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Postmarketing Surveillance Conference April 11, 2007

2. Overview. Complexities of Vaccine DevelopmentOverview of Current Surveillance SystemMenactra Case StudyEnhancing the SystemConclusions and Recommendations. Menactra Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine . 3. Vaccine Development and Safet

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Postmarketing Surveillance Conference April 11, 2007

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    1. 1 Postmarketing Surveillance Conference April 11, 2007

    2. 2 Overview Complexities of Vaccine Development Overview of Current Surveillance System Menactra® Case Study Enhancing the System Conclusions and Recommendations

    3. 3 Vaccine Development and Safety: Commitment to Public Health

    4. 4 Development of New Vaccines - Current Environment

    5. 5

    6. 6 Current US surveillance system has played a key role in monitoring immunization safety... But how can we make a good system better?

    7. 7 Vaccine Safety Datalink – Shared MCO databases linking vaccination records with health outcomes

    8. 8 Menactra® Case Study VAERS reports of GBS following the administration of Menactra® vaccine prompted a comprehensive review and data collection effort by FDA, CDC, and sanofi pasteur Frequent communication and information sharing among these organizations resulted in rapid assessment and public reporting of these events Public/private partnerships are key to meet vaccine safety surveillance goals and reassure the public that the system works This case study also identified areas where the safety surveillance system could be enhanced

    9. 9 A Comprehensive Effort CDC, FDA and sanofi pasteur held weekly meetings to share data, discuss case findings, review Menactra® distribution data, and coordinate investigations CDC utilized numerous resources and partners to collect data Safety Branch and VSD partners CISA centers State surveillance The Brighton Collaboration Sanofi pasteur clinical, regulatory, and medical affairs teams worked closely with FDA to provide updated labeling and rapid communications to healthcare professionals Comprehensive communications designed to prompt immediate reporting of potential cases

    10. 10

    11. 11 What has sanofi pasteur, along with CDC and FDA, done to ensure HCPs were informed and proactively looking for GBS cases…

    12. 12 Effective Public/Private Partnership

    13. 13 Update through the end of January 2007: Total of 19 cases of GBS after Menactra® vaccine with onset interval of 2-33 days 17 cases were in the 11-19 years old age group VSD Rapid Cycle Analysis project: 156,542 doses administered Zero cases observed among vaccine recipients 11-19 years old within 6 weeks of vaccination Projection: 0-1 cases were expected Does the number of reported GBS cases exceed the expected rate? Observed compared to expected rate calculations Confounders/uncertainties: age, season, background rates

    14. 14

    15. 15

    16. 16 Enhancing the surveillance system will provide additional data

    17. 17 Enhanced surveillance needed to further assess potential relationship between Menactra® and GBS Complications Rare outcome (if associated, attributable risk is on the order of 1 per million) Uncertainty regarding background rates Confounding with age and seasonality Expanded cohort surveillance needed VSD, even in current expanded form, too small The potential exists to establish a much-expanded VSD-like capability There are < 10 very large MCOs Taken together, they could contribute 100-150 M covered lives No economic incentive for MCOs to participate MCO participation would rest on public health importance, assurance of non-intrusiveness

    18. 18 Menactra® Case Study

    19. 19 Menactra® Case Study

    20. 20 Menactra® Case Study

    21. 21

    22. 22 Moving forward…

    23. 23 Moving forward…

    24. 24 Moving forward…

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