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When it comes to getting people vaccinated, the EU is trailing behind the U.K., the U.S. and Israel — and a growing number of critics blames the European Commission.
Over the weekend, Markus Söder, leader of Germany’s Christian Social Union, and BioNTech CEO Uğur Şahin criticized the Commission for not purchasing enough of the BioNTech/Pfizer vaccine, the first to be approved by European regulators.
The Commission fired back Monday, saying it had secured more than 2 billion doses of vaccines from seven producers with member states’ participation throughout the process.
“I don’t think that the issue is really the number of vaccines, it is the fact that we are at the beginning of a rollout,” Commission chief spokesperson Eric Mamer said. “We’re all judging this as if this campaign is over; in fact, the campaign is just starting.”
It’s certainly been a slow start. EU countries have vaccinated hundreds of thousands of people collectively, but the numbers differ drastically between countries.
Even Germany, which has vaccinated 265,000 people — more than any other EU country— as of January 4, is still far off from the 1.3 million doses it has available.
Meanwhile, the U.K. has given jabs to around a million people and the U.S. more than 4 million. Both countries got a weeks-long head start and are facing their own issues (the U.S. has 13.2 million doses available, for example), but the EU’s slow rollout is down to delays in producing the vaccines, a more substantive but bureaucratic approval process, and poor planning in many EU countries.
Why didn’t the Commission buy enough BioNTech/Pfizer jabs to inoculate everyone in the EU?
In June, when the Commission began purchasing vaccines, nobody knew for sure which one would be successful let alone which would be available first.
BioNTech/Pfizer, as well as Moderna, Oxford/AstraZeneca and Johnson & Johnson, were among the quickest to begin large-scale human trials and boasted ambitious timelines. But each of these vaccines had different hurdles to overcome, and no one expected any of them to be more than 90 percent effective — certainly not ones based on mRNA technology, which had never been approved by regulators before.
So the Commission diversified its vaccine portfolio, securing more than 2 billion doses of vaccines from six producers. It is close to a deal to purchase a further 200 million doses of the Novavax jab.
Shouldn’t the EU have agreed to buy more?
As BioNTech/Pfizer was first out with a jab, everyone wants as much of the vaccine as they can get, but that will almost certainly be a short-term issue.
Compared to other vaccines, the BioNTech/Pfizer jab is difficult to distribute because it needs to be stored in dry ice at -70 degrees C (it can be kept in normal refrigerators for just five days) and it’s expensive, at about €12 a shot compared to Oxford/AstraZeneca which is less than €2 per dose, according to a leaked price list.
Still, the Commission secured 200 million doses of the German-American vaccine with the option to purchase another 100 million (the biggest deal for BioNTech/Pfizer vaccines at the time).
For comparison, the U.S. purchased 100 million doses of the vaccine with the option to purchase 500 million more back in July. After criticism, the U.S. government purchased another 100 million on December 23 — still smaller than the EU’s initial purchase.
But even if the EU had purchased more vaccines, it probably wouldn’t have made a difference at this point in time. The issue now is largely to do with manufacturing bottlenecks and countries being unprepared to roll out the jabs quickly.
Should countries have just purchased and approved vaccines themselves?
The argument for teaming up is that EU countries would secure better deals by negotiating as a bloc.
They’ve learned from past experience: During the 2009 swine flu pandemic, pharma companies played EU countries off one another to charge more money for vaccines, with some states ending up with too many doses and selling them to neighbors.
This time, EU countries agreed to let the Commission handle the negotiations. EU countries are still part of the process, however, as seven countries participate in the negotiations and all EU countries approve the deals before they’re signed.
The EU technically could have purchased 1 billion doses of each vaccine, but money was a constraint. It’s not certain to what extent, as almost all of the information in the EU’s vaccine contracts is secret. We know the Commission used about €2.1 billion as down-payments on the vaccines, and asked EU countries for another €750 million in the fall. Each EU country pays per dose when they submit orders for vaccines. Still, they’ve amassed one of the largest vaccine portfolios in the world.
