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Coronavirus and the EU Vaccines Strategy

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On 17 June, the European Commission presented a European strategy to accelerate the development, manufacturing and deployment of vaccines against COVID-19. The EU Vaccines Strategy intends to ensure the production in Europe of qualitative, safe and efficacious vaccines, and to secure swift access to them for Member States and their populations. Moreover, the Strategy  reflects the global solidarity effort and ensures equitable access to an affordable vaccine as early as possible.

Joint action  at  EU  level  is  the  surest,  quickest  and  most  efficient  way  of achieving  these objectives. No Member State on its own has the capacity to secure the investment in developing and producing a sufficient number of vaccines. It is only through swift and unified action by the EU and its Member States that sufficient and speedy supplies of a safe and effective vaccine can be ensured. A common strategy allows better hedging of bets, sharing of risks and pooling investments to achieve economies of scale, scope and speed.

The Commission has signed two first contracts to allow the purchase of a vaccine, once proven safe and efficient, with AstraZeneca and Sanofi-GSK. Successful exploratory talks were concluded with Johnson & Johnson on 13 August, CureVac on 18 August, Moderna on 24 August and BioNTech on 9 September.*

NEGOTIATION PROCESS

Are all Member States represented in the Steering Committee and in the Negotiation Team?

All Member States have endorsed the approach set out by the Vaccines Strategy and signed up to an agreement for its implementation. As a result, all Member States are represented at the Steering Committee which discusses and reviews all  aspects of  the  Advanced Purchase Agreement (APA) contracts before signature. The Committee appoints the members of the Joint Negotiation Team, which negotiates the APAs with the vaccines developers and reports to the Committee.  All participants in these instances have been appointed by their Governments and have signed declarations of absence of conflict of interest and confidentiality.

What is the difference between concluding an Advanced Purchase Agreement (APA) and signing a contract with a pharmaceutical company?

Before an Advanced Purchase Agreement (APA) is negotiated, the Negotiation Team holds exploratory talks with the company to find out whether proceeding into detailed contractual negotiations is reasonable. If this is the case and a common understanding is reached on a terms sheet, a tender invitation is sent to the company, which then has to propose an offer.

An APA is concluded when both sides have finalised the contractual work. This is discussed and agreed with the Steering Committee. The conclusion of an APA requires the approval of the Commission.

If the APA provides for an obligation for the Member States to purchase vaccine doses (even if there might also be additional optional doses in the APA), Member States have 5 working days to notify if they wish to opt-out. The contract is only signed if at least four Member States are ready to be bound by it.

If the APA provides only for an option for Member States to purchase vaccine doses at a later date, the Commission can approve and sign the APA directly with the company concerned. Member States can decide later whether to exercise the option. It are the Member States that are responsible for purchasing the vaccines when they become available.

Will the Commission publish the contracts signed with pharmaceutical companies?

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.

Finally, the Commission is accountable towards the other European institutions and the European citizen. The Commission is acting in full compliance with all applicable rules regarding financial management, which can be subject to audit at a later stage.

LIABILITY & INDEMNIFICATION

Has the Commission made concessions on liability to the industry, in particular on indemnification for certain liabilities?

The Commission ensures that any agreement made to secure vaccines through the Vaccines Strategy will be fully compliant with EU law. The contracts the Commission is negotiating fully respect and protect citizens’ rights, in line with the Product Liability Directive. 

In line with EU product liability rules, liability remains with the company. However, in order to compensate for potential risks taken by manufacturers due to the unusually shorter timespan for vaccines development, the APAs provide for Member States to indemnify the manufacturer for possible liabilities incurred only under specific conditions set out in the APAs.

The Commission has made clear throughout the implementation of the Vaccines strategy that it is not prepared to make compromises on the application of the existing rules that apply to bringing a pharmaceutical product into the market. These principles are equally valid for any indemnification clause the Commission negotiates.

Thus, the provisions on liability and indemnification do not alter in any way the regulatory burden of proof borne by the companies to demonstrate the safety and efficacy of their products. Any vaccine put on the market will have to meet the necessary safety requirements and undergo the independent scientific assessment by the European Medicines Agency as part of the EU market authorisation procedure.

The EU and Member States will continue taking all necessary measures to protect citizens, ensuring that:

  • a strict, independent scientific assessment (looking at quality, safety and efficacy) must be carried out before a vaccine is approved;
  • citizens’ rights remain fully protected;
  • Member States are ready to financially cover certain of the companies risks to ensure that vaccines are actually available for EU citizens to protect public health.

AUTHORISATION PROCESS

How can a COVID-19 vaccine be developed and authorised within a 12-18 months timeframe when the normal process takes around 10 years? What are the roles of the European Medicines Agency (EMA) and the European Commission in this context and how can the process of marketing authorisation be speeded up in emergency situations?

