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VLA2001
Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies. In April 2022, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) approved the vaccine, being the first in the world to do so. It was approved for medical use in the European Union in June 2022. Technology It is a whole inactivated virus vaccine, grown in culture using the Vero cell line and inactivated with BPL. It also contains two adjuvants: alum and CpG 1018. It uses the same manufacturing technology as Valneva's Ixiaro vaccine for Japanese encephalitis. History Clinical trials Valneva COVID-19 vaccine completed phase I/II trial with 153 participants in the United Kingdom. The trials were supported by the UK National Institute for Health Research and four British universities. In April 2021, Valneva COVID-19 vaccine commenced phase III trials with approxim ...
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Valneva SE
__NOTOC__ Valneva SE is a French biotech company headquartered in Saint-Herblain, France, developing and commercializing vaccines for infectious diseases. It has manufacturing sites in Livingston, Scotland; Solna, Sweden, and Vienna, Austria, with other offices in France, Canada and the United States. __TOC__ Background Valneva was founded in 2013 through the merger of Austrian company Intercell and French company Vivalis SA. It has been listed since 28 May 2013 on the Euronext Paris in Paris and used to be listed on the Vienna Stock Exchange. Products Released Vaccines Vaccines marketed by Valneva include Ixiaro, a vaccine against Japanese encephalitis (approved in Europe, America and Australia) and Dukoral, a vaccine against cholera (approved in Europe and Australia). Failed developments Some of its candidates have failed in clinical trials: VLA43, a therapeutic vaccine against Pseudomonas aeruginosa, V710, a therapeutic vaccine against Staphylococcus aureus (in collabora ...
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COVID-19 Vaccine
A COVID19 vaccine is a vaccine intended to provide acquired immunity against severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2), the virus that causes coronavirus disease 2019 ( COVID19). Prior to the COVID19 pandemic, an established body of knowledge existed about the structure and function of coronaviruses causing diseases like severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). This knowledge accelerated the development of various vaccine platforms during early 2020. The initial focus of SARS-CoV-2 vaccines was on preventing symptomatic, often severe illness. In January 2020, the SARS-CoV-2 genetic sequence data was shared through GISAID, and by March 2020, the global pharmaceutical industry announced a major commitment to address COVID19. In 2020, the first COVID19 vaccines were developed and made available to the public through emergency authorizations and conditional approvals. Initially, most COVID19 vaccines were two ...
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Severe Acute Respiratory Syndrome Coronavirus 2
Severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) is a strain of coronavirus that causes COVID-19 (coronavirus disease 2019), the respiratory illness responsible for the ongoing COVID-19 pandemic. The virus previously had a Novel coronavirus, provisional name, 2019 novel coronavirus (2019-nCoV), and has also been called the human coronavirus 2019 (HCoV-19 or hCoV-19). First identified in the city of Wuhan, Hubei, China, the World Health Organization declared the outbreak a public health emergency of international concern on January 30, 2020, and a pandemic on March 11, 2020. SARS‑CoV‑2 is a positive-sense single-stranded RNA virus that is Contagious disease, contagious in humans. SARS‑CoV‑2 is a virus of the species ''severe acute respiratory syndrome–related coronavirus'' (SARSr-CoV), related to the Severe acute respiratory syndrome coronavirus 1, SARS-CoV-1 virus that caused the 2002–2004 SARS outbreak. Despite its close relation to SARS-CoV-1, i ...
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National Institute For Health Research
The National Institute for Health and Care Research (NIHR) is the British government’s major funder of clinical, public health, social care and translational research. With a budget of over £1.2 billion in 2020–21, its mission is to "improve the health and wealth of the nation through research". The NIHR was established in 2006 under the government's Best Research for Best Health strategy, and is funded by the Department of Health and Social Care. As a research funder and research partner of the NHS, public health and social care, the NIHR complements the work of the Medical Research Council. NIHR focuses on translational research (translating discoveries from the laboratory to the clinic), clinical research and applied health and social care research. History The NIHR (originally named National Institute for Health Research) was created in April 2006 under the government's health research strategy, Best Research for Best Health. This strategy outlined the direction that ...
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Clinical Trials
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on dosage, safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial—their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted. Depending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary i ...
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European Commission
The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President. It includes an administrative body of about 32,000 European civil servants. The Commission is divided into departments known as Directorates-General (DGs) that can be likened to departments or ministries each headed by a Director-General who is responsible to a Commissioner. There is one member per member state, but members are bound by their oath of office to represent the general interest of the EU as a whole rather than their home state. The Commission President (currently Ursula von der Leyen) is proposed by the European Council (the 27 heads of state/governments) and elected by the European Parliament. The Council of the European Union then nominates the other members of the Commission in agreement with the nominated President, and the 27 members as a team are then ...
