The EU vaccine programme has come under intense scrutiny in recent weeks and months following very public spats with pharmaceutical giant AstraZeneca over vaccine deliveries, and with the UK over alleged blockades of vaccines. This article answers the key questions about the EU vaccine programme, including how it is progressing, and plans for EU-wide vaccine passports.
How does the EU vaccine programme work?
The EU vaccine programme has four distinct elements:
- Procurement — managed by the European Commission
- Regulatory approval — managed by the European Medicines Agency (EMA)
- Distribution — managed by vaccine manufacturers and member states, and overseen by the Commission
- National vaccination programmes — managed by member states
The European Commission has so far agreed contracts with six vaccine producers on behalf of the 27 EU member states, plus the EEA countries (Norway, Iceland and Liechtenstein). Together, these contracts amount to over 2.5 billion doses, for an EU/EEA population of around 450 million people.
Most deliveries are expected this year. The Commission has also concluded exploratory talks with Novavax and Valneva to buy a further 260 million doses, but contracts have not yet been finalised.
Responsibility for assessing the safety and effectiveness of vaccines lies with the EMA. So far it has approved four vaccines for general use in EU/EEA countries: the Pfizer/BioNTech, Moderna, Oxford/AstraZeneca and Johnson & Johnson vaccines. The EMA’s monitoring committee is currently assessing the Johnson & Johnson vaccine (which is not yet approved in the UK), to see whether regulatory action needs to be taken following concerns it is linked to cases of rare blood clots. The Sanofi-GSK and CureVac vaccines are also under rolling review.
Once approved and manufactured, vaccines are made available to all member states at the same time. Vaccines are allotted according to the size of member state populations, with each receiving a proportionate share of the EU/EEA total. The EU also recently took steps to reserve three million doses for the five members with the lowest vaccination rates. Logistically, deliveries are made by manufacturers directly to hubs within member states.
National vaccine programmes
Although the Commission has established overall vaccination targets for the EU as a whole — 80% of over 80s by the end of March and 70% of adults by the end of July — member states decide for themselves which groups they prioritise and in what phases they roll out their vaccination programmes.
Most have a similar prioritisation to the UK, looking to vaccinate the elderly and health and care workers first – although there are some differences across the EU.
Are member states bound by the EU programme?
In terms of procurement, it is unclear. The Commission President Ursula von der Leyen has stated that “No member state is allowed to negotiate in parallel” with vaccine companies.
However, Germany did negotiate preliminary agreements with two vaccine companies in summer 2020, while the Commission was also in negotiations. The German government has said that it will not receive these additional deliveries until EU contracts have been satisfied.
France and Germany have recently held talks with Russia over the potential supply of Sputnik V vaccines, with Germany now in negotiations; while and Hungary and Slovakia have already procured doses. In March, Denmark and Austria made an agreement with Israel to collectively research and develop future vaccines together.
On vaccine approvals, member states are able to seek emergency use authorisation through their domestic regulators without waiting for the EMA. So far, only Hungary has done this, approving the Russian Sputnik V, Chinese Sinopharm and Convidecia, and Indian Covishield vaccines.
But even once vaccines are approved, domestic regulators can and do institute their own guidance on vaccine use in their country.
For instance, while the EMA continues to say that the AstraZeneca vaccine is recommended for general adult use, medicines regulators in a host of European countries have limited its use to only people over a certain age (ranging from over 55s to over 65s), or suspended its use entirely.
Although the Commission has set EU-wide targets, member states have defined their own priority populations and vaccine rollout plans.
Do EU member states have a particular problem with AstraZeneca?
There is no clear evidence that suspensions of the AstraZeneca vaccine are politically motivated. The plainest fact is that UK medical regulators have followed a number of European counterparts in recommending younger people don’t have the AstraZeneca jab. In the UK’s case, it’s recommended that those aged 18-30 are offered another vaccine, due to a possible link to rare blood clots.
The EMA has listed these blood clots a ‘very rare side effect’, but continues to recommend it for general use. And it’s not just a European issue – other countries, such as Australia, also recommend the vaccine not be given to younger people.
How is the vaccination programme proceeding?
The EU’s vaccination programme remains behind the UK’s – and there is significant variation between countries – but it does appear to be gathering pace.
