Final Analysis of Covaxin Efficacy Trials Will be Public Soon, Says Bharat Biotech

Final Analysis of Covaxin Efficacy Trials Will be Public Soon, Says Bharat Biotech Bharat Biotech has submitted Covaxin's Phase III trial data and now awaits WHO approval on June 23, 2021. (ANI photo)

New Delhi: As more and more doubt grows for Bharat Biotech to publish the phase-III data for indigenously developed Covaxin, the Hyderabad-based manufacturers said it is committed to data transparency and will be making the final data analysis of the efficacy trials public soon.

“Demonstrating its scientific commitment to data generation and data transparency, Bharat Biotech shares full data of all research studies of its Covaxin and has published as many as nine research papers on its safety and efficacy in five globally reputed peerreviewed journals in a span of 12 months,” the vaccine maker said in a statement on Saturday.

These journals also include The Lancet Infectious Diseases, Clinical Infectious Diseases, Cellpress, Nature Communications and Journal of Travel Medicine.

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“The published studies are widely cited for the rigor and breadth that Bharat Biotech brings to its clinical trials,” it added.

“Our humble request to ‘Where is your data?’ Our publications do the talking!” Bharat Biotech also said in a tweet and added that Covaxin has numerous firsts to its credit in data transparency.

“It is the first and only product to have published any data from human clinical trials in India. It is the only product to have any data on emerging variants. It is also the first and only Covid-19 vaccine to have efficacy data in Indian populations,” it said.

This above-mentioned statement from the company statements came in right after a heated Twitter spat between Bharat Biotech’s SARSCoV-2 vaccine project lead Raches Ella and Kolkata-based endocrinologist Dr Awadhesh Kumar Singh over a study showing the immune responses of Covaxin and Covishield by Singh.

The spat also saw several netizen call out Bharat Biotech for lack of transparency as it has not yet released the final Phase-III data.

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“Currently, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being analysed and compiled. Upholding its uncompromising commitment to integrity, the company will soon make Phase III trials data from the final analysis public,” it said, adding that the complete data for Phase I and II, and partial data for Phase III trials of Covaxin have been thoroughly scrutinised by the regulators in India.

Covaxin is also one of the three COVID-19 vaccines presently being administered in India.

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