Second Serum Institute vaccine set for phase-3 clinical trial by mid-May

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-2/3 observer-blind, randomised, controlled study to determine the safety and immunogenicity of Covovax [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) 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.

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.