The World Health Organization’s technical advisory group on Tuesday requested “additional clarifications” from Bharat Biotech on the Covid-19 Covaxin vaccine for a final risk-benefit assessment of the vaccine’s emergency use list. Hyderabad-based Bharat Biotech, which developed Covaxin, submitted an EOI (Expression of Interest) to the World Health Organization on April 19 for the Vaccine Emergency Use List (EUL).
A technical advisory group met on Tuesday to review data on Covaxin to include emergency uses for a locally made vaccine in India. In an email response to a question by WHO, WHO said: “TAG met today (October 26, 2021) and determined that additional clarifications from the manufacturer were needed to make a final assessment of the risks and benefits of the EUL for global use of the vaccine.
Covaxin showed 77.8 percent efficacy against symptoms of COVID-19 and 65.2 percent protection against the new delta variant. In June, the company said it had completed the final analysis of Covaxin’s efficacy from Phase 3 trials.
Covaxin and AstraZeneca from Bharat Biotech and Oxford University’s Covishield are the two most widely used vaccines in India. The World Health Organization has so far approved Covid-19 vaccines from Pfizer-BioNTech, AstraZeneca-SK Bio/Serum Institute of India, Johnson & Johnson-Janssen, Moderna and Sinopharm for emergency use.
Last week, the World Health Organization said it expected one additional piece of information from Bharat Biotech regarding Covaxin and stressed that it must conduct a thorough evaluation to ensure vaccines are safe and cannot cut corners before recommending a vaccine for emergency use. The United Nations health agency said the time frame for making an emergency use list depends on how quickly the company producing the vaccine is able to provide the data needed to the World Health Organization to assess the vaccine’s quality, safety, efficacy and suitability for a low and medium vaccine. income countries.
When the information provided addresses all of the questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation on whether or not to award the emergency use list for the vaccine. Earlier, WHO chief scientist Somya Swaminathan said the WHO’s technical advisory group would meet on October 26 to consider the emergency use list for Covaxin.
“The Technical Advisory Group will meet on October 26 to consider an end-user license agreement for #Covaxin. WHO is working closely with @BharatBiotech to complete the dossier. Our goal is to have a broad range of vaccines approved for emergency use and expand access to populations everywhere,” she said.