International 27/01/2021

The EU is in the hands of pharmaceutical companies that do not honour agreements

The Commission will ask AstraZeneca for further clarifications on the delay in the delivery of vaccines

4 min
Archive image of one of AstraZeneca's laboratories
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Brussels / LondonThe European Commission is in the spotlight, as it is solely responsible for the purchase of vaccines to ensure that the doses reach the 27 European partners. However, only Brussels and, for example, AstraZeneca know what conditions were agreed upon in contracts that are secret, also for the rest of the pharmaceutical companies, with the partial exception of the one signed with CureVac.

In a field marinated by the lack of information, doubts about the European management - with a very slow pace of vaccination - are easily appearling, especially after AstraZeneca, manufacturer of the Oxford vaccine, reported last Friday that it will not meet the commitments to deliver the doses agreed for the first quarter of this 2021. In Brussels the discomfort is immense.

Therefore, the Commission has raised the tone to the whole pharmaceutical sector and has announced the creation of a transparency mechanism so that laboratories that produce in Europe are obliged to report before exporting doses outside the EU. A mechanism that will be defined at the end of this week and that seeks, a posteriori, guarantees which in the only contract that has been publicly known, albeit partially - that of CureVac -, do not appear. A spokesman for the Commission has refused on Tuesday to answer whether the AstraZeneca contract is similar, nor does it set any penalty in case of delays in the arrival of vaccines.

Sweden threatens not to pay Pfizer

In any case, it remains to be seen whether the EU will imitate Sweden, which today announced that they were paralyzing payments to the US pharmaceutical company Pfizer until the issue of the number of doses of the coronavirus vaccine is clarified. Initially, they said there were 5 in each. However, the European Medicines Agency recommended updating the information to specify that each vial contains up to six if the appropriate material is used, one more than the five that were recommended so far. The pharmacist updated the technical data sheet explaining that syringes "that do not leave a significant dead volume" should be used to achieve the sixth dose. They began calculating vaccine shipments by counting the extra dose. Given that the price paid by the EU (12 euros) is per dose, not per vial, with fewer vials you get a 20% increase in income. The Swedish Public Health Agency (FHM) urged the European Commission (EC) and Pfizer to reach an agreement that clarifies the situation. "As long as this does not happen, we have told the company that we must wait with any invoices until what is at stake is clarified", Swedish chief epidemiologist Anders Tegnell told the Dagens Nyheter newspaper.

"Europe has invested billions to develop the first coronavirus vaccines, now the companies have to meet their obligations", Commission President Ursula von der Leyen said, speaking on Tuesday at the Davos Economic Forum, which has claimed that it is a matter of "business", not protectionism.

In the background, there is the suspicion that the Anglo-Swedish AstraZeneca has sold to third countries doses of its vaccine when at the same time it claims to not be able to meet the deliveries agreed with the EU. A shadow of doubt that the company's CEO, Pascal Soriot, has categorically denied this afternoon in an interview published by several European print media.

In any case, Brussels has already demanded explanations in two meetings on Monday, and it will also do so in a third meeting that will take place today. The EU government says that so far the answers obtained are not satisfactory. The arguments of the Anglo-Swedish laboratory have been limited to the explanation of "technical problems" in the production chain in Europe.

At the beginning of the pandemic, Brussels already activated a mechanism to monitor exports of medical equipment outside the EU due to the shortage of products, which was then in the midst of debating Europe's "strategic autonomy".

Additionally, the United Kingdom accuses the EU of wanting to "ban" exports of vaccines, which Brussels denies: "We do not want to impose a ban on exports or restrictions, it is mainly a transparency mechanism, to provide clarity on manufacturing capacity", Commissioner Valdis Dombrovskis said on Tuesday.

The vaccination campaign

In August, the EU agreed with AstraZeneca on 300 million doses, expandable to 400 million doses. With Pfizer, the initial agreement was for 300 million doses, expandable to 300 more.

AstraZeneca had to deliver 80 million doses of the Oxford vaccine by the end of March, once it was approved by the European Medicines Agency (EMA), a circumstance that will presumably occur next Friday, January 29. Although after AstraZeneca's announcement, no pharmaceutical company official has quantified the impact of the manufacturing problems, Reuters reported that "deliveries would be reduced to 31 million doses [60% less than initial forecasts]".

The EU's goal is to have 70% of the population vaccinated by the end of the summer. Nevertheless, this is becoming an increasingly impossible mission, both because of AstraZeneca's delays and because of delays in deliveries by Pfizer/BioNTech, which has reduced the volume of vials it will ship during February, in this case due to the work that is needed to expand production capacity at the Puurs plant in Belgium.

So far, the EU has only vaccinated less than two citizens out of a hundred. By contrast, the UK has already injected the first dose to 10% of the population. Among other reasons, the difference lies in the variation in the timing of vaccine approval. The British started the campaign on 8 December. The EU, on the 27th. London gave the go-ahead for the Oxford vaccine on 30 December. The EMA, as noted above, will do so next Friday.

However, analyst Rasmus Bech Hansen, CEO and founder of Airfinity, a London-based company that analyzes scientific data and collects it on the vaccination process around the world, says the problem is not just one of timing, but also of investment and foresight. "Compared to the European Union, the United Kingdom has invested up to seven times more per capita in production and clinical trials than the European Union", although he says that precisely because of the opacity of the contracts, both those of the EU and those of the United Kingdom and the United States, it is impossible to know the exact amounts that the different governments have allocated.

It is known, however, that the EU has bought the dose from Oxford/AstraZeneca at a cheaper price (1.78 euros) than the United Kingdom or the United States, which provided the pharmaceutical company with 1.2 billion dollars to increase its production capacity. Another of the EU's strategic errors, according to the version given by Bech Hansen, is that it initially bet on a horse - the Sanofi/GSK vaccine - that has been left far behind in the race. A delay that directly impacts directly on the Community's production capacity, because it is Sanofi who has more numbers in the Union - and not Oxford/AstraZeneca. The Anglo-Swedish company can produce up to 300 million doses per year in the UK plant (80 already committed to the UK by 2021) and in India (Serum Institute), the factory with the largest capacity in the world (one billion doses). However, those that are produced in India will either stay there or will go to Brazil, Argentina, the Dominican Republic, El Salvador, México and Morocco, countries where the vaccine was approved on January 6, well before the EU.

The European Commission, therefore, has a serious problem: it is trapped between a pandemic that does not stop, and pharmaceutical companies that have perhaps promised more than they should have - more than the capacity they could offer. The opacity of the contracts, for the moment, prevents scrutiny of who, or why, the vaccination process in the EU-27 is in danger.

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