The guilt game of the EU coronavirus vaccine. Why so slow? – POLITICIAN

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

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

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

“I don’t think the issue is really the number of vaccines, it’s the fact that we are at the beginning of an implementation,” said Commission spokesman Eric Mamer. “We all judge it as if this campaign is over; in fact, the campaign is just beginning. “

It has certainly been a slow start. EU countries have collectively vaccinated hundreds of thousands of people, but the figures differ drastically between countries.

Even Germany, which vaccinated 265,000 people, more than any other EU country, as of January 4, is still far from the 1.3 million doses it has available.

Meanwhile, the UK has hit close to a million people and the United States more than 4 million. Both countries had an advanced lead of weeks and are facing their own problems (the US has 13.2 million doses available, for example), but the slow deployment of the EU is reduced to delays in vaccine production. , a more substantial but bureaucratic approval process, and poor planning in many EU countries.

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

In June, when the Commission began buying vaccines, no one knew for sure what the success would be, let alone which ones would be available first.

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

Thus, the Commission diversified its vaccine portfolio, reaching more than 2 billion doses of vaccines from six producers. It is close to an agreement to buy an additional 200 million doses of the Novavax jab.

Shouldn’t the EU have agreed to buy more?

Since BioNTech / Pfizer first came out with a punch, everyone wants most of the vaccine they can get, but it will surely be a problem in the short term.

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

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

In comparison, the United States bought 100 million doses of the vaccine with the option to buy 500 million more in July. Following the criticism, the US government bought 100 million more on December 23, even smaller than the initial EU purchase.

But even if the EU had bought more vaccines, it probably wouldn’t have made a difference at the time. The problem now has to do with manufacturing bottlenecks and countries that are not ready to launch the blows quickly.

Should countries have bought and approved the vaccines themselves?

The argument for team building is that EU countries would get better deals by negotiating en bloc.

They have learned from past experience: during the 2009 swine flu pandemic, pharmaceutical companies clashed with EU countries to charge more for vaccines, and some states end up with too many doses and sell them to neighbors.

This time, the EU countries agreed that the Commission should be in charge of the negotiations. However, EU countries remain part of the process, with seven countries participating in the negotiations and the EU as a whole. countries approve bids before signing them.

Technically, the EU could have acquired 1 billion doses of each vaccine, but money was a limitation. It is not known to what extent, as almost all information on EU vaccine contracts is secret. We know that the Commission used around € 2.1 billion in vaccine revenue and asked for € 750 million from EU countries in the autumn. Each EU country pays per dose when sending vaccine orders. However, they have amassed one of the largest vaccine portfolios in the world.

Some countries decided to buy other vaccines or more vaccines on top of EU offers. In the autumn, Germany bought an additional 30 million doses of BioNTech / Pfizer and CureVac vaccines, although this goes against EU strategy.

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

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

Did the Commission slow down Germany?

Germany helped force the Commission’s hand in June by partnering with France, Italy and the Netherlands to sign an EU-wide agreement on up to 400 million Oxford / AstraZeneca vaccines, so that the US does not they could snatch them all.

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

German media are now reporting the onset of the “vaccine disaster.” Bild reported that Spahn apologized for the stance of the four-country alliance in a “humiliating tone” so that Commission President Ursula von der Leyen and German Chancellor Angela Merkel could do the same. “big gesture” of letting the EU take over.

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

“For a country in central Europe … dependent on the free flow of goods, with a personal interest in a functioning Schengen area,” every man by himself “cannot be the way,” he said.

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

As some have claimed, the EU signed vaccine offers too late? Most of the agreements were completed in early August: the Commission did not get the signature of EU countries until months later.

It is true that the United Kingdom and the United States were able to vaccinate hundreds of thousands of people before European regulators approved the first coronavirus vaccine. There are a few reasons for this, including that the European Medicines Agency recommended a conditional marketing authorization, which includes more chains for drug manufacturers than British emergency authorization procedures. As a result, if there are unforeseen problems with vaccines, the UK government will be responsible; while in the EU, drug manufacturers would be stuck.

It also takes longer, as it requires input from all EU countries. Countries stood firm in their support for this process throughout December, but as British and American images were vaccinated, Hungary, Poland, Germany and Italy pushed the EU to go further. press.

The EMA advanced its recommendation dates and the Commission streamlined its authorization process from day to hour, but it seems likely that the EU process will continue to take longer as other countries issue emergency authorizations.

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

The EMA also conducts ongoing reviews of the Oxford / AstraZeneca and Johnson & Johnson vaccines (although the former has not formally submitted a conditional marketing authorization application, which could lead to delays).

Shouldn’t a vaccine be good to do once it has the green light?

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

BioNTech / Pfizer has not been able to deliver the 12.5 million vaccines it promised to the EU by the end of 2020, mainly due to supply chain problems. BioNTech CEO Şahin told Der Spiegel that more vaccines need to be approved as the company increases manufacturing 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 came to using the blows, most countries started on December 27 in a show of EU solidarity (Germany, Hungary and Slovakia jumped the gun and started a day earlier). Other countries were unprepared.

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

Many others have been incredibly slow, especially France, which had only vaccinated 138 people by December 30th.

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

This article is part of POLITICIANpremium policy service: Pro HealthCare. From pricing of drugs, EMAs, vaccines, pharmaceuticals and more, our specialist journalists keep you up to date on the issues driving the healthcare policy agenda. e-mail [email protected] for a free trial.

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