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EU Politics

Explainer: COVID-19 vaccination in the EU

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The Pfizer-BioNTech COVID-19 vaccine is the first vaccine to be made readily available in some parts of the world. BioNTech

With which companies have you concluded COVID-19 vaccine agreements?

The Commission is negotiating intensely to build a diversified portfolio of vaccines for EU citizens at fair prices. Contracts have been concluded with AstraZeneca (400 million doses), Sanofi-GSK (300 million doses), Johnson and Johnson (400 million doses ), BioNTech-Pfizer 300 million doses, CureVac (405 million doses) and Moderna (160 million doses). The Commission has concluded exploratory talks with the pharmaceutical company Novavax with a view to purchasing up to 200 million doses.

This means that the Commission has secured a portfolio of more than 2 billion doses. For the Commission it was important from the beginning to build a diversified portfolio of vaccines based on different technologies, to increase the chances that one or more of the vaccine candidates are approved by EMA. Should all vaccines candidates turn out to be safe and effective, Member States have the possibility to donate part of their doses to lower and middle income countries.

Which vaccine is now authorised?

The Commission has given on 21 December the conditional marketing authorisation for the vaccine developed by BioNTech and Pfizer, following EMA positive assessment of its safety and efficacy. It is now waiting for EMA’s opinion on the possible conditional marketing authorisation for the vaccine by Moderna, which should be provided by 6 January at the latest.

No other vaccine producer has formally applied for a marketing authorisation to EMA. In order to accelerate the process, EMA has started rolling reviews on the vaccines produced by Johnson and Johnson and AstraZeneca.

How will vaccines be monitored post authorisation under the Conditional Marketing Authorisation (CMA)?

The monitoring of the safety and effectiveness of vaccines after authorisation is a requirement under EU law and a cornerstone of the EU’s pharmacovigilance system relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. The system is exactly the same than for a normal market authorisation.

The safety and effectiveness of vaccines which have received conditional marketing authorisations are rigorously monitored, as for all medicines, through the EU’s established medicines monitoring system.

In addition, special measures are in place to quickly collect and evaluate new information. For example, manufacturers must usually send a safety report to the European Medicines Agency every six months. For COVID-19 vaccines, safety reports must be sent every month.

The European Medicines Agency will set up additional large-scale safety monitoring given the exceptionally high numbers of people expected to receive the vaccines.

Once authorised, when will vaccines be available in the EU?

In line with the EU vaccine strategy agreed with Member States, once authorised and produced, each vaccine will be available to Member States at the same time and at the same conditions. 

The distribution will start progressively. This means that in the first few months, there will not be enough doses available to vaccinate all adults. The first doses will go to the priority groups identified by Member States (e.g. healthcare professionals, persons over 60 years of age). Supplies will increase over time, and all adults should be able to get vaccinated during the course of 2021.

For most contracts concluded, the majority of delivery is foreseen to be completed in 2021. Under some contracts, first deliveries are expected to already start in the first quarter of 2021.

First deliveries of the BioNTech and Pfizer vaccine are expected within days of authorisation and first vaccinations would take place in the context of the EU vaccination days of 27-29 December.

The Commission has been asking national authorities to prepare as early as possible for organising the fast and accessible deployment of vaccines, according to national vaccination plans and has issued guidance on the large-scale vaccination deployment.

The Commission is following the developments of national vaccination plans very closely and provides support notably by organising joint procurement for vaccination supplies, such as syringes and needles, and running a stress test of the national vaccination plans ahead of deployment together with the ECDC.

Will the EU have enough capacity to manufacture the COVID vaccines?

There is already substantial vaccine production capacity in the EU – and the Commission is working intensively to increase it. In addition, and in order to ensure that vaccine developers have the necessary capacity to scale up the production of COVID-19 vaccines as soon as they have been approved by the EMA, the Commission supports the necessary investment in the development of such production capacities.

How will logistics work? How will vaccines be distributed?

Logistics and transportation is a key aspect on which all Member States have to work, as emphasised in the Communication on preparedness for COVID-19 vaccination strategies and vaccine deployment of 15 October.

Delivery to national distribution hub(s) will be ensured by the manufacturers.

Further distribution to vaccination centres will be ensured by Member States, who will also be responsible for the vaccination of their population.

Who should be vaccinated first?

