U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Emergency Preparedness and Response
  3. Public Health Preparedness and Response
  4. Innovative Technologies
  5. Improving Influenza Vaccine Reagent Production
  1. Innovative Technologies

Improving Influenza Vaccine Reagent Production

Principle Investigator: Jerry Weir, PhD 
FDA Center: Center for Biologics Evaluation and Research (DVP)
Project Start Date: October 2022

Project Description: Due to the constant evolution of influenza viruses, seasonal influenza vaccines must be updated periodically in an effort to match the vaccine antigens included in the vaccine with the most current circulating strains of influenza viruses.  Influenza vaccines for viruses with pandemic potential such as H5 and H2 influenza viruses, which also undergo constant antigenic drift in animal populations in which they circulate, are likewise periodically assessed, and updated as needed for pandemic preparedness. The overwhelming majority of all seasonal and pre-pandemic influenza vaccines produced world-wide are inactivated, subunit, and recombinant vaccines, and for each antigen included in such vaccines, strain-specific reagents are necessary for testing potency and identity. 

Standardized reagents ensure that influenza vaccines produced by multiple manufacturers contain the same amount of antigen for each of the recommended virus strains.  Nevertheless, timely preparation of potency reagents is challenging and always a potential bottleneck in influenza vaccine production and is a special concern for pandemic preparedness.  The objective of the proposed research project is to adapt new technologies to generate influenza virus vaccine reagents that do not require access to live virus (eliminates difficulties in obtaining viruses, particularly pandemic viruses, and minimizes alterations in the virus antigens), can be prepared more rapidly than possible with current methodologies, and may be better matched to circulating viruses. 

Project Goal: The goal of this project is to adapt new technologies to generate influenza virus vaccine reagents that do not require access to live virus (eliminates difficulties in obtaining viruses, particularly pandemic viruses, and minimizes alterations in the virus antigens), can be prepared more rapidly than possible with current methodologies, and may be better matched to circulating viruses.  Seasonal influenza vaccines must be updated periodically according to the most current circulating strains. Vaccine periodic updating is important in pandemic situations, where viruses undergo constant antigenic drifts in animal populations. All pre- pandemic and influenza vaccines produced are inactivated, subunits, and recombinant vaccines. These antigens included in such vaccines, strain- specific reagents necessary for testing potency and identity. It is important to have standardized reagents to determine the amount of antigen present in the vaccine produced by different manufactures. This standardized reagent preparation is the bottleneck of the vaccine production.       

Project Outcomes: 

  • Initial results were presented as a poster at the 2024 CBER Research Day (January 23, 2024) - "Improving Influenza Vaccine Reagent Production” M Odin, F Schmeisser, J Soto, J Weir   
  • Publication submitted for peer-review 

Contact the Office of Regulatory and Emerging Science: ORES@fda.hhs.gov

SUBSCRIBE

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top