Immunization Safety Office Updates Centers for Disease Control and Prevention

1. Immunization Safety Office UpdatesCenters for Disease Control and Prevention Tom Shimabukuro, MD, MPH, MBA Immunization Safety Office Division of Healthcare Quality Promotion National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention (CDC) Advisory Commission on Childhood Vaccines (ACCV) December 5, 2013 National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion – Immunization Safety Office 1

2. Topics • October 2013 Advisory Committee on Immunization Practices (ACIP) meeting summary • http://www.cdc.gov/vaccines/acip/meetings/downloads/agenda-archive/agenda-2013-10.pdf • http://www.cdc.gov/vaccines/acip/meetings/slides-oct-2013.html • Communications updates • Selected publications 2

3. October 2013 ACIP meeting update • Meningococcal vaccine session • MenACWY-CRM (Menveo®) can be used for protection against serogroups A, C, W, and Y in increased risk infants aged 2 through 23 months • Infants aged 2 through 8 months who travel to or reside in countries in which meningococcal disease is hyperendemic or epidemic are recommended to receive MenACWY-CRM prior to travel to provide protection against meningococcal serogroups A and W • MenACWY-CRM may be co-administered with PCV13, including in asplenic children 3

4. October 2013 ACIP meeting update • Pneumococcal conjugate vaccine (PCV) session: discussion on reduced number of doses • 3 dose schedule not approved by FDA but has been approved by European Medicines Agency (EMEA) • Evidence supporting 3 dose PCV series are effective against invasive pneumococcal disease, pneumonia and otitis media • Strong direct and indirect (herd) effects observed in countries using 3-dose PCV schedules • Programs may not always deliver high coverage rates 4

5. October 2013 ACIP meeting update • Human papillomavirus (HPV) vaccine session: 9-valent HPV (9vHPV) manufacturer presentation • Includes 5 additional cancer-causing HPV types • Potential to prevent ~90% of cervical cancers and ~80% of high grade disease (CIN 2 or worse) • ~13,300 subjects administered 9vHPV; size of safety database similar to that for HPV4 • Six Phase III studies completed; results to be presented at EUROGIN conference November 2013 5

6. October 2013 ACIP meeting update • Influenza session • Fluzone High-Dose manufacturer post-licensure efficacy trial • ~32,000 participants aged ≥65, spanning 2011-12 and 2012-13 • Randomized to receive either Fluzone or FluzoneHigh-Dose • Followed for illness until end of each season • Blood collected for HAI titers in randomly selected subset • Serious AEs and AE of special interest collected 6 months post vaccination • Results • FluzoneHigh-Dose was 24.2% more effective in preventing influenza of any strain in adults aged ≥65 relative to Fluzone (95% CI: 9.7% to 36.5%) • Reaffirms safety of Fluzone-High as observed in past seasons 6

7. Communications updates • Frequently Asked Questions about HPV Vaccine Safety: Do HPV vaccines cause ovarianfailure? • Available on the CDC website at: http://www.cdc.gov/vaccinesafety/Vaccines/HPV/hpv_faqs.html#six • CDC Expert Commentary, October 2013: Rotavirus Vaccine and Intussusception: The Latest Data – Do these new findings change recommendations for rotavirus vaccination of US infants? (Dr. Frank DeStefano) • http://www.medscape.com/partners/cdc/public/cdc-commentary 7

8. Selected publications • Glanz et al. Association Between Undervaccination With Diphtheria, Tetanus Toxoids, and Acellular Pertussis (DTaP) Vaccine and Risk of Pertussis Infection in Children 3 to 36 Months of Age. JAMA Pediatr. 2013 Nov 1;167(11):1060-4. • Undervaccination with DTaP vaccine increases the risk of pertussis among children 3 to 36 months of age • Rowhani-Rahbar et al. Effect of Age on the Risk of Fever and Seizures Following Immunization With Measles-Containing Vaccines in Children. JAMA Pediatr. 2013 Oct 14 [Epub ahead of print] • Measles-containing vaccines are associated with a lower increased risk of seizures when administered at 12 to 15 months of age (compared to children aged >15 months) • Findings of this study that focused on safety outcomes highlight the importance of timely immunization of children with the first dose of measles-containing vaccines 8

9. Selected publications • McCarthy et al. Evaluating the safety of influenza vaccine using a claims-based health system. Vaccine. 2013 Dec 5;31(50):5975-82. • After claims history review, we ultimately found no increased outcome risk (included GBS and seizures) following administration of 998,881 TIV and 538,257 H1N1 vaccine doses in the 2009-2010 season, and 1,158,932 TIV doses in the 2010-2011 season. • Moro et al. Safety of Influenza A (H1N1) 2009 Live Attenuated Monovalent Vaccine in Pregnant Women. Obstet Gynecol. 2013 Dec;122(6):1271-8 • Rates of spontaneous abortion, preterm birth, and major birth defects in pregnant women who received live H1N1 vaccine were similar to or lower than published background rates. No concerning patterns of medical conditions in infants were identified. 9

10. Centers for Disease Control and PreventionAtlanta, GA Division of Healthcare Quality Promotion – Immunization Safety Office National Center for Emerging and Zoonotic Infectious Diseases

11. Thank You National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion – Immunization Safety Office