COVID-19 vaccine's Phase III trials may commence soon

The Brihanmumbai Municipal Corporation (BMC) will soon start the third phase of the COVID-19 vaccine’s clinical trials once the first batch of the volunteers complete 28 days of the first vaccination. The move comes after the civic body completed the second trial of the COVID-19 vaccine being developed by Oxford University.

Meanwhile, the civic body authorities have also written to Indian Council of Medical Research (ICMR) inquiring if they want to include more number of volunteers for the second phase of the vaccine trial.

The second phase trial of the pandemic vaccine was completed on October 23 in which 200 healthy volunteers were administered intramuscular injections of 'Covishield', the potential COVID-19 vaccine.

“We have completed Phase 2 and now the trial report will be submitted to the Data Safety Monitoring Board, to the Central Drugs Standard Control Organisation to get approval for the third stage of the trial,” said Suresh Kakani, Additional Municipal Commissioner, BMC.

Moreover, as per the ICMR guidelines, the third phase of the trial can only be conducted on volunteers after a gap of 28 days.

On September 26 this year, the first dosage of the drug trial was given to three volunteers between the ages of 20 years and 45 years at KEM hospital. On October 23, they completed 28 days of their first vaccination. So, it is expected that the civic body will start the third trial by next week.

“As we have achieved our target of 100 volunteers, we have asked ICMR if they want us to include more volunteers. So far, we haven’t received any response. However, we have kept additional volunteers at the standby,” said Dr Ramesh Bharmal, dean of BYL Nair hospital.

Meanwhile, the civic body is ready to start the third phase as they will not wait for the ICMR response because the volunteers who have been administered the vaccines have completed 28 days.

“We can’t wait any further as we need to provide the third dosage to the first volunteers who have completed their 28 days of waiting period,” he said.

In August this year, the ICMR had selected King Edward Memorial (KEM) Hospital and BYL Nair Hospital for the human clinical trial of the coronavirus vaccine. It was instructed to take 160 volunteers at each hospital. Later, the number of total volunteers was reduced to 200 for conducting the second phase of the clinical trial.

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.

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.

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