PharmaLytica 2021 Hyderabad review.

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Full research data of COVAXIN shared by Bharat Biotech

the company has already published as many as nine research studies on the safety and efficacy of COVAXIN in five globally reputed peer-reviewed journals

12th June, 2021 Mumbai

Bharat Biotech has shared full data of all research studies of COVAXIN, its COVID-19 vaccine.

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. In a timely approach to peer review, the company has already published as many as nine research studies on the safety and efficacy of COVAXIN in five globally reputed peer-reviewed journals in a span of just twelve months, as per company statement.

In vaccine development, preclinical studies involve testing of vaccine candidates in laboratory animals. Bharat Biotech completed three preclinical studies, which are published in Cellpress, a peer-reviewed journal. The studies on COVAXIN’s Phase I (done to assess a vaccine’s safety, immune response and to determine right dosage), and Phase II clinical trial (carried out to assess the safety and the ability of the vaccine to generate an immune response) are published by the peer-reviewed journal, The Lancet – Infectious Diseases, the statement informed.

The full data from studies on COVAXIN’s neutralization of variants are already published at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine. The study on the neutralization of Beta and Delta variants (B.1.351 and B.1.617.2 respectively) 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 added.

The published studies are widely cited for the rigour and breadth that Bharat Biotech brings to its clinical trials. 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 make Phase III trials data from the final analysis public soon, said Bharat Biotech.

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