India’s indigenous Coronavirus vaccine ‘Covaxin’ commenced 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 involving 26,000 volunteers across India.
Covaxin is being developed by Bharat Biotech in partnership with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) and one of the largest clinical trials and largest third phase efficacy trials ever conducted for a COVID-19 vaccine in India.
Trial volunteers will receive two intramuscular injections approximately 28 days apart and will be randomly selected to receive Covaxin or placebo. The trial is said to be double-blinded, which means that the investigators, the participants and the company will not be aware of who is assigned to which group.
The Phase-I and Phase-II clinical trials of Covaxin have been assessed in 1,000 subjects which have shown promising safety and immunogenicity data. Volunteers who want to take part in this trial should be adults over 18 years of age.
This indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) biocontainment facility.
Being a purified and inactivated vaccine, manufactured in a Vero cell manufacturing platform, Covaxin has exceptional history of providing safety by supplying more than 300 million doses.
This multicenter phase-III study is being conducted at various locations across the country.
The volunteers participating in the Phase-III trials will undergo vaccination and will be monitored to detect the phenomenon of COVID-19 disease in them.
Modi will visit vaccine centres to review the stock of the vaccine development work.
Prime Minister Narendra Modi is scheduled to arrive in Hyderabad on Saturday to review the status of India's first indigenous Covid-19 vaccine — Covaxin to take stock of the vaccine development work.
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Before his visit in Hyderabad, Modi will first visit the facilities of Zydus Cadila in Ahmedabad, where ZyCoV-D is being developed, and Serum Institute of India in Pune where AstraZeneca-Oxford vaccine is being manufactured.
Currently, all these three vaccine candidates are undergoing Phase three clinical trials in the country.