India’s Covaxin gets WHO approval for emergency use listing

The World Health Organization today approved India's indigenous Covid-19 vaccine "Covaxin" for emergency use listing (EUL) status.

"Covaxin, developed by Bharat Biotech was granted the EUL listing to a growing portfolio of vaccines validated by WHO for the prevention of Covid-19," WHO said in its official website said, reports our News Delhi correspondent.

WHO's Technical Advisory Group (TAG) approved the decision after reviewing the data provided by Bharat Biotech, the Hyderabad-based Indian pharma, in April regarding Covaxin's safety and efficacy.

The TAG had on October 26 sought "additional clarifications" from Bharat Biotech to conduct a final "risk-benefit assessment" EUL.

The TAG-EUL is an independent advisory group that provides recommendations to WHO on whether a Covid-19 vaccine can be listed for emergency use under the EUL procedure.

Meanwhile, a statement by Bharat Biotech today said India's Central Drugs Standard Control Organisation (CDSCO) has approved the extension of the shelf life of Covaxin from six months to 12 months from the date of manufacture.

Bharat Biotech was initially given permission for the sale and distribution of Covaxin with a shelf life of six months, which was later extended to nine months, a company spokesperson said.

"The CDSCO has approved the extension of shelf life of Covaxin up to 12 months, from the date of manufacture. This approval of shelf-life extension is based on the availability of additional stability data, which was submitted to CDSCO," Bharat Biotech said in a tweet.

Covaxin has demonstrated 77.8 percent effectiveness against symptomatic Covid-19 and 65.2 percent protection against the Delta variant.

Bharat Biotech had in June said it concluded the final analysis of Covaxin efficacy from Phase-3 human trials.

Covaxin and Oxford University's Covishield/AstraZeneca, produced by Serum Institute of India, are the two most widely used Covid vaccines in India which began the inoculation drive on January 16.