Pune-based Serum Institute of India (SII), which has signed a licensing agreement with AzstraZeneca to supply one billion doses of the Oxford University vaccine candidate against Covid-19, will start the trials in India within couple of weeks, The Economic Times reported.
Serum Chief Executive Adar Poonawalla, said in a statement, “We will be applying for the licensure trials to the Indian regulator in a week’s time. As soon as they grant us permission, we will begin with the trials for the vaccine in India. In addition, we will soon start manufacturing the vaccine in large volumes.”
The announcement comes close on the heels of a study (based on early-stage human trial and published in medical journal The Lancet) revealing that that the vaccine developed by scientists at UK's Oxford University is safe and induces strong antibody and T cell immune responses among the adult test subjects.
AstraZeneca is supporting the vaccine development efforts of the Oxford's Jenner Institute.
AstraZeneca is building a number of supply chains in parallel across the world to support global access at no profit during the pandemic and has so far secured manufacturing capacity for two billion doses of the potential vaccine. The company has signed agreements with governments around the globe to supply the vaccine should it be cleared for use.
In June this year, AzstraZeneca and Serum Institute of India signed a licensing agreement to supply one billion doses of the Oxford University vaccine candidate against Covid-19 to middle and low income countries, including India.
Serum Institute is the world’s largest vaccine manufacturer.
ET reporting quoted goverment source as saying that Serum Institute’s vaccine candidate is currently undergoing a bio safety trial at the government's Central Drug Laboratory (CDL), Kasauli.
To expedite the development of its vaccine, Serum Institute may also consider applying for Phase I/II waiver to the Drug Controller General of India (DCGI).
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