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Brexit
Brexit (; a portmanteau of "British exit") was the withdrawal of the United Kingdom (UK) from the European Union (EU) at 23:00 GMT on 31 January 2020 (00:00 1 February 2020 CET).The UK also left the European Atomic Energy Community (EAEC or Euratom). The UK is the only sovereign country to have left the EU or the EC. Greenland left the EC (but became an OTC) on 1 February 1985. The UK had been a member state of the EU or its predecessor the European Communities (EC), sometimes of both at the same time, since 1 January 1973. Following Brexit, EU law and the Court of Justice of the European Union no longer have primacy over British laws, except in select areas in relation to Northern Ireland. The European Union (Withdrawal) Act 2018 retains relevant EU law as domestic law, which the UK can now amend or repeal. Under the terms of the Brexit withdrawal agreement, Northern Ireland continues to participate in the European Single Market in relation to goods, and to be a member o ...
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PR Newswire
PR Newswire is a distributor of press releases headquartered in Chicago. The service was created in 1954 to allow companies to electronically send press releases to news organizations, using teleprinters at first. The founder, Herbert Muschel, operated the service from his house in Manhattan for approximately 15 years. The business was eventually sold to Western Union and then United Newspapers of London. In December 2015, Cision Inc. announced it would acquire the company. On January 1, 2021, Cision formally merged PR Newswire into the company, ending its status as a legal entity after 66 years. Cision plans to continue utilizing the brand name for the foreseeable future in the United States, as well as in Europe and the Asia-Pacific regions. History PR Newswire was founded in March 1954 by Herbert Muschel, who ran the business from his town house in New York City for the first 15 years of its operation. The company used telecommunications lines and teleprinters owned by Weste ...
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Livingston, West Lothian
Livingston ( sco, Leivinstoun, gd, Baile Dhunlèibhe) is the largest town in West Lothian, Scotland. Designated in 1962, it is the fourth post-war new town to be built in Scotland. Taking its name from a village of the same name incorporated into the new town, it was originally developed in the then-counties of Midlothian and West Lothian along the banks of the River Almond. It is situated approximately fifteen miles (25 km) west of Edinburgh and thirty miles (50 km) east of Glasgow, and is close to the towns of Broxburn to the north-east and Bathgate to the north-west. The town was built around a collection of small villages, Livingston Village, Bellsquarry, and Livingston Station (now part of Deans). The town has a number of residential areas. These include Craigshill, Howden, Ladywell, Knightsridge, Deans, Dedridge, Murieston, Almondvale, Eliburn, Kirkton, and Adambrae. There are several large industrial estates in Livingston, including Houston industrial esta ...
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The Brussels Times
''The Brussels Times'' is an English-language Belgian news website and magazine, headquartered at Avenue Louise in Brussels. It was founded in 1965. It serves Belgium, particularly covering Brussels and many European countries. It originates from ''The Brussels Times'' newspaper, which was established back in 1965 and now has the largest readership of any English-language media in Belgium. The media is owned by BXL Connect. The digital site has a soft paywall and the print magazine is sold in shops and available for subscription. History ''The Brussels Times was founded in 1965 as a broadsheet newspaper. In 2014, the media and brand was revived with a new design and strategy adapted for the digital age. Audience ''The Brussels Times'' covers general news, business, EU Affairs, op-eds, and other topic areas. It is today the largest English-language print & digital media in the Benelux. The readership consists of high income, high educated diplomats, politicians, business ...
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Bloomberg News
Bloomberg News (originally Bloomberg Business News) is an international news agency headquartered in New York City and a division of Bloomberg L.P. Content produced by Bloomberg News is disseminated through Bloomberg Terminals, Bloomberg Television, Bloomberg Radio, ''Bloomberg Businessweek'', ''Bloomberg Markets'', Bloomberg.com, and Bloomberg's mobile platforms. Since 2015, John Micklethwait has served as editor-in-chief. History Bloomberg News was founded by Michael Bloomberg and Matthew Winkler in 1990 to deliver financial news reporting to Bloomberg Terminal subscribers. The agency was established in 1990 with a team of six people. Winkler was first editor-in-chief. In 2010, Bloomberg News included more than 2,300 editors and reporters in 72 countries and 146 news bureaus worldwide. Beginnings (1990–1995) Bloomberg Business News was created to expand the services offered through the terminals. According to Matthew Winkler, then a writer for ''The Wall Street Journal ...
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Phase III Trials
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases start with testing for safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays. Summary Clinical trials testing potential medical products are commonly classified into four phases. The drug development process will normally proceed through all four phases over many years. If the drug successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population. Phase IV trials are 'post-marketing' or 'surveillance' studies conducted to monitor safety over severa ...
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