Serum Institute of India seeks DCGI permission for phase 2/3 clinical trials of Oxford's COVID 'vaccine'

Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing Oxford vaccine candidate for COVID-19, has sought permission from Drugs Controller General of India (DCGI) for conducting phase 2/3 human clinical trials of potential vaccine, highly-placed sources said on Saturday.

sources told PTI that Pune-based drug firm submitted its application to DCGI on Friday seeking permission for conducting trials of 'Covidshield'.

"According to application, it would conduct an observer-blind, randomised controlled study to determine safety and immugenicity of 'Covishield' (COVID-19) in healthy Indian adults. firm said that an around 1,600 participants of more than 18 years would be enrolled in study," a source said.

Initial results of first two-phase trials of vaccine conducted in five trial sites in UK showed it has an acceptable safety profile and homologous boosting increased antibody responses, source said.

To introduce vaccine, SII, world's largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture potential vaccine developed by Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.

On partnership with AstraZeneca, Serum Institute of India CEO Adar Poonawalla had said, "Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply 1 billion doses of COVID-19 vaccine being developed by Oxford University." se vaccines will be for India and middle and low income countries across world (GAVI countries), he had said.

firm plans to start phase 2 and 3 human trials in India in August.

Oxford University on Monday anunced satisfactory progress with vaccine, making it one of leading ones among dozens of vaccine candidates being developed around world.

According to a report in Lancet, initial trial results showed that vaccine is safe and prompts protective immune response.