EU drugs agency says national authorising of Sputnik V is ‘Russian roulette’

“I would strongly advise against a national emergency authorisation,” an EMA official said, making it clear that there is not yet sufficient safety data about those who had already been given the vaccine. [Shutterstock/Zambranas]

Updates with comments from the company that produces Sputnik V

The European Medicines Agency (EMA) has described as a “Russian roulette” the decision of some EU member states to unilaterally grant market authorisation to Russia’s Sputnik V COVID-19 vaccine at this stage, without prior approval at the EU level.

Hungary has already approved the vaccine, while Prague and Bratislava have made orders and stressed they were not going to wait for EMA’s approval. Asked to comment on Austria’s intention to follow a similar approach, EMA management board chair, Christa Wirthumer-Hoche, told Austria’s ORF broadcaster:

“It’s somewhat comparable to Russian roulette. I would strongly advise against a national emergency authorisation,” she said, making it clear that there is no sufficient safety data yet about those who had already been given the vaccine.

“We could have Sputnik V on the market in future, when we’ve examined the necessary data,” she added.

The EMA started a rolling review of Sputnik only last week.

Demand for public apology 

The company that produces Sputnik V reacted strongly to the statement, asking from the EMA official to apologise publicly.

“We demand a public apology from EMA’s Christa Wirthumer-Hoche for her negative comments on EU states directly approving Sputnik V. Her comments raise serious questions about possible political interference in the ongoing EMA review,” the company tweeted.

“Europeans deserve an unbiased review as was undertaken by 46 other countries. After postponing Sputnik V review for months, EMA does not have the right to undermine credibility of 46 other regulators that reviewed all of the necessary data,” it added.

A poll in Slovakia showed that an increasing number of Slovaks put trust in the Russian vaccine. The poll found that Russia’s Sputnik V is the second most acceptable vaccine for Slovaks, ahead of the AstraZeneca and Moderna vaccines, with 53% of Slovaks voting to be vaccinated with it, compared to 35% who oppose its use.

Slovaks trust Russia’s vaccine more than AstraZeneca, Moderna

Being vaccinated with the Russian vaccine Sputnik V is acceptable to approximately the same number of Slovaks as the Pfizer/BioNTech vaccine, according to a survey carried out by Focus Agency in February. 

The survey showed that some 55% of the …

On the other hand, the vast majority of Poles do not want the government to use COVID-19 vaccines from China or Russia.

Commission does not see any ‘political aspect’

The debate over Russia’s Sputnik has heated up lately, especially after the EU faced severe delays in vaccine deliveries from the pharmaceutical companies that Brussels had signed contracts with.

While some countries started pushing for a broader palette of vaccines EU citizens could use, a number of countries and politicians have voiced concern about Russia’s hidden political ambitions behind the push for Sputnik.

Donald Tusk, the current chief of the centre-right European People’s Party (EPP), recently called on Poles and Europeans not to be “naive” about the intentions of Moscow and Beijing.

Asked by EURACTIV if the Commission also takes into account potential political implications when it comes to Sputnik, the chief spokesperson of the European Commission, Eric Mamer, replied:

“When it comes to the assessment process that EMA undertakes on vaccination and market authorisation, which then comes if EMA has given a positive assessment, the only consideration is obviously a health-related one.”

“This is the only thing that we, as a responsible public organisation, can take into account when looking at a vaccine,” he added.

The European Commission chief Ursula von der Leyen has recently publicly wondered why Moscow is promising millions of vaccines to many countries across the world while it has not vaccinated its own people first.

In turn, Moscow accused von der Leyen of trying to politicise the issue.

The permanent mission of Russia in Brussels said in a statement that her statement was “either an effort to politicise the issue in an unsubstantiated and, indeed, deplorable way, or it indicates an inadequate level of awareness of the top-level official”.

[Edited  by Zoran Radosavljevic]

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