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Suspected cholera cases in crisis-torn Yemen near 900,000

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Already struggling to cope with a dire humanitarian crisis, war-torn Yemen is now facing the fastest-growing cholera epidemic ever recorded, with some 895,000 suspected cases as of 1 November, the United Nations relief wing reported Thursday.

The UN Office for the Coordination of Humanitarian Affairs (OCHA) said that nearly have the suspected cases are children. Overall, there have been nearly 2,200 associated deaths since 27 April.

The outbreak is affecting over 90 per cent of districts across 21 of the country’s 22 governorates. Despite the enormous challenges, humanitarian partners have established 234 Diarrhoea Treatment Centres and 1,084 Oral Rehydration Corners in 225 affected districts in 20 governorates, according to OCHA.

Some 3.6 million people have been connected to disinfected water supply networks in 12 governorates. Over 17 million people in all governorates were reached with cholera prevention messages.

OCHA warned today that Yemen is also facing the world’s largest food emergency and widespread population displacement. After more than two years of war, nearly 21 million people need urgent humanitarian assistance, seven million of whom are severely food insecure, staving off the threat of famine.

Despite challenging conditions and limited funding, the UN and its humanitarian partners provided direct assistance to more than seven million people this year.

“The humanitarian response to the world’s worst hunger crisis and its worst cholera outbreak must be fully resourced”, said UN Emergency Relief Coordinator Mark Lowcock during his recent mission to Yemen. “With only two months left in the year, the UN Humanitarian Response Plan is only 56 per cent funded. I know that we can do more.”

Against that background, he called on donors to step up their support to the Response Plan to ensure the most effective and coordinated response across the country.

“Across the country, and on both sides of the frontline, Yemenis are being kept alive by brave humanitarian aid workers, working under extremely difficult conditions,” said Mr. Lowcock, who is also the UN Under-Secretary-General for the Coordination of Humanitarian Affairs, stressing that while relief workers “are able to be effective because we remain impartial, neutral and independent […] we need to do more – and we need more support.”

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Technological Revolution Accelerated by Coronavirus Crisis in Latin America

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Latin America and the Caribbean is in the midst of a “Fourth Industrial Revolution” of technological innovation which requires enhancing the productivity of the services sector, investing in human capital and rethinking labor regulations and social protection policies, according to a new World Bank report.

These policy priorities have become all the more urgent now that the COVID-19 pandemic is fueling the biggest contraction in economic activity since the great depression. Digitization has become more important to support economic activity at a time of social distancing and is accelerating this technological transformation, potentially putting jobs at risk across Latin America and the Caribbean (LAC).

According to Going Viral: COVID-19 and the Accelerated Transformation of Jobs in Latin America and the Caribbean employment transformations that were already apparent in the last few decades are bound to deepen, and the question in this context is how to recover from the crisis and build back better.

We need to rethink the future and not just try to get back to where we were before the pandemic,” said World Bank Vice President for Latin America and the Caribbean Carlos Felipe Jaramillo. “Governments need to find ways to support the creation of new jobs, train workers to be ready for these new jobs and support their citizens through this disruptive transformation.”

Premature deindustrialization and rapid technological innovation will require policies to support a smooth transformation of jobs that is socially acceptable. The region was already struggling with the end of the so-called “Golden Decade” (2003-2013) of rapid development and strong improvements in social indicators. Economic growth and poverty reduction had stalled. The pandemic has only made things worse.

While fears of mass “technological unemployment” are largely unfounded, many jobs are at risk due to lower external demand, a protracted period of quarantines and lockdowns, solvency problems for firms, and financial crises in some cases. In addition, the social unrest seen in 2019 is a warning. It is urgent to restore economic growth and create more and better jobs.

However, this “Fourth Industrial Revolution” of technological innovation means that further industrialization or re-industrialization will be limited in many developing countries. Low-paid, uneducated workers and those in high-contact activities typical of the informal sector are at highest risk of being replaced by machines. In addition, informal workers are harder to reach with essential social protection programs. The COVID-19 crisis could accelerate these changes, bringing the future much closer than anticipated.

With limited scope for employment growth in manufacturing, modernizing the services sector is a priority. This calls for  an emphasis on removing the distortions that prevent competition and innovation from occurring at a rapid pace.

