Bharat Biotech submits additional data on Covaxin to WHO ahead of November 3 meeting on EUL


As Bharat Biotech awaits approval of its COVID-19 Covaxin vaccine from the World Health Organization, the Hyderabad-based pharmaceutical company said on Wednesday it had submitted additional data requested by the technical advisory group of the global health body before the final assessment to be conducted on November 3.

The Technical Advisory Group, which licenses a vaccine for its Emergency Use List (EUL), requested additional data from Bharat Biotech on Oct. 26 to conduct a final risk-benefit assessment before proceeding. approve the Covid-19 jab for EUL.

According to a report, the additional information requested included immunogenicity data for people over the age of 60, as well as sex-disaggregated data on the immunogenicity and efficacy of the vaccine. Last week, Bharat Biotech submitted these details as requested by the technical advisory group, sources said. The advisory committee is now expected to conduct a final assessment on November 3.

Bharat Biotech first submitted its dossier to the WHO on July 6 as part of the continuous submission of data. The drug company then submitted additional data to the WHO on September 27, after which the SAGE committee prepared its policy recommendation.

The WHO had mentioned that it could not compromise before recommending a vaccine for emergency use and that the process also depended on how quickly the company provides data to assess the safety, quality and the effectiveness of a vaccine.

WHO has so far administered EUL to seven coronavirus vaccines.

Meanwhile, Australia today recognized Covaxin for allowing entry of travelers who had received the vaccine.

The Therapeutic Goods Administration (TGA), the Australian medicines regulatory authority, has announced that it has recognized two other Covid-19 vaccines not registered in Australia but widely used internationally, including Covaxin and BBIBP- CorV from Bharat Biotech (manufactured by Sinopharm, China).

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Posted on: Monday November 01, 2021, 8:03 PM IST


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