Covid-19 vaccine trial begins at Mumbai’s KEM Hospital today; three volunteers to be given first dose
The King Edward Memorial (KEM) Hospital will administer the first dose of the Covid-19 vaccine candidate developed by the Oxford University and AstraZeneca on three volunteers on Saturday, while another 10 volunteers have been selected for the clinical trial. The other city hospital, BYL Nair, to conduct the clinical trial will begin the process from Monday.
All three volunteers have been screened to rule out any underlying health issues, said KEM Hospital officials, adding that they have also undergone RT-PCR and antibody testing. “The three participants have been screened after their consent and they don’t have any comorbidity. As per randomisation, out of every four participants, one will receive placebo (false drug),” said Dr Hemant Deshmukh, Dean, KEM Hospital.
As per Indian Council of Medical Research (ICMR) guidelines, each of the volunteers has been covered with ₹1-crore life insurance if they die owing to any side effect during the trial. Also, they have ₹50lakh for medical insurance if they develop any adverse effect from the vaccine.
Suresh Kakani, additional municipal commissioner, Brihanmumbai Municipal Corporation (BMC), said the ethics committee on Tuesday gave its nod to the hospital to start the screening of registered volunteers. After which, till Friday, 13 volunteers have been screened, of which three volunteers have been found completely fit for the clinical trials. “We will administer the first dose of Covid-19 vaccine to the three volunteers on Saturday, following which they have to stay at the hospital for two hours to check if they are having any complications,” he said.
Kakani said the volunteers given the vaccine dose will be checked regularly and within 29 days a second dose will be given to them.
Meanwhile, 10 more people will be screened on September 26, taking the number of volunteers to 23. “We will check how they respond after the inoculation and test them for antibodies,” said Kakani.
The vaccine induces a strong immune response. It provokes a T cell (white blood cells that can attack cells infected with the coronavirus) response within 14 days of the dose, and an antibody response within 28 days.
“We are screening volunteers at present. By Monday, we will start the trial and provide the first dosage at our hospital,” said Dr Ramesh Bharmal, dean of Nair Hospital.
In the second week of September, both KEM and Nair Hospitals had to halt the trial process after a participant developed an adverse event in the United Kingdom (UK). Later, Drug Control General of India (DCGI) gave its nod to conduct the second and third phase of the trial. However, both civic hospitals had to get the final approval from their ethics committees before starting with the screening of volunteers.
Pune-based Serum Institute of India (SII), which is the world’s largest manufacturer of vaccines in terms of volume, and British-Swedish pharmaceutical giant AstraZeneca partnered together to manufacture the vaccine candidate formulated at the University of Oxford.
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