We are currently in the middle of the most severe public health crisis in modern times. Finding a safe and effective vaccine will be a key element of the exit strategy from the pandemic. Europe and the world need to act swiftly and teams around the world are working with the ambition of delivering a successful vaccine within a timeframe  of  12 -18  months. Delivering a successful vaccine within a compressed timeframe does however not mean compromising on safety, on the contrary, the safety and effectiveness of vaccines is non-negotiable and a fundamental requirement for any vaccine to reach the EU and other markets.

It is indeed true that vaccine development can take time and this is why we created our Vaccines Strategy to come together and work on all fronts, around the clock, with all Member States, global partners, researchers and scientists to develop a safe and efficacious vaccine in a short time frame. The often-quoted 10 year timeframe refers to the time from concept to authorisation, including gathering the necessary evidence through clinical trials. Reducing this timeline to 12-18 months means both accelerating development and manufacturing timelines as well as the marketing authorisation.

The regulatory processes will be flexible but will remain as rigorous as always. Together with the Member States and the European Medicines Agency, the Commission will use existing flexibilities in the EU’s regulatory framework to accelerate the authorisation and availability of successful vaccines against COVID-19, while maintaining the standards for vaccine quality, safety and efficacy.

Market authorisation process

The vaccine producers will decide if and when to submit an application for a marketing authorisation for a vaccine. The role of the EMA in this context is to carry out an independent scientific assessment of the application and submit its scientific opinion to the European Commission which is responsible for issuing a marketing authorisation that is valid for the entire EU. The marketing authorisation will only be granted if the benefit-risk balance is positive following an assessment of the quality, safety and efficacy of the product.

Variations to usual development plans are possible in the emergency context and developers can reduce timelines, for example, by conducting some studies in parallel, instead of carrying them out sequentially, and by using a variety of trial designs and endpoints to determine efficacy. Developers are advised to discuss development plans with regulators to clarify requirements for marketing approval.

Clinical trials for COVID-19 vaccines are being carried out more quickly than usual because the effort being put into their organisation and conduct has been significantly increased by the sponsors, researchers and regulators. The widespread nature of the pandemic means that large numbers of trial participants can be recruited in a relatively short time, without compromising the quality of the trials themselves.

The EU regulatory system is dedicating significant resources to supporting the rapid development and authorisation of safe, effective and high-quality COVID-19 vaccines. EMA’s pandemic Task Force (COVID-ETF), which brings together in one group the best scientific experts from the EU regulatory network, will work closely with EMA’s human medicines committee (CHMP) for optimal and fast coordination of activities related to the development, authorisation and safety monitoring of vaccines against COVID-19.

Can a vaccine be approved before completion of phase 3 of clinical trials?

A core objective of the Commission and the European Medicines Agency, through the EU Vaccines Strategy, is to ensure the quality, safety and efficacy of vaccines. As such, any vaccine can only be granted a marketing authorisation in the EU after a thorough evaluation. To recommend the authorisation of a vaccine, EMA needs to have sufficient information on its safety, efficacy and pharmaceutical quality. Marketing authorisation is only granted when the evidence shows that the benefits of the vaccine outweigh any risks.

In principle, large-scale Phase 3 efficacy trials involving thousands of participants are required to support the marketing authorisation of a COVID-19 vaccine. These trials should be designed to measure the vaccine’s efficacy in protecting against COVID-19 (efficacy endpoints) and its safety. This is because there are no known indicators (such as the levels of antibodies in the blood) that can predict protection and could be used instead of efficacy endpoints. In addition, we are currently in a situation where the virus is circulating, which makes it feasible to establish the efficacy of a vaccine in large-scale clinical trials.

The protocols of such clinical trials, including any plans for interim analyses, are subject to regulatory approval.

What does the scientific assessment by the European Medicines Agency consist of? What is the process of approval?

To obtain a marketing approval for a vaccine in the EU, a vaccine developer needs to submit the results of all testing/investigations to the medicines regulatory authorities in Europe as part of a ‘marketing authorisation’ application.

Applications for marketing authorisation submitted to EMA undergo a comprehensive, independent scientific assessment carried out by EMA’s expert scientific committees on human medicines and on safety (the “CHMP” and “PRAC”), made up of experts working in national medicines’ regulatory agencies. As for all medicines, EU legislation requires that the initial evaluations are carried out separately by two different assessment teams (led by a so-called Rapporteur and Co-Rapporteur) and reviewed by the Committee as a whole.

For COVID-19, EMA has put in place rapid review procedures to deliver assessments of applications quickly while ensuring robust scientific opinions. Key to this shortening of timescales are ‘rolling reviews’. In a public health emergency, EMA assesses data for promising medicines or vaccines as they become available. Through these rolling reviews, EMA can therefore start evaluating data while the development is still ongoing. When the medicine’s development is progressed enough for a marketing authorisation application, the formal assessment procedure can take place in a shorter than usual timeframe, because the data have already been scrutinised during the rolling review.