All Member States will have access to COVID-19 vaccines at the same time on the basis of the size of their population. The overall number of vaccine doses will however be limited during the initial stages of deployment and before production can be ramped up. The Commission has therefore provided examples of unranked priority groups to be considered by countries once COVID-19 vaccines become available.

Most countries have defined priority groups and are further refining who should get priority in these priority groups e.g. older person over 80 years of age. The ECDC published an overview of where EU/EEA countries and the UK are with the development of their vaccination plans/strategies. ECDC is also working on a modelling exercise on prioritisation to support Member States. This report should be published before Christmas.

Will citizens know which vaccine they will be getting?

Yes.

When vaccines receive conditional marketing authorisation, the package leaflet with details on the specific vaccine will be translated into all languages and published in electronic form by the Commission.

All health care professionals and all patients would therefore have access to a leaflet in electronic form in their own languages.

The vaccine companies are responsible for putting in place the necessary mechanisms to ensure that each patient receives the package leaflet in print form in his/her language upon request without burdening healthcare professionals administering the vaccine.

What labelling and packaging information will citizens and health care professionals get with the COVID-19 vaccines?

In order to allow for a rapid deployment of COVID-19 vaccines at large scale, the Commission has developed, with Member States and the European Medicines Agency, labelling and packaging flexibilities for a temporary period. Flexibility in the labelling and packaging requirements is expected to reduce transport costs and storage space, improving the distribution of the doses between Member States and limit possible impact on the production of other routine vaccines. Despite these flexibilities, anyone vaccinated and health care professionals will have access to all the information on the vaccine used.

An example of such flexibilities is the fact that the outer and immediate packaging may only be printed in English. Also, the package leaflet does not have to be included inside the package of the medicinal product, but will be provided separately by the vaccine company, who will be responsible for the distribution of the printed package leaflet locally in the national language(s).

Some Member States do not require the package leaflet to be printed in their national language(s). The leaflet may be printed in English only, but the information contained in the leaflet should still be available in the national language(s), for instance via a QR code printed in the package leaflet and also available in the EMA website in all languages.

How will the Commission support Member States in the rolling-out of vaccines?

The Commission stands ready to support Member States to ensure the smooth deployment of COVID-19 vaccines. A number of EU instruments in the programming period 2021-2027 can offer financial support in this regard.

For instance, investments to support health reforms and resilient, effective and accessible health systems are eligible under the Recovery and Resilience Facility (RRF), and can be included in the national Recovery and Resilience Plans. Furthermore, the Cohesion Policy funds (European Regional Development Fund – ERDF and European Social Fund Plus – ESF+) as well as the REACT-EU programme can provide financing to Member States and their regions to strengthen their health systems, both in terms of managing and recovering from the current health crisis and as well as ensuring their resilience in the longer term.

Collectively, these programmes can support a range of investment needs, for example, in health infrastructure, training of health professionals, health promotion, disease prevention, integrated care models, digital transformation of healthcare, and equipment, including critical medical products and supplies to strengthen the resilience of health systems.

In this context, investments to prepare health systems for the roll out COVID-19 vaccines are eligible under these programme, especially given the direct link to the resilience of health systems, the availability of critical medical products and disease prevention. However, it will be up to each Member State to decide on the priorities and content of their Recovery and Resilience Plan and also their Programmes for the Cohesion Policy funds.

How will vaccination certificates work?

A common approach to pharmacovigilance, and to trusted, reliable and verifiable vaccination certificates across the EU could reinforce the success of vaccination programmes in Member States and the trust of citizens.

Registering data on vaccination is important both at individual and population levels. For an individual, it is a means to know and demonstrate their vaccination status. Proof of vaccination should be available from the moment vaccination starts. Vaccination certificates could for example be useful in the context of travel, showing that a person has been vaccinated and therefore may not need testing and quarantine upon arrival in another country.

The Commission and Member States, together with WHO, are working on vaccination certificates. This work includes a minimum dataset, including a unique identifier, for each individual vaccination which will ease the issuance of certificates and vaccination monitoring on a Europe-wide basis from the moment that the COVID-19 vaccines are authorised.

The development of the common specifications framework will take account of and contribute to the work of WHO. EU funds, such as RRF, ERDF, InvestEU can support the setting up of the Immunisation Information Systems (IIS), Electronic Health Records and secondary use of health data on immunisation.

