The Indian government is ready to expedite processes involved in Serum Institute of India’s upcoming phase 3 trial of the promising covid-19 vaccine that was developed by University of Oxford, NITI Aayog member V.K. Paul said at a press conference today.
Apart from expediting processes through the Drug Controller General of India’s office, the government has also said it is willing to provide whatever financial and other support that vaccine developers need for development of the crucial vaccine, Paul said. Paul is the chairperson of the National Task Force for Covid-19.
“Regulatory facilitation will be ensured. It is already being undertaken. If resources need to be supplemented, that will be actively considered. The government of India will leave no stone unturned to ensure that the people of India and the international community has access to an Indian vaccine as early as possible,” Paul said.
Rajesh Bhushan, officer on special duty and health secretary-designate, added that a process of accelerated approval for vaccines, drugs and other medical products to fight the covid-19 pandemic is already available, and even foreign developers are able to use that pathway.
Serum Institute of India chief executive officer Adar Poonawalla in a statement on Monday had said that the company will apply for a phase 3 trials for the Oxford vaccine in India next week and will begin the study soon.
“As soon as they grant us permission, we will begin with the trials for the vaccine in India. In addition, we will soon start manufacturing the vaccine in large volumes,” Poonawalla said.
Last month, AstraZeneca licenced the vaccine candidate, which it is jointly developing with the University of Oxford, to Serum Institute of India for supply of an additional one billion doses, principally for low- and middle-income countries. Total manufacturing capacity currently stands at two billion doses.
The vaccine has come out as the front runner among the over 150 candidates that are currently being developed, with interim data from a clinical study published in The Lancet, a peer-reviewed medical journal, on Monday showing that the University of Oxford’s vaccine candidate was safe and started providing immunity against the fatal respiratory disease after 14 days of the first dose.
Preliminary results from a phase-1 and- 2 Oxford trial, involving 1,077 healthy adults in the age group of 18-55 years, found that vaccine induced strong antibody and T cell immune responses up to day 56 of the ongoing trial.
Serum Institute is also co-developing its own vaccine with US-based firm Codagenix, which is currently in pre-clinical trial. Currently, there are seven vaccine candidates being developed by Indian firms, with one each by Zydus Cadila and Bharat Biotech International Ltd under phase 1 and 2 human trials and the rest in the pre-clinical stage.