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European Commission authorises COVID 19 vaccine developed by Moderna

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Today, the European Commission has granted a conditional marketing authorisation (CMA) for the COVID‑19 vaccine developed by Moderna, the second COVID-19 vaccine authorised in the EU. This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.

The President of the European Commission, Ursula von der Leyen, said: “We are providing more COVID-19 vaccines for Europeans. With the Moderna vaccine, the second one now authorised in the EU, we will have a further 160 million doses. And more vaccines will come. Europe has secured up to two billion doses of potential COVID-19 vaccines. We’ll have more than enough safe and effective vaccines for protecting all Europeans.”

Stella Kyriakides, Commissioner for Health and Food Safety, said: “We are all in this together and united. This is why we have negotiated the broadest vaccine portfolio in the world for all our Member States. Today we are authorising a second safe and effective vaccine from Moderna, which together with BioNTech-Pfizer, will ensure that 460 million doses will be rolled out with increasing speed in the EU, and more will come. Member States have to ensure that the pace of vaccinations follows suit. Our efforts will not stop until vaccines are available for everyone in the EU.”

Moderna submitted on 30 November 2020 an application for marketing authorisation to EMA, which had already started a rolling review of the data in November. Thanks to this rolling review, EMA has been assessing the quality, safety and efficacy of the vaccine as data has become available. EMA’s human medicines committee (CHMP) has thoroughly assessed the data and recommended by consensus that a formal conditional marketing authorisation is granted. A conditional marketing authorisation is one of EU’s regulatory mechanisms for facilitating early access to medicines that fulfil an unmet medical need, including in emergency situations such as the current pandemic.

On the basis of EMA’s positive opinion, the Commission has verified all the elements supporting the marketing authorisation and consulted Member States before granting the conditional market authorisation.

The Moderna vaccine is based on messenger RNA (mRNA). mRNA plays a fundamental role in biology, transferring instructions from DNA to the cells’ protein making machinery. In an mRNA vaccine, these instructions produce harmless fragments of the virus, which the human body uses to build an immune response to prevent or fight disease. When a person is given the vaccine, their cells will read the genetic instructions and produce a spike protein, a protein on the outer surface of the virus which it uses to enter the body’s cells and cause disease. The person’s immune system will then treat this protein as foreign and produce natural defences — antibodies and T cells — against it.

Next steps

Moderna, with whom the Commission signed a contract on 25 November, will deliver the total amount of 160 million doses between the first and the third quarters of 2021. It will add to the 300 million doses of the vaccine distributed by BioNTech/Pfizer, the first vaccine to have been authorised in the EU on 21 December 2020.

Background

A conditional marketing authorisation (CMA) is an authorisation of medicines on the basis of less complete data required for a normal marketing authorisation. Such a CMA may be considered if the benefit of a medicine’s immediate availability to patients clearly outweighs the risk linked to the fact that not all the data are yet available. However, once a CMA has been granted, companies must provide within certain deadlines further data including from ongoing or new studies to confirm that the benefits continue to outweigh the risks.

Moderna submitted on 30 November 2020 an application for a CMA for their vaccine to EMA. EMA has already been assessing data on the vaccine’s safety, effectiveness and quality and results from laboratory studies and clinical trials in the context of a rolling review. This rolling review and the assessment of the CMA application allowed EMA to quickly conclude on the safety, effectiveness and quality of the vaccine. EMA recommended granting the conditional marketing authorisation as the benefits of the vaccine outweigh its risks.

The European Commission has verified whether all necessary elements – scientific justifications, product information, educational material to healthcare professionals, labelling, obligations to marketing authorisation holders, conditions for use, etc. – were clear and sound. The Commission also consulted the Member States, as they are responsible for the vaccines marketing and the use of the product in their countries. Following the Member States’ endorsement and on the basis of its own analysis, the Commission decided to grant the conditional market authorisation.

