Texas Pediatric SocietyNovember 19, 2009

H1N1: Vaccine Delivery

Flor M. Munoz, MDAssistant Professor of Pediatrics

Section of Infectious DiseasesMolecular Virology and Microbiology

Baylor College of Medicine

Susan Penfield, MDMonica Gamez

Infectious Disease Prevention SectionTexas Department of State Health Services (DSHS)

H1N1

• Epidemiology in Texas• Vaccine • Treatment

Page 4

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

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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.

Patient AgeNumber of

Hospitalizations*Number ICU admissions

Number of H1N1

deaths**

< 1 yr of age 165 25 7

1 – 4 yrs of age 160 22 4*

5 – 9 yrs 186 24 5

10 – 18 yrs 163 24 13

19 – 24 yrs 111 18 7

25 – 49 yrs 315 102 71

50 – 64 yrs 219 85 36

65 + yrs 79 26 7

TOTALS 1398 326 150

Age Distribution for Certain Novel Influenza A (H1N1) Cases Compared to Texas Population

0

510

1520

25

3035

4045

50

< 1 1-4 5-9 10-18 19-24 25-49 50-64 65+

Age Group in Years

Hospitalized* ICU Admissions Deaths** Population

* Hospitalizations reported for 9/20-11/07/09

** Confirmed deaths from April to 11/07/09

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

Patient Age

Number of H1N1 ICU

Admissions in NBS

Number with chronic health conditions

Percent

< 1 year 25 13 52.0

1 – 4 yrs of age 8 5 62.5

5 – 9 yrs 17 9 52.9

10 – 18 yrs 15 10 66.7

19 – 24 yrs 10 6 60.0

25 – 49 yrs 75 56 74.7

50 – 64 yrs 65 60 92.3

65 + yrs 17 16 94.1

TOTALS 232 175 75.4

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

Patient Age

Number of H1N1 ICU

Admissionsin NBS

Number with chronic health

conditionsPercent

Pediatric 64 37 57.8

Adult 168 138 82.1

Total 232 175 75.4

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Novel H1N1: Deaths & Chronic Medical Conditions –Texas

Confirmed Novel H1N1 deaths from end of April to 11/07/09

* One of these was a Mexico City resident.

Patient AgeNumber of

H1N1 deaths in NBS

Number with chronic health conditions

Percent

< 1 year 5 4 80.0

1 – 4 yrs of age 3* 2 66.6

5 – 9 yrs 5 3 60.0

10 – 18 yrs 13 7 53.8

19 – 24 yrs 7 4 57.1

25 – 49 yrs 68 58 85.3

50 – 64 yrs 37 32 86.5

65 + yrs 7 7 100.0

TOTALS 145 117 80.7

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H1N1 Deaths - Percent of Individuals with Underlying Health Conditions by

Age Group

0

10

20

30

40

50

60

70

80

90

100

< 1year

1 – 4yrs ofage

5 – 9yrs

10 – 18yrs

19 – 24yrs

25 – 49yrs

50 – 64yrs

65 +yrs

Total

Age Group

Pe

rce

nt

ICU Admissions Deaths

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Novel H1N1 Deaths in Texas – Health Conditions

Confirmed Novel H1N1 deaths from end of April to 11/07/09

Chronic Health Condition

Child < 19 years (n=16)N %

Adult (n=101)N %

History of prematurity / developmental delay / Down’s syndrome

9 (56.2%) 1 (1.0%)

Neuromuscular/seizures 6 (37.5%) 6 (5.9%)

Lung disease/ Asthma 12 (75.0%) 19 (18.8%)

Cardiac 2 (12.5%) 12 (11.9%)

Diabetes 0 (0.0%) 31 (30.7%)

Kidney 0 (0.0%) 12 (11.9%)

Obesity 1 (6.3%) 18 (17.8%)

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Novel H1N1 Deaths/Chronic Conditions

Patient AgeNumber of

H1N1 deaths in NBS

Number with chronic health

conditionsPercent

Pediatric 26* 16 61.5

Adult 119 101 84.9

Total 145 117 80.7

* Includes child from Mexico City

Texas from end of April to 11/07/09

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

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Invasive Pneumococcal Disease –Preliminary – CDC from 1 site

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

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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.

DSHS Vaccine Allocation

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

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

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

Number of Providers

• Pre-registered providers: 12,706

• Final registered providers: 11,055

• New provider registrations in ImmTrac: 3,482

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.

•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

Vaccine Ordering & Distribution

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

Reporting the Administration of the H1N1 Vaccineto 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

ImmTrac

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

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

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)

State Law Requirements

How to Report Administration of the H1N1 Vaccine to ImmTrac

There are two (2) ways to report the administration ofthe H1N1 vaccine to ImmTrac*

1. Direct ImmTrac Online Application Entry

2. 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.

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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

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

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

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

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