The CHMP, once it has concluded its scientific evaluation of the data and after assessing the quality, safety and efficacy of the medicinal product in question, makes a recommendation on whether the medicine should be given a marketing authorisation in the EU.

However, if comprehensive data would not be available at the time of the marketing authorisation application, the EU regulatory system is designed to potentially accommodate this situation by providing for a conditional authorisation system. This means that the initial (“conditional”) authorisation granted by the Commission is based on less comprehensive data than would normally be the case (nonetheless with a positive benefit-risk balance), and with obligations on the marketing authorisation holders for the data to be completed afterwards and to be submitted for assessment. Conditional marketing authorisations are closely monitored and are subject to annual review.

The European Commission takes a decision on whether or not to issue the marketing authorisation on the basis of the recommendation from the EMA. The decision-making timeframe will also be reduced by shortening the period for consulting Member States, and allowing translation of the documents into the full set of languages after the authorisation, rather than before.

What safety requirements need to be met?

In order to authorise any medicinal product, EMA needs to have and assess robust information on its safety, efficacy and pharmaceutical quality, with safety being of the utmost importance. The safety requirements for COVID-19 vaccines remain as high as for any other vaccine in the EU, the context of a pandemic will not change this. 

Before a vaccine is approved for use, the main body of evidence for its safety and efficacy comes from the results of clinical trials, where participants are selected carefully and followed up under controlled conditions.

In addition, after authorisation, EU law requires that the safety of the vaccine – as is the requirement all medicinal products – will be monitored while in use. In addition to safety, the vaccine’s effectiveness should also be monitored. As part of such monitoring, studies are carried out after marketing. Some of these studies may be imposed on companies as part of the conditions for maintaining their marketing authorisation; other studies will be conducted by public authorities responsible for vaccination programmes.

The EU has a comprehensive safety monitoring (pharmacovigilance) system that allows measures to be put in place to minimise risk, to ensure reporting of suspected side effects, to detect any potential adverse effects, and introduce any necessary mitigating actions early.

Specifically for COVID-19 vaccines, EMA in close collaboration with the Commission, Member States, European and international partners, is establishing  enhanced safety monitoring activities. These activities are aimed at making sure that any new information collected post-marketing will be identified and evaluated as quickly as possible, and appropriate regulatory actions are taken in a timely manner to protect patients and safeguard public health. These activities include the collection of exposure data, enhanced safety signal detection and management, enhanced transparency and setting a European infrastructure for vaccines monitoring, including multicentre observational studies on COVID-19 patients. Prompt and clear communication of the outcomes of these evaluations will be ensured.

ONCE A VACCINE IS AVAILABLE

What actually happens when the vaccine is available?

A vaccine will only become available after meeting the established safety requirements, having first undergone the robust scientific assessment by the European Medicines Agency and completed the EU market authorisation procedure.

The Member States will then be able to benefit from those doses by purchasing them, according to the APA concluded.

Where will the doses be stored?

Each Member State will decide on the best way to store the vaccines. The technical storage conditions are defined by each manufacturer based on specific requirements of each type of vaccine so as to ensure they quality.

Who will receive  the first doses?

All Member States will have equal access to the available doses. The Member States will then decide whom they will offer the vaccines to among their population.

COVID-19 VACCINE GLOBAL ACCESS FACILITY (COVAX)

What is the Commissions involvement with COVAX?

The COVAX Facility, co-led by Gavi, the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI) and WHO, aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access for every country in the world.

Supporting equal and global access to a safe and efficient vaccine for everyone in the world is a priority for the Commission. No region of the world is safe until we are all safe. That is why, on 31 August, the Commission’s expressed its interest to participate in COVAX. The 31 August announcement included a support of €400 million in guarantees for the COVAX Facility. The vaccines purchased in this context are for Low and Medium Income Countries.

The Commission and Member States joining the COVAX Facility reaffirm that they are supporting COVAX’s objectives and interest as a group, in order to make the EU Vaccines Strategy and the COVAX Facility complementary and thus mutually reinforcing.

The Commission and Member States are currently pursuing a joint approach for their participation in COVAX, and the 31 August expression of interest is part of this process. Talks are ongoing with Gavi and CEPI to reach an agreement in September on terms and conditions for the EU’s participation in the COVAX Facility. .

Will the Commission procure vaccines through the COVAX facility?

