Mumbai: So far, 163 healthy volunteers in the city have been administered intramuscular injections of 'Covishield', the potential Covid-19 vaccine as part of the Phase 2 human trials. The Brihanmumbai Municipal Corporation (BMC) is seeking 50 more volunteers before it concludes the selection process for the pan-India trial in Mumbai. Civic officials said they had not received any complaints from volunteers about any side effects from the vaccine, so far.
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).
On September 26, both, the King Edward Memorial (KEM) and BYL Nair Hospitals had embarked on clinical trials of the vaccine, for which many had volunteered. “So far, the trials are going well and we are planning to add 50 more volunteers, which means 25 each from the two hospitals, as we have to conduct trials on 200 volunteers. However, if we are unable to find 50 more volunteers and experts feel that 163 candidates are enough to conclude the second phase of the trial, we may stop selecting more candidates,” said Additional Municipal Commissioner Suresh Kakani.
One of the volunteers said there was no side effect of the vaccine and the medical health officer from KEM hospital was regularly monitoring their health through phone calls. “I had participated in the vaccine trial in the first week of October and have not experienced any health problems since then,” he said.
As per the Indian Council of Medical Research (ICMR), each of the volunteers have a Rs 1 crore life insurance cover in the event of their death from any side effect during the trial. Also, they have Rs 50 lakh as medical insurance if they suffer any adverse reaction from the vaccine. “So far, none of the participants has reported any adverse effect,” Kakani said.
“Each of the participants has to undergo an RT-PCR (reverse transcription-polymerase chain reaction) test to check if they are carrying the Covid-19 pathogen. Then, through rapid antibody testing, we cross-check if the participants were ever infected with the virus in the past. Most of the participants are young, 20-45 years,” he added.
The vaccine induces a strong immune response. It provokes a T-cell (white blood cells that can attack cells infected with the virus) response within 14 days of vaccination and an antibody response within 28 days.
The Pune-based Serum Institute of India (SII), which is the world’s largest manufacturer of vaccines in terms of volume, and the British-Swedish pharmaceutical giant AstraZeneca have partnered to manufacture the experimental Covid-19 vaccine candidate formulated at the University of Oxford.