Blame for the EU’s coronavirus vaccine. Why so slow? – POLITICO

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When it comes to vaccinating people, the EU is lagging behind the UK, US and Israel – and a growing number of critics are blaming the European Commission.

Last weekend, Markus Söder, leader of Germany’s Christian Social Union, and BioNTech CEO Uğur Şahin criticized the Commission for not buying enough of the BioNTech / Pfizer vaccine, the first to be approved by European regulators.

The Commission fired back on Monday, saying it had received more than 2 billion doses of vaccines from seven producers with member states participating throughout the process.

“I don’t think the problem is really the number of vaccines, it’s the fact that we are at the beginning of a rollout,” said Commission spokesman Eric Mamer. “We are all judging this as if this campaign is over; in fact, the campaign has just started. “

It has certainly been a slow start. EU countries have collectively vaccinated hundreds of thousands of people, but the numbers vary drastically from country to country.

Even Germany, which has vaccinated 265,000 people since January 4 – more than any other EU country – is still a long way from the 1.3 million doses available.

Meanwhile, the UK has given injections to about a million people and the US more than 4 million. Both countries got weeks ahead and are facing their own problems (for example, the US has 13.2 million doses available), but the slow EU rollout is due to delays in the production of the vaccines, a more substantial one but bureaucratic approval process, and poor planning in many EU countries.

Why didn’t the Commission buy enough BioNTech / Pfizer shots to vaccinate everyone in the EU?

In June, when the Commission began to buy vaccines, no one was sure which one would be successful, let alone which one would be available first.

BioNTech / Pfizer, as well as Moderna, Oxford / AstraZeneca and Johnson & Johnson, were among the fastest to begin large-scale human trials and had ambitious timelines. But each of these vaccines had several hurdles to overcome, and no one expected any of them to be more than 90 percent effective – certainly not based on mRNA technology, which had never been approved by regulators before.

That is why the Commission has diversified its vaccine portfolio and secured more than 2 billion doses of vaccines from six manufacturers. Buying another 200 million doses of the Novavax shot is almost a deal.

Shouldn’t the EU have agreed to buy more?

Since BioNTech / Pfizer came out first with a shot, everyone wants to get as much of the vaccine as possible, but that will almost certainly be a short-term problem.

Compared to other vaccines, the BioNTech / Pfizer shot is difficult to distribute because it has to be stored in dry ice at -70 ° C (it can only be stored in normal refrigerators for five days) and it is expensive, around € 12 per shot compared with Oxford / AstraZeneca which, according to a leaked price list, is less than € 2 per dose.

Still, the Commission secured 200 million doses of the German-American vaccine with the option to purchase a further 100 million (the largest deal for BioNTech / Pfizer vaccines at the time).

In comparison, the US bought 100 million doses of the vaccine with the option to buy another 500 million in July. After criticism, the US government bought an additional € 100 million on December 23 – still less than the original EU purchase.

But even if the EU had bought more vaccines, it probably wouldn’t have made a difference at this point. The problem now has largely to do with bottlenecks in production and countries unprepared to roll out the incentives quickly.

Should countries have just bought and approved vaccines?

The argument for cooperation is that EU countries would make better deals by negotiating as a bloc.

They learned from past experience: During the 2009 swine flu pandemic, pharmaceutical companies split up EU countries to charge more money for vaccines, with some states eventually over-dosing and selling them to neighbors.

This time, the EU countries agreed to let the Commission handle the negotiations. However, the EU countries are still part of the process as seven countries participate in the negotiations and all EU countries countries approve the deals before they are signed.

The EU could technically have bought 1 billion doses of each vaccine, but money was a limitation. It is uncertain to what extent, as almost all information in the EU’s vaccine contracts is classified. We know that the Commission used about € 2.1 billion as a down payment for the vaccines, and in the fall it asked EU countries for an additional € 750 million. Each EU country pays per dose when it places orders for vaccines. Still, they have amassed one of the largest vaccine wallets in the world.

Some countries decided to buy other vaccines or more injections 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 strategy.

When asked why by POLITICO, Health Minister Jens Spahn said Germany wanted to buy more, but “there wasn’t really a greater need from Member States at that stage.”

Once these additional purchases became more public, Denmark said it would follow suit and purchase 2.6 million additional doses.

Was Germany stopped by the Commission?

Germany helped force the Commission in June by working with France, Italy and the Netherlands to negotiate a deal for up to 400 million Oxford / AstraZeneca vaccines for the entire EU, so the US couldn’t get them all.

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 agreement between Oxford and AstraZeneca to the Commission.

This is now being reported in German media as the beginning of the “vaccine disaster”. Bild reported that Spahn apologized for the Four-Country Alliance’s position in a “humiliating tone” so that Commission President Ursula von der Leyen and German Chancellor Angela Merkel could make the “grand gesture” to let the EU take the lead.

Steffen Siebert, head of the German government’s press service, backed 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 movement of goods, with a vested interest in a functioning Schengen area, ‘everyone for themselves’ cannot be the way,” he said.

So why does the EU take so long to vaccinate people?

As some say, has the EU signed vaccine agreements too late? Most deals were finalized by early August – the Commission did not receive approval from EU countries until months later.

It is true that the UK and US 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 has recommended a conditional marketing authorization, which is more stringent for pharmaceutical manufacturers than the UK emergency authorization procedures. As a result, the UK government is held accountable if there are unforeseen problems with the vaccines; while in the EU drug manufacturers would be hooked.

It also takes longer as it requires input from every EU country. Countries largely held on to their support for this process in December, but when they saw images of Britons and Americans being vaccinated, people like Hungary, Poland, Germany and Italy urged the EU to move faster.

The EEA has pushed forward its recommendation dates and the Commission has streamlined its authorization process from days to hours, but it seems likely that the EU process will take longer as other countries issue emergency authorizations.

The next decision for the EMA this week will be on Moderna’s vaccine, although the US company has limited manufacturing capacity in the EU.

The EMA is also conducting ongoing reviews of the Oxford / AstraZeneca and Johnson & Johnson vaccines (although the former has not formally submitted an application for a conditional marketing authorization, which may cause delays).

Shouldn’t a vaccine be good once it gets the green light?

Once the BioNTech / Pfizer vaccine was approved by the EU, the companies had to bring the vaccine out and countries had to use it. This is largely where we see problems now.

BioNTech / Pfizer has been unable to deliver the 12.5 million vaccines it promised to the EU by the end of 2020, largely due to supply chain issues. BioNTech CEO Şahin told Der Spiegel more vaccines should be approved as the company expands manufacturing capacity.

“It doesn’t look good – there is a gap because there is 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 kicked off a show of EU solidarity on December 27 (Germany, Hungary and Slovakia jumped on fire and started a day earlier). Other countries simply weren’t prepared.

The Netherlands will only start vaccinating this week. Health Minister Hugo De Jonge said this was because they believed Oxford / AstraZeneca would be the first approved vaccine. “Perhaps this should and should have happened differently,” he wrote in a letter to parliament on Monday.

Many others were just unbelievably slow, most notably France, which had only vaccinated 138 people by December 30.

Hans von der Burchard, Sarah Wheaton and Merlin Sugue contributed to the reporting.

This article is a part of POLITICSPremium policy service: Pro HealthCare. From drug prices, EMA, vaccines, pharmaceuticals and more, our specialist journalists will keep you updated on the topics driving the health policy agenda. E-mail [email protected] for a free trial.

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