The Commission is only purchasing vaccines on behalf of EU Member States via the mechanism set up in the EU Vaccines Strategy and finances it through the Emergency Support Instrument (ESI). The Commission’s participation in COVAX supports a global effort to produce and distribute vaccines to all in need, in particular for low and middle income countries. The detailed terms and conditions for the EU’s and Member States’ participation and contribution is under discussion and will be worked out in the coming days and weeks.

Can Member States buy vaccines through COVAX?  

Member States have committed, as part of the EU Vaccines Strategy, not to enter into parallel negotiations with the same vaccine manufacturers with which talks are on-going at EU level.  This does not exclude the possibility to take part in negotiations with other vaccine companies through COVAX.

What will the guarantees be used for and why not give cash?          

The Commission is providing financial guarantees backing COVAX negotiations on advanced purchase agreements of vaccines. These guarantees will enable COVAX to lower the risk and conclude advanced purchase agreements with a larger portfolio of vaccine producers.

Contracts under negotiation by COVAX require a strong financial backing which the EU guarantees will provide.

How does the Commission ensure complementarity between the EU Vaccines Strategy and COVAX?

The EU Vaccines Strategy goes hand in hand with the EU’s commitment to global solidarity. This applies at different levels: support to companies in their capacity expansion, advancing research and support development for the benefit of the world population. Investing upfront in the accelerated development and manufacturing of vaccines to the benefit of the rest of the world. By providing financial resources to the international institutions, such as WHO, CEPI, GAVI, the EU is also supporting access to vaccines for the whole world.

Manufacturers with whom the EU negotiates are also committed to supply future doses to other countries in the world, there is no exclusivity for delivery to Europe only and no export restriction.

What Europe is doing is making important and risky investments so that together with the regulatory authorisation procedures that we have in place, we accelerate the development of safe and efficacious vaccines, which will also be to the benefit of the rest of the world.

What we do in Europe is complementary and mutually reinforcing with our action for global solidarity. That is also why the Commission and the EU Member States have decided to join the COVAX facility.

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EU interoperability gateway for contact tracing and warning apps

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What is a coronavirus tracing and warning app?

Most public health authorities in the EU have developed apps that support contact tracing and warning in the fight against coronavirus. The apps notify you if you have been at risk of exposure to the virus over the last 14 days, whether or not you feel symptoms. You will then get appropriate health advice. This helps to minimise the spread of the virus and speed up a return to normal life within the EU. Furthermore, you can get tested and receive any necessary treatment promptly and lower the risk of serious consequences, if you get alerted at an early stage.

Tracing and warning apps are part of a package of measures to prevent the spread of the virus, along with hygiene measures such as hand washing, social distancing and using everyday facemasks.

Why using a coronavirus tracing and warning app?

A tracing and warning app can help break the chain of coronavirus infections, nationally and across borders, and help save lives by complementing manual tracing. The faster people who have been diagnosed with COVID-19 and their contacts can be informed, the less quickly and widely the virus can spread. The app therefore help to protect yourself, your family, your friends and everyone around you.

If you use an official app available in your country, developed with the health authorities, you can trust them and use them without concerns. More information also on re-open EU.

How does a coronavirus tracing and warning app work?

A coronavirus tracing and waring app informs you if you have been, for a certain period, close, to another app user who was confirmed infected with COVID-19. Such an encounter would be considered a high-risk exposure. Typically, this means a contact for more than 15 minutes and less than 2 meters. The exact parameters are set by national health authorities.

When you have installed the app, your smartphone generates random ‘keys’ multiple times a day. These keys are exchanged through Bluetooth between nearby smartphones running a tracing app, and stored on the device for 14 days.

In case you are tested positive for COVID-19, you can share this information to warn the people you have previously been close to. Your phone will then share the keys generated during the last 14 days with the backend server of your national app.

On the basis of the keys received, each app calculates the risk score of a user, who may receive an exposure alert if the criteria are met.

What data will I share when using these apps?

The apps generate arbitrary identifiers, which are random sets of numbers and letters. These arbitrary identifiers do not allow the identification of an individual person. The keys are exchanged via Bluetooth between phones at short distance. No geolocation or movement data are used.

Do tracing apps use a lot of data or battery?

Once you have downloaded the app, its data usage is minimal. You should also not notice a significant difference in terms of battery life, nor should your smartphone overheat. The contact and warning app runs in the background. It uses Bluetooth Low Energy, a technology designed to be particularly energy efficient.

Can I use the app without internet connection?

For the tracing functionality as such, a permanent Internet connection is not necessary. Bluetooth, which is used to detect proximity with other app users, does not require Internet. It would even work in flight mode if you switch on Bluetooth during the flight. However, the app does need to connect to the internet at least once a day to download the information necessary to check if you have been exposed to other, infected users. Hence, to check infection chains, to receive alerts, and for additional functionalities, the apps will need to connect through mobile Internet or Wi-Fi.

Is the exposure notification automatic?

