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India’s first COVID-19 vaccine, Covaxin ready to enter Phase-III of clinical trial

India’s first COVID-19 vaccine candidate, Covaxin, developed by Bharat Biotech in association with the Indian Council of Medical Research (ICMR) has sought approval of The Drugs Controller General of India to initiate large scale phase III clinical trial in the country. The vaccine will use adjuvant Alhydroxiquim-II to boost immune response and longer lasting immunity in humans.

The regulator has asked the vaccine maker to submit “complete safety and immunogenicity data of the phase II trial” and adequate clarifications before moving on to the next stage.

In the initial phase, Covaxin was tested in 12 hospitals across the country on volunteers between the ages of 18 and 55 with no co-morbidity conditions. 

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