‘Misleading’: Centre denies claims of rushed approval for Covaxin

NEW DELHI: 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.

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.

Authorisation to COVID-19 vaccines including Covaxin for restricted use in emergency situation with various conditions and restrictions were granted by the national regulator only on the recommendations of the Subject Expert Committee of CDSCO.