9 studies on safety, efficacy of Covaxin published in 12 months: Bharat Biotech
Facing criticism about the clinical data of Covaxin, Hyderabad-based Bharat Biotech on Saturday said the complete data for Phase I and II, and partial data for Phase III trials of its COVID-19 vaccine Covaxin, has been thoroughly scrutinized by the regulators in India.
By Newsmeter Network Published on 12 Jun 2021 11:14 AM GMT
Hyderabad: Facing criticism about the clinical data of Covaxin, Hyderabad-based Bharat Biotech on Saturday said the complete data for Phase I and II, and partial data for Phase III trials of its COVID-19 vaccine Covaxin, has been thoroughly scrutinized by the regulators in India. 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 12 months, it further said.
Reaffirming its commitment to data generation and data transparency, Bharat Biotech said it will share the full data of all research studies of the vaccine.
"Covaxin, a whole-virion inactivated coronavirus vaccine, has many firsts to its credit in data transparency. It is the first and only product to have published any data from human clinical trials in India. 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," the company said.
Bharat Biotech also said that the firm has completed three preclinical studies that have been published in 'Cellpress', a peer-reviewed journal. The studies on Covaxin's Phase I (done to assess a vaccine's safety, immune response and to determine right dosage), and Phase II clinical trial (carried out to assess the safety and the ability of the vaccine to generate an immune response) have been published in the peer-reviewed journal 'The Lancet - Infectious Diseases', it added.
The full data from studies on Covaxin's neutralization of variants are already published in the peer-reviewed journals 'bioRxiv', 'Clinical Infectious Diseases', and 'Journal of Travel Medicine', the Hyderabad-based firm said. Further, it said that the study on the neutralization of Beta and Delta variants (B.1.351 and B.1.617.2, respectively) is published in 'bioRxiv', and the study on B1.1.28 variant in 'Journal of Travel Medicine'. Meanwhile, the studies on B.1.617 variant and Alpha variant (B.1.1.7) have been published in the journals 'Clinical Infectious Disease' and 'Journal of Travel Medicine', respectively, it said.
"The published studies are widely cited for the rigor and breadth that Bharat Biotech brings to its clinical trials. Currently, data from both efficacy and safety follow-up of Covaxin's Phase III trial is being analyzed and compiled. Upholding its uncompromising commitment to integrity, the company will soon make Phase III trials data from the final analysis public," the firm said.
