New Delhi: The Union Health Ministry on Thursday rejected media reports that Covaxin manufacturer Bharat Biotech skipped certain processes and accelerated clinical trials due to political pressure, calling them “completely misleading, fallacious and ill-informed”.
“The government of India and the national regulator Central Drugs Standard Control Organisation (CDSCO) have followed a scientific approach and prescribed norms in approving the Covid-19 vaccines for emergency use authorization,” the Ministry said.
The media reports had claimed that Bharat Biotech, manufacturer of the indigenous Covaxin, “had to skip certain processes” and “speed” up clinical trials due to political pressure.
They also alleged that there were several irregularities in the three phases of the clinical trials.
The Ministry said that the Subject Expert Committee (SEC) of CDSCO met on January 1-2, 2021 and after due deliberations, made the recommendations in respect of proposal for Restricted Emergency Approval of the vaccine.
“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,” it added.
The SEC’s approval for commencement of phase 3 clinical trial of proposed dose of Covaxin was based on scientific data and established practices in this regard.
“Moreover, the purported aunscientific 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.”
The Ministry added that 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 the vaccine in ‘clinical trial mode’ was removed on March 11, 2021.
“Authorisation of 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 SEC.
“The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine,” it added.