Hyderabad-based Bharat Biotech has said it has commenced Phase III trials of COVAXIN™ today (November 17, 2020).
According to the company, this exercise, conducted in partnership with ICMR, will involve 26,000 volunteers across India.
This is being claimed as the largest clinical trial conducted for a COVID-19 vaccine in India and the country’s first phase 3 efficacy study for a Covid-19 vaccine, and the largest phase III efficacy trial ever conducted in India.
Registered at www.ctri.nic.in (CTRI/2020/11/028976), the trial has been approved by the Drugs Controller General of India.
Volunteers taking part in the trial will receive two intramuscular injections approximately 28 days apart.
They will be randomly assigned to receive COVAXIN or placebo. The trial is double blinded, such that the participants, the investigators and the company will not be aware of who is assigned to which group.
Suchitra Ella, Joint Managing Director of Bharat Biotech said, “The development and clinical evaluation of COVAXIN marks a significant milestone for vaccinology in India, for a novel vaccine.”
She said it is important for Indian companies to innovate and develop indigenous vaccines, especially during a pandemic. COVAXIN has garnered interest from several countries
worldwide for supplies and introduction.
So far, COVAXIN has been tested in ~ 1000 subjects in Phase I and Phase II clinical trials. Volunteers willing to participate in this trial should be adults over 18 years of age.
COVAXIN is India’s indigenous Covid-19 vaccine developed by Bharat Biotech in association with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio containment facility develops and manufactures this indigenous, inactivated vaccine.
(With inputs from The OnLook News Research Bureau)