Some countries decided to purchase other vaccines or more shots on top of the EU deals. In the fall, Germany bought an additional 30 million doses of the BioNTech/Pfizer and CureVac vaccines, even though this goes against the EU’s strategy.
When asked why by POLITICO, Health Minister Jens Spahn said Germany wanted to purchase more but “there was not really a larger need from member states at that stage.”
Once these additional purchases became more public, Denmark said it would follow suit and purchased 2.6 million additional doses.
Was Germany held back by the Commission?
Germany helped force the Commission’s hand in June by teaming up with France, Italy and the Netherlands to sign a deal for up to 400 million Oxford/AstraZeneca vaccines for all of the EU so the U.S. couldn’t snatch them all up.
Other countries, notably Belgium, were critical of the initiative and the Commission stepped in to negotiate for the bloc. The four countries eventually transferred the Oxford/AstraZeneca deal to the Commission.
This is now being reported in German media as the start of the “vaccine disaster.” Bild reported that Spahn apologized for the four-country alliance’s stance in a “humiliating tone,” so Commission President Ursula von der Leyen and German Chancellor Angela Merkel could make the “grand gesture” of letting the EU take charge.
Steffen Siebert, head of the German government’s press office, stood by the decision on Monday, saying he was convinced it was “the right way.”
“For a country in the center of Europe … dependent on the free flow of goods, with a vested interest in a functioning Schengen area, ‘every man for himself’ cannot be the way,” he said.
So why is the EU taking so long to vaccinate people?
Did, as some are claiming, the EU sign deals for vaccines too late? Most of the deals were completed by early August — the Commission just didn’t get EU countries’ sign-off until months later.
It is true that the U.K. and U.S. were able to vaccinate hundreds of thousands of people before European regulators approved the first coronavirus vaccine. There are a few reasons for this, most notably that the European Medicines Agency recommended a conditional marketing authorization, which comes with more strings attached for drugmakers than the British emergency authorization procedures. As a result, if there are any unforeseen issues with the vaccines, the U.K. government will be held liable; while in the EU, drugmakers would be on the hook.
It also takes longer because it requires input from every EU country. Countries largely held firm in their support for this process throughout December, but as they saw footage of Brits and Americans getting vaccinated, the likes of Hungary, Poland, Germany and Italy pushed the EU to go faster.
The EMA moved its recommendation dates forward and the Commission streamlined its authorization process from days to hours, but it seems likely the EU’s process will continue to take longer as other countries issue emergency authorizations.
The next decision for the EMA will be on Moderna’s vaccine this week, although the American company has limited production capacity in the EU.
The EMA is also conducting rolling reviews of the Oxford/AstraZeneca and Johnson & Johnson vaccines (although the former has not formally submitted a conditional marketing authorization application, which might cause delays).
Shouldn’t a vaccine be good to go once it gets the green light?
Once the BioNTech/Pfizer vaccine had the EU’s approval, the companies needed to get the vaccine out, and countries needed to use them. This is largely where we see problems now.
BioNTech/Pfizer hasn’t been able to supply the 12.5 million vaccines it promised the EU by the end of 2020, largely due to supply chain issues. BioNTech CEO Şahin told Der Spiegel that more vaccines need to be approved while the company ramps up manufacturing capacity.
“It doesn’t look good — a hole is appearing because there’s a lack of other approved vaccines and we have to fill the gap with our own vaccine,” he said.
When it comes to using the jabs, most countries began on December 27 in a show of EU solidarity (Germany, Hungary and Slovakia jumped the gun and started a day earlier). Other countries just weren’t prepared.
The Netherlands won’t begin vaccinating until this week, with Health Minister Hugo De Jonge saying this was because they thought Oxford/AstraZeneca would be the first vaccine approved. “Perhaps this could and should have been done differently,” he wrote in a letter to parliament Monday.
Many others have just been incredibly slow, notably France, which had only vaccinated 138 people as of December 30.
Hans von der Burchard, Sarah Wheaton and Merlin Sugue contributed reporting.
This article is part of POLITICO’s premium policy service: Pro HealthCare. 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.