Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for Covid-19, has sought permission from the Drugs Controller General of India (DCGI) for conducting phase 2/3 human clinical trials of the potential vaccine, highly-placed sources said on Saturday.The sources told PTI that the Pune-based drug firm submitted its application to the DCGI on Friday seeking permission for conducting the trials of ‘Covidshield’.“According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ (Covid-19) in healthy Indian adults. The firm said that an around 1,600 participants of more than 18 years would be enrolled in the study,” a source said.Initial results of the first two-phase trials of the vaccine conducted in five trial sites in the UK showed it has an acceptable safety profile and homologous boosting increased antibody responses, the source said.To introduce the vaccine, SII, the world’s largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.On the partnership with AstraZeneca, Serum Institute of India CEO… Read full this story
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