Over the past four days, the Indian arm of the American pharmaceutical giant Pfizer, the Pune-based Serum Institute of India, and the Hyderabad-based pharmaceutical company Bharat Biotech, applied to the Comptroller General of Drugs of India (DCGI) an emergency use authorization for your potential Covid -19 vaccines.
In a press conference, NITI member Aayog (Health) VK Paul said that the Covid-19 situation in India has stabilized with active cases showing a “clear downward trend” despite the fact that the situation of the pandemic in many other countries is becoming quite serious.
The concern and anxiety that arose after an increase in daily cases of infection in Delhi have also now settled, he said.
When asked what steps the DCGI would take in the absence of a watertight emergency use authorization law to license vaccine manufacturers, Union Health Secretary Rajesh Bhushan said that not all regulatory frameworks or rules and acts of the countries mention the authorization of emergency use.
“So, the fact that this phrase is not used in the national regulatory framework of any country does not mean that a specific country does not have an enabling provision to grant an approval that is anticipated and that is different from a regular approval of the market.
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“India’s regulatory framework has a specific provision for granting emergency use authorization. Although this phrase is not used,” he said.
The 2019 New Drugs and Clinical Trials Rules clearly specify that, in specific special situations, approval of the relaxation, abbreviation, omission or deferral of data, including data from local clinical trials, may be considered.
“This is our law. Similarly, other countries also have their laws,” Bhushan said.
Offering a bird’s-eye view of the Indian landscape of Covid-19 vaccines, Bhushan mentioned that eight vaccines are in different stages of development.
One is Covishield, which is being manufactured by the Serum Institute of India in collaboration with AstraZeneca. Phase two and three clinical trials of this vaccine are underway and the company has applied for an emergency use authorization.
Another is Covaxin, which is being indigenously developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and is currently in phase three of clinical trials. It has also requested the authorization of emergency use from DCGI.
The third is ZyCOV-D, which is being developed by Cadila Healthcare Ltd in Ahmedabad in collaboration with the Central Government Department of Biotechnology and is in phase two of the trials.
The fourth candidate vaccine is Sputnik V, which is being manufactured by Dr. Reddy’s Lab, Hyderabad, in collaboration with the Gamaleya National Center of Russia and in accordance with their mutual agreement. The phase two trial in India has ended and phase three will begin next week.
The fifth is NVX-CoV2373, which is being developed by the Serum Institute of India in collaboration with Novavax and its phase three clinical trial is under consideration with the drug regulator.
The sixth candidate vaccine is a recombinant protein antigen-based vaccine, which will be manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA. Its preclinical studies in animals have been completed and phase human clinical trials have begun. one and two. Another is HGCO 19 manufactured by Genova in Pune in collaboration with HDT, USA Its preclinical studies in animals have been completed and phases one and two clinical trials are scheduled to begin.
The eighth vaccine is being developed by Bharat Biotech International Ltd in collaboration with Thomas Jefferson University, USA and is in the preclinical stages.
“Another vaccine, which is in the early stages, is the one being developed by Aurbindo Pharma. So there are a total of nine vaccines of which six are in clinical trials and three are in the preclinical stage,” Bhushan said.
“There are several candidate vaccines in different stages of development and some may be licensed in the next few weeks. But we cannot predict at this time because licensing or market authorization is the domain of the national regulator.”
Most vaccines are two or three doses and are given three to four weeks apart. It is important to note that even after vaccination, precautions against Covid must be taken and this has also been recommended by the WHO, Bhushan said, adding: “Vaccination does not mean that people become carefree.”
Regarding the increase of the cold chain infrastructure, the health secretary said that currently the system consists of 85,634 equipment for the storage of vaccines in approximately 28,947 points of the cold chain throughout the country.
“Data on frontline healthcare workers is uploaded to Co-WIN software in preparation for Covid-19 vaccination. The current cold chain is capable of storing the first three-crore batch of Covid-19 vaccines for healthcare, frontline workers, “he said.
He told the press conference that while 2.38 lakh from assistant nurse midwives (ANM) provide vaccination under the universal immunization program, only 1.54 lakh from such health workers will be used for Covid-19 inoculation.
“The National Group of Experts on the Administration of Vaccines for Covid-19 (NEGVAC) has recommended that around one million healthcare workers should be prioritized in the vaccination campaign,” added Bhushan.
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