COVID-19: Phase II Human Trials Begin for Covaxin in Nagpur
Covaxin has been jointly developed by Hyderabad’s Bharat Biotech, Indian Council of Medical Research.
Phase II of human trials for India’s first potential COVID vaccine ‘Covaxin’ have kickstarted in Nagpur, according to recent reports. Several sites had been readied to carry out phase 1 and 2 trials across the country.
What You Need to Know About Covaxin
Covaxin has been jointly developed by Hyderabad’s Bharat Biotech, Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). It has been produced with the help of inactive COVID-19 particles, making it an ‘inactivated vaccine’.
“Once the vaccine is injected into a human, it has no potential to infect or replicate since it is a killed virus. It just serves to the immune system as a dead virus and mounts an antibody response towards the virus.”Bharat Biotech
All you Need to Know About Covaxin Trials
Phase 1 trials of the vaccine kick-started last month at AIIMS Delhi and Patna, PGI, Rohtak and other sites. Phase II of human trials have now begun for the homegrown vaccine at the Gillurkar Hospital and Research Institute in Nagpur.
To ensure its safety and efficacy, a vaccine candidate undergoes three stages of human trials. The Phase I is conducted with 80-100 participants, to understand the body’s reaction to the drug as well as the dose range required. Clinical trials in Phase II entail administering the potential vaccine on hundreds of volunteers, to study the immune system response generated by the vaccine, and to obtain data on any side effects that may occur.
The vital parameters of the participants after Phase I of Covaxin trials were found to be normal and healthy, and a second dose of the vaccine was then administered. Their blood sample have now been taken for further tests.
“Through the blood test, we will check whether the first dose of Covaxin has developed any antibodies in participants. If antibodies are found, they will confirm the effectiveness of the vaccine,” Dr Gillurkar told TOI in a statement.
Results of the blood tests are expected in the next few days.
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