Covovax, the second COVID-19 vaccine candidate being developed and manufactured by the Pune based Serum Institute of India (SII) is likely to go into phase-3 clinical trials by mid May.
The Data Safety Monitoring Board has reviewed the initial safety data of 200 participants of phase-2 clinical trial 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 jointly performing a phase-2 and 3 observer-blind, randomized and controlled study to determine the safety and immunogenicity of Covovax with Matrix-M1™ adjuvant in Indian adults.
The largest vaccine manufacturer, SII has already manufactured Covishield vaccine in technical collaboration with AstraZeneca and Oxford University. The firm’s CEO, Adar Poonawalla, had earlier tweeted that they hope to launch Covovax by September this year. 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 19 sites across the country, four of them in Pune. Researchers across these sites said the process of recruiting volunteers for the larger phase-3 trial will begin soon.