The third phase of human trials of indigenous COVID-19 vaccine Covaxin began at All India Institute of Medical Science (AIIMS) in New Delhi on Thursday. M V Padma Srivastava, the chief of Neurosciences Centre, and three other volunteers received the first dose of Covaxin. Around, it will give 15 thousand volunteers the shot as part of the clinical trials at AIIMS. 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).
The largest phase of vaccine
Bharat Biotech announced the commencement of Phase-III trials of Covaxin on November 16. The Phase-III trials will involve 26 thousand volunteers across India, conducted in partnership with ICMR. It is the largest clinical trial conducted for a COVID-19 vaccine in India. This is India's first Phase-III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in India.
Participants will select randomly
Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will randomly receive Covaxin or placebo. The trial is double-blinded, such that the investigators, the participants, and the company will not be aware of who is assigned to which group.
The trail over 18 years of age
Covaxin has been tested in 1,000 subjects in Phase-I and Phase-II clinical trials, with promising safety and immunogenicity data. Volunteers who wish to take part in this trial should be adults over 18 years of age.
Volunteers will detect corona infection
The inactivated vaccine was developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) biocontainment facility. Covaxin is a highly purified and inactivated vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of over 300 million doses supplied. Volunteers who undergo vaccination in the Phase-III trials will monitor to detect the occurrence of COVID-19 infection.
