__NOTOC__ Valneva SE is a French biotech company headquartered in

Saint-Herblain Saint-Herblain (; br, Sant-Ervlan, ) is a Communes of France, commune in the Loire-Atlantique Departments of France, department, administrative region of Pays de la Loire (Brittany (historical province), Brittany as historical region), France. I ...

, France, developing and commercializing

vaccine A vaccine is a biological Dosage form, preparation that provides active acquired immunity to a particular infectious disease, infectious or cancer, malignant disease. The safety and effectiveness of vaccines has been widely studied and verifie ...

s for infectious diseases. It has manufacturing sites in

Livingston Livingston may refer to: Businesses * Livingston Energy Flight, an Italian airline (2003–2010) * Livingston Compagnia Aerea, an Italian airline (2011–2014), also known as Livingston Airline * Livingston International, a North American custom ...

, Scotland;

Solna Solna Municipality ( sv, Solna kommun or , ) is a municipality in Stockholm County in Sweden, located just north of Stockholm City Centre. Its seat is located in the town of Solna, which is a part of the Stockholm urban area. Solna is one of t ...

, Sweden, and

Vienna en, Viennese , iso_code = AT-9 , registration_plate = W , postal_code_type = Postal code , postal_code = , timezone = CET , utc_offset = +1 , timezone_DST ...

, 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 Intercell AG was a biotechnology company based in Vienna which focused on the development of modern prophylactic and therapeutic vaccines against infectious diseases. The company merged with Vivalis to form Valneva SE in 2012. Intercell was formed ...

and French company Vivalis SA. It has been listed since 28 May 2013 on the

Euronext Paris Euronext Paris is France's securities market, formerly known as the Paris Bourse, which merged with the Amsterdam, Lisbon, and Brussels exchanges in September 2000 to form Euronext NV. As of 2022, the 795 companies listed had a combined marke ...

in Paris and used to be listed on the

Vienna Stock Exchange en, Viennese , iso_code = AT-9 , registration_plate = W , postal_code_type = Postal code , postal_code = , timezone = CET , utc_offset = +1 , timezone_DST ...

Products

Released Vaccines

Vaccines marketed by Valneva include Ixiaro, a vaccine against

Japanese encephalitis Japanese encephalitis (JE) is an infection of the brain caused by the Japanese encephalitis virus (JEV). While most infections result in little or no symptoms, occasional inflammation of the brain occurs. In these cases, symptoms may include he ...

(approved in Europe, America and Australia) and Dukoral, a vaccine against

cholera Cholera is an infection of the small intestine by some strains of the bacterium ''Vibrio cholerae''. Symptoms may range from none, to mild, to severe. The classic symptom is large amounts of watery diarrhea that lasts a few days. Vomiting and ...

(approved in Europe and Australia).

Failed developments

Some of its candidates have failed in clinical trials: VLA43, a

therapeutic vaccine A therapeutic vaccine is a vaccine which is administered after a disease or infection has already occurred. A therapeutic vaccine works by activating the immune system of a patient to fight an infection. A therapeutic vaccine differs from a prophyla ...

against

Pseudomonas aeruginosa ''Pseudomonas aeruginosa'' is a common encapsulated, gram-negative, aerobic–facultatively anaerobic, rod-shaped bacterium that can cause disease in plants and animals, including humans. A species of considerable medical importance, ''P. aerugi ...

, V710, a therapeutic vaccine against

Staphylococcus aureus ''Staphylococcus aureus'' is a Gram-positive spherically shaped bacterium, a member of the Bacillota, and is a usual member of the microbiota of the body, frequently found in the upper respiratory tract and on the skin. It is often positive ...

(in collaboration with

Merck Merck refers primarily to the German Merck family and three companies founded by the family, including: * the Merck Group, a German chemical, pharmaceutical and life sciences company founded in 1668 ** Merck Serono (known as EMD Serono in the Unite ...

), and IC41, therapeutic vaccine against

hepatitis C Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver; it is a type of viral hepatitis. During the initial infection people often have mild or no symptoms. Occasionally a fever, dark urine, a ...

COVID-19 vaccine

Valneva along with Dynavax Technologies developed a candidate inactivated whole virus vaccine against

COVID-19 Coronavirus disease 2019 (COVID-19) is a contagious disease caused by a virus, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The first known case was COVID-19 pandemic in Hubei, identified in Wuhan, China, in December ...

, VLA2001 derived from its Ixiaro Japanese encephalitis vaccine, which is undergoing a Phase 1/2 trial in the United Kingdom. The Phase 1/2 trial has 150 participants testing three dose levels for safety, tolerability, and immunogenicity. The trial is expected to be complete by 15 February 2021, with full reporting completed by August 2021. Valneva and dynavax technologies had reached an agreement with the UK government to provide up to 100 million doses to be manufactured at its facility in

, Scotland. The UK government pre-ordered 60 million doses. The trials are being supported by the UK

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 "impr ...

and four British universities. Due to government support, Valneva would progress immediately into Phase 3 trials and develop production capacity before the full evaluation of the Phase 1/2 trial, rather than the traditional slower sequential approach which has lower financial risk. The company manufacturing facility in

Scotland Scotland (, ) is a country that is part of the United Kingdom. Covering the northern third of the island of Great Britain, mainland Scotland has a border with England to the southeast and is otherwise surrounded by the Atlantic Ocean to the ...

produces the VLA2001 vaccine. In September 2021, Valneva announced that the UK government had cancelled their vaccine order. The cancellation reason was not officially given, but seems to be related to difficulties getting building materials due to

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 ...

and not vaccine quality. On 14 April 2022, the UK

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably ...

(MHRA) approved the vaccine, being the first in the world to do so. On 17 May 2022 the

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 o ...

cancelled its advance purchase agreement for the vaccine which would have seen Valneva provide 60 million doses over two years.

Other vaccines under development

Valneva is also working on four other vaccines : * Vaccine against

chikungunya Chikungunya is an infection caused by the ''Chikungunya virus'' (CHIKV). Symptoms include fever and joint pains. These typically occur two to twelve days after exposure. Other symptoms may include headache, muscle pain, joint swelling, and a ra ...

* VLA15 : a vaccine against

Lyme disease Lyme disease, also known as Lyme borreliosis, is a vector-borne disease caused by the ''Borrelia'' bacterium, which is spread by ticks in the genus ''Ixodes''. The most common sign of infection is an expanding red rash, known as erythema migran ...

that is planned for release around 2024. * A vaccine against ''Clostridiodes difficile'' infection * A vaccine against the

Zika virus ''Zika virus'' (ZIKV; pronounced or ) is a member of the virus family ''Flaviviridae''. It is spread by daytime-active ''Aedes'' mosquitoes, such as '' A. aegypti'' and '' A. albopictus''. Its name comes from the Ziika Forest of Uganda, whe ...

On 20 June 2022, American Biotech firm

Pfizer Pfizer Inc. ( ) is an American multinational pharmaceutical and biotechnology corporation headquartered on 42nd Street in Manhattan, New York City. The company was established in 1849 in New York by two German entrepreneurs, Charles Pfizer ...

announced a 90.5 million euros ($95.24 million) investment, buying an 8.1% percent stake in Valneva as part of a partnership to tackle Lyme disease.

References

External links

*
Vienna Stock Exchange: Market Data Valneva SE
{{Portal, Companies Manufacturing companies based in Vienna Biotechnology companies of France Pharmaceutical companies established in 2013 Companies listed on Euronext Paris COVID-19 vaccine producers