Dr. Reddy’s, Russia Get India Approval for Human Vaccine Trial
The phase 2/3 trial will be a multi-center and randomized controlled study that will include safety and immunogenicity.
(Bloomberg) -- Dr. Reddy’s Laboratories Ltd. and Russia’s sovereign wealth fund got approval to conduct human clinical trials of their coronavirus vaccine in India, according to an emailed statement from one of the vaccine developers.
The phase 2/3 trial will be a multi-center and randomized controlled study that will include safety and immunogenicity, according to the statement by the Russian Direct Investment Fund.
The Kremlin has pinned great hopes on the Sputnik V vaccine, which President Vladimir Putin is promoting as the first registered inoculation in the world, to help establish Russia as a leader in the race to subdue the global coronavirus pandemic. The name is a nod to the world’s first artificial satellite that was launched by the Soviet Union in 1957.
Dr. Reddy’s and RDIF formed a partnership in September to conduct clinical trials of the vaccine and its distribution in India. RDIF will supply 100 million doses of the vaccine to Dr. Reddy’s upon receiving regulatory approval in India, it said in the statement. The vaccine would be produced in India and some of it could be sent back to Russia, which is experiencing setbacks maintaining the serum’s stability while expanding production.
The vaccine, developed by the Moscow-based Gamaleya Institute, has been taken by prominent members of the Russian elite, including one of Putin’s daughters, top officials and billionaires, outside the trial groups without waiting for the results of the full study. Despite the hype, Putin hasn’t tried the vaccine himself.
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