Serum Institute inches closer to get Govt nod for Oxford Coronavirus vaccine trials

 Serum Institute of India (SII) is w a step closer to conduct phase two and three clinical trials in India on a potential COVID-19 vaccine.  Subject Expert Committee at Central Drugs Standard Control Organisation (CDSCO) has recommended to top drug regulator to grant permission to world's largest vaccine maker to go ahe with trials, a Health Ministry official said on Friday.

"After a thorough evaluation, Subject Expert Committee (SEC) has sent its recommendation to DCGI asking it to give approval to Serum Institute's phase two and three human clinical trials of Oxford Vaccine candidate for COVID-19," official told ANI.

Earlier this week, committee observed certain observations and redirected Serum Institute to furnish a revised protocol to perform clinical trials in India for COVID-19 candidate vaccine. domestic pharma giant has partnered with British drugmaker AstraZeneca for manufacturing Oxford vaccine candidate for COVID-19.

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SII h on July 25 submitted its application to DCGI seeking permission to perform phase two and three human clinical trials of potential vaccine.

pharmaceutical company will perform an observer-blind, randomised controlled study enrolling at least 1,600 participants to determine safety and immugenicity of 'Covishield'.Lancet medical journal report has stated that a vaccine candidate developed at University of Oxford has shown encouraging results and it appears to be "safe, well-tolerated, and immugenic".

A few days back Oxford University anunced satisfactory progress with vaccine making it a leing one among dozens of vaccine candidates being developed around world. clinical trials of a potential COVID-19 vaccine on humans began in April.

(With ANI inputs)

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