Health
Covid-19: The first Indian vaccine trials will be conducted at 12 hospitals including Karnataka
The first Indian vaccine clinical trials against Covid-19 will take place in about 12 hospitals, including one in Karnataka and two AIIMS in Delhi and Patna, but ironically, the ongoing Covid-19 pandemic May slow down the process a little.
The Jeevan Sakhi multi-specialty hospital in Belgavi will be one of the units in which multi-city clinical trials of vaccines will be conducted. Two All-Indian Institutes of Medical Science and Nizam Institute of Medical Sciences in Hyderabad will also be part of the study.
Follow: Coronavirus India Update: Confirmed Cases by State, Deaths on 2 July
The first few batches of the vaccine named Covaxin, developed by Hyderabad-based Bharat Biotech, will be sent to the Kassori Central Laboratory for certification and then to the hospitals involved in the trial. In parallel, the Ethics Committee has been approved.
“While the trial is set to start in July 2020, placing vaccine transport logistics in the middle of the sheer number of restrictions imposed by the government for the Covid-19 pandemic can be a challenge. It turned out that we can’t promise now when the trial will start and when the results will be available.
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India’s Drug Controller General has granted permission to initiate Phase I and II human clinical trials after submitting the results of preclinical studies demonstrating safety and immune responses. Phase 1 trials will check vaccines for human safety, whereas Phase II will be limited in efficacy.
During the trial, medical researchers will examine the efficacy of the vaccine in single and double doses on Days 1 and 14. This vaccine was made from a null strain of Covid-19 virus isolated at the National Institute of Viruses in Pune.
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Inactivated vaccines have been around for decades. Some of these vaccines are used to combat seasonal flu, polio, rabies, whooping cough, and Japanese encephalitis.
When the vaccine is injected into humans, it is a virus that has been killed, so it cannot infect or replicate. Causes the immune system to function as a dead virus, initiating an antibody response to the virus.
Bharat Biotech produced the first GMP grade batch of vaccine within 40 days of receiving the isolate from NIV.
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