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375 participants will take part in Phase I. They will be split into three groups of 125 and be administered two doses - one each of the candidate and control vaccine - 14 days apart. Pending satisfactory completion of Phase I, a further 750 participants will be registered for Phase II of the clinical trials.
According to the application made by Hyderabad-based Bharat Biotech, the timeframe for Phase I is 28 days, which means the trial must start by July 18 to meet the government's promise of releasing a vaccine by August 15.
It is unclear, however, if a COVID-19 vaccine can be released after finishing just one of three trial phases. Typically, the first two test for safety, while the third tests for efficacy. Each can take months, or years, to be completed.
In its application, which has been accessed by NDTV, Bharat Biotech replied "1 year, 3 months" in response to a question on "estimated duration of trial".
At a meeting of the CDSCO (Central Drugs Standard Control Organisation) on June 25, Bharat Biotech said it had already conducted safety and immunogenicity tests on rat, mice and rabbits. This was in response to a query by the CDSCO on animal toxicity data.
Bharat Biotech was then told to submit results of Phase I to the DGCI Drug Controller General of India) before proceeding to Phase II and to use the RT-PCR test as "confirmatory test for COVID-19 during screening".
Of the 12 hospitals and institutes selected by the ICMR for Phase I, II trials, seven have yet to be cleared by an ethics committee. These include the prestigious All India Institute of Medical Sciences in Delhi and Patna.
According to Bloomberg the timeline for launch of Bharat Biotech's COVAXIN is "markedly shorter than other front-runner vaccine efforts from American and Chinese drug makers, most of which started human clinical trials months ago and are now entering the last of three stages of testing".
On Sunday the Ministry of Science and Technology released a press statement that said although 11 of 140 coronavirus vaccine candidates in the world were in human trials, "none of these are likely to be ready for mass use before 2021". That line was edited out in a revised version of the statement.
Two of the world's leading vaccine candidates - AZD1222 (British firm AstraZeneca) and MRNA-1273 (US-based Moderna) - have been cleared for Phase II, III trials. Across the world over 1.14 crore COVID-19 cases have been reported, including 5.34 lakh deaths. India is now the third worst-affected country, with over seven lakh infections.
With input from Bloomberg
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