European Commission–AstraZeneca COVID-19 vaccine dispute

In anticipation that a successful vaccine against COVID-19 would be developed, various countries pre-ordered doses of vaccine from the organisations doing research. The United Kingdom pre-ordered 100 million doses of the Oxford–AstraZeneca COVID-19 vaccine in June 2020.[6] The company made a similar agreement on 13 June with the Inclusive Vaccines Alliance, a group made up of France, Germany, Italy and the Netherlands, to supply up to 400 million doses to all EU member states.[7] In the past, the European Union had left member states to decide on their own health policies, but during the summer of 2020, Brussels was asked to take charge of vaccine procurement in what Ursula von der Leyen called a "European Health Union". Member states could opt out of this, but none did.[8] Negotiating on behalf of the whole EU, the European Commission signed a deal with AstraZeneca on 27 August 2020.[6] An analysis by Isaac and Deutsch in Politico Europe indicate the UK involvement began with a £65 million grant to Oxford University in April 2020 to develop a production plan for their vaccine which evolved into a binding agreement in May 2020 with AstraZeneca. This agreement related to UK supply and became the basis for the formal UK contract signed on 28 August 2020, a day after the EU contract. The UK contract differences include being in English law rather than Belgium law and has more specific details key points that relate to interruptions in UK supply.[9]

When the Oxford–AstraZeneca vaccine was approved for use in the United Kingdom on 30 December 2020, vaccinations began to be rolled out. It was the second vaccine to enter the national rollout programme,[10] joining the Pfizer–BioNTech vaccine which had been approved on 2 December 2020.[11] The European Medicines Agency approved the use of the Oxford–AstraZeneca vaccine on 29 January 2021[1] joining the Pzifer vaccine, approved on the 21st December 2020,[12] and the Moderna vaccine on the 6th January 2021.[13] Hours earlier, French president Emmanuel Macron had stated that the vaccine was "quasi-ineffective for people over 65", but the EMA recommended its use for anyone from age 18.[14] By the end of January, two per cent of the population of the European Union had received the first of the required two vaccines shots compared with around ten per cent in the United Kingdom.[1]

In the third week of January 2021, AstraZeneca announced that problems at the Belgian plant where it produced the vaccine would reduce the supply available to the European Union from the 80 million doses expected by the end of March, to 31 million doses. This news came at a time when Pfizer had also reduced the output of its vaccine to allow for an upgrade of its facilities. This left the European Union with a shortfall on its requirements.[1] On 25 January, Stella Kyriakides, Europe's health commissioner, stated that discussions were taking place with AstraZeneca, but that the company had not given satisfactory answers as to which doses had been manufactured and to whom they had been delivered.[15] The company responded by stating that its contract with the United Kingdom gave that nation the first claim to vaccines produced domestically, whereas its contract with the European Union only required it to make its "best efforts" to deliver the doses on time.[1] The contract with the UK also included the best efforts clause.[16] The EU contract was subsequently published, shedding light on the matter.[17]

The Brexit deal guarantees free movement of goods on the border between Northern Ireland and the Republic of Ireland. On 29 January, the European Commission published its export transparency mechanism to gain oversight of the movement of vaccines. This included reference to the possible use of Article 16 of the Northern Ireland Protocol in introducing export controls, to prevent supplies of vaccine aimed at the Republic of Ireland moving to Britain via Northern Ireland. Article 16 allows limited unilateral deviation from the Protocol, subject to various criteria being met. This move was criticised in Northern Ireland, the Republic of Ireland and the UK, with the first minister of Northern Ireland, Arlene Foster, stating it was "an absolutely incredible act of hostility".[3] The EU reversed the decision the following day acknowledging that a mistake had been made.[3] However, it is introducing export controls on coronavirus vaccines made inside the bloc. They will have to be approved by national governments, unless they are destined for the Covax mechanism to supply the poorest countries or for a number of European states not in the EU. The World Health Organization criticised this move as likely to prolong the pandemic and slow economic recovery around the world.[18] The European Union's chief Brexit negotiator, Michel Barnier, asked the Commission to step back from the deepening row.[19]

