Influenza A (H1N1) 2009 monovalent vaccine – Implementation overview

1. COCA Conference Call: Influenza A (H1N1) 2009 monovalent vaccine – Implementation overview August 26, 2009 Pascale Wortley, MD, MPH Vaccine Implementation Team CDC

2. Outline • Epidemiology overview • ACIP recommendations • Clinical trials and licensure • Safety monitoring • Vaccine logistics • Vaccine financing

3. Pandemic (H1N1) 2009 influenza - Summary of key epidemiologic findings in the US* • Distribution of cases/hospitalizations/deaths • Highest incidence lab confirmed infections in school age children • Highest hospitalization rates among 0 through 4 year olds • Hospitalization rates for Apr-Jul 2009 approach cumulative rates for seasonal influenza among school age children and 19 through 49 year old adults • Fewest cases but highest case-fatality ratio in older adults • Distribution of cases by age group is markedly different compared to seasonal influenza • Higher proportion of hospitalized cases in children and young adults • Few cases in older adults • No outbreaks among elderly in long term care facilities • 70% of hospitalized cases have an underlying medical condition that confers higher risk for complications • Pregnancy is a higher risk condition *ACIP Influenza Workgroup Considerations. ACIP Meeting, July 29, 2009.

4. ACIP Recommendations: Influenza A (H1N1) 2009 monovalent vaccine use*§ • Vaccinate as many as possible in 5 initial target groups (~159 mil) • Pregnant women • Household and caregiver contacts of children younger than 6 months of age (e.g., parents, siblings, and daycare providers) • Health-care and emergency medical services personnel1 • Persons from 6 months through 24 years of age • Persons aged 25 through 64 years who have medical conditions associated with a higher risk of influenza complications2 • Seasonal influenza vaccine coverage in these target groups is only 20-50% *ACIP Influenza Workgroup Considerations. ACIP Meeting, July 29, 2009. §For unadjuvanted H1N1 vaccine

5. ACIP Recommendations: Influenza A (H1N1) 2009 monovalent vaccine use*§ (2) • Prioritization within these 5 target groups might be necessary if initial vaccine availability is insufficient to meet demand (~42 mil) • Pregnant women • Household and caregiver contacts of children younger than 6 months of age • Health-care and emergency medical services personnel with direct patient contact • Children from 6 months through 4 years of age • Children and adolescents aged 5 through 18 years who have medical conditions associated with a higher risk of influenza complications

6. ACIP Recommendations: Influenza A (H1N1) 2009 monovalent vaccine use*§ (3) Once demand is met for the 5 initial target groups include: • All other persons ages 25 through 64 years Followed by: • All persons 65 years and older -------------------------------------------------------------------- • Decisions about when to begin offering vaccination to persons outside of the initial target groups should be made in consultation with local public health authorities

7. Summary vaccination of population groups over time§ Increasing vaccine availability and demand met by immunization programs Consult local public health authorities Adults 65+ (38 million) Primary target groups* Healthy adults 25-64 (103 million) Proportion of population Pregnant women Infant contacts HCP/EMS Persons 6m—24y Adults high risk <65y (159 million) Population groups §ACIP Influenza Workgroup Considerations. ACIP Meeting, July 29, 2009. *Note prioritization of ~42 million persons within primary target groups if vaccine demand exceeds availability: 1)pregnant women; 2) contacts and care providers for infants <6 months old; 3) HCP/EMS with direct contact with patients or infectious material; 4) children aged 6m through 4 y; and, 5) children aged 5y through 18 y with chronic medical conditions

8. ACIP Recommendations: Influenza A (H1N1) 2009 monovalent vaccine use*§ (4) • Vaccine should not be held in reserve for patients who already have received 1 dose but might require a second dose. • Simultaneous administration of inactivated vaccines against seasonal influenza viruses and pandemic (H1N1) 2009 virus IS PERMISSIBLE if different anatomic sites are used. • Simultaneous administration of live, attenuated vaccines against seasonal viruses and pandemic (H1N1) 2009 virus is NOT RECOMMENED. • All persons currently recommended for seasonal influenza vaccine, including those aged ≥65 years, should receive the seasonal vaccine as soon as it is available.

9. Influenza A (H1N1) 2009 monovalent vaccine – Clinical trial basic design concepts* Licensed Manufacturers • Monovalent vaccine • Designed to inform dose, dosing regimen and safety • Randomized, double-blind, controlled, dose ranging • 2 doses (0,21d) with post-dose 1 immunogenicity assessment • Adult and pediatric studies • Unadjuvanted and adjuvanted arms *FDA Vaccines and Related Biological Products Advisory Committee Update. ACIP Meeting, July 29, 2009.

