Transcript Vaccine and School Guidance Aug 26

COCA Conference Call:
Influenza A (H1N1) 2009 monovalent
vaccine – Implementation overview
August 26, 2009
Pascale Wortley, MD, MPH
Vaccine Implementation Team
CDC
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Outline
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Epidemiology overview
ACIP recommendations
Clinical trials and licensure
Safety monitoring
Vaccine logistics
Vaccine financing
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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
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*ACIP Influenza Workgroup Considerations. ACIP Meeting, July 29, 2009.
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%
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*ACIP Influenza Workgroup Considerations. ACIP Meeting, July 29, 2009. §For unadjuvanted H1N1 vaccine
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
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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
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Summary vaccination of population groups over time§
Increasing vaccine availability and demand met by immunization programs
Consult local public health authorities
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Proportion of population
Adults 65+
(38 million)
Primary target groups*
Healthy adults 25-64
(103 million)
0.5
Pregnant women
Infant contacts
HCP/EMS
Persons 6m—24y
Adults high risk <65y
(159 million)
0
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:
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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
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.
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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.
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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 vaccine analogous to
seasonal strain change supplement
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Influenza A (H1N1) 2009 monovalent
vaccine - Safety monitoring
Objectives of the safety monitoring response:
1. Identify clinically significant adverse events
following receipt of vaccine in a timely manner
2. Rapidly evaluate serious adverse events following
receipt of vaccine and determine public health
importance
3. Evaluate if there is a risk of Guillain-Barré
syndrome (GBS) associated with receipt of
vaccine
4. Communicate vaccine safety information in a clear
and transparent manner to healthcare providers,
public health officials, and the public
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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
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Influenza A (H1N1) 2009 monovalent
vaccine - Safety monitoring (3)
Methods (continued):
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Vaccine Safety Datalink
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Vaccine Analytic Unit
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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
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Collaboration among the Department of Defense, CDC and the
FDA
Emerging Infections Programs
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Collaborative effort between CDC and eight large managed care
organizations
Collaboration to enhance VAERS reporting of neurological events,
including GBS
Clinical Immunization Safety Assessment (CISA)
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Collaboration between CDC and 6 academic centers
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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
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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
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Influenza A (H1N1) 2009 monovalent
vaccine distribution
Vaccine and Ancillary supplies
• Will be sent by a central distributor to statedesignated locations or providers which will include
a mix of local health departments, provider offices,
workplaces, schools, hospitals, retail settings, and
other sites
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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
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Influenza A (H1N1) 2009 monovalent
vaccine – Public health planning efforts
• Planning large scale clinics and schoollocated clinics
• Reaching out to providers to assess
interest and capacity to provide Influenza
A (H1N1) 2009 monovalent vaccine in a
variety of settings
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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
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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
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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 nontraditional settings, where contracts with insurers have been
established"
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Don’t forget about seasonal influenza
vaccination!
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H1N1 web resources
• http://www.cdc.gov/h1n1flu/general_info.htm
• http://www.cdc.gov/h1n1flu/vaccination/
• http://www.flu.gov
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Thank you!
Please send any additional questions to
[email protected]
with “vaccine” in the subject line
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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 Year
August 26, 2009
Francisco Alvarado-Ramy, MD, FACP
CDR, US Public Health Service
Community Measures Task Force
CDC 2009 H1N1 Influenza Response
Centers for Disease Control and Prevention
CDC Guidance for School Responses
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
Background – U.S. Schools
• 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
Changes from Previous Guidance
• 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
Summary
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)
Recommended School Responses
(Similar Severity as in Spring 2009)
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
(Increased Severity)
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 Strategies:
Stay Home when Sick
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:
Separate ill Students and Staff
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:
Hand Hygiene and Respiratory Etiquette
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:
Routine Cleaning
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:
Early Treatment, Selective Dismissals
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
If Severity Increases:
Active Screening for Illness
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:
Permit High Risk Persons to Stay Home
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:
Students with Ill Household Members
Stay Home
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:
Increase Distance between People
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:
Extended Exclusion Period for Ill Persons
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: School Dismissals
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
School Dismissal Monitoring
Report dismissals to CDC, the U.S.
Department of Education, and your state
health and education agencies at
www.cdc.gov/FluSchoolDismissal
Generate real-time, national summary data
daily on the number of school
dismissals/closures and # of impacted
students, teachers
Additional Information, Assistance
www.cdc.gov/h1n1flu/schools/
Send additional questions to [email protected]
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