Govt rubbishes reports on approval for Covaxin due to political pressure

No external pressure to accelerate development of Covaxin, says Bharat Biotech

The Union Health Ministry on November 17 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.

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.