Hyderabad/UNI: Demonstrating its scientific commitment to data generation and data transparency, Bharat Biotech shared full data of all research studies of its Covaxin, India’s first indigenous 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, a release here said on Saturday.
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 populations, the release said.
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 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.
The published studies are widely cited for the rigor 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, the release added.