'Working With WHO To Get Covaxin Approval at the Earliest': Bharat Biotech

Bharat Biotech's statement comes after reports of delay in the WHO approval of Covaxin.

Brazil's federal prosecutors have initiated an investigation into a contract worth $324 million between the Brazilian government and Bharat Biotech for 20 million doses of Covaxin.

(Photo: Bharat Biotech)

After reports of further delay in the World Health Organization (WHO)'s approval of the COVID-19 vaccine Covaxin, drugmaker Bharat Biotech has said that it is working with the WHO to obtain emergency use listing for the indigenously manufactured vaccine at the earliest.

"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 EUL at the earliest."

Bharat Biotech

The WHO has sought more data on Covaxin from Bharat Biotech, news agency ANI reported on Tuesday, 28 September, citing WHO officials. The emergency use authorisation (EUA) for the vaccine will be delayed by a few more days, the sources indicated.

Following the media reports, the Covaxin manufacturer issued a statement, saying:

"We request media organisations to exercise restraint while reporting on public health-related issues and timelines, 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."

Bharat Biotech, on 12 July, had said that the pharmaceutical company expected to receive the EUL for Covaxin very soon. "All documents required for Emergency Use Listing (EUL) of Covaxin have been submitted to WHO as of 9 July," the drugmaker had stated in an official release.

"The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest," it had then said.

As recently as 24 September, Union Minister of State in the Health Ministry Bharati Pravin Pawar had stated that the emergency use authorisation for Covaxin was expected soon.