Bharat Biotech’s coronavirus vaccine Covaxin is 77.8% effective against the infection, ANI reported on Tuesday, citing sources on phase 3 ...
Bharat Biotech’s coronavirus vaccine Covaxin is 77.8% effective against the infection, ANI reported on Tuesday, citing sources on phase 3 trial results of the jab. Bharat Biotech had submitted the trial results to the Drug Controller General of India over the weekend.
On Tuesday, a Subject Expert Committee of the Central Drugs Standard Control Organisation, the country’s apex drug regulatory body, reviewed and accepted the data, according to The Indian Express.
The data has not been published in a peer-reviewed journal yet. However, Bharat Biotech can now approach the World Health Organization for emergency use listing of the vaccine which would make it easier for Covaxin to receive approvals in other countries. Bharat Biotech is expected to submit its proposal to the WHO on Wednesday, reports said.
Review of phase 3 trials of a vaccine by the drug regulator of the country of its origin is required for emergency use listing by the WHO, according to Business Standard.
The indigenously developed Covaxin shot was granted emergency use authorisation in January though data of phase 3 trials were not available at that time. The company had then said it would submit efficacy results by March. On June 9, it said that the data will be made public in July.
In April, an interim analysis of Covaxin’s phase three data...
