1. National Immunization Conference March 30, 2011 Elaine R. Miller, RN, MPH Beth Hibbs, RN, MPH What Healthcare Providers Need to Know about the Vaccine Adverse Event Reporting System (VAERS)—Reporting and Public Health Uses National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality and Promotion,- Immunization Safety Office

2. The findings in this presentation are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention 2

3. Objectives  Part 1--Describe the Vaccine Adverse Event Reporting System (VAERS) and explain how to report  Part 2--Describe recent examples of VAERS data contributing to public health 3

4. Vaccine Adverse Event Reporting System (VAERS) (Part 1)  National spontaneous reporting system for adverse events after US-licensed vaccines  Received ~31,000 reports in 2010 (2006-2010 average per year ~28,000)  Requires a report be filed; accepts reports from healthcare providers, manufacturers and lay persons  Jointly administered CDC and FDA, authorized by National Childhood Vaccine Injury Act of 1986  VAERS data publicly available 4

5. Purpose of VAERS VAERS is used to:  Rapidly detect new, unusual, or rare vaccine adverse events (VAEs)  Assess the safety of newly licensed vaccines  Rapidly identify vaccine lots with increased numbers or types of reported adverse events (FDA lead)  Identify potential risk factors in vaccinees for particular types of adverse events  Monitor trends in known adverse events, particularly increases  Rapidly respond to vaccine safety concerns or public health emergencies 5

6. Vaccine Adverse Event Reporting System (VAERS) Strengths Rapid signal detection Can detect rare adverse events (AE) Generates hypothesis for further study Encourages reports from healthcare providers and accepts reports from others Data available to the public Limitations Reporting bias (e.g., underreporting, stimulated reporting) Inconsistent data quality and completeness Generally cannot assess if vaccine caused an AE Lack of unvaccinated comparison group 6

7. What to Report to VAERS  Report any clinically significant adverse event following immunization (www.vaers.hhs.gov)www.vaers.hhs.gov  Even if you are not certain the vaccine caused the event  The National Childhood Vaccine Injury Act mandates healthcare providers also report specific adverse events that occur after vaccination  Events listed in the Table of Reportable Events http://vaers.hhs.gov/resources/VAERS_Table_of _Reportable_Events_Following_Vaccination.pdf http://vaers.hhs.gov/resources/VAERS_Table_of _Reportable_Events_Following_Vaccination.pdf 7

8. VAERS Reporting Form  The report asks for information about pt, provider and reporter demographics, adverse event, vaccines received and any preexisting conditions  Include as much information as possible in the report (e.g., vaccination location, date, vaccine type, lot number and dose number)  Reports with incomplete information accepted  Report as soon as possible but no time limit on reporting demographics AE vax 8

9. How to Submit a VAERS Report: One of Several Methods May Be Used 1)Online via a secure website at https://vaers.hhs.gov 2)Download a reporting form: http://vaers.hhs.gov/resources/vaers_form.pdf http://vaers.hhs.gov/resources/vaers_form.pdf ∙ Fax a completed form: 877-721-0366 ∙ Mail a completed VAERS form to VAERS P.O. Box 1100, Rockville, MD, 20849 To request a reporting form or for other VAERS assistance: call 800-822-7967 or email: info@vaers.org info@vaers.org 9

10. How Can VAERS Data Be Obtained? VAERS data (without identifiable personal information) are accessible to the public* through 2 systems: 1.CDC Wide-ranging Online Data for Epidemiologic Research (WONDER) online search tool http://wonder.cdc.gov/vaers.html 1.Download raw data files for import into a database, spreadsheet, or text editing program http://vaers.hhs.gov/ * Data available about 4-6 weeks after report received 10

11. HHS Vaccine Safety Resources  CDC  Immunization Safety Office Web site www.cdc.gov/vaccinesafety www.cdc.gov/vaccinesafety  800-CDC-INFO (232-4636)  ACIP recommendations http://www.cdc.gov/vaccines/pubs/acip- list.htm  VAERS -CDC/FDA  800-822-7967  http://vaers.hhs.gov http://vaers.hhs.gov  FDA  www.fda.gov/cber www.fda.gov/cber  Vaccine Injury Compensation- Health Resources and Services Administration  800-338-2382  www.hrsa.gov/vaccinecompensation/ www.hrsa.gov/vaccinecompensation/ 11

12. General Recommendations on Immunization http://www.cdc.gov/mmwr/pdf/rr/rr6002.pdf 12

13. For Immunization Questions:  Call 800-CDC INFO  Email Nipinfo@cdc.govNipinfo@cdc.gov 13

14. (Part 2) Immunization Safety Office Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic Infectious Diseases Centers for Disease Control and Prevention (CDC) Recent Examples of How VAERS Data Contributes to Public Health National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion – Immunization Safety Office 14

