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EMA recommends COVID-19 Vaccine AstraZeneca for authorization in the EU

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EMA has recommended granting a conditional marketing authorisation for COVID-19 Vaccine AstraZeneca to prevent coronavirus disease 2019 (COVID-19) in people from 18 years of age, including those over 55.

After the EMA’s human medicines committee (CHMP) has thoroughly assessed the data on the quality, safety and efficacy of the vaccine and recommended by consensus a formal conditional marketing authorisation be granted by the European Commission. This is the third COVID-19 vaccine that EMA has recommended for authorisation.  This will assure EU citizens that the vaccine meets EU standards and puts in place the safeguards, controls and obligations to underpin EU-wide vaccination campaigns.

“With this third positive opinion, we have further expanded the arsenal of vaccines available to EU and EEA member states to combat the pandemic and protect their citizens,” said Emer Cooke, Executive Director of EMA. “As in previous cases, the CHMP has rigorously evaluated this vaccine, and the scientific basis of our work underpins our firm commitment to safeguard the health of EU citizens.”

Combined results from 4 clinical trials in the United Kingdom, Brazil and South Africa showed that COVID-19 Vaccine AstraZeneca was safe and effective at preventing COVID-19 in people from 18 years of age. These studies involved around 24,000 people altogether. Half received the vaccine and half were given a control injection, either a dummy injection or another non-COVID vaccine. People did not know if they had been given the test vaccine or the control injection.

The safety of the vaccine has been demonstrated across the four studies. However, the Agency based its calculation of how well the vaccine worked on the results from study COV002 (conducted in the UK) and study COV003 (conducted in Brazil). The other two studies had fewer than 6 COVID-19 cases in each, which was not enough to measure the preventive effect of the vaccine. In addition, as the vaccine is to be given as two standard doses, and the second dose should be given between 4 and 12 weeks after the first, the Agency concentrated on results involving people who received this standard regimen.

These showed a 59.5% reduction in the number of symptomatic COVID-19 cases in people given the vaccine (64 of 5,258 got COVID-19 with symptoms) compared with people given control injections (154 of 5,210 got COVID-19 with symptoms). This means that the vaccine demonstrated around a 60% efficacy in the clinical trials.

Most of the participants in these studies were between 18 and 55 years old. There are not yet enough results in older participants (over 55 years old) to provide a figure for how well the vaccine will work in this group. However, protection is expected, given that an immune response is seen in this age group and based on experience with other vaccines; as there is reliable information on safety in this population, EMA’s scientific experts considered that the vaccine can be used in older adults. More information is expected from ongoing studies, which include a higher proportion of elderly participants.

EU

NextGenerationEU: €93 million recovery and resilience plan in line for Luxembourg

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The European Commission has today (18 June) adopted a positive assessment of Luxembourg's recovery and resilience plan. This is an important step towards the EU disbursing €93 million in grants under the Recovery and Resilience Facility (RRF). This financing will support the implementation of the investment and reform measures outlined in Luxembourg's recovery and resilience plan. It will support Luxembourg's efforts to emerge stronger from the COVID-19 pandemic.

The RRF – at the heart of NextGenerationEU – will provide up to €672.5 billion (in current prices) to support investments and reforms across the EU. The Luxembourgish plan forms part of an unprecedented coordinated EU response to the COVID-19 crisis, to address common European challenges by embracing the green and digital transitions, to strengthen economic and social resilience and the cohesion of the Single Market.

Commission President Ursula von der Leyen said: “Today, the European Commission has decided to give its green light to Luxembourg's recovery and resilience plan. The plan places a strong emphasis on measures that will help secure the green transition, demonstrating Luxembourg's commitment to creating a more sustainable future. I am proud that NextGenerationEU will play an important role in supporting these efforts.”

The Commission assessed Luxembourg's plan based on the criteria set out in the RRF Regulation. The Commission's assessment considered in particular whether the investments and reforms set out in Luxembourg's plan support the green and digital transitions; contribute to effectively addressing challenges identified in the European Semester; and strengthen its growth potential, job creation and economic and social resilience.

Securing Luxembourg's green and digital transition  

The Commission's assessment finds that Luxembourg's plan allocates 61% of total expenditure to measures that support climate objectives. This includes measures to supply renewable energy to a housing district project in Neischmelz, a support scheme for the deployment of charging points for electric vehicles, and the “Naturpakt” scheme encouraging municipalities to protect the natural environment and biodiversity.

The Commission finds that Luxembourg's plan devotes 32% of total expenditure to measures that support the digital transition. This includes investments in the digitalisation of public services and procedures; digitalisation of projects for healthcare, such as an online solution for remote healthcare checks; and the establishment of a laboratory for testing ultra-secure communication connections based on quantum technology. In addition, investments in targeted training programmes will provide job seekers and workers on short-time work schemes with digital skills.

