Serum Institute's second COVID-19 vaccine, Covovax, is likely to go into phase-3 trial later this month. Serum Institute has partnered with Novavax to develop the second coronavirus vaccine.
The Data Safety Monitoring Board has reviewed the safety data of the phase-2 trial, which comprised of 200 participants, and has given its recommendation, the Indian Express reported.
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The Drugs Controller General of India (DGCI) has also given its approval for the phase-3 trial, the report said.
Serum Institute is conducting the trials in collaboration with the Indian Council of Medical Research (ICMR).
Dr Abhijit Kadam, coordinating principal investigator from ICMR-National AIDS Research Institute of the trial, said that tentatively phase-3 should start by mid-May.
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"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," he said, as quoted by the newspaper.
The ICMR and SII are jointly performing a phase-2/3 observer-blind, randomised, controlled study to determine the safety and efficacy of the Covovax vaccine.
Covovax has been developed by US-based Novavax. It has signed a pact with SII, wherein the latter would produce about 1 billion doses of Covovax for supply to India and other countries.
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The Novavax vaccine, which uses different technology from the doses already widely licensed around the world, is a protein-based vaccine engineered from the genetic sequence of the first strain of the coronavirus.
It can be stored at a temperature between 2 and 8 degrees Celsius (35 - 46.4 degrees Fahrenheit).
Earlier, SII CEO Adar Poonawalla had said that the firm plans to launch the vaccine by September.
"Covovax trials finally begin in India; the vaccine is made through a partnership with Novavax and Serum Institute of India. It has been tested against African and UK variants of COVID-19 and has overall efficacy of 89 percent. Hope to launch by September 2021," Poonawalla has said in a tweet in March.
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