Govt dismisses claims that Covaxin was rushed due to political pressure

Media reports had claimed that Covaxin maker Bharat Biotech skipped 'certain processes' and 'sped' up clinical trials under political pressure. These media reports are completely misleading, fallacious and ill-informed, the government said.

The Narendra Modi government on Thursday dismissed reports that claimed that regulatory approval for Covaxin was rushed due to political pressure. Terming the reports as misleading and fallacious, the Union Health Ministry said scientific approach and prescribed norms adhered to in approving Covid-19 vaccines for Emergency Use Authorization.

Media reports had claimed that Covaxin maker Bharat Biotech skipped 'certain processes' and 'sped' up clinical trials under political pressure. The reports also 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, the government said.

In a statement, the government clarified that the health ministry and national regulator Central Drugs Standard Control Organisation (CDSCO) followed prescribed norms in approving COVID-19 vaccines for emergency use authorization. 

Laying out the facts, the CDSCO's Subject Expert Committee (SEC) met on January 1-2, 2021 and held detailed deliberations before recommending Restricted Emergency Approval to Bharat Biotech's Covaxin. The Subject Expert Committee reviewed the data on the safety and immunogenicity of Covaxin before approving it for restricted emergency use in January 2021.

The SEC recommended granting permission for restricted use in an emergency situation in the public interest as an abundant precaution in clinical trial mode to have more options for vaccinations, especially in case of infection by mutant strains. 

The SEC's approval for the commencement of phase 3 clinical trial of the proposed dose of Covaxin was based on Bharat Biotech's scientific data and established practices. Additionally, later on, the condition of COVID-19 vaccine administration in 'clinical trial mode' was removed on March 11, 2021, based on further submissions made by Bharat Biotech and an assessment of interim efficacy and safety data by CDSCO SEC.