CBER Research

The committee heard an overview of the research programs in the Laboratory of Immunoregulation (LIR) and the Laboratory of Retroviruses (LR), Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research (CBER), FDA.

Flu strain vote

The committee voted unanimously (14 of 14 members) in agreement with the WHO’s recommendations for the northern hemisphere 2019-2020 season.

Dengvaxia vote

A majority of the committee, 13 of 14 members, voted that the available data are adequate to support the effectiveness of Dengvaxia for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in individuals 9 through less than 17 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

A majority of the committee, 10 of 14 members, voted that the available data are adequate to support the safety of Dengvaxia for this use.

A majority of the committee, 7 of 14 members, including one member who abstained from voting), voted that the available data are not adequate to support the effectiveness of Dengvaxia for Sanofi’s proposed use, which was the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4 in individuals 9 through 45 years of age with laboratory-confirmed previous dengue infection and living in endemic areas.

The committee was split regarding whether the safety was adequately demonstrated for this use.