Jahnavi Sarma
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Written By: Jahnavi Sarma | Updated : November 28, 2020 11:02 AM IST
The Phase-III trials will involve 26,000 volunteers across India, conducted in partnership with ICMR.
A vaccine for COVID-19 is likely to be in the market soon though it may be some time before the general population has access to it. We have recently seen many vaccine developers announcing the efficacy rate of their candidate on the basis of final stage clinical trials. Many companies are also coming forth with possible costs of the vaccines. Against this backdrop, the phase-III human trials of India's 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 15,000 volunteers at AIIMS will be given the shot as part of the clinical trials.
Bharat Biotech announced the commencement of Phase-III trials of Covaxin on November 16. The Phase-III trials will involve 26,000 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. Trial volunteers will receive two intramuscular injections approximately 28 days apart. Participants will be randomly assigned to 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.
Covaxin has been evaluated in 1,000 subjects in Phase-I and Phase-II clinical trials, with promising safety and immunogencity data. Volunteers who wish to participate in this trial should be adults over 18 years of age. 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).
This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio containment facility. Covaxin is a highly purified and inactivated vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses supplied. This multicenter phase-III study is conducted at various sites across India. Participating Volunteers who undergo vaccination in the Phase-III trials, will be monitored to detect occurrence of COVID-19 disease.
Covaxin uses an inactivated strain of SARS-CoV-2, the virus that causes COVID-19. This inactivated strain does not multiply inside human cells. Instead, it boosts the immune system and stimulates antibody response against the virus. This is the same technology that is used in several other vaccines like the ones for seasonal influenza, polio, pertussis, rabies, and Japanese Encephalitis. The inactivated strain was isolated by NIV. Then, ICMR transferred it to Biotech Bharat on May 9. After receiving the isolated strain, Bharat Biotech developed the first set of vaccines and conducted preclinical animal trials within 50 days.
(With inputs from IANS)