It has missed its first target: to vaccinate 80% of over 80s by the start of April. As of 28 March the rate was 59.8%. The EU’s next target is to vaccinate 70% of its population at least once by the end of July.
As of 7 April, 13.8% of the EU population had received at least one vaccine dose, ranging from 36.3% in Malta to 6.1% in Bulgaria. The equivalent UK figure was 46.9%.
The number of daily vaccinations in the EU continues to climb steadily, to the point where it is now vaccinating roughly the same share of its population each day as the UK.
This is accompanied by a narrowing of the gap between UK and EU in terms of the number of people who have received a first dose. The gap has halved since mid-February.
5.7% of the EU’s population was also fully vaccinated by 7 April. The equivalent UK figure was 9%. The UK was, until late March, behind the EU average on this metric, but has overtaken it in recent weeks as more and more people require their second dose. The increase in second doses is part of the reason why the EU is catching up on first doses administered.
The EU’s increased vaccination rate is driven in part by a growing vaccine supply. 100 million doses had been distributed to member states by the end of March, with at least another 300 million doses expected by the end of June.
The increased supply is coupled with more effective administration of doses: for example, the Netherlands was administering just 49% of available doses in early February, but this has now risen to 66%. The rate is now above 80% in most states.
Why had the EU programme been perceived to have problems?
There are five reasons why the EU seemed to be behind some countries in getting its delivery of vaccines up and running: bad luck in some procurement choices; contracts issues; slower regulatory approval; disruption in the production of approved vaccines, in part because later contracts meant slower start-up; and a slow start to some national programmes.
Like the UK, the European Commission signed contracts for a diverse range of viable vaccine candidates to guard against risks of failure. One of the candidate vaccines in its portfolio — Sanofi/GSK — has been delayed, as its clinical performance was poor.
The Commission was relatively slow in concluding contracts with vaccine companies. A deal was done with Pfizer in late August whereas the UK completed its contract in July.
The relatively slow initial approval of vaccines, at least compared to the UK, also meant a slower rollout. The EMA approved the Pfizer vaccine at the end of December (compared to early December in the UK) and the AstraZeneca vaccine in late January (compared to late December in the UK). It should be noted that the EMA has now approved one more vaccine (Johnson & Johnson) than the UK.
The production issues with the AstraZeneca vaccine in particular appear to be down to either the contract being signed later, or the exact terms of the contracts signed with the UK and EU respectively.
Regardless, this has resulted in AstraZeneca delivering roughly a third of its allotted 90 million doses to the EU by April. One of its main factories in Europe – run by the company Halix – only received EU regulatory approval in March, with the EU citing a lack of necessary data from AstraZeneca. Delays with the Pfizer vaccine also point wider difficulties in upscaling production at short notice.
Finally, there has been variable performance across member states in administering what vaccines are available, although overall performance is improving.
Have EU countries suffered from centralising procurement?
It depends. Most EU member states are small economies with populations of less than 10 million people. Many would have struggled alone to secure the vaccines they can access through the EU scheme, and the EU has taken further steps to ringfence some vaccines for smaller states with the lowest vaccination rates.
Larger member states may have been slowed down by being part of the EU scheme. The EU Vaccine Alliance of four large member states (France, Germany, Italy and the Netherlands), which was already in talks with pharmaceutical companies in June 2020, may have been nimbler than the Commission in negotiating contracts, although it is not clear they would have obtained better prices.
Has the UK been able to act more quickly because of Brexit?
It’s not because of Brexit that the UK was able to procure its own vaccine supplies. The EU’s joint procurement scheme is optional, meaning the UK could have signed the same agreements as an EU member. This could well have led to major political pressure on the UK but – as seen with Germany’s negotiations over Sputnik vaccines – the EU cannot stop such a course of action.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) used the emergency authorisation powers available to national regulators while the UK was still subject to EU rules during the transition period to approve the Pfizer and AstraZeneca vaccines. So it would have still been able to do that if the UK had been a continuing member state.
Vaccine administration is a matter for member states, so – apart from access to supply – Brexit had no effect on that.
Is the EU banning exports of vaccines produced in the EU to the UK?
