H1N1 Vaccine

1. H1N1 Vaccine Barbara Baker, MS, RNC Director of Nursing St. Joseph County Health Department

2. Contributions from: Kelly Jolliff Epidemiologist & Emergency Preparedness Supervisor St. Joseph County Health Department Lesley Craft, MPH, CHES Director of Health Education St. Joseph County Health Department Indiana State Department of Health

3. Vaccine Manufacturing • CDC provided H1N1 virus gene segment for vaccine manufacturing in May 2009 • Novel H1N1 vaccine is being procured by the U.S. government from five (5) vaccine manufacturers (4 have been approved by FDA) • Inactivated licensed novel H1N1 vaccine will be available in multi-dose vials and in single-dose syringes • Live attenuated vaccine will be available in limited numbers in inhaler sprayers • made employing the same methods and facilities used annually to produce seasonal influenza vaccine • clinical trials at this time to determine the size of the dose and the number of doses that will be needed for protection

4. Vaccine Purchase & Allocation • H1N1 vaccine will be made available at no cost • Syringes, needles, sharps containers, alcohol swabs, and pocket-size vaccination cards will also be provided • Gloves and band aids will NOT be provided • Some providers may be able to charge an administration fee • Vaccine will be allocated to states proportional to their population • Indiana will allocate vaccine to each Local Health Department by county or city population • St. Joseph County initially to receive up to 39,144 doses • Additional weekly shipments of 17,397

5. H1N1 Vaccine • What we know: • CDC estimates that approximately 45 million doses of H1N1 influenza vaccine will be available in mid-October • Approximately 20 million doses will be released in each subsequent week • What we don’t know: • Exactly when the vaccine will be ready-probably mid-late October • If it is 1 shot or 2 shots (early data indicates 1 for adults) • When and how it will be delivered • Exactly who will get it first • SJCHD is currently working with ISDH and CDC to determine how to deliver vaccinations to the target groups and community

6. Vaccine Delivery System • Centralized distribution through McKesson • This system will allow for a larger number of ship-to sites (up to 76 in St. Joseph County) • Local Health Department responsible for working with local health care providers to determine which sites are eligible for direct ship (at least 100 doses) • St. Joseph County Health Department to receive remaining vaccine Maintain the cold chain!

7. Vaccine Administration • Novel H1N1 vaccine must be maintained at 2-8°C • CDC is developing a H1N1 Vaccine Provider Agreement and a Vaccine Information Statement (VIS) • All vaccine doses must be entered into CHIRP within 24-48 hours of administration • Two doses may be needed per person, with 21 to 28 days between the first and second doses • However, vaccine should NOT be kept in reserve for later administration of a second dose Maintain the cold chain!

8. Administration Fees • The federal implementation funds that public health is receiving may be expected to cover these costs (decisions are pending) • Health care providers and clinics with contractual arrangements with insurance companies may bill those companies for the administration fee • Medicare will cover administration fees • It is NOT known whether providers will be able to charge uninsured patients for vaccine administration Maintain the cold chain!

9. Private Sector Partners • Private sector partners who wish to administer the H1N1 vaccine are asked to work with the Health Department • Health Department responsibilities when providing H1N1 vaccine to private sector partners include: • Maintaining the cold chain • Managing target/priority groups receiving the vaccine • Ensuring that all vaccine doses are entered into CHIRP Maintain the cold chain!

10. Monitoring Coverage, Safety & Effectiveness • Initially, providers will be expected to report weekly on the number of doses administered and the ages of persons who were vaccinated • Such data are critical for assessing early uptake • In addition, the Vaccine Adverse Event Reporting System (VAERS) will serve as the foundation for safety monitoring • VAERS accepts reports from patients, providers, public health officials and others • VAERS reporting information is currently available on www.chirp.in.gov Maintain the cold chain!

11. 2009-2010Seasonal Influenza Vaccine Seasonal influenza vaccine was approved by the FDA in July The vaccine became available in late August and September Vaccination efforts should begin as soon as the vaccine is available The process for ordering the vaccine is unchanged from previous years Season influenza vaccine is not expected to protect against the novel H1N1 virus Seasonal influenza and H1N1 vaccines may be able to be administered on the same day Maintain the cold chain!

12. H1N1 Vaccine Target Groups When vaccine is first available, ACIP recommends that programs and providers administer vaccine to persons in the following five target groups (order of target groups does not indicate priority): Pregnant women Persons who live with or provide care for infants aged <6 months (e.g., parents, siblings, and daycare providers) Health-care and emergency medical services personnel Persons aged 6 months-24 years Persons aged 25-64 years who have medical conditions that put them at higher risk for influenza-related complications Source: http://www.cdc.gov/mmwr/PDF/rr/rr5810.pdf

13. Subset of Target Group Subset of Target Groups During Limited Vaccine Availability Pregnant women Persons who live with or provide care for infants aged <6 months (e.g., parents, siblings, and daycare providers), Health-care and emergency medical services personnel who have direct contact with patients or infectious material, Children aged 6 months-4 years, and Children and adolescents aged 5-18 years who have medical conditions that put them at higher risk for influenza-related complications Source: http://www.cdc.gov/mmwr/PDF/rr/rr5810.pdf

14. Pregnant Women Reduce excess hospitalizations and deaths Reduce pre-term labor and delivery May protect the infant in utero and the first six months Pregnant women account for only 1% of US population During the Novel H1N1 pandemic pregnant women have accounted for 6% of laboratory confirmed cases and 8% of deaths (CDC)

15. How? Prenatal clinics Family practice OB/GYN Community Health Clinics Pharmacists Local Health Department clinics Other ideas? Maintain the cold chain!

