Indian state rejects approved Bharat Biotech vaccine without efficacy data

By Krishna N. Das

NEW DELHI (Reuters) – An opposition-controlled Indian state said on Thursday that it had asked the federal government to stop supplying a locally grown COVID-19 vaccine until its effectiveness could be proven in an ongoing trial.

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

Bharat Biotech, which created COVAXIN with the state-run Indian Medical Research Council, said data on the efficacy of the final-stage clinical trial with about 26,000 volunteers will be released next month, leading to criticism from epidemiologists that it was approved with much haste for emergency use.

India’s drug developers and regulator say the vaccine is safe and effective based on initial and intermediate studies.

Chhattisgarh, a central-eastern state with about 32 million inhabitants, said he would likely receive injections of COVAXIN shortly after the start of his campaign with 588,000 doses of the AstraZeneca product.

“There is an inhibition / concern among the wider community regarding the use of COVAXIN,” wrote the state health minister, TS Singh Deo, in a letter to his federal counterpart, Harsh Vardhan, and shared on Twitter.

“This concern arises from the fact that phase 3 clinical trials have not yet been completed.”

Vardhan responded with a letter stating that both vaccines were “safe and immunogenic and should be used quickly to provide protection to priority beneficiaries quickly”.

He countered Singh Deo’s claim that COVAXIN vials have no expiration details, attaching a photo marking the manufacturing and expiration dates affixed to a Bharat Biotech vaccine bottle.

Vardhan urged Chhattisgarh to step up vaccines, saying he covered only 9.6% of his front-line employees, such as police and sanitation officials, despite having vaccine stocks. However, it has already given the first dose to 70% of its health professionals, one of the best coverage rates in the country.

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

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

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

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

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