The Sputnik V vaccine is in a phase 3 clinical trial, Russian researchers said last week (Representation)
New Delhi:
In an important development related to the COVID-19 vaccine, Russia has expressed its willingness to the Indian government to collaborate in the manufacture of the COVID – Sputnik V vaccine, a government official said on Tuesday.
It is relevant to note that Russia claims to have developed the first COVID-19 Sputnik V vaccine, a human adenoviral vector vaccine that fights the deadly coronavirus disease. It was developed by the Gamaleya National Research Institute in Epidemiology and Microbiology. Last week, Russian researchers informed that the vaccine is currently in a phase 3 clinical trial.
“Regarding the Sputnik V vaccine, India and Russia are in communication. Some initial information has been shared while detailed information is awaited,” said Rajesh Bhushan, Union Health Secretary on Tuesday, in response to a question as to whether the Russian government has filed an official request to manufacture its Sputnik V vaccine in India.
“The Vaccines and Research and Development Working Group co-chaired by Dr Vinod Paul (member of Niti Aayog and Professor Vijayraghavan who is the Senior Scientific Advisor) will consider suggestions for potential collaborations for vaccine development. The committee, with contributions from members, in particular the Department of Biotechnology and ICMR will review information on the topic and link potential collaborators where strong and value-added collaborations are achievable and meaningful, ”a government official said. .
“More than 40,000 people in 45 medical centers are participating in a multicenter, randomized, double-blind, placebo-controlled clinical study on the efficacy, immunogenicity and safety of the Sputnik V vaccine in Russia, concurrent with the vaccination of volunteers belonging to groups at risk. ”Russian researchers said during an online press briefing last week.
Asked about any joint venture plans with Indian pharmaceutical companies, Kirill Dmitriev, CEO of Russian Direct Investment Fund (RDIF), said: “Yes, vaccine production is a big issue, we are looking to Indian drug producers for to cooperate, because we believe India is capable of producing the Gamaleya Institute vaccine and it is important to say that these partnerships should produce a vaccine that allows us to meet the demand that we have received. “
Phase 1 and 2 clinical trials of the vaccine were completed on August 1. “All volunteers feel well, no unforeseen or unwanted side effects were observed. The strong antibodies and cellular immune response induced by the vaccine. Not a single participant in the Current clinical trials has been infected with COVID- 19 after being administered with the vaccine, ”said researchers from the National Gamaleya Institute.
A phase 3 clinical trial involving more than 2,000 people in Russia, a number of countries in the Middle East (UAE and Saudi Arabia) and Latin America (Brazil and Mexico) began on August 12. The vaccine received a registration certificate from the Russian Ministry of Health on August 11 and according to the emergency rules adopted during the COVID-19 pandemic can be used to vaccinate the population in Russia. Mass production of the vaccine is expected to begin in September 2020, they said.
