How the EU Got Its COVID Vaccine Program Back on Track

Just three months on from January’s low point, the European Union’s vaccination effort has rebounded, predicting 70% of adults protected by mid July.

In a frenzied week at the end of January, officials handling the European Union’s vaccination efforts were in a state of panic.

On Friday, January 22, the news dropped that AstraZeneca would not only fail to meet its target of delivering 100 million vaccine doses to the bloc in the first quarter of 2021, but would miss it by a mile. 100 million had become 31 million, and the hope of a swift vaccine roll out evaporated.

These were days when Commission President Ursula von der Leyen – like plenty of Europeans – was looking enviously across the English Channel. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) had stolen a lead on the EU by approving the BioNTech/Pfizer vaccine three weeks ahead of the European Medicines Agency (EMA), and for AstraZeneca the UK had a head start of four.

The vaccination program of the EU and India were off to a slow start, also because both regions have been exporting significant amounts of vaccine doses, other than the US and UK (c) World in Data

That was not all. The UK’s National Health Service was particularly agile at getting doses into arms, and the UK’s own AstraZeneca production was up and running, while the plants at Seneffe, Belgium and Leiden, Netherlands were struggling.

As if that were not galling enough, BioNTech/Pfizer vaccines were being exported from a plant at Puurs, Belgium to fulfil the UK’s contract for that vaccine that had been signed four months before the EU’s. Meanwhile across the Atlantic, vaccination efforts were likewise ramping up considerably faster than in the EU.

Need for Change

It was in those febrile January days that the European Commission realised the EU’s vaccination approach needed to change. Vaccines were flowing out of the European Union, and none were flowing in. Why, the Commission was asking, could UK plants not be used to make up for the European plants’ supply shortfall? The least the Commission should do, reasoned von der Leyen, was to make it clear what vaccines were being sent where, and so on January 29, the EU’s transparency and authorisation mechanism was launched.

Von der Leyen even managed to make Brexit overshadow the birth of the authorisation mechanism, having included a specific reference to preventing vaccine supplies going from Ireland to Northern Ireland in the initial draft – having given fellow Commissioners next to no time to raise their objections in the evening of Friday, January 29. In both Dublin and London, the blowback against von der Leyen was swift and fierce, and the reference was swiftly dropped. But the repercussions of the Commission President’s misstep rumbled on for weeks afterwards.

Whose Vaccines?

The first direct impact of the authorisation mechanism was an export block on 250,000 AstraZeneca doses destined for Australia in early March, to date the only shipment actually blocked by the mechanism. Why, the argument went at that stage, are AZ doses en route to a country that has far lower infection rates than the EU? Critics of the mechanism saw this as a sign of the EU abandoning its decades long commitment to global trade. Not only was the EU struggling to get vaccines to its own citizens, but it was simultaneously sacrificing its principles.

As observers on Twitter and news website Axios pointed out, the EU and India have both exported large numbers of vaccine doses to countries in need, while the US effectively banned any vaccine exports.

It was at this stage that the solidarity between Member States and the EU began to seriously fray. Austrian Chancellor Sebastian Kurz and his Danish counterpart Mette Frederiksen launched a broadside against the EU’s slow vaccine procurement and approvals process, and sought an agreement with Israel for second generation vaccines, outside the EU framework. Hungary and Slovakia looked to Russia for supplies of Sputnik V.

Yet when the first statistics on EU exports leaked in mid-March the numbers were astounding. In just five weeks since the introduction of the new mechanism at the end of January, the EU had exported 34 million vaccine doses, including 9.1 million to the United Kingdom.

When von der Leyen presented updated numbers at a European Council summit at the end of March, including estimates for the period prior to the introduction of the new rules, the total export number amounted to 77 million doses, including 21 million to the UK – about 40% of the total doses administered by the British Government at that stage. This was not the go-it-alone post-Brexit success Johnson trumpeted: The UK’s vaccine roll out was built on supplies from the EU.

That was not all. Behind the scenes the EU was sharpening its approach. Stung by the January episode, and keen to build on good will from the summer of 2020 when joint procurement of vaccines by the EU was widely praised, von der Leyen had given her pugnacious Industry Commissioner Thierry Breton the task of pinning down what was up with vaccine supply chains in the EU, with AstraZeneca foremost on his list, not least as the first quarter supply debacle had been followed up with a scaling-back of second quarter projections as well – down to 70 million from 180 million. Visits to the Halix manufacturing plant in Leiden, Netherlands and a raid on the Catalent bottling facility at Anagni, Italy, followed, while Belgian regulators were keeping tabs on the facility at Seneffe.

