No external pressure to accelerate development of Covaxin-Bharat Biotech

Covid-19 vaccine Covaxin maker Bharat Biotech on Thursday said there was no external pressure on the firm to speed up its development.

In a press release, the vaccine maker said with several hundred million doses administered worldwide, Covid-19 vaccine Covaxin has demonstrated an excellent safety record with minimal adverse events and no vaccine associated cases detected for myocarditis or thrombocytopenia.

Refuting some media reports around the approvals for Covaxin, the vaccine maker said it condemns the ''targeted narrative'' against the vaccine put forth by a select few individuals and groups who have no expertise in vaccines or vaccinology, the firm said.

''There was no external pressure to accelerate development of Covaxin,'' it said, adding 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. Covaxin is one of the most highly studied Covid-19 vaccines worldwide and was evaluated in approximately 20 pre-clinical studies, including three challenge trials and nine human clinical studies, more than any other Indian Covid-19 vaccine even as these trials have clearly demonstrated safety and efficacy of the vaccine, the company said.

The entire product development and clinical studies were executed as per global guidelines and submitted worldwide and the data from Covaxin has resulted in more than 20 publications, documenting every aspect of its development, Bharat Biotech further said.

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