The maker of one of India’s leading COVID-19 vaccine candidates said on Tuesday (Dec. 22) its recruitment of volunteers for a late-stage trial of the shot was on track, following reports of a shortage of participants.
Bharat Biotech has signed up 13,000 volunteers for the Phase 3 trial, backed by India’s government medical research body, and is progressing towards its goal of 26,000, the company said. The trial began in mid-November at multiple sites across India.
Local news reports last week suggested that some of those trial sites were well short of reaching intended recruitment targets.
A study at the government-run AIIMS medical institute had only signed up some 200 participants, compared with a goal of 1,500-2,000, Reuters partner ANI reported last week, citing a doctor at the institute.
The shot, called COVAXIN, was evaluated in about 1,000 participants in early and mid-stage trials.
“We are overwhelmed with the steady rise in participation,” Bharat Biotech joint Managing Director Suchitra Ella said in a statement on Tuesday.
With more than 10 million infections, India, the world’s biggest vaccine producing country, is also the second worst-hit nation by COVID-19 behind the United States, although the rate of growth in infections has been slowing.
Its drug regulators are in talks with U.S. firms Pfizer and Moderna - whose COVID-19 vaccines have been approved in the United States - while other vaccine candidates including AstraZeneca’s shot are in trials.