Health Ministry denies reports on rejection of SII, Bharat Biotech's Covid-19 vaccine's authorisation

The Ministry of Health and Family Welfare on Wednesday dismissed the media report about the rejection of Serum Institute India (SII) and Bharat Biotech's emergency use authorisation of COVID vaccine and called it "fake".

According to the (fake) report, the proposals made by SII and Bharat Biotech to the government for emergency vaccine use have not been cleared due to inadequate safety and efficacy data.

"This was decided in the Central Drugs Standard Control Organisation's (CDSCO) Subject Expert Committee meeting on Wednesday, which reviewed the applications of Pfizer, SII and Bharat Biotech," the report claimed.

On December 6, the SII has applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for its COVID-19 vaccine "Covishield" in the country.

This came after Pfizer India sought a similar approval from India's drug regulator for its coronavirus vaccine.

"SII has applied for emergency use authorisation to DCGI. The application will be reviewed by the expert committee and after that final call will be taken," a senior government official had confirmed to ANI.

The SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.

The Pune-based company earlier stated that 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 aged 56-69 and those over 70 years of age.

After Prime Minister Narendra Modi visited the company's pandemic level facility in Pune last month, Poonawalla had said there are indications that the Central government may purchase 300-400 million doses by July 2021.

He had said the SII has already produced 40-50 million doses of the vaccine per month, and the pharma giant is planning to stretch it up to 100 million doses of the vaccine per month by February.