3 volunteers to get 1st shot of vaccine; Covishield human trials at KEM today

Three volunteers will be administered the first doses of 'Covishield', the potential Covid-19 vaccine at the King Edward Memorial (KEM) hospital on Saturday. Civic officials said the volunteers were fit for the clinical trials, as their both RT-PCR and antibody tests were negative.Meanwhile, BYL Nair Hospital has announced that from September 28, it will also embark on trials and administer the first doses to eligible volunteers. Currently, the process of screening suitable volunteers is underway, hospital authorities said.

“Three participants were screened after obtaining their consent and they did not have any co-morbidities. As per randomisation, out of every four participants, one will receive a placebo,” said Dr Hemant Deshmukh, Dean, KEM hospital.

Covishield has been developed and is being tested by researchers at Oxford University and is being made and manufactured by the Pune-based Serum Institute of India (SII).

Additional Municipal Commissioner Suresh Kakani said that on Tuesday, the ethics committee had given the hospital the green signal to start the screening of registered volunteers. So far, 13 volunteers have been screened, of whom three have been found completely fit for the clinical trials. “We will administer the first dose of the Covid-19 vaccine to the three volunteers on Saturday, following which they will have to remain in hospital for two hours, to check whether they develop complications,” he said.

Kakani further said, those vaccinated would be checked regularly and would be administered the second dose within 29 days. In the meanwhile, 10 more volunteers would be screened on September 26 and with this, the number of volunteers would increase to 23. “We will check how they have responded after the inoculation and test them for antibody titre. We will keep checking them over a period of time, to observe how long the antibody cover is available and how the person responds with the cover,” he added.

Last week, the Drugs Controller General Of India (DCGI) had given SII the nod to conduct Phases 2 and 3 of the human clinical trials of Covishield in India. About 1,600 people, all above 18, will participate in the trials across 17 selected sites in India, including four hospitals in Pune and two hospitals in Mumbai. From the 1,600 volunteers, 100 will undergo Phase 2 human trials, to assess the safety profile of the vaccine.

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