DCGI approaches Serum Institute to update convention for stage 2, 3 preliminaries of Oxford COVID-19 vaccine

DCGI approaches Serum Institute to update convention for stage 2, 3 preliminaries of Oxford COVID-19 vaccine


  • Post By : Kumar Jeetendra

  • Source: PTI

  • Date: 30 Jul,2020

The Subject Expert Committee (SEC) on COVID-19 that held its meeting Tuesday deliberated about the program by SII and requested that the Pune-based company to revise its own protocol to the stage 2 and 3 clinical trials, aside from needing some extra details.

On Wednesday evening, SII filed a revised protocol for running the trials into the DCGI.

“The company on Tuesday was requested to clearly specify phase 2 and stage 3 portion of this protocol and resubmit their application for analysis from the SEC,” an official source said.

The panel also suggested that the proposed clinical trial websites be dispersed across India, the source stated.

“In addition they haven’t provided justification for the planned enrolment of all 1,600 subjects throughout the trial,” the source added.

Additional Manager, Government Affairs, SII, Prakash Kumar Singh stated,”We’ve filed our revised protocol to DCGI office now evening for additional actions by SEC and DCGI.”

The SII that has partnered with AstraZeneca for fabricating the Oxford vaccine candidate for COVID-19 had filed its application to the DCGI on July 24, looking for permission for running the stage 3 and 2 trials of the possible vaccine’Covidshield’.

“According to this program, it might run an observer-blind, randomised controlled study to ascertain the safety and immunogenicity of’Covishield’ in healthy Indian adults. The company said that the roughly 1,600 participants of over 18 years will be registered in the study,” a source had stated.

Initial results of this initial two-phase trials of this vaccine ran in five trial sites in the united kingdom revealed it’s an acceptable safety profile and homologous fostering increased antibody responses, the source stated.

To present the vaccine, SII, the world’s largest vaccine manufacturer by number of doses sold and produced, has signed an agreement to fabricate the prospective vaccine produced from the Jenner Institute (Oxford University) in cooperation with British-Swedish pharma firm AstraZeneca.

On the partnership with AstraZeneca, Serum Institute of India CEO Adar Poonawalla had stated,”Serum Institute of India has entered a production partnership with AstraZeneca to create and provide 1 billion doses of this COVID-19 vaccine being developed by Oxford University.”

These vaccines would be for India and low and middle income nations throughout the planet (GAVI states ), he’d stated. The company plans to initiate the stage 3 and 2 individual trials in India in August.

Oxford University recently had declared satisfactory progress using the vaccine, which makes it one of the primary ones among the dozens of vaccine candidates being developed across the globe.

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