Covaxin phase-3 trial data to be out soon, says top executive

The phase-3 trial data of Covaxin will be out soon, said Raches Ella, project lead Covid-19 vaccines at Bharat Biotech, which manufacturers the indigenous vaccine. “Phase-3 (trial data) will be out very soon,” Ella tweeted, reacting to a story published by ET on June 7 which said that both Covishield and Covaxin work well but Covishield may have a greater ability to produce antibodies. He also expressed surprise that researchers have reached this conclusion on the basis of non-peer-reviewed work.

More than five months after the Indian government approved Covaxin, the Hyderabad-based company has yet to publish its phase-3 trial data. The submission of data is also mandatory to get the World Health Organization’s Emergency Use Listing (EUL).

The company has applied for EUL of its vaccine and approvals are expected between July and September. The latest status of Covid-19 vaccines within WHO EUL/PQ evaluation process' guidance document dated May 18 on the WHO website said Bharat Biotech had submitted an expression of interest on April 19 and that more data is required. The WHO’s EUL is a prerequisite for Covax facility vaccine supply.