Hyderabad-based pharma major Bharat Biotech said on Tuesday that the company is diligently working with the World Health Organization (WHO) to get Emergency Use Listing (EUL) for its Covid vaccine, Covaxin.
Bharat Biotech said in a statement that it will make an announcement to indicate the availability of regulatory approval at an appropriate time.
The WHO’s EUL approval for Covaxin was expected by 5 October as WHO’s Strategic Advisory Group of Experts on Immunization (SAGE) was scheduled to meet on this day to make its recommendations on Bharat Biotech’s Covaxin for Emergency Use Listing. The process has been delayed as more technical data has been sought from the pharma major.
“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. We are diligently working with the WHO to obtain the EUL at the earliest,” the statement said.
“At an appropriate time we will make the announcement to indicate the availability of regulatory approval,” it added.
Earlier this month, Bharat Biotech had said that it had submitted all the data to the WHO for the EUL for Covaxin and was awaiting feedback from the UN public health agency.
“Covaxin’s clinical trial data was fully compiled and made available in June 2021. All the data was submitted for EUL application to the World Health Organization in early July. We have responded to any clarifications sought by WHO and are awaiting further feedback,” the pharma company had tweeted.