Reinforcing Luxembourg's economic and social resilience

The Commission considers that Luxembourg's plan is expected to contribute to effectively addressing all or a significant subset of challenges identified in the relevant country-specific recommendations (CSRs). Specifically, it contributes to addressing CSRs on  labour market policies through addressing skills mismatches and enhancing the employability of older workers. It also contributes to increasing the resilience of the healthcare system, increasing available housing, the green and digital transitions, and the enforcement of the anti-money laundering framework.

The plan represents a comprehensive and adequately balanced response to Luxembourg's economic and social situation, thereby contributing appropriately to all six pillars of the RRF Regulation.

Supporting flagship investment and reform projects

Luxembourg's plan proposes projects in five European flagship areas. These are specific investment projects dealing with issues that are common to all Member States in areas that create jobs and growth and are needed for the green and digital transitions. For instance, Luxembourg has proposed measures aimed at increasing the effectiveness and efficiency of public administration service through enhanced digitalization.

An Economy that Works for People Executive Vice President Valdis Dombrovskis said: “Congratulations to Luxembourg for designing a recovery plan whose focus on the green and digital transitions goes way beyond the minimum requirements. This will make a significant contribution to Luxembourg's recovery from the crisis, promising a brighter future for its young people by investing in digital skills programmes, training for jobseekers and the unemployed, as well as increasing the supply of affordable and sustainable housing. These investments will make Luxembourg's economy fit for the next generation. It is also good to see Luxembourg's plans to invest in renewable energy and further digitalize its public services – both areas with potential for solid economic growth.”

The assessment also finds that none of the measures included in the plan significantly harm the environment, in line with the requirements laid out in the RRF Regulation.

The control systems put in place by Luxembourg are considered adequate to protect the financial interests of the Union. The plan provides sufficient details on how national authorities will prevent, detect and correct instances of conflict of interest, corruption and fraud relating to the use of funds.

Economy Commissioner Paolo Gentiloni said: “Although its financial contribution is relatively limited in size, Luxembourg's recovery and resilience plan is set to deliver real improvements in a number of areas. Particularly positive is the strong focus on supporting the Grand Duchy's climate transition, with important measures to encourage the take-up of electric vehicles and increase energy efficiency in buildings. Citizens will also benefit from the drive to boost digital public services and provide more affordable housing. Lastly, I welcome the fact that the plan includes significant steps to further reinforce the anti-money laundering framework and its enforcement."

Next steps

The Commission has today adopted a proposal for a Council Implementing Decision to provide €93m in grants to Luxembourg under the RRF. The Council will now have, as a rule, four weeks to adopt the Commission's proposal.

The Council's approval of the plan would allow for the disbursement of €12m to Luxembourg in pre-financing. This represents 13% of the total allocated amount for Luxembourg.

The Commission will authorize further disbursements based on the satisfactory fulfilment of the milestones and targets outlined in the Council Implementing Decision, reflecting progress on the implementation of the investments and reforms. 

More information

Questions and Answers: European Commission endorses Luxembourg's €93m recovery and resilience plan

Recovery and Resilience Facility: Questions and Answers

Factsheet on Luxembourg's recovery and resilience plan

Proposal for a Council Implementing Decision on the approval of the assessment of the recovery and resilience plan for Luxembourg

Annex to the Proposal for a Council Implementing Decision on the approval of the assessment of the recovery and resilience plan for Luxembourg

Staff-working document accompanying the proposal for a Council Implementing Decision

Recovery and Resilience Facility

Recovery and Resilience Facility Regulation

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Defence

When it comes to online extremism, Big Tech is still our main problem

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Over the past two months, lawmakers in the UK and Europe have introduced a number of major new bills aimed at curbing the malicious role that Big Tech plays in the spread of extremist and terrorist content online, writes Counter Extremism Executive Director Project David Ibsen.

In this new legislative climate, social media giants such as Facebook, Twitter, and YouTube, who for years have been complacent, if not deliberately negligent, in policing their platforms, are finally beginning to come under pressure. Unsurprisingly, their belated efforts to appease governments through self-regulatory initiatives such as Digital Trust and Safety Partnership are already giving way to a search for scapegoats.

Lately, Big Tech advocates have begun to promote the idea that extremist and terrorist content online remains an issue solely for smaller social media sites and alternative encrypted platforms. While tackling extremism and terrorism on smaller and alternative sites is certainly worth getting ahead of, the overall narrative here is more than a little convenient for Silicon Valley and flawed in a number of crucial respects.

The spread of extremist and terrorist material remains a big problem for Big Tech. In the first place, we are not yet anywhere near the promised land of a mainstream social media environment free of extremist messaging. Far from Big Tech leading the way in content moderation, a study of media responsibility published in February of this year found that Facebook, Twitter, and YouTube are being significantly outpaced by smaller platforms in their efforts to eliminate harmful posts.

In the same month, CEP researchers discovered an extensive cache of ISIS content on Facebook, including executions, exhortations to commit acts of violence, and combat footage, which had been completely ignored by moderators.

