Covaxin's WHO approval delayed; India-made COVID-19 shot may now get EUL in Oct

The World Health Organisation’s (WHO) approval for the emergency use authorisation (EUA) to COVID-19 vaccine Covaxin, developed by the Hyderabad-based Bharat Biotech, is likely to be delayed till October. As per WHO, the Strategic Advisory Group of Experts on Immunisation (SAGE) would be meeting on 5 October to make its recommendations on Emergency Use Listing of the vaccine. SAGE is authorised to advise WHO on overall global policies and strategies, ranging from vaccines and technology, research and development, to delivery of immunisation and its linkages with other health interventions. Hanna Nohynek, a member of SAGE, will be presenting a draft recommendation for the vaccine and the session will make its recommendations. The session will thoroughly discuss the clinical data on Covaxin from phase one, two, three trials and post-marketing studies on safety, immunogenicity, efficacy and effectiveness, besides update on global, regional and country-level plans for vaccine safety monitoring, the agenda said. The process for approval of a vaccine by WHO consists of four steps: an acceptance of the manufacturer’s expression of interest (EOI), a pre-submission meeting between WHO and the manufacturer, acceptance of the dossier for review by WHO, a decision on the status of assessment, and the final decision on approval. Bharat Biotech recently said it has submitted all the data pertaining to Covaxin to the WHO for EUL and is awaiting feedback from the global health watchdog. The WHO is currently reviewing the data submitted by the vaccine maker and the date for a decision on the jab is yet “to be confirmed,” according to the update available on the WHO website. In an update on its website, the WHO said it began rolling data of the vaccine on 6 July. Rolling data allows the WHO to start its review right away, as information continues to come in, to accelerate the overall review process. Covaxin is one of the six vaccines that have received emergency use authorisation from India’s drug regulator and is being used in the nationwide inoculation programme, along with Covishield and Sputnik V. With inputs from PTI