Valneva

Valneva is a specialty vaccine company focused on prevention against diseases with major unmet needs.

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Website Transparency Register Profile

ID: 116284040570-75

Lobbying Activity

Meeting with Marie-Hélène Pradines (Head of Unit Internal Market, Industry, Entrepreneurship and SMEs)

12 Jun 2025 · Small midcaps recommendation

Response to Biotech Act

11 Jun 2025

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Meeting with Florika Fink-Hooijer (Director-General Health Emergency Preparedness and Response Authority)

3 Jun 2025 · Discussion in the margins of HERA Industry days

Response to EU Strategy on medical countermeasures

6 May 2025

Valneva is a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. Our vision is to contribute to a world in which no one dies or suffers from a vaccine-preventable disease. Public health threats to Europe can come in different shapes: from a pandemic or epidemic outbreak of an infectious disease to health issues related to climate change to the silent pandemic of Anti-Microbial Resistance (AMR). In many cases, vaccines can be an important component in the response to such crises. Chikungunya can be taken as an example of an outbreak disease. It is transmitted by Aedes mosquitoes that have become prevalent in large parts of continental Europe. Chikungunya can lead to fast and important outbreaks, as is currently the case on the island of La Réunion (an outermost region of the EU). Modelling has shown that vaccination if initiated early enough can be an important tool to control outbreaks . This in turn requires stockpiles of approved vaccines, ready for deployment. Development of vaccines is a long and expensive process. Investments over 500 M$ are needed for bringing a vaccine to approval, an effort that takes typically 10-15 years . Thereafter, manufacturing of vaccines is recognized as one of the most challenging industries2. On average, it takes between 12-36 months to manufacture a vaccine before it is ready for distribution . Vaccines are complex biological products with lengthy manufacturing and control processes. Therefore, it is usually not feasible to wait for a public health threat to materialise before production is initiated. Moreover, certain pathogens carry a real risk for public health, as evidenced by different institutions such as WHO - but may not present a sufficiently attractive commercial market to justify the entrepreneurial risk and investment to complete the development of a vaccine as Medical Countermeasure (MCM). Accordingly, targeted support is required to support the development and approval of such vaccines: Financial support during development, e.g. by appropriate grant funding for industrial clinical research Creating opportunities where there is no market or not sufficient demand to justify the continuous production of vaccines, e.g. by stockpiling or ever-warm production capacity We commend the advent of HERA, as a new actor situated at the intersection of science, supply, public health and procurement. To further deliver on its mission, HERA must be able to act decisively and boldly: mechanisms for rapid interventions, fast decision-making and significant investment also outside of crisis mode to prepare ahead for the next health emergency. Consequently, HERA should be doted with appropriate financial means and the necessary autonomy to support the development of MCM and securing their availability. 1) Pérez-Estigarribia, P.E., Ribeiro dos Santos, G., Cauchemez, S. et al. Modeling the impact of vaccine campaigns on the epidemic transmission dynamics of chikungunya virus outbreaks. Nat Med (2025). https://doi.org/10.1038/s41591-025-03684-w 2) Plotkin S, Robinson JM, Cunningham G, Iqbal R, Larsen S. The complexity and cost of vaccine manufacturing - An overview. Vaccine. 2017;35(33):4064-4071. doi:10.1016/j.vaccine.2017.06.003 3) https://www.ifpma.org/publications/the-complex-journey-of-a-vaccine-the-steps-behind-developing-a-new-vaccine/ (accessed May 2025) 4) https://www.vaccineseurope.eu/about-vaccines/how-are-vaccines-produced 5) https://www.who.int/publications/m/item/pathogens-prioritization-a-scientific-framework-for-epidemic-and-pandemic-research-preparedness (accessed May 2025)

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Meeting with András Tivadar Kulja (Member of the European Parliament)

