Hyderabad-based Bharat Biotech has submitted additional data sought by the World Health Organisation’s (WHO) technical advisory group ahead of the final assessment to be conducted on November 3, CNN-News18 has learnt.
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. The company had submitted the data last week, said government sources in the know of the development.
The sources also said that 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. The advisory committee is now expected to conduct a final assessment on November 3.
What has happened so far?
Bharat Biotech had first submitted its dossier to WHO on July 6 as part of rolling data submission. The pharma company again submitted additional data to WHO on September 27, following which the SAGE committee prepared its policy recommendation.
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.
SAGE or the Strategic Advisory Group of Experts on immunisation has already analysed and completed its review on Covaxin for global use. It has prepared its policy recommendation on the broader use of the vaccine on October 12.
The license from the technical advisory group, however, is still awaited. The independent group assesses the clinical trial data to review the safety, efficacy and manufacturing processes of the vaccine.
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