With three vaccine-makers having applied for emergency use authorisation in India, the vaccination drive in India is all likely to be kicked off soon though the Union Health Ministry did not specify the exact date, leaving it upon the DCGI approval for license.
Three COVID-19 vaccines candidates, developed by Bharat Biotech, Serum Institute of India and Pfizer, are under active consideration of India’s drug regulator and there is hope that early licensure is possible for all or any of them, Union Health Secretary Rajesh Bhushan said at a presser here on Tuesday.
Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for their potential COVID-19 vaccines.
“Once we get a green signal from our scientists, we’ll launch massive production of the vaccine. We’ve made all the preparations and drawn an outline to ramp up production of the vaccine to make it available to each and every person in the shortest possible time,” said the Secretary.
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, Bhushan 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 specific country does not have an enabling provision to accord an approval which is early and which is distinct from a regular market approval.
“India’s regulatory framework has a specific provision for grant of emergency use authorisation. Although this phrase is not used,” he said.
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.
Presently, eight vaccines are at different stages of development in the country.
One is Covishield, which is being manufactured by Serum Institute of India in collaboration with AstraZeneca. Phase two and three clinical trials of this vaccine is underway and the firm has applied form emergency use authorisation.
Another is Covaxin, which is being indigenously developed by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) and is presently in phase three of clinical trials. It has also applied to the DCGI seeking emergency use authorisation.
The third one is ZyCOV-D, being developed by Cadila Healthcare Ltd in Ahmedabad in collaboration with central government’s Department of Biotechnology and is in phase two of the trials.
The fourth vaccine candidate is Sputnik V which is being manufactured by Dr Reddy’s Lab, Hyderabad, in collaboration with Russia’s Gamaleya National Centre and according to their mutual agreement. 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 Serum Institute of India in collaboration with Novavax and its phase three clinical trial is under consideration with the drug regulator while the sixth vaccine candidate is Recombinant Protein Antigen based vaccine, to be manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA. Another one is HGCO 19 being manufactured by Genova in Pune in collaboration with HDT, USA.
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.
However, Bhushan said, adding, “Vaccination does not mean people become carefree.”
NITI Aayog member (Health) V K Paul said the COVID-19 situation in India has stabilised with active cases showing a “clear-cut declining trend” even though 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.