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Challenges and opportunities in RSV vaccine development: Meeting report from FDA/NIH workshop

Jeffrey N Roberts1, Barney S Graham2, Ruth A Karron3

  • 1Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA, Silver Spring, MD, USA.

Vaccine
|August 28, 2016
PubMed

Insights

No licensed vaccines exist for Respiratory Syncytial Virus (RSV), a major cause of infant respiratory illness. This workshop convened experts to discuss RSV vaccine development strategies for key populations.

Area of Science:

  • Virology
  • Immunology
  • Vaccinology

Background:

  • Respiratory syncytial virus (RSV) is a leading cause of severe lower respiratory tract infections in infants and a significant health burden for the elderly and immunocompromised.
  • Currently, no licensed vaccines are available to prevent RSV infection, representing a critical unmet medical need.
  • Understanding immune correlates of protection and the mechanisms behind vaccine-associated enhanced respiratory disease (ERD) is crucial for effective vaccine development.

Purpose of the Study:

  • To convene scientists, regulators, and industry stakeholders to discuss RSV vaccine development.
  • To identify research gaps and challenges in developing RSV vaccines for different target populations.
  • To foster collaboration and advance strategies for RSV vaccine development.

Main Methods:

  • A workshop was organized and co-sponsored by the FDA's Center for Biologics Evaluation and Research (CBER) and NIH's National Institute of Allergy and Infectious Diseases (NIAID).
  • Discussions focused on general RSV vaccine development and specific considerations for infants, children, pregnant women, and individuals over 60 years of age.
  • The workshop concentrated on vaccine development for high-income countries, referencing prior discussions on low- and middle-income countries.

Main Results:

  • The workshop facilitated a comprehensive discussion on clinical, scientific, and regulatory perspectives for RSV vaccine development.
  • Key research gaps and lessons learned were identified across different target populations.
  • Agreed-upon clinical and serological endpoints for evaluating RSV vaccine efficacy were considered.

Conclusions:

  • Advances in vaccine technology are driving renewed interest in RSV vaccine development.
  • Addressing the lack of licensed RSV vaccines requires continued research into protective immunity and potential adverse events.
  • Collaborative efforts among researchers, regulators, and industry are essential to accelerate the development of safe and effective RSV vaccines.

Keywords:
Animal modelsBronchitisClinical trialsElderlyHuman challengeInfantsMaternal immunizationNeutralizationRSVSubunit vaccineVaccinationVaccine vectorVaccine-enhanced illnessWheezing

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