Texas Pediatric Society November 19, 2009 H1N1: Vaccine Delivery

1. Texas Pediatric SocietyNovember 19, 2009H1N1: Vaccine Delivery Flor M. Munoz, MD Assistant Professor of Pediatrics Section of Infectious Diseases Molecular Virology and Microbiology Baylor College of Medicine Susan Penfield, MD Monica Gamez Infectious Disease Prevention Section Texas Department of State Health Services (DSHS)

2. H1N1 • Epidemiology in Texas • Vaccine • Treatment

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5. Disease Reporting • Report hospitalizations with PCR or culture confirmed novel H1N1 • Report ICU admissions with PCR or culture confirmed novel H1N1 • Report deaths due to PCR or culture confirmed novel H1N1 • One page investigation form for deaths and ICU admissions • Report to local health department • May be done through hospital infection control prevention

6. Confirmed Novel H1N1 Hospitalizations, ICU Admissions, and Deaths as of week ending 11/7/09 *Hospitalization numbers include ICU admissions. * Includes child from Mexico City. Page 6

7. Age Distribution for Certain Novel Influenza A (H1N1) Cases Compared to Texas Population * Hospitalizations reported for 9/20-11/07/09 ** Confirmed deaths from April to 11/07/09

8. Novel H1N1: ICU Admissions & Chronic Health Conditions - Texas 9/20/09-11/07/09 Page 8

9. Novel H1N1 ICU Admissions in Texas from 9/20/09-11/7/09 Page 9

10. Novel H1N1: Deaths & Chronic Medical Conditions –Texas Confirmed Novel H1N1 deaths from end of April to 11/07/09 Page 10 * One of these was a Mexico City resident.

11. H1N1 Deaths - Percent of Individuals with Underlying Health Conditions by Age Group

12. Novel H1N1 Deaths in Texas – Health Conditions Confirmed Novel H1N1 deaths from end of April to 11/07/09 Page 12

13. Novel H1N1 Deaths/Chronic Conditions Texas from end of April to 11/07/09 * Includes child from Mexico City Page 13

14. Antiviral Treatment • ICU Admissions • 50% of pediatric ICU admissions received AV treatment within 48 hours of symptom onset • 30% of adult ICU admissions received AV treatment within 48 hours of symptom onset • Deaths • 45% of pediatric deaths received AV treatment within 48 hours of symptom onset • 20% of adults deaths received AV treatment within 48 hours of symptom onset Page 14

15. Invasive Pneumococcal Disease –Preliminary – CDC from 1 site

17. Antiviral Resistance DSHS and CDC are collaborating on resistance testing for novel H1N1 A few confirmed Tamiflu resistant cases in Texas, associated with prophylaxis or use in persons with significant immunocompromise No confirmed resistance to Zanamivir/Relenza All novel H1N1 viruses tested by CDC have been resistant to amantadines, including those in Texas Use antivirals appropriately to decrease resistance development; trend is towards watchful waiting rather than prophylaxis after exposure Page 17

18. Vaccine Administration Intervals and Types • Inactivated vaccine – seasonal and novel H1N1 – any interval or simultaneously • Seasonal and H1N1 at same time– can give 2 inactivated or one inactivated and one intranasal LAIV; can also give at any interval between • Interval between live (LAIV) vaccinations of any type should be 28 days but could be at least 21 days • Novel H1N1 Vaccine types • 3 injectable vaccines and one live attenuated influenza virus intranasal vaccine are in use in the U.S. • One of the injectable vaccines (CSL) has been expanded for use from 6 months of age and up. • FDA has just approved an additional manufacturer’s injectable for use in persons 18 years old or older. Page 18

20. DSHS Vaccine Allocation • DSHS manages vaccine distribution in accordance with the recommendations of the CDC’s Advisory Committee on Immunization Practices (ACIP).

21. Priority Groups • Vaccine has been made available for these priority groups: • Pregnant women • HCW / EMS • Close contacts of children < 6 months of age • Children 6 – 59 months • High risk children 5 thru 18 years • High risk adults 19 thru 64 • Once vaccine supply is sufficient, the groups will be expanded to the two remaining high risk groups--healthy children and healthy adults 19 – 25. IN CHOOSING WHOM TO VACCINATE: PROVIDERS SHOULD USE CLINICAL JUDGMENT, BASED ON THEIR EXPERIENCE AND SITUATION

22. Vaccine Supply as of Monday, November 16th, 2009 • Approximately 48 million doses available nationally • 3.7 million doses made available to Texas • Virtually all has been made available to providers

23. Number of Providers • Pre-registered providers: 12,706 • Final registered providers: 11,055 • New provider registrations in ImmTrac: 3,482

24. Vaccine Ordering and Distribution • H1N1 vaccine distribution relies on Texas’ successful public and private healthcare partnerships. • State, regional and local public health recruited private-sector partners for H1N1 vaccine administration. • Public and private providers registered at www.TexasFlu.org to receive H1N1 vaccine. • The Vaccine Ordering and Reporting System (VORS) at www.TexasFlu.org manages vaccine allocation, ordering, distribution information, and reporting.

