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The data from both efficacy and safety follow-up of covid19 vaccine Covaxin’s Phase III trial is being analysed and compiled, Bharat Biotech has said on Saturday.
“The company will soon make Phase III trials data from the final analysis public,” the Hyderabad based vaccine maker said in a release.
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 it said adding that, “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.”
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 full data from studies on Covaxin’s neutralisation of variants are already published at the peer-reviewed journals of Clinical Infectious Diseases, and Journal of Travel Medicine .
The study on the neutralisation of Beta and Delta variants (B.1.351 and B.1.617.2 respectively) is published at bioRxiv , 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, according to the company.
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