The Central Drugs Standard Control Organization’s Subject Expert Committee met on January 1 and 2, 2021 and made recommendations on Bharat Biotech’s proposal for Restricted Emergency Approval of the COVID-19 virus vaccine
New Delhi: The Union Health Ministry on Thursday termed “misleading” and “fallacious” media reports which claimed that regulatory approval for the 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 the 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 the proposal for Restricted Emergency Approval of the 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 the safety and immunogenicity of the vaccine and recommended for grant of 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 scientific data presented by Bharat Biotech and established practices in this regard, the ministry said.
Moreover, the purported ‘unscientific changes’ in clinical trials of Covaxin, as claimed in the news reports, were made after submission made by Bharat Biotech in CDSCO, compliance of due process in CDSCO and approval from the DGCI.
Based on the further submission made by Bharat Biotech and assessment of interim efficacy and safety data by SEC of CDSCO, the condition of administration of the COVID-19 vaccine in ‘clinical trial mode’ was removed on March 11, 2021, the ministry said. Authorisation for COVID-19 vaccines including Covaxin for restricted use in an emergency situation with various conditions and restrictions was 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, internal medicine, etc.
