www.cdc.gov/h1n1flu coca conference call: h1n1update: epidemiology and clinical features h1n1...
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www.cdc.gov/H1N1flu
COCA Conference Call:COCA Conference Call:H1N1Update: Epidemiology and Clinical FeaturesH1N1Update: Epidemiology and Clinical Features
H1N1 Vaccine: H1N1 Vaccine: Development, ManufacturingDevelopment, Manufacturingaand Program Implementationnd Program Implementation
Joseph Bresee, MDJoseph Bresee, MD
Tom Shimabukuro, MD, MPH, MBATom Shimabukuro, MD, MPH, MBA
Pascale Wortley, MD, MPHPascale Wortley, MD, MPH
July 15, 2009July 15, 2009
www.cdc.gov/H1N1flu
Continuing Education Disclaimer
In compliance with continuing education requirements, all presenters must disclose any financial or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters as well as any use of unlabeled product(s) or product(s) under investigational use.
CDC, our planners, and our presenters wish to disclose they have no financial interests or other relationships with the manufacturers of commercial products, suppliers of commercial services, or commercial supporters. This presentation does not involve the unlabeled use of a product or product under investigational use.
There is no commercial support.
www.cdc.gov/H1N1flu
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www.cdc.gov/H1N1flu
July 15, 2009
Joseph Bresee, MDChief, Epidemiology and Prevention Branch
Influenza Division, NCIRDCenters for Diseases Control and Prevention
Update on the epidemiology and clinical features of Novel H1N1
The contents of this presentation are those of the presenters and do not necessarily reflect the views of CDC
www.cdc.gov/H1N1flu
Increased swine influenza detection in humans 2005-9
Triple-Reassortant Swine Influenza A (H1) in Humans in the United States, 2005–2009
Shinde, et al. N Engl J Med. 2009 Jun 18;360(25):2616-25
• January 2007 – “Novel influenza A” made a Nationally Notifiable Disease but CSTE – part of pandemic preparedness efforts• RT-PCR for influenza capabilities developed by public health labs in U.S.• Increasing numbers of swine influenza infections in humans being detected from improved surveillance• Increasing efforts at states, CDC, and USDA to investigate human cases of swine influenza
www.cdc.gov/H1N1flu
Novel Influenza A (H1N1) Detected
March 2009
• 2 cases of febrile respiratory illness in children in late March• No common exposures, no pig contact• Uneventful recovery• Residents of adjacent counties in southern California• Tested because part of enhanced influenza surveillance
• Reported to CDC as possible Novel influenza A virus infections• Swine influenza A (H1N1) virus detected on April 15 th,17th at CDC Both viruses genetically identical
• Contain a unique combination of gene segments previously not recognized among swine or human influenza viruses in the US
MMWR
www.cdc.gov/H1N1flu
Confirmed and Probable Novel H1N1 Cases by Report Date10 JUN 2009 (N=37,246)
0
4000
8000
12000
16000
20000
24000
28000
32000
36000
40000
Week Ending Date
Ca
ses
www.cdc.gov/H1N1flu
Descriptive Statistics of Novel Influenza A (H1N1) Cases Reported to CDC by States-
10 JUL 2009
Sex: 50% male/female Median age:
- all cases 12 years- hospitalized 20 years- died 37 years
CASES HOSPS DEATHS
37,246 4,132 211
54 48 24SLTTs AFFECTED
US TOTALS
CASES
www.cdc.gov/H1N1flu
International MapPandemic H1N1 – 10 JUL 2009
www.cdc.gov/H1N1flu
Epidemiology/Surveillance Pandemic H1N1 Hospitalizations Reported to CDC Clinical Characteristics as of 19 JUN 2009 (n=268)
83%
54%
40% 37% 36% 36%31% 31% 29%
24% 24%
93%
0%
20%
40%
60%
80%
100%
Fever
*Cou
gh
SOB
Fatig
ue/w
eakn
ess
Chills
Mya
lgia
sRhi
norrh
eaSor
e th
roat
Heada
che
Vomitin
gW
heez
ing
Diarrh
ea
www.cdc.gov/H1N1flu
Epidemiology/Surveillance Pandemic H1N1 Cases Rate per 100,000 Population by Age Group
As of 09 JULY 2009 (n=35,860*)
17.2
21.6
5.4
31.0
0
5
10
15
20
25R
ate
/ 1
00
,00
0 P
op
by
Ag
e G
rou
p
0-4 Yrs 5-24 Yrs 25-49 Yrs 50-64 Yrs ≥65 Yrs
Age Groups
n=17829
*Excludes 1,386 cases with missing ages.Rate / 100,000 by Single Year Age Groups: Denominator source: 2008 Census Estimates, U.S. Census Bureau at: http://www.census.gov/popest/national/asrh/files/NC-EST2007-ALLDATA-R-File24.csv
