Bharat Biotech’s Covaxin has got WHO approval on Wednesday as the technical advisory team has recommended the India-made vaccine for emergency use listing for 18 years and above. 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 and the world body has also announced it on its social media platform.
“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 #COVID19. The Technical Advisory Group, convened by WHO and made up of regulatory experts from around the world, has determined that the #Covaxin vaccine meets WHO standards for protection against #COVID19, that the benefit of the vaccine far outweighs risks & the vaccine can be used. #Covaxin vaccine was also reviewed by WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), and recommended use of this vaccine in two doses, with a dose interval of four weeks, in all age groups 18 and above. Available data on vaccination of pregnant women with the #Covaxin vaccine are insufficient to assess vaccine safety or efficacy in pregnancy; studies in pregnant women are planned, including a pregnancy sub-study and a pregnancy registry,” WHO tweeted.
Rolling data for the EUL 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.
What does WHO EUL for Covaxin will mean for India?
The emergency use listing of Covaxin will open the door of many countries for Indians vaccinated with Covaxin. Many countries like Guyana, Iran, Mauritius, Mexico, Nepal, Paraguay, the Philipines, Zimbabwe, Australia, Oman, Sri Lanka, Estonia, Greece have approved Covaxin, many countries were waiting for WHO’s decision before extending approval to Covaxin.
Apart from its significance to Indians inoculated with this vaccine, the WHO recognitions brings recognition for Indian scientists as Covaxin is the first India-made vaccine against Covid-19.