New Delhi: Indians, especially students, who had taken Covaxin continue to be on tenterhooks vis-à-vis foreign travel as Bharat Biotech’s COVID-19 vaccine still doesn’t have global recognition.
It’s been months since Bharat Biotech asserted that it had submitted all data required for emergency use listing (EUL) clearance by World Health Organization.
Weeks are passing by, but the UN agency keeps delaying the approval ostensibly because it needs further clarifications.
Union Foreign Secretary Harsh Vardhan Shringla said that India’s first indigenous COVID vaccine will be approved soon, adding that the delay is due to a technical process.
“It is a technical process, not an administrative or a political process. There’s a technical committee that evaluates the submission made by Bharat Biotech which manufactures Covaxin. The committee has asked some questions and I believe some answers have been given. I am sure the approval of Covaxin from WHO will come at the soonest possible time,” ANI quoted Shringla as saying.
It was expected that WHO’s Strategic Advisory Group of Experts (SAGE) would take a call on October 5 after a discussion on Phase 1-3 trial results of Covaxin. But that didn’t happen as WHO tweeted last week a meeting is scheduled for “next week” to assess risk and benefits of Covaxin to decide on its emergency using authorisation.
Now, India is hoping that WHO will give the nod “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 tweeted two days ago.
“Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional information at WHO’s request on 27 September. WHO experts are currently reviewing this info and if it addresses all questions raised, WHO assessment will be finalized next week,” WHO added.