The official website of the European Commission, providing access to information about its political priorities, policies and services. Protecting the health and safety of citizens is the EU's top priority. The main EU institutions each have a press room with facilities for journalists, where briefings and conferences are organised regularly. The study includes an open-label dose-escalation phase and will be conducted as a randomized, double-blind, multicenter study. If clinical development is successful, an initial approval may be granted in the second half of 2021. The Commission’s approval for the transaction is conditional on the proposed engagements that consist of: A transfer of Bombardier Transportation’s contribution to the V300 ZEFIRO very high … We also use third-party cookies that help us analyze and understand how you use this website. Focusing on vaccines for infectious diseases with major unmet needs. T +43 (0)1 20620 1116 This website uses cookies to improve your experience. Saint-Herblain (France), January 12, 2021 – Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001. The European Commission responded to the European Citizens' Initiative ‘Minority Safepack – one million signatures for diversity in Europe', the fifth successful Initiative supported by over 1 million citizens across the EU. communications@valneva.com. Corporate Communications Specialist Representing the interests of the EU as a whole. This website presents the activities, working documents and news about the Aquaculture Advisory Council (AAC). The United Kingdom left the European Union on 31 January 2020, after 47 years of EU membership. Fast facts, background information, progress and more in depth information on main EU issues. The European Commission has approved, under the EU Merger Regulation, the creation of a joint venture by German companies Dr. Ing. ... Press release 12 January 2021. Anja Vladisavljevic. Valneva is providing the information in this press release as of the date hereof and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. M +33 (0)6 4516 7099 1 The primary endpoint was the annual rate of decline in forced vital capacity (FVC) assessed over a 52-week period. Commission proposes to purchase up to 300 million additional doses of BioNTech-Pfizer vaccine. Thomas Lingelbach, Chief Executive Officer of Valneva, said, “Today’s announcement helps to ensure that millions of Europeans potentially have access to a proven and well-established inactivated vaccine approach, upon approval of VLA2001. The European Parliament and the European Commission also have press … Dedicated to innovation in vaccine research and development. Because of this, the European Union decided to propose emergency changes. The press office holds press events, offers ... European Council President Charles Michel and European Commission President Ursula von der Leyen held a leaders’ meeting with China, represented by President Xi Jinping, via videoconference on 30 December 2020. About VLA2001-201 Investor and Media Contacts About the Novel Coronavirus SARS-CoV-2 and COVID-19 Disease Highlights, press releases and speeches. Overall, 150 healthy young adults aged 18 to 55 years will be recruited. Under the partnership agreement, if vaccine development is successful, Valneva will provide the UK government with 60 million doses in the second half of 2021. The main EU institutions each have a press room with facilities for journalists, where briefings and conferences are organised regularly. Forward-Looking Statements European Commission Press Release, supra note 1. In accordance with the Withdrawal Agreement, it is now officially a third country... 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VLA2001-201 is the first-in-human Phase 1/2 study evaluating three dose levels of VLA2001 (low, medium, high) for safety, tolerability and immunogenicity in a two-dose schedule with intra muscular vaccinations three weeks apart. Press releases, latest news and media resources, I hereby confirm that I have read and understood the data privacy declaration.*. European Commission - Press release State aid: Commission approves investment aid for Czech orchards and irrigations; opens in-depth investigations into Czech measures in favour of large agricultural companies Brussels, 12 January 2021 The European Commission has approved two Czech investment aid support schemes for the We would like to show you a description here but the site won’t allow us. Migrant Crisis: EU Plans Penalties for Refusing Asylum Seekers, supra note 5. Commissioners swear an oath at the European Court of Justice in Luxembourg City, pledging to respect the treaties and to be completely independent in carrying … Valneva is a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need. Zagreb. press release as PDF Website and Open Call STARTS Prize 2021 Photo album STARTS Prize 2020 Ars Electronica Blog (Linz/Brussels, 11 January, 2021) As of today, scientists, technologists, artists, institutions, labs and companies are invited once again to submit their best projects for the STARTS Prize 2021 of the European Commission. 