15. VAERS Contribution to the H1N1 Public Health Emergency  VAERS provided first national data during 2009-10 H1N1 response-- 1 st 2 months of data was published 3 months after the start of the program*  Safety profile of H1N1 vaccine in VAERS was consistent with that observed for seasonal influenza vaccines**  VAERS received and analyzed ~10,000 reports after H1N1 vaccine for persons vaccinated during first 4 months of the program  93% non-serious (self-limited, not requiring hospitalization)  Reporting rate higher after 2009 H1N1 vaccines than 2009-10 seasonal influenza vaccines (may partially be due to stimulated reporting) *CDC Safety of Influenza A (H1N1) 2009 Monovalent Vaccines --- United States, October 1--November 24, 2009. MMWR 2009, Dec. 11. 58(48) :1351-1356. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5848a4.htmhttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm5848a4.htm **Vellozzi C, Broder K, Haber et al. Adverse events following influenza A (H1N1) 2009 monovalent vaccines reported to the Vaccine Adverse Event Reporting System, United States, October 1, 2009-January 31, 2010.Vaccine. 2010.28(45) 15

16. Tetanus, Diphtheria, Pertussis (Tdap) Vaccines  Tdap vaccines were licensed in 2005, but only for persons <65 years old, although older persons may acquire and transmit pertussis  Pertussis is an endemic disease in the US, with frequent outbreaks (nearly 17,000 reported cases in 2009)  During 2010, CA had an outbreak of pertussis (8627*cases reported) and the state recommended off-label use of Tdap in ≥ 65 as part of control measures  Concurrently, in 2010 the Advisory Committee on Immunization Practices (ACIP) Pertussis Working Group identified lack of licensure of Tdap for persons aged ≥ 65 years as a gap for optimal coverage Preliminary data from CADH website at : http://www.cdph.ca.gov/programs/immunize/Documents/PertussisReport2011-01-31.pdf 16

17. VAERS Contributed Data to Support New Vaccination Policy for Tdap in Persons ≥ Age 65  Conducted VAERS review of Tdap reports in age ≥ 65 to help monitor safety in this age group and inform ACIP policy deliberation about using Tdap in older persons  During 9/1/05-9/08/10, VAERS received 243 reports in adults ≥ 65 years who were given Tdap vaccine  A review of data suggested safety profile of Tdap similar to safety profile of Td in persons aged ≥ 65 years, which has good track record for safety*  VAERS data have limitations and further assessment of safety is needed as Tdap use in older persons becomes more widespread  Because Tdap is not licensed for use in this age group, comparisons between these reports and other reports need to be interpreted with caution * P. Moro and CDC VAERS staff, unpublished data. 17

18. Updated Recommendations for use of Tdap vaccine --- Advisory Committee on Immunization Practices (ACIP), 2010 Adults Aged 65 years and Older:  Those who have or anticipate having close contact with an infant less than 12 months of age should receive a single dose of Tdap  Other adults ages 65 years and older may be given a single dose of Tdap CDC Updated Recommendations for Use of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis (Tdap) Vaccine from the Advisory Committee on Immunization Practices, 2010. MMWR 60(1) 13-15. Available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6001a4.htm?s_cid=mm6001a4_w 18

19. VAERS provided data to Severe Combined Immunodeficiency (SCID) and Rotavirus Vaccine Issue  SCID - rare, life-threatening genetic disorders that result in profound deficiencies in immune system function  Rotavirus vaccine recommended at age 2,4 and 6 months, SCID usually diagnosed after age 4 months  VAERS was a source for reports of documented cases of rotavirus illness (severe gastroenteritis and prolonged vaccine viral shedding) that were found to be caused by the rotavirus vaccine in SCID infants who were vaccinated prior to being diagnosed with SCID  VAERS data provided support for adding SCID as an ACIP contraindication to rotavirus vaccine 19

20. New Contraindication for Rotavirus Vaccines: Severe Combined Immunodeficiency (SCID)  Package inserts were updated to add SCID as a contraindication for rotavirus vaccines (Dec 2009 RV5 Feb 2010 RV1) *,†  In June 2010, CDC updated the list of contraindications for rotavirus vaccine: “Rotavirus vaccine (both RV5 and RV1) is contraindicated in infants diagnosed with SCID”*  Vaccine Information Statement (VIS) also updated §  On May 21, 2010 the U.S. Department of Health and Human Services approved the addition of SCID to the uniform screening panel for all newborns *CDC. MMWR. June 2010. available at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5922a3.htmhttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm5922a3.htm † Bakare N, Menschik D, Tiernan R, Hua W, Martin D. Vaccine. 2010 Sept 14;28(40): 6609-12. §Vaccine Information Statement available at http://www.cdc.gov/vaccines/pubs/vis/default.htmhttp://www.cdc.gov/vaccines/pubs/vis/default.htm 20

