Final analysis of Phase III clinical trials data will be public soon: Bharat Biotech

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Hyderabad-based Bharat Biotech on Saturday stated that the scientific standards and commitment of its indigenously manufactured Covid-19 vaccine Covaxin are transparent and emphasized that the company has as of now launched as many as nine research studies on the parameters of its safety and efficacy.

In a tweet, co-founder of Bharat Biotech and joint MD, Suchitra Ella stated, “Covaxin’s scientific standards+commitment is transparent. Academic journals, peer reviewers, NIV-ICMR-BB researchers -scientists, 9 studies and data published.”

Bharat Biotech stated the regulatory authorities are reviewing the complete data of phase I and phase II trials of Covaxin and the partial data of the Phase III clinical trials.

In a statement, Bharat Biotech revealed, “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.”

“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 make Phase III trials data from the final analysis public soon,” said the Hyderabad-based pharmaceutical firm.

The statement further added, “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.” Recently, the ICMR-NIV published a study where it determined that Covaxin has been proven to be effective in neutralizing the Delta and Alpha variants of Covid-19.

Bharat Biotech indicated it has published the complete data based on studies on Covaxin’s neutralisation of variants at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine. The company added the data about the Phase I and II have been released in peer-reviewed journal, The Lancet – Infectious Diseases and Cellpresss also contains data about the three preclinical studies.

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