Russia receives finalized approval for COVID-19 vaccine trials in India

Russia has also reached an agreement with the biotechnology department of India's Science and Technology Ministry to use its laboratories as a base for the Indian clinical trial, the source said.

By ZACHARY KEYSER, REUTERS
Scientists develop a vaccine against the coronavirus disease in Saint Petersburg (photo credit: REUTERS)
Scientists develop a vaccine against the coronavirus disease in Saint Petersburg
(photo credit: REUTERS)
The Russian Direct Investment Fund (RDIF) and India-based Dr. Reddy's Laboratories received approval from the Drug Control General of India (DCGI) to conduct adaptive phase II and III human clinical trials in India to test the Sputnik V COVID-19 vaccine, the sovereign wealth fund announced on Saturday.
Large-scale trials of the Sputnik V vaccine in India were first announced and then knocked back by Indian regulators, who said the scale of Phase I and II trials conducted in Russia earlier this year were too small, requesting that they be repeated.
Following the new agreement, India will conduct the adaptive phase II and III trials - involving 1,500 participants - within the country.
"We acknowledge DCGI’s scientific rigour and guidance in the entire process," said Co-chairman and Managing Director of Dr. Reddy’s Laboratories G.V. Prasad. "This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic."
Dr. Reddy will personally conduct the trials, and subject to approval, distribute the finished vaccine in India. In return, the RDIF will supply 100 million doses of the vaccine to Dr. Reddy's.
Russia, the first country to grant regulatory approval for a novel coronavirus vaccine, is also conducting Phase III trials of Sputnik V in Belarus, Venezuela and the United Arab Emirates.
RDIF has reached agreements with Indian manufacturers to produce 300 million doses of the shot.
"We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial," said CEO of the RDIF Kirill Dmitriev. "This data will further strengthen the clinical development of Sputnik V vaccine in India."
A Phase III trial testing the Sputnik V vaccine involving 40,000 participants is currently underway in Moscow, with 16,000 people having already received the first dose of the two-shot vaccine.
Interim results are expected to be published in early November.
Indian regulators have agreed to incorporate data, provided by Russia on a weekly basis, from the Moscow trial, a source close to the deal told Reuters.
Russia has also reached an agreement with the biotechnology department of India's Science and Technology Ministry to use its laboratories as a base for the Indian clinical trial, the source said.