How much does the vaccine cost? What is the price of the vaccine?

The Commission negotiated advantageous deals with vaccine manufacturers to secure access to almost 2 billion doses so far.

At this stage the specific pricing per dose is covered by confidentiality obligations. However, a significant part of the overall costs are funded by a contribution from the overall EU funding for vaccines.

Will the vaccine be free in all EU Member States?

While this is a Member State responsibility, the large majority of the Member States intend to offer vaccination free of charge.

Are the contracts with the companies publicly available?

The focus for the Commission is the protection of public health and securing the best possible agreements with companies so that vaccines are affordable, safe and efficacious.

Contracts are protected for confidentiality reasons, which is warranted by the highly competitive nature of this global market. This is in order to protect sensitive negotiations as well as business related information, such as financial information and development and production plans.

Disclosing sensitive business information would also undermine the tendering process and have potentially far-reaching consequences for the ability of the Commission to carry out its tasks as set out in the legal instruments that form the basis of the negotiations. All companies require that such sensitive business information remains confidential between the signatories of the contract. The Commission therefore has to respect the contracts it concludes with the companies.

When will the vaccine allow the control of the pandemic?

For some known communicable diseases, it is understood that herd immunity allowing to control a pandemic and eventually eradicate a disease requires around 70% of the population to have protection either from vaccination or previous infection.

Depending on the pace of vaccination and natural infections, the pandemic might be controlled by the end 2021 in Europe.

Can we still spread the disease once vaccinated?

We do not yet know. Additional evaluations will be needed to assess the effect of the vaccine in preventing asymptomatic infection, including data from clinical trials and from the vaccine’s use post-authorization.

Therefore, and for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and respect social distance, so on. Other factors, including how many people get vaccinated and how the virus is spreading in communities may also prompt revision of this guidance.

If I have already had COVID-19 and recovered, do I still need to get the vaccine?

There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again; this is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this.

EU Politics

EU clears way for the EU Digital COVID Certificate

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Today, the Presidents of the three EU institutions, the European Parliament, the Council of the EU and the European Commission attended the official signing ceremony for the Regulation on the EU Digital COVID Certificate, marking the end of the legislative process. On this occasion Presidents David Sassoli and Ursula von der Leyen and Prime Minister António Costa said:

“The EU Digital COVID Certificate is a symbol of what Europe stands for. Of a Europe that does not falter when put to the test. A Europe that unites and grows when faced with challenges. Our Union showed again that we work best when we work together. The EU Digital COVID Certificate Regulation was agreed between our institutions in the record time of 62 days. While we worked through the legislative process, we also built the technical backbone of the system, the EU gateway, which is live since 1 June.

We can be proud of this great achievement. The Europe that we all know and that we all want back is a Europe without barriers. The EU Certificate will again enable citizens to enjoy this most tangible and cherished of EU rights – the right to free movement. Signed into law today, it will enable us to travel more safely this summer. Today we reaffirm together that an open Europe prevails.”

EU Digital COVID Certificate

The aim of the EU Digital COVID Certificate is to facilitate safe and free movement inside the EU during the COVID-19 pandemic. All Europeans have the right to free movement, also without the certificate, but the certificate will facilitate travel, exempting holders from restrictions like quarantine.

The EU Digital COVID Certificate will be accessible for everyone and it will:

  • cover COVID-19 vaccination, test and recovery;
  • be free of charge and available in all EU languages;
  • be available in a digital and paper-based format;
  • be secure and include a digitally signed QR code;

Member States shall refrain from imposing additional travel restrictions on the holders of an EU Digital COVID Certificate, unless they are necessary and proportionate to safeguard public health.

In addition, the Commission committed to mobilising €100 million under the Emergency Support Instrument to support Member States in providing affordable tests.

The Regulation will apply for 12 months as of 1 July 2021.

Background

On 17 March 2021, the European Commission presented a proposal to create an EU COVID Certificate to facilitate the safe free movement of citizens within the EU during the pandemic. On 20 May, co-legislators reached a provisional agreement. On 1 June, the technical backbone of the systems, the EU gateway, went live. The gateway allows the verification of the security features contained in the QR codes.

Following the official signature today, the Regulation will enter into application on 1 July, with a phasing-in period of six weeks for the issuance of certificates for those Member States that need additional time.

