‘Diligently working with WHO to obtain EUL at the earliest’, says Bharat Biotech on Covaxin

“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 said.
Covaxin is one among the three vaccines being used in India's immunisation programme against Covid-19.(AP )
Covaxin is one among the three vaccines being used in India's immunisation programme against Covid-19.(AP )
Published on Sep 28, 2021 04:17 PM IST
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Written by Srivatsan K C | Edited by Avik Roy, Hindustan Times, New Delhi

Hyderabad based Bharat Biotech on Tuesday said that the company is working “diligently” with the World Health Organization (WHO) regarding the emergency use listing (EUL) for Covid-19 vaccine Covaxin. The company also said that it did not want to speculate or comment further about the regulatory process and the timelines.

“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,” the company said on Tuesday.

The statement came a day after several news reports showed that the emergency use authorization (EUA) for Covaxin has been delayed by the WHO. The UN health body has asked for more data from Bharat Biotech regarding the vaccine, news agency ANI reported citing sources familiar with the development. However, the Strategic Advisory Group of Expert on Immunization (SAGE) meeting regarding Covaxin’s approval still remained scheduled for October 5 and has not been deferred.

Bharat Biotech in its statement, has asked the 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.”

Also read | WHO's nod for Covaxin delayed again over technical queries: Reports

“At appropriate times, we will make announcements to indicate the availability of regulatory approvals,” it added.

Covaxin is one among the three vaccines being used in the country’s immunisation programme against Covid-19, the other two vaccines being Covishield, manufactured by the Serum Institute of India and Russia’s Sputnik V vaccine. Alongside Covaxin, the company is also in the process of developing BBV154, an intranasal vaccine against the disease.

Obtaining an EUA from the WHO would imply that the vaccine could be accepted for travel to other countries. A delay from the WHO could affect Indian citizens, especially students and those who are travelling abroad for other reasons. Several government officials, including minister of state for health and family welfare Dr Pravin Bharati Pawar and Niti Aayog member for health Dr VK Paul have said that the EUA from WHO is expected soon for the vaccine.

Meanwhile, the number of vaccine doses administered under India’s Covid-19 vaccination drive crossed the 870-million mark, the Union ministry of health and family welfare said on Tuesday. Also, more than 10 million doses were administered in the 24-hour period ending earlier on Tuesday morning, the ministry added.

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Wednesday, December 01, 2021