The Drug Controller General of India has allowed a revision in protocol, doing away with the placebo arm of the trial, and Phase 3 clinical trials of Covovax can begin as soon as mid-June.
The Drug Controller General of India (DCGI) has approved the revision in protocol for conducting Phase 3 clinical trials of Covovax, the second Covid-19 vaccine candidate being manufactured at Pune-based Serum Institute of India (SII).
As per the revision, the placebo arm of the trial has been done away with and the trial will now test Covovax and Novavax in 1,400 volunteers above the age of 18 across 20 sites in the country. Of these, four are in Pune, including Sahyadri, Noble and D Y Patil hospitals, and KEM-Vadu.
The Indian Council of Medical Research 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 initial safety data collected for the participants was presented to the Data Safety Monitoring Board (DSMB). The DSMB accorded recommendation, and based on this, DCGI has permitted initiation of the Phase 3 part of the study.
Dr Abhijit Kadam, Scientist C, Coordinating Principal Investigator from ICMR-NARI, said tentatively, Phase 3 should begin by mid-June. Researchers said the process of recruiting volunteers for the trial will begin soon.
Last year, US-based biotechnology company Novavax had announced a license agreement with SII for the development and commercialisation of NVX-COV2373, its Covid-19 vaccine candidate in low and middle-income countries and India. Subsequently, Novavax published results of the UK Phase 3 study which had assessed the efficacy of the vaccine during a period of high transmission, and with the Alpha variant circulating widely. The results had found that its vaccine was 89.7 per cent effective in preventing Covid-19.
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