Serum Institute of India has asked approval from the Drugs Controller General of India (DGCI) to start the phase II and III trial of the COVID-19 vaccine, developed by the University of Oxford, in India.
Known as AZD1222, the vaccine candidate has been made by the Jenner Institute, a part of the Nuffield Department of Medicine at the University of Oxford. The formulation is backed by by AstraZeneca PLC, a British-Swedish pharmaceutical company. AstraZeneca has joined hands with Serum Institute of India to produce the potential vaccine.
According to a report by news agency Press Trust of India (PTI), Adar Poonawalla led drug firm submitted its application to the DCGI on Friday seeking permission for conducting the trials of the vaccine candidate. The company will launch the vaccine under the brand name of Covishield if the trials are successful.
Around 1,600 participants will take part in the phase II human trial of COVID-19 vaccine candidate. The trial will start next month. "According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of 'Covishield' in healthy Indian adults," according to PTI.
The vaccine candidate is safe and prompts protective immune response, according to a report in The Lancet.
"By the end of this year, we should be able to produce 3 to 4 million doses come end of December. That’s the target and I hope we can do that," Poonawalla said earlier. Serum Institute will manufacture up to 70 million doses of the vaccine per month up to October and plans to take it up to 100 million per month by December.
Asked about the pricing of Oxfords's COVID-19 vaccine in India, Poonawalla said, "It is too early to comment on the vaccine’s price. However, we will keep it under ₹1,000 per dose."
He further added it is extremely likely that the COVID-19 vaccine would require two or more doses, like in the case of antidotes for measles and other diseases.
"I don’t think any citizen of India or of any other country is going to have to pay for it because it is going to be bought by the government and distributed free," Poonawalla said. They expect the vaccine to reach the people of India in large numbers by the first quarter of 2021, he added.