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EU Politics

Presidents of Parliament to gather for Athens Summit

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Presidents of Parliament from the 47 Council of Europe member states, as well as many neighbouring and observer countries and other partner parliamentary assemblies, will meet on 21 and 22 October 2021 in Athens, on the occasion of a conference organised by the Hellenic Parliament and the Parliamentary Assembly of the Council of Europe (PACE).

The Conference will be opened by the President of the Hellenic Parliament Constantine An. Tassoulas, PACE President Rik Daems, and the Secretary General of the Council of Europe Marija Pejčinović Burić.

Some 60 Presidents and Speakers, together with 300 other delegates, are expected at the biennial summit to discuss three major topical issues:

  • Democracies facing the Covid-19 public health crisis: sharing experiences
    Key-note speeches by the President of the Romanian Senate Anca Dana Dragu; the Speaker of the Russian Federation Council Valentina Matviyenko; and the President of Austria’s National Council Wolfgang Sobotka.
  • #EnvironmentRightNow’: national parliaments and the right to a healthy and sustainable environment
    Key-note speeches by the Speaker of the Parliament of Georgia Kakha Kuchava; the Speaker of the Parliament of Finland Anu Vehviläinen, and a member of the Council of Europe Advisory Council on Youth, Spyros Papadatos.
  • The common future of all European citizens
    Key-note speeches by the President of the Belgian Senate Stephanie D’Hose; the President of the Cypriot House of Representatives, Anita Demetriou; and the President of the Slovenian National Assembly, Igor Zorčič.

Secretaries General of the participating parliaments and assemblies are also due to meet on the margin of the conference.

The first conference was held in 1975. It takes place every two years, hosted alternately in Strasbourg or in the capital of a Council of Europe member state. At the invitation of the Hellenic Parliament, it is held this year in Athens, when the country celebrates the bicentennial of its independence.

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EU Politics

Lorenzo Natali Media prize 2021: Winners announced

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The European Commission announced the three winners of the 2021 ‘Lorenzo Natali’ Media prize: Pari Saikia, for her work on the plight of the Rohingya, Maria Altimira, for her work on the labour exploitation of migrants and Srishti Jaswal for bringing to light the hunger situation in India. For nearly three decades, the prize has recognised courageous journalism and focused on compelling, compassionate reporting that brings to light stories that matter on the global challenges impacting society.

Commissioner for International Partnerships, Jutta Urpilainen, presented the prizes to the winners at today’s award ceremony: “This award of this year’s Lorenzo Natali Media prize, recognizes three exceptional journalists, whose work exemplifies the courage, integrity and dedication to global equity. As development journalists you help bring about change – whether it is tackling inequalities, protecting universal human rights, or responding to the existential threat of climate change.”

The 2021 prizewinners, selected by a grand jury from among more than 1,100 applications from across the world, are:

Grand prize

Pari Saikia of Vice Media India, for:

“Rohingya Brides Thought They Were Fleeing Violence. Then They Met Their Grooms”

Pari Saikia’s story on the exploitation of Rohingya refugee women exposes the drivers and the methods used in trafficking women in the region.

Europe prize

Maria Altimira writing in Diario Ara, for:

“Abusos en los campos de fresas”

In this piece, Maria Altimira shines a light on the labour and sexual abuse suffered by farm workers, and attempts to hold oversight agencies accountable for abuses happening on their watch.

Best Emerging Journalist prize

Srishti Jaswal, writing in Stories Asia, for:

“The Global Hunger Index Reveals India’s Ignored Hunger Crisis”

Srishti Jaswal’s investigation reveals India’s hidden hunger crisis and the under-reporting of deaths due to starvation.

The winners were chosen by a Grand Jury of experts in the fields of journalism and development:

  • Diana Moukalled (Daraj.com)
  • Sulemana Braimah (Media Foundation for West Africa)
  • Jana Ciglerová (Denik N)
  • Zuliana Lainez (International Federation of Journalists)
  • Steve Sapienza (Pulitzer Center).