10. Influenza A (H1N1) 2009 monovalent vaccine – Licensure of unadjuvanted monovalent vaccines made by licensed process • Manufacturers will submit a supplement to their seasonal influenza biologics license for the Influenza A (H1N1) 2009 monovalent vaccineanalogous to seasonal strain change supplement

11. Influenza A (H1N1) 2009 monovalent vaccine - Safety monitoring Objectives of the safety monitoring response: • Identify clinically significant adverse events following receipt of vaccine in a timely manner • Rapidly evaluate serious adverse events following receipt of vaccine and determine public health importance • Evaluate if there is a risk of Guillain-Barré syndrome (GBS) associated with receipt of vaccine • Communicate vaccine safety information in a clear and transparent manner to healthcare providers, public health officials, and the public

12. Influenza A (H1N1) 2009 monovalent vaccine - Safety monitoring (2) Methods: • Vaccine Adverse Event Reporting System (VAERS) will be the front-line monitoring system for collecting and analyzing voluntary reports of adverse events following receipt of vaccine

13. Influenza A (H1N1) 2009 monovalent vaccine - Safety monitoring (3) Methods (continued): • Vaccine Safety Datalink • Collaborative effort between CDC and eight large managed care organizations • Vaccine Analytic Unit • Collaboration among the Department of Defense, CDC and the FDA • Emerging Infections Programs • A population-based network of CDC and 10 state health departments (CA, CO, CT, GA, MD, MN, NM, NY, OR, TN) • American Academy of Neurologists and CDC • Collaboration to enhance VAERS reporting of neurological events, including GBS • Clinical Immunization Safety Assessment (CISA) • Collaboration between CDC and 6 academic centers

14. Influenza A (H1N1) 2009 monovalent vaccine products • Vaccines developed by five manufacturers • CSL, GSK, MedImmune, Novartis, Sanofi • Both inactivated and live intranasal vaccine • Thimerosal-free vaccine should be available for pregnant women and young children • Storage identical to seasonal vaccine • Ancillary supplies will be provided • Syringes, needles, sharps containers, alcohol swabs

15. Influenza A (H1N1) 2009 monovalent vaccine purchase and allocation Vaccine and Ancillary supplies • Procured and purchased by US government and made available at no cost to providers* (defined broadly) • Will be allocated across states proportional to population *Primary care clinicians, hospitals, public health clinics, schools, retail clinics, workplaces, pharmacies, others

16. Influenza A (H1N1) 2009 monovalent vaccine distribution Vaccine and Ancillary supplies • Will be sent by a central distributor to state-designated locations or providers which will include a mix of local health departments, provider offices, workplaces, schools, hospitals, retail settings, and other sites

17. Influenza A (H1N1) 2009 monovalent vaccine planning assumptions • Vaccine available starting mid-October • Initial amount: At least 45 million doses will be available by Oct 15, followed by a projected average of 20M per week (up to the 195 million doses already purchased) • Likely 2 doses required, 3-4 wks apart

18. Influenza A (H1N1) 2009 monovalent vaccine – Public health planning efforts • Planning large scale clinics and school-located clinics • Reaching out to providers to assess interest and capacity to provide Influenza A (H1N1) 2009 monovalent vaccine in a variety of settings

19. Influenza A (H1N1) 2009 monovalent vaccine providers State/Local public health (PH) departments will designate who can serve as a vaccine provider • Providers will enter into an agreement with state/local PH to receive vaccine • State/Local PH will advertise registration process to potential providers • CDC is compiling a list of state websites and/or contacts for interested providers. List will be posted on CDC website

20. Influenza A (H1N1) 2009 monovalent vaccine financing • Providers CANNOT charge a fee for the vaccine, syringes or needles since they are being provided at no cost to the provider • Providers may charge a fee for the administration of the vaccine to the patient, their health insurance plan, or other third party payer • Providers are encouraged to vaccinate under- or uninsured patients; however, if unable, providers should refer these patients to a public health clinic or affiliated PH provider

21. Influenza A (H1N1) 2009 monovalent vaccine financing (2) Association of Health Insurance Plans (AHIP), on behalf of its members: "Every year health plans contribute to the seasonal flu vaccination campaign in several ways: a) Health plans communicate directly with plan sponsors and members on the current ACIP recommendations and encourage immunization; they also provide information on where to get vaccinations, and who to contact with any questions. b) Just as health plans have provided extensive coverage for the administration of seasonal flu vaccines in the past, public health planners can make the assumption that health plans will provide reimbursement for the administration of a novel (A) H1N1 vaccine to their members by private sector providers in both traditional settings e.g., doctor’s office, ambulatory clinics, health care facilities, and in non-traditional settings, where contracts with insurers have been established"

22. Don’t forget about seasonal influenza vaccination!

23. H1N1 web resources • http://www.cdc.gov/h1n1flu/general_info.htm • http://www.cdc.gov/h1n1flu/vaccination/ • http://www.flu.gov

24. Thank you! Please send any additional questions tococa@cdc.gov with “vaccine” in the subject line

25. COCA Conference Call:CDC Guidance for State and Local Public Health Officials and School Administrators for School (K-12) Responses to Influenza during the 2009-2010 School YearAugust 26, 2009 Francisco Alvarado-Ramy, MD, FACP CDR, US Public Health ServiceCommunity Measures Task Force CDC 2009 H1N1 Influenza Response Centers for Disease Control and Prevention

