EMA begins review of Russia Sputnik V jab

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 on Thursday it would begin evaluating Russia’s coronavirus jab, Sputnik V, as the bloc wants to speed up its vaccination program.

“EMA will evaluate that Sputnik V complies with the usual EU standards for efficiency, safety and quality. Although EMA cannot predict the overall timelines, it will need less time to evaluate a final application,” the regulator said in a statement. said a statement.

The EMA uses an ongoing review to study the data for the jab developed in Russia. This enables the European medical authority to assess its effectiveness as it receives all the necessary information before the vaccine manufacturer can apply for a formal authorization. By analyzing the studies before the application, the potential approval of the EMA can come faster than usual.

The news comes after a number of European countries indicated they could start administering Sputnik V and bypassing the regulator. Slovakia and Hungary have already ordered doses of the Russian jab while the Czech Republic and Austria are considering vaccination.

In January, German Chancellor Angela Merkel said she was ‘open’ to the idea of ​​producing Russia’s coronavirus vaccine in the European Union.

Under pressure

European countries are under pressure to speed up the launch of Covid jabs, as their program is clearly lagging behind in other parts of the world, such as Israel, the United States and the United Kingdom.

The region is still mostly closed due to social constraints, which the economy and livelihoods of people demand.

Austria and Denmark have also recently joined forces with Israel in the production of second-generation vaccines, aimed at handling the Covid-19 variant. At the time of the announcement, Austrian Chancellor Sebastian Kurz mentioned that the EMA was too slow to approve vaccines to fight the pandemic.

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

In addition, European countries have criticized pharmaceutical companies for some barriers to vaccine production and delivery.

European countries agreed that coordinated action would be the best way to deal with the health crisis, and instructed the European Commission to negotiate contracts with pharmaceutical companies.

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

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