Health Ministry denies media reports on rushed regulatory approval for Covaxin due to political pressure

Health Ministry denies media reports on rushed regulatory approval for Covaxin due to political pressure

New Delhi, November 18, 2022

The Union Ministry of Health & Family Welfare (MoHFW) has denied media reports claiming the regulatory approval for Covaxin, a COVID-19 vaccine, was rushed due to political pressure as “misleading and fallacious".

“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 Ministry said in a statement on Thursday.

“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,” the statement said.

The statement said the Government of India and the national regulator CDSCO had 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 the proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Bharat Biotech,” it added.

“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.

“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,” the statement said.

Additionally, later on, 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 COVID-19 vaccine in "clinical trial mode" was removed on March 11, 2021, it added.

“Authorization to 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 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.,” the statement added.

NNN

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