16. Persons who live with or provide care for infants aged <6 mos (Parents, siblings, daycare providers) Younger infants are at higher risk of influenza-related complications and cannot be vaccinated. Vaccination of those in close contact with infants less than 6 months of age might help protect infants by “cocooning” them from the virus. Includes Children six months to four years not in daycare New parents Household contacts of children under six months

17. How? Family Practice OB/GYN Providers WIC Pediatricians Community Health Clinics Health Department Clinics Pharmacists Other ideas? Maintain the cold chain!

18. Reduce risk of illness Sustain health system functioning Reduce absenteeism among front-line providers Reduce transmission to patients Additional protection in increased exposure Health Care Workers and EMS Personnel

19. Health Care Workers and EMS Personnel Clarification Health-care personnel (HCP) include all paid and unpaid persons working in health-care settings who have the potential for exposure to patients with influenza, infectious materials, including body substances, contaminated medical supplies and equipment, or contaminated environmental surfaces. Source: MMWR vol. 58: Use of Influenza A (H1N1) 2009 Monovalent Vaccine Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm

20. Health Care Workers and EMS Personnel Clarification The recommendations in this report apply to HCP in acute-care hospitals, nursing homes, skilled nursing facilities, physicians' offices, urgent care centers, and outpatient clinics, and to persons who provide home health care and emergency medical services. Emergency medical services personnel might include persons in an occupation (e.g., emergency medical technicians and fire fighters) who provide emergency medical care as part of their normal job duties.

21. How? Occupational settings Community clinics Pharmacists Providers’ offices Other ideas? Maintain the cold chain!

22. Persons Six Months Through 24 Years High risk of illness Disruptive school closures Reduce transmission into the community Also applies to child care centers

23. How? School mass vaccination efforts Colleges & Universities PK-12 Remember permission slips! Pediatricians Family physicians Community Health Clinics Head Start Pharmacists for children four and over Other ideas? Maintain the cold chain!

24. Persons 19 to 64 with Chronic Diseases Under age 65 Asthma COPD Obesity (not so much) Other chronic conditions and immune deficiencies

25. How? Occupational settings Provider offices Home Care Agencies Community Health Clinics Health Department Offices Other ideas? Maintain the cold chain!

26. Then Everyone Else Once demand for vaccine for the prioritized groups has been met, providers should begin vaccinating everyone from the ages of 25-64 years. Current studies indicate the risk for infection among persons age 65+ is less than the risk for younger age groups. Once demand has been met among younger age groups, vaccination should be offered to people 65 years of age and older Mass Vaccination sites for the public? Maintain the cold chain!

27. Who Should Not Be Vaccinated? People who have a severe allergy to chicken eggs People who have had a severe reaction to a past influenza vaccine Children less than 6 months of age People who have a moderate or severe illness with a fever

28. What St. Joseph County is doing… • Pan Flu Working Group and Immunization Task Force Meetings held in August to outline methods for vaccinating target groups • Engaging additional community partners • Letter sent to all providers 9/14/09 with a brief survey to collect data on: Willingness to administer H1N1 Vaccine, Target Population Stats, CHIRP Registry status, Office Point of Contact Maintain the cold chain!

29. What St. Joseph County is doing… SJCHD to review survey results and determine which sites are appropriate for Direct Ship and those who will have to receive from SJCHD Send Direct Ship Provider Agreements Ensure all sites registered for CHIRP-Roll out CHIRP MIM module training for direct ship sit

30. More… Identify Community Clinic Locations (including school based clinics), staffing needs, and estimates target groups to reach out to Utilize federal grant funding to support vaccination efforts Develop educational materials and launch campaign to inform public about H1N1 vaccine sites Question: How to best Communicate? Maintain the cold chain!

31. CDC Vaccines and Immunization Contact Information Telephone 800-CDC-info (for patients and parents) E-mail www.nipinfo@cdc.gov (for providers) Website www.cdc.gov/vaccines CDC H1N1

32. Additional Information • United Way 211 • www.nd.edu/~pandflu • www.in.gov/isdh • www.in.gov/flu • www.who.int • www.pandemicflu.gov

33. Contact Information: Barbara Baker, MS, RNC Director of Nursing St. Joseph County Health Department 235-9745 bbaker@co.st-joseph.in.us