Bharat Biotech on Saturday said scientific standards of the indigenously-developed Covaxin are transparent, and the company has so far published nine research studies on its safety and efficacy.
“Covaxin’s scientific standards+commitment is transparent. Academic journals, peer reviewers, NIV-ICMR-BB researchers-scientists, 9 studies & data published,” Bharat Biotech co-founder and joint managing director Suchitra Ella said in a tweet.
“Currently, data from both efficacy and safety follow-up of Covaxin’s Phase III trial is being analysed and compiled. Upholding its uncompromising commitment to integrity, the company will make Phase III trials data from the final analysis public soon,” Bharat Biotech said in a statement.
The complete data for Phase I and II trials, and partial data for the Phase III trial has been thoroughly scrutinised by the regulators in India, the company said.
“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,” it added.
Covaxin, a whole-virion inactivated coronavirus vaccine, is the first and only product to have published any data from human clinical trials in India, Bharat Biotech said.
“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,” it added.
Bharat Biotech completed three preclinical studies, which are published in a scientific journal by Cell Press. The studies on Covaxin’s Phase I and Phase II clinical trials have been published in The Lancet Infectious Diseases, Bharat Biotech said.
The full data from studies on Covaxin’s neutralisation of variants are already published at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine, it added.
