Valneva SE

Valneva was founded in 2013 through the merger of Austrian company Intercell and French company Vivalis SA.{{cite news |url=https://www.biospace.com/article/releases/vivalis-to-buy-intercell-ag-in-european-biotech-merger-for-174-million-/ |title=Vivalis to Buy Intercell AG in European Biotech Merger for $174 Million |website=BioSpace |date=17 December 2012 |access-date=2 February 2021}}{{cite news |url=https://www.globenewswire.com/news-release/2013/02/28/1783874/0/en/Vivalis-announces-that-the-Intercell-AG-Extraordinary-General-Meeting-has-approved-the-proposed-merger-of-equals-with-Vivalis-SA-to-create-Valneva-SE.html |title=Vivalis announces that the Intercell AG Extraordinary General Meeting has approved the proposed merger of equals with Vivalis SA to create Valneva SE |website=GlobeNewswire |date=28 February 2013 |access-date=2 February 2021}} It has been listed since 28 May 2013 on the Euronext Paris in Paris and used to be listed on the Vienna Stock Exchange.{{cn|date=October 2022}}

Vaccines marketed by Valneva include Ixiaro, a vaccine against Japanese encephalitis (approved in Europe, America and Australia){{cite web |url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000963/human_med_000862.jsp&mid=WC0b01ac058001d124 |title=Ixiaro, Japanese-encephalitis vaccine (inactivated, adsorbed) |publisher=European Medicines Agency |date=5 June 2009 |access-date=25 April 2017}} and Dukoral, a vaccine against cholera (approved in Europe and Australia).{{cite web |url=http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000476/human_med_000745.jsp&mid=WC0b01ac058001d124 |title=Dukoral, cholera vaccine (inactivated, oral) |publisher=European Medicines Agency |date=30 April 2009 |access-date=25 April 2017}}

Some of its candidates have failed in clinical trials: VLA43, a therapeutic vaccine against Pseudomonas aeruginosa,{{cite web|url=http://www.fiercebiotech.com/biotech/valneva-writes-off-hospital-acquired-infection-vaccine-following-phii-iii-miss|title=Valneva writes off hospital-acquired infection vaccine following PhII/III miss|publisher=FierceBiotech, Questex LLC.|date=2016-09-01|access-date=2017-04-25}} V710, a therapeutic vaccine against Staphylococcus aureus (in collaboration with Merck),{{cite web|url= https://www.reuters.com/article/us-intercell-merck-idUSTRE75711P20110608|title= Merck ends trial of Intercell's MRSA vaccine|publisher=Reuters|date=2011-06-08|access-date=2017-04-25}} and IC41, therapeutic vaccine against hepatitis C.{{cite web|url=http://www.fdanews.com/newsletter/article?articleId=97461&issueId=10614|title=Intercell Hepatitis C Vaccine Meets Primary Endpoints|publisher=FDA News|date=22 August 2007 |access-date=15 August 2008}}

{{main article|Valneva COVID-19 vaccine}}

Valneva along with Dynavax Technologies{{Cite web|url=https://www.fdanews.com/articles/199049-valneva-dynavax-inks-15-billion-covid-19-vaccine-supply-deal-with-uk|title=Valneva, Dynavax Inks $1.5 Billion COVID-19 Vaccine Supply Deal with UK}} developed a candidate inactivated whole virus vaccine against COVID-19, VLA2001,{{cite web |url=https://www.precisionvaccinations.com/vaccines/vla2001-covid-19-vaccine |title=VLA2001 COVID-19 Vaccine |website=Precision Vaccinations |date=31 December 2020 |access-date=11 January 2021}} derived from its Ixiaro Japanese encephalitis vaccine, which underwent a Phase 1/2 trial in the United Kingdom.{{cite news |url=https://www.bbc.co.uk/news/uk-scotland-edinburgh-east-fife-55316690 |title=Covid: Clinical trials begin for Valneva vaccine |work=BBC News |date=16 December 2020 |access-date=11 January 2021}}{{cite web |url=https://valneva.com/press-release/valneva-initiates-phase-1-2-clinical-study-of-inactivated-adjuvanted-covid-19-vaccine-candidate/ |title=Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate |website=Valneva SE |date=16 December 2020 |access-date=18 December 2020}} The Phase 1/2 trial had 150 participants, testing three dose levels for safety, tolerability, and immunogenicity. The trial was expected to be complete by 15 February 2021, with full reporting completed by August 2021.{{cite web |url=https://clinicaltrials.gov/ct2/show/NCT04671017 |title=Dose Finding Study to Evaluate Safety, Tolerability and Immunogenicity of an Inactiviated Adjuvanted Sars-Cov-2 Virus Vaccine Candidate Against Covid-19 in Healthy Adults |website=clinicaltrials.gov |publisher=U.S. National Library of Medicine |date=30 December 2020 |access-date=11 January 2021}}