13 Member States have already started to issue EU Digital COVID Certificates.

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EU Politics

EU proposes a strong multilateral trade response to the COVID-19 pandemic

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EU has submitted its proposal seeking the commitment of World Trade Organization (WTO) members for a multilateral trade action plan to expand the production of COVID-19 vaccines and treatments, and ensure universal and fair access. With this proposal to the WTO, divided in two communications, the EU underlines the WTO’s central role in the response to the COVID-19 pandemic and urges fellow WTO members to agree on a set of commitments, including on intellectual property rights.

President von der Leyen said: “The EU has actively shown solidarity with the world since the beginning of the pandemic. The European Union authorized exports of around half of the total amount of vaccines produced in Europe. Our immediate, urgent goal is to ensure equitable access for low – and middle-income countries, to share vaccines wider and faster. And we continue to help ramping up production. The EU proposes concrete short and medium term solutions to ensure universal access at affordable prices. I am looking forward to discuss with the G7 leaders next week how to achieve this goal. Beyond the current crisis, it is important to ensure global preparedness for future pandemics: diversifying manufacturing so that it is not centralised only in a handful of countries and strengthening the resilience of the healthcare infrastructure in least developed countries”.

Executive Vice-President and Commissioner for Trade Valdis Dombrovskis said: “The pandemic is still with us and there can be no room for complacency. We need to urgently concentrate on proposals that accelerate the equitable distribution of COVID-19 vaccines worldwide. In this respect, a strong multilateral trade response could deliver a huge boost in the fight against COVID-19. In reality, the main problem at this moment relates to the lack of sufficient manufacturing capacity to rapidly produce the required quantities. The objective must be to ensure that any available and adequate manufacturing capacity anywhere in the world is used for the COVID-19 vaccines production.”

More on the EU’s proposal

The EU calls on governments to:

  1. Ensure that COVID-19 vaccines, treatments and their components can cross borders freely;
  2. encourage producers to expand their production, while ensuring that those countries most in need of vaccines receive them at an affordable price, and;
  3. facilitate the use of compulsory licensing within the WTO’s existing Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The TRIPS Agreement already provides this flexibility, which is a legitimate tool during the pandemic that can be used swiftly where needed

The first element aims to limit the use of export restrictions and keep supply chains open. Vaccine-producing countries should be ready to export a fair share of their domestic production. Supply chains are highly interconnected and should not be disrupted. In addition, the EU considers that supplies to the COVAX Facility should never be restricted, and no measures should limit trade in inputs necessary for the production of COVID-19 vaccines and treatments. 

The second element calls on governments to strongly encourage and support vaccine manufacturers and developers to expand production and ensure the affordable supply of vaccines to low- and middle-income countries. Such actions could include licensing agreements, the sharing of expertise, tiered pricing including non-profit sales to low-income countries, contract manufacturing and new investments in manufacturing facilities in developing countries. The EU expects all vaccine producers and developers to make concrete pledges that increase supplies to vulnerable developing countries. In this regard, the EU welcomes the commitment of companies such as BioNTech and Pfizer, Johnson & Johnson and Moderna, which have already committed to delivering 1.3 billion doses this year to low-income countries at no profit and to middle-income countries at lower cost.

The third element, on intellectual property, sets out that voluntary licences are the most effective instrument to facilitate the expansion of production and sharing of expertise. Where voluntary cooperation fails, compulsory licences, whereby a government grants a targeted licence allowing a willing producer to make a vaccine without the consent of a patent holder, are a legitimate tool in the context of a pandemic. The EU considers that all WTO members should be ready to:

  • agree that the COVID-19 pandemic is an exceptional circumstance of national emergency, and that the requirement to negotiate with the rights’ holder may be legitimately waived where needed;
  • support manufacturers that are ready to produce vaccines and/or treatments at affordable prices under a compulsory licence so that the level of remuneration paid by the manufacturer to the patent holder reflects such affordable prices;
  • agree that the compulsory licence could cover any exports destined to countries that lack manufacturing capacity, including via the COVAX facility.

The EU is also tabling a dedicated communication on intellectual property to the WTO body in charge of implementing the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Council). Here, the EU provides more detail and clarity on each of the three points on intellectual property and links them with the specific provisions in the TRIPS Agreement. As regards the broad waiver proposed by a number of WTO members, the European Commission, while ready to discuss any option that helps end the pandemic as soon as possible, is not convinced that this would provide the best immediate response to reach the objective of the widest and timely distribution of COVID-19 vaccines that the world urgently needs. Today’s proposals aim at achieving that objective in a swift and effective manner.

