As Bharat Biotech awaits nod for its COVID-19 vaccine Covaxin from the World Health Organisation, the Hyderabad based pharma company on Wednesday said that it has submitted additional data sought by the global health body's technical advisory group ahead of the final assessment to be conducted on November 3.
The technical advisory group, which gives licence to a vaccine for its emergency use listing (EUL), had asked Bharat Biotech on October 26 for additional data to conduct a final risk-benefit assessment before approving the Covid-19 jab for EUL.
According to a report, the additional information sought included the immunogenicity data for those aged above 60 years, and also the gender-wise split data on immunogenicity and efficacy of the vaccine. Last week, Bharat Biotech submitted these details as sought by the technical advisory group, sources said. The advisory committee is now expected to conduct a final assessment on November 3.
Bharat Biotech had first submitted its dossier to WHO on July 6 as part of rolling data submission. The pharma company then submitted additional data to WHO on September 27, following which the SAGE committee prepared its policy recommendation.
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WHO had mentioned that it cannot cut corners before recommending a vaccine for emergency use and that the process is also dependent on how quickly the company provides data to evaluate a vaccine’s safety, quality and efficacy.
The WHO has given EUL to seven coronavirus vaccines so far.
Meanwhile, Australia today recognised Covaxin for allowing entry of travellers who had received the vaccine.
The Therapeutic Goods Administration (TGA), the Australian drug regulator, announced that it has recognised two more Covid-19 vaccines not registered in Australia but used widely internationally, which includes Bharat Biotech's Covaxin and BBIBP-CorV (manufactured by Sinopharm, China).
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