Valneva and dynavax technologies{{Cite web|url=https://valneva.com/press-release/valneva-and-dynavax-announce-commercial-supply-agreement-for-inactivated-adjuvanted-covid-19-vaccine/|title = Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine – Valneva}} had reached an agreement with the UK government to provide up to 100 million doses to be manufactured at its facility in Livingston, Scotland. The UK government pre-ordered 60 million doses. The trials were supported by the UK National Institute for Health Research 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.{{cite news |url=https://www.pharmaceutical-technology.com/features/valneva-manufacturing-uk-government-covid19/ |title=Q&A with Valneva: UK Government scales up Covid-19 manufacturing |last=Nawrat |first=Allie |website=Pharmaceutical Technology |date=6 August 2020 |access-date=11 January 2021}}

The company manufacturing facility in Livingston, Scotland produces the VLA2001 vaccine.{{cite web |url=https://www.edinburghlive.co.uk/news/edinburgh-news/biotech-valneva-european-union-buy-19625622| title=Biotech Valneva: European Union to buy '30 million doses of unique West Lothian Covid-19 vaccine' | date=14 January 2021 | publisher=Edinburgh News |access-date=18 January 2021}}{{cite news |url=https://www.thetimes.com/uk/healthcare/article/scotland-factory-to-produce-valneva-covid-vaccine-cdz7t9tlc| title=Scotland factory to produce Valneva Covid vaccine | work=The Times |access-date=18 January 2021| last1=Yeomans | first1=Emma }}{{subscription required|s}}

In September 2021, Valneva announced that the UK government had cancelled their vaccine order.{{Cite news|url=https://www.bbc.co.uk/news/business-58499064|title = UK scraps Covid-19 vaccine deal with French firm Valneva|work = BBC News|date = 13 September 2021}} The cancellation reason was not officially given, but seemed to be related to difficulties getting building materials due to Brexit{{Cite news | url=https://www.bloomberg.com/news/articles/2021-11-24/u-k-threw-covid-vaccine-maker-under-bus-over-contract-ceo-says | title=U.K. Threw Covid Vaccine Maker Under Bus over Contract, Valneva CEO Says | newspaper=Bloomberg.com | date=24 November 2021 }} and not vaccine quality.

On 14 April 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) approved the vaccine, being the first in the world to do so.{{Cite web |title=Regulatory approval of COVID-19 Vaccine Valneva |url=https://www.gov.uk/government/publications/regulatory-approval-of-covid-19-vaccine-valneva |access-date=2022-04-14 |website=GOV.UK |language=en}}

On 17 May 2022 the European Commission cancelled its advance purchase agreement for the vaccine which would have seen Valneva provide 60 million doses over two years.{{Cite web |last=Dunleavy |first=Kevin |date=2022-05-17 |title=Valneva's COVID-19 vaccine faces uncertain future after Europe cancels supply contract |url=https://www.fiercepharma.com/pharma/valneva-covid-19-vaccine-faces-uncertain-future-after-europe-cancels-supply-contract |access-date=2022-06-21 |website=Fierce Pharma |language=en}}

Valneva is also working on four other vaccines:{{cn|date=October 2022}}

• Ixchiq, a chikungunya vaccine approved by the Food and Drug Administration in November 2023.{{Cite news |last=Malhi |first=Sabrina |date=10 November 2023 |title=FDA approves first vaccine against mosquito-borne virus chikungunya |url=https://www.washingtonpost.com/health/2023/11/10/chikungunya-vaccine-approved-mosquito-bites/ |access-date=13 November 2023 |newspaper=The Washington Post}} The application for its vaccine was accepted by the European Medicines Agency on November 27, 2023.{{Cite web |last=Sorgho |first=Olivier |date=27 November 2023 |title=Valneva says EU regulator accepts its chikungunya vaccine application |url=https://www.reuters.com/business/healthcare-pharmaceuticals/valneva-says-eu-regulator-accepts-its-chikungunya-vaccine-application-2023-11-27/ |access-date=27 November 2023 |website=Reuters}}
• VLA15, a vaccine against Lyme disease that is planned for release around 2026.
• A vaccine against Clostridiodes difficile infection
• A vaccine against the Zika virus

On 20 June 2022, American biotech firm Pfizer announced a 90.5 million euro ($95.24 million) investment, buying an 8.1% stake in Valneva as part of a partnership to tackle Lyme disease.{{Cite news |title=Pfizer to buy 8.1% stake in French vaccines company Valneva |work=The Economic Times |url=https://economictimes.indiatimes.com/news/international/business/pfizer-to-buy-8-1-stake-in-french-vaccines-company-valneva/articleshow/92330582.cms |access-date=2022-06-21}}

{{Reflist}}

• {{Official website|http://www.valneva.com/}}
• [https://www.wienerborse.at/en/market-data/shares-others/quote/?ID_NOTATION=81269105&ISIN=FR0004056851 Vienna Stock Exchange: Market Data Valneva SE]

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Category:Manufacturing companies based in Vienna

Category:Biotechnology companies of France

Category:Pharmaceutical companies established in 2013

Category:Companies listed on Euronext Paris

Category:COVID-19 vaccine producers