Centre on Thursday said that 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 are completely misleading, fallacious and ill-informed
Centre on Thursday said that 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 are completely misleading, fallacious and ill-informed.
The Union Ministry for Health and Family Welfare said that the reports further claim that there were several irregularities in the three phases of the clinical trials conducted for the vaccine, which it said are 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 said in a statement.
Centre stated that the Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and after due deliberations made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Bharat Biotech.
Before Covaxin was approved the 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, the Ministry's statement read.
The government has said that the SEC’s approval for commencement of phase 3 clinical trial of proposed dose of Covaxin was based on scientific data presented by Bharat Biotech, 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 with approval from the DGCI.
Union Health Ministry further noted 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.