21. Febrile Seizures after Fluzone ® Vaccine 2010-2011  2010 Southern Hemisphere CSL TIV was associated with a transient increased risk for febrile seizures in young children *  In the US, TIV before 2010-11 season not previously associated with increased risk for febrile seizure  ACIP recommended for US 2010-11 season not using CSL vaccine for children aged <9 years; Fluzone ® was the only recommended US 2010-11 TIV product for children aged 6-23 months  Febrile seizures have a good prognosis, but are still frightening to parents and caregivers  Because of the CSL product association, monitoring for potential risk for seizures was a focus in the US 2010-2011 influenza safety monitoring in VAERS and other systems 21 *CDC. MMWR Aug. 13, 2010. Update: Recommendations of the Advisory Committee on Immunization Practices (ACIP) Regarding Use of CSL Seasonal Influenza Vaccine (Afluria) in the United States During 2010--11 Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5931a4.htm?s_cid=mm5931a4_whttp://www.cdc.gov/mmwr/preview/mmwrhtml/mm5931a4.htm?s_cid=mm5931a4_w

22. 2010-11 Fluzone ® Influenza Vaccine and VAERS Reports of Febrile Seizures in Children  VAERS detected an increase in febrile seizure reports after 2010-2011 Fluzone ® vaccine in children ages 6-23 months (43 verified cases*)  Clinical presentation was consistent with typical febrile seizures; all recovered  These VAERS findings served as an indication that further investigation was warranted  Vaccine Safety Datalink (VSD) preliminary findings – there is a statistically significant excess risk for febrile seizures in 12-23 month old children after receiving TIV + PCV13** vaccines (+/- other vaccines)  Attributable risk of 61/100,000 doses***  Risk is temporary on vaccination day and one day after  No excess risk seen for TIV* or PCV13* vaccinees §  Recommendations for the use of 2010-2011 influenza vaccine in children did not change  Issue under discussion with ACIP for future recommendations 22 * As of 3/15/11 **PCV13 - pneumococcal 13-valent conjugate vaccine ***http://www.cdc.gov/vaccines/recs/acip/slides-feb11.htm#immunsafety § +/- other non-TIV, non-PCV vaccines

23. FDA and CDC Announcements on Fluzone ® and Febrile Seizures  FDA website  FDA and CDC Update on Fluzone ® Influenza Vaccine and VAERS Reports of Febrile Seizures in Children (January 20, 2011)*  VAERS website  UPDATE: Vaccine Adverse Event Reporting System (VAERS) Data on Febrile Seizures after Vaccination with Fluzone®, a 2010-2011 Trivalent Inactivated Vaccine, in Children (January 21, 2011) †  ACIP presentation link http://www.cdc.gov/vaccines/recs/acip/slides-feb11.htm#immunsafety http://www.cdc.gov/vaccines/recs/acip/slides-feb11.htm#immunsafety *http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm240037.htmhttp://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm240037.htm † http://vaers.hhs.gov/resources/VAERSupdate_FebrileSeizures_Children.pdf http://vaers.hhs.gov/resources/VAERSupdate_FebrileSeizures_Children.pdf 23

24. Summary of Recent Examples of VAERS Contribution to Public Health 24 ExampleVAERS FindingContribution 2009-10 H1N1 Influenza Vaccine Similar safety profile for H1N1 and seasonal vaccine - First US safety data during large emergency H1N1 vaccination program Tdap VaccineSimilar safety profile for Tdap and Td in ages ≥ 65 -Inform ACIP policy change for use of Tdap in ages ≥ 65 - Monitoring safety of the new recommendations Rotavirus VaccineIdentified new high risk population for severe adverse event: persons with severe combined immunodeficiency (SCID) - Support package insert and ACIP change to make SCID a contraindication for rotavirus vaccines 2010-11 Fluzone ® Trivalent Inactivated Influenza Vaccine Identified signal for febrile seizures in children aged <2 years -Identified need for further assessment - Showed clinical features of reports were typical of febrile seizures (good prognosis)

25. Acknowledgements CDC/Immunization Safety Office Karen Broder, MD Pedro Moro, MD, MPH Zanie Leroy, MD, MPH Kamesha Smith, MPH FDA/Center for Biologics Evaluation and Research David Martin, MD, MPH Tom Buttolph, MD 25

26. National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion – Immunization Safety Office Centers for Disease Control and Prevention Atlanta, GA 26

27. For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Thank you National Center for Emerging and Zoonotic Infectious Diseases Division of Healthcare Quality Promotion – Immunization Safety Office 27

28. For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA 30333 Telephone, 1-800-CDC-INFO (232-4636)/TTY: 1-888-232-6348 E-mail: cdcinfo@cdc.gov Web: www.cdc.gov The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention. Extra slide 28

29. VAERS Table of Reportable Events Following Vaccination http://vaers.hhs.gov/resources/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf 29