National Center for Immunization and Respiratory Diseases

1. U.S. Influenza Activity and Vaccine Effectiveness UpdateLisa Grohskopf, MD MPHVaccine and Related Biologic Products Advisory Committee Meeting28 February 2014 National Center for Immunization and Respiratory Diseases Influenza Division

2. Influenza Activity UpdateLyn Finelli, DrPH, MSInfluenza Surveillance and Outbreak Response TeamEpidemiology and Prevention BranchInfluenza Division ACIP February 26, 2013

3. Virologic Surveillance

4. U.S. World Health Organization and National Respiratory and Enteric Virus Surveillance System Collaborating Laboratories, National Summary, 2010-14

5. Antiviral ResistanceOctober 1, 2013– February 15, 2014 • High levels of resistance to the adamantanes (amantadine and rimantadine) persist among pH1N1 and influenza A (H3N2) viruses currently circulating globally.

6. ILI Syndromic Surveillance

7. Percentage of Visits for Influenza-like Illness (ILI) Reported by the U.S. Outpatient Influenza-like Illness Surveillance Network (ILINet), Weekly National Summary, 2013-14 and Selected Previous Seasons 6.1% 4.6%

9. hospitalization Surveillance

10. Rates of Lab-Confirmed Influenza Hospitalization FluSurvNet, October 1, 2013 – February 15, 2014 55/100K 41/100K Overall Rate 26.1/100K pop 38/100K 18/100K 7/100K

11. Mortality Surveillance

12. Number of Influenza-Associated Pediatric Deaths by Week of Death: 2010-11 to February 15, 2014

13. Pneumonia and Influenza Mortality 122 U.S. Cities Surveillance SystemNational Summary, 2009-2014 9.9% 8.7% EpidemicThreshold SeasonalBaseline 2009 2010 2011 2012 2013 2014

14. Influenza Deaths by Age Group122 Cities Mortality Reporting System, Number of Influenza Deaths by Age Group and Year * ** *Data from week 15, 2009 – week 39, 2010 **Data as of week 6, 2014

15. Influenza Activity Summary • Influenza activity in the US during the 2013–14 season began approximately 4 weeks earlier than usual, and occurred at moderate levels • Activity peaked in late December/early January • Influenza A (H1N1) viruses predominated • There are higher rates of influenza-associated hospitalization in 2013-14 in persons 18-64 years of age than during the past several seasons • There were higher numbers of influenza deaths in the 122 Cities Mortality Surveillance System in 2013-14 in persons 25-64 years than during past several seasons

16. Acknowledgements Michael Jhung Carrie Reed Alicia Fry Seema Jain Anna Bramley Victoria Jiang Sandra Dos Santos Chaves Daniel Jernigan Joe Gregg Larissa Gubareva Terri Wallace Xiyan Xu Nancy Cox Joseph Bresee Scott Epperson Lenee Blanton Krista Kniss Rosaline Dhara Desiree Mustaquim Alejandro Perez Michelle Leon Andrea Giorgi Craig Steffens Ashley Fowlkes Julie Villanueva Sophie Smith

17. Interim Estimates of 2013-14 Seasonal Influenza Vaccine Effectiveness — United States, February 2014 Data from the U.S. Flu VE Network December 2, 2013-January 23, 2014 Brendan Flannery, PhD Influenza Division Presentation to the ACIP Influenza Working Group February 18, 2014 National Center for Immunization & Respiratory Diseases Influenza Division

18. Lisa Jackson Mike Jackson Ed Belongia Arnold Monto Suzanne Ohmit US Flu VE Network: Five Study Sites and Principal Investigators Manju Gaglani Rick Zimmerman Patricia Nowalk

19. US Flu VE Network: Methods Enrollees: All persons aged >6 months with medically attended acute respiratory illness (MAARI) – ambulatory care visits from Dec 2, 2013-Jan 23, 2014 Methods : Prospective case-control study (test negative design) • Influenza infection confirmed with CDC RT-PCR • Cases: Outpatient ARI and influenza PCR-positive • Controls: Outpatient ARI and influenza PCR-negative • Vaccination status: receipt of ≥1 dose of 2013-14 seasonal flu vaccine confirmed by medical records and registries (2 sites) and self-report and medical records (3 sites) Analysis: VE = (1 – adjusted OR) x 100% • Adjustment for study site, age, sex, race/ethnicity, self-rated health and days from illness onset to enrollment

