The wait for the Covid-19 vaccine may be over soon, and according to sources, after the second phase of human trials of the vaccine in the country has passed, it is likely to be used on the frontline staff involved in the treatment of the coronavirus epidemic.
The human trials of India biotech vaccine Kovaxin made in the country will begin on Wednesday. Industry sources say that human trials of another vaccine involving coronavirus may begin in July. However, experts believe that even if the vaccine completes the third phase of clinical trials, it will still take at least a year to get marketing permission.
The first phase of testing primarily tests vaccine toxicity on a small population and typically takes a month or more. At the same time, its effect is seen in the second phase test and its dose is determined which may take about six months. If all goes well, some vaccines associated with Covid-19 may complete another level of human trials by the end of this year.
An industry source said, 'However, there is a possibility that after the completion of Phase II testing, at least the frontline staff, especially doctors and other health professionals, have no option of treatment in critical conditions. But the vaccine can be given. The source said that the information related to the vaccine's effect and its safety will be available from the second phase itself, and the third phase test can continue simultaneously. However, the local industry feels that even if the vaccine is used based on no other alternative, the vaccine will not be available before March next year.
A senior government official said that no decision has been taken yet. He said, 'We are closely monitoring the situation. It is important to protect the frontline employees. Also, plasma therapy is being used as a second option for serious patients and other trials are also underway. Therefore, we will take any decision at the right time only after the data related to human testing comes. But the safety of citizens is first.
Experts say this is an unprecedented situation. Rajiv Gandhi Biotechnology Center's Chief Scientific Officer E Srikumar says that the use of these drugs has been started in the event of no alternative and similarly these vaccines without approval should be used for high-risk groups. Can. Even if this happens, it can be considered only after the second phase of testing.
The industry believes that the vaccination campaign for the treatment of Covid 19 is a major task in the country. Even if only 10 percent of the country's population is vaccinated, it will still be 130 million doses. If two shots are needed in the vaccine, then it means that 26 crore doses will have to be produced. A vaccine manufacturer said it would take a few years before the whole of India is covered. This will be a huge task. The manufacturers believe that the Covid 19 vaccine will be a multiple shot vaccine.
Bharat Biotech has indicated that they will begin human trials from Wednesday and data on first phase trials will be introduced soon. However, the company has not given any deadline for this. On Monday, the company claimed that the Drug Controller General of India approved to start the first and second phase of human clinical trials when the company presented the results of pre-clinical (animal) studies that showed safety and immunity response. Gave it The SARS-COV-2 strain was separated into the National Institute of Virology, Pune, an institute under the Indian Council of Medical Research (ICMR) and transferred to Bharat Biotech. The fully indigenous, inactivated vaccine was developed at Bharat Biotech's Biosafety Level 3 plant in Hyderabad.
The race to produce the Covid 19 vaccine includes Cadila Healthcare in Ahmedabad, Rambana Biotech (with Rifana) in Delhi, and Serum Institute in Pune (along with AstraZeneca for the Oxford vaccine). Globally, Oxford-AstraZeneca, Moderna, and China's Synovac Biotech are also going to conduct large-scale trials in July. In this case, the competition will be very strong. Other sources in the industry say that the Drug Controller General of India has approved simultaneous Phase I and Phase II trials for the Bharat Biotech vaccine, indicating that the government also wants to speed it up.
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