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Committed to data transparency on Covaxin, published 9 articles in 12 months: Bharat Biotech | India News

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HYDERABAD: Amid growing clamor for Bharat Biotech to declare final data from phase III trials of the locally developed Covaxin vaccine, Bharat Biotech said on Saturday that it is committed to data transparency and that it will soon be obtaining the data of the final. public review of efficacy trials.
Demonstrating its scientific commitment to data generation and data transparency, Bharat Biotech shares comprehensive data from all its Covaxin research studies and has published up to nine research articles on the safety and efficacy of Covaxin in five peer-reviewed journals. world-renowned within 12 months, the company said in a statement Saturday.
These include leading peer-reviewed journals such as The Lancet Infectious Diseases, Cell press, Clinical Infectious Diseases, Journal of Travel Medicine, and Nature Communications, as well as the BioRxiv prepress server, the company said that emphasizes its point of data transparency. “Published studies are widely cited for the rigor and breadth that Bharat Biotech brings to its clinical trials,” he added.
The company added that Covaxin has many firsts under its belt in data transparency. “It is the first and only product to have published data from human clinical trials in India. It is the only product that has data on emerging variants. It is also the first and only Covid-19 vaccine that has efficacy data in Indian populations, ”said Bharat Biotech.
The company’s remarks came after a dispute sparked by a Twitter feud between Bharat Biotech’s head of business development and promotion, Raches Ella, and Kolkata-based endocrinologist Dr. Awadhesh Kumar Singh, over the study. of the latter comparing the immune responses of Covaxin and Covishield to various Twitterati raising questions about the fault. transparency, as final Covaxin phase III data has not yet been released.
“Currently, efficacy and safety follow-up data from the phase III trial of Covaxin are being analyzed and compiled. Maintaining its unwavering commitment to integrity, the company will soon release the data from the Phase III trials of the final analysis, ”he said, adding that the complete data from Phase I and II, and the partial data from the Phase III trials III of Covaxin have been thoroughly analyzed. by regulators in India.
The company noted that it had completed three preclinical studies, involving testing of vaccine candidates in laboratory animals, which were published in Cell press and Nature Communications, both of which are peer-reviewed journals.
Phase I trials, conducted to assess the safety of a vaccine, the immune response, and to determine the correct dose, as well as the Phase II clinical trial, which is conducted to assess the safety and ability of the vaccine to generate an immune response. they were published by a prestigious peer-reviewed journal, The Lancet Infectious Diseases.
The company added that full COVAXIN variant neutralization study data was published in peer-reviewed journals such as Clinical Infectious Diseases and the Journal of Travel Medicine, as well as on the BioRxiv preprint server.
“The study on the neutralization of the Beta and Delta variants (B.1.351 and B.1.617.2 respectively) is published in bioRxiv, and the study on the B1.1.28 variant, in the Journal of Travel Medicine, while the studies on B.1.617 variant and Alpha variant (B.1.1.7) are published in Clinical Infectious Disease and Journal of Travel Medicine respectively, “he said.



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