MP CM clarifies on death of man 10 days after COVAXIN trial, terms it as a ‘misconception'

Update at 6:15 PM : Bharat Biotech issues statement

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Amid Indian vaccines being politicised, Madhya Pradesh CM Shivraj Singh Chouhan on Saturday, urged people to desist from spreading misconceptions on vaccines, after a man died ten days after he participated in the clinical trial for Covaxin held at a private hospital. While the post-mortem report suggested poisoning, Chouhan stated that the matter must be handled sensitively so that the vaccination rollout will not be affected. The state government is awaiting the deceased's viscera test reports.

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Man dies 10 days after COVAXIN trial

A 42-year-old volunteer from Bhopal in Madhya Pradesh died nearly ten days after he participated in the clinical trial for Covaxin held at a private hospital, its vice-chancellor said on Saturday. While a government official suspected poisoning but added that the exact cause of the death will be known after the viscera test. Dr Rajesh Kapur, Vice-Chancellor, People's Medical College and Hospital where the trial was conducted, told PTI that Deepak Marawi had participated in the Covaxin trial held on December 12, 2020.

"After Marawi's death on December 21, we informed the Drug Controller General of India and Bharat Biotech, which is the producer and sponsor of the trial," Dr Kapur said. He added, "All protocols were followed and Marawi's consent was taken before allowing him to participate in the trial".  Dr Kapur, however, said he cannot confirm whether Marawi was administered the vaccine shot or was given a placebo. "We monitored his health for 7 to 8 days," he claimed.

"When he returned home he felt uneasy and experienced some health problems. He complained of shoulder pain on December 17. Two days later, he spewed foam. He refused to see a doctor saying he would be alright in a day or two. When his condition deteriorated, he was being rushed to hospital but he died midway (on December 21)," said the deceased's family.

Days after participating in vaccine trial, man dies in Bhopal

DCGI gives nod to COVISHIELD & COVAXIN

On Sunday, Drug Controller General of India (DCGI) VG Somani announced that the vaccines of Serum Institue of India (Covishield) and Bharat Biotech (Covaxin) have been granted permission for restricted use in an emergency situation. Covishield - a Recombinant Chimpanzee Adenovirus vector vaccine - has an efficacy of 70.42%, with interim safety and immunogenicity data of Phase-II/III trials submitted to the SEC. Covaxin - a Whole Virion Inactivated Corona Virus Vaccine - 22,500 participants vaccinated in Phase-III trials and was found to be safe as per the data available till date. Meanwhile, Zydus-Cadilla's nCov-Vaccine using DNA platform technology has been allowed to conduct Phase-III clinical trial in 26000 Indian participants. After a day of heavy politicisation over the vaccines and their approvals, the two manufacturers - Serum Institute of India & Bharat Biotech issued a joint statement pledging global access to their vaccines.