On 30 January, the Commission brought in an export authorisation requirement for vaccines produced in the EU and being exported elsewhere. A similar measure was imposed at the start of the pandemic for PPE.
It requires vaccine producers to gain authorisation from member states and the Commission before being able to export vaccines out of the EU. If they assess that such a delivery ‘poses a threat’ to the fulfilment of the EU’s vaccine contracts, such exports can essentially be banned.
The EU is also asking companies for data on their vaccine exports dating back to 29 October 2020 to build a picture of historical vaccine movements out of the EU. The Commission argues this measure is mainly about transparency so that it can track the movement of vaccines out of the EU.
This requirement was strengthened on 24 March, introducing principles of reciprocity and proportionality. The first principle asks member states to consider whether the export destination restricts its own exports of vaccines or raw materials. The second principle calls for consideration of whether conditions in the export country are better or worse than the EU’s.
The UK is on the list of countries that this applies to (there is an extensive list of exemptions). As a result, it is possible that member states and the Commission could block vaccine exports from the EU to the UK.
However, the UK and EU issued a joint statement on the same day the reciprocity and proportionality requirements were introduced, noting continued discussions to ‘ensure a reciprocally beneficial relationship’.
Why did the EU threaten to invoke Article 16 of the Northern Ireland Protocol?
The now shelved proposal to invoke Article 16 of the Northern Ireland Protocol by the Commission was part of the implementation of this export authorisation policy. The Commission had assessed that the Irish border was a potential loophole through which companies might export vaccines out of the EU.
After all, extensive efforts were made in the Brexit talks to keep that border open, resulting in the Northern Ireland Protocol. In order to plug that loophole, the Commission had proposed invoking Article 16 of the Protocol, which is an emergency safeguard clause.
This would essentially have instituted a vaccine border on the island of Ireland.
The Commission quickly removed this proposal following outrage across the political spectrum in Northern Ireland, from the UK and Irish governments, and from other officials in the Commission and across the EU.
Is the UK blocking exports to the EU?
There is no record of the UK formally blocking any vaccine exports from the UK to the EU or elsewhere, and the UK Government denies it has done so, though there are no records of any of the UK’s AstraZeneca vaccines being exported from the UK to the EU. The European Council President Charles Michel has questioned the lack of data on vaccine exports from the UK.
It’s also certainly true that the EU has so far not received its expected quota of AstraZeneca vaccines (which are also produced in the US and EU), and a smaller share of its expected supply than the UK has. It’s not clear why this is the case.
Are EU countries developing vaccine passports?
The certificate will contain digital proof that a person has either had a negative test result, has recovered from Covid-19, or has been vaccinated (with an EU-approved vaccine, although member states will have discretion to accept other vaccines).
The system will be used across the EU, and in Iceland, Liechtenstein and Norway. These states will be obliged to accept proof of vaccination, testing and recovery as contained in the certificates. Those travelling with a certificate will therefore have the same rights within the state they are visiting as nationals/residents of that country.
The certificate does not altogether eliminate the need for quarantine and testing on arrival – but states requiring certificate holders to do this must notify the Commission and other EU states, with the reasons for such measures.
The certificate be available in digital or paper form, containing a scannable QR code which is used to check an individual’s status. It will be issued by an individual’s relevant state of citizenship/residence, and contain basic identity information. This data cannot be retained by other member states.
It’s not yet clear what the implications of the system are for UK travellers. The certificate will be available for non-EU citizens ‘legally staying or residing in the EU’. This suggests that a UK national on holiday or living in Spain could in theory obtain a green certificate there and use it to travel to any other EU country.
The Commission also says it is trying to ensure its certificates are compatible with and recognised by similar systems outside the EU.
Some EU states are introducing separate, domestic vaccine passport systems. Denmark’s ‘Coronapas’ will show that a holder either has either been vaccinated, recently recovered from Covid-19, or has tested negative in the last 72 hours.
From the 6 April, it has been required to access services such as hairdressers, and will be required increasingly widely as society opens up, for example at outdoor food and drink services and, later, indoor restaurants. It is linked in most cases to an individual’s unique digital social security ID.
Similar plans are being discussed elsewhere – for example in Estonia and Sweden – but have not yet been introduced.