India’s drug regulator has declined to approve an application from Dr. Reddy’s Laboratories to conduct phase 3 trials of Sputnik V, the controversial coronavirus vaccine already given the go-ahead by Russian authorities.
Instead, India’s Central Drugs Standard Control Organisation (CDSCO) has asked for smaller-scale trials first, pointing out that the current safety and immunogenicity data on the Russian vaccine is limited and that there is no data on Indian patients.
Russian regulators officially approved the vaccine, dubbed Sputnik V, in August, before large-scale studies had begun. A phase 3 trial of the vaccine involving 40,000 participants is now underway in Russia. But Russia has already sold the production rights to millions of doses to countries including India, Brazil and Mexico.
The Russian Direct Investment Fund, which is marketing the vaccine, is hoping for a global rollout and had announced plans to collaborate with Dr. Reddy’s on a large-scale study in India.
Rather than launching a large-scale trial of the vaccine in India, an expert panel from CDSCO asked Dr. Reddy’s to resubmit its trial protocol and advised that the company conduct a combined phase 2/3 trial instead.