Bharat Biotech has published as many as nine research studies on the safety and efficacy of indigenously-developed Covaxin in five globally reputed peer-reviewed journals in a span of just twelve months.
The complete data for Phase I and II and partial data for Phase III trials have also been thoroughly scrutinized by the regulators in India.
Many firsts to its credit
- Covaxin is the first and only vaccine to have published any data from human clinical trials in India.
- It is also the only vaccine to have any data on emerging variants.
- It is also the first and only COVID-19 vaccine to have efficacy data in Indian populations.
Bharat Biotech completed three preclinical studies, which were published in Cellpress, a peer-reviewed journal. The studies on COVAXIN’s Phase I and Phase II clinical trial have been 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,” said Bharat Biotech.
Currently, data from both efficacy and safety follow-up of COVAXIN’s Phase III trial is being analyzed and compiled with Bharat Biotech saying it will soon make Phase III trials data from the final analysis public.
13 countries have given EUA to Covaxin
Bharat Biotech has developed Covaxin in collaboration with ICMR’s Pune-based National Institute of Virology (NIV).
The vaccine has shown strong results in all the studies conducted to date including a vaccine efficacy rate of 78 per cent overall efficacy and 100 per cent in severe Covid-19 disease, including hospitalisations, in second interim results of Bharat Biotech’s Phase 3 clinical trial, reported IANS.
The vaccine effectively neutralized the Brazil variant of SARS-CoV-2, B11282, the alpha variant, B117, which was first identified in the UK, as well as the delta variant, B1617, identified in India.
13 countries have given emergency use authorisations to Covaxin and applications for emergency use authorisation is pending in more than 60 countries.