Later, on 29 January, the UK was left off a list of 120 countries to which vaccines could be exported freely. Instead, manufacturers in the EU must notify national authorities before exporting vaccines to any country not on the list. The authorities have the right to refuse to allow the export if they consider that doing so would jeopardise the supply of vaccines to the EU. The new measures meant that vaccines from AstraZeneca plants in the EU might be prevented from being exported to the UK. Additionally Pfizer, which also makes vaccines in the EU, might be prohibited from exporting vaccines to fulfil their contract with the UK.[20]

Also, on 29 January, the European Commission released a redacted version of the bloc's contract with AstraZeneca. The redacted portions included those covering prices, delivery dates and intellectual property rights.[21] The Commission claimed the contract made it "crystal clear" that AstraZeneca had to supply vaccine produced in the UK to make up for the production shortfall at its EU plants but the firm disputed this, citing the best efforts clause. Article 5.4 of the contract stated that Astra-Zeneca should use "best reasonable efforts" to manufacture the vaccine for the EU at sites in the EU and the UK, but that other sites could also be used to accelerate supply to the EU. The contract included agreed delivery amounts and dates. It also included a statement in Article 13.1.e that Astra-Zeneca was not under any obligation to another party, contractual or otherwise, that would impede its complete fulfillment of its obligations under the contract with the EU.[22] Any legal proceedings would take place in Belgian courts.[23]

On 31 January 2021, Ursula von der Leyen announced by Twitter that a "step forward" had been made in negotiations between AstraZeneca and the EU. The company committed to delivering a further 9 million doses of vaccine by March 2021, and would be expanding manufacturing capacity in Europe. They also stated that deliveries would start being made around a week earlier than previously promised.[24][25] Meanwhile, the European Union had been having other vaccine procurement problems; a 25% shortfall it the number of jabs, from the US biotech firm Moderna, and major shortfalls in the distribution of the Pfizer–BioNTech vaccine.[8]

In a speech to the European Parliament on 11 February 2021, Ursula von der Leyen maintained that when the European Commission took over responsibility for the rollout of the vaccine programme across the EU, this was the correct decision to make. She admitted underestimating the difficulties of mass production of vaccines, and stated that the EU vaccination rollout was "still not where we want to be". She also stated that she "deeply regretted" the threat that had been made by the EU to restrict the flow of vaccine between the Republic of Ireland and Northern Ireland.[26]

By the beginning of March, rollout of the vaccination programme in the EU had been fraught with difficulties, especially with regard to the AstraZeneca vaccine. Reports of more side effects in health workers receiving the AstraZeneca vaccine led to bad publicity[27] and a questioning of the vaccine's efficacy in over-65s had contributed to a poor uptake of the jab in Germany. Over 30% of the UK population had been vaccinated compared to about 8% of the EU population. Thomas Mertens, chairman of Germany's Standing Committee on Vaccination, stated that "the whole thing has somehow gone badly" while affirming that the AstraZeneca vaccine was "very good".[28]

On 4 March, Italy became the first EU country to block exports of the AstraZeneca vaccine. It refused the company permission to export 250,000 doses from its Rome plant to meet a contract with the Australian government.[29][30] The European Commission accepted the Italian export block and the Australian government has asked for a formal review of the decision. The export was to form part of a batch of vaccines intended to be used while Australian production was set-up.[31]

By early March, several EEC member countries had become frustrated by the shortage of vaccine supplies arranged by the EMA, and began to look for alternative sources of supply. Austria, the Czech Republic, Denmark, Poland and Slovakia joined Hungary in sidetracking the EU's common approach by obtaining the Sputnik V vaccine from Russia, and supplies of vaccine from China.[32]

On 9 March, Charles Michel, the President of the European Council, accused Britain of banning the export of COVID-19 vaccines stating "The United Kingdom and the United States have imposed an outright ban on the export of vaccines or vaccine components produced on their territory". This statement was fervently denied by Boris Johnson, the UK prime minister, who denied that the government had blocked sales of vaccines to other countries.[33]

