U.S. Food and Drug Administration

1
U.S. Food and Drug Administration

• Notice Archived Document
• The content in this document is provided on the
  FDAs website for reference purposes only. It was
  current when produced, but is no longer
  maintained and may be outdated.

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Vaccines and Related Biological Products Advisory
Committee Meeting

• Cervarix Human Papillomavirus Bivalent (Types
  16 and 18) Vaccine, Recombinant
• Applicant GlaxoSmithKline Biologicals (GSK)
• Questions

3
Questions for the Committee

• 1A. Do the data support the efficacy of Cervarix
  for the prevention of HPV 16/18 related
  cervical cancer, CIN2, AIS, and CIN1in females
  15-25 years of age?

4
Questions for the Committee

• 1B. Do the immunogenicity bridging data support
  effectiveness for prevention of HPV 16/18
  related cervical cancer, CIN2, AIS, and
  CIN1in in adolescent females10-14 years of age?

5
Questions for the Committee

• Please comment on the strength of the data to
  support the efficacy of Cervarix for the
  prevention of any non-vaccine HPV related CIN2
  in females 10-25 years of age.

6
Questions for the Committee

• Do the safety data support the safety of Cervarix
  for use in females 10-25 years of age?
• Please comment on imbalance noted in spontaneous
  abortions in 15-25 year old females around the
  time of vaccination.
• Please comment on findings for neuroinflammatory
  events and diseases of potential autoimmune
  etiology.

7
Questions for the Committee

• Please comment on other recommendations for
  post-marketing commitments.