Bharat Biotech on June 12, 2021 shared the complete data of all research studies of its COVID-19 vaccine, Covaxin.
The company officials shared that the complete data of Covaxin’s Phase I, Phase II and Phase III trials has been thoroughly scrutinised by the regulators in India.
The company has also published as many as nine research studies on Covaxin’s safety and efficacy in five globally reputed peer-reviewed journals in a span of just twelve months.
• Bharat Biotech completed three preclinical studies that involved testing of the vaccine candidates on laboratory animals. The studies have been published in Cellpress, a peer-reviewed journal
• The studies conducted on Covaxin’s Phase I trials aimed to assess the vaccine’s safety, immune response and to determine right dosage.
• The studies on Phase II clinical trial were carried out to assess the safety and the ability of the vaccine to generate an immune response.
• These studies have been published by the peer-reviewed journal- “Lancet-Infectious Diseases”, informed the company.
• Besides this, Bharat Biotech stated that the full data from studies on Covaxin’s neutralization of variants has already been published at “bioRxiv”, 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 and the study on B1.1.28 variant have been published at the Journal of Travel Medicine.
• The studies on B.1.617 variant and Alpha variant B.1.1.7 have been published at Clinical Infectious Disease, and Journal of Travel Medicine respectively.
Bharat Biotech’s official statement read that the published studies are widely cited for the rigour and breadth that Bharat Biotech brings to its clinical trials. It stated that currently, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being analyzed and compiled.
The company will soon make the Phase III trials data from the final analysis public, as promised earlier.
• India’s first indigenously-made vaccine is a whole-virion inactivated coronavirus vaccine.
• It is the first and only product to have published any data from human clinical trials in India.
• Further, Covaxin is known as the only product to have any data on emerging variants.
• As per Bharat Biotech, Covaxin is also the first and only COVID-19 vaccine to have efficacy data in Indian populations.
India began the world’s largest COVID-19 vaccination drive on January 16, 2021, with two vaccines- indigenously made Covaxin and Serum Insitute of India’s Covishield.