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In terms of vaccinating people, the EU is behind the UK, the US and Israel – and a growing number of critics blame the European Commission.
Markus Söder, leader of the Christian Social Union in Germany, and Uğur Şahin, CEO of BioNTech, 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 secured more than 2 billion doses of vaccines from seven producer participating countries throughout the process.
“I do not think the issue is really the number of vaccines, it is the fact that we are at the beginning of a rollout,” said Commission spokesman Eric Mamer. ‘We all judge it as if this campaign is over; the campaign is actually just starting. ”
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 since January 4 – more than any other EU country – is still far from the 1.3 million doses available there.
Meanwhile, the UK has given more than 4 million to about a million people and the US. Both countries have a week-long lead and they have faced their own problems (the US has 13.2 million doses available, for example), but the slow EU implementation is due to delays in the production of the vaccines, a more substantial but bureaucratic approval process, and poor planning in many EU countries.
Why did the Commission not buy enough BioNTech / Pfizer jabs to vaccinate everyone in the EU?
In June, when the Commission started buying vaccines, no one knew for sure which one would be successful, let alone the first.
BioNTech / Pfizer, as well as Moderna, Oxford / AstraZeneca and Johnson & Johnson, were among the fastest to start large-scale human trials and boasted ambitious timelines. But each of these vaccines had different barriers 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.
Thus, the Commission has diversified its vaccine portfolio, securing more than 2 billion doses of vaccines from six producers. It is close to an agreement to buy another 200 million doses of Novavax jab.
Should not the EU have agreed to buy more?
Since BioNTech / Pfizer spoke to a jab for the first time, everyone wants as much of the vaccine as possible, but this will be almost a short-term problem.
Compared to other vaccines, the BioNTech / Pfizer jab is difficult to disperse because it needs to be stored in dry ice at -70 degrees C (it can only be kept in normal refrigerators for five days) and is expensive, at about € 12 per year compared to Oxford / AstraZeneca, which is less than € 2 per dose, according to a leaked price list.
The Commission nevertheless secured 200 million doses of the German-American vaccine with the option to purchase another 100 million (the largest transaction for BioNTech / Pfizer vaccines at the time).
By comparison, the US bought 100 million doses of the vaccine with the option to buy 500 million more in July. Following criticism, the US government bought another 100 million on December 23 – still smaller than the EU’s initial purchase.
But even if the EU had bought more vaccines, it probably would not have made a difference at this point. The issue now mainly concerns the manufacture of bottlenecks and countries unprepared to roll out the sting quickly.
Should countries have just bought and approved vaccines themselves?
The argument for co-operation is that EU countries would facilitate better transactions by negotiating as a bloc.
They have learned from previous experience: during the 2009 swine flu pandemic, pharmaceutical companies pitted EU countries against each other to demand more money for vaccines, and some countries received too many doses and sold them to neighbors.
This time, EU countries agreed to let the Commission handle the negotiations. However, EU countries are still part of the process, as seven countries are taking part in the negotiations and the whole EU countries approve the transactions before they are signed.
The EU could technically buy 1 billion doses of each vaccine, but money was a constraint. It is not certain to what extent, as almost all the information in the EU’s vaccine contracts is secret. We know that the Commission used about € 2.1 billion in installments on the vaccines, and the EU countries asked for another € 750 million in the autumn. Each EU country pays per dose when submitting vaccination orders. Yet they have amassed one of the largest vaccine portfolios in the world.
Some countries have decided to buy other vaccines or more shots on top of EU transactions. In the autumn, Germany bought another 30 million doses of BioNTech / Pfizer and CureVac vaccines, even though this is contrary to the EU strategy.
Asked by POLITICO, Health Minister Jens Spahn said Germany wanted to buy more, but “there was not really a greater need for member states at that time.”
After these additional purchases became more well-known, Denmark said it would follow suit and bought 2.6 million extra doses.
Was Germany detained by the Commission?
Germany helped force the Commission’s hand in June by signing an agreement with France, Italy and the Netherlands for up to 400 million Oxford / AstraZeneca vaccines for the whole EU, so that the US could not snatch 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 handed over the Oxford / AstraZeneca agreement to the Commission.
It is now reported in the German media as the beginning of the ‘vaccine disaster’. Bild reported that Spahn had apologized in a “humiliating tone” for the four-nation alliance’s position, so that Commission President Ursula von der Leyen and German Chancellor Angela Merkel could make the “big gesture” that the EU takes the lead.
Steffen Siebert, head of the press office of the German government, stood by the decision on Monday and said he was convinced that it was ‘the right way’.
“For a country in the middle of Europe … depending on the free flow of goods, with a fixed interest in a functioning Schengen area, ‘every man for himself’ can not be the way,” he said. said.
Why then does the EU take so long to vaccinate people?
Has the EU, as some claim, signed vaccine deals too late? Most transactions were concluded in early August – the Commission received the signatures from EU countries just months later.
It is true that the UK and the US were able to vaccinate hundreds of thousands of people before European regulators approved the first coronavirus vaccine. There are several reasons for this, in particular that the European Medicines Agency recommends a conditional marketing authorization, which contains more drug products than the UK emergency authorization procedures. As a result, if there are unforeseen problems with the vaccines, the British government will be held accountable; drug producers will be on the hook in the EU.
It also takes longer because it requires input from every EU country. Countries largely held back in December to give their support to this process, but when they saw footage of British and Americans being vaccinated, people like Hungary, Poland, Germany and Italy pushed the EU to go faster.
The EMA has moved its recommendation dates forward and the Commission has streamlined the authorization process from day to hour, 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 production 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 applied for conditional marketing authorizations, which may cause delays).
Shouldn’t a vaccine be good once it turns green?
After the EU approved the BioNTech / Pfizer vaccine, companies had to obtain the vaccine and countries had to use it. This is largely where we now see problems.
By the end of 2020, BioNTech / Pfizer was unable to deliver the 12.5 million vaccines it had promised to the EU, mainly due to supply chain issues. BioNTech CEO Şahin told Der Spiegel that more vaccines need to be approved while the company increases its manufacturing capacity.
“It does not look good – there is a gap because there are other approved vaccines missing and we have to fill the gap with our own vaccine,” he said.
As for the use of the jabs, most countries started on 27 December with a show of EU solidarity (Germany, Hungary and Slovakia jumped the gun and started a day earlier). Other countries were just not prepared.
The Netherlands will only start vaccinating this week, and Health Minister Hugo De Jonge said it was because they thought Oxford / AstraZeneca would be the first vaccine to be approved. “Perhaps it would and should have been done differently,” he wrote in a letter to parliament on Monday.
Many others were just incredibly slow, especially France, which vaccinated only 138 people on December 30th.
Hans von der Burchard, Sarah Wheaton and Merlin Sugue reported.
This article is part of POLITICOpremium policy service: Pro HealthCare. Our specialized journalists keep you up to date on topics affecting healthcare policies, from prices for medicines, EMAs, vaccines, pharmaceuticals and more. Email [email protected] for a complimentary trial run.