Serum Institute gets DCGI nod to conduct clinical trials of Oxford COVID-19 vaccine

New Delhi, Aug 3: In a major development, Drugs Controller General of India (DCGI) gave a green signal to the Serum Institute of India (SII) to conduct Phase 2 and phase 3 human clinical trials of Oxford-AstraZeneca coronavirus vaccine in India.

 

 

 

The vaccine will be called Covishield in India. This decision comes after the expert panel at the Central Drugs Standard Control Organisation (CDSCO) had on Friday recommended granting permission for phase 2 and 3 clinical trials of the vaccine - Covishield on healthy adults in India. The firm has to submit safety data, evaluated by the Data Safety Monitoring Board (DSMB), to the CDSCO before proceeding to phase 3 clinical trials.

 

The officials said that the SII had submitted a revised proposal on Wednesday after the expert panel on Tuesday, following deliberation over its application, had asked it to revise its protocol for the phase 2 and 3 clinical trials besides seeking some additional information. It also attached a memorandum of understanding (MoU) signed with India’s apex health research body, the Indian Council of Medical Research (ICMR).

 

According to the revised proposal, 1,600 people aged above 18 years will participate in the trials across 17 selected sites, including AIIMS Delhi, B J Medical College in Pune.

 

Serum Institute CEO Adar Poonawalla said the Oxford-AstraZeneca coronavirus vaccine will be branded as Covishield and they are hopeful that it will be an efficacious, immunogenic vaccine, viable for mass use. He said they hope to launch it by the end of 2020 and by first quarter Covishield will start reaching masses.

 

SII, the world’s largest vaccine manufacturer. SII has partnered with AstraZeneca which has got the license of manufacturing Oxford's vaccine. It has invested USD 100 million on a potential COVID-19 vaccine to ensure equitable supply of the AZD1222 vaccine doses to India as well as low-and-middle-income countries.

 

Currently, phase 2, 3 clinical trials of the Oxford sponsor vaccine is ongoing in the United Kingdom, phase 3 clinical trial in Brazil, and phase 1, 2 clinical trials in South Africa. More than 10,000 people will participate in the next stage of the trials in the United Kingdom. The vaccine prompted no serious side effects and elicited antibody and T-cell immune responses with the strongest response seen in people who received two doses.