Reports of Covaxin approval rushed due to political pressure ‘misleading’: Govt
The ministry clarified that the government of India and the national regulator— Central Drugs Standard Control Organisation (CDSCO)— have followed the due process in vaccine approval
Union health ministry refuted allegations that regulatory approval for Covaxin was rushed due to political pressure as ‘misleading’ and ‘fallacious’ in a statement issued on Thursday.
“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 reports 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 authorisation.
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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.
“The SEC’s approval for commencement of phase 3 clinical trial of proposed dose of Covaxin was based on scientific data presented by M/s Bharat Biotech and established practices in this regard. Moreover, the purported ‘unscientific changes’ in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by M/s Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI”, the statement added.
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.
The ministry added that the 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.
The subject expert committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics and internal medicine.