The government has denied media reports that Covaxin regulatory approval was rushed due to “political pressure.”
According to the reports, due to political pressure, Bharat Biotech, the manufacturer of the indigenous COVID-19 vaccine – Covaxin, “had to skip certain processes” and “speed” up clinical trials. According to the reports, there were several irregularities in the three phases of the vaccine’s clinical trials.
In a statement issued on Thursday, the Union Ministry of Health and Family Welfare stated, “These media reports are completely misleading, fallacious, and ill-informed.”
It is clarified that the Government of India and the national regulator, i.e. The Central Drugs Standard Control Organization used a scientific approach and prescribed norms in approving COVID-19 vaccines for emergency use authorization, according to the ministry.
The national regulator only granted authorization to COVID-19 vaccines, including Covaxin, for restricted use in an emergency situation with various conditions and restrictions based on the recommendations of the CDSCO Subject Expert Committee.
According to the ministry statement, the Subject Expert Committee is made up of domain knowledge experts from fields such as pulmonology, immunology, microbiology, pharmacology, paediatrics, and internal medicine.
The statement went on to say that the CDSCO’s Subject Expert Committee (SEC) met on January 1st and 2nd, 2021, and made recommendations on Bharat Biotech’s proposal for Restricted Emergency Approval of COVID-19 virus vaccine.
“Before Covaxin was approved for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on the vaccine’s safety and immunogenicity 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 statement said.
The ministry also claimed that the SEC’s approval for the start of the proposed dose of Covaxin phase 3 clinical trial was based on scientific data presented by Bharat Biotech and established practises in this regard. Furthermore, the purported ‘unscientific changes’ in Covaxin clinical trials, as claimed in news reports, were made following Bharat Biotech’s submission to CDSCO, compliance with due process in CDSCO, and approval from the DGCI, according to the ministry.
Furthermore, based on Bharat Biotech’s subsequent submission and the SEC of CDSCO’s assessment of interim efficacy and safety data, the condition of administering COVID-19 vaccine in ‘clinical trial mode’ was removed on March 11,
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