Vaccine-maker Bharat Biotech has denied that there was any external pressure to accelerate development of Covaxin, its vaccine for COVID-19. "We condemn the targeted narrative against Covaxin put forth by a select few individuals and groups who have no expertise in vaccines or vaccinology. It is well known that they helped perpetuate misinformation and fake news throughout the pandemic. They are unable to comprehend global product development and licensure processes," the Hyderabad-based company said in a statement on Thursday.
"The pressure was all internal to develop a safe, and effective vaccine for the Covid-19 pandemic, to save lives and livelihoods in India and globally," it added. Covaxin was evaluated in about 20 preclinical studies, including three challenge trials and nine human clinical studies, more than any other Indian Covid-19 vaccine. These trials have clearly demonstrated safety and efficacy of Covaxin, Bharat Biotech said. "The entire product development and clinical studies were executed as per global guidelines and submitted worldwide. Data from Covaxin has resulted in more than 20 publications, documenting every aspect of its development," it added.
Bharat Biotech’s statement comes days after a report on STAT, citing internal documents, alleged discrepancies in the trial and approval processes. Reacting to this, Bharat Biotech called the reports “incorrect” and “erroneous”, saying, "These few individuals and organisations were mostly involved in fake news and false information during the pandemic. They fail to understand product development and licensure pathways worldwide."
The Union Health Ministry also refuted the allegations, saying that all prescribed norms were followed while approving the vaccine for Emergency Use Authorisation.
(With IANS inputs)