WHO panel recommends Emergency Use Listing status for Bharat Biotech's Covaxin
The Technical Advisory Group (TAG), an independent advisory committee of the World Health Organisation (WHO), has recommended Emergency Use Listing (EUL) status forCOVID-19 vaccine Covaxin, sources in the know of the development said.
The WHO is in the process of evaluating Covaxin's clinical trial data for use of EUL.
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.
"The Technical Advisory Group of WHO has recommended Emergency Use Listing status for Covaxin," a source told PTI.
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.
Image source: Bharat Biotech Twitter page
Covaxin has demonstrated 77.8 percent effectiveness against symptomatic COVID-19 and 65.2 percent 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.
In another development, Vaccine maker Bharat Biotech on Wednesday 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.
"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.
The shelf life extension has been communicated to "our stakeholders," it added.
The approval for the extension of shelf life of the vaccine comes ahead of a crucial World Health Organisation (WHO) meeting for a final risk-benefit assessment for the emergency use listing (EUL) for the vaccine.
The WHO's Technical Advisory Group for EUL last week had sought additional clarifications from Bharat Biotech for Covaxin.