Amid reports of delay in emergency use authorisation (EUA) for Covid-19 vaccine Covaxin by the World Health Organisation (WHO), Bharat Biotech on Tuesday said it does not find it appropriate to comment on the regulatory approval process.
The Indian pharma company also asserted that it is diligently working with the WHO to obtain Emergency Use Listing (EUL) at the earliest.
Bharat Biotech issued a statement shortly after it was reported that the WHO has sought more information on Covaxin and delayed its emergency use approval once again.
In its statement, Bharat Biotech said, “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 timeliness.”
“We are diligently working with the WHO to obtain Emergency Use Listing (EUL) at the earliest,” it added.
The statement further read, “We request media organisations to exercise restraint while reporting on public health-related issues and timeliness, as it has an impact on millions of lives and livelihoods.”
“At appropriate times, we will make announcements to indicate the availability of regulatory approvals,” it said concluding the statement.
Earlier in the day, sources said that the EUA for Bharat Biotech’s Covaxin has once again been delayed by the WHO. The sources further said that the UN public health agency has asked for more data from Bharat Biotech for Covaxin.
This delay will affect Indians especially students and who have international travel plans. The EUA is important because without it Covaxin will not be accepted by most countries.
The Strategic Advisory Group of Expert on Immunization (SAGE) will be meeting on October 5 on EUA to Covaxin.