Even as the Hyderabad-based Bharat Biotech waits for the much sought-after emergency use authorisation (EUA) from the World Health Organization (WHO) for its indigenous Covid-19 vaccine ‘Covaxin’, it seems that the wait is to continue for at least a bit longer. The international public health body is likely to have once again delayed its approval for the Covaxin shot, this time till October 5. According to a report by the ANI news agency, the Strategic Advisory Group of Experts on Immunization (SAGE) will be meeting on October 5 to decide on granting the EUA to Covaxin.
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The SAGE session of the specialised agency of the United Nations will recommend EUA based on the clinical on Covaxin from Phase 1, 2, and 3 trials, according to the report. The session will also consider the post-marketing studies on safety, immunogenicity, efficacy, and effectiveness; and review updates on global, regional, and country-level plans for vaccine safety monitoring.
Based on the assessments of the SAGE working group, WHO will then consider the available pieces of evidence to determine EUA. Meanwhile, Bharat Biotech said on Friday that it has submitted all the data to WHO for emergency use listing (EUL) of Covaxin and is now awaiting feedback. However, the company said that it did not find it “appropriate” to comment on the approval process and its timeline.
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The Phase-3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent. All the relevant trial data has been submitted to WHO for EUL, and all clarifications sought by the UN health agency have been responded to, Bharat Biotech said. “We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines,” the Hyderabad-based company said in a statement.
So far, the WHO has approved Covid-19 vaccines manufactured by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna, and Sinopharm. UN agency’s approval makes international travel easy for people who receive those vaccines and the company also gets a boost to market its product in the global market.