n=3621
n=5774n=1673
n=382
www.cdc.gov/H1N1flu
Epidemiology/SurveillancePandemic H1N1 Hospitalization Rate per 100,000 Population
by Age Group (n=3,779) as of 09 JULY 2009
*Hospitalizations with unknown ages are not included (n=353) *Rate / 100,000 by Single Year Age Groups: Denominator source: 2008 Census Estimates, U.S. Census Bureau at: http://www.census.gov/popest/national/asrh/files/NC-EST2007-ALLDATA-R-File24.csv
www.cdc.gov/H1N1flu
Influenza-Associated Hospitalizations Deaths By Age Group
*Thompson WW, JAMA, 2004
0
100
200
300
400
500
600
0 - 4 Yrs 5 - 49 Yrs 50 - 64 Yrs 65+ Yrs
Age Group
Ho
spit
aliz
atio
ns
Per
100
,000
Per
son
Yea
rs
100
0
60
40
20
80
Death
s Per 100,000 P
erson
Years
www.cdc.gov/H1N1flu
Epidemiology/Surveillance Pandemic H1N1 Hospitalizations Reported to CDC
Underlying Conditions as of 19 JUN 2009 (n=268)
*Excludes hypertension
www.cdc.gov/H1N1flu
Pandemic H1N1 Cases by StateRate / 100,000 State Population
As of 9 JUL 2009
www.cdc.gov/H1N1flu
Epidemiology/SurveillancePandemic H1N1 – 9 JUL 2009 EDT
Percentage of Visits for Influenza-like Illness (ILI) Reported by the US Outpatient Influenza-like Illness Surveillance Network (ILINet),National Summary 2008-09 and Previous Two Seasons
† There was no week 53 during the 2006-07 and 2007-08 seasons, therefore the week 53 data point for those seasons is an average of weeks 52 and 1.
www.cdc.gov/H1N1flu
Epidemiology/SurveillancePandemic (H1N1) – 9 JUL 2009
U.S. WHO/NREVSS Collaborating Laboratories Summary, 2008-09
* Percentage of all positive influenza specimens that are Influenza A (Pandemic H1N1) or Influenza A (unable to subtype) for the week indicated
37%*
55%*
68%*
73%*
81%*
80%*
85%*
76%*
72%*
66%*
Summary of Antiviral Resistance, U.S. 2008-09
Influenza viruses
AntiviralSeasonal A (H1N1)
Seasonal A (H3N2)
Seasonal BPandemic
H1N1
Adamantanes Susceptible Resistant No activity Resistant
Oseltamivir Resistant Susceptible Susceptible Susceptible
Zanamivir Susceptible Susceptible Susceptible Susceptible
www.cdc.gov/H1N1flu
Oseltamivir-resistance among Pandemic H1N1 viruses
3 oseltamivir-resistant isolates of Pandemic H1N1 detected
- 2 cases found to have resistant strain while on oseltamivir chemoprophylaxisJapan and Denmark
- 1 case detected by Hong Kong Department of Health reported a resistant virus isolated from a 16 year-old girl who had a fever upon arrival at the Hong Kong International airport Illness began prior to boarding the plane in San Francisco No exposure to No illness among close contacts No sign of community transmission
- Al recovered uneventfullyNo change in recommendations for treatment or prophylaxis of persons with
influenza
www.cdc.gov/H1N1flu
Antiviral Treatment Recommendations
Priority: Hospitalized Patients with suspected or Priority: Hospitalized Patients with suspected or confirmed pandemic H1N1 virus infectionconfirmed pandemic H1N1 virus infection• Treatment recommended with Oseltamivir or ZanamivirTreatment recommended with Oseltamivir or Zanamivir• Treat patients as soon as possible (duration: 5 days)Treat patients as soon as possible (duration: 5 days)
Outpatients with suspected or confirmed Outpatients with suspected or confirmed pandemic H1N1 virus infection who are at high pandemic H1N1 virus infection who are at high risk for complicationsrisk for complications• Persons with chronic pulmonary, cardiac, renal, hepatic, Persons with chronic pulmonary, cardiac, renal, hepatic,
metabolic, hematological disorders; immunosuppression, metabolic, hematological disorders; immunosuppression, pregnant women, children <5 years; adults pregnant women, children <5 years; adults ≥65 years ≥65 years
• Treatment recommended with Oseltamivir or ZanamivirTreatment recommended with Oseltamivir or Zanamivir• Treat patients as soon as possible (duration: 5 days) Treat patients as soon as possible (duration: 5 days)
http://www.cdc.gov/h1n1flu/recommendations.htm
www.cdc.gov/H1N1flu
Antiviral Chemoprophylaxis
Post-exposure chemoprophylaxis with Oseltamivir or Post-exposure chemoprophylaxis with Oseltamivir or Zanamivir can be considered:Zanamivir can be considered:
• Close contacts of cases who are at high risk for Close contacts of cases who are at high risk for complications of influenzacomplications of influenza
