Viewpoint: Prepare now for a potential H5N1 pandemic

The American Association for the Advancement of Science has published the following letter addressing the growing zoonotic threat posed by the ongoing H5N1 influenza virus outbreak. The letter is reproduced here in full and can also be accessed through the URL at the foot of the article:

The H5N1 virus has crossed species and adapted to mammalian hosts, including dairy cattle, causing widespread exposure and sporadic human illness¹. Although most cases have been mild, H5N1 can cause severe disease². Given H5N1’s potential to spread, urgent action is needed to address pandemic preparedness gaps.

Rapid influenza vaccine availability is highly constrained by currently approved technologies, such as protein-based vaccines^3,4. Vaccine availability is also slowed by the time required to conduct immunogenicity and efficacy assessments and lot release and potency assays⁵. Furthermore, many regulatory agencies lack the resources and capacity needed to quickly but robustly evaluate pandemic vaccines⁵. To streamline vaccine development, assessment, production, and access, industry, governments, and regulators should enhance collaboration on new technologies, such as mRNA-based vaccines and vaccines using novel antigens; align regulatory pathways and requirements; and modernize immunogenicity assessment and lot release tools. To ensure equitable access, a global access framework should be established, including an entity that can provide financing and advanced vaccine purchases for low- and middle-income countries.

Immunization programs are complex and demand advance planning. Success requires defined roles, responsibilities, and financing as well as effective information and supply chain management. Strategies should build on experiences from seasonal influenza, COVID-19, and other outbreaks; use existing infrastructure; and engage those who will implement the programs. Immunization and communications planning must be integrated and engage affected communities, and planning must transcend political divisions. Global, federal, state, and local authorities need to clearly understand their responsibilities and the circumstances under which plans activate. Consideration of societal and economic risks from both a pandemic and potential mitigations should be integrated into decision-making. Proactive analysis is also required to prepare for impacts on supply chains for vaccines and source materials as well as effects on health care and other sectors.

To effectively address these gaps, pandemic preparedness initiatives should be urgently resourced and implemented⁶. First, an effort to develop rapidly scalable pandemic influenza vaccines [building on models such as Operation Warp Speed⁷] should engage industry, governments, regulators, and the scientific community, with equitable access supported by a funded global framework. Such an initiative would, ideally, also include development of and access to improved therapeutics, diagnostics, personal protective equipment, and other needed medical countermeasures. Second, a comprehensive outreach and communications program, supported by behavioral science, should work to better understand and respond to concerns about vaccines and rebuild trust in public health. Finally, pandemic response plans should undergo transparent in-depth testing, during which countries should share plans and playbooks and form global collaborations that incorporate different disease scenarios and immunization strategies. Similar initiatives should address ongoing agricultural outbreaks (8). Enhancing readiness now can save lives and reduce societal and economic disruption if H5N1 or another outbreak becomes a pandemic.

Article authors

Opinions are the authors’ own and do not necessarily reflect the views of their institutions.

• Jesse L. Goodman – Georgetown University Medical Center
  (first and corresponding author – jesse.goodman@georgetown.edu)
• Rebecca Katz – Georgetown University Medical Center
• Lawrence O. Gostin – Georgetown University Law Center
• Nicole Lurie – Coalition for Epidemic Preparedness Innovations
• Rick A. Bright – Bright Global Health
• Bruce G. Gellin – Global Health Institute, Georgetown University
• Norman W. Baylor – Biologics Consulting Group

References

^{1. “H5 bird flu: Current situation” (Centers for Disease Control and Prevention, 2025); https://www.cdc.gov/bird-flu/situation-summary/index.html.}

^{2. “LDH reports first U.S. H5N1-related human death” (Louisiana Department of Health, 2025); https://ldh.la.gov/news/H5N1-death.}

^{3. Center for Infectious Disease Research and Policy, “Influenza vaccines R&D roadmap” (Regents of the University of Minnesota, 2023); https://ivr.cidrap.umn.edu/sites/default/files/IVR_Feb_2023.pdf}

^{4. “CEPI 2.0 and the 100 days mission” (Coalition for Epidemic Preparedness Innovations, 2024); https://cepi.net/cepi-20-and-100-days-mission.}

^{5. N. W. Baylor, J. L. Goodman, Vaccines 10, 2136 (2022).}

^{6. “H5N1 influenza vaccines and the current outbreak” (Georgetown University Global Health Institute, 2025); https://globalhealth.georgetown.edu/publications/h5n1-influenza-vaccines-and-the-current-outbreak.}

^{7. M. Slaoui, M. Hepburn, N. Engl. J. Med. 383, 1701 (2020).}

^{8. National Academies of Sciences, Engineering, and Medicine, Potential Research Priorities to Inform U.S. Readiness and Response to Avian Influenza A (H5N1): Proceedings of a Workshop—In Brief, E. P. Carlin, S. Singaravelu, L. Brown, Eds. (National Academies Press, 2024).}

Competing interests

J.L.G. serves on the Board and Science Committee of GSK and as a volunteer member of the board of the nonprofit United States Pharmacopeia.

R.A.B. receives nonfinancial support from the Coalition for Epidemic Preparedness Innovations (CEPI) for serving on its scientific advisory committee, receives fees from CEPI and Cidara, and has patents for virus-like particle vaccine design issued to Novavax with no financial gain.

For further reading please visit

www.science.org/doi/10.1126/science.adw3278

https://cepi.net/cepi-steps-h5n1-preparedness-outbreak-cattle-persists