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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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Commission sets out key actions for a united front to beat COVID-19

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Two days ahead of the meeting of European leaders on a coordinated response to the COVID-19 crisis, the Commission set out a number of actions needed to step up the fight against the pandemic. In a Communication adopted today, it calls on Member States to accelerate the roll-out of vaccination across the EU: by March 2021, at least 80% of people over the age of 80, and 80% of health and social care professionals in every Member State should be vaccinated. And by summer 2021, Member States should have vaccinated a minimum of 70% of the adult population.

The Commission also calls on Member States to continue to apply physical distancing, limit social contacts, fight disinformation, coordinate travel restrictions, ramp up testing, and increase contact tracing and genome sequencing to face up to the risk from new variants of the virus. As recent weeks have seen an upward trend in case numbers, more needs to be done to support healthcare systems and to address “COVID-fatigue” in the coming months, from accelerating vaccination across the board, helping our partners in the Western Balkans, the Southern and Eastern neighbourhood and in Africa.

Today’s Communication sets out key actions for Member States, the Commission, the European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) which will help reduce risks and keep the virus under control:

Speeding up the roll-out of vaccination across the EU

By March 2021, at least 80% of people over the age of 80, and 80% of health and social care professionals in every Member State, should be vaccinated.

By summer 2021, Member States should have vaccinated 70% of the entire adult population.

The Commission, Member States and the EMA will work with companies to use the EU’s potential for increased vaccine manufacturing capacity to the fullest.

The Commission is working with Member States on vaccination certificates, in full compliance with EU data protection law, which can support the continuity of care. A common approach is to be agreed by the end of January 2021 to allow Member States’ certificates to be rapidly useable in health systems across the EU and beyond.

Testing and genome sequencing

Member States should update their testing strategies to account for new variants and expand the use of rapid antigen tests.

Member States should urgently increase genome sequencing to at least 5% and preferably 10% of positive test results. At present, many Member States are testing under 1% of samples, which is not enough to identify the progression of the variants or detect any new ones.

Preserving the Single Market and free movement while stepping up mitigation measures

Measures should be applied to further reduce the risk of transmission linked to the means of travel, such as hygiene and distancing measures in vehicles and terminuses.

All non-essential travel should be strongly discouraged until the epidemiological situation has considerably improved.

Proportionate travel restrictions, including testing of travellers, should be maintained for those travelling from areas with a higher incidence of variants of concern.

Ensuring European leadership and international solidarity

To ensure early access to vaccines, the Commission is to set up a Team Europe mechanism to structure the provision of vaccines shared by Member States with partner countries. This should allow for sharing with partner countries access to some of the 2.3 billion doses secured through the EU’s Vaccines Strategy, paying special attention to the Western Balkans, our Eastern and Southern neighbourhood and Africa.

The European Commission and Member States should continue supporting COVAX, including through early access to vaccines. Team Europe has already mobilised €853 million in support of COVAX, making the EU one of COVAX’s biggest donors.

Members of the College said:

President of the European Commission, Ursula von der Leyen, said: “Vaccination is essential to get out of this crisis. We have already secured enough vaccines for the entire population of the European Union. Now we need to accelerate the delivery and speed up vaccination. Our aim is to have 70% of our adult population vaccinated by summer. That could be a turning point in our fight against this virus. However, we will only end this pandemic when everyone in the world has access to vaccines. We will step up our efforts to help secure vaccines for our neighbours and partners worldwide.”

Vice-President Margaritis Schinas, responsible for Promoting our European Way of Life, said: “The emergence of new variants of the virus and substantial rises in cases leave us no room for complacency. Now more than ever must come a renewed determination for Europe to act together with unity, coordination and vigilance. Our proposals today aim to protect more lives and livelihoods later and relieve the burden on already stretched health care systems and workers. This is how the EU will come out of the crisis. The end of the pandemic is in sight though not yet in reach.”

Stella Kyriakides, Commissioner for Health and Food Safety, said: “Working together with unity, solidary and determination, we can soon start to see the beginning of the end of the pandemic. Now in particular, we need swift and coordinated action against the new variants of the virus. Vaccinations will still take time until they reach all Europeans and until then we must take immediate, coordinated and proactive steps together. Vaccinations must accelerate across the EU and testing and sequencing must be increased – this is show we can ensure that we leave this crisis behind us as soon as possible.”

