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Report that the Center rejected the IBS vaccine, Bharat Biotech for false emergency use: Ministry of Health | India News

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NEW DELHI: The Ministry of Health and Family Welfare on Wednesday dismissed the media report on the Serum Institute India (SII) rejection and authorization of emergency use of the Covid vaccine from Bharat Biotech, calling it “false.”
According to the report, proposals made by SII and Bharat Biotech to the government for the use of emergency vaccines have not been approved due to inadequate safety and efficacy data.
“This was decided at the meeting of the Subject Matter Experts Committee of the Central Drug Standards Control Organization (CDSCO) on Wednesday, which reviewed the applications of Pfizer, SII and Bharat Biotech,” the report states.
On December 6, the SII had applied to the Comptroller General of Drugs of India (DCGI) for an emergency use authorization for its Covid-19 “Covishield” vaccine.
This came after Pfizer India sought similar approval from the Indian drug regulator.
“The SII has requested the authorization of emergency use from the DCGI. The request will be reviewed by the committee of experts and after that last call it will be answered,” a senior government official confirmed to ANI.
IBS is the first indigenous company to apply for emergency approval for the vaccine developed together with the global pharmaceutical giant AstraZeneca and the University of Oxford.
The Pune-based company previously stated that the ChAdOx1 nCov-2019 coronavirus vaccine, developed by teams at the University of Oxford, has been shown to trigger a robust immune response in healthy adults ages 56 to 69 and in those older than 70 years.
After Prime Minister Narendra Modi visited the company’s pandemic-level facility in Pune last month, Poonawalla had said that there are indications that the central government may purchase between 300 and 400 million doses by July 2021.
He said IBS has already produced between 40 and 50 million doses of the vaccine per month, and the pharmaceutical giant plans to roll it out to 100 million doses of the vaccine per month by February.

Times of India

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