India's drug authority has denied permission for Phase III trials for Russia’s Sputnik-V vaccine.
The drug authority has asked Dr Reddy's Laboratories Ltd, the Indian pharmaceutical company that has partnered with the Russian fund, to conduct Phase II trials of the vaccine in the country first.
"The safety & immunogenicity data in overseas Phase I/II studies is small and there is no data available on Indian subjects," the Subject Expert Committee (SEC) that looks into proposals for drug trials said on October 5.
The Russian Direct Investment Fund announced last month that it would supply 100 million doses of Sputnik-V vaccine to Dr Reddy's, and cooperate with the firm for clinical trials and distribution.
After "detailed deliberation" the SEC has asked Dr Reddy's to resubmit a protocol for consideration by the committee to conduct phase II trials first.
India has reported more than 6.9 million cases of coronavirus, including more than 106,000 deaths.
At a press conference last month, the health minister said Covaxin, the indigenous vaccine being developed by Bharat Biotech and National Institute of Virology Pune, and the Serum Institute of India's collaboration with Oxford University and Codagenix USA respectively, are the vaccines at the most advanced stages.