New Delhi: The Ministry of Health and Family Welfare on Wednesday dismissed a media report on the approval of Serum Institute India (SII) and Bharat Biotech’s Emergency Use Covid Vaccine and called it “fake”.
According to the report, the proposals for emergency vaccine use by the SAI and the Bharat Biotech government have not been cleared of inadequate safety and efficacy data.
“This was decided on Wednesday at a meeting of the Central Drugs Standard Control Organization (CDSCO) Content Expert Panel, which reviewed the applications of Pfizer, SII and Bharat Biotech,” the report said.
On 6 December, the SII filed an application with the Drugs Controller General of India (DCGI) seeking permission for its use of the Kovid-19 vaccine “CovShield”.
This is after Pfizer India sought a similar approval from India’s drug regulator.
“SCI has applied to DCGI for emergency use visualization. The application will be reviewed by a panel of experts and a final call will be taken,” a senior government official confirmed to the ANI.
SII was the first local company to seek emergency approval for a vaccine developed by global pharma giant AstraZeneca and with the University of Oxford.
The ChAdOx1 nCov-2019 Coronavirus Vaccine, developed by teams from the University of Oxford, triggers an immune response in healthy adults aged 56-69 years and over 70 years ago, the Pune-based company said.
After Prime Minister Narendra Modi visited the company’s epidemic facility in Pune last month, Poonawalla said there were indications that the central government would buy 300-400 million doses by July 2021.
SAI has already produced 40-50 million doses of vaccine per month, and the pharma giant plans to expand it to 100 million doses per month by February, he said.


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