The clinical trial of Corona virus indigenous vaccine Covaxin will begin this week. The vaccine prepared by ICMR’s NIV and Bharat Biotech together will be tested in 12 institutes. The codename for this vaccine is BBV152. ICMR has chosen institutes where there is a clinical pharmacology wing and health care professionals with experience in human trials.
The vaccine trial will begin from July 10 in AIIMS Patna. At the same time, the trial process has started on Tuesday at the Nizam Institute of Medical Sciences (NIMS) in Hyderabad. According to Monday’s update to the Clinical Trials Registry, the first enrollment of vaccine will be on July 12.
Currently samples of vaccine are being tested-
While 12 institutes have started enrolling participants for the trial. On the other hand, the samples of the vaccine are being chased. He is undergoing quality and safety tests at a government center. These tests, which started last Friday, are expected to be completed by next week.
It cannot be hurried because it is being ensured that the vaccine is safe for use on humans. Testing can begin only after the vaccine stock reaches the institute. For this, Bharat Biotech will need clearance from Central Drugs Laboratory in Kasauli.
How will the trial of vaccine take place?
NIMS Director Dr. K. Manohar told PTI that he will choose some healthy people and his blood sample will be taken. These samples will be sent to a lab in New Delhi. After getting the green signal from there, they will be given the first shot of the vaccine after examining them. Dr. Manohar said that all the details will be sent to ICMR. At the same time the data is being analyzed. He also said that at least 30 people would be needed for a human trial.
How long will the trial take?
According to the protocol on the clinical trials registry, the first phase will take at least one month. The data received from him will have to be presented to the Drug Controller of India and then the next stage permission will be obtained. Phases 1 and 2 may take a year and three months in total.
AIIMS will be trial on 100 people in Patna
A team of doctors has been formed at AIIMS Patna. Superintendent Dr. CM Singh here told our colleague TOI that the pre-clinical trial of vaccine on animals has been successful. Its results were also encouraging. He said that initially 100 healthy people will be tried, whose age will be between 22 to 50 years. In the second phase, the number of people can be increased.