Through this video, you will come to know the developmental stages of vaccine. Each vaccine need to go through different phases of clinical trial before introducing it in the market. Preclinical trial or animal study is the initial study in which the vaccine developed is tried in animals like mice, rabbit or guinea pig. If the trial proves that the developed vaccine is safe and efficacious, then it will move to Phase 1 clinical trial. In Phase 1 study, the developed vaccine will be tried in human beings. Healthy individuals only will be participating in this study. Safety and maximum tolerable dosage limit will be obtained from this phase 1 trial. If the phase 1 results are safe, then it will move to phase 2 trial. In phase 2, efficacy and safety of the drug can be known. Developed vaccine will be provided to moderate quantity of individual ( Say100 to 1000 ) of different age group, different gender and also for healthy individual as well as individuals with any comorbid conditions like diabetes or hypertension. If Phase 2 trial results are proven to be safe and efficacious in tested individuals , then it moves to Phase 3. In phase 3, large number of individuals will be used to confirm whether the dose is efficacious and safe. In phase 3, the group will be divided into 2; one is the experimental group who will be receiving the actual developed vaccine and other is the control group who will receive placebo. Large population from various countries of different age group, different gender and also for healthy individual as well as individuals with any comorbid conditions like diabetes or hypertension will be involved in phase 3 trial. Both the groups will be allowed to interact with people and move with the society as usual. After a stipulated time frame, both the groups will be tested for the efficacy of drug. If in experimental group, most of all the individuals were tested negative, when comparing with the placebo group, we can confirm that the developed vaccine is effective in developing the antibodies against the virus. If Phase 1,2 & 3 results prove the developed vaccine is safe and effective, then it will be moved for FDA approval. FDA examine the results and if its good as per the trials, then they approve to launch the vaccine in the market.
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17 май 2021
