Valneva SE

Last updated
Valneva SE
Company type Societas Europaea
Euronext Paris:  VLA
CAC Mid 60
ISIN FR0004056851
Industry Biotechnology
PredecessorMerger of Intercell and Vivalis SA
Founded2013
Headquarters
Saint-Herblain
,
France
Key people
Thomas Lingelbach (CEO), Frédéric Grimaud (Chairman of the supervisory board)
ProductsDevelopment of vaccines
Website www.valneva.com

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. [1] [2] [3]

Contents

Background

Valneva was founded in 2013 through the merger of Austrian company Intercell and French company Vivalis SA. [4] [5] It has been listed since 28 May 2013 on the Euronext Paris in Paris and used to be listed on the Vienna Stock Exchange.[ citation needed ]

Products

Released vaccines

Vaccines marketed by Valneva include Ixiaro, a vaccine against Japanese encephalitis (approved in Europe, America and Australia) [6] and Dukoral, a vaccine against cholera (approved in Europe and Australia). [7]

Failed developments

Some of its candidates have failed in clinical trials: VLA43, a therapeutic vaccine against Pseudomonas aeruginosa, [8] V710, a therapeutic vaccine against Staphylococcus aureus (in collaboration with Merck), [9] and IC41, therapeutic vaccine against hepatitis C. [10]

COVID-19 vaccine

Valneva along with Dynavax Technologies [11] developed a candidate inactivated whole virus vaccine against COVID-19, VLA2001, [12] derived from its Ixiaro Japanese encephalitis vaccine, which underwent a Phase 1/2 trial in 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 in Livingston, Scotland. The UK government pre-ordered 60 million doses. [12] [13] The trials were supported by the UK National Institute for Health Research and 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 in Livingston, Scotland produces 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 to Brexit [21] 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. [22]

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. [23]

Other vaccines under development

Valneva is also working on four other vaccines:[ citation needed ]

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. [26]

Related Research Articles

<span class="mw-page-title-main">H5N1 vaccine clinical trials</span> Clinical trials of influenza vaccine

H5N1 clinical trials are clinical trials concerning H5N1 vaccines, which are intended to provide immunization to influenza A virus subtype H5N1. They are intended to discover pharmacological effects and identify any adverse reactions the vaccines may achieve in humans.

<span class="mw-page-title-main">Intercell</span> Defunct biotechnology company in Austria

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 in 1998 as a spin-off of the Research Institute of Molecular Pathology (IMP) in Vienna. It employs 400 people in Austria, Scotland and the United States.

<span class="mw-page-title-main">Sinovac Biotech</span> Chinese biopharmaceutical company

Sinovac Biotech Ltd. is a Chinese biopharmaceutical company based in Haidian District, Beijing that focuses on the research, development, manufacture, and commercialization of vaccines that protect against human infectious diseases. The company was listed on the Nasdaq but the exchange halted Sinovac's trading in February 2019 due to a proxy fight. The company has faced bribery probes in China. Its COVID-19 vaccine was also the target of a covert disinformation campaign by the US government.

<span class="mw-page-title-main">Japanese encephalitis vaccine</span> Vaccine against Japanese encephalitis

Japanese encephalitis vaccine is a vaccine that protects against Japanese encephalitis. The vaccines are more than 90% effective. The duration of protection with the vaccine is not clear but its effectiveness appears to decrease over time. Doses are given either by injection into a muscle or just under the skin.

<span class="mw-page-title-main">H5N1 vaccine</span> Vaccine designed to provide immunity against H5N1 influenza

A H5N1 vaccine is an influenza vaccine intended to provide immunization to influenza A virus subtype H5N1.

<span class="mw-page-title-main">Novavax</span> American biotechnology company

Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland, that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory syncytial virus (RSV), as well as Ebola and other emerging infectious diseases. During 2020, the company redirected its efforts to focus on development and approval of its NVX-CoV2373 vaccine for COVID-19.

<span class="mw-page-title-main">Bharat Biotech</span> Indian multinational biotechnology company and vaccine manufacturer

Bharat Biotech International Limited (BBIL) is an Indian multinational biotechnology company based in Hyderabad, which is engaged in drug discovery, drug development, and the manufacture of vaccines, biotherapeutics, pharmaceuticals and healthcare products.

