Finally, Covaxin gets WHO nod

Breather For Vaccinated People

- Technical Advisory Group (TAG) of WHO on October 26 had sought 'additional clarifications' from Bharat Bio

- PM Narendra Modi met WHO Director General Dr Tedros Adhanom Ghebreyesus at the G20 summit recently

- TAG of WHO has recommended Emergency Use Listing status for Covaxin

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

New Delhi: In a major development, the WHO on Wednesday said it has granted emergency use listing (EUL) to Bharat Biotech's Covid-19 vaccine Covaxin. On the other hand, vaccine maker Bharat Biotech said the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of shelf life of its Covid-19 vaccine Covaxin up 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 told PTI.

WHO's approval comes after the Technical Advisory Group (TAG), an independent advisory committee of WHO recommended EUL status for Covaxin.

"WHO has granted emergency use listing (EUL) to #COVAXIN (developed by Bharat Biotech), adding to a growing portfolio of vaccines validated by WHO for the prevention of COVID-19," the global health body said in a tweet. Dr Poonam Khetarpal Singh, Regional Director of WHO South East Asia, in a tweet, said, "congratulations India for Emergency Use Listing of its indigenously produced Covid-19 vaccine Covaxin." "The Technical Advisory Group of WHO has recommended Emergency Use Listing status for Covaxin," a source told PTI before the WHO announcement. The TAG on October 26 had sought "additional clarifications" from the company for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine. Prime Minister Narendra Modi met WHO Director General Dr Tedros Adhanom Ghebreyesus at the G20 summit recently. 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. Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant.

In June, the company said it concluded the final analysis of Covaxin efficacy from Phase-3 trials. Bharat Biotech's Covaxin and AstraZeneca and Oxford University's Covishield are the two widely used vaccines in India.

Bharat Biotech tweeted that "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. The shelf life extension has been communicated to our stakeholders."