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EU drugs agency starts reviewing Russian vaccine

Sputnik V becomes 1st jab under scrutiny outside EU's common purchase scheme

Agnes Szucs   | 04.03.2021
EU drugs agency starts reviewing Russian vaccine

BRUSSELS

The European Medicines Agency (EMA) started evaluating Russia's Sputnik V novel coronavirus vaccine, the regulatory body announced on Thursday.

The EMA started the review based on "results from laboratory studies and clinical studies in adults" which "indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19," the EU watchdog wrote in a press statement.

The EMA will assess whether the Russian vaccine is "compatible with the usual EU standards for effectiveness, safety, and quality," the statement added.

The review will take as long as the EMA gathers enough evidence to issue a conditional marketing authorization.

If approved, it will be produced by a German company since the bloc requires manufacture to take place in an EU member state.

This is the first jab under scrutiny by the EU drugs agency which has been developed without the EU's financial support.

The bloc signed advanced purchase agreements with six biotechnological firms -- Pfizer/BioNTech, Moderna, AstraZeneca, CureVac, Johnson & Johnson, and Sanofi/GlaxoSmithKline -- to buy about 2.6 billion vaccine doses for the bloc's 450 million population and its neighboring countries.

So far, the vaccines of Pfizer/BioNTech, Moderna, and AstraZeneca have been approved by the EMA and the regulatory agency is expected to give the green light for the product of Johnson & Johnson next week.

The EU has been criticized for the slow roll-out of vaccines.

To speed up inoculation efforts, Hungary and Slovakia have decided to buy Sputnik V vaccines.

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