The World Health Organisation’s approval for emergency use listing (EUL) of Bharat Biotech’s Covaxin is expected to take a few more weeks to arrive. The decision, however, will be taken in October itself. WHO’s Strategic Advisory Group of Experts on Immunisation (SAGE) is holding its meetings from October 4 to 8, during which it will examine the latest evidences to prepare policy recommendations for the best use of Covaxin. The policy guidelines will be issued once the EUL process is completed.
Though Covaxin was on the agenda of SAGE’s meeting on Tuesday, officials said the decision on EUL approval is still pending. The WHO said in response to an email query from TOI: “The EUL decision on Covaxin is still pending. Bharat has been submitting data to WHO on a rolling basis and submitted additional information at WHO’s request on 27 September. WHO experts are currently reviewing this information and if it addresses all questions raised, WHO and the Technical Advisory Group (TAG) will carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to the vaccine.”
The Technical Advisory Group (TAG) related to EUL is expected to convene its meeting next week. A final call will be taken based on the recommendations of both TAG and SAGE.
According to WHO, the EUL process is centred on determining if a manufactured product is quality-assured, safe and effective. The WHO SAGE is responsible for issuing evidence-based policy recommendations for the best use of vaccines against Covid-19. “Such product-specific recommendations are issued once a vaccine is authorised through a regulatory process, including the assessment of safety and efficacy from phase III clinical trials,” it said.