25. Vaccine Ordering & Distribution • Provider allocations are posted online in the Vaccine Ordering and Reporting System (VORS). • Providers are notified by email and blast fax to place their orders for H1N1 vaccine in VORS. • Providers place their order in VORS up to their maximum amount of available allocated vaccine. • The Immunization Branch sends the orders to the distributors for shipment • Distributor’s delivery time is 5 – 10 days

26. Doses Administered Reporting • Providers are required to go into VORS and report doses administered on a weekly basis • Total Number of doses administered are reported by age group for the following ages: • 6-23 months • 24-59 months • 5-18 years • 19-24 years • 25-49 years • 50-64 years • 65+ years

27. Reporting the Administration of the H1N1 Vaccineto ImmTrac

28. ImmTrac • ImmTrac is the Texas immunization registry • Serves as the tracking and reporting tool for Texas community preparedness effort • Free service from the Texas Department of State Health Services (DSHS) • Repository of immunization histories for • Texas children • Texas first responders • First responder family members 18 years of age and older • Disaster-related information

29. State Law Requirements Texas Administrative Code, Title 25 Part 1 Chapter 100 Rule § 100.7 & § 100.8 • Allows for the inclusion of information about persons who receive antivirals, immunizations or other medications (AIMs) in preparation for, or in response to, a potential or declared disaster or public health emergency into ImmTrac

30. State Law Requirements • As the reporting and tracking tool, ImmTrac will include information on all individuals who receive an antiviral, immunization or medication (AIM) in response to, or in preparation for, a public health emergency or disaster event (providers should notify each client receiving the vaccine of this information) • Healthcare providers administering AIMs must report such information to ImmTrac

31. State Law Requirements • ImmTrac will retain impacted individuals’ records for the mandated retention period of 5 years after the event has been declared over • Opportunity to grant consent to remain an ImmTrac participant may be requested anytime prior to the end of the mandated retention period for any disaster/emergency (see Disaster Information Retention Form section)

32. There are two (2) ways to report the administration of the H1N1 vaccine to ImmTrac* Direct ImmTrac Online Application Entry Electronic Reporting Interface Standard Import Data File Process Delimited File Format Excel Spreadsheet Template *Providers who are unable to report to ImmTrac using any of the methods listed above may contact ImmTrac via email at ImmTrac@dshs.state.tx.us (please type Reporting to ImmTrac in the subject) or you may contact us via telephone at 1-800-348-9158. How to Report Administration of the H1N1 Vaccine to ImmTrac

33. Vaccine Safety • Modern vaccine development: • Improved process for manufacturing vaccines • FDA must approve after testing on animals and humans • Method for developing H1N1 vaccine is the same as that used for seasonal flu • This method is both proven and safe • Made with much of the same ingredients for seasonal flu vaccines • Clinical trials for effectiveness and safety are still underway • Ongoing monitoring after release - VAERS Page 33

34. Vaccine Adverse Event Reporting System (VAERS) • Texas VAERS reports are sent to DSHS • DSHS sends reports to the CDC • CDC analyses reports and conducts investigations on VAERS reports • CDC maintains national VAERS data

36. H1N1 Help Desks • 2-1-1 Texas (877-541-7905 or www.211texas.org) In addition to usual information and referral specialists, 2-1-1 is also staffed by nurses who respond to the public and healthcare providers on H1N1 clinical questions, VORS questions, and other H1N1 questions. • DSHS H1N1 Vaccine Call Center opened 10-08-09 (888-777-5320 or VacCallCenter@dshs.state.tx.us) Is staffed by Immunization Branch employees and temporary staff who respond to provider’s questions on vaccine allocation, ordering, distribution, and administration. Responds to approximately 300 calls per day

37. Acknowlegements • Lesley Bullion • Julie Borders • Rita Espinoza • Grace Kubin • Irene Brown • Allison Banicki • Tony Aragon • Local Health Departments • DSHS Health Service Regions • Austin Clinical Epidemiology Team

38. Contact Information and Links • www.texasflu.org • http://www.cdc.gov/h1n1flu/ • Susan Penfield MD • Susan.penfield@dshs.state.tx.us • 512-458-7455 • Flor M. Munoz, MD • Assistant Professor of Pediatrics • Baylor College of Medicine • Houston, Texas 77030 • Tel: 713-798-5248 • florm@bcm.tmc.edu