Biotechnology company Bharat Biotech on Monday said it has begun the phase 3 clinical trials of its coronavirus vaccine candidate, Covaxin, in India, with 26,000 participants from across 22 sites in the country.
In a press release, Bharat Biotech said the trials will be conducted in partnership with the Indian Council of Medical Research. The trial has been registered with the clinical trials registry of India, and approved by the Drugs Controller General of India, reported Hindustan Times.
“Participants will be randomly assigned to receive Covaxin or placebo,” the Hyderabad-based company said in its statement, according to the Hindustan Times. “The trial is double blinded, such that the investigators, the participants and the company will not be aware of who is assigned to which group.”
The vaccine has so far been evaluated in 1,000 subjects in Phase I and Phase II clinical trials, the company added.
The company’s Joint Managing Director Suchitra Ella tweeted about the development, congratulating the team. “The development and clinical evaluation of Covaxin marks a significant milestone for vaccinology in India for a novel vaccine,” Ella said in the company’s official statement.
Earlier this month, senior ICMR scientist Rajni Kant had expressed hope that the Bharat Biotech vaccine could be available as early as February, months earlier than expected.
However, India has not yet signed a deal for a coronavirus vaccine so it is unclear when it will be available for use in the country, despite some leaders promising it will be available from as early as January. Availability of the vaccine in India will be subject to approval by domestic regulators, and the Indian government agreeing to purchase them. So far, many other nations including the United States, United Kingdom, the European Union, Australia and Israel have made deals to buy millions of doses of the vaccines.
Meanwhile, India recorded 29,163 new coronavirus cases – the lowest in over four months – taking the country’s total to 88,45,127 on Tuesday. The toll rose to 1,30,519 with 449 more deaths. The number of active cases stood at 4,53,401. As many as 82,90,370 people have recovered from the disease so far.