The apps work in the background of the device without requiring any daily action. Notifications come in automatically. You do not have to activate updates manually, however you need to have the exposure notification function switched on.

May I use several national coronavirus tracing and warning apps at the same time?

No. Using two or more apps at the same time is not possible as the Google/Apple exposure notification interface always supports only one tracing app at a time. Thanks to the EU interoperability gateway service, citizens can use one single app even when they travel cross-borders, while continuing to benefit from contact tracing and being able to report a positive test or to receive an alert.

  1. In case of a notification

What should I do if I receive an alert?

Receiving a contact alert does not necessarily mean you have been infected with COVID-19. An alert is a simple way of making you aware that there is a risk of exposure to coronavirus. The app will guide you on what you should do, according to the instructions of national health authorities, such as advice to get tested or to self-isolate, and who you have to contact.

Which criteria are used to assess exposure risk levels?

Potential exposures happen when you encounter, for a certain amount of time and at a certain distance, a person who has reported being infected with the virus. Bluetooth technology is used to determine whether or not an encounter is close and long enough to result in a potential exposure. There are typically three levels of risk:

Low risk: The app user had no encounter with anyone known to have been diagnosed with COVID-19, or if they have had such an encounter it was not close and/or long enough according to the criteria. The user is informed about generally applicable social distancing regulations and hygiene recommendations.

Increased risk: The user is informed that the check of their exposure logging has shown an increased risk of infection, as they have encountered at least one person in the last 14 days who has been diagnosed with COVID-19. The person is recommended to stay at home if possible, and to seek advice from their general practitioner or local health authorities.

Unknown risk: If the risk identification has not been activated for long enough by the person, then no risk of infection can be calculated yet. Risk identification is possible within 24 hours of installation, at which point the status information displayed changes from “unknown risk” to “low risk” or “increased risk”.

Can the app warn me how to avoid contact with people who tested positive?

No, the app cannot predict such contacts or detect risky contact in real time. To protect user privacy, no app user can be identified or located using the app, and no app can detect whether there is an infected person in, for example a supermarket. The app is no substitute for the usual necessary precautions, like wearing a mask.

  1. EU interoperability gateway: contact tracing across borders

How do coronavirus tracing and warning apps work across borders?

Coronavirus does not stop at borders. This is why Member States, supported by the Commission, were working on an interoperability solution for national contact tracing and warning apps, to allow citizens to use one single app when they travel abroad in Europe, while continuing to benefit from contact tracing and being able to receive an alert.

At the request of Member States, the Commission has set up an interoperability gateway service, an interface to efficiently receive and pass on relevant information from national contact tracing apps. It will ensure the secure and efficient cross-border exchange between participating apps while keeping mobile data usage to a minimum.

How does the exchange of data between the apps work?

The individual coronavirus tracing and warning apps only connect to their own national backend server. The national backend servers do not connect directly with each other. They exchange the information via the EU interoperability gateway service, which reduces data consumption compared with direct exchanges between participating apps.

The exchange consists of two main parts: Uploading of national keys to the gateway server takes places if users upload their keys and have agreed with sharing them with other European app users; downloading of keys to the national backend server is required so that the keys can be distributed to the users of the individual national app.

What is the EU interoperability gateway service?

The interoperability gateway service (gateway) is a digital infrastructure that ensures the secure transmission of generated keys between the backend servers of participating national contact tracing and warning apps. While doing so, the gateway will share the minimum information necessary for a person to be alerted if they have been exposed to an infected person also using one of the participating apps.

The data exchanged will only be stored in the gateway for a maximum period of 14 days. No other information except the keys, generated by the national apps, will be handled by the gateway.

The design of the gateway builds on the guidelines for interoperability, the set of technical specifications agreed between Member States and the Commission, the principles set out in the EU toolbox and the Commission and European Data Protection Board guidelines on data protection for contact tracing and warning apps.

The gateway was developed and set up by companies T-Systems and SAP, and is operated from the Commission’s data centre in Luxembourg.

Are all contact tracing apps interoperable?

The gateway ensures a safe exchange of information between contact tracing apps based on a ‘decentralised’ architecture. This concerns the vast majority of tracing apps that were, or are to be, launched in the EU. Apps that are interoperable can exchange information among themselves, so people in the EU only need install one app – typically the app of their home country – and still be able to report a positive test or to receive an alert, even if they travel in the EU.

What is the difference between ‘centralised’ and ‘decentralised’ apps?

Confronted with the new potential of smartphones to combat the coronavirus pandemic, developers discussed mainly two different ways of how to set up contact tracing and waring apps, typically referred to as ‘decentralised’ and ‘centralised’ architectures. In both approaches, smartphones exchange temporary keys via Bluetooth and communicate with a central server. The main difference is in the calculation of the exposure risk of users and the storage of the data. Regardless of the approach, none of the tracing apps track location or movements

In a centralised system, a central server receives the keys of the contacts collected by users confirmed with COVID-19, and the server does the matchmaking to alert users at risk.

