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Developing vaccines for emerging pathogens is crucial. Regulatory pathways like Emergency Use Authorization (EUA) offer alternatives to full licensing for faster deployment against global health threats.

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Area of Science:

  • Global health
  • Vaccinology
  • Infectious disease

Background:

  • Emerging pathogens pose a significant global health challenge, with limited licensed vaccines available.
  • Antimicrobial resistance (AMR) and climate change exacerbate the threat by increasing pathogen potential and disease vector spread.
  • Vaccination is a key defense, but commercial incentives for developing vaccines against rare outbreaks are often lacking.

Purpose of the Study:

  • To review the current status of vaccine development for emerging pathogens.
  • To identify hurdles in achieving Emergency Use Authorization (EUA) or equivalent regulatory status.
  • To explore how these regulatory pathways can impact future vaccine development and stockpiling.

Main Methods:

  • Literature review of vaccine development for emerging pathogens.
  • Analysis of regulatory mechanisms for expedited vaccine approval, including EUA.
  • Discussion of challenges and future implications for vaccine preparedness.

Main Results:

  • Many emerging pathogens lack licensed vaccines due to high development costs and limited commercial viability.
  • Regulatory pathways such as EUA offer viable alternatives for deploying vaccines during outbreaks.
  • Overcoming regulatory hurdles is essential for building a robust vaccine stockpile.

Conclusions:

  • Vaccine development for emerging pathogens faces significant challenges, including funding and regulatory approval.
  • Utilizing mechanisms like EUA can expedite vaccine availability, improving global health security.
  • Strategic approaches to regulation and development are needed to prepare for future pandemics.