The Russian Fund for Direct Investment has signed an agreement with Dr. Reddy’s Laboratories to conduct a clinical trial and distribution of Sputnik V in India. Under the agreement, Russia’s sovereign wealth fund will supply 100 million doses of Russia’s COVID-19 vaccine to the Indian pharmaceutical company. Both the trials and the supply agreement depend on approval from the central drug regulator. If the trials are successful, the vaccine will be available in India later this year.
“India is among the countries most affected by COVID 19 and we believe that our human adenovirus dual vector platform will provide a safe and scientifically validated option for India in the battle against COVID-19,” said RDIF Executive Director Kirill Dmitriev, in a statement.
Commenting on the union, GV Prasad, Co-Chairman and Managing Director of Dr. Reddy’s Laboratories, said: “We will conduct phase III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of the Indian Regulators. The Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India. “
Last week NITI Aayog (health) member VK Paul said that the Indian government is willing to facilitate a phase 3 trial for the Russian Sputnik V vaccine, for which between 2 and 4 Indian companies are in talks to mass manufacture.
Russia became the first country in the world to register a COVID-19 vaccine after less than two months of human testing. Developed by the Gamaleya Research Institute and the Russian Defense Ministry, the vaccine underwent the necessary tests, Russia said. Russian President Vladimir Putin said at the time that large-scale production was due to start in September.
The Russian Ministry of Health claimed that the coronavirus vaccine offers long-lasting immunity against the virus. The vaccine is expected to provide immunity against the coronavirus for up to two years, according to the health ministry.
“The human adenoviral vector platform, which is the core of the Russian vaccine, has been tested in more than 250 clinical studies over decades and has been found safe with no potential long-term negative consequences.” Dmitriev said.
Early results from trials of Russia’s potential coronavirus vaccine show no major negative side effects, a study published in the peer-reviewed medical journal The Lancet revealed.
“The two 42-day trials, which included 38 healthy adults each, found no serious adverse effects among participants and confirmed that vaccine candidates elicit an antibody response,” the study authors wrote.
Russian Health Minister Mikhail Murashko said last week that the first batch of Russia’s COVID-19 vaccine is likely to be delivered to all regions of the country by September 14, according to TASS.
Post-registration clinical trials of the Sputnik V vaccine are currently underway involving 40,000 volunteers. More than 55,000 volunteers have applied to participate in post-registration tests. The first results of these trials are expected to be published in October-November this year.
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