Home >Science >Health >Govt puts clearances for Serum Institute’s vaccine on fast track

NEW DELHI : The government is speeding up the regulatory clearances needed for the Serum Institute of India’s upcoming phase 3 trial of the promising covid-19 vaccine being developed by the University of Oxford, NITI Aayog member V.K. Paul said on Tuesday.

Apart from expediting processes through the drug controller general’s office, the government is also willing to provide whatever financial and other support is needed by vaccine developers to develop the vaccine, said Paul, 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 the people of India and the international community have 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 of vaccines, drugs and other medical products for covid-19 is already in place, and even foreign developers can use that route.

In a statement on Monday, Serum Institute of India chief executive officer Adar Poonawalla said that the company will apply for permission for 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 licensed the vaccine candidate, which it is jointly developing with the University of Oxford, to the Serum Institute of India for the 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 on Monday showing that the Oxford vaccine candidate was safe and started providing immunity against the fatal respiratory disease after 14 days of the first dose.

Preliminary results from phase-1 and- 2 Oxford trials, involving 1,077 healthy adults in the age group of 18-55 years, found that the 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, seven vaccine candidates are being developed by Indian firms -- 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.

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