22 Apr 2025 · Climate change-related disease outbreaks

Response to EU Life sciences strategy

12 Apr 2025

VALNEVA SE is a European biotech company developing, manufacturing and commercialising vaccines against infectious diseases with a large unmet medical need. Its affiliate Valneva Austria is a member of BIOTECH AUSTRIA, the association which represents the interests of the growing Austrian biotechnology industry sector. Valneva and Biotech Austria welcome the opportunity to contribute to the EU Life Science Strategy Call for Evidence. We see the Life Science Strategy as an opportunity to position the life sciences and biotech industries as key drivers of EU competitiveness in particular smaller and mid-sized companies that bring innovation and advance candidates from early research to clinical development. However, data show that Europe is lacking behind the USA. 73% of the global top 30 high tech companies have been founded in the US, while only 10% are from Europe. During the last fifty years, not a single new company from within the EU managed to break the 100 billion capitalization threshold. We want to highlight in particular the following major barriers to success in Europe: 1. access to finance 2. regulatory and bureaucratic burdens and fragmentation Ad 1., access to finance The Life Science Strategy should highlight pathways to facilitate investments into the biotech sector. It should also review the non-dilutive funding mechanisms available in Europe. Creative public-private partnerships are also a potential means to supporting the Life Science industry in Europe and enabling their access to funds. Ad 2, Simplification to improve Competitiveness We commend the Commission recent Omnibus proposal which proposed several avenues for regulatory simplification, particularly with regards to ESG reporting. Another necessary improvement is related to possible legal forms for young enterprises. Definition of Pharmaceutical Small and Mid-Caps should be mordernised. Finally, we appreciate the work performed by DG HERA and hope it is doted with sufficient funds during the next Multiannual Financial Framework. Please find attached a more extensive feedback. We remain available for further discussions and thank you for your consideration of the points raised.

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Meeting with Felice Zaccheo (Head of Unit Directorate-General for International Partnerships) and Coalition for Epidemic Preparedness Innovations and

31 Mar 2025 · Exchange of views on bi-regional cooperation and private sector investment in strengthening LAC’s health sector self-sufficiency, regulatory harmonisation, regional tech transfers and manufacturing in Latin America.

Meeting with Ann-Sofie Ronnlund (Cabinet of Commissioner Ekaterina Zaharieva)

25 Mar 2025 · Microsoft Teams Meeting- life sciences research and innovation

Meeting with András Tivadar Kulja (Member of the European Parliament)

28 Jan 2025 · Infectious diseases addressing unmet medical needs

Meeting with Günther Sidl (Member of the European Parliament)

11 Dec 2024 · General Exchange of Views

Meeting with Tomislav Sokol (Member of the European Parliament)

13 Nov 2024 · Health policy

Response to Review of the Health Emergency Preparedness and Response Authority (HERA)

19 Feb 2024

Valneva sees HERA as an important new actor situated at the intersection of science, supply, public health and procurement. We appreciated its actions during the COVID pandemic, and since. To further live up to its expectations, in our opinion, HERA must be able to act decisively and boldly: mechanisms for rapid interventions, fast decision-making and significant investment both in times of crises and in those in between, when we need to prepare ahead for the next health emergency. This requires two things: First, HERA would need its own budget, one that is large enough for HERA to make a difference and find its place in the international spectrum of Public Health. Valneva would expect HERAs financial autonomy to increase over the next budgetary cycles even as the COVID health emergency recedes, further threats are looming, such as viral outbreak diseases. Funds are required to support development of new counter-measures, procure and stock-pile certain products, and prepare for new crises. The creation of HERA leads to opportunities to enhance preparedness across the entire emerging diseases portfolio. The budget needs therefore to be ample and guaranteed over a long period of time (considering the standard timelines for vaccine development, and the cycles for the emergence of health threats). Second, HERA needs autonomy in decision making (within the EUs framework). This is coupled with its own budget on the one side. On the other, certain procedures and topics should be clearly centralised with HERA, with the appropriate checks and balances in place. Organisationally, this could be achieved by transforming HERA into a separate agency. This would strengthen continuity for the European plans of strategic autonomy and prevention of future health crises. The added certainty of working with an established agency also provides more security for industry looking to engage on the long term. Valneva also commends HERAs efforts to support vaccine development through new instruments such as HERA Invest. To support HERAs mission and counter future serious cross-border health threats, additional financial contributions for the development of new counter-measures such as vaccines against outbreak diseases or AMR, and mechanisms to sustain production in Europe such as stockpiling contracts are needed (we think that collaborative research requirements make Horizon Europe programs unfit to quickly advance vaccine development). Finally, Valneva is thankful for the opportunity to provide feedback, and is looking forward to continuing to engage with HERA to provide views from a smaller European company focused on developing and producing vaccines against unmet medical needs.

