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Not so fast: Experts on DCGI approving Covishield and Covaxin for restricted emergency use 

In a statement, All India Drug Action Network said that with respect to Covaxin, they are alarmed because it signifies the grant of regulatory approval without any efficacy data.

Published: 04th January 2021 02:39 AM  |   Last Updated: 04th January 2021 06:47 AM   |  A+A-

covishield, Covaxin

DGCI has accepted the govt panel's recommendation to grant restricted emergency use authorization to Covishield, Covaxin. (File Photo)

Express News Service

BENGALURU:  The news that the Drugs Controller General of India has approved Covid-19 vaccines Covishield and Covaxin for restricted emergency use, has alarmed experts.

They have raised concerns about the lack of data in the public domain.

While Covishield is developed by Oxford University-AstraZeneca-Serum Institute of India, the indigenous Covaxin is developed by Bharat Biotech.

In a statement, All India Drug Action Network said that with respect to Covaxin, they are alarmed because it signifies the grant of regulatory approval without any efficacy data.

“The Phase 3 trials are currently ongoing and it is too early for data to meet the criterion for an interim analysis. The only human data available on safety and immunogenicity is on 755 participants in Phase 1 & 2 trials. Other than this, there is data from animal studies. This would amount to rolling out an untested and unproven vaccine to the public which raises concerns,” the statement said.

Regarding Serum’s Covishield vaccine, it said that it is clear that the data for all participants in the Indian trial were not submitted.

"The very objective of a bridging study to assess the vaccine candidate in an Indian population is lost if the data are not reviewed in the process of regulatory approval. While data from overseas trials has been considered, we do not know exactly what data and analysis from the Oxford University/AstraZeneca/ trials were taken into consideration,” they said.

Shahid Jameel, Indian virologist and Director of Trivedi School of Biosciences at Ashoka University, too spoke about the need for transparency.

He said, “For Covishield, there are no final results. And the concern is the same with Covaxin, where the trials are still ongoing.  The safety of vaccines on individuals is tested in Phase 2 of trials and then safety is checked on larger populations in Phase 3. In both these vaccines, it needs to be checked on a larger population still.”

Dr T Jacob John, retired professor of virology from Christian Medical College, Vellore, said that Covaxin is well into the Phase 3 trials, but for Covishield there is lack of data.

“Given that we do not have other options, we might have to take these vaccines,” said Dr Vishal Rao, member of Karnataka Covid consultative group.

These vaccines may have been approved as they require to be stored in 2 to 8 degrees Celsius in cold storage capacity unlike other vaccines which require -70 degrees, that is not available in India as of now, he said.



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