DCGI asks Serum Institute to revise protocol for phase 2, 3 trials of Oxford COVID vaccine

A CDSCO expert panel has sought clarifications from Serum Institute of India (SII) over its application to Drugs Controller General of India (DCGI) seeking permission for conducting phase 2 and 3 human clinical trials of Oxford vaccine candidate for COVID-19, official sources said on Wednesday. Subject Expert Committee (SEC) on COVID-19 which held its meeting on Tuesday deliberated on application by SII and asked Pune-based firm to revise its protocol for phase 2 and 3 clinical trials, besides seeking some ditional information. On Wednesday evening, SII submitted a revised protocol for conducting trials to DCGI.

" company on Tuesday was asked to clearly define phase 2 and phase 3 part of protocol and resubmit ir application for evaluation by SEC," an official source said.

panel also recommended that proposed clinical trial sites be distributed across India, source said.

"y also have t given justification for proposed enrolment of 1,600 subjects during trial," source ded.

ditional Director, Government Affairs, SII, Prakash Kumar Singh said, "We have submitted our revised protocol to DCGI office today evening for furr action by SEC and DCGI."

SII which has partnered with AstraZeneca for manufacturing Oxford vaccine candidate for COVID-19h submitted its application to DCGI on Friday, seeking permission for conducting phase 2 and 3 trials of potential vaccine 'Covidshield'. "According to application, it would conduct an observer-blind, randomised controlled study to determine safety and immugenicity of 'Covishield' in healthy Indian ults.

firm said that an around 1,600 participants of more than 18 years would be enrolled in study," a source h 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 ar Poonawalla h 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 h said. firm plans to start phase 2 and 3 human trials in India in August. Oxford University recently h anunced satisfactory progress with vaccine, making it one of leing ones among dozens of vaccine candidates being developed around world.