Hyderabad-based Bharat Biotech has submitted “additional data” to the Technical Advisory Group (TAG) of the World Health Organization (WHO), which is needed for it to finalise the assessment required for granting the much-awaited Emergency Use Listing (EUL) to Covaxin.
According to sources, TAG had sought “gender wise” immunogenicity data on adults aged 60 plus from the company.
“There is a particular format that the company had to follow. Separate data for both male and female was needed from the company,” according to the people cited.
The data was submitted on Friday, they said.
In its meeting on October 26, the TAG had sought “additional clarification” from Bharat Biotech to conduct a final risk-benefit assessment for global use of Covaxin.
WHO had said that TAG will reconvene for the final assessment on Wednesday, if Bharat Biotech is able to send the required data.
“The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November,” WHO told ET in an email response.
WHO’s TAG is an independent advisory group that provides recommendations to the WHO on whether a Covid 19 vaccine can be listed for emergency use under the EUL procedure.
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.
“Covaxin has not taken longer than all the other vaccines that have been through EUL,” WHO told ET.