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

H1N1 Vaccine

Barbara Baker, MS, RNCDirector of Nursing

St. Joseph County Health Department

Contributions from:Kelly JolliffEpidemiologist & Emergency Preparedness SupervisorSt. Joseph County Health Department

Lesley Craft, MPH, CHESDirector of Health EducationSt. Joseph County Health Department

Indiana State Department of Health

Vaccine Manufacturing Vaccine Manufacturing CDC provided H1N1 virus gene segment for vaccine manufacturing

in May 2009Novel 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 syringesLive attenuated vaccine will be available in limited numbers in inhaler

sprayersmade employing the same methods and facilities used annually to

produce seasonal influenza vaccineclinical trials at this time to determine the size of the dose and the

number of doses that will be needed for protection

Vaccine Purchase & Allocation 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 providedSome 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 populationSt. Joseph County initially to receive up to 39,144 dosesAdditional weekly shipments of 17,397

H1N1 VaccineWhat 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

OctoberIf it is 1 shot or 2 shots (early data indicates 1 for adults)When and how it will be deliveredExactly 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

Vaccine Delivery System 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!

Vaccine AdministrationVaccine AdministrationNovel H1N1 vaccine must be maintained at 2-8°CCDC 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 administrationTwo 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


Administration FeesAdministration FeesThe 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 feesIt is NOT known whether providers will be able to charge

uninsured patients for vaccine administration


Private Sector PartnersPrivate Sector PartnersPrivate sector partners who wish to administer the H1N1

vaccine are asked to work with the Health DepartmentHealth Department responsibilities when providing H1N1

vaccine to private sector partners include:Maintaining the cold chainManaging target/priority groups receiving the vaccineEnsuring that all vaccine doses are entered into CHIRP


Monitoring Coverage, Safety & Monitoring Coverage, Safety & Effectiveness 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 uptakeIn addition, the Vaccine Adverse Event Reporting System

(VAERS) will serve as the foundation for safety monitoringVAERS accepts reports from patients, providers, public

health officials and othersVAERS reporting information is currently available on

www.chirp.in.gov


2009-20102009-2010Seasonal Influenza Vaccine Seasonal 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

availableThe process for ordering the vaccine is unchanged from previous

yearsSeason influenza vaccine is not expected to protect against

the novel H1N1 virusSeasonal influenza and H1N1 vaccines may be able to be

administered on the same day


H1N1 Vaccine Target GroupsWhen vaccine is first available, ACIP recommends that programsand providers administer vaccine to persons in the following fivetarget groups (order of target groups does not indicate priority):Pregnant womenPersons 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 yearsPersons 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

Subset of Target GroupSubset of Target Groups During Limited Vaccine AvailabilityPregnant womenPersons 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

Pregnant WomenReduce excess hospitalizations and deathsReduce pre-term labor and deliveryMay protect the infant in utero and the first six

monthsPregnant 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)

How?Prenatal clinicsFamily practiceOB/GYNCommunity Health ClinicsPharmacistsLocal Health Department clinicsOther ideas?


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 parentsHousehold contacts of children under six months

How?Family PracticeOB/GYN ProvidersWICPediatriciansCommunity Health ClinicsHealth Department ClinicsPharmacistsOther ideas?


Reduce risk of illnessSustain health system functioningReduce absenteeism among front-line

providersReduce transmission to patientsAdditional protection in increased

exposure

Health Care Workers and EMS Personnel

Health Care Workers and EMS Personnel ClarificationHealth-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), 2009http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0821a1.htm

Health Care Workers and EMS Personnel ClarificationThe 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.

How?Occupational settingsCommunity clinicsPharmacistsProviders’ officesOther ideas?


Persons Six Months Through 24 YearsHigh risk of illnessDisruptive school closuresReduce transmission into the communityAlso applies to child care centers

How?School mass vaccination efforts

Colleges & UniversitiesPK-12Remember permission slips!

PediatriciansFamily physiciansCommunity Health ClinicsHead StartPharmacists for children four and overOther ideas?


Persons 19 to 64 with Chronic DiseasesUnder age 65AsthmaCOPDObesity (not so much)Other chronic conditions and immune

deficiencies

How?Occupational settingsProvider officesHome Care AgenciesCommunity Health ClinicsHealth Department OfficesOther ideas?


Then Everyone ElseOnce 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?


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

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


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

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?


CDC Vaccines and Immunization Contact InformationTelephone 800-CDC-info (for patients and parents)E-mail [email protected] (for providers)Website www.cdc.gov/vaccinesCDC H1N1

Additional InformationUnited Way 211

www.nd.edu/~pandflu

www.in.gov/isdh

www.in.gov/flu

www.who.int

www.pandemicflu.gov

Contact Information:Barbara Baker, MS, RNC

Director of NursingSt. Joseph County Health Department

[email protected]

Documents

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