New Delhi: The British-Swedish biopharmaceutical giant AstraZeneca has put a hold on its ongoing late-stage trials of Covid 19 vaccine after a participant developed a serious reaction to it. A news report by PTI says that trials have been paused until the company determines if the ‘potentially unexplained’ illness is a side effect of the vaccine.
The report says that the company released a statement on Tuesday about the development and said that its "standard review process triggered a pause to vaccination to allow the review of safety data". AstraZeneca has said that it's possible that the problem could be a coincidence.
“We are working to expedite the review of the single event to minimize any potential impact on the trial timeline," the company statement said. The company has not given any details about the illness.
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In late-stage trials, the vaccine candidate is tested on a large group usually over the age of 18. At this stage which considered to be the most important one, researchers are also on a lookout for possible side effects that were not detected in earlier stages. The report also says that such a temporary pause is not unusual and testing such reactions is part of the process.
"This is not something to be alarmed about. Instead, it's reassuring that the company is pausing the study to figure out what's happening and carefully monitoring the health of study participants,” said Deborah Fuller, a University of Washington researcher who is also working on Covid 19 vaccine research. She also added that it's likely the unexplained illness was serious enough to require hospitalization and not a mild side effect such as fever or muscle pain.
AstraZeneca had started expanding its trials and was collaborating with different countries such as Brazil and South Africa. In India, Pune based Serum Institute of India (SII) had reached an agreement with the AstraZeneca to produce the vaccine for India. Last month, India's apex drug regulatory body had granted approvals to Serum Institute of India to conduct late-stage human trials for the Oxford Covid-19 vaccine candidate in India. A company official had informed that SII has invested USD 100 million on the Oxford University vaccine candidate.
Trials Of Oxford University Corona Vaccine Paused After Participant Falls Sick
ABP News Bureau
Updated at:
09 Sep 2020 09:25 AM (IST)
British-Swedish biopharmaceutical giant AstraZeneca has put a temporary pause on its late-stage trials of Covid 19 vaccine candidate after a participant developed unexplained illness.
(Representative Image/Getty)
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