Covid-19: No adverse effect of Oxford University vaccine on 163 Mumbai volunteers during clinical trials, says BMC
As many as 163 volunteers in Mumbai have participated in clinical trials of Covid-19 vaccine produced by the University of Oxford and Brihanmumbai Municipal Corporation (BMC) may enrol an additional 50 before concluding the selection process of the pan-India trial in Mumbai.
Both BMC-run King Edward Memorial (KEM) Hospital and BYL Nair Hospital started clinical trials of the vaccine last month in Mumbai .
“We are planning to include 50 more volunteers, 25 each from the two hospitals, for the trial. We are expected to run the trial on 200 volunteers. But if experts believe 163 candidates are enough for the conclusion of the second phase, we may stop selecting more candidates,” said BMC additional municipal commissioner Suresh Kakani.
As per the Indian Council of Medical Research (ICMR), each volunteer is covered with Rs 1 crore life insurance if they die due to any side effect during the trial. Also, they have Rs 50 lakh medical insurance if they develop any adverse effect from the vaccination. “So far, none of the participants has not had any adverse effect,” said Kakani.
The vaccine induces a strong immune response. It provokes a T-cell (white blood cells that can attack cells infected with Covid-19) response within 14 days of vaccination and an antibody response within 28 days.
Every participant has to undergo RT-PCR (Reverse transcription polymerase chain reaction) test to check if they are carrying Covid-19 pathogen. Then, through rapid antibody testing, the participants are cross-checked if they were infected with the virus in the past. Most participants are between the age group of 20 and 45 years.
In the second week of September, both hospitals had to halt the trial after a participant developed an adverse reaction in the United Kingdom. Later, the Drug Control General of India granted permission to run the second and third phases of the trial. However, both civic hospitals had to seek final approval from their ethics committees before starting the process of screening volunteers.
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.