New Delhi: Three COVID-19 vaccines candidates are under active consideration of India’s drug regulator (DCGI), the Union Health Ministry said Tuesday. The vaccines have been developed by Bharat Biotech, Serum Institute of India (SII) and Pfizer. There is hope that early licensure is possible for all or any of them, the Health Ministry informed.
Over the last four days, Pfizer, SII and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India (DCGI). All three have sought emergency use authorisation for their potential COVID-19 vaccines.
At a press briefing, NITI Aayog member (Health) VK Paul said the COVID-19 situation in India has stabilized. He said the active cases are showing a ‘clear-cut declining trend’. However, the pandemic situation in many other countries is becoming quite serious. The concern and anxiety that arose following an increase in daily cases of infection in Delhi has also settled now, he said.
Union Health Secretary Rajesh Bhushan was asked what steps would be followed by the DCGI in the absence of a water-tight emergency use authorisation law for granting licence to vaccine makers. He said not all countries’ regulatory framework or rules and acts mention emergency use authorisation.
“So, the fact that this phrase is not used in the national regulatory framework of any country does not mean that it does not have an enabling provision to accord an approval which is early and which is distinct from a regular market approval,” Bhushan said.
“India’s regulatory framework has a specific provision for grant of emergency use authorisation. Although this phrase is not used,” asserted Bhushan.
“The ‘New Drugs and Clinical Trials Rules, 2019’, clearly specifies that under specific special situations, relaxation, abbreviation, omission, or deferment of data including local clinical trial data may be considered for approval. This is our law. Similarly other countries also have their legislations,” Bhushan said.
Giving a bird’s-eye view of the Indian landscape of COVID-19 vaccines, Bhushan said that eight are at different stages of development.
One is ‘Covishield’, which is being manufactured by SII in collaboration with AstraZeneca. Another is ‘Covaxin’, which is being indigenously developed by Bharat Biotech in collaboration with ICMR. The third one is ZyCOV-D, being developed by Cadila Healthcare Ltd in Ahmedabad. It is being done in collaboration with central government’s ‘Department of Biotechnology’. Currently this vaccine is in phase two of the trials.
The fourth vaccine candidate is Sputnik V. It is being manufactured by Dr Reddy’s Lab, Hyderabad, in collaboration with Russia’s Gamaleya National Centre. The phase two trial in India is over and phase three will begin next week.
The fifth one is NVX-CoV2373, which is being developed by SII in collaboration with Novavax. Its phase three clinical trial is under consideration with the drug regulator.
The sixth vaccine candidate is Recombinant Protein Antigen based vaccine, to be manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA. Its pre-clinical animal studies have concluded and phase one and two human clinical trials have started. Another one is HGCO 19 being manufactured by Genova in Pune in collaboration with HDT, USA. Its pre-clinical animal studies are over and phase one and two clinical trials is set to start.
The eighth vaccine is being developed by Bharat Biotech International Ltd in collaboration with Thomas Jefferson University, USA and it is at the pre-clinical stages.
“Another vaccine, which is in initial stages, is the one being developed by Aurbindo Pharma. So there are a total of nine vaccines out of which six are in clinical trials and three are in pre-clinical stage,” Bhushan said.
