Have reached agreement for Sputnik V trials, distribution in India, says Russia
The Sputnik V has yet to complete large scale clinical trials but was approved by the Russian government last month, becoming the first Covid-19 vaccine to be cleared for human use anywhere in the world. Scientists have, however, cautioned against use of any shot that has not passed full safety and efficacy checks.Updated: Sep 17, 2020, 05:24 IST
Russia’s sovereign wealth fund said on Wednesday it has reached an agreement with pharmaceuticals major Dr Reddy’s Laboratories for clinical trials and distribution of its experimental vaccine Sputnik V in India, a process that is yet to be cleared by the Drugs Controller General of India (DCGI).
The Sputnik V has yet to complete large scale clinical trials but was approved by the Russian government last month, becoming the first Covid-19 vaccine to be cleared for human use anywhere in the world. Scientists have, however, cautioned against use of any shot that has not passed full safety and efficacy checks.
“Upon regulatory approval in India, RDIF shall supply to Dr Reddy’s 100 million doses of the vaccine,” the Russian Direct Investment Fund (RDIF) said in a statement.
Indian officials said approvals will be given only after a thorough review. “We are yet to receive a formal application in this regard. And merely applying for approvals is not enough, clearances will be given only after experts of the subject concerned review the data thoroughly and are satisfied the with the results presented before us,” said a senior official privy to the matter in the DCGI office, asking not to be named.
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The Sputnik V is among several vaccine candidates being considered by Indian authorities for the country. The director general of the Indian Council of Medical Research (ICMR), Dr Balram Bhargava, earlier said that a high-level government committee was looking into the data coming from Russia on its Covid-19 vaccine.
“Russia has a good history as far as manufacturing vaccines is concerned; they make good vaccines so we presume this vaccine is good. They have published first study of 76 patients in the medical journal The Lancet which is showing good effectiveness and good antibody immunity generation. Because they have not yet complicated a phase 3 trial; they have only started a phase 3 trial, and for us here to do a phase 3 trial of a product from outside of the country has to go through the regular processes of clearances from the regulatory agencies India,” said Dr Bhargava.
According to phase 1/2 trial data published in The Lancet journal earlier this month, the vaccine did not lead to side effects and triggered adequate immune response in 76 volunteers. But the results have been disputed by some groups of scientists, who have sought a review of the data, citing what they said were striking similarities between patients.
The RDIF on Wednesday reiterated the vaccine is safe. “The Sputnik V vaccine, which is based on well-studied human adenoviral vector platform with proven safety, is undergoing clinical trials for the Coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India,” a statement said.
“We are pleased to partner with RDIF to bring the vaccine to India. The Phase I and II clinical trials have shown promising results. We will be conducting Phase-III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against Covid- 19 in India,” said GV Prasad, co-chairman and managing director, Dr Reddy’s Laboratories.
Russia’s envoy to India, Nikolay Kudashev, has held discussions with Indian officials in recent weeks on cooperation in the development of a vaccine, including joint development and production of Sputnik V.
The Russian side also formally shared modalities for cooperation on the vaccine with Indian authorities, which are yet to take a call on the matter, people familiar with developments said on condition of anonymity.
The vaccine is also believed to have figured in discussions held during external affairs minister S Jaishankar’s visit to Moscow last week for a meeting of the foreign ministers of the Shanghai Cooperation Organisation (SCO) states.