New Delhi: The Union health ministry refuted allegations that regulatory approval for Covaxin was rushed due to political pressure as ‘misleading’ and ‘fallacious’ in a statement.
“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 STAT report further claims 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,” read the health ministry statement.
The ministry clarified that the government of India and the national regulator— Central Drugs Standard Control Organisation (CDSCO)— have followed a scientific approach and prescribed norms in approving COVID-19 vaccines for emergency use authorization.
The subject expert committee (SEC) of 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 developed by 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,” read the health ministry statement.
Additionally, later on, based on further submission made by Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of COVID-19 vaccine in ‘clinical trial mode’ was removed on March 11, 2021, said the health ministry.
