Published 13:09 IST, December 13th 2020
Peru suspends China vaccine trials due to 'serious adverse event'
Peru has halted the clinical trials for China’s Sinopharm COVID-19 vaccine candidate reportedly due to “serious adverse event” involving one of the volunteers.
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Peru has halted the clinical trials for China’s Sinopharm COVID-19 vaccine candidate reportedly due to a “serious adverse event” involving one of the volunteers for the study. The Peruvian government reportedly said in a statement that the event is currently “under investigation to determine if it is related to the vaccine or if there is another explanation.”
China’s Sinopharm Group Co Ltd is conducting trials in Peru with nearly 12,000 volunteers and neurological problems in one of its participants just when it was about to complete the first stage of trials in the next few days. Meanwhile, as Peru has recorded more than 36,000 deaths due to COVID-19, the country’s health ministry said in a statement that the decision to “temporarily suspend” clinical trials is a safety measure that contemplated in the regulations for clinical trials along with the protocols established to safeguard the health of research subjects.
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Earlier on December 11, Peru’s National Institute of Health said that it had suspended the clinical trials for the COVID vaccine manufactured by the Chinese drug firm. The chief researcher, German Malaga also told media outlets that that trial was halted after a volunteer faced difficulty in moving their arms. He further added that the symptoms aligned to a condition called the Guillain-Barre syndrome.
Malaga said, “Several days ago we signalled, as we are required, to the regulatory authorities that one of our participants (in trials) presented neurological symptoms which could correspond to a condition called Guillain-Barre syndrome”.
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What is Guillain-Barre syndrome?
The Guillain-Barre syndrome is a rare and non-contagious disorder that affects the movement of the arms and legs and can also lead to paralysis. According to reports, Peru’s clinical trials for the Sinopharm vaccine were due to conclude this week, after testing thousands of people. Now, if and when the trial is successful, the Peruvian government is expected to but up to 20 billion doses to inoculate two-thirds of its population. Meanwhile, UAE had granted Sinopharm's COVID-19 vaccine candidate, emergency approval.
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13:09 IST, December 13th 2020