Chhattisgarh rejects Bharat Biotech vaccine approved without efficacy data

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

By Krishna N. Das

NEW DELHI (Reuters) - 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 licensed from AstraZeneca and Oxford University.

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 say the vaccine is safe and effective based on early and intermediate studies.

Chhattisgarh, a east-central state of some 32 million people, said it was likely to be sent COVAXIN shots soon 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."

Vardhan responded with a letter stating that both vaccines were "safe and immunogenic and should be used expeditiously to rapidly confer protection to prioritised beneficiaries".

He rebutted Singh Deo's assertion that COVAXIN vials carry no expiry details, attaching a picture marking the manufacturing and use-by dates affixed to a Bharat Biotech vaccine bottle.

Vardhan urged Chhattisgarh to step up inoculations, saying it had covered only 9.6% of its front-line workers, like those in the police and sanitation, despite having vaccine stocks. It, however, has given the first dose to 70% of its healthcare workers, one of the best coverage rates in the country.

Bharat Biotech did not respond to a request for comment. It plans to export the shot to Brazil and the United Arab Emirates soon.

So far the Indian 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.

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.

 

(Reporting by Krishna N. Das; Editing by Mark Heinrich)