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Union Health ministry refutes allegations of irregularity in nod to Bharat Biotech Covaxin

New Delhi: The Union Health Ministry on Thursday termed as misleading and incorrect the media reports which claimed that due to political pressure Bharat Biotech's corona vaccine COVAXIN has been banned from the Corona epidemic (Covid 19).

By Priyanka Verma 
Updated Date

New Delhi: The Union Health Ministry on Thursday termed as misleading and incorrect the media reports which claimed that due to political pressure Bharat Biotech’s corona vaccine COVAXIN has been banned from the Corona epidemic (Covid 19). There was a rush to license the vaccine. It has also been claimed in these reports that there were many irregularities in the three phases of the clinical trial conducted for the vaccine. The ministry said that scientific approach and prescribed norms have been followed to license Covaxin as Corona Vaccine.

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Responding to this, the Government of India said that it is being claimed in some media reports that due to political pressure, there has been haste in giving regulatory approval to COVAXIN. All these reports are misleading and wrong. The government said that scientific approach and prescribed norms have been followed to approve its (COVAXIN) emergency use as a corona vaccine.

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. The Subject Expert Committee (SEC) of CDSCO met on 1 and 2 January last year and after due deliberations, it made recommendations in respect of the proposal for restricted emergency approval of covid-19 vaccine developed by Bharat Biotech, the government release said.

The health ministry said in the statement, “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 statement further added, “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”.

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The submission made by the firm 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 11 March last year, the government said. 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.

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