FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Advisory Committee Unsure About Generalizability of Pfizer S. aureus Vaccine

Nov. 10, 2017
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An FDA advisory committee was divided in a discussion about the safety and efficacy of Pfizer’s investigational vaccine against Staphylococcus aureus infection for elective orthopedic surgery patients.

In a non-voting meeting Tuesday, members of the Vaccines and Related Biological Products Advisory Committee discussed whether the vaccine’s safety and efficacy trial data could be generalized for all elective orthopedic procedures.

Several committee members expressed support for an indication for certain similar surgical populations rather than for elective orthopedic surgical populations across the board. Members also expressed reservations about whether safety in lower-risk patients could be extrapolated from a single trial in higher-risk patients.

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