After some media reports pointed out that the internal documents on India's Covid-19 vaccine raise troubling questions about approval process, Bharat Biotech in a statement condemned the targeted narrative against COVAXIN and asserted that there was no external pressure to accelerate development of Covaxin. The company clarified that the pressure was all internal to develop a safe, and effective vaccine for the Covid-19 pandemic.
"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 Biotech company said in a statement.
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Reiterating the precautionary measures taken during the vaccine development. "Covaxin is one of the most highly studied Covid-19 vaccines worldwide. The vaccine was evaluated in ~20 pre-clinical studies, including three challenge trials and nine human clinical studies, more than any other Indian Covid-19 vaccine. These trials have clearly demonstrated the safety and efficacy of Covaxin.
"With several hundred million doses administered worldwide, Covaxin has demonstrated an excellent safety record with minimal adverse events and no vaccine-associated cases detected for myocarditis or thrombocytopenia," the biotech company said in a statement.
Stating that the recent media reports were to mislead people, Bharat Biotech said, "The recent media reports around the approvals for Covaxin are incorrect and erroneous. These few individuals and organizations were mostly involved in fake news and false information during the pandemic.
"While these people and organizations were busy with false information and fake news during the pandemic, more than 1000 personnel at Bharat Biotech across India were busy developing, testing, manufacturing and distributing Covaxin. Our diligent efforts have resulted in a universal Covid-19 vaccine for adults and children alike, which can be administered repeatedly as booster doses without safety concerns."