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Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

26 Oct 2023 · Vaccines

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

27 Jun 2023 · Vaccines

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair) and FIPRA International SRL

23 Mar 2023 · Exchange of views on HERA - APA

Meeting with Pierre Delsaux (Director-General Health Emergency Preparedness and Response Authority)

13 Mar 2023 · Valneva updated HERA on their products available and in development.

Meeting with Valérie Hayer (Member of the European Parliament)

27 Jan 2023 · Stratégie européenne de santé

Meeting with Max Orville (Member of the European Parliament)

9 Dec 2022 · Présentation travaux sur les vaccins Covid-19 et maladies rares

Meeting with Günther Sidl (Member of the European Parliament)

22 Nov 2022 · General Exchange of Views

Meeting with Kathleen Van Brempt (Member of the European Parliament, Committee chair)

8 Nov 2022 · Production of vaccines and the EU's longterm vaccine strategy

Meeting with Thierry Breton (Commissioner)

2 Mar 2021 · Vaccine production

Response to European Health Emergency Response Authority

24 Feb 2021

Valneva very much welcomes the Commission’s initiative to create a European Health Emergency Preparedness and Response Authority (HERA). The current pandemic has shown that Europe needs more and better coordination in order to respond to cross-border health crises and to establish well in advance a comprehensive toolbox that can provide robust health preparedness measures. Customised funding and partnerships. Over the last decades Europe has seen a number of important novel medicines and their technology platforms being developed outside the EU. This is mainly due to the gap between funding the initial research and allowing the commercialisation of the products. Whereas some novel technologies were originally invented in Europe and often received some sort of seed funding from European public authorities, the actual support for the launch of broad clinical research was taken over by public and private stakeholders outside the EU. Such development has important repercussions on intellectual property, brain drain of employees, and ultimately even access and availability to novel medicinal products for European citizens. The current European practice, whereby EU research funding (e.g. Horizon, IMI, etc.) is mainly accessible through consortia, seems more beneficial to a limited number of big pharma companies and academia that have sufficient human and/or financial recourses to participate and handle the often complex bureaucratic processes. Response to emerging diseases. It is positive to see that the HERA IIA explicitly refers to establishing a development capacity whereby the innovation for medical countermeasures against anticipated cross-border health threats might be supported. Development of new medicinal products to emerging threats is very demanding and involves several risks, as we are currently all experiencing with the development of novel COVID-19 vaccines. The final stages of clinical trials and the commercialisation of a product require enormous financial resources. Without clear and outspoken support from public authorities during this critical development stage, smaller and intermediate biotechnology companies with novel solutions will have hardly any chance to access the global competitive healthcare market. This is where public authorities and mechanisms such as HERA should play a role to provide safeguards that validated research will eventually result into product procurement. The role of mid-size companies. European biotech and mid-size companies are essential players in the development of novel medicines. Therefore, it is important that this part of the healthcare industry is involved at an early stage when HERA is conceptualised and established. As outlined in the above, there is quite a difference in capabilities to engage with stakeholders between SMEs/mid-caps such as Valneva and larger pharmaceutical companies. Valneva supports the Commission’s suggested policy option 3, whereby a future HERA shall be entailed as a fully competent EU authority empowered to streamline the various initiatives and to support the end-to-end development of medical countermeasures. A coordinated EU body that allows in a holistic manner (based on threat assessment, capacity analysis, validation of early-stage research and competitive bidding) the required investments in health preparedness will ultimately enable and accelerate the research and development of new medical countermeasures such as vaccines against emerging diseases. Valneva looks forward to working together with the Commission and other stakeholders to build solutions that support continued innovation in medical research and health preparedness against current and future health threats.

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