<span class="mw-page-title-main">CoronaVac</span> Vaccine against COVID-19

CoronaVac, also known as the Sinovac COVID-19 vaccine, was a whole inactivated virus COVID-19 vaccine developed by the Chinese company Sinovac Biotech. It was phase III clinically trialled in Brazil, Chile, Indonesia, the Philippines, and Turkey and relies on traditional technology similar to other inactivated-virus COVID-19 vaccines, such as the Sinopharm BIBP vaccine, another Chinese vaccine, and Covaxin, an Indian vaccine. CoronaVac does not need to be frozen, and both the final product and the raw material for formulating CoronaVac can be transported refrigerated at 2–8 °C (36–46 °F), the temperatures at which flu vaccines are kept.

<span class="mw-page-title-main">Sinopharm BIBP COVID-19 vaccine</span> Vaccine against COVID-19

The Sinopharm BIBP COVID-19 vaccine, also known as BBIBP-CorV, the Sinopharm COVID-19 vaccine, or BIBP vaccine, is one of two whole inactivated virus COVID-19 vaccines developed by Sinopharm's Beijing Institute of Biological Products. It completed Phase III trials in Argentina, Bahrain, Egypt, Morocco, Pakistan, Peru, and the United Arab Emirates (UAE) with over 60,000 participants. BBIBP-CorV shares similar technology with CoronaVac and Covaxin, other inactivated virus vaccines for COVID-19. Its product name is SARS-CoV-2 Vaccine, not to be confused with the similar product name of CoronaVac.

<span class="mw-page-title-main">Covaxin</span> Vaccine against COVID-19

Covaxin is a whole inactivated virus-based COVID-19 vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research - National Institute of Virology.

<span class="mw-page-title-main">Valneva COVID-19 vaccine</span> Vaccine candidate against COVID-19

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.

<span class="mw-page-title-main">Novavax COVID-19 vaccine</span> Vaccine against COVID-19

The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax, among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations.

<span class="mw-page-title-main">CoVLP</span> COVID-19 vaccine candidate produced in a plant

CoVLP was a COVID-19 vaccine developed by Medicago in Canada and GlaxoSmithKline (GSK). The product and Medicago, Inc. were owned by Mitsubishi who terminated the company and program in February 2023 due to high international market competition for COVID-19 vaccines.

<span class="mw-page-title-main">SCB-2019</span> Vaccine candidate against COVID-19

SCB-2019 is a protein subunit COVID-19 vaccine developed by Clover Biopharmaceuticals using an adjuvant from Dynavax technologies. Positive results of Phase I trials for the vaccine were published in The Lancet and the vaccine completed enrollment of 29,000 participants in Phase II/III trials in July 2021. In September 2021, SCB-2019 announced Phase III results showing 67% efficacy against all cases of COVID-19 and 79% efficacy against all cases of the Delta variant. Additionally, the vaccine was 84% effective against moderate cases and 100% effective against hospitalization.

<span class="mw-page-title-main">Sanofi–GSK COVID-19 vaccine</span> Protein subunit vaccine against COVID-19

The Sanofi–GSK COVID-19 vaccine, sold under the brand name VidPrevtyn Beta, is a COVID-19 vaccine developed by Sanofi Pasteur and GSK.

iNCOVACC Vaccine candidate against COVID-19

iNCOVACC is an intranasal COVID-19 vaccine candidate developed by Bharat Biotech, American company Precision Virologics and the Washington University School of Medicine in St Louis, Missouri, United States.

<span class="mw-page-title-main">Sinopharm WIBP COVID-19 vaccine</span> Vaccine against COVID-19

The Sinopharm WIBP COVID-19 vaccine, also known as WIBP-CorV, is one of two inactivated virus COVID-19 vaccines developed by Sinopharm. Peer-reviewed results show that the vaccine is 72.8% effective against symptomatic cases and 100% against severe cases. The other inactivated virus COVID-19 vaccine developed by Sinopharm is the BIBP vaccine (BBIBP-CorV) which is comparably more successful. 1 billion doses are expected to be produced per year.

<span class="mw-page-title-main">MVC COVID-19 vaccine</span> Vaccine against COVID-19

The MVC COVID-19 vaccine, designated MVC-COV1901 and also known as the Medigen COVID-19 vaccine, is a protein subunit COVID-19 vaccine developed by Medigen Vaccine Biologics Corporation in Taiwan, American company Dynavax Technologies, and the U.S. National Institutes of Health.

<span class="mw-page-title-main">COVAX-19</span> Vaccine candidate against COVID-19

COVAX-19 is a recombinant protein-based COVID-19 vaccine developed by South Australian-based biotech company Vaxine, in collaboration with CinnaGen, a private company with operations in the Middle East. It is under clinical trial in collaboration with the Iranian company CinnaGen.

