Three COVID-19 vaccine 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, the Union health ministry said.
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.
NITI Aayog member (Health) VK 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.
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, Union Health Secretary Rajesh 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,” Mr Bhushan said.
“India’s regulatory framework has a specific provision for grant of emergency use authorisation. Although this phrase is not used,” he added.
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,” Mr Bhushan said.
He mentioned that eight vaccines are at different stages of development.
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.
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,” Mr Bhushan said.
“There are multiple vaccine candidates in different stages of development and some may get licensed in the next few weeks. But we cannot foretell at this moment because licensure or market authorization is the domain of the national regulator.”
Most of the vaccines are of two or three doses to be administered three to four weeks apart. Significant to note that even after vaccination, COVID precautions must be taken and this has been advised by WHO also, Mr Bhushan said, adding: “Vaccination does not mean people become carefree.”
About cold chain infrastructure augmentation, the health secretary said presently the system consists of 85,634 equipment for storage of vaccine at about 28,947 cold chain points across the country.
“Data on frontline healthcare workers being is uploaded on Co-WIN software in preparation of COVID-19 vaccination. The current cold chain is capable of storing the first lot of three crore COVID-19 vaccines for healthcare, frontline workers,” he said.
He said while 2.38 lakh auxiliary nurse midwives (ANMs) provide vaccination under universal immunisation programme, only 1.54 lakh such health workers will be used for COVID-19 inoculation.
“National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) has recommended that around one crore health workers should be given priority in the vaccination drive,” Mr Bhushan added.