28,590 talking about this. The European Commission is coordinating a common European response to the coronavirus outbreak. The AAC is a balanced stakeholder representative organisation created for consultation on elements of Union policies which could affect aquaculture under Articles 34 and 44 of Regulation (EU) No 1380/2013. Valneva’s vaccine candidate is based on a proven approach and will leverage the Company’s existing manufacturing platform being used for its US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approved Japanese encephalitis vaccine. On July 5, 2018, the European Commission published a position paper launching several proposals to modernize the WTO and one of those addresses solutions to the Appellate Body’s nomination crisis. SARS-CoV-2 is a new coronavirus identified in late 2019 and belongs to a family of enveloped RNA viruses that include MERS and SARS, both of which caused serious human infections of the respiratory system. The European Commission has concluded exploratory talks with the pharmaceutical company Valneva with a view to purchasing its potential vaccine against COVID-19. CpG 1018 is a component of the US FDA-approved HEPLISAV-B® vaccine.VLA2001 is expected to conform with standard cold chain requirements (2 degrees to 8 degrees Celsius). The European Commission’s approval is based on the results of the SENSCIS ® trial, a Phase III, double-blind, placebo-controlled trial conducted to investigate the efficacy and safety of nintedanib in patients with SSc-ILD. Give feedback about this website or report a problem. Any cookies that may not be particularly necessary for the website to function and is used specifically to collect user personal data via analytics, ads, other embedded contents are termed as non-necessary cookies. True believer in EU’s values. Migrant Crisis: EU Plans Penalties for Refusing Asylum Seekers, supra note 5. VLA2001 consists of inactivated whole virus particles of SARS-CoV-2 with high S-protein density, in combination with two adjuvants, alum and CpG 1018. h.c. F. Porsche AG, a subsidiary of the Volkswagen group, and Schuler AG of the Andritz group, to build and operate a metal press plant in Germany. The Initiative aims to improve the protection of persons belonging to national and linguistic minorities. The President of the European Commission is the head of the European Commission, the executive branch of the European Union.The President of the Commission leads a Cabinet of Commissioners, referred to as the College, collectively accountable to the European Parliament.The President is empowered to allocate portfolios amongst, reshuffle or dismiss Commissioners as necessary. The European Commission (EC) is the executive branch of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU. The EU is active in a wide range of policy areas, from human rights to transport and trade. h.c. F. Porsche AG, a subsidiary of the Volkswagen group, and Schuler AG of the Andritz group, to build and operate a metal press … BIRN. We are grateful to the European Commission for their support and eager to partner with them to address the ongoing pandemic. About Valneva SE The press office holds press events, offers ... European Council President Charles Michel and European Commission President Ursula von der Leyen held a leaders’ meeting with China, represented by President Xi Jinping, via videoconference on 30 December 2020. These forward-looking statements are based on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. Following an evaluation of Part A data (i.e., data up to Day 36) from the present study, further clinical studies may be initiated. The process, which has already been upscaled to final industrial scale, includes inactivation with BPL to preserve the native structure of the S-protein. press release as PDF Website and Open Call STARTS Prize 2021 Photo album STARTS Prize 2020 Ars Electronica Blog (Linz/Brussels, 11 January, 2021) As of today, scientists, technologists, artists, institutions, labs and companies are invited once again to submit their best projects for the STARTS Prize 2021 of the European Commission. Necessary cookies are absolutely essential for the website to function properly. VLA2001 is Valneva’s vaccine candidate against the SARS-CoV-2 virus. Laetitia Bachelot-Fontaine Since this outbreak was first reported, the virus has caused approximately 2 million reported deaths globally. Sessions; About; FAQ; Filter: In particular, the expectations of Valneva could be affected by, among other things, uncertainties involved in the development and manufacture of vaccines, unexpected clinical trial results, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, the ability to obtain or maintain patent or other proprietary intellectual property protection and the impact of the COVID-19 pandemic. This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to the progress, timing, design, data read-outs, anticipated results and completion of clinical