India First COVID-19 Vaccine Trial
COVAXIN is being developed by Hyderabad-based BHARATBIOTECH in collaboration with the Indian Council of Medical Research’s Pune-based National Institute of Virology. Covaxin has started the first phase of human clinical trials For India’s first coronavirus vaccine candidate Covaxin.
It is an "inactivated" vaccine made particles of COVID-19 virus were killed so they would not harm or replicate in the human body while vaccines injected in the body. It is RNA based vaccine that is released a SARAS-COV-2 to observe how the immune system responds. This type of inactivated vaccine usually doesn't provide immunity protection that's a strong as live vaccines that mean you will take a booster shot of vaccine within time to time.
AIIMS to start first Human Trial of COVAXIN
AIIMS Delhi will begin the human trial of India,s first COVID-19 vaccine, Covaxin, from Monday, the test applies on 100 healthy human volunteers which are aged between 18 to 55. Aiims clinical committee gave its human trial for covaxing on 18 July 2020, Saturday.
Generally, there are several stages of the development cycle of vaccines such as the Exploratory stage, the Preclinical stage, Clinical development regulatory review, and approval, Manufacturing then Quality control. So now vaccines passed two-stage and enter in Human clinical trial stage.
Clinical Development is a three-phase process.
PHASE I
Phase 1 trial examines a small group of people between 20 to 80 individual who tests different doses of diseases of an experimental treatment.
Over several months, monitor each volunteer after the treatment and observe what common side effects of doses.
PHASE II
Phase 2 trial examines a hundred groups of people and monitors for several months.it is a secondary measure of safety, at this stage select volunteer according to their health and age because some have chronic condition likely to develop severe symptom to others like heart, diabetes problem so this can monitor in phase2
PHASE III
Phase 3 trials follow a 500 to 8000 volunteer several times. Researchers observe side effects with a large group of people that occur during the trial period .they can catch the long term effect as they emerge. This phase must be decided that a given drug or vaccine provides the medicinal benefits. This phase has to prove the target of curing people so it is the most important phase for the approval vaccine forward to deliver in the market.
so DCGI drug controller general of India approval for phase I and phase II human clinical trial will begin across India from July 2020 after the pre-clinical trial by BHARAT BIOTECH. After it vaccinates group volunteers observe for 7-10 days while collecting data on the vaccine safety from this group then it is submitted to Data Safety and Monitoring who study the information and decide whether it is safe to human or not. If safety symptoms observed then the site will be allowed to continue the trial and vaccinate many people participants in phase I and will be vaccinated twice in phase I trials.
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