In a decentralised approach, the keys of the contacts remain on the phone. The app downloads the arbitrary keys of COVID-19 infected users and checks whether there is a match, directly on the device. The decentralised approach uses a joint interface provided by Apple and Google (see below). In the end, almost all national health authorities in the EU opted for a decentralised app, and these apps are all potentially interoperable.

Which national apps are, or will be, linked to the gateway?

About two third of EU Member States have developed compatible tracing and warning apps, and the gateway is open to all of them, once they are ready to connect. The connection will gradually take place during October and November, however apps can also connect at a later stage if national authorities wish so. An ‘onboarding protocol’ has been developed, setting out the necessary steps.

While your app is able to detect proximity with other participating apps everywhere in the world, including during flights in a plane, it does of course matter if people around you also have access to and use a participating app.

The overview of participating countries is updated regularly and available here.

What about if I did a test in another EU country?

You can only insert a positive coronavirus test result in the app of the country where the test was taken. However, when you enter the code in that app, thanks to the interoperability, citizens from the country that you have visited will get notified that they have been in close contact of an infected case.

I never travel anywhere. Do I need to take part in interoperability?

Downloading and using an app is voluntary, and participating in the interoperability framework is as well. To do so, you need to agree to your data being processed. However, even if you do not intend to travel, other people may do so, and you may be close to them without knowing. Therefore, interoperability also benefits those who stay in their home country.

Do I need to download a new app to benefit from interoperability?

No. You can continue to use your national app. Most EU Member States have decided to set up a national coronavirus tracing and warning app, and almost all of those have opted for a decentralised system – all these apps are potentially interoperable and can connect to the gateway, once they are ready. Once an app gets connected to the gateway, an update needs to be issued in the app stores so the additional functionality can be used. Users need to install that update so that their app works cross-border.

How do I update the app?

If your phone is set to update automatically, your tracing app will update automatically within a few days of the update being released. If you want to update manually:

  • For iPhone users, open the App Store and tap ‘Today’ at the bottom of the screen. Then tap your profile icon to bring up your Account. Scroll down until you see your national app and then tap ‘Update’.
  • For Android users, open the ‘Play Store’ and tap on the three horizonal lines at the top-left of the screen to open the sidebar. Open ‘My apps & games’ and select the ‘Updates’ tab. Then scroll down to your national app and tap ‘Update’.
  1. Privacy and security

Can tracing apps be used by authorities to monitor quarantine?

No, this is technically impossible. Contact tracing and warning apps do not gather any location or movement data.

 How is my privacy protected?

Throughout the entire process of design and development of contact and warning tracing apps, respect for privacy has been of paramount importance:

  • The app does not collect any data that could lead to unveiling your identity. It does not ask for and cannot obtain your name, date of birth, address, telephone number, or email address.
  • The app does not collect any geolocation data, including GPS data. It also does not track any movements.
  • The Bluetooth Low Energy code is generated completely randomly and does not contain any information about you or your device. This code changes several times each hour, as a further protection.
  • All data stored by the app on your smartphone, and all connections between the app and the server, and between the servers and the gateway, are encrypted.
  • All data, whether stored on your device or on the server, is deleted when no longer relevant, i.e. 14 days after transfer between app and server.
  • The data is stored on secure backend servers, managed by national authorities. The gateway uses a secure server, hosted by the Commission in its own data centre in Luxembourg.
  • EU rules, notably the General Data Protection Regulation (GDPR) and the ePrivacy Directive, provide the strongest safeguards of trustworthiness (e.g. voluntary approach, data minimisation).
  • The apps – as well as the gateway – are time-limited, that means they will only be in place as long as the pandemic persists.
  • The European Data Protection Board was consulted on the draft guidance and issued a letter to welcome the Commission’s initiative to develop a pan-European and coordinated approach.

 Will personal data be shared between Member States through the gateway?

The Commission developed with Member States a privacy preserving interoperability protocol. If an app from one Member State is to work in another Member State, some encrypted data will be shared with the server of that other Member State. All backend servers are under the control of the competent national authority. Each app must be fully compliant with the EU data protection and privacy rules, following the Commission’s guidance.

  1. App usage information

 How will we know that tracing apps are working?

Member States are monitoring and evaluating the apps and their contribution to the fight against the pandemic. The Commission, with the European Centre for Disease Prevention and Control, is assisting Member States to identify a series of assessment criteria to evaluate the effectiveness of the apps. Some of those criteria could include, for example, the uptake of the app as a percentage of population and number of users notified of potential exposure.

