The U.S. government has taken a significant step towards avian flu preparedness by ordering 4.8 million doses of a cell-based, adjuvanted H5-vaccine from influenza vaccine producer CSL Seqirus. This decision comes as part of the National Pre-Pandemic Influenza Vaccine Stockpile program, aiming to enhance the country’s readiness for potential outbreaks.

CSL Seqirus, selected for its expertise, will be responsible for completing the fill and finish process for the vaccine. The company’s manufacturing facility in Holly Springs, North Carolina, established in partnership with the Biomedical Advanced Research and Development Authority, is recognized as the largest cell-based influenza vaccine producer globally.

Alongside this development, the Administration for Strategic Preparedness and Response at HHS is actively supporting the clinical evaluation of an influenza A/Astrakhan/3212/2020–like virus vaccine. A recent MMWR article highlighted the progress of the clinical study, which has successfully completed enrollment.

The study, officially titled ‘A Phase 2, Multi-Center, Randomized, Observer-Blind Study, to Evaluate Safety and Immunogenicity of Homologous or Heterologous Priming and Booster Vaccinations With H5N8 or H5N6 MF59-adjuvanted, Cell Culture-derived Influenza Vaccine in Healthy Subjects ≥18 Years of Age,’ marks a crucial step in assessing the vaccine’s efficacy and safety.

Effective communication by the U.S. government regarding the selection of this candidate vaccine, utilizing the Astrakhan H5 antigen, the MF59 adjuvant, and cell-based production, will be vital. This proactive approach aims to engage various stakeholders, including the public, healthcare providers, journalists, and policymakers, in understanding the rationale behind the chosen vaccine components.

As the country continues to strengthen its defenses against potential health threats, such initiatives underscore the importance of preparedness and collaboration in safeguarding public health.