Three COVID-19 vaccines candidates, created by Bharat Biotech, Serum Institute of India and Pfizer, are beneath active consideration of India’s drug regulator and there is hope that early licensure is attainable for all or any of them, the Union well being ministry mentioned on Tuesday. Over the final 4 days, the Indian arm of US pharmaceutical giant Pfizer, Pune-primarily based Serum Institute of India and Hyderabad-primarily based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India (DCGI) searching for emergency use authorisation for their possible COVID-19 vaccines.
At a press briefing, NITI Aayog member (Health) V K Paul mentioned the COVID-19 predicament in India has stabilised with active instances displaying a “clear-cut declining trend” even although the pandemic predicament in quite a few other nations is becoming fairly significant. The concern and anxiousness that arose following an boost in every day instances of infection in Delhi has also settled now, he mentioned.
Asked what methods 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 mentioned not all countries’ regulatory framework or guidelines 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 mentioned. The New Drugs and Clinical Trials Rules, 2019, clearly specifies that beneath distinct unique scenarios, relaxation, abbreviation, omission, or deferment of information like regional clinical trial information may perhaps be regarded as for approval.
“This is our law. Similarly other countries also have their legislations,” Bhushan mentioned. Giving a bird’s-eye view of the Indian landscape of COVID-19 vaccines, Bhushan talked about that eight vaccines are at unique stages of improvement.
One is Covishield, which is getting manufactured by Serum Institute of India in collaboration with AstraZeneca. Phase two and 3 clinical trials of this vaccine is underway and the firm has applied kind emergency use authorisation.
Another is Covaxin, which is getting indigenously created by Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) and is presently in phase 3 of clinical trials. It has also applied to the DCGI searching for emergency use authorisation. The third one particular is ZyCOV-D, getting created 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 getting 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 more than and phase 3 will start subsequent week.
The fifth one particular is NVX-CoV2373, which is getting created by Serum Institute of India in collaboration with Novavax and its phase 3 clinical trial is beneath consideration with the drug regulator.
The sixth vaccine candidate is Recombinant Protein Antigen primarily based vaccine, to be manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA. Its pre-clinical animal research have concluded and phase one particular and two human clinical trials have began. Another one particular is HGCO 19 getting manufactured by Genova in Pune in collaboration with HDT, USA. Its pre-clinical animal research are more than and phase one particular and two clinical trials is set to start off.
The eighth vaccine is getting created 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 mentioned. “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 3 doses to be administered 3 to 4 weeks apart. Significant to note that even soon after vaccination, COVID precautions have to be taken and this has been advised by WHO also, Bhushan mentioned, adding, “Vaccination does not mean people become carefree.”
About cold chain infrastructure augmentation, the well being secretary mentioned presently the technique consists of 85,634 gear for storage of vaccine at about 28,947 cold chain points across the nation. “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 mentioned.
He told the press conference that although 2.38 lakh auxiliary nurse midwives (ANMs) present vaccination beneath universal immunisation programme, only 1.54 lakh such well being workers will be utilised 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,” Bhushan added