Measly March

Caused by a combination of EU nerves, AstraZeneca CEO Soriot’s interview with a group of European newspapers, and UK belligerence about doses it was supposedly due, controversy had swirled throughout March over whether AZ was keeping doses in the UK rather than sending them from British plants to supply the EU.

Breton and the European Commission were meanwhile steadily coming to another more mundane conclusion: this was not a problem of supply diversion, but an absence of supply. AstraZeneca’s supply chain in the EU was not reliable enough, and production not scale-able enough, to ever meet the projected delivery figures, and that the EU would better look elsewhere to prevent its vaccine supply efforts becoming even more of a fiasco.

Since this realisation, change has been swift. Denmark has concluded it does not need AstraZeneca doses at all any more, an option for a further 100 million AZ doses has not been taken up, and the European Commission is considering taking AstraZeneca to court for not having been able to stick to its delivery schedule.

Bringing Manufacturing Back Home

A further fear in the European Commission was that the AZ-UK-EU spat would be repeated between the EU and the USA over the Johnson & Johnson vaccine, developed and produced in Leiden, Netherlands by J&J subsidiary Janssen. The initial plan was for vaccine produced in Leiden to be shipped to the United States for bottling, before then being sent back to the EU. But those doses would have been in danger of not being returned until J&J fulfilled its contracts in the United States, as the USA uses its Defence Production Act to restrict exports.

Avid vaccine watchers on Twitter have followed the early twist and turns of the debate – but also pointed to the massive ramp-up in EU production and delivery of vaccines that’s ahead. (c) Jacob F Kirkegaard

A bottling line originally intended for a dengue vaccine at IDT Biologika, Dessau, Germany was swiftly repurposed for Johnson & Johnson for a three month period, and J&J production and finishing at Reig Jofre, Barcelona, Spain will be on stream by June. Crisis averted. On top of that, the plant intended to be used for J&J bottling in the USA has subsequently been forced to close, making the EU’s scramble to put together an EU-only supply chain seem even more sensible. The EU is due to receive 55 million Johnson & Johnson doses in the second quarter.

While AstraZeneca and Johnson & Johnson have provoked all the public debate, another vaccine has steadily been rising to pre-eminence in the European Union, namely the joint venture of BioNTech from Mainz, Germany and US concern Pfizer.

mRNA on the Rise

Back in the summer of 2020 when the European Commission was starting its vaccine procurement, no one was sure which vaccines would work out, so a portfolio approach was chosen. Six Advance Purchase Agreements were concluded covering three different vaccine technologies – mRNA (BioNTech/Pfizer, Moderna, Curevac), vector virus (AstraZeneca, Johnson & Johnson) and recombinant protein-based (Sanofi-GSK).

BioNTech/Pfizer won the race to be the first vaccine to be licensed for use and is still the vaccine with the highest effectiveness – 95%. Its use has not been beset by a concern about side effects that has dogged AstraZeneca and Johnson & Johnson. Its public funding comes from just two sources: the European Investment Bank made available a €100 million loan to BioNTech in June 2020, and the German government followed up with €375 million in September.

BioNTech to the Rescue

That second funding boost allowed BioNTech to purchase a further plant in Marburg, Germany and hence be able to massively scale their vaccine production. A deal with German chemical firm Evonik has also established the final part of BioNTech/Pfizer’s supply chain that until recently had been off shore.

Even before the Marburg plant came on stream, BioNTech/Pfizer exceeded its first quarter shipments to the EU by 1 million. With doses from Marburg now shipping, the company has since been able to up its projections for the second quarter to 250 million doses, more than all the other vaccines at the EU’s disposal put together.

Apart from a minor hiccup at the Puurs, Belgium plant in January, BioNTech/Pfizer have been able to deliver on schedule week after week, month after month. The Commission, by now confident both in the vaccine’s effectiveness and BioNTech/Pfizer’s ability to deliver, has placed a further order for 1.8 billion doses for delivery in 2022 and 2023.

A comparatively small Moderna shipment – 35 million doses of its mRNA vaccine are due in the second quarter – completes the European Union’s vaccine line-up for now, with a further supplier – Curevac – due to be approved by the early summer.

Back on Track

So just three months on from January’s low point, the EU’s vaccination effort has rebounded. France and Germany are regularly breaking their own daily vaccination records. The European Commission is confident at least twelve EU Member States will have 70% of their adult populations vaccinated by mid-July. Joint procurement has meant even the EU Member States with no vaccine manufacturing have received supplies.

And perhaps most significant of all, EU vaccine supply is not only solid, but the lion’s share is BioNTech/Pfizer, the best performing vaccine with the most reliable supply chain. January’s angst feels like a long way behind us now.

Jon Worth is a Berlin based consultant and blogger. He teaches EU politics at the College of Europe in Bruges.

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