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

Authors

Jeffrey N. Roberts, Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA, Silver Spring, MD, USA
Barney S. Graham, Vaccine Research Center, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Ruth A. Karron, Center for Immunization Research, Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD 21205, USA.
Flor M. Munoz, Department of Pediatrics and Department of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, TX, USA.
Ann R. Falsey, Rochester Regional HealthFollow
Larry J. Anderson, Department of Pediatrics, School of Medicine, Emory University and Children's Healthcare of Atlanta, Atlanta, GA, USA.
V Marshall, Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA, Silver Spring, MD, USA.
Sonnie Kim, Division of Microbiology and Infectious Disease, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.
Judy A. Beeler, Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA, Silver Spring, MD, USA.

Department

Medicine

Document Type

Article

Publication Title

Vaccine

Abstract

Respiratory syncytial virus (RSV) is the most common cause of serious acute lower respiratory illness in infants and young children and a significant cause of disease burden in the elderly and immunocompromised. There are no licensed RSV vaccines to address this significant public health need. While advances in vaccine technologies have led to a recent resurgence in RSV vaccine development, the immune correlates of protection against RSV and the immunology of vaccine-associated enhanced respiratory disease (ERD) remain poorly understood. FDA's Center for Biologics Evaluation and Research (CBER) and NIH's National Institute of Allergy and Infectious Diseases (NIAID) organized and co-sponsored an RSV Vaccines Workshop in Bethesda, Maryland on June 1 and 2, 2015. The goal of the conference was to convene scientists, regulators, and industry stakeholders to discuss approaches to RSV vaccine development within the context of three target populations - infants and children, pregnant women, and individuals >60years of age. The agenda included topics related to RSV vaccine development in general, as well as considerations specific to each target population, such as clinical and serological endpoints. The meeting focused on vaccine development for high income countries (HIC), because issues relevant to vaccine development for low and middle income countries (LMIC) have been discussed in other forums. This manuscript summarizes the discussion of clinical, scientific, and regulatory perspectives, research gaps, and lessons learned.

First Page

4843

Last Page

4849

DOI

10.1016/j.vaccine.2016.07.057

Volume

34

Issue

41

Publication Date

9-22-2016

Medical Subject Headings

Aged; Animals; Biomedical Research; Child, Preschool; Clinical Trials as Topic; Congresses as Topic; Female; Humans; Infant; Maryland; National Institutes of Health (U.S.); Pregnancy; Respiratory Syncytial Virus Infections (prevention & control); Respiratory Syncytial Virus Vaccines (therapeutic use); Respiratory Syncytial Virus, Human; United States; United States Food and Drug Administration

PubMed ID

27566900

Recommended Citation

Roberts, J. N., Graham, B. S., Karron, R. A., Munoz, F. M., Falsey, A. R., Anderson, L. J., Marshall, V., Kim, S., & Beeler, J. A. (2016). Challenges and opportunities in RSV vaccine development: Meeting report from FDA/NIH workshop. Vaccine, 34 (41), 4843-4849. https://doi.org/10.1016/j.vaccine.2016.07.057