Phase 2 of human trials of Oxford vaccine to begin in Pune, Russia in touch with India for manufacturing ‘Sputnik V’

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Phase 2 of human trials of the coronavirus vaccine developed by Oxford University  researchers is expected to commence in India on Wednesday with the doses arriving at Pune on Tuesday. The trials are likely to be conducted at 17 sites selected by Indian pharma major Serum Institute of India.

Five volunteers have been identified to start with who will undergo COVID-19 and antibodies test. Of these, those whose reports are negative will be earmarked for vaccination.

Pune-based Bharti Vidyapeeth Medical College and Research Centre will be enrolling 300-350 volunteers within the 18-99 years age group for testing. After the volunteers are administered the vaccine, doctors will maintain  close watch on their health as per standard operating procedure.

World’s largest vaccine manufacturer, Serum Institute has signed an agreement to manufacture the potential COVID-19 vaccine developed by the Jenner Institute of Oxford University in collaboration with British-Swedish pharma company AstraZeneca.

Phase 2 human trials will also be conducted at  B J Medical College in Pune where the trials are expected to start next week.

Meanwhile, in a significant development, union health ministry has said that Russia is in touch with India for collaboration to manufacture COVID-19 vaccine ‘Sputnik V’. The Russian vaccine – a human adenoviral vector vaccine – has been developed by the Gamaleya National Research Institute of Epidemiology and Microbiology. Russian researchers have informed that ‘Sputnik V’ vaccine is in phase 3 of clinical trial.

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“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.

“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,” said a government official.

“Over 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. Phase 1 and 2 clinical trials of the vaccine have been completed on August 1.

“All 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,” said researchers from Gamaleya National Institute.

Russian researchers observed, “The high efficacy of the vaccine was confirmed by high precision tests for antibodies in the blood serum of volunteers (including analysis for antibodies that neutralize the coronavirus), as well as the ability of the immune cells of the volunteers to activate in response to the spike S protein of the coronavirus, which indicates the formation of both antibody and cellular immune vaccine response.”

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.

(With ANI inputs)

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