Vaccines and Related Biological Products Advisory Committee

Vaccines and Related Biological Products Advisory Committee
Meeting on November 16, 2011, from approximately 8 a.m. to 5:30 p.m.

Agenda: On November 16, 2011, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Method Development, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA. The committee will also hear an update on the evaluation of Gullian-Barre Syndrome after Influenza Vaccine among Medicare population, 2010-2011. The committee will then discuss and make recommendations on the safety and immunogenicity (surrogate endpoint) of Pneumococcal 13-valent conjugate vaccine (Diphtheria CRM197 Protein) in adults aged 50 years and older using an accelerated approval regulatory pathway.