The Indian regulator has approved Phase II and III clinical trials for the Sputnik V vaccine.
The tests will be carried out by the pharmaceutical company Dr. Reddy’s, which is one of the largest in India.
According to the Russian Direct Investment Fund, the Comptroller General of Medicines of India has allowed multicenter and randomized controlled trials to be conducted in the country. The experts’ task is to test the safety and immunogenicity of the Russian drug.
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“We are delighted to be working with regulatory authorities in India and will provide data on the safety and immunogenicity of the vaccine from Phase 3 trials in Russia, in addition to data from clinical trials in India to facilitate successful Sputnik V trials in the country”, – said Kirill Dmitriev, head of Russian Direct Investment Fund.