EU regulator urges caution on Sputnik COVID-19 vaccine

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'We need documents that we can review. We also don't at the moment have data...about vaccinated people,' said a senior European Medicines Agency (EMA) official.

FILE PHOTO: FILE PHOTO: Vials of the Sputnik V vaccine are seen at the Del-Pest Central Hospital in Budapest

"We need documents that we can review. We also don't at the moment have data...about vaccinated people. It is unknown. That's why I would urgently advise against giving a national emergency authorisation," EMA managing board head Christa Wirthumer-Hoche told a talk show on Austrian broadcaster ORF. "Data packages are coming from Russian manufacturers and of course they will be reviewed according to European standards for quality, safety and efficacy. When everything is proven then it will also be authorised in the European Union," she added.

 

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