<span class="mw-page-title-main">Skycovione</span> Vaccine candidate against COVID-19

Skycovione is a COVID-19 vaccine candidate developed by SK Bioscience and the Institute for Protein Design of the University of Washington, It is South Korea's first homegrown COVID-19 vaccine and utilizes GSK's AS03 adjuvant technology.

References

  1. ↑ "Manufacturing and Services". Valneva. Retrieved 11 January 2021.
  2. ↑ "Marketing and Distribution". Valneva. Retrieved 11 January 2021.
  3. ↑ "Valneva Expands its Commercial Operations with the Opening of its French Commercial Office". Valneva. 9 January 2020. Retrieved 11 January 2021.
  4. ↑ "Vivalis to Buy Intercell AG in European Biotech Merger for $174 Million". BioSpace. 17 December 2012. Retrieved 2 February 2021.
  5. ↑ "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. Retrieved 2 February 2021.
  6. ↑ "Ixiaro, Japanese-encephalitis vaccine (inactivated, adsorbed)". European Medicines Agency. 5 June 2009. Retrieved 25 April 2017.
  7. ↑ "Dukoral, cholera vaccine (inactivated, oral)". European Medicines Agency. 30 April 2009. Retrieved 25 April 2017.
  8. ↑ "Valneva writes off hospital-acquired infection vaccine following PhII/III miss". FierceBiotech, Questex LLC. 2016-09-01. Retrieved 2017-04-25.
  9. ↑ "Merck ends trial of Intercell's MRSA vaccine". Reuters. 2011-06-08. Retrieved 2017-04-25.
  10. ↑ "Intercell Hepatitis C Vaccine Meets Primary Endpoints". FDA News. 22 August 2007. Retrieved 15 August 2008.
  11. ↑ "Valneva, Dynavax Inks $1.5 Billion COVID-19 Vaccine Supply Deal with UK".
  12. 1 2 "VLA2001 COVID-19 Vaccine". Precision Vaccinations. 31 December 2020. Retrieved 11 January 2021.
  13. 1 2 "Covid: Clinical trials begin for Valneva vaccine". BBC News. 16 December 2020. Retrieved 11 January 2021.
  14. ↑ "Valneva Initiates Phase 1/2 Clinical Study of Inactivated, Adjuvanted COVID-19 Vaccine Candidate". Valneva SE. 16 December 2020. Retrieved 18 December 2020.
  15. 1 2 "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. Retrieved 11 January 2021.
  16. ↑ "Valneva and Dynavax Announce Commercial Supply Agreement for Inactivated, Adjuvanted COVID-19 Vaccine – Valneva".
  17. ↑ Nawrat, Allie (6 August 2020). "Q&A with Valneva: UK Government scales up Covid-19 manufacturing". Pharmaceutical Technology. Retrieved 11 January 2021.
  18. ↑ "Biotech Valneva: European Union to buy '30 million doses of unique West Lothian Covid-19 vaccine'". Edinburgh News. 14 January 2021. Retrieved 18 January 2021.
  19. ↑ Yeomans, Emma. "Scotland factory to produce Valneva Covid vaccine". The Times. Retrieved 18 January 2021.(Subscription required.)
  20. ↑ "UK scraps Covid-19 vaccine deal with French firm Valneva". BBC News. 13 September 2021.
  21. ↑ "U.K. Threw Covid Vaccine Maker Under Bus over Contract, Valneva CEO Says". Bloomberg.com. 24 November 2021.
  22. ↑ "Regulatory approval of COVID-19 Vaccine Valneva". GOV.UK. Retrieved 2022-04-14.
  23. ↑ Dunleavy, Kevin (2022-05-17). "Valneva's COVID-19 vaccine faces uncertain future after Europe cancels supply contract". Fierce Pharma. Retrieved 2022-06-21.
  24. ↑ Malhi, Sabrina (10 November 2023). "FDA approves first vaccine against mosquito-borne virus chikungunya". The Washington Post . Retrieved 13 November 2023.
  25. ↑ Sorgho, Olivier (27 November 2023). "Valneva says EU regulator accepts its chikungunya vaccine application". Reuters . Retrieved 27 November 2023.
  26. ↑ "Pfizer to buy 8.1% stake in French vaccines company Valneva". The Economic Times. Retrieved 2022-06-21.
This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.