Preparing workers for the changes is also fundamental. “Education offers the best insurance against the risks of automation,” said the report’s lead author Guillermo Beylis, Research Economist in the World Bank’s Office of the Chief Economist for Latin America and the Caribbean. “Workers will have to adapt to demand for cognitive or analytical skills, as well as interpersonal skills.”

Adult learning and re-training will be key as new automation technologies are adopted in LAC countries. The focus should be on policy reforms to increase productivity in the services sector, which already employs 60% of the workforce and will play an increasingly important role in the future.

Finally, a rethinking of labor regulations and social protection policies is needed. This involves flexible regulation of the emerging forms of work in a way that encourages employment and supports formalization, thereby expanding the coverage of social protection to larger segments of the population.

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Progress on Sudan political transition, but challenges remain

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UN peacekeepers from Pakistan engage the local population in North Darfur, Sudan. Photo: UNAMID

Political developments in Sudan continue to move along a positive trajectory, while planning for a UN mission to assist the transitional government is progressing, the UN Security Council heard on Friday. 

Ambassadors met in person in the Economic and Social Council (ECOSOC) Chamber at UN Headquarters in New York, where they were briefed by UN political affairs chief Rosemary DiCarlo, and the head of UN Peacekeeping, Jean-Pierre Lacroix. 

“As the Secretary-General highlights in his report, Sudan’s political transition continues to move in the right direction”, said Ms. DiCarlo, speaking via video link.  

Developments on the political front 

After nearly a year of talks, the transitional Government of Sudan and two key armed movements from Darfur – the Sudan Revolutionary Front (SRF) alliance and the Sudan Liberation Movement/Minni Minnawi (SLM/MM) – initialed a peace agreement at the end of August.   

Signing is scheduled for 3 October, and the parties have agreed to a 39-month transitional period effective from that date.   

A faction from another group, the Sudan People’s Liberation Movement-North (SPLM-N), has also signed a declaration of principles agreement. 

Significant work ahead 

Ms. DiCarlo outlined other recent developments in Sudan, including the appointment of interim civilian governors in all 18 states, two of whom are women.   

She said the parties should be commended for persevering with the peace process, adding that “it is not too late” for others to join. 

“As we embrace the recent progress in the peace process, we are also mindful of the significant work ahead”, she cautioned.  

“The various accords and respective peace agreements on regional issues must be moulded into a single, coherent framework. Additionally, the parties and the Government must form a joint vision on the way forward and to uphold their respective commitments.” 

Goodwill into action 

For the UN’s peacekeeping chief, the initialling of the agreement marked an important milestone for Darfur, where years of brutal fighting have left some 300,000 people dead and millions of others displaced, according to UN estimates. 

Mr. Lacroix hoped the goodwill expressed by the parties will translate into lasting change on the ground, although some “key players” have yet to join the peace process.  

He urged the international community to work to bring all stakeholders on board. 

“Furthermore, the implementation phase which is now beginning will be just as crucial as the drafting of the agreement itself”, said Mr. Lacroix, who also briefed ambassadors via video-link. 

Among the key provisions is a 12,000-strong joint security force for Darfur, to be deployed within 90 days of the signing.  It will be made up of equal numbers of members of the Sudanese security forces and from the signatory armed groups. 

“As forces are deployed and resources are mobilized in support of the implementation, it is essential to ensure that local Darfuri communities feel ownership of the agreement and fully participate in the implementation,” he stressed. 

Progress on new UN mission 

Meanwhile, planning continues for the new UN Integrated Transition Assistance Mission in Sudan (UNITAMS), Ms. DiCarlo told the Council. 

UNITAMS will assist the political transition, and support implementation of peace accords in conflict areas, national-led peacebuilding efforts, and strengthening of human rights, among other tasks. 

“Gender issues are mainstreamed throughout the mandate of the mission, which will have dedicated gender expertise, including at the senior level, to implement our commitments to advance gender equality and the women, peace and security agenda”, said Ms. DiCarlo. 

UNITAMS is a follow-on to the African Union-United Nations Hybrid Operation in Darfur (UNAMID).  The Security Council authorized the establishment of the new mission in June and the start-up team is set to deploy to Sudan next month. 

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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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