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.