EU Commission casts doubt on Russian Sputnik vaccine

“We still wonder why Russia is offering theoretically millions of millions of doses while not sufficiently progressing in vaccinating their own people,” she told reporters.

“This is also a question I think that should be answered,” she added.

Neither the Russian vaccine nor its Chinese counterpart have so far reached out to the European Medicines Agency (EMA) for market authorisation.

Such a step is required for EU-wide use, which also ensures safety and liability guarantees should things go wrong.

“They have to submit the whole set of data, indeed go through the whole scrutiny process like any other vaccine,” von der Leyen pointed out.

The Russian and Chinese vaccines are not being produced in Europe.

Because of that, von der Leyen said inspection on the production side also needs to be carried out to guarantee quality.

EU industrial commissioner Thierry Breton also weighed in.

“Manufacturing is another story, it is very complex, if you look at Sputnik,” he said.

He noted that the vaccine requires two doses, rendering the manufacturing process more complex.

The Financial Times reported Russia’s production of Sputnik is currently being outsourced to private companies all operating under different national regulations.

This includes factories in Brazil, China, South Korea, India, and Iran.

A large part of the production is outsourced to a plant in India, which is still awaiting approval from national regulators, according to the newspaper.

The peer-reviewed medical journal Lancet declared Sputnik earlier this month as safe and effective.

But EU health commissioner Stella Kyriakides said the Russian and Chinese vaccine still have to first undergo an EMA independent scientific assessment.

“This process allows for pharmacovigilance and it is something that we must never forget,” she said.

The EU has so far approved three vaccines, with new additional ones likely in the near future.

Hungary rolls out Russian and Chinese jabs

But some EU states are still being enticed by the Russian and Chinese vaccines.

Governments in the EU are allowed to purchase the vaccines without EMA approval, if deemed urgent.

But doing so forgoes all the safety and liability issues covered by EU validated vaccines.

Among them is Hungary, which is rolling out both to its population.

This week, it gave the first batch of 2,800 Sputnik doses to elderly people. A large shipment from China has also arrived, which is set to inoculate 275,000 people.

“The issue of the vaccine should be depoliticised,” said Hungary’s prime minister Viktor Orban on Wednesday.

“For Hungary, speed is the most important thing,” he said, adding that the vaccine must be obtained quickly and with the necessary safety checks.

But the move is still raising thorny questions given the production and regulatory pitfalls the vaccines face.

Some 33 million doses of the EU’s approved vaccines have been delivered to people throughout the European Union, according to von der Leyen.

Tackling variants

The comments come as the European Commission on Wednesday unveiled its latest efforts to speed up the production of vaccines to tackle new variants.

It has described the variants as a potential paradigm shift in the global fight against Covid-19.

It will next week present its proposal to EU heads of state and government.

The plan includes pooling public-private cooperation along with scientists and regulators to detect and mass produce vaccines against any new variants.

It means tweaking already-approved vaccines at the EU level, setting up a European clinical trials network, and upscaling mass production of new vaccines.

It has also set aside some €75m to help detect new variants and €150m for research projects.

The EU has some 16 industrial sites capable of producing vaccines and other 15 companies able to bottle and finalise the roll outs.

“We need to insure that our continent can be fully autonomous when it comes to vaccine production,” said Breton.