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Another vaccine developed by SII ‘Covovax’ will go under 3rd phase of clinical trial

The second vaccine developed and manufactured by the Serum Institute of India, Covovax will go under its third phase of clinical trial in mid-May.

The Data Safety Monitoring Board has analysed the underlying safety information of 200 volunteers of stage 2 clinical preliminary of Covovax and has given its recommendation. The Drugs Controller General of India has given the go-ahead for a larger phase-3 trial.

The ICMR and SII are together playing out a stage 2/3 observer visually impaired, randomized, controlled research to decide the wellbeing and immunogenicity of Covovax [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant] in Indian adults.

The SII which is the largest manufacturer of vaccine in the world has already manufactured Covid-19 vaccine Covidshield developed by Oxford-AstraZeneca. The SII chief had however said, that they were expecting to launch Covovax somewhere around September.

Dr Abhijit Kadam, Scientist C, coordinating principal investigator from ICMR-National AIDS Research Institute of the trial, said that tentatively phase-3 should start by mid-May. There are total 19 sites, 4 out of them are in Pune. Researchers from these sites have said that recruitment of volunteers will start soon.

Last year, US-based biotechnology company Novovax had announced a licence agreement with SII for the development and commercialisation of NVX-COV2373, its Covid-19 vaccine candidate in low- and middle-income countries and India. Novavax subsequently published results of the study, which assessed the efficacy of NVX-COV2373 vaccine during a period with high transmission and with the UK variant circulating widely.

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