New Delhi
Bharat Biotech is working with the World Health Organization (WHO) to obtain Emergency Use Listing (EUL) for Covaxin, its Covid-19 vaccine, the Indian vaccine maker said on Tuesday, urging an end to speculation on the permission being delayed.
The company was responding to reports that said the grant of EUL could be delayed further as WHO had more technical queries regarding the inactivated whole virus vaccine.
“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,” the company said in a statement on Tuesday. “We are diligently working with the WHO to obtain EUL at the earliest.”
The authorisation, when it comes, will pave the way for wider recognition of Covaxin in documentation sought by many countries that have made inoculation mandatory for entry from their borders. In the past, students who sought to study abroad faced problems because Covaxin is recognised as a Covid-19 vaccine only in a few countries.
The company earlier said that it had submitted all the necessary documents, including trial data, to the UN health agency for the grant of EUL.
“Covaxin clinical trial data was fully compiled and available in June 2021. All data was submitted for emergency use listing (EUL) application to World Health Organisation in early July. We have responded to clarifications sought by WHO and are awaiting further feedback,” the company had said on September 17.
On July 12, Bharat Biotech announced that it submitted all documents required for EUL to WHO on July 9. “The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest ,” Krishna Ella, chairman and managing director of Bharat Biotech, had said in a statement.
Bharat Biotech attended a pre-submission meeting with representatives of WHO on June 23.
WHO began a rolling review of Covaxin on July 6, according to people familiar with the matter who requested anonymity.
According to the UN health body, EUL is a risk-based procedure to assess and list unlicensed vaccines, therapeutics and in-vitro diagnostics to expedite availability of these products to people affected by a public health emergency.
On June 22, India’s subject expert committee assessed Bharat Biotech’s phase 3 clinical trials data of Covaxin, and found it to be 77.8% efficacious in preventing symptomatic Covid-19.
While the Indian drugs regulator has approved six Covid-19 vaccines for emergency use, Covaxin and Serum Institute of India-manufactured Covishield are the mainstay of the country’s inoculation programme.
