EMA starts reviewing Sputnik V’s Russian 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 that it will begin evaluating the Russian coronavirus vaccine, Sputnik V, as the bloc seeks to accelerate its vaccination program.

“The EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality. Although the EMA cannot predict the overall deadlines, it should take less time than usual to assess a possible application,” said the regulator in a statement.

EMA is using a continuous review to study data from the jab developed in Russia. This allows the European medical authority to assess its effectiveness as it receives all the necessary information, before the vaccine manufacturer can apply for formal authorization. When analyzing the studies before application, the possible approval of the EMA may come faster than normal.

The news comes after several European countries indicated that they could start administering Sputnik V, bypassing the regulator. Slovakia and Hungary have already ordered doses of the Russian vaccine, 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 launch of Covid jabs, as their program is clearly lagging behind other parts of the world, such as Israel, the United States and the United Kingdom.

The region is still practically closed due to social restrictions, which affect the economy and people’s lives.

Austria and Denmark 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 mentioned that EMA has been very slow in approving vaccines to combat the pandemic.

The institution has already approved three vaccines: Pfizer, AstraZeneca and Moderna.

In addition, European countries criticized pharmaceutical companies for some obstacles in the production and delivery of vaccines.

European nations agreed that coordinated action would be the best way to deal with the health emergency and charged the European Commission to negotiate contracts with pharmaceutical companies.

However, EU Member States can still, under European law, approve their own vaccines without waiting for approval at EU level.

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