• Health care personnel, public health workers, first Health care personnel, public health workers, first responders with unprotected close contact exposure to responders with unprotected close contact exposure to an ill person with pandemic H1N1 virus infection while an ill person with pandemic H1N1 virus infection while in the infectious periodin the infectious period
• Chemoprophylaxis: 7-10 days after last known Chemoprophylaxis: 7-10 days after last known exposureexposure
http://www.cdc.gov/h1n1flu/recommendations.htm
www.cdc.gov/H1N1flu
Summary of key points
Once emerged, pandemic H1N1 virus spread to all 5 states and globally quickly
Some areas more affected than others Expect continued summertime circulation with focal
outbreaks Elderly seemingly relatively spared Capable of causing severe disease and death
Most severe outcomes among people with underlying heath problems that are associated with high risk of influenza complications
Virus remains sensitive to oseltamivir and zanamvir
www.cdc.gov/H1N1flu
What’s Next
Northern Hemisphere
Southern Hemisphere
Disease likely persists through summer in US, expected surge in fall
Severity of Fall epidemic difficult to predict
Southern Hemisphere being monitored for subtypes, spread, and severity
Vaccine being readied Surveillance continuing
www.cdc.gov/H1N1flu
Pandemic H1N1 Vaccine: Development and Manufacturing
Tom Shimabukuro, MD, MPH, MBA
Immunization Services DivisionCenters for Disease Control and Prevention
July 15, 2009
www.cdc.gov/H1N1flu
New HorizonsH1N1 Vaccines
National Strategy for Pandemic Influenza (Nov. 2005) goal is to provide vaccine to everyone in U.S. w/in 6 mo. of pandemic onset
H1N1 Vaccine Strategy follows pandemic playbook for vaccine development, production, and administration
Clinical studies will inform vaccine formulation and safety profile Key decision issues:
Vaccine product type Use of thimerosal preservative Use of oil-in-water adjuvant Post-vaccination safety monitoring
Courtesy Robin Robinson, PhD, HHS/ASPR/BARDA Director
www.cdc.gov/H1N1flu
Phases of a vaccination program
Vaccine development
Commercial scale manufacturing
Distribution and administration
Post-launch effectiveness, safety and utilization monitoring
www.cdc.gov/H1N1flu
Vaccine development
Vaccine reference strain development
Master seed strain preparation
Clinical investigational lot manufacturing
Clinical studies
To assess immunologic response and safety
Will inform formulation decisions
www.cdc.gov/H1N1flu
Commercial scale production Potency assay reagents preparation and
calibration Commercial scale bulk antigen manufacturing
without adjuvant Commercial bulk antigen manufacturing with
adjuvant Bulk adjuvant manufacturing Commercial scale syringe/needle manufacturing Vaccine formulation fill-finish
www.cdc.gov/H1N1flu
Courtesy Robin Robinson, PhD, HHS/ASPR/BARDA Director
www.cdc.gov/H1N1flu
Vaccine manufacturers
Novartis (45.7%)- Also manufactures MF59 adjuvant for potential pre-
formulation with vaccine
Sanofi Pasteur (26.4%)
CSL (18.7%)
MedImmune (5.8%)
GSK (3.4%)- Also manufactures ASO3 adjuvant in a separate vial
for potential mixing at the place of administration
www.cdc.gov/H1N1flu
Vaccine products (general)
Unadjuvanted multidose vials*
Unadjuvanted p-free pre-loaded syringes†
Nasal sprayers (live attenuated)†
Potentially Multidose vials pre-formulated with adjuvant Multidose vials formulated for adjuvant to be
mixed at the place of administration (separate antigen and adjuvant vials)
*All multidose vials will contain thimerosal preservative†Up to 20% of vaccine may be p-free pediatric formulation
www.cdc.gov/H1N1flu
Vaccine ancillary supplies
Needle/syringe units for multidose vials
Sharps containers
Alcohol pads
Mixing syringes if adjuvanted vaccine is used
www.cdc.gov/H1N1flu
Vaccine products
Novartis (45.7%)
- Multidose vials: standard unadjuvanted
- Multidose vials pre-formulated with Novartis MF59 adjuvant*
Sanofi Pasteur (26.4%)
- Multidose vials: standard unadjuvanted and formulated for GSK ASO3 adjuvant (separate antigen and adjuvant)*
- P-free pre-loaded syringes
*Decision to use an adjuvanted vaccine is TBD
www.cdc.gov/H1N1flu
Vaccine products cont.
