Drug regulator gets committee approval for nod to clinical trials by Serum Institute for Oxford COVID-19 vaccine
Jul 31, 2020
New Delhi [India], July 31 : The Subject Expert Committee at Central Drugs Standard Control Organisation (CDSCO) has recommended to the top drug regulator to grant permission to Serum Institute of India (SII) to conduct phase two and three clinical trials in India on a potential COVID-19 vaccine, a Health Ministry official said on Friday.
"After a thorough evaluation, the 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," the official told ANI.
Earlier this week the committee observed certain observations and redirected Serum Institute to furnish a revised protocol to perform the clinical trials in India for COVID-19 candidate vaccine.
The domestic pharma giant has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19.
On 25 July, ANI reported that SII had submitted its application to the Drugs Controller General of India (DCGI) seeking permission to perform the phase two and three human clinical trials of the potential vaccine.
The pharmaceutical company will perform an observer-blind, randomised controlled study enrolling at least 1,600 participants to determine the safety and immunogenicity of 'Covishield'.
Lancet medical journal report has stated that a vaccine candidate developed at the University of Oxford has shown encouraging results and it appears to be "safe, well-tolerated, and immunogenic".
A few days back Oxford University announced satisfactory progress with the vaccine making it a leading one among the dozens of vaccine candidates being developed around the world. The clinical trials of a potential COVID-19 vaccine on humans began in April.
