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Government Refutes Reports that Covaxin Approval was Rushed due to Political Pressure

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PTI    18 November 2022

On November 17, the government called a report claiming that regulatory approval for the COVID-19 vaccine Covaxin was rushed due to political pressure as misleading and fallacious. The Union government clarified that all scientific approaches and prescribed norms were followed for the approval of covaxin for emergency use authorization.

 

The report stated that the manufacturers of the vaccine skipped certain steps to speed up the clinical trial due to political pressure. The report further added that there were several irregularities in the results of the three phases of the clinical trial.

 

The government, in response to the report, clarified that the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) met on January 1 and 2, 2021, and made recommendations for restricted emergency approval of the COVID-19 virus vaccine of Bharat Biotech. Before approving the vaccine, the Subject Expert Committee reviewed the data on the safety and immunogenicity of the vaccine.

 

On the other hand, in a press release, the vaccine makers stated that several hundred million doses have been administered worldwide. They also stated that Covaxin has a good safety profile, with few adverse events and no vaccine-associated cases of myocarditis or thrombocytopenia.

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