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Post-Marketing Safety Surveillance for Quadrivalent Human Papillomavirus Vaccine (HPV4) Julianne Gee, MPH Immunization Safety Office Division of Healthcare.

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Presentation on theme: "Post-Marketing Safety Surveillance for Quadrivalent Human Papillomavirus Vaccine (HPV4) Julianne Gee, MPH Immunization Safety Office Division of Healthcare."— Presentation transcript:

1 Post-Marketing Safety Surveillance for Quadrivalent Human Papillomavirus Vaccine (HPV4) Julianne Gee, MPH Immunization Safety Office Division of Healthcare Quality Promotion Centers for Disease Control and Prevention

2 CDC’s Immunization Safety Office Vaccine Safety Monitoring Systems  Vaccine Adverse Event Reporting System:  National passive reporting system that accepts reports from the public on adverse events (AEs) following vaccination  Vaccine Safety Datalink (VSD) Project:  Collaboration between CDC and 8 managed care organizations that allows for rigorous monitoring and evaluation of the safety of vaccines  Clinical Immunization Safety Assessment (CISA) Network:  Studies the pathophysiology of adverse events following immunization, identifies risk factors, and develops guidance to assist clinicians

3 Monitoring HPV4 Vaccine Safety  VAERS:  Monitors and reviews reports on a daily basis  Follow-up on serious reports and deaths  Post licensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine JAMA. 2009; 302(7):  CISA:  Conduct clinical case reviews of reports received by the CISA Network and to VAERS  VSD  Active surveillance of selected outcomes

4 VAERS  National post-licensure passive surveillance system for vaccine adverse events operated by CDC and FDA  Serves as an early warning system for vaccine safety surveillance  Permits monitoring for known AEs  Detects signals for previously unrecognized/rare AEs  Generates hypotheses for further study  Limitations  Risk of underreporting and reporting biases  Incomplete data  Lack of availability of denominator data  Cannot assess causality

5 Summary of HPV4 Adverse Event Reports Published in JAMA  First published HPV post licensure study  AEs reported to VAERS from June 1, 2006-December 31, 2008 ( US reports only)  Methods:  Reported signs/symptoms were assigned MedDRA codes and classified as serious or non-serious  Serious Adverse Event: an adverse event that is life threatening, results in death, permanent disability, congenital anomaly, hospitalization, or prolonged hospitalization  Describe characteristics of adverse event reports  Datamining: detects disproportionality in reporting (as compared to other vaccines)  Proportional reporting ratios (PRR)  Empirical Bayesian geometric mean (EBGM)  Detailed case reviews conducted on select AEs *Medical Dictionary for Regulatory Activities:

6 Summary of HPV4 Adverse Event Reports Published in JAMA  Total HPV4 VAERS reports: 12,424  Most frequently reported AEs included:  Syncope (n=1847, 15%)  Dizziness (n=1763, 14%)  Nausea (n=1170, 9%)  Headache (n=957, 8%)  Injection site reactions (n=926, 7.5%)  Serious adverse events: 772 (6%)

7 Summary of Select HPV4 Adverse Event Reports Published in JAMA Adverse Event Total No. HPV4 only Serious AE RR* Syncope Anaphylaxis GBS Death Transverse Myelitis VTE *RR= Reporting Rate (total reports) per 100,000 doses distributed 23 million doses distributed

8 Summary of HPV4 Adverse Event Reports Published in JAMA  Conclusions  Vast majority of reports were non-serious  Disproportional reporting of syncope and venous thrombotic events (VTE)  Syncope: 1896 reports  200 Head injuries (Fractures, dental injuries, contusions, lacerations, intercranial hemorrages)  Serious reports: 93  VTE: 56 reports  31 with sufficient information for clinical review  30 reports with HPV4 alone  Risk factors associated with VTE reports  Results generally consistent with pre-licensure trials  Post-licensure monitoring is continuing and epidemiologic studies considered to assess potential signals

9 Vaccine Safety Datalink (VSD) Project Collaboration: CDC and Managed Care Organizations (MCOs) in the US 8 participating MCOs Annual population > 9.2 million Advantages of VSD for vaccine safety research Large, well-defined population Computerized, linkable administrative data files Powerful tool for controlled population-based studies

10 VSD Rapid Cycle Analysis: HPV4  Near real-time monitoring to evaluate the associations between HPV4 and pre-specified list of outcomes in females aged 9-26 yrs  Using sequential statistical methodologies, outcomes are evaluated on a weekly basis  Comparison groups:  Historical:  Background rates  Outcomes: GBS, Appendicitis, Stroke, VTE  Concurrent:  Females in the same age range who had a preventative or vaccination visit during the same time period as the exposed group  Outcomes: Seizures, Syncope, Allergic reactions  Descriptive analysis for anaphylaxis  Medical record review:  GBS, VTE, and Anaphylaxis cases identified in automated data

11 VSD RCA: Preliminary Results  Total number of HPV4 doses administered (through August 30, 2009): 562,988  9-17 yrs: 389,706  yrs: 173,282  We did not find any statistically significant differences for the outcomes being monitored following HPV4 and their comparison groups.

12 VSD: Next Steps  Formal weekly analyses will end soon  Long-term surveillance for VTE, Stroke, and GBS  Monitor outcomes until 1 million doses administered

13 HPV4 Vaccine and General Vaccine Safety References Reports of Adverse Events Following Gardasil ® (on the CDC Vaccine safety web site): Gardasil ® Package Insert: VAERS information: VAERS public search tool: CDC. General Recommendations on Immunization; MMWR 2006; 55(RR15);1-48

14 Thank You


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