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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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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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Brexit deal: How new EU-UK relations will affect you

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EU-UK relations are changing following Brexit and the deal reached at the end of 2020. Find out what this means for you.

The UK left the EU on 31 January 2020. There was a transition period during which the UK remained part of the Single market and Customs Union to allow for negotiations on the future relations. Following intense negotiations, an agreement on future EU-UK relations was concluded end of December 2020. Although it will be provisionally applied, it will still need to be approved by the Parliament before it can formally enter into force. MEPs are currently scrutinising the text in the specialised parliamentary committees before voting on it during a plenary session.

A number of issues were already covered by the withdrawal agreement, which the EU and the UK agreed at the end of 2019. This agreement on the separation issues deals with the protection of the rights of EU citizens in the UK and UK citizens living in other parts of the EU, the UK’s financial commitments undertaken as a member state, as well as border issues, especially on the Isle of Ireland.

Living and working in the UK or the EU

EU citizens in the UK or UK citizens in an EU member state who were already living there before January 2021 are allowed to continue living and working where they are now provided they registered and were granted settlement permits by the national authorities of the member states or the UK.

For those UK citizens not already living in the EU, their right to live and work in any EU country apart from the Republic of Ireland (as the UK has a separate agreement with them) is not automatically granted and can be subject to restrictions. Also, they no longer have their qualifications automatically recognised in EU countries, which was previously the case.

For UK citizens wanting to visit or stay in the EU for more than 90 days for any reason need to meet the requirements for entry and stay for people from outside the EU. This also applies to UK citizens with a second home in the EU.

People from the EU wanting to move to the UK for a long-term stay or work – meaning more than six months – will need to meet the migration conditions set out by the UK government, including applying for a visa.

Travelling

UK citizens can visit the EU for up to 90 days within any 180-day period without needing a visa.

However, UK citizens can no longer make use of the EU’s fast track passport controls and customs lanes. They also need to have a return ticket and be able to prove they have enough funds for their stay. They also need to have at least six months left on their passport.

EU citizens can visit the UK for up to six months without needing a visa. EU citizens will need to present a valid passport to visit the UK.

Healthcare

EU citizens temporarily staying in the UK still benefit from emergency healthcare based on the European Health Insurance Card. For stays longer than six months, they need to pay a healthcare surcharge.

Pensioners continue to benefit from healthcare where they live. The country paying for their pension will reimburse the country of residence.

Erasmus

The UK has decided to stop participating in the popular Erasmus+ exchange programme and to create its own exchange programme. Therefore EU students will not be able to participate in exchange programme in the UK anymore. However, people from Northern Ireland can continue to take part.

Trade in goods and services

With the agreement, goods exchanged between the UK and EU countries are not subject to tariffs or quotas. However, there are new procedures for moving goods to and from the UK as border controls on the respect of the internal market rules (sanitary, security, social, environmental standard for example) or applicable UK regulation are in place. This means more red tape and additional costs. For example, all imports into the EU are subject to customs formalities while they must also meet all EU standards so they are subject to regulatory checks and controls. This does not apply to goods being moved between Northern Ireland and the EU.

Regarding services, UK companies no longer have the automatic right to offer services across the EU. If they want to continue operating in the EU, they will need to establish themselves here.

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