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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India’s Health Ministry today rubbished 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.
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. CDSCO have followed a scientific approach and prescribed norms in approving COVID-19 vaccines for emergency use authorisation,” the ministry stated.
The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) met on January 1 and 2, 2021 and after due deliberations made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Bharat Biotech.
Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.
Bharat Biotech International has aslo said that there was no external pressure to accelerate the development of Covaxin, its Covid-19 vaccine
The Hyderabad-based vaccine maker was responding to a “targeted narrative against Covaxin, put forth by a select few individuals and groups in online publications and social media.
“We condemn the targeted narrative against COVAXIN put forth by a select few individuals and groups who have no expertise in vaccines or vaccinology,’‘ the company said in a statement.
“There was no external pressure to accelerate development of Covaxin. 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 said.