Indian home-grown COVID-19 shot wins WHO emergency use approval

The WHO tweeted that its technical advisory group had ruled that the benefits of the shot, known as Covaxin, significantly outweighed the risks and that it met WHO standards for protection against COVID-19.

The decision had been delayed as the advisory group sought additional clarifications from Bharat Biotech before conducting a final risk-benefit assessment for the vaccine's global use.

WHO's Strategic Advisory Group of Experts on Immunization also recommended Covaxin's use in two doses, with an interval of four weeks, in age groups 18 and above.

Covaxin was given emergency-use authorisation in India in January even before the completion of its late-stage trial, which later found the shot to be 78% effective against severe COVID-19.

WHO's decision is expected to help millions of Indians who have received Covaxin to travel nL4N2RM0WR outside the country.

The emergency use listing would allow Bharat Biotech to ship Covaxin to countries that rely on WHO guidance for their regulatory decisions.

WHO's approval may also clear the way for India to commit supplies to the COVAX global vaccine sharing effort, which is co-led by the WHO and aims to provide equitable access to shots for low- and middle-income countries.

Before curbing overseas vaccine shipments in April, India had donated or sold more than 66 million COVID-19 doses, including Covaxin.

Bharat Biotech said in a statement that it has established Covaxin manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021, with technology transfer activities in progress with companies in India and elsewhere.

According to GlobalData's Pharma Intelligence Center, Covaxin is the second-most popular vaccine after Covishield as part of the COVID-19 vaccination drive in India.

The Hyderabad-based firm, which developed Covaxin with an Indian state research body, started sharing data with the WHO in early July.