Valneva SE
 | |
| Company type | Societas Europaea |
|---|---|
| Euronext Paris:VLA | |
| ISIN | FR0004056851 |
| Industry | Biotechnology |
| Predecessor | Merger ofIntercelland Vivalis SA |
| Founded | 2013 |
| Headquarters | , |
Key people | Thomas Lingelbach(CEO),Frédéric Grimaud(Chairmanof thesupervisory board) |
| Products | Development ofvaccines |
| Website | www |
Valneva SEis a French biotech company headquartered inSaint-Herblain,France, developing and commercializingvaccinesfor infectious diseases. It has manufacturing sites inLivingston,Scotland;Solna,Sweden, andVienna,Austria; with other offices in France, Canada and the United States.[1][2][3]
Background
[edit]Valneva was founded in 2013 through the merger of Austrian companyIntercelland French company Vivalis SA.[4][5]It has been listed since 28 May 2013 on theEuronext Parisin Paris and used to be listed on theVienna Stock Exchange.[citation needed]
Products
[edit]Released vaccines
[edit]Vaccines marketed by Valneva includeIxiaro,a vaccine againstJapanese encephalitis(approved in Europe, America and Australia)[6]and Dukoral, a vaccine againstcholera(approved in Europe and Australia).[7]
Failed developments
[edit]Some of its candidates have failed in clinical trials: VLA43, atherapeutic vaccineagainstPseudomonas aeruginosa,[8]V710, a therapeutic vaccine againstStaphylococcus aureus(in collaboration withMerck),[9]and IC41, therapeutic vaccine againsthepatitis C.[10]
COVID-19 vaccine
[edit]Valneva along with Dynavax Technologies[11]developed a candidateinactivated whole virus vaccineagainstCOVID-19,VLA2001,[12]derived from its Ixiaro Japanese encephalitis vaccine, which underwent aPhase 1/2 trialin the United Kingdom.[13][14]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.[15]
Valneva and dynavax technologies[16]had reached an agreement with the UK government to provide up to 100 million doses to be manufactured at its facility inLivingston,Scotland. The UK government pre-ordered 60 million doses.[12][13]The trials were supported by the UKNational Institute for Health Researchand four British universities.[15]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.[17]
The company manufacturing facility inLivingston,Scotlandproduces the VLA2001 vaccine.[18][19]
In September 2021, Valneva announced that the UK government had cancelled their vaccine order.[20]The cancellation reason was not officially given, but seemed to be related to difficulties getting building materials due toBrexit[21]and not vaccine quality.
On 14 April 2022, the UKMedicines and Healthcare products Regulatory Agency(MHRA) approved the vaccine, being the first in the world to do so.[22]
On 17 May 2022 theEuropean Commissioncancelled its advance purchase agreement for the vaccine which would have seen Valneva provide 60 million doses over two years.[23]
Other vaccines under development
[edit]Valneva is also working on four other vaccines:[citation needed]
- Ixchiq, achikungunyavaccine approved by theFood and Drug Administrationin November 2023.[24]The application for its vaccine was accepted by theEuropean Medicines Agencyon November 27, 2023.[25]
- VLA15, a vaccine againstLyme diseasethat is planned for release around 2024.
- A vaccine againstClostridiodes difficileinfection
- A vaccine against theZika virus
On 20 June 2022, American biotech firmPfizerannounced 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.[26]
References
[edit]- ^"Manufacturing and Services".Valneva.Retrieved11 January2021.
- ^"Marketing and Distribution".Valneva.Retrieved11 January2021.
- ^"Valneva Expands its Commercial Operations with the Opening of its French Commercial Office".Valneva.9 January 2020.Retrieved11 January2021.
- ^"Vivalis to Buy Intercell AG in European Biotech Merger for $174 Million".BioSpace.17 December 2012.Retrieved2 February2021.
- ^"Vivalis announces that the Intercell AG Extraordinary General Meeting has approved the proposed merger of equals with Vivalis SA to create Valneva SE".GlobeNewswire.28 February 2013.Retrieved2 February2021.
- ^"Ixiaro, Japanese-encephalitis vaccine (inactivated, adsorbed)".European Medicines Agency.5 June 2009.Retrieved25 April2017.
- ^"Dukoral, cholera vaccine (inactivated, oral)".European Medicines Agency. 30 April 2009.Retrieved25 April2017.
- ^"Valneva writes off hospital-acquired infection vaccine following PhII/III miss".FierceBiotech, Questex LLC. 2016-09-01.Retrieved2017-04-25.
- ^"Merck ends trial of Intercell's MRSA vaccine".Reuters. 2011-06-08.Retrieved2017-04-25.
- ^"Intercell Hepatitis C Vaccine Meets Primary Endpoints".FDA News. 22 August 2007.Retrieved15 August2008.
- ^"Valneva, Dynavax Inks $1.5 Billion COVID-19 Vaccine Supply Deal with UK".
- ^ab"VLA2001 COVID-19 Vaccine".Precision Vaccinations.31 December 2020.Retrieved11 January2021.
- ^ab"Covid: Clinical trials begin for Valneva vaccine".BBC News.16 December 2020.Retrieved11 January2021.
- ^"Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate".Valneva SE.16 December 2020.Retrieved18 December2020.
- ^ab"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".clinicaltrials.gov.U.S. National Library of Medicine. 30 December 2020.Retrieved11 January2021.
- ^"Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine – Valneva".
- ^Nawrat, Allie (6 August 2020)."Q&A with Valneva: UK Government scales up Covid-19 manufacturing".Pharmaceutical Technology.Retrieved11 January2021.
- ^"Biotech Valneva: European Union to buy '30 million doses of unique West Lothian Covid-19 vaccine'".Edinburgh News. 14 January 2021.Retrieved18 January2021.
- ^Yeomans, Emma."Scotland factory to produce Valneva Covid vaccine".The Times.Retrieved18 January2021.(Subscription required.)
- ^"UK scraps Covid-19 vaccine deal with French firm Valneva".BBC News.13 September 2021.
- ^"U.K. Threw Covid Vaccine Maker Under Bus over Contract, Valneva CEO Says".Bloomberg.com.24 November 2021.
- ^"Regulatory approval of COVID-19 Vaccine Valneva".GOV.UK.Retrieved2022-04-14.
- ^Dunleavy, Kevin (2022-05-17)."Valneva's COVID-19 vaccine faces uncertain future after Europe cancels supply contract".Fierce Pharma.Retrieved2022-06-21.
- ^Malhi, Sabrina (10 November 2023)."FDA approves first vaccine against mosquito-borne virus chikungunya".The Washington Post.Retrieved13 November2023.
- ^Sorgho, Olivier (27 November 2023)."Valneva says EU regulator accepts its chikungunya vaccine application".Reuters.Retrieved27 November2023.
- ^"Pfizer to buy 8.1% stake in French vaccines company Valneva".The Economic Times.Retrieved2022-06-21.
