Vaccine / Covaxin gets WHO approval for Emergency Use Listing

New Delhi: Bharat Biotech's Covaxin has moved a step closer to getting WHO approval on Wednesday as the technical advisory team has recommended the India-made vaccine for emergency use listing for 18 years and above, people familiar with the development said. This marks a major victory for India's journey in vaccination against Covid-19. Covaxin is a vaccine, completely 'made in India', by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research. The emergency listing got delayed last month as the technical advisory group sought some additional clarification from Bharat Biotech for its final risk assessment. The technical advisory group met on Wednesday to take the final call, and Covaxin has been recommended for emergency use listing.

The technical advisory group is an independent advisory body that provides recommendations to WHO for approval of vaccines. The team met last October 26 and sought additional clarifications from Bharat Biotech which the company submitted. The team went through those data on Wednesday and gave its nod that Covaxin 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. Bharat Biotech said that it concluded the final analysis of Covaxin efficacy from Phase 3 trials. WHO has so far approved Covid-19 vaccines of Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson 7 Johnson - Janssen, Moderna, and Sinopharm for emergency use.

What's the next step?

The go-ahead from the technical team can be considered as getting approval from WHO, though WHO will make it official on its website in a few days. Rolling data for theEUL review of Covaxin started in July 2021 and the decision date was in October when the technical team of the WHO sought additional gender-wise data from the manufacturer.