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 the safety and efficacy of Covaxin in five globally reputed peer-reviewed journals in a span of 12 months, the company said in a statement on Saturday.
These include top peer-reviewed journals like The Lancet Infectious Diseases, Cell press, Clinical Infectious Diseases, Journal of Travel Medicine and Nature Communications as well as pre-print server BioRxiv, the company said to drive home its point on data transparency. “The published studies are widely cited for the rigour and breadth that Bharat Biotech brings to its clinical trials,” it added.
The company went on to add that 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,” Bharat Biotech said.
The company’s statements came after a row sparked by a Twitter spat between Bharat Biotech’s business development & advocacy head Raches Ella and Kolkata-based endocrinologist Dr Awadhesh Kumar Singh over the latter’s study comparing immune responses of Covaxin and Covishield let to several Twitterati raising questions about lack of transparency as final Phase-III data of Covaxin is yet to be made public.
“Currently, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being analyzed 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 scrutinized by the regulators in India.
The company pointed out it had completed three preclinical studies, which involve testing of vaccine candidates in laboratory animals, that were published in Cell press and Nature Communications, both of which are peer-reviewed journals.
The Phase I trials, conducted to assess a vaccine’s safety, immune response and to determine the right dosage, as well as the Phase II clinical trial, which is carried out to assess the safety and the ability of the vaccine to generate an immune response, were published by a reputed peer-reviewed journal, The Lancet Infectious Diseases.
The company added that the full data from studies on COVAXIN’s neutralization of variants were published in peer-reviewed journals like Clinical Infectious Diseases, and Journal of Travel Medicine as well as pre-print server BioRxiv.
“The study on the neutralization of Beta and Delta variants (B.1.351 and B.1.617.2 respectively) is published at bioRxiv, and the study on B1.1.28 variant, at Journal of Travel Medicine, while the studies on B.1.617 variant and Alpha variant (B.1.1.7) are published at Clinical Infectious Disease, and Journal of Travel Medicine respectively,” it said
Committed to data transparency on Covaxin, published 9 papers in 12 months: Bharat Biotech - Times of India
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