Nine publications on Covaxin in one year: Bharat Biotech

Hyderabad firm stated that the data from efficacy and safety follow-up of Covaxin’s phase III trial is being analysed and compiled, and it will soon make the data from the final analysis public

Hyderabad: Bharat Biotech said its 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. The Hyderabad-based company has already published as many as nine research studies on the safety and efficacy of the vaccine in five global peer-reviewed journals in a span of one year.

Currently, data from both efficacy and safety follow-up of Covaxin’s phase III trial is being analysed and compiled. The company said it will make phase III trials data from the final analysis public soon.

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The company stated, “Covaxin, a whole-virion inactivated coronavirus vaccine, 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 population.”

In vaccine development, pre-clinical studies involve testing of vaccine candidates in laboratory animals. Bharat Biotech completed three pre-clinical 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 full data from studies on Covaxin’s neutralisation of variants are already published at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine, the company said.

The study on the neutralisation 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.

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