WHO seeks more info from Bharat Biotech for emergency listing of Covaxin

The documents showed Bharat Biotech submitted Expression of Interest with the WHO for emergency use listing (EUL) on April 19

The World Health Organization (WHO) has sought more information from Bharat Biotech on its emergency use listing (EUL) application for Covaxin, according to the documents on the global health agency's website.

The documents showed Bharat Biotech submitted Expression of Interest with the WHO for EUL on April 19.

Bharat Biotech will hold a pre-submission meeting with WHO in May or June. After the meeting, there are further three stages where the application will be reviewed before the approval.

The WHO’s EUL opens the door for countries to expedite their own regulatory approval processes to import and administer the vaccine. It also enables UNICEF and the other organisations to procure the vaccine for distribution to countries in need.

WHO has so far listed the Pfizer-BioNTech vaccine and AstraZeneca-Oxford vaccine --- which is produced locally by Serum Institute of India --- for emergency use . Apart from these, Johnson & Johnson, Moderna, and China’s Sinopharm have also bagged the health agency's nod for emergency listing.

Bharat Biotech has conveyed to the government that it has already submitted 90 per cent of documents to WHO for obtaining emergency listing for Covaxin vaccine, news agency PTI reported citing sources.

"The remaining documents are expected to be submitted by June, the Hyderabad-based Bharat Biotech Ltd told the Central government during a discussion on obtaining the World Health Organisation's authorisation for emergency use listing for Covaxin."

Noting that Covaxin has already received regulatory approval from 11 countries, the report said there was also interest from other 11 companies in seven nations for technology transfer and production of Covaxin.

Bharat Biotech is planning Covaxin trials for 2-18 age group from June. The company said it will be ramping up the manufacturing capacity to 700 million doses by the end of this year.

The EUL pathway involves a rigorous assessment of late phase II and phase III clinical trial data as well as substantial additional data on safety, efficacy, quality and a risk management plan. These data are reviewed by independent experts and WHO teams who consider the current body of evidence on the vaccine under consideration, the plans for monitoring its use, and plans for further studies.

Experts from individual national authorities are invited to participate in the EUL review. Once a vaccine has been listed for WHO emergency use, WHO engages its regional regulatory networks and partners to inform national health authorities on the vaccine and its anticipated benefits based on data from clinical studies to date.