Bharat Biotech Denies Reports Of Sharing Phase 3 Covaxin Data With WHO

Hyderabad based Bharat Biotech has denied reports stating that it has shared its Phase 3 trial results of Covaxin to the World Health Organisation for Emergency Use Listing.

Bharat Biotech took to Twitter to clarify that reports by media organisations suggesting that it had not submitted Phase 3 trial datawith WHO and this news was reported without any evidence. The company which indigenously produced Covaxin in collaboration with the Indian Council of Medical Research and the National Institute of Virology, is yet to share its Phase 3 trials data which will denote its final efficacy. The newspaper reports also claimed that the company was meeting the WHO on June 23 for receiving Emergency Use Listing.

India approved Covaxin for Emergency Use Authorisation without waiting for its Phase 3 results and this move was criticised by several scientists. With the lack of data, the US Food and Drug Administration also asked the company's American partner to provide more data and apply for complete authorisation and did not give it an EUA.

Also Read:Why India's Homegrown Covaxin Faced Rejection From US FDA

Many US universities also wrote to its students that they would have to be re-vaccinated. if they had received Covaxin or Russia's Sputnik V. These universities stated the lack of approval by the US FDA, WHO and the Europeran Union as a reason for pushing re-vaccination.

The WHO has approved the Oxford-AstraZeneca vaccine produced by SK Bio in Korea and Serum Institute of India, the Pfizer-BioNTech vaccine, the Moderna vaccine, the Jannsen vaccine, and the Sinopharm vaccine as emergency use listings. This allows the vaccine manufacturers to distribute their vaccines across the world.

The Indian manufacturers stated that they would be sharing their Phase 3 trial data with the Subject Expert Committee of the Central Drugs Standard Control Organisation, the Indian drug regulating body in July.

On June 16, 2021, the company also refuted rumours that the vaccine contained new born calf serum in it.

Also Read:Health Ministry, Bharat Biotech Deny Covaxin Has New Born Calf Serum