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Coronavirus response: EU support for regions to work together in innovative pilot projects

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The Commission has announced the winners of a new EU-funded initiative for interregional partnerships in four areas: coronavirus-related innovative solutions, circular economy in health, sustainable and digital tourism, and hydrogen technologies in carbon–intensive regions. The aim of this new pilot action, which builds on the successful experience of a similar action on “interregional innovation projects” launched at the end of 2017, is to mobilise regional and national innovation actors to address the impact of coronavirus. This initiative also helps the recovery using the new Commission programmes through scaling up projects in new priority areas, such as health, tourism or hydrogen.

Commissioner for Cohesion and Reforms, Elisa Ferreira, said: “Interregional partnerships are proof that when we cooperate beyond borders, we are stronger as we come up with smart and useful solutions for all. This new pilot initiative supporting interregional innovative partnerships is especially important in the current coronavirus context, showing how much cohesion policy is committed to contribute to Europe’s prompt response and recovery.” 

Following a Commission’s call for expression of interest launched in July 2020, four interregional partnerships were selected, with one or several coordinating regions in the lead:

  • País Vasco (ES), together with three regions, will focus on the support to an emerging industry sector for prediction and prevention of the coronavirus pandemic;
  • In the field of Circular Economy in Health, the RegioTex partnership on textile innovation involves 16 regions led by North Portugal (PT);
  • In the field of Sustainable and Digital Tourism, the partnership coordinated by the Time Machine Organisation, an international cooperation network in technology, science and cultural heritage, involves five regions and Cyprus, led by Thüringen (DE); 
  • In order to enable the development of innovative solutions based on Hydrogen technologies in carbon–intensive regions with a broad geographical coverage, two partnerships will merge: the European Hydrogen Valleys partnership gathering 12 regions led by Aragon (ES), Auvergne Rhône Alpes (FR), Normandie (FR) and Northern Netherlands (NL), and the partnership led by Košice Region (SK) with four other regions.

These partnerships will benefit from the Commission experts’ support, providing, among others, advice on how to best combine EU funds to finance projects. In addition to this hands-on support from the Commission, each partnership can benefit from external advisory service of up to €100,000 for scale-up and commercialisation activities. The money comes from the European Regional Development Fund (ERDF).

Next steps

The work with the partnerships will start in this month and will run for one year.This pilot further stimulates interregional cooperation, with the possibility for the partnerships to apply for support under the new programmes and the “Interregional Innovation Investment” instrument from 2021 onwards.

Background

In recent years, the Commission has called on national and regional authorities to develop smart specialisation strategies aiming at more effective innovation policies and enhanced interregional cooperation in value chains across borders. To date, more than 180 regional smart specialisation strategies have been adopted. Their implementation is supported by €40 billion of EU Cohesion policy funds.

As part of a set of actions presented in 2017 by the Commission to take smart specialisation a step further, a pilot action on “Interregional innovation projects” sought to test new ways to encourage regions and cities to develop new value chains and scale up their good ideas in the EU single market. This pilot action, which involved nine partnerships in high-tech priority sectors, was completed in 2019 and showed significant potential to accelerate the investment readiness of interregional investment projects.

The lessons learned will be integrated in the new “Interregional Innovation Investment” instrument proposed in the framework of the post 2020 Cohesion Policy package.

The new pilot action has similar goals. Moreover, in the context of the crisis, it aims at finding solutions to the coronavirus challenges and accelerating the recovery through the commercialisation and scale-up of innovation investment. 

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Commission proposes to purchase up to 300 million additional doses of BioNTech-Pfizer vaccine

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image: BioNTech

The European Commission today proposed to the EU Member States to purchase an additional 200 million doses of the COVID-19 vaccine produced by BioNTech and Pfizer, with the option to acquire another 100 million doses.  

This would enable the EU to purchase up to 600 million doses of this vaccine, which is already being used across the EU.

The additional doses will be delivered starting in the second quarter of 2021. 

The EU has acquired a broad portfolio of vaccines with different technologies. It has secured up to 2.3 billion doses from the most promising vaccine candidates for Europe and its neighbourhood.  

In addition to the BioNTech-Pfizer vaccine, a second vaccine, produced by Moderna, was authorised on 6 January 2021. Other vaccines are expected to be approved soon.  

This vaccine portfolio would enable the EU not only to cover the needs of its whole population, but also to supply vaccines to neighbouring countries.

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