All entries underwent an initial pre-selection phase conducted by four journalism schools: Vesalius College in Brussels, Universidade Católica Portuguesa in Lisbon, Universidad de Navarra in Pamplona and Université Saint Joseph in Beirut.

Background

Established in 1992, the European Commission’s Lorenzo Natali Media Prize is awarded in memory of Lorenzo Natali, a former Commissioner for Development and Cooperation. He was a staunch defender of freedom of expression, democracy, human rights and development.

The prize recognises high-quality, courageous reporting on compelling issues such as climate change, women´s rights, inequality, healthcare, democracy and human rights.

The prize’s three categories in 2021 were:

  • Grand prize: for reporting published by a media outlet based in one of the European Union’s partner countries.
  • Europe prize: for reporting published by a media outlet based in the European Union.
  • Best Emerging Journalist prize: for reporting by journalists under the age of 30, published in a media outlet based in the European Union or in one of its partner countries.

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EU Politics

70% of the EU adult population fully vaccinated

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Today, the EU has reached a crucial milestone with 70% of the adult population now fully vaccinated. In total, over 256 million adults in the EU have now received a full vaccine course. Seven weeks ago already, the Commission’s delivery target was met, ahead of time: to provide Member States, by the end of July, with enough vaccine doses to fully vaccinate 70% of the adult EU population.

The President of the European Commission, Ursula von der Leyen, said:  “The full vaccination of 70% of adults in the EU already in August is a great achievement. The EU’s strategy of moving forward together is paying off and putting Europe at the vanguard of the global fight against COVID-19.  But the pandemic is not over. We need more. I call on everyone who can to get vaccinated. And we need to help the rest of the world vaccinate, too. Europe will continue to support its partners in this effort, in particular the low and middle income countries.”

Stella Kyriakides, Commissioner for Health and Food Safety, said:  “I am very pleased that as of today we have reached our goal to vaccinate 70% of EU adults before the end of the summer. This is a collective achievement of the EU and its Member States that shows what is possible when we work together with solidarity and in coordination. Our efforts to further increase vaccinations across the EU will continue unabated. We will continue to support in particular those Member States that are continuing to face challenges. We need to close the immunity gap and the door for new variants and to do so, vaccinations must win the race over variants.”

Global cooperation and solidarity

The rapid, full vaccination of all targeted populations – in Europe and globally – is key to controlling the impact of the pandemic. The EU has been leading the multilateral response. The EU has exported about half of the vaccines produced in Europe to other countries in the world, as much as it has delivered for its citizens.  Team Europe has contributed close to €3 billion for the COVAX Facility to help secure at least 1.8 billion doses for 92 low and lower middle-income countries. Currently, over 200 million doses have been delivered by COVAX to 138 countries.

In addition, Team Europe aims to share at least 200 million more doses of vaccines secured under the EU’s advance purchase agreements to low and middle-income countries until the end of 2021, in particular through COVAX, as part of the EU sharing efforts

Preparing for new variants

Given the threat of new variants, it is important to continue ensuring the availability of sufficient vaccines, including adapted vaccines, also in the coming years. That is why the Commission signed a new contract with BioNTech-Pfizer on 20 May, which foresees the delivery of 1.8 billion doses of vaccines between the end of the year and 2023. For the same purpose, the Commission has also exercised the option of 150 million doses of the second Moderna contract. Member States have the possibility to resell or donate doses to countries in need outside the EU or through the COVAX Facility, contributing to a global and fair access to vaccines across the world. Other contracts may follow. This is the EU’s common insurance policy against any future waves of COVID-19.

Background

A safe and effective vaccine is our best chance to beat coronavirus and return to our normal lives. The European Commission has been working tirelessly to secure doses of potential vaccines that can be shared with all.

The European Commission has secured up to 4.6 billion doses of COVID-19 vaccines so far and negotiations are underway for additional doses. The Commission is also working with industry to step up vaccine manufacturing capacity.

At the same time, the Commission has started work to tackle new variants, aiming to rapidly develop and produce effective vaccines against these variants on a large scale. The HERA Incubator helps in responding to this threat.

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