Media Reports claiming regulatory approval for Covaxin was rushed due to Political Pressure are Misleading and Fallacious says the Government of India

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Media Reports claiming regulatory approval for Covaxin was rushed due to Political Pressure are Misleading and Fallacious

Scientific approach and prescribed norms adhered to in approving Covid-19 vaccines for Emergency Use Authorization

By PIB Delhi

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 claim 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 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 authorization. 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 M/s 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. 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.

Additionally, later on, based on further submission made by M/s 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 11th March 2021.

Authorization 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, internal medicine, etc.

About Post Author

Suman Munshi

Founder Editor of IBG NEWS (15/Mar/2012- 09/Aug/2018). Recipient of Udar Akash Rokeya Shakhawat Hossain Award 2018. National Geographic & Canon Wild Clicks 2011 jury and public poll winner. Studied Post Graduate Advance Dip in Computer Sc., MBA IT,LIMS (USA & Australia), GxP(USA & UK),BA (Sociology) Dip in Journalism (Ireland), Diploma in Vedic Astrology, Numerology, Palmistry, Vastu Shastra & Feng Sui 25 years in the digital & IT industry with Global MNCs' worked & traveled in USA, UK, Europe, Singapore, Australia, Bangladesh & many other countries. Education and Training advance management and R&D Technology from India, USA, UK, Australia. Over 30 Certification from Global leaders in R&D and Education. Computer Science Teacher, IT & LIMS expert with a wide fan following in his community. General Secretary West Bengal State Committee of All Indian Reporter’s Association
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