Sputnik V vaccine is in Phase 3 clinical trial, Russian researchers had said last week (Representational)
New Delhi:
In a significant development related to the COVID-19 vaccine, Russia has expressed its willingness to the Indian government for collaboration in the manufacturing of COVID vaccine – Sputnik V, a government official said on Tuesday.
It is pertinent to note that Russia claims to have developed the first COVID-19 vaccine Sputnik V, a human adenoviral vector vaccine that fights against the deadly coronavirus disease. It has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology. Last week, Russian researchers informed that presently the vaccine in Phase 3 clinical trial.
“As far as Sputnik V vaccine is concerned, both India and Russia are in communication. Some initial information has been shared while some detailed information is awaited,” Rajesh Bhushan, Union Health Secretary said on Tuesday responding to a question on whether the Russian government has placed any formal request for the manufacturing of its Sputnik V vaccine in India.
“The Vaccine and Research and Development Taskforce co-chaired by Dr Vinod Paul (Member of the Niti Aayog and Professor Vijayraghavan who is Principal Scientific Advisor) will examine the suggestions for potential collaborations on vaccine development. The committee, with inputs from members, particularly the Department of Biotechnology and the ICMR, will examine the information on the matter and will link potential collaborators where robust and value-added collaborations are feasible and meaningful,” a government official said.
“More than 40,000 people in 45 medical centres are participating in a randomized, double-blind, placebo-controlled multicenter clinical study of the efficacy, immunogenicity, and safety of the Sputnik V vaccine in Russia, simultaneously with the vaccination of volunteers from risk groups,” Russian researchers had said during an online press briefing last week.
When asked about any plans for a joint venture with Indian pharma companies, Kirill Dmitriev, CEO of Russian Direct Investment Fund (RDIF) said: “Yes, production of the vaccine is an important issue, we look to Indian drug producers to co-partner as we believe India is capable of producing Gamaleya Institute vaccine and it is important to say that these partnerships should produce a vaccine that enables us to cover the demand that we have received.”
Phase 1 and 2 clinical trials of the vaccine have been completed on August 1. “All the volunteers are feeling well, no unforeseen or unwanted side effects were observed. The vaccine-induced strong antibody and cellular immune response. Not a single participant of the current clinical trials got infected with COVID-19 after being administered with the vaccine,” researchers from Gamaleya National Institute said.
Phase 3 clinical trial involving more than 2,000 people in Russia, a number of Middle Eastern (UAE and Saudi Arabia), and Latin American countries (Brazil and Mexico) started on August 12. The vaccine has received a registration certificate from the Russian Ministry of Health on August 11 and under 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 start in September 2020, they said.
