Dr. Reddy’s Enters Research, Distribution Deal for Russia’s Sputnik V Vaccine

Indian pharmaceutical company Dr. Reddy’s will assist in phase 3 clinical trials and distribution in India for Russia’s COVID-19 vaccine, Sputnik V, the company and Russian government announced.

Russia’s sovereign wealth fund, the Russian Direct Investment Fund (RDIF), said that it has agreed to supply 100 million doses of the controversial vaccine to Dr. Reddy’s if the vaccine receives regulatory approval from the Indian government and claimed that distribution could begin in India late this year if late-stage trials are successful. Financial terms of the agreement were not disclosed.

Developed by Moscow’s Gamaleya Institute, Sputnik V came under fire internationally when the Russian government approved it before the start of  late-stage trials (DID, Aug. 12). Although two phase 1/2 trials showed that Sputnik V was well-tolerated and led to antibody generation in all participants, the study only enrolled a small number of patients and did not use a placebo or a control vaccine (DID, Sept. 8).

Phase 3 trials of the vaccine are currently ongoing in Russia, Saudi Arabia, the Philippines and the United Arab Emirates, and the initial results are expected in October or November. — James Miessler