More EU countries eyeing separate deals with Russia for Sputnik vaccine

As the EU’s vaccine rollout continues to sputter, some countries hoping for a European deal on Russia’s Sputnik V are thinking about working with Moscow directly.

If these agreements materialize, they would most likely be stand-alone national deals rather than an EU-wide advance purchase agreement (APA), as Brussels inked with major drugmakers. Until Sputnik’s team can demonstrate authorized capacity to meet a sizeable order for the EU — and prove that the science behind the vaccine is sound — it would fall short of the Commission’s criteria for APAs.

Some leaders are now signaling they might consider this route. One indication came earlier this week, when German Chancellor Angela Merkel and French President Emmanuel Macron spoke with Russian President Vladimir Putin. While the conversation covered a range of topics, it also alerted Putin to their interest in Sputnik V.

Italy’s Prime Minister Mario Draghi has also broached the idea, saying in March he’d like to secure an order for Sputnik. But if EU coordination isn’t possible, Italy will “do otherwise,” he said.

That said, the three leaders still maintain that sign-off by the European Medicines Agency is key — a nod to growing concerns over potential side effects of vaccines, especially the Oxford/AstraZeneca jab.

“The vaccine cannot be marketed in Germany without [EU] approval,” said Sebastian Gülde, spokesperson for the German health ministry.

However, this caution hasn’t stopped Germany and France from preliminary talks with Russia. If they sign a contract, it would put them at the front of the queue for doses — if the EMA does eventually recommend a license for the vaccine.

That is still at least weeks off, given that the EMA isn’t slated to assess facilities in Russia until later in April.

Doing it their way

While most of Europe waits for the EMA’s green light, four countries — Hungary, Slovakia, Austria and the Czech Republic — are taking a different approach.

Hungary was the first to get its hands on Sputnik, starting in January, apparently accepting Russia’s regulatory review of the jab as sufficient. It’s also been deploying China’s Sinopharm vaccine, which no other EU country has yet to order. As of Wednesday, Hungary ranked among the highest vaccination rates in the EU, around 21 percent. But it is also one of the worst-hit countries overall, with a spiraling death rate that’s quadruple Europe’s average.

Austria, meanwhile, may follow suit. Chancellor Sebastian Kurz said earlier this week he anticipates placing an order for 1 million Sputnik doses next week. Although he previously insisted EMA approval would be needed, he has omitted that detail in more recent statements.

The one country where the national medicines regulator is assessing Sputnik is Slovakia — also hard hit, with a death rate twice the EU average. Its agency, the SIDC, is assessing Sputnik — reviewing submitted data, replicating lab studies and visiting a Russian facility. SIDC chief Zuzana Baťová is making it her personal mission to complete this work.

A decision on the vaccine was expected last week, but was delayed following the government’s collapse amid political fallout following now-former Prime Minister Igor Matovič’s unilateral order of 2 million doses of the jab. That purchase remains contested.

Tomáš Valášek, former Slovakian ambassador to NATO and currently director of Carnegie Europe, said the national regulator’s assessment is “really no replacement for EMA certification.” Constrained by equipment and expertise, Baťová’s review can cover only around 20 percent of the tests that the EMA would do, he warned.

But for now, it looks like Matovič’s order won’t go to waste even though he lost his job over the move. Russia has delivered an initial shipment of 200,000 doses, which remain in storage. Subsequent shipments of 200,000 doses a month are scheduled to arrive — although the delivery for March has yet to come through.

“It’s not unusual for the Russians … to over-promise and under-deliver,” Valášek said, noting that Hungary also saw a long lag.

Meanwhile, the Czech Republic is torn as it also grapples with its own brutal infection and death rates. Health Minister Jan Blatný has been insisting on an EMA sign-off on Sputnik, but President Miloš Zeman wants to bypass the process. Zeman is asking for unprecedented political approval so the jab can be used — in effect, taking the route that Hungary followed.

Roman Prymula, advisor to Prime Minister Andrej Babiš and briefly health minister, laid out two scenarios last week. Either the country waits for the EMA’s decision for the entire bloc, or Sputnik is granted exceptional approval by the health ministry. (The EU permits national approvals of vaccines in an emergency, but in such cases the drugmakers must bear liability.)

For now, Blatný is facing severe pressure to resign. A Cabinet reshuffle is expected in April, according to local media, and some have speculated that Prymula may take back the health minister job. If that happens, it could pave the way for a speedy deal for Sputnik in the next month.

The manufacturing crunch

Signing contracts is one thing. Delivering on pledged doses is another.

Sputnik’s manufacturer, like all pharma companies, must demonstrate that it can meet production pledges if it wants an EU contract.

The capacity to supply within the EU is “one of the main criteria taken into account when engaging on negotiations with companies,” the Commission stated on its advance purchase agreements for vaccines.

“Information on the availability and production capacities of the vaccine and a well-founded prospect of approval are prerequisites for further steps towards contractual regulations at both the EU and the federal government level,” said Gülde of the German health ministry.

The manufacturing question is all the more pressing in light of the strong demand for Sputnik, with approval in 58 countries as of April 1.

The Russian Direct Investment Fund, which is commercializing the vaccine outside Russia, has in recent weeks announced manufacturing partnerships in China, India, Serbia, Italy, Germany, Spain and France. But for those deals to go forward in the EU, the facilities need the EMA’s approval.

Questions also remain about the other criteria for an EU-wide contract, including the soundness of the scientific approach and the technology used.

The EMA began in March a rolling review of some data supporting Sputnik — the first step towards gaining an EU license. But the drugs agency has played its cards close to its chest, revealing few details on the data. EMA chief Emer Cooke said last week the agency is waiting for outstanding questions on the data to be answered.

“Russian developers need to open their books and submit all data on safety and efficacy for EMA’s assessment,” an EU official said.

As for the Commission, a January Q&A on vaccines noted that the “soundness of scientific approach and technology used” is among the requirements for an APA.

A Commission spokesperson said Friday, however, that the Commission “is confident that the supply from the four vaccine companies currently producing and delivering to the member states will allow the EU to achieve its vaccination target” by the end of the summer without Sputnik, whether or not it gets the green light from the EMA.

For now, despite the apparent support in certain countries, the Commission hasn’t received the four national requests needed to even start talks on a Sputnik-EU contract. For those capitals eager to get the jab as part of their offensive against a pandemic that still rages on, stand-alone national deals may be the only option for now.

Jillian Deutsch and Laurenz Gehrke contributed reporting.

This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.