By therandomsci / July 8, 2020
Covaxin India’s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). It is announced by ICMR that the coronavirus vaccine will be available on 15 Aug (Independence Day of India). It is possible to have a vaccine on such short term notice?
What is a clinical trial?
The clinical trial way that researchers find out if a new treatment, like a new drug or diet or medical device is safe and effective in people.
Clinical trials have four phases to test a treatment, find the appropriate dosage, and look for side effects. If, after the first three phases, researchers find a drug or other intervention to be safe and effective, the FDA (U.S. Food and Drug Administration) approves it for clinical use and continues to monitor its effects.
Clinical trials of drugs are usually described based on their phase. The FDA typically requires Phase I, II, and III trials to be conducted to determine if the drug can be approved for use.
PRECLINICAL TESTING: Scientists give the vaccine to animals such as mice or monkeys to see if it produces an immune response.
PHASE I SAFETY TRIALS: Scientists give the vaccine to a small number of people to test safety and dosage as well as to confirm that it stimulates the immune system.
PHASE II EXPANDED TRIALS: Scientists give the vaccine to hundreds of people split into groups, such as children and the elderly, to see if the vaccine acts differently in them. These trials further test the vaccine’s safety and ability to stimulate the immune system.
PHASE III EFFICACY TRIALS: Scientists give the vaccine to thousands of people and wait to see how many become infected, compared with volunteers who received a placebo. These trials can determine if the vaccine protects against the coronavirus.
APPROVAL: Regulators in each country review the trial results and decide whether to approve the vaccine or not. During a pandemic, a vaccine may receive emergency use authorization before getting formal approval.
In Phase II, III and FDA approval trials take approx. 3 years but if accelerated experts say it takes up to 1.5 years.
Any medicine or vaccine can do work of 1.5 years in just 1 month?
If possible. Is it safe to consume?
ICMR says Covaxin is the top priority project monitored at the topmost level of the government. So, is ICMR under pressure from the government to give some good news on Independence Day (15 Aug.)?
Maybe!
Reference and further reading:
https://www.nytimes.com/interactive/2020/science/coronavirus-vaccine-tracker.html
Good
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