Health Ministry Rejects Claims of Rushed Approval for Covaxin Due to ‘Political Pressure’


On Thursday, rejected media reports that Covaxin manufacturer Bharat Biotech skipped specific processes and accelerated clinical trials due to political pressure, calling them “completely misleading, fallacious and ill-informed.”

The Ministry said, “The government of India and the national regulator Central Drugs Standard Control Organization (CDSCO), have followed a scientific approach and prescribed norms in approving the Covid-19 vaccines for emergency use authorization”.

This is the first time a senior company official has responded to allegations against the company. In April, the WHO suspended the supply of Covaxin to UN agencies citing deficiencies in good manufacturing practices. The WHO also said Bharat Biotech made some changes in the manufacturing processes after receiving an emergency-use license for Covaxin. The company didn’t tell the differences, nor did it respond to queries related to its ‘corrective’ action.

The Ministry said that the Subject Expert Committee (SEC) of CDSCO met on January 1-2, 2021. After due deliberations, made the recommendations in respect of the 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 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,” it added.

The SEC’s approval for the commencement of phase 3 clinical trial of the proposed dose of Covaxin was based on scientific data 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 Bharat Biotech in CDSCO, compliance of due process in CDSCO and with approval from the DGCI.”

The Ministry added that 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 vaccine in ‘clinical trial mode’ was removed on March 11, 2021.

“Authorisation of 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 SEC.

“The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, pediatrics, and internal medicine,” it added.


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