26. Purpose Provide guidance on suggested means for reducing exposure of students and staff to influenza during the 2009-2010 school year Goals Decrease spread of flu among students and staff Minimize disruption of day-to-day social, educational, and economic activities CDC Guidance for School Responses

27. 55 million students >130,000 public and private schools 7 million adult teachers and staff U.S. schools’ services to students Educate Feed Child care Health care Stable routine Background – U.S. Schools

28. Recommends specific interventions for use this school year New exclusion period guidance Suggests interventions for use if flu conditions become more severe Accompanied by supplemental materials Technical Report Communications Toolkit Provides decision-making considerations Changes from Previous Guidance

29. Currently, potential benefits of preemptive school dismissal often outweighed by negative consequences; but may be recommended in the future if severity increases Guidance offers a menu of strategies based on severity of outbreak during spring 2009 and additional interventions to consider if severity increases Balance goals of reducing illness and death with goal of minimizing social disruption Based on local goals, disease conditions, feasibility, and acceptability Interventions determined through collaborative decision making (education and public health agencies, parents, and community) Summary

30. Stay home when sick Separate ill students and staff Hand hygiene and respiratory etiquette Early treatment of high-risk students and staff Routine cleaning Consideration of selective school dismissal Recommended School Responses (Similar Severity as in Spring 2009)

31. Active screening High-risk students and staff members stay home Students with ill household members stay home Increase distance between people at schools Extend the period for ill persons to stay home School dismissals Recommended School Responses (Increased Severity)

32. Individuals with ILI should remain home for at least 24 hours after they are free of fever or feverishness without the use of fever-reducing medications 3 to 5 days in most cases Avoid contact with others Can shed virus before fever, > 24 hours after fever ends, without any fever, and while using antivirals Hand hygiene Respiratory etiquette Longer exclusion period may be appropriate for settings with high numbers of high-risk persons Recommended Strategies: Stay Home when Sick

33. Move students and staff with ILI symptoms to separate room immediately until they can be sent home Have them wear surgical masks when near others Designate non-high-risk staff to mind students Staff who provide care for persons with ILI should use appropriate personal protective equipment Recommended Strategies: Separate ill Students and Staff

34. Wash hands often – especially after coughing or sneezing Time, facilities and materials should be provided for students to wash hands as needed Alcohol-based hand cleaners are also effective Cover nose and mouth to cough or sneeze Discard tissue after use Recommended Strategies: Hand Hygiene and Respiratory Etiquette

35. Regularly clean areas and items likely to have frequent hand contact and when visibly soiled Use cleaning agents usually used Not necessary to disinfect beyond routine cleaning Train custodians and others who clean Recommended Strategies:Routine Cleaning

36. Encourage ill staff and students at high risk for complications to seek early treatment Selective school dismissals May be considered based on population of individual schools Rare event Local decision Goal of protecting students and staff at high risk Not likely to have a significant effect on community-wide transmission Recommended Strategies: Early Treatment, Selective Dismissals

37. Ask about fever and other symptoms Send home people with symptoms of acute respiratory infection Be vigilant throughout the day Send students and staff who appear ill for further screening by school-based health care worker If possible, have ill person wear a mask until sent home If Severity Increases: Active Screening for Illness

38. School and school board should consider ways to allow people to stay home Decide with health care provider Schools should plan for continuing education for these students If Severity Increases: Permit High Risk Persons to Stay Home

39. School-aged children who live with people with ILI should remain home for 5 days from day first household member got sick Based on household transmission data If Severity Increases: Students with Ill Household Members Stay Home

40. Explore innovative methods Rotate teachers rather than students Cancel classes that bring students together from multiple classrooms Outdoor classes Move desks farther apart Move classes to larger spaces Discourage use of school buses and public transit Postpone some class trips If Severity Increases: Increase Distance between People

41. If influenza severity increases, people with ILI should stay home for at least 7 days, even if they have no symptoms sooner If people are still sick after 7 days, they should stay home until 24 hours after they have no symptoms If Severity Increases: Extended Exclusion Period for Ill Persons

42. Preemptive dismissals CDC will consider need to recommend based on global and national risk assessments Goal: decrease spread of influenza virus and reduce demand on health care system Use early and in conjunction with other strategies Time to vaccine-induced immunity may be considered If dismissing, do so for 5 to 7 days and reassess Allow staff to continue to use facilities Plan for prolonged dismissals and secondary effects If Severity Increases: School Dismissals

43. Report dismissals to CDC, the U.S. Department of Education, and your state health and education agencies atwww.cdc.gov/FluSchoolDismissal Generate real-time, national summary datadaily on the number of school dismissals/closures and # of impacted students, teachers School Dismissal Monitoring

44. www.cdc.gov/h1n1flu/schools/ Send additional questions to coca@cdc.gov with Attn to: Pediatrics deck - at CDC’s Emergency Operations Center (EOC) POCs Georgina Peacock, MD MPH Lisa Barrios, DrPH MS Francisco Alvarado-Ramy, MD FACP EOC Phone # is 770-488-7100 Additional Information, Assistance