BB publishes studies on the efficacy of Covid vaccine

New Delhi: In a span of just twelve months, Bharat Biotech has published as many as nine research studies on the protection and efficacy of indigenously-developed Covaxin in five globally reputed peer-reviewed journals.

The entire data for Phase I and II and partial data for Phase III trials have also been fully examined by the regulators in India.

Many firsts to its credit:

1. Covaxin is the first and only vaccine to have issued any data from human clinical trials in India.
2. It is also the only vaccine to have any data on developing variants.
3. It is also the first and only Covid-19 vaccine to have efficacy data in Indian populations.

Three preclinical studies were completed by Bharat Biotech that were issued in Cellpress, a peer-reviewed journal. The studies on Covaxin’s Phase I and Phase II clinical trial have been issued by the peer-reviewed journal, The Lancet – Infectious Diseases. The full data from investigations on Covaxin’s neutralization of variants are already issued 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.

At present, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being examined and organized with Bharat Biotech announcing that it will soon make Phase III trials data from the final report.

Covaxin is developed by Bharat Biotech, in collaboration with ICMR’s Pune-based National Institute of Virology (NIV). As reported by IANS, the vaccine has recorded strong results in all the studies administered to date including a vaccine efficacy rate of 78 percent overall efficacy and 100 percent in severe Covid-19 disease, including hospitalizations, in the second interim results of Bharat Biotech’s Phase 3 clinical trial. The vaccine efficiently neutralized the Brazil variant of SARS-CoV-2, B11282, the alpha variant, B117, which was first recognized in the UK, as well as the delta variant, B1617, classified in India.

Emergency use authorizations to Covaxin have been given by 13 countries, but requests for emergency use authorization are pending in more than 60 countries.