HYDERABAD: As the clamour grows for Bharat Biotech to publish the phase-III data for indigenously developed Covaxin, the company said it is committed to data transparency and will soon be making the final analysis data of the efficacy trials public.
“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 include The Lancet Infectious Diseases, Cellpress, Clinical Infectious Diseases, Journal of Travel Medicine and Nature Communications.
“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!” the company also tweeted from its Twitter handle to drive home this point and said Covaxin has many 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.
The company’s statements came in the wake of a heated Twitter exchange between Bharat Biotech’s SARSCoV-2 vaccine project lead Raches Ella and Kolkata-based endocrinologist Dr Awadhesh Kumar Singh over the latter’s study comparing immune responses of Covaxin and Covishield.
The spat also saw several Twitterati accuse Bharat Biotech of lack of transparency as it has not yet declared the final Phase-III data.
“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’s clinical trials are being conducted by US-based clinical research player IQVIA, formerly Quintiles and IMS Health Inc.
Giving details of Covaxin studies published in peer-reviewed journals, it said results of Phase I trials, which are conducted to assess a vaccine’s safety, immune response and to determine the right dosage, as well as Phase II clinical trials (carried out to assess the safety and the ability of the vaccine to generate an immune response) were published by renowned British medical journal, The Lancet Infectious Diseases.