All research data for the vaccine, according to the business, has been fully scrutinized by Indian officials. Over a year, the company published nine research studies on Covaxin in five internationally renowned peer-reviewed journals.
Bharat Biotech, situated in Hyderabad, which manufactures Covaxin, has given full data from all Covaxin research studies so far. The complete Phase III study data will be available soon, according to the business.
According to a press release from the company, it has shared entire data from Phase I pre-clinical trials and Phase II clinical trials, as well as partial data from Phase III clinical trials.
Bharat Biotech revealed that one of its Phase I trials, efficacy research in hamsters, was published in CellPress, followed by efficacy research in primates, which was published in Nature Communications. CellPress published the preclinical and immunogenicity research.
Bharat Biotech said in a statement that Covaxin is the only product with data from human clinical studies in India and efficacy evidence for the Indian population. Covaxin is the only Covid vaccination in the country with published data on most new virus strains, according to the vaccine manufacturer.
The pharmaceutical company also indicated that the Phase III final analysis data would be released soon. “All subjects must have efficacy and two-month safety follow-up data for the final analysis. This is the CDSCO and the USFDA, respectively “According to the firm. “The final analysis will be submitted to CDSCO, followed by peer-reviewed journal submissions and media dissemination,” the statement continued.
Bharat Biotech announced on Saturday that it will conduct clinical trials in the United States to support Covaxin’s marketing application in the country.
Bharat Biotech claimed it has given comprehensive data from all Covaxin research studies with Indian regulators about Phase 3 clinical trial results. The two-dose vaccination was created using platform technology derived from Whole-Virion Inactivated Vero Cells.
A total of 25,800 participants have been enrolled and randomized in a 1:1 ratio to receive the vaccination and control in an event-driven, randomized, double-blind, placebo-controlled, multicentre phase 3 study for Covaxin, according to the information given by Bharat Biotech.
