Why has the EU botched its vaccine rollout?

The EU’s vaccine procurement programme is in deepening trouble. Supply problems at Pfizer’s Belgian plant and AstraZeneca’s announcement that its first quarter delivery to the bloc would be 75 million doses less than expected have only made matters worse. While the UK has now vaccinated 11 per cent of its population and the US has managed seven per cent, the EU figure is just two per cent.

But how exactly has the EU managed to get it so wrong?

First of all, it’s important to understand how the EU went about procuring its vaccines.

The European Commission negotiates deals with individual vaccine producers on behalf of all EU countries. Member states must then approve the deals before they’re signed.

The Commission has secured around 2.3 billion vaccine doses for the whole bloc through advance purchase agreements. The EU’s Emergency Support Instrument funded €2.1 billion of the purchase, with member states contributing an additional €750 million.

The EU opted for a “broad portfolio of vaccines’”, signing contracts with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNTech-Pfizer, CureVac and Moderna.  So far, the European Medicines Agency (EMA), the bloc’s medical regulator, has only authorised the use of the Moderna and BioNTech-Pfizer vaccines.

Once available and authorised at EU level, each country submits their orders for vaccines and pays per dose but, crucially, they receive them under the same conditions: at the same time and price, with doses shared among the states in proportion to their population size.

One reason for teaming up was that EU countries could strengthen their bargaining power by negotiating as a bloc. During the 2009 swine flu pandemic, pharma companies managed to charge more money for their vaccines by playing EU countries off against one another. This time round, letting the Commission handle negotiations seemed like a way to secure cheaper deals.

And, to some extent, the tactic worked. For the initial 300 million doses of the Pfizer vaccine that the EU ordered, they secured a price of €12 a dose. Meanwhile, the US have paid Pfizer $19.50 a dose and an Israeli official disclosed that Netanyahu’s government has paid a hefty $30 per jab.

In total, the UK and US have each spent about seven times more upfront, per capita, on vaccine development, procurement and production than the European bloc, according to data gathered by Airfinity, a London-based life sciences analytics company.

But the centralised approach came at a cost.

The need to coordinate between all 27 member states has caused delays in securing deals on vaccines and delays in authorising their use. The EU was slow to sign vaccine contracts while the UK and US signed supply deals for the BioNTech-Pfizer jab within weeks of its encouraging early trial results in July. The EU only finalised its deal on November 11.

“The European purchasing procedure was inadequate,” according to the Minister President of Bavaria, Markus Soder, who told German newspaper Bild am Sonntag: “There was probably too much bureaucracy at the European Commission, too few of the right vaccines were ordered and price debates went on for too long”.

As the AzstraZeneca disaster unfolds, the EU is paying a high price for its dithering. The pharma giant’s CEO, Pascal Soriot, told La Repubblica on Tuesday that the UK experienced problems with its supply chain too, problems not dissimilar to those currently hampering production capacity at the EU’s vaccine manufacturing sites. The crucial difference, however, was that the UK signed its contract for 100 million doses of the vaccine in May. This gave them an extra three months to sort out any manufacturing problems.

What is especially galling for Germany, the Netherlands, France and Italy is that the four tried to get things moving quicker with AstraZeneca, fearing that supplies would get snatched up by the US. They formed a group known as the Inclusive Vaccine Alliance and attempted to sign a deal with AstraZeneca in June. However, the European Commission insisted that the IVA couldn’t formalise the deal on behalf of EU. The deal was transferred to the Commission and talks dragged on for another two months. These extra talks led to no changes to the contract, but instead delayed arrangements to produce the vaccine in the EU site.

And, unlike with Pfizer, lengthy negotiations would have made no difference to the price they paid for the vaccine because AstraZeneca has committed to selling its vaccine at-cost to everyone throughout the pandemic.

The EU has also been slow to approve vaccines.

Under EMA rules, a vaccine must be approved by representatives of every EU member state before it can enter general circulation in the bloc. And while the EMA only offers standard licensing, the US and the UK have accelerated the approval process by issuing emergency authorisations.

The latter approach has a drawback: with emergency authorisations, the government takes the risk of product liability away from the vaccine manufacturer. Many in the EU are reluctant to adopt this approach as they fear it encourages vaccine scepticism.

Emergency authorisation has accelerated the UK and US’s vaccine roll-out. The BioNTech-Pfizer vaccine was signed off in the UK on 2 December, in the US on 11 December but not until 21 December in the EU. The AstraZeneca vaccine has still not been approved in the EU – though it’s likely to be approved on the 29 January.

Another EU strategy – which could have paid off but hasn’t – was the decision to buy moderate amounts of a wide range of vaccines. The head of BioNTech, Uğur Şahin, told German magazine Der Spiegel that the EU has spread orders too thinly across different manufacturers and it was unwise to assume that several vaccines would get approved at once.

Part of the problem was that there were disagreements between countries over which vaccines to prioritise. Germany, for instance, tried to encourage other countries to purchase more of the BioNTech-Pfizer vaccine. They declined, however, because many considered the mRNA vaccines too expensive and difficult to store. Some wanted to invest more in the cheaper AstraZeneca vaccine – and mistakenly predicted that this would be the first to get approval.

We are now witnessing a breakdown of solidarity between some member states. Germany has made a side deal with BioNtech to secure an additional 30 million doses of the vaccine. Once these additional purchases were made public, Denmark said it would follow suit and purchased 2.6 million additional doses. EU agreements forbid members to negotiate parallel deals with vaccine makers but, technically, this isn’t a breach because they will receive these extra doses after the EU supply.

Perhaps the most significant breach to date has come from Hungary. Frustrated by the time the EMA is taking to approve the AstraZeneca vaccine, the Hungarian government has reached a separate deal with Russia to buy up large quantities of its Sputnik V vaccine which hasn’t even received EU approval.

Will the EU vaccination programme bounce back from this bumpy start? European officials are still hoping that, over time, their strategy of buying moderate amounts of a range of vaccines will pay off as more are approved.

Johnson & Johnson’s Janssen jab could prove crucial. The EU has secured up to 400 million doses of this jab and the EMA has been conducting rolling reviews to speed up approval which is likely to be in February.

The bloc may also benefit from a boost in supply later in the year, once Moderna increases production. The EU has ordered 160m doses of this vaccine and has already approved it.

Meanwhile, Pfizer has insisted that it will make up for the shortfall in supply and honour the first quarter deliveries to which it has committed. And it’s not yet clear how seriously Brussels will pursue its recent threat to block Pfizer vaccine exports to safeguard supplies within Europe. What is clear, however, is that AstraZeneca is not planning on exporting supplies being made at its UK site to the EU.

The Commission’s aim for member states to have vaccinated at least 80 per cent of those over 80 and 80 per cent of health and social care workers by March will be a considerable challenge.