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Amid Clamour for Phase 3 Trials Data, Bharat Biotech Says 'Committed to Transparency'

File photo of Bharat Biotech's Covaxin.

File photo of Bharat Biotech's Covaxin.

The 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, Bharat Biotech said in a statement.

Bharat Biotech on Saturday said scientific standards and commitment of the indigenously-developed Covid-19 vaccine Covaxin are transparent, and the company has so far published nine research studies on its safety and efficacy. "Covaxin's scientific standards+commitment is transparent. Academic journals, peer reviewers, NIV-ICMR-BB researchers -scientists,9 studys & data published," BharatBiotech CoFounder & Joint MD Suchitra Ella said in a tweet.

The 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, Bharat Biotech said in a statement. "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," it added.

Covaxin, a whole-virion inactivated coronavirus vaccine, is the first and only product to have published any data from human clinical trials in India, Bharat Biotech said. "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," it added.

Bharat Biotech completed three preclinical studies, which are published in Cellpress, a peer-reviewed journal. The studies on Covaxin's Phase I and Phase II clinical trial are published by the peer-reviewed journal, The Lancet - Infectious Diseases, Bharat Biotech said. The full data from studies on Covaxin's neutralisation of variants are already published at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine, it added.

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"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," Bharat Biotech said.

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