In a recent development to the Covovax Phase 3 trial, the Drugs Controller General of India has approved the revision in the protocol for conducting the clinical trials by doing away with placebo.
In a placebo-controlled trial, some volunteers are administered the drug while some are given a placebo to help researchers compare and understand the efficacy of the medication.
As per the revised guidelines, Covovax, the vaccine SII is manufacturing in partnership with US vaccine maker Novavax will be administered 1400 volunteers above 18 years of age across 20 sites in the country.
The coordinating principal investigator from ICMR–NARI, Dr. Abhijit Kadam said the Phase 3 trial is likely to begin by mid-June. Researchers across the 20 sites earmarked for the purpose said recruiting volunteers for the Phase 3 trial will begin soon.
The initiation of Phase 3 part of the study was permitted after safety data collected from 200 participants were presented to the Data Safety Monitoring Board (DSMB).
In August 2020, Novavax had announced a license agreement with SII for the development and commercialization of NVX-COV2373 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 NVX-COV2373. The results found that the vaccine was 89.7 percent effective in preventing Covid-19 infection.
The largest vaccine manufacturer, SII has already manufactured the Covishield vaccine in 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.
India added 1.14 lakh new coronavirus cases over the last 24 hours while deaths from Covid-19 rose by 2,667. The country’s overall caseload now stands at 2.88 crores, while total fatalities are at 3.46 lakh.