Oxford COVID Vaccine Trial in India: Serum Institute to conduct phase two, three clinical trials in India
Oxford Vaccine Trial India: A special committee has recommended India's national drug controller to grant Serum Institute of India permission to conduct phase two and phase three clinical trials of the Oxford COVID vaccine candidate in India.
Oxford COVID Vaccine Trial in India: A special committee has recommended India's top drug regulator, Central Drugs Standard Control Organisation (CDSCO) to grant permission to the Serum Institute of India (SII) to conduct phase two and phase three clinical trials of the Oxford COVID vaccine candidate in India.
The Subject Expert Committee after a thorough evaluation sent its recommendation to DCGI asking it to grant approval to Serum Institute to conduct Oxford COVID Vaccine trials in India. The committee had earlier this week redirected Serum Institute to furnish a revised protocol to perform the clinical trials in India for the Oxford COVID-19 candidate vaccine.
The Serum Institute has partnered with AstraZeneca and Oxford to manufacture their COVID Vaccine candidate. The institute had earlier on July 25 submitted its application to the Drugs Controller General of India (DCGI) to get permission to conduct phase 2 and phase 3 trials of the potential vaccine in India. The Pune-based institute has said that it will start manufacturing the vaccine even before the final approval so that it has sizeable volumes are ready once the vaccine gets all the required permissions.
India readies five sites for Oxford Vaccine Trials
India is readying five sites across the country for the final phase of human trials of the Oxford COVID Vaccine. The announcement was made by Department of Biotechnology (DBT) Secretary Renu Swarup on July 27, 2020.
The Oxford Vaccine trial in India is essential to gather necessary data within the nation before the vaccine is administered to Indians. The DBT has already started its work on setting up clinical sites for phase 3 of the vaccine trial.
Oxford COVID Vaccine Trials in India
• The Serum Institute of India, which is the world's largest vaccine manufacturer, is partnering with the Oxford researchers to develop the vaccine. The institute was selected earlier by Oxford and its partner AstraZeneca to manufacture the vaccine once it is ready.
• The SII will perform an observer-blind, randomised controlled study involving around 1,600 volunteers to determine the safety and immunogenicity of the vaccine candidate 'Covishield'.
• The Oxford COVID Vaccine candidate is one of the leading vaccine candidates being developed around the world. The clinical trials of the potential vaccine began in April. Recently, the Oxford COVID vaccine entered its third and final stage of human clinical trials.
• The phase 1 and phase 2 trials of the vaccine, ChAdOx1 nCoV-19, showed promising results, as the vaccine triggered a strong immune response, stimulating the bodies of the volunteers to produce both antibodies and killer T-cells, potentially offering a double protection against COVID-19.
• The vaccine also did not show any serious side effects, according to trial results published in The Lancet medical journal. Some of the minor side effects caused could be reduced by taking paracetamol. The vaccine,if successful, is expected to be available for the Indian population by the first quarter of 2021.
The Oxford COVID vaccine is the clear frontrunner among the more than 100 COVID vaccine candidates being developed across the world including India. Oxford had begun its first phase of human trials on April 23. The university has currently begun its phase III of human trials and they are expected to be completed by September.
The Oxford COVID vaccine trials involve thousands of people from the UK, Brazil and South Africa. If the trials go as planned and show effective results then the vaccine could be available for use by sometime around September.
Seven other clinical trials are also underway, some of them in the United States and China. India is also all set to begin the human trials of its indigenous COVID vaccine - COVAXIN.