On Aug. 1, 2020, the Serum Institute of India (SII) got the approval to start human trials in India for the Covid-19 vaccine candidate developed by University of Oxford, after the company submitted a revised protocol to the drug regulatory authority, people in the know told ET.

On Wednesday, a committee of experts had deferred a decision on the request of SII to start trials and asked the company to amend its protocol for the clinical study. The subject expert committee (SEC) had recommended eight amendments to be made to the firm’s proposal to conduct Phase-II and -III trials.

According to the minutes of Wednesday’s meeting, the SEC had asked Serum to distribute clinical trial sites across India and demarcate the phase-II and Phase-III part of the protocol. ET has seen the minutes of the meeting.

As per the new proposal, 1,600 people will participate in the trials in over 20 cities spread across India.

A meeting of the SEC was called on Friday where it gave the approval to Serum’s amended protocol, a government official said. Serum has tied up with Swedish-British drug maker AstraZeneca to produce around a billion doses for low- and middle-income countries by early next year.