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EU Politics

EU Digital COVID Certificate: Parliament and Council reach agreement

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Photo: Lukas Souza/Unsplash

The Commission welcomes today’s provisional political agreement between the European Parliament and the Council on the Regulation governing the EU Digital COVID Certificate. This means that the certificate (previously called the Digital Green Certificate) is well on track to be ready end of June, as planned. Today’s agreement has been reached in record time just two months after the Commission’s proposal. The negotiations on the certificate for the Commission have been led by Commissioner Didier Reynders in close cooperation with Vice-Presidents Vera Jourová and Margaritis Schinas and Commissioners Thierry Breton, Stella Kyriakides, and Ylva Johansson.

Welcoming this swift progress, President Ursula von der Leyen said:

“We are delivering on our commitment to have the EU Digital COVID Certificate up and running before the summer. European citizens are looking forward to travelling again, and today’s agreement means they will be able to do so safely very soon.

The EU Digital COVID Certificate is free of charge, secure and accessible to all. It will cover vaccination, test and recovery offering different options to the citizens. It fully respects citizens’ fundamental rights, including protection of personal data.

All EU citizens have a fundamental right to free movement in the EU. The EU Digital COVID Certificate, available in paper or digital format, will make it easier for Europeans to travel – whether to see their families and loved ones or to get some well-deserved rest.

We would like to thank the European Parliament and the Portuguese Presidency for their dedication, perseverance and immense work at record speed to find an agreement on the proposal we presented.

Work still remains. At EU level, the system will be ready in the next few days. It is now crucial that all Member States press ahead with the roll-out of their national systems to ensure that the system can be up and running as soon as possible. This is what EU citizens rightly expect.

Today’s agreement has demonstrated that with the commitment and cooperation of all, the EU Digital COVID Certificate will be available on time.”

The EU Digital COVID Certificate – key features

Following the agreement reached by the European Parliament and the Council, the EU Digital COVID Certificate:

  • will cover vaccination, test and recovery;
  • will be available in a digital and paper-based format, depending on the choice of the recipients, and contain a digitally signed QR code;
  • will be free of charge, be obtained easily and also available to persons vaccinated before the EU Digital COVID Certificate Regulation has entered into force;
  • may also be used by Member States for national purposes, if this is provided for in national law.
  • Member States shall refrain from imposing additional travel restrictions on the holders of an EU Digital COVID Certificate, unless they are necessary and proportionate to safeguard public health.
  • The Commission will also mobilise €100 million to support Member States in providing affordable tests.

Next Steps

The political agreement will now have to be formally adopted by the European Parliament and the Council. The Regulation will enter into force on 1 July, with a phasing-in period of six weeks for the issuance of certificates for those Member States that need additional time.

In parallel, the Commission will continue to support the Member States in finalising their national solutions for the issuance and verification of EU Digital COVID Certificate, and to provide technical and financial support to Member States to on-board the gateway.

Background

On 17 March 2021, the European Commission presented a proposal to create an EU COVID certificate to facilitate the safe free movement of citizens within the EU during the COVID-19 pandemic. At the Commission’s request, the Parliament voted in favour of the activation of the urgent procedure for the two proposals on 25 March. The Council adopted its negotiating position on 14 April, and the Parliament did so on 29 April. On 20 May co-legislators reached provisional agreement on this file.

In parallel to the legislative process, important progress was already made on the technical side. The EU Gateway, which allows to verify certificates across borders, is ready and will go live as of June. Successful pilot tests took place with 17 Member States and Iceland during the last two weeks, further five Member States will test next week.

The Commission also provide open source reference software to support Member States to develop their national solution to issue certificates, to scan and check the QR codes, and a reference wallet for storage.

Previously, on 21 April, technical specification guidelines were adopted by Member States representatives in the eHealth Network, a voluntary network connecting national authorities responsible for eHealth. They are building on the close work of the Commission with the Member States, having resulted in first guidelines adopted in January and updated on 12 March, and a trust framework outline agreed on 12 March 2021. In addition, a common design template was developed in the eHealth network.

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