How will the subjects be selected?
The report says that subjects will first be tested for physical fitness and their blood and swab samples will be sent to ICMR-designated lab in New Delhi. After getting reports, NIMs will check further and issue fitness certificates to the subjects.
What will happen during trials?
Each subject will receive two vaccine dosages of three micrograms and six micrograms. The second dose will be given 14 days after the first one. After the subject, is injected the vaccine, they will be monitored for two days in the ICU. If there are no complications, they will be sent home and further monitoring will be done virtually.
The report says that phase 1 of the trial will have 375 subjects while phase 2 will see 875 subjects.
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ICMR's deadline
Last week Bharat Biotech had announced that the vaccine being developed by the company will soon enter human trials. The vaccine being developed by the Hyderabad company is India's first vaccine candidate to enter clinical trials.
According to a report by ANI, the company developed the vaccine, Covaxin in collaboration with ICMR and the national institute to virology (NIV) by using a strain of SARS-CoV-2 which was isolated at the NIV. The inactive virus was then used to create Covaxin in the company’s Bio Safety Level 3 (BSL-3) lab located in Genome Valley, Hyderabad.
But the vaccine is now in controversy after the ICMR Director General Balram Bhargava sent a note to institutes participating in the trials to fast track all the approvals for launch and to initiate subject enrolment by July 7.
The medical body also stated that the vaccine trials have to be completed by August 15 before its public launch. The instruction is facing criticism from experts across the country who feel that it is not feasible to develop a functioning vaccine in such a short time.