Indian state rejects Bharat Biotech vaccine approved without efficacy data

An opposition-ruled Indian state said on Thursday it had asked the federal government to halt the supply of a homegrown COVID-19 vaccine until its efficacy could be proven in an ongoing late-stage trial.

India, which has reported the world's second-highest number of COVID-19 cases after the United States, has vaccinated more than 7 million front-line workers since Jan. 16 using COVAXIN developed by Bharat Biotech as well as a vaccine licenced from AstraZeneca and Oxford University.

So far the federal government has ordered 10 million COVAXIN doses and 21 million AstraZeneca shots, locally made by the Serum Institute of India for low- and middle-income countries.

Bharat Biotech, which created COVAXIN with the state-run Indian Council of Medical Research, has said efficacy data from the late-stage clinical trial on nearly 26,000 volunteers will be out by next month, leading to criticism from epidemiologists that it was approved too hastily for emergency use.

The developers and India's drug regulator, however, say the vaccine is safe and effective based on early and intermediate studies.

Chhattisgarh, a central-eastern state of about 32 million people, said it was likely to be soon sent COVAXIN shots after starting its campaign with 588,000 doses of the AstraZeneca product.

"There's an inhibition/concern among the community in general regarding the use of COVAXIN," state health minister T.S. Singh Deo wrote in a letter to his federal counterpart, Harsh Vardhan, and shared on Twitter.

"This concern arises from the fact that the clinical trials of phase 3 are yet to be completed."

Singh Deo also said on Twitter that COVAXIN vials do not display any expiry date and that he had requested Vardhan to halt its supply to Chhattisgarh "until these issues are addressed to the satisfaction of our Health Department to avoid the wastage of the early expiration doses of the drug".

A spokeswoman for the federal Ministry of Health and Family Welfare did not respond to a request for comment.

Bharat Biotech said it might comment later. It plans to export the shot to Brazil and the United Arab Emirates soon.

India's COVID-19 infections rose 12,923 in the past 24 hours to 10.87 million in total. Deaths increased by 108 to 155,360.