Russia receives renewed approval for COVID19 vaccine trials in India
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 was too small, requesting that they be repeated.
Bottles with Russia's Sputnik-V vaccine (Reuters))
Moscow: The Russian Direct Investment Fund (RDIF) and Dr. Reddy’s Laboratories Ltd have received renewed approval to conduct late-stage clinical trials in India of the Russian COVID-19 vaccine, the sovereign wealth fund said 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 was too small, requesting that they be repeated.
Following a new agreement, India will now carry out an adaptive phase II and III human clinical trial involving 1,500 participants, RDIF, which is marketing the vaccine abroad, said on Saturday. Under the deal, Dr. Reddy’s will conduct the clinical trials and, subject to approval, distribute the finished vaccine in India. RDIF will supply 100 million doses 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.
A Phase III trial involving 40,000 participants is currently underway in Moscow, with 16,000 people have 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. (Reuters)
Read Also : Adani Green signs a 20 yr long term agreement with Sri Lanka government
News Must Read
- BPCL signs agreement with Noida International Airport
- Indian Bank Q4 results, net profit up by 6 percent on Quarter basis
- PSU Stocks tumbled amid RBI draft circular on lenders
- Paytm share price plunges 4% as president and COO Bhavesh Gupta resigns
- GAIL Global USA and Kinder Morgan Operating LLC signed MOU
- SJVN signs agreement with Tata Power RE for 460 MW Renewable Energy Project
- Keel Laying of the First Next Generation Offshore Patrol Vessel At Goa Shipyard Ltd
- REC Ltd received NOC to set up wholly owned subsidiary in Gift City, Gujarat
- Atanu Chakraborty Reappointed as part-time Chairman of HDFC Bank
- MRPL Q4 Results: Net profit slips 40%, Annual Gains Strong