In mid-March, thirteen member states of the EU, including Germany, France, Italy, Spain, Cyprus, Latvia and Lithuania, joined several other countries around the world and suspended using the AstraZeneca vaccine after reports of blood clots in some recipients.[34] The company, UK regulators and the European Medicines Agency stated that the vaccine was safe and there was no evidence of an increased risk of blood clots among recipients.[35] The decision was later rescinded following a report by the EU European Medicines Agency that the AstraZeneca vaccine was safe and effective.[34] Other EU member states declared they will not suspend AZ vaccinations as "the benefit of taking the vaccine is incomparably greater than the potential so-called post-vaccination symptoms".[36] The approach of countries that suspended vaccinations quoting "precautionary principle" has been criticized as "focusing on completely wrong risk".[37]

The row led to large falls in public confidence in the vaccine across the EU; in France some 61% of the population believed the AstraZeneca vaccine was unsafe, an increase of 18% from before the row. Similar decreases in confidence were seen in Italy and Spain. This contrasted with Britain where confidence in the vaccine remained high, with just 9% believing it unsafe, a rise of 4%.[38] The British Medical Journal reported that the effects of the row over safety were likely to cause a long-lasting reduction in the willingness of EU subjects to take the vaccine.[39] On 17 March the European Commission accused some member states of stockpiling AstraZeneca vaccine doses in the aftermath of the safety row.[40]

On 20 March, the European Commission asked the Italian government to verify some unreported batches of vacine at an AstraZeneca filling plant near Rome.[41] EU sources told journalists that they thought the plant was filling vaccine vials for export for the UK, against an Italian export ban. The Carabinieri raided the plant over the following days and found 29 million doses. It was found that 13 million doses were due for export to the Covax scheme (which is part funded by the UK and EU) to supply vaccines to low-income countries and the remaining 16 million were due for export to the EU in March and April.[42]

On 21 March, the row escalated with the European Commission announcing that the heads of EU nations would meet on 25 March to discuss preventing the export of all vaccine and vaccine ingredients. Such a move has the potential to delay the British vaccination programme by two months and speed up the EU vaccination programme by one week.[43] The British government stated that the plant at the centre of the row, at Haix in the Netherlands was under contractual obligations to supply Britain and did not have regulatory approval to supply EU states. British prime minister Boris Johnson was said to be discussing the matter with EU leaders in an attempt to prevent an export ban.[44] Pfizer was reported to have urged the EU to reconsider its proposal because lipid nanoparticles, a vital component for the Pfizer–BioNTech vaccine, are manufactured by Croda International at its factory at Snaith, North Yorkshire, and if Britain were to retaliate, production of the Pfizer vaccine would soon halt.[45] Pfizer warned the EU of the risks to production in such instances with a spokesperson stating: "We have been clear with all stakeholders that the free movement of goods and supply across borders is absolutely critical to Pfizer and the patients we serve".[46] At a summit on 25 March, European leaders decided not to institute an export ban.[47]

UK-EU discussions were held in late March over stockpiles at a plant producing AstraZeneca vaccines in Leiden, the Netherlands. Vaccines produced at the plant were not used because AstraZeneca only applied for approval of the site on 24 March 2021.[48] Two days later, on 26 March, the approval was granted to start distribution.[49]

Lower than expected yields at British plants in Oxford and Staffordshire and a temporary ban on exports from India led Britain to look for supplies from Leiden, which was included as a supplier in its contract with AstraZeneca. The EU has the power to block such an export under its January regulations.[50] The Leiden plant has the capacity to produce around 5 million doses per month. In negotiations from 23 March progress was made but there were sticking points over the proportion of output to go to each party. Britain wanted a 50-50 split whereas the EU wanted a split based on relative population.[51] The EU's internal market commissioner, Thierry Breton, stated on April 1 that there would be no export of the AstraZeneca vaccine to the UK until the company had met its commitment to the EU.[52]