The EU coronavirus vaccine blames the game. Why so slow? – POLITICAL

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

Over the weekend, Markus Söder, leader of the German Christian Social Union, and BioNTech CEO Uğur Shahin criticized the Commission for not purchasing enough of the BioNTech / Pfizer vaccine, the first to be approved by European regulators.

The commission withdrew on Monday, saying it had delivered more than 2 billion doses of vaccines from seven producers with the participation of member states throughout the process.

“I don’t think the problem is really the number of vaccines, but the fact that we are at the beginning of a launch,” said Commission spokesman Eric Mamer. “We all judge this as if this campaign was over; in fact, the campaign is just beginning. “

It was definitely 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 – since January 4, is still far from the 1.3 million doses it has available.

Meanwhile, Britain has hit about a million people and the US over 4 million. Both countries were a few weeks ahead and facing their own problems (the US has 13.2 million doses available, for example), but the slow launch of the EU is reduced to delays in vaccine production, a more substantial approval process, but bureaucratic, and poor planning in many EU countries.

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

In June, when the Commission started buying vaccines, no one 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 fastest to start large-scale human studies and boasted ambitious timelines. But each of these vaccines had various hurdles to overcome, and no one expected any of them to be more than 90% effective – certainly not those based on mRNA technology, which had never been approved by regulators.

Thus, the Commission has diversified its vaccine portfolio, providing over 2 billion doses of vaccines from six manufacturers. It is close to a deal to buy another 200 million doses of Novavax jav.

Shouldn’t the EU have agreed to buy more?

Since BioNTech / Pfizer came out with a jab for the first time, everyone wants the vaccine as much as possible, but it can certainly be a short-term problem.

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

However, the Commission provided 200 million doses of German-American vaccine with the option to purchase another 100 million (the largest bid for BioNTech / Pfizer vaccines at the time).

For comparison, the US bought 100 million doses of vaccine with the option to buy another 500 million in July. According to critics, the US government bought another 100 million on December 23 – even less than the initial EU acquisition.

But even if the EU had bought more vaccines, it probably wouldn’t have made a difference at the moment. The problem is now largely related to manufacturing bottlenecks and the fact that countries are not prepared to launch quickly.

Should countries buy and approve vaccines?

The argument for teaming up is that EU countries would secure better agreements through bloc negotiations.

They learned from previous experience: during the 2009 swine flu pandemic, pharmaceutical companies played with each other in EU countries to raise more money for vaccines, with some states reaching too many doses and selling them to neighbors.

This time, the EU countries agreed to let the Commission deal with the negotiations. However, EU countries are still part of the process, as seven countries are participating in the negotiations and the whole EU countries approve transactions before they are signed.

Technically, the EU could have bought 1 billion doses of each vaccine, but the money was a constraint. It is not certain to what extent, as almost all information in EU vaccination contracts is secret. We know that the Commission used around € 2.1 billion as advances for vaccines and asked EU countries for another € 750 million in the autumn. Each EU country pays per dose when ordering vaccines. However, they have amassed one of the largest vaccine portfolios in the world.

Some countries have decided to buy other vaccines or more photos in addition to EU agreements. In the autumn, Germany bought another 30 million doses of BioNTech / Pfizer and CureVac vaccines, even if this goes against the EU’s strategy.

When asked why by POLITICO, Health Minister Jens Spahn said Germany wanted to buy more, but “there was really no greater need from Member States at that stage”.

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

Was Germany detained by the Commission?

Germany helped force the Commission’s hand in June by teaming up with France, Italy and the Netherlands to sign an agreement for up to 400 million Oxford / AstraZeneca vaccines across the EU so that the US cannot take them all.

Other countries, notably Belgium, criticized the initiative, and the Commission intervened to negotiate the bloc. The four countries eventually transferred the Oxford / AstraZeneca agreement to the Commission.

This is now reported in the German media as the beginning of the “vaccine disaster”. Bild reported that Spahn apologized for the alliance’s position in four countries in a “humiliating tone”, so that Commission President Ursula von der Leyen and German Chancellor Angela Merkel could make the “big move” to allow the EU to take the lead.

Steffen Siebert, the head of the German government’s press office, backed the decision on Monday, saying he was convinced it was the “right way”.

“For a country in central Europe … dependent on the free movement of goods, with its own interest in a functioning Schengen area, ‘every man for himself’ cannot be the way,” he said.

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

As some argue, has the EU signed vaccine agreements too late? Most transactions were completed in early August – the Commission did not receive the signatures of EU countries until months later.

It is true that the United Kingdom and the United States managed to vaccinate hundreds of thousands of people before European regulators approved the first coronavirus vaccine. There are several reasons for this, in particular the fact that the European Medicines Agency has recommended a conditional marketing authorization, which comes with more strings attached for manufacturers of medicines than the British emergency authorization procedures. As a result, if there are unforeseen problems with vaccines, the British government will be held accountable; while in the EU, drug manufacturers would be in love.

It also takes longer, as it requires input from all EU countries. Countries have strongly supported this process throughout December, but as they have seen images of British and Americans being vaccinated, such as Hungary, Poland, Germany and Italy have pushed the EU to move faster.

The EMA has advanced the recommendation data and the Commission has streamlined its authorization process from day to hour, but it looks like the EU process will continue to take longer as other countries issue emergency authorizations.

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

The EMA also carries out ongoing reviews of the Oxford / AstraZeneca and Johnson & Johnson vaccines (although the former has not formally applied for conditional marketing authorization, which could cause delays).

Shouldn’t a vaccine be good after taking the green light?

Once the BioNTech / Pfizer vaccine received EU approval, companies had to remove the vaccine and countries to use it. This is largely where we see problems now.

BioNTech / Pfizer has failed to deliver the 12.5 million vaccines the EU has promised by the end of 2020, largely due to supply chain problems. Shahin, CEO of BioNTech, told Der Spiegel that more vaccines must be approved as the company increases production capacity.

“It doesn’t look good – a hole appears because other approved vaccines are missing and we have to fill the gap with our own vaccine,” he said.

When it comes to the use of jabs, most countries started on December 27 in an EU solidarity show (Germany, Hungary and Slovakia jumped at gunpoint and started a day earlier). Other countries were simply not prepared.

The Netherlands will not start vaccination until this week, Health Minister Hugo De Jonge said this was due to the fact that they believed Oxford / AstraZeneca would be the first vaccine approved. “Perhaps this could and should have been done differently,” he wrote in a letter to parliament on Monday.

Many others have been incredibly slow, especially France, which has vaccinated only 138 people since December 30.

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

This article is part of politicalPremium Policy Service: Pro HealthCare. From the prices of medicines, EMAs, vaccines, pharmaceuticals and much more, our specialist journalists keep you up to date with the topics that drive the health care policy agenda. E-mail [email protected] for a free trial.

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