Due to political pressure, the government dismisses reports on the approval of Covaxin.

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Due to political pressure, the government dismisses reports on the approval of Covaxin.

On Thursday, the Union Health Ministry referred to media claims that suggested the regulatory approval for the Covid-19 vaccination Covaxin was hurried because of political pressure as “misleading” and “fallacious.” It said that in licencing Covid-19 vaccines for emergency use authorization, a scientific methodology and required rules were adhered to.

According to media allegations, government pressure forced Bharat Biotech, the company that makes the locally produced COVID-19 vaccine Covaxin, to “skip some steps” and “speed” up clinical studies.

The research also noted that the three phases of the immunisation clinical trials that were conducted had a number of abnormalities.

“These media reports are completely inaccurate, incorrect, and uneducated.” It is made clear that the Indian government and the national regulator, CDSCO, used a scientific approach and established standards to approve the COVID-19 vaccines for emergency use authorization, according to the ministry.

The SEC's approval for commencement of phase 3 clinical trial of proposed dose of Covaxin was based on scientific data presented by Bharat Biotech and established practices in this regard, the ministry said.
(File photo/Reuters for representation)

On January 1 and 2, 2021, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) met and, after careful consideration, provided recommendations regarding the proposal for Restricted Emergency Approval of Bharat Biotech’s COVID-19 virus vaccine. Prior to Covaxin’s approval for restricted emergency use in January 2021, the Subject Expert Committee reviewed the data on the vaccine’s safety and immunogenicity and recommended that permission be granted for restricted use in emergency situations in the public interest as a generous precaution, in clinical trial mode, to have more options for vaccinations, particularly in case of infection by mutant strains.According to the ministry, the SEC’s permission for the start of the suggested dose of Covaxin’s phase 3 clinical study was based on the scientific evidence provided by Bharat Biotech and accepted procedures in this area.

In addition, the alleged “unscientific adjustments” to the clinical trials of Covaxin, as stated in press reports, were carried out following a submission by Bharat Biotech to CDSCO, in accordance with the CDSCO’s established procedures, and with clearance from the DGCI.

On March 11, 2021, the requirement that the COVID-19 vaccine be administered in “clinical trial mode” was eliminated based on further information provided by Bharat Biotech and an evaluation of interim efficacy and safety data by SEC of CDSCO, according to the ministry.

Only on the advice of the Subject Expert Committee of CDSCO did the national regulator authorise COVID-19 vaccines, including Covaxin, for restricted use in emergency situations with a variety of criteria and restrictions.

The Subject Expert Committee is made up of experts in pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, and other domains

 

 

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