U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only.

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Presentation transcript:

U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA’s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

2 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 CIN1+in females 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 CIN1+in in adolescent females10-14 years of age?

5 Questions for the Committee 2. 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 years of age.

6 Questions for the Committee 3. Do the safety data support the safety of Cervarix for use in females years of age? a. Please comment on imbalance noted in spontaneous abortions in year old females around the time of vaccination. b. Please comment on findings for neuroinflammatory events and diseases of potential autoimmune etiology.

7 Questions for the Committee 4. Please comment on other recommendations for post-marketing commitments.