Covaxin Gets WHO Approval For Emergency Use Listing

The Technical Advisory Group (TAG), an independent advisory committee of the World Health Organisation (WHO), has recommended Emergency Use Listing (EUL) status for Bharat Biotech COVID-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. 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.

Hyderabad-based Bharat Biotech had submitted EOI (Expression of Interest) to the World Health Organisation on April 19 for the vaccine's Emergency Use Listing (EUL).

India's Bharat Biotech has been submitting data on the EUL of Covaxin regularly and very quickly to a technical committee which hopes to have a final recommendation to the WHO next week, a top official of the global health agency said on Thursday, stressing that the UN body "trusts" the Indian industry that manufactures high-quality vaccines.

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The WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna, and Sinopharm for emergency use.

Bharat Biotech on Wednesday also issued a statement saying that the Central Drugs Standard Control Organisation (CDSCO) has approved the extension of the shelf life of its COVID-19 vaccine Covaxin up to 12 months from the date of manufacture. This move will help hospitals, especially private hospitals, use up their stock of the vaccine.

"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.