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.
The Union Health Ministry on Thursday termed as "misleading" and "fallacious" media reports which claimed that regulatory approval for Covid-19 vaccine Covaxin was rushed due to political pressure.
It said scientific approach and prescribed norms were adhered to in approving Covid-19 vaccines for emergency use authorisation.
There have been media reports claiming that Bharat Biotech, manufacturer of the indigenous Covid-19 vaccine Covaxin, “had to skip certain processes” and “speed” up clinical trials due to political pressure, the ministry said.
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The reports further claimed that there were several irregularities in the three phases of the clinical trials conducted for the vaccine.
"These media reports are completely misleading, fallacious and ill-informed.It is clarified that Government of India and the national regulator i.e. Central Drugs Standard Control Organisation have followed a scientific approach and prescribed norms in approving Covid-19 vaccines for emergency use authorisation," the ministry stated.