trials for VLA2001. The envisaged contract with Valneva would provide for the possibility for all EU Member States to purchase together 30 million doses, and they could further purchase up to 30 million more doses. The EU has a unique institutional set-up where broad priorities are set by the European Council; decision-making involves European Parliament, Council of the EU and European Commission and number of other institutions. The European Commission’s approval is based on the results of the SENSCIS ® trial, a Phase III, double-blind, placebo-controlled trial conducted to investigate the efficacy and safety of nintedanib in patients with SSc-ILD. Review recent and past Novartis healthcare news stories, including media releases and featured information. This adjuvant combination has consistently induced higher antibody levels in preclinical experiments than alum-only formulations and shown a shift of the cellular immune response towards Th1. We'll assume you're ok with this, but you can opt-out if you wish. [1] Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine, [2] Valneva Announces Major COVID-19 Vaccine Partnership with U.K. Government. We are taking resolute action to reinforce our public health sectors and mitigate the socio-economic impact in the European Union. The European Commission has approved, under the EU Merger Regulation, the acquisition of Refinitiv by the London Stock Exchange Group (‘LSEG'). investors@valneva.com, Teresa Pinzolits It has been declared a pandemic by the World Health Organization (WHO). The European Commission against Racism and Intolerance (ECRI) is a unique human rights monitoring body which specialises in questions relating to the fight against racism, discrimination (on grounds of “race”, ethnic/national origin, colour, citizenship, religion, language, sexual orientation, gender identity and sex characteristics), xenophobia, antisemitism and … VLA2001 is currently the only inactivated vaccine candidate in clinical trials against COVID-19 in Europe. 1 The primary endpoint was the annual rate of decline in forced vital capacity (FVC) assessed over a 52-week period. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made during this presentation will in fact be realized. The meeting focused in particular on progress achieved on negotiations on investment. Director Investor Relations & Corporate Communications We are taking resolute action to reinforce our public health sectors and mitigate the socio-economic impact in the European Union. The Company has several vaccines in development including unique vaccines against Lyme disease, COVID-19 and chikungunya. October 16, 2020 11:27. The President of the European Commission is the head of the European Commission, the executive branch of the European Union.The President of the Commission leads a Cabinet of Commissioners, referred to as the College, collectively accountable to the European Parliament.The President is empowered to allocate portfolios amongst, reshuffle or dismiss … Publications of the University of Michigan Law School Faculty, 1859-includes published books, articles, book chapters, essays, introductions, forewords and book reviews written or edited by the University of Michigan Law faculty.For additional information see Persons and Materials Included and Excluded sections below. The European Commission has approved, under the EU Merger Regulation, the creation of a joint venture by German companies Dr. Ing. European Commission President Ursula von der Leyen delivers a statement at EU headquarters in Brussels on Sunday. Upon analysis of the data, Valneva will select the best dose and commence the second part of the Phase 1/2 clinical development. VLA2001-201 is conducted in two parts: Part A (Day 1 to Day 36) and Part B (Day 37 to Day 208). About VLA2001 31 July 2020 – Alstom and Bombardier welcome the European Commission’s (EC) decision for conditional clearance of the proposed acquisition of Bombardier Transportation by Alstom.. This website uses cookies to improve your experience while you navigate through the website. Highlights, press releases and speeches. Saint-Herblain (France), January 12, 2021 – Valneva SE, a specialty vaccine company focused on prevention of infectious diseases with significant unmet medical need, today announced it is in advanced discussions with the European Commission (EC) for the supply of up to 60 million doses of its COVID-19 vaccine, VLA2001.VLA2001 is currently the only … This category only includes cookies that ensures basic functionalities and security features of the website. We increasingly see wider recognition that our vaccine will be one that the world cannot do without.”