Final decision on Covaxin clearance next week, says WHO
The World Health Organisation (WHO) has said that it'll announce the final decision on granting the much-awaited Emergency Use Listing (EUL) to Covaxin next week.
“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 global health body said in a tweet on Tuesday.
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.#COVID19pic.twitter.com/jJyS1hiz44— World Health Organization (WHO) (@WHO) October 5, 2021
Covaxin manufacturer, Bharat Biotech, has been submitting data to the WHO on a rolling basis and submitted additional information at the WHO’s request on September 27.
“WHO experts are currently reviewing this info & if it addresses all questions raised, WHO assessment will be finalised next week,” said the WHO.
The Emergency Use Listing process - done by WHO and the Technical Advisory Group of independent experts - is centred on determining if a manufactured product (e.g. a vaccine) is “quality-assured”, “safe” and “effective”.
The Hyderabad-based pharma company last month had responded to all clarifications sought by the WHO on their EUL Application for the Made in India Covid-19 vaccine -- Covaxin. The pharma firm, popularly known for vaccine manufacturing, said it has provided the global health watchdog with all the details and was awaiting EUL approval.
Data of clinical trials was fully compiled and available in June this year. The final data for the EUL application was submitted in early July. The EUL application provides advice before the submission of the final dossier.
Before that, Union Health Minister Mansukh Mandaviya had also met WHO Chief Scientist Dr Soumya Swaminathan to discuss the approval of Covaxin, reported news agency ANI.
Meanwhile, the WHO has already approved Pfizer-BioNTech, AstraZeneca, Moderna, Sinopharm and Johnson and Johnson Covid-19 vaccines.