The World Health Organization (WHO) on Tuesday said a meeting is scheduled for the next week to assess the risk and benefits of Bharat Biotech's Covaxin to decide on its emergency using authorisation. In a series of tweets, the UN health agency said that Bharat Biotech has been submitting data on a rolling basis and submitted additional information at the WHO's request on September 27.
“WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin,” the health agency tweeted.
WHO further stated that the assessment will be finalised next week if the additional information submitted by the manufacturer addresses all the questions raised by the experts. The Emergency Use Listing process is centred on determining if the vaccine is quality-assured, safe and effective, according to the WHO.
So far, the WHO has approved Covid-19 vaccines manufactured by Pfizer-BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm. Bharat Biotech, the Indian biotechnology company, has been awaiting approval from the WHO for weeks, which is important for promoting its product in the global as well as domestic market. The emergency use listing also makes international travel easy.
“As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines,” Bharat Biotech had said in a statement late last month.
{{/usCountry}}“As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines,” Bharat Biotech had said in a statement late last month.
{{/usCountry}}“We are diligently working with the WHO to obtain EUL at the earliest,” it added.