Mumbai’s KEM Hospital starts Oxford’s Covid-19 vaccine trial, 3 volunteers administered dosage on Day 1
After days of delay, Parel’s King Edward Memorial (KEM) Hospital finally on Saturday started the clinical trial of the Covid-19 vaccination produced by the University of Oxford. On Day 1, three volunteers between 20 and 45 years of age were administered the first dosage of the drug.
According to hospital sources, two of the volunteers are businessmen, while the third is a researcher with a government body. None of them have any comorbidity. They underwent reverse transcription-polymerase chain reaction (RT-PCR) test to ascertain if they are infected with Covid-19. Their antibody test revealed that they were exposed to the virus.
“The volunteers were given the dosage in the afternoon, following which they rested in the hospital for an hour. Later, they were discharged from the hospital, but we will keep a close check on their health,” said Dr Hemant Deshmukh, dean, KEM Hospital.
“As per randomisation, out of every four participants, one will receive a placebo (false drug),” he said.
The hospital has selected 20 more volunteers for the trials. As per the Indian Council of Medical Research (ICMR), each of the volunteers has been covered under ₹1-crore life insurance, in case they die due to any side-effect during the trial. Also, they have been given a medical insurance of ₹50 lakh, in case they develop any adverse effect from the vaccination.
The vaccine induces a strong immune response. It provokes a T cell (white blood cells that can attack cells infected with coronavirus) response within 14 days of vaccination and an antibody response within 28 days.
Meanwhile, BYL Nair Hospital has selected three women volunteers for the clinical trial, which is likely to start from Monday.
In the second week of September, KEM and Nair hospitals had to halt the trial after a participant developed an adverse condition in the United Kingdom (UK). Later, the Drug Control General of India (DCGI) gave its nod to run the second and third phases of the trial. However, both the civic hospitals had to get the final approval from their ethics committees before starting with the screening of the volunteers.
Meanwhile, Pune-based Serum Institute of India (SII) – which is the world’s largest manufacturer of vaccines in terms of volume – partnered with British-Swedish pharmaceutical giant AstraZeneca to manufacture the experimental Covid-19 vaccine candidate, formulated at the University of Oxford.