20. US Flu VE Network: Results • 2,319 enrolled from 2 December, 2013-23 January, 2014 • 1,535 (66%) influenza RT-PCR negative • 784 (34%) influenza RT-PCR positive

21. Adjusted VE* and 95% CIs against influenza A and B for ≥1 dose of 2013-14 seasonal influenza vaccine, by age group * Vaccine effectiveness was estimated as 100% X (1 – odds ratio [ratio of odds of vaccination among flu-positive cases to odds of vaccination among flu-negative controls]) using multivariable logistic regression including study site, age, sex, race/ethnicity, self-rated health status and days from illness onset to enrollment.

22. Comparison of adjusted VE estimates against H1N1pdm09 associated outpatient ARI over several influenza seasons * Adjusted VE and 95% CI for primary healthcare patients: 42% (-97%-83%). Source: Castilla J, Eurosurveillance 2014 .

23. Conclusions • 2009 H1N1pdm virus predominated among influenza viruses identified from Dec 2, 2013-Jan 23, 2014 in U.S. • Interim adjusted VE against H1N1pdm09 associated medically attended ARI = 62% (95% CI: 53-69) • Similar for all age groups • Similar to VE estimates from previous seasons • Consistent with laboratory data • Final analyses for 2013-14 season will investigate effects of prior vaccination • Ability to estimate VE for H3N2 or B infections will depend upon final sample size

24. US Flu VE Network • University of Michigan and Henry Ford Health System: Arnold S. Monto, MD, Suzanne E. Ohmit, DrPH, Joshua G. Petrie, MPH, Emileigh Johnson, Rachel T. Cross, MPH, Casey Martens, Marcus Zervos, MD, Lois Lamerato, PhD, Mary Ann Aubuchon, William Fredrick; • University of Pittsburgh Schools of the Health Sciences and UPMC: Richard K. Zimmerman, MD, Mary Patricia Nowalk, PhD, Jonathan M. Raviotta, MPH, Heather Eng, Stephen R. Wisniewski, PhD, Charles R. Rinaldo, Jr, MD, Arlene Bullotta, Joe Suyama, MD, Evelyn Reis, MD, Donald B. Middleton, MD, Rhett H. Lieberman, MD, Michael Susick, MPH, Krissy K. Moehling, MPH, Mallory Schaffer, BS; • Baylor Scott and White Health, Texas A&M University Health Science Center College of Medicine:ManjushaGaglani, Lydia Clipper, RN, Anne Robertson, AA, Kempapura Murthy, MPH, Monica Weir, Hope Gonzales, Martha Zayed,  Teresa Ponder, Virginia Gandy, RN, Patricia Sleeth, RN, Sophia V James, MS, , Michael Reis, MD, Cathleen Rivera, MD, David Morgan, MD, and Baylor College of Medicine : Pedro Piedra, MD, Vasanthi Avadhanula, PhD; • Group Health Research Institute: Michael L. Jackson, PhD, Lisa A. Jackson, MD, C. Hallie Phillips, MEd, Joyce Benoit, RN, Lawrence T. Madziwa, MS, Matt B. Nguyen, MPH, Julia P. Anderson, MA; • Marshfield Clinic Research Foundation:Edward A. Belongia, MD, Huong Q. McLean, PhD, Deanna Cole, Donna David, Sarah Kopitzke, MS, Tamara A. KronenwetterKoepel, Jennifer K. Meece, PhD, Carla Rottscheit, Sandra K. Strey, Maria E. Sundaram, MSPH, Laurel A. Verhagen; • CDC:Alicia M. Fry, MD, Swathi N. Thaker, PhD, Jessie Clippard, MPH, Ivo Foppa, PhD, Jill Ferdinands, PhD, LaShondra Berman, MS, Angie Foust, MS, Wendy Sessions, MPH, Sarah Spencer, PhD, Erin Burns, MA, Joseph Bresee, MD, Nancy Cox, PhD.