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Concerns as India to roll out home-grown vaccine

Concerns as India to roll out home-grown vaccine
AFP
1/15/2021
AFP
© Gagan NAYAR
Wage labourer Mannsingh Parihar, 70, said he had received the Covaxin jab, but was not told it was part of a trial
A homegrown coronavirus vaccine will be rolled out in India from Saturday even though clinical trials haven t been completed. But the government insists it will be safe and effective.
The All India Drug Action Network (AIDAN), an independent watchdog, led a chorus of concern from experts saying it was shocked and baffled by the emergency approval of Covaxin.
© Dibyangshu SARKAR
India has been hit hard by the virus, logging the second-highest number of Covid-19 infections globally ....

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Health experts 'shocked' as Indian authorities grant emergency approval to homegrown vaccine - World

Authorities say that Covaxin might work better against new Covid-19 strains. ....

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Bharat Biotech vaccine trial participants claim they had no idea what they were getting into

Representational image.
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Manjunath Kiran / AFP
Seventy-four-year-old Man Singh Parihar is agitated sitting outside his neighbour’s house in Bhopal on a cold January afternoon. He has been feeling feverish and complaining of body ache for some time now. Without knowing it, he had participated in a Covid-19 vaccine trial in December 2020. He thinks he was given the vaccine, which was causing these adverse side effects.
It did not occur to him to call up the hospital, where he was given the injection, until this interview with
IndiaSpend. Clinical trial sponsors and investigators are supposed to check on and keep records of participants’ health. He then asked his son to call the hospital, but his son has not had credit on his phone for nearly five months, since he lost his job after contracting tuberculosis. With no money to make phone calls, Parihar could not contact a doctor about his poor health following the vaccine trial. He said he h ....

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Questions over India's Covaxin side effects, ethical violations

Questions over India’s Covaxin side effects, ethical violations
Quartz
1/12/2021
A shadow is lurking over the trial process of India’s homegrown Covid-19 vaccine.
Covaxin, the novel coronavirus vaccine co-developed by Bharat Biotech and the Indian Council for Medical Research, has been accused by some trial participants of sidestepping procedures and not making adverse events public. It has denied these charges, but trial volunteers want the government to intervene and halt the phase 3 human trials.
Bharat Biotech began courting controversy on On Jan. 4, when scientists expressed grave concerns over the hasty approval given to Covaxin. Now, its trial participants in Madhya Pradesh’s Bhopal allege that they were not informed that the jab would be given to them as part of a clinical trial. Covaxin’s third phase of human trials has 25,800 participants across the country. ....

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750 participants in Indian vaccine trial say they weren't informed they were test subjects

The Straits Times
We weren’t told we were part of trial, say test subjects in India
A medic administers Covaxin to a health worker during its trials in Ahmedabad, India, on Nov 26, 2020.PHOTO: REUTERS
PublishedJan 12, 2021, 3:00 pm SGT
https://str.sg/JDyi
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