. On January 8th 2021, a Data Safety Monitoring Board (DSMB) gave approval to progress into the study’s full randomization phase. ... Press release 8 January 2021. In September 2020, Valneva announced a major COVID-19 vaccine partnership with the UK government for the supply of up to 190 million doses of its inactivated vaccine candidate, VLA2001[2]. Press contacts Contact spokesperson's and press officers of the European Commission as well as press officers in national EC representations Commission spokesperson's service Lee, supra note 3. Valneva’s portfolio includes two commercial vaccines for travelers: IXIARO®/JESPECT® indicated for the prevention of Japanese encephalitis and DUKORAL® indicated for the prevention of cholera and, in some countries, prevention of diarrhea caused by ETEC. Here posts the Social Media Team. Lee, supra note 3. VLA2001 is produced on Valneva’s established Vero-cell platform, leveraging the manufacturing technology for Valneva’s licensed Japanese encephalitis vaccine, IXIARO®. These cookies will be stored in your browser only with your consent. Sessions; About; FAQ; Filter: European Commission STREAMING SERVICE OF THE EUROPEAN COMMISSION. We are deeply committed to providing broad access to our inactivated SARS-CoV-2 vaccine candidate and, as we proceed with clinical development, we will simultaneously continue working with partners, including the European Commission and the UK Government, to help us reach that goal. These cookies do not store any personal information. The future partnershipThe United Kingdom left the European Union on 31 January 2020, after 47 years of EU membership. Broadcast professionals have free access to the full range of audiovisual services provided by the European institutions. Launched end 2005, the European Jewish Press is the sole online Jewish news agency in Europe. European Commission - Press release State aid: Commission approves investment aid for Czech orchards and irrigations; opens in-depth investigations into Czech measures in favour of large agricultural companies Brussels, 12 January 2021 The European Commission has approved two Czech investment aid support schemes for the But opting out of some of these cookies may have an effect on your browsing experience. The privately funded Brussels-based outlet is an independent media body. All official European Union website addresses are in the europa.eu domain.. See all EU institutions and bodies All EU institutions, bodies and agencies have their own dedicated press services and contacts. All EU institutions, bodies and agencies have their own dedicated press services and contacts. The main EU institutions each have a press room with facilities for journalists, where briefings and conferences are organised regularly. Journalists, film crews and photographers require accreditation in order to access the EU institution buildings. Out of these cookies, the cookies that are categorized as necessary are stored on your browser as they are as essential for the working of basic functionalities of the website. President of the European Commission Ursula von der Leyen takes off her protective face mask prior to speaking during a media conference at EU headquarters in Brussels, Thursday, Aug. 27, 2020. MEPs Press European Commission, Council, to Ratify Istanbul Convention. The EU reached its current size of 28 member countries with the accession of Croatia on 1 July 2013. VLA2001 entered Phase 1/2 clinical studies in December 2020[1] and Valneva expects to report initial safety and immunogenicity data in April 2021. EU institutions and bodies The EU institutions and bodies offer numerous subscription services, ranging from the latest headlines to specialised publications. The American Complaint You also have the option to opt-out of these cookies. In some cases, you can identify forward-looking statements by words such as “could,” “should,” “may,” “expects,” “anticipates,” “believes,” “intends,” “estimates,” “aims,” “targets,” or similar words. It is mandatory to procure user consent prior to running these cookies on your website. Basic facts and figures on EU population and size, economy, employment levels and quality of life, and also some basic information about EU administration, its staff, languages and location. The European Parliament and the European Commission also have press officers in each EU member country. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be indicative of future results. FILE - In this Friday, Oct. 19, 2016 file photo Josef Aschbacher attends a press conference in Rome, Italy. ... Press release 12 January 2021. European Union top officials and Chinese President Xi Jinping have concluded a long-awaited business investment deal with the potential to annoy the … European Commission STREAMING SERVICE OF THE EUROPEAN COMMISSION. The virus, which causes a disease named COVID-19, has never before been found in humans. The European Commission is coordinating a common European response to the coronavirus outbreak. The meeting focused in particular on progress achieved on negotiations on investment. European Commission Press Release, supra note 1. All official European Union website addresses are in the europa.eu domain.. See all EU institutions and bodies Valneva has operations in Austria, Sweden, the United Kingdom, France, Canada and the U.S. with over 500 employees. 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