Hyderabad: Covaxin manufacturer Bharat Biotech said on Saturday that the company had published nine research studies on the safety and efficacy of its vaccine in a year.
“In a period of just twelve months, the company has published up to nine research studies on the safety and efficacy of Covaxin in five world-renowned peer-reviewed journals,” Bharat Biotech said in a statement.
As part of its preclinical studies on testing vaccine candidates on laboratory animals, the company has already completed three studies published in Cellpress.
Similarly, phase I studies of Covaxin have been performed to evaluate the safety of the vaccine, immune response and correct dose as well as phase II clinical trials, as well as the ability of a vaccine to generate immune response in the journal ‘The Lancet – Infectious Diseases’.
“The complete data of studies on the neutralization of Covaxin of variants have already been published in bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine,” the pharmaceutical chief said.
Similarly, the study on neutralization of beta and delta variants (B.1.351 and B.1.617.2 respectively) and the study of B1.1.28 variant were published in the ‘Journal of Travel Medicine’.
Studies on B.1.617 variant and Alpha variant B.1.1.7 have been published by the journal ‘Clinical Infectious Disease’ and ‘Journal of Travel Medicine’ respectively.
‘The published studies are widely cited for the accuracy and breadth that Bharat Biotech brings in its clinical trials. “Currently, data on both the efficacy and the safety follow-up of Covaxin’s phase III investigation are being analyzed and compiled,” the statement read.
According to the company, complete data for Phase I, II and partial data from Phase III trials with Covaxin have been thoroughly investigated by the Indian regulators.
The company in Hyderabad has promised that it will soon release the Phase III trial data of the final analysis.
Bharat Biotech, which demonstrates its scientific commitment to data generation and data transparency, shares complete data from all research studies of its Covaxin, India’s first native Covid-19 vaccine, ”reads the statement.
Source: The Siasat Daily