Bharat Biotechs Covaxin gets the nod for phase 3 clinical trials

Covaxin, the indigenous COVID-19 vaccine candidate has received a nod for Phase-3 clinical trials in the country.
Sheena

Updated: Oct 24, 2020 01:29:20 pm

Bharat Biotechs Covaxin gets the nod for phase 3 clinical trials

24 October 2020 Current Affairs:

The vaccine developed by Bharat Biotech in collaboration with the Indian Council Of Medical Research (ICMR) — Covaxin, has been cleared for the third phase of clinical trials.

Highlights:
♦ Covaxin, the indigenous COVID-19 vaccine candidate has received a nod for Phase-3 clinical trials in the country. 
♦ The vaccine is developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
♦ The Drug Controller General of India has given assent for the last phase of clinical trials with certain conditions. 
♦ The development comes even as several companies across the world are racing against time to develop an effective vaccine against Coronavirus which has claimed more than 10 lakh lives worldwide.
♦ In the 3rd and final phase of trials, scheduled to begin in the first week of next month, the potential vaccine candidate will be tested on over 28,000 people aged 18 years and above. 
♦ These tests will be conducted across 10 states and 19 sites including Delhi, Mumbai, Patna and Lucknow among others.
♦ Besides, Bharat Biotech’s COVAXIN, ZydusCadila Limited is another indigenously developed vaccine candidate which is in Phase -2 of human clinical trials.
♦ Recently, drug maker–Bharat Biotech submitted safety and immunogenicity data from an ongoing phase II trial to DCGI for conducting phase III clinical trial for Covaxin. 
♦ However, the expert committee asked the pharma company to submit safety and immunogenicity data from the phase II clinical trial for consideration.
♦ The DCGI - Drug Controller General of India had granted permission in July to Bharat Biotech pharma giant to conduct phase I and II clinical trials to develop an indigenous vaccine for COVID-19.
♦ Bharat Biotech in collaboration with ICMR is making COVID-19 vaccine using the virus strain isolated by Pune-based National Institute of Virology (NIV). 

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