Scientists at Oxford University say their experimental coronavirus vaccine has been shown in an early trial to prompt a protective immune response in hundreds of people who got the shot.
The royal looked at a laboratory where samples from the clinical trial were being examined by researchers.
According to the minutes of the meeting, the SEC has asked Serum to distribute clinical trial sites pan India, demarcate the phase II and Phase III part of the protocol. ET has seen the minutes of the meeting.
Phase I human trials were completed in the UK. In India, the volunteers will be administered two doses of the potential vaccine. Thereafter, four weeks apart, its safety and immunogenicity will be assessed.
As the Oxford-AstraZeneca's COVID-19 vaccine gains momentum after showing positive results in the initial trials, Serum Institute of India, headed by Adar Poonawalla is all set to conduct trials for the vaccine in India, and begin production of the doses as well. In an exclusive conversation with TIMES NOW's Swati Joshi, Adar Poonawalla talked about Oxford COVID-19 vaccine, its effectiveness and availability, Bharat Biotech-ICMR controversy and more. Listen-in!!!Oxford COVID vaccine likely to hit Indian market by early 2021: Serum Institute's CEO Poonawalla
Initial study shows that the Oxford-AstraZeneca vaccine for Covid-19 triggers antibody response and is safe. ET’s Divya Rajagopal gives an in-depth analysis of the vaccine which will go on trial in India soon. WatchOxford University Coronavirus vaccine: Why it raises hope
The trial data of a COVID-19 vaccine developed by AstraZeneca and Oxford University reveals that it is safe and induces immune response, with mild side effects in some participants, scientists announced on Monday.
Serum Institute to start manufacturing Oxford University's COVID vaccine in 3 weeks; launch by October if trials succeed
"Our team has been working closely with Dr Hill from Oxford University, and we are expecting to initiate production of the vaccine in 2-3 weeks and produce 5 million doses per month for the first 6 months, following which, we hope to scale up production to 10 million doses per month," Serum Institute India (SII) CEO Adar Poonawalla said.
Pharma giant AstraZeneca on Saturday said that clinical trials for the AstraZeneca Oxford coronavirus vaccine, AZD1222, have resumed in the UK following confirmation by the Medicines Health Regulatory Authority (MHRA) that the trials were safe.
"We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials", said Adar Poonawala, CEO of Serum Institute of India in a statement.
The study had been previously stopped in July for several days after a participant who got the vaccine developed neurological symptoms; it turned out to be an undiagnosed case of multiple sclerosis that was unrelated to the vaccine.
The regulator had issued a show cause notice to SII on Wednesday evening asking it to explain why trials shouldn’t be suspended. SII had said earlier that it would be continuing with trials despite the global halt.