Recently the central drug standard control organization (CDSCO) has allowed Bharat Biotech India (BBIL) for conducting Phase 1 and 2 clinical trials on humans of "COVAXIN". The trial has been started from 1st July 2020. The Drug Controller General of India (DCGI) has given approval to the company for Phase 1 and II clinical trials.
According to the report of BBIL, this vaccine has a form of killed virus that doesn't have any potential for infecting or replicating in the body. It just enhances the immune system by allowing it to produce an antibody response against the virus.
Newly developed vaccines are required to fulfill the four stages of the testing process starting from preclinical trials and ending at Phase 3 clinical trial which is conducted on thousands of infected patients. After successful trials, the company monitors the use of vaccines on patients and submits their post-marketing surveillance details which check for long term side effects.
BBIL directed human trials in July but the testing report and final authorization are doubtful. Before approving Covaxin two other medications are already approved named Favipiravir 200 mg and other as Remdesivir.
Testing stages of COVAXIN:
In the first phase, a small group of patients will be injected by this vaccine, and the following reports are submitted mentioning whether the patient has any effective building in immunity or any side effect.
In the 2nd phase, this test will be performed on a group of thousand patients characterized on the basis of age and sex.
After successful trials, post-marketing surveillance is done to check any long-term adverse reaction of this injection on sufferers.
Read:- US Bought more than 90 percent stock of COVID Medication Remdesivir
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