‘Final analysis to be public soon’: Bharat Biotech on Phase III trial data

Bharat Biotech also said that the complete data of Phase I and Phase II trials of Covaxin along with the partial data for Phase III trials have been scrutinised by the regulatory authorities.

Hyderabad-based pharmaceutical company Bharat Biotech on Saturday said that the scientific standards and commitment of the Covaxin Covid-19 vaccine are transparent and highlighted that the company has so far released nine research studies on its safety and efficacy.

A health worker writes the date on a vial as she prepares to administer the COVAXIN coronavirus vaccine for people arriving to get their second dose at a public health center in Hyderabad. (AP Photo)

“Covaxin's scientific standards+commitment is transparent. Academic journals, peer reviewers, NIV-ICMR-BB researchers -scientists, 9 studies and data published,” co-founder of Bharat Biotech and joint MD Suchitra Ella said in a tweet.

Bharat Biotech also said that the complete data of Phase I and Phase II trials of Covaxin along with the partial data for Phase III trials have been scrutinised by the regulatory authorities.

“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,” Bharat Biotech in a statement.

“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,” it 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 further added. The ICMR-NIV recently published a study where it found that the Covaxin has been effective in neutralising the Delta and Alpha variants of Covid-19.

The pharmaceutical company pointed out that it has published full data from studies on Covaxin's neutralisation of variants at bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine. It also said that studies on Covaxin's Phase I and Phase II clinical trials have been published by the peer-reviewed journal, The Lancet - Infectious Diseases and Cellpress has also published its three preclinical studies.