The World Health Organization on Wednesday said it will take a decision on Indian biotechnology company Bharat Biotech’s application seeking emergency use listing for its coronavirus vaccine in October.
The status of Covaxon’s assessment is “ongoing”, the global health body said in a document.
Emergency use listing is a procedure by the World Health Organization to approve vaccines and other products for use during public health emergencies. The duration of the emergency use listing process depends on the quality of the data submitted by the vaccine manufacturer.
The World Health Organization said that Bharat Biotech began submitting “rolling data” on July 6. In a rolling review, the global health body can analyse information as and when it comes in from an applicant, thus accelerating the process, according to PTI.
On September 28, Bharat Biotech said it was diligently working with the World Health Organization to obtain emergency use listing at the earliest. It had urged the media to “exercise restraint” while reporting on public health-related timelines.
“As a responsible manufacturer with past approvals for our vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines,” the company said.
The Drugs Controller General of India granted approval for restricted emergency use to Covaxin in January. Covaxin and Oxford-AstraZeneca’s Covishield were the first Covid-19 vaccines to be approved in India.
Approval from the World Health Organization will allow Bharat Biotech to export its vaccines. Additionally, it will facilitate easier international travel of Indian citizens who have been administered Covaxin.
According to the latest data on the government’s CoWin dashboard, 10,14,33,835 doses of Covaxin have been administered to beneficiaries in India so far.
More than 88 crore vaccine doses have been administered in the country since the beginning of the inoculation drive on January 16, according to the Union health ministry’s data. Of these, over 65 lakh doses were administered to beneficiaries on Thursday.