EMA starts assessment of Russian Sputnik V shot

A woman receives the second component of the Gam-COVID-Vac (Sputnik V) COVID-19 vaccine.

Valentin Sprinchak | TASS | Getty Images

LONDON – The European Medicines Agency said Thursday it will begin reviewing Russia’s coronavirus shot, Sputnik V, as the bloc aims to speed up its vaccination program.

“EMA will assess whether Sputnik V meets the usual EU standards for effectiveness, safety and quality. While EMA cannot predict overall timelines, it should take less time than usual to evaluate a potential application,” the report said. supervisor in a statement.

The EMA uses a continuous overview to study the data for the jab developed in Russia. This allows the European Medical Authority to assess its effectiveness, as it receives all necessary information before the vaccine manufacturer can apply for a formal authorization. By analyzing the studies prior to the application, the potential approval from the EMA could come faster than usual.

The news comes after a number of European countries have indicated that they can administer Sputnik V, bypassing the regulator. Slovakia and Hungary have already ordered doses of the Russian injection, while the Czech Republic and Austria are considering the vaccine.

In January, German Chancellor Angela Merkel said she was “open” to the idea of ​​producing the Russian coronavirus vaccine in the European Union.

Under pressure

European countries are under pressure to accelerate the rollout of Covid jabs as their program is clearly behind other parts of the world such as Israel, the United States and the United Kingdom.

The region is still largely closed due to social constraints, which take a toll on the economy and people’s livelihoods.

Austria and Denmark have also recently joined forces with Israel in the production of second-generation vaccines aimed at dealing with variants of Covid-19. At the time of the announcement, Austrian Chancellor Sebastian Kurz said the EMA has been too slow to approve vaccines to combat the pandemic.

The institution has approved three vaccines so far: Pfizer’s, AstraZeneca’s and Moderna’s.

In addition, European countries have criticized pharmaceutical companies for a number of hurdles in the production and delivery of the vaccines.

European countries agree that coordinated action is the best way to face the health emergency and have mandated the European Commission to negotiate contracts with the pharmaceutical companies.

However, under European law, EU member states are still allowed to approve their own vaccines without waiting for approval at EU level.

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