This week, with rates of antisemitic violence surging across the US and Europe, CEP has once again identified explicit neo-Nazi content across a host of mainstream platforms including YouTube, Facebook-owned Instagram, and Twitter.

Secondly, even in an imagined future where extremist communications take place primarily through decentralised platforms, extremist groups would still be reliant on some form of connection to mainstream outlets to grow their ideological support base and recruit new members.

Every story of radicalisation starts somewhere and regulating Big Tech is the greatest step we could possibly take to prevent ordinary citizens from being drawn down extremist rabbit holes.

And while dangerous and hateful content can flow more freely on unmoderated sites, extremists and terrorists still desire access to large, mainstream platforms. The near ubiquitous nature of Facebook, Twitter, YouTube, and others offer extremists the ability to reach broader audiences—to either terrify or recruit as many people as possible. For instance, Christchurch killer Brenton Tarrant, who took to live streaming his atrocities on Facebook Live, had his attack video re-uploaded more than 1.5 million times.

Whether it’s jihadists seeking to ignite a worldwide caliphate or neo-Nazis trying to start a race war, the goal of terrorism today is to capture attention, inspire like-minded extremists, and destabilise societies to the greatest extent possible.

To this end, the amplificatory effects of major social media channels simply cannot be underestimated. It is one thing for an extremist to communicate to a small group of ideological cohorts on an obscure encrypted network. It is something entirely different for them to share their propaganda with hundreds of millions of people on Facebook, Twitter, or YouTube.

It would be no exaggeration to say that preventing the latter from happening through effective regulation of Big Tech would help to fundamentally tackle modern terrorism and prevent extremists and terrorists from attaining a mainstream audience.

The increasing decentralisation of online extremism is an important issue that lawmakers must deal with, but anyone who brings it up to try and obscure the importance of regulating Big Tech simply does not have the public’s best interest at heart.

David Ibsen serves as executive director for the Counter Extremism Project (CEP), which works to combat the growing threat of extremist ideology particularly by exposing extremists’ misuse of financial, business, and communications networks. CEP uses the latest communications and technological tools to identify and counter extremist ideology and recruitment online.

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Democratic Republic of the Congo

EU boosts access to electricity in the Virunga area in the Democratic Republic of the Congo

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The Commission has announced an additional €20 million to finance a new power plant in Rwanguba, that will provide a further 15 Megawatt of electricity. The European Union's rapid response to the urgent environmental crisis in the Democratic Republic of the Congo has helped to restore up to 96% of the power lines and 35% of the water pipes damaged in Goma due to the eruption of the Nyiragongo volcano on 22 May. This has allowed half a million people to access drinking water, and to have electricity in two important hospitals.

Speaking on the European Development Days panel on Virunga, International Partnerships Commissioner Jutta Urpilainen said: “Access to electricity saves lives and is crucial for economic and human development in this vulnerable region. This is why the European Union reacted rapidly to support the population affected by the recent Nyiragongo volcanic eruption. With this additional €20m, we will increase supply, more households and schools and provide opportunities for sustainable growth.”

The EU supports the construction of hydroelectric power plants and distribution networks around the National Park of Virunga, already supplying 70% of Goma's electricity needs. Power cuts are life-threatening for the local population as they lead to water shortage, the spread of diseases such as cholera, increased inequalities and poverty.

Background

The Virunga National Park is a UNESCO World Heritage Site. The EU is its longest and most important donor, supporting the National Park since 1988.

Since 2014, the EU has supported ongoing actions with a total of €112 million in grants. The EU's financial contributions support the day-to-day operation of the Park, inclusive growth and sustainable development initiatives in the area, the hydro-electrification of North Kivu and the development of sustainable agricultural practices. These activities have contributed to creating 2,500 direct jobs, 4,200 jobs in connected small and medium enterprises (SMEs) and 15,000 indirect jobs in value chains.

In December 2020, the European Union, environmentalist and Academy Award ® - winning actor Leonardo DiCaprio, and Re:wild (former Global Wildlife Conservation) launched an initiative to safeguard the Virunga National Park in the Democratic Republic of the Congo. This type of initiative exemplifies the EU's commitment to delivering the EU's Green Deal around the world, in cooperation with key players such as Re:wild whose mission is to conserve the diversity of life on earth.

The EU's integrated approach links nature conservation with economic development while improving the living standards of local populations. It contributes to prevent poaching and supports sustainable forest management, including efforts to combat illegal logging and deforestation. Virunga National Park is already well-known as the most biodiverse protected area in Africa, notably with its wild mountain gorillas. In parallel, the EU invests in value chains such as chocolate, coffee, chia seeds, papaya enzymes for the cosmetic industry, making sure that resources reach small community-based farms and cooperatives while promoting inclusive growth and sustainable development.

More information

Press release: The EU, Leonardo DiCaprio and Global Wildlife Conservation team up to protect biodiversity

The European Green Deal and International Partnerships

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