CSL (18.7%)
- Multidose vials: standard unadjuvanted and formulated for GSK ASO3 adjuvant (separate antigen and adjuvant)*
- P-free pre-loaded syringes MedImmune (5.8%)
- Nasal sprayers, p-free GSK (3.4%)
- Multidose vials: standard unadjuvanted and formulated for GSK ASO3 adjuvant (separate antigen and adjuvant)*
- ASO3 adjuvant*Decision to use an adjuvanted vaccine is TBD
www.cdc.gov/H1N1flu
Storage and handling
Inactivated vaccine
- 2-8°C Live attenuated
- 2-8°C Oil-in-water adjuvant
- 2-8°C, 2-5 year shelf life Inactivated vaccine mixed with adjuvant
- Stable up to 8 hours after mixing
www.cdc.gov/H1N1flu
Emergency Use Authorization
“… use of an unapproved medical product or an unapproved use of an approved medical product during a declared emergency …”
- Unadjuvanted pandemic H1N1 vaccine may be licensed in a manner similar to a seasonal flu vaccine strain change and therefore would not need an EUA
- Adjuvanted vaccines, if used (for the 2009-10 flu season), will be administered under an EUA
www.cdc.gov/H1N1flu
www.cdc.gov/H1N1flu
Pascale Wortley, MD, MPH
Immunization Services DivisionCenters for Disease Control and Prevention
July 15, 2009
Pandemic H1N1 Vaccine: Program Implementation
www.cdc.gov/H1N1flu
Vaccine purchase, allocation, and distribution
Vaccine procured and purchased by US government
Vaccine will be allocated across states proportional to population
Vaccine will be sent to state-designated receiving sites: mix of local health departments and private settings
www.cdc.gov/H1N1flu
Vaccine planning assumptions:
Vaccine available starting mid-October Initial amount: 40, 80, or 160 million doses
over one month period Subsequent weekly production: 10, 20 or 30
million doses 2 doses required Preservative free single dose syringes for
young children and pregnant women
www.cdc.gov/H1N1flu
Vaccine planning assumptions:
Populations to plan for:
Students and staff (all ages) associated with schools (K-12) and children (age >6 m) and staff (all ages) in child care centers
Pregnant women, children 6m-4yrs, new parents and household contacts of children <6 months of age
Non-elderly adults (age <65) with medical conditions that increase risk of influenza
Health care workers and emergency services personnel
www.cdc.gov/H1N1flu
Delivery model
Public health-coordinated effort that blends vaccination in public health-organized clinics and in the private sector (provider offices, workplaces, retail settings)
Private sector providers who wish to administer H1N1 vaccine will
need to enter into an agreement with public health in order to
receive vaccine
www.cdc.gov/H1N1flu
Public Health planning efforts
Reaching out to private providers (defined broadly) to assess interest in providing H1N1 vaccine
Retail sector, pharmacists may be involved
Planning large scale clinics
- Especially important for school-age children given limited private sector capacity
www.cdc.gov/H1N1flu
Issues for administration in provider offices
Storage capacity
Administering according to recommended age groups
Reporting doses administered early on
Insurance reimbursement for administration
www.cdc.gov/H1N1flu
Monitoring vaccine coverage
Initially, states will be required to report doses administered on a weekly basis
Transition to assessment via population surveys (BRFSS, NIS)
www.cdc.gov/H1N1flu
Monitoring vaccine safety
Vaccine Adverse Event Reporting System (1-800-822-7967, http://vaers.hhs.gov/contact.htm ) for signal detection
Network of managed care organizations representing approximately 3% of the U.S. population, the Vaccine Safety Datalink (VSD) to test signals.
Active surveillance for Guillain Barre Syndrome through states participating in Emerging Infections Program.
www.cdc.gov/H1N1flu
Monitoring vaccine effectiveness (VE)
VE for prevention of PCR-confirmed medically attended influenza at 4 community-based sites
VE for prevention of influenza hospitalizations diagnosed by provider-ordered clinically available tests at 10 sites nationwide through the Emerging Infections Program
DoD will be assessing VE in active duty service members
www.cdc.gov/H1N1flu
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