 | |
| Company type | Societas Europaea |
|---|---|
| Euronext Paris: VLA CAC Mid 60 | |
| ISIN | FR0004056851 |
| Industry | Biotechnology |
| Predecessor | Merger ofIntercell and Vivalis SA |
| Founded | 2013 |
| Headquarters | , |
Key people | Thomas Lingelbach(CEO), Frédéric Grimaud(Chairman of thesupervisory board) |
| Products | Development ofvaccines |
| Website | www |
Valneva SE is a French biotech company headquartered inSaint-Herblain, France, developing and commercializingvaccines for 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]
Valneva was founded in 2013 through the merger of Austrian companyIntercell and French company Vivalis SA.[4][5] It has been listed since 28 May 2013 on theEuronext Paris in Paris and used to be listed on theVienna Stock Exchange.[citation needed]
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]
Some of its candidates have failed in clinical trials: VLA43, atherapeutic vaccine againstPseudomonas aeruginosa,[8] V710, a therapeutic vaccine againstStaphylococcus aureus (in collaboration withMerck),[9] and IC41, therapeutic vaccine againsthepatitis C.[10]
Valneva along with Dynavax Technologies[11] developed a candidateinactivated whole virus vaccine againstCOVID-19, VLA2001,[12] derived from its Ixiaro Japanese encephalitis vaccine, which underwent aPhase 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 inLivingston, Scotland. The UK government pre-ordered 60 million doses.[12][13] The trials were supported by the UKNational 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 inLivingston,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 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 Commission cancelled its advance purchase agreement for the vaccine which would have seen Valneva provide 60 million doses over two years.[23]
Valneva is also working on four other vaccines:[citation needed]
On 20 June 2022, American biotech firmPfizer 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]
