A new pandemic has not been determined, a specific pathogen is not known – and yet the health authorities of the USA and Europe are already preparing to develop corresponding vaccines. On October 16, 2026, the U.S. Department of Health and Human Services officially added the hypothetical threat “Threat X” to a list of nine priority virus threats. The European Union has been pursuing a similar strategy for some time under the term “Disease X” and has production capacities for up to 325 million vaccine doses available annually.
The new announcement comes from the Biomedical Advanced Research and Development Authority (BARDA), an agency of the U.S. Department of Health and Human Services HHS. In an official announcement dated October 16, 2026, BARDA stated that it would use nine priority virus threats to review and further develop medical technologies in the future. In addition to well-known pathogens such as Nipah, Dengue, MERS-CoV and the West Nile virus, this list also includes a notable name: “Threat-X”.
The special thing about it is that no specific pathogen has been identified for this threat. Nevertheless, it is intended to test the adaptability of technologies for the rapid development of vaccines, drugs and diagnostic procedures. BARDA relies on platform technologies that can be converted to new pathogens as quickly as possible in the event of a future health crisis. However, the authority emphasizes that inclusion on the priority list does not yet mean a binding commitment to a complete development program.
The US journalist Jon Fleetwood picked up on this development in an article published on November 4. In particular, he criticizes the fact that the government first defines a hypothetical biological threat and then uses it as the basis for research priorities and possible government funding programs. Pharmaceutical companies are explicitly encouraged by BARDA to consider the relevant technologies and to monitor future financing opportunities.
This raises a fundamental question: If a pathogen is not yet known, what criteria are used to decide which technologies are developed, which companies are promoted and which public money is used for them?
Europe has been working on the same strategy for a long time
What now officially appears on the priority list in the United States under the name “Threat X” is by no means new in Europe. The World Health Organization (WHO) has been using the term “Disease X” since 2018. It refers to a hypothetical disease that could be triggered by a previously unknown pathogen and cause a serious international epidemic.
The European Union has also incorporated this concept into its health policy. An official document from the European Commission dated 22 May 2024 explicitly states that the European health authority HERA is building up a broad portfolio of measures to be able to respond quickly to “Disease X”. This includes the development of medical countermeasures, the promotion of new technologies, the monitoring of possible pathogens and the provision of industrial production capacities.
HERA was created after the Corona pandemic and is responsible for preparing for future health crises. The Authority works with EU Member States, research institutions and pharmaceutical companies to develop, procure and, if necessary, produce vaccines and medicines as early as possible.
In the meantime, the European Commission has further expanded its health policy preparations. On 13 May 2026, it adopted a new initiative on global health resilience, which aims to strengthen cooperation and crisis preparedness internationally.
325 million vaccine doses per year – production capacities are ready
European preparations are particularly advanced in terms of production capacities. The so-called EU FAB network was already set up in June 2023. It includes vaccine manufacturers in Belgium, Ireland, the Netherlands and Spain.
The EU has thus secured production capacities of up to 325 million vaccine doses per year in total. The systems are to be kept permanently operational so that they can be activated quickly in the event of a health crisis. Various technologies are planned, including mRNA vaccines, vector-based vaccines and protein-based preparations.
These are not 325 million vaccine doses already produced, but contractually secured production capacities. The European Commission can activate it in the event of a corresponding health emergency.
Nevertheless, the dimension of these preparations is remarkable. While the public does not yet know which pathogen could trigger a possible next pandemic, state-organized research structures, contracts with manufacturers and reserved industrial capacities already exist.
The official reason is to be able to react faster in an emergency than during the Corona pandemic. At the same time, this creates a lasting link between state health care, public research funding and the pharmaceutical industry.
The unknown disease as the basis for permanent pandemic preparation
Behind the terms “Threat X” and “Disease X” is a fundamental change in pandemic policy. While vaccines are traditionally developed against identified pathogens, today technological platforms are said to be available before it is clear against which pathogen they could one day be used.
This does not mean that a finished vaccine against a completely unknown disease already exists. Without knowledge of the pathogen, neither the specific target structures of a vaccine nor its efficacy can be determined. Rather, technologies, manufacturing processes and research platforms are developed and prepared, which are to be adapted accordingly later.
From the point of view of the authorities, this is a necessary precautionary measure. From a critical perspective, however, the model raises questions about democratic control, economic interests and the limits of state pandemic preparation.
Who determines which hypothetical hazards are sufficiently significant to justify substantial public investment? Which companies benefit in the long term from government-funded development programs and reserved production capacities? And how can it be ensured that the political desire for vaccine development as quickly as possible does not come at the expense of independent safety tests?
The experiences from the Corona pandemic also make these questions relevant. At that time, vaccines were developed within an exceptionally short time, procured by the state and used in large quantities. The procurement contracts, the costs for the public sector and the transparency of political decisions subsequently caused considerable controversy.
The next pandemic is unknown – preparations are already underway
With the official inclusion of “Threat X” in the American research priorities, the United States has now taken another step towards long-term pandemic preparation. Europe has been pursuing this strategy for several years with HERA, EU FAB and the integration of “Disease X” into health policy planning.
The official documents do not prove an imminent pandemic or a plan to trigger one. However, they show that governments, international health organizations and the pharmaceutical industry are increasingly gearing their structures towards rapid response to previously unknown pathogens.
This brings to the fore a question that goes far beyond medical research: How far can state and industry prepare for a hypothetical health crisis go, and who controls the political and economic decisions that arise from it?
Sources
- U.S. Department of Health and Human Services/BARDA, October 16, 2026: Official inclusion of “Threat-X” in the list of priority threats for the validation of medical technologies.
https://www.medicalcountermeasures.gov/newsroom/stories/preparing-for-the-unknown - Jon Fleetwood, November 4, 2026: HHS Invents ‘Threat X’ Pandemic Category, Then Uses Its Own Hypothetical Threat to Justify Vaccine and Drug Development.
https://jonfleetwood.substack.com/p/hhs-invents-threat-x-pandemic-category - World Health Organization (WHO): Official definition of “Disease X” and list of priority pathogens.
https://www.who.int/activities/prioritizing-diseases-for-research-and-development-in-emergency-contexts - European Commission, 22 May 2024: Communication on the European Health Union and preparations for Disease X.
https://commission.europa.eu/document/download/98c6e4dc-0fc3-4ec6-8ec2-bfcdcb2f018a_en?filename=policy_com-2024-206_en.pdf - European Commission: EU FAB network with production capacities for up to 325 million vaccine doses per year.
https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/addressing-market-challenges_en - European Commission: Health crisis preparedness, the role of HERA and European pandemic preparedness.
https://commission.europa.eu/topics/public-health/european-health-union/health-crisis-preparedness_en - European Commission, 2026: Global Health Resilience Initiative, adopted on 13 May 2026.https://commission.europa.eu/priorities-2024-2029/global-europe/implementation-tracker_en
