transverse myelitis', but that her condition was improving and she was likely to be discharged soon.
During phase-3 clinical trials, the participants are given a dose of a real vaccine, or that of a dummy. However, Soriot clarified that the participant had received a real vaccine.
After the participants are injected with the vaccine, they are allowed to go to their normal life, and are checked after a weeks to understand whether the group which had been injected with the real vaccine had resisted the infection better than the other group.
Soriot also mentioned that the trials had been halted once earlier in July as well, when another participant had also developed neurological problems. The patient was later diagnosed with multiple sclerosis, however, it was claimed that the illness was not related to the vaccine.
Meanwhile, India's drug regulator issued a show-cause notice to the Pune-based Serum Institute of India for not sharing the information about the halt on AstraZeneca vaccine.
Serum Institute has an agreement with AstraZeneca to manufacture and produce the vaccine in India. The institute is also carrying out phase-2 and phase-3 trials of that vaccine with the approval of the office of the Drug Controller General of India (DCGI).
In response, Serum said it would follow DCGI's instructions and abide by the standard protocols.
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