Currently, download rates range from below 10% to above 40%, depending on the Member State. But even at low uptake, apps can make a difference, according to researchers – and each notification is a life potentially saved.

What are the minimum device requirements?

All coronavirus tracing and warning apps should be accessible to everybody. They can be used on the vast majority of devices with commonly used operating systems. The required update to the relevant operating system (iOS, Android) is usually carried out automatically on smartphones. The apps run on iOS smartphones from the iPhone 6s upwards using iOS 13.5, and on Android-based smartphones from Android 6 upwards. If the result of your COVID-19 test is verified via QR code, the camera on your phone must be functional.

What role do Apple and Google play?

Almost all, that is 99% of smartphones in the EU, run on iOS or Android mobile operating systems. In the context of the development of contact tracing and warning apps, Apple and Google provided a uniform standard for Bluetooth distance measurement. This was important so apps running on the two main operating systems would be able to register each other’s Bluetooth signal. Furthermore, the companies needed to ensure that the Bluetooth signal continues to operate passively in the background in battery-saving mode, even if the apps is not actively used. National apps based on a ‘decentralised’ architecture rely on this basic functionality – these are interoperable and can be linked to the gateway.

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Commission lists key steps for effective vaccination strategies and vaccines deployment

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As Europe learns to live with the pandemic, the development and swift global deployment of safe and effective vaccines against COVID-19 remains an essential element in the eventual solution to the public health crisis. In this context, the Commission is working to ensure that there will be access to safe vaccines across Europe, and encourages a coordinated approach of vaccination strategies for deployment of the vaccines. Today, ahead of the discussion of EU Leaders, the Commission is presenting the key elements to be taken into consideration by Member States for their COVID-19 vaccination strategies in order to prepare the European Union and its citizens for when a safe and effective vaccine is available, as well as priority groups to consider for vaccination first.

President of the European Commission, Ursula von der Leyen, said: “A safe and effective vaccine is our best shot at beating coronavirus and returning to our normal lives. We have been working hard to make agreements with pharmaceutical companies and secure future doses. Now, we must ensure that once a vaccine is found, we are fully prepared to deploy it. With our Vaccination Strategy, we are helping EU countries prepare their vaccination campaigns: who should be vaccinated first, how to have a fair distribution and how to protect the most vulnerable. If we want our vaccination to be successful, we need to prepare now.”  

Vice-President for Promoting the European Way of Life, Margaritis Schinas, said: “While the evolution of the pandemic is getting back to March levels, our state of preparedness is not. Today we are adopting a milestone in the ongoing EU response to the COVID-19 pandemic; the aim is to ensure safe, affordable and accessible COVID-19 vaccines for all in the EU, once they will become available. It is only by acting together that we will avoid the cacophony and be more efficient than in the past.”

Stella Kyriakides, Commissioner for Health and Food Safety, said: “It is with great concern that I am witnessing the increasingly rapid rise of infection rates all across the EU. Time is running out – everyone’s first priority should be to do what it takes to avoid the devastating consequences of generalised lockdowns. And we must all prepare for the next steps. The vaccine will not be a silver bullet, but it will play a central role to save lives and contain the pandemic. And when and if a safe and efficient vaccine is found, we need to be prepared to roll it out as quickly as possible, including building citizens’ trust in its safety and efficacy. Vaccines will not save lives – vaccinations will.”

In line with the 17 June EU Vaccines Strategy, the European Commission and Member States are securing the production of vaccines against COVID-19 through Advance Purchase Agreements with vaccine producers in Europe. Any vaccine will need to be authorised by the European Medicine Agency according to regular safety and efficacy standards. Member States should now start preparing a common vaccination strategy for vaccine deployment.

Member States should, among others, ensure:

  • capacity of vaccination services to deliver COVID-19 vaccines, including skilled workforce and medical and protective equipment;
  • easy and affordable access to vaccines for target populations;
  • deployment of vaccines with different characteristics and storage and transport needs, in particular in terms of cold chain, cooled transport and storage capacity;
  • clear communication on the benefits, risks and importance of COVID-19 vaccines to build public trust.

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

  • healthcare and long-term care facility workers;
  • persons over 60 years of age;
  • persons whose state of health makes them particularly at risk;
  • essential workers;
  • persons who cannot socially distance;
  • more disadvantaged socio-economic groups.

Whilst awaiting the arrival of approved vaccines against COVID-19, and in parallel to safeguarding the continuation of other essential healthcare and public health services and programmes, the EU must continue mitigating the transmission of the virus. This can be done through the protection of vulnerable groups and ensuring that citizens adhere to public health measures. Until then and most likely also throughout the initial vaccination rollout phases, non-pharmaceutical interventions, such as physical distancing, closure of public places and adapting the work environment, [1] will continue to serve as the main public health tools to control and manage COVID-19 outbreaks.

