European regulator starts review of Russian vaccine - RTHK
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European regulator starts review of Russian vaccine

2021-03-04 HKT 17:47
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  • A medical worker holds a syringe with the Sputnik V vaccine, at a vaccination centre in Saint Petersburg, Russia. File photo: Reuters
    A medical worker holds a syringe with the Sputnik V vaccine, at a vaccination centre in Saint Petersburg, Russia. File photo: Reuters
Europe's medicines regulator said on Thursday it has started an ongoing review of the Sputnik V Covid-19 vaccine developed by Russia's Gamaleya Institute for possible approval in the region, in a major sign of confidence in the shot.

The human medicines committee of the European Medicines Agency (EMA) will review data from ongoing trials of the vaccine until there is enough clinical data for approval, the regulator said.

Sputnik V was almost 92 percent effective in fighting Covid-19, based on peer-reviewed late-stage trial results published in The Lancet medical journal last month.

The two-shot vaccine uses two different weakened common cold viruses to deliver immune-building protein to the human body.

EMA's "rolling reviews" are aimed to speed up the process of approving a successful vaccine by allowing researchers to submit findings in real-time, even before final trial data is ready.

Russia expects several European countries to approve the Sputnik V this month, the chief of its sovereign wealth fund said.

Europe currently has approved vaccines from Pfizer/BioNTech, Moderna and AstraZeneca/Oxford, while ongoing reviews for CureVac and Novavax's candidates are already underway.

The EMA is also expected to give its verdict on J&J's single-shot vaccine on March 11. (Reuters)