Background

As Europe moves to the next stage of the COVID-19 pandemic, it is even more imperative that countries follow common vaccination strategies and approaches. At the Special European Council meeting of 2 October, Member States called on the Council and Commission to further step up the overall coordination effort and the work on the development and distribution of vaccines at EU level[2]

On 24 September, the European Centre for Disease Prevention and Control (ECDC) published its updated risk assessment regarding the COVID-19 pandemic, alongside a set of guidelines for non-pharmaceutical interventions (such as hand hygiene, physical distancing, cleaning and ventilation).

As stressed by President von der Leyen in the State of the Union 2020 Address, Europe needs to continue to handle the COVID-19 pandemic with extreme care, responsibility and unity, and use the lessons learnt to strengthen the EU’s crisis preparedness and management of cross-border health threats.

On 15 July, the Commission adopted a Communication on short-term EU health preparedness, calling on Member States to have prevention, preparedness and response measures ready in case of future COVID-19 outbreaks. The Communication made a set of recommendations to achieve this, in the areas of e.g. testing, contact tracing and health system capacities. The effective implementation of these measures requires coordination and effective information exchange between Member States. The recommendations provided in the Strategy are still relevant and Member States are encouraged to follow them.

One of the main action points necessary for Europe to overcome the coronavirus pandemic is accelerating the development, manufacturing, and deployment of vaccines against COVID-19. The EU’s vaccines strategy published in June charts the way forward.

Vaccine safety, quality and efficacy are the cornerstones of any vaccine development and authorisation process, and vaccine developers are required to submit extensive documentation and data to the European Medicines Agency through the EU Marketing Authorisation procedure. After authorisation, EU law requires that the safety of the vaccine as well as its effectiveness be monitored. Further evidence will need to be centrally collected to assess the impact and effectiveness of COVID-19 vaccines once rolled out in the population from a public health perspective. This will be key to overcoming the pandemic and instilling confidence in Europeans.

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Sakharov Prize 2020: meet the finalists

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The finalists for this year's Sakharov Prize for Freedom of Thought

The democratic opposition in Belarus, Honduran environmental activists and the Archbishop of Mosul are the 2020 Sakharov Prize finalists.

Chosen at a joint meeting of the foreign affairs and development committees on 12 October, the finalists for this year’s Sakharov Prize for Freedom of Thought are:

  • The democratic opposition in Belarus, represented by the Coordination Council, initiative of brave women and political and civil society figures
  • The Guapinol environmental activists and Berta Cáceres from Honduras
  • Monsignor Najeeb Michaeel, Archbishop of Mosul.

The democratic opposition in Belarus

The democratic opposition in Belarus is represented by the Coordination Council, initiative of brave women (main opposition candidate Sviatlana Tsikhanouskaya, Nobel Laureate Svetlana Alexievich, musician and political activist Maryia Kalesnikava, and political activists Volha Kavalkova and Veranika Tsapkala), as well as political and civil society figures (video blogger and political prisoner Siarhei Tsikhanouski, Ales Bialiatski, founder of the Belarusian human rights organisation Viasna, Siarhei Dyleuski, Stsiapan Putsila, founder of the Telegram channel NEXTA, and Mikola Statkevich, political prisoner and presidential candidate in the 2010 election).

In a resolution adopted in September 2020, the European Parliament condemned the Belarusian authorities for their violent repression of peaceful protests.

The Guapinol environmental activists and Berta Cáceres from Honduras

Porfirio Sorto Cedillo, José Avelino Cedillo, Orbin Naún Hernández, Kevin Alejandro Romero, Arnold Javier Aleman, Ever Alexander Cedillo, Daniel Marquez and Jeremías Martínez Díaz are members of the Municipal Committee in Defence of Common and Public Goods of Tocoa. They are imprisoned for their participation in a peaceful protest against a mining company, whose activities had led to the contamination of the rivers Guapinol and San Pedro. While other inmates were set free, the Guapinol defenders are still detained and the prosecution has not presented any solid evidence to justify this prolonged detention.

Assassinated in March 2016, Berta Cáceres was an activist from the indigenous Lenka community in Honduras who co-founded the Council of Indigenous People of Honduras (COPINH). Over more than two decades, she fought against land grabbing, illegal logging and mega-projects.

Monsignor Najeeb Michaeel, Archbishop of Mosul

When the self-proclaimed Islamic State arrived in Mosul in August 2014, Monsignor Najeeb Michaeel, since elected Archbishop of Mosul, ensured the evacuation of Christians, Syriacs and Chaldeans to Iraqi Kurdistan and safeguarded more than 800 historic manuscripts dating from the 13th to the 19th century. These manuscripts were later digitised and exhibited in France and Italy.

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