Update on Pandemic Influenza A H1N1 Virus and Vaccine for Occupational Health

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• Update on Pandemic Influenza A (H1N1) Virus and
  Vaccine for Occupational Health

William L. Atkinson, MD, MPH National Center for
Immunization and Respiratory Diseases
September 30, 2009
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Disclosures

• The speaker is a federal government employee with
  no financial interest or conflict with the
  manufacturer of any product named in this
  presentation
• The speaker will not discuss the off-label use of
  any product or a product that is not currently
  licensed by the Food and Drug Administration

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Objectives

• Summarize the current situation with pandemic
  Influenza A (H1N1) virus in the United States
• Describe the characteristics of the vaccine being
  produced for pandemic Influenza A (H1N1) virus
• List initial target groups for influenza A (H1N1)
  2009 monovalent vaccine

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Pandemic Influenza A (H1N1) VirusClinical
Features and Diagnosis

• Signs and symptoms of novel influenza A (H1N1)
  virus infection are similar to those of seasonal
  influenza
• Definitive diagnosis of pandemic influenza A
  (H1N1) virus infection requires specific testing
  for H1N1 viruses using real-time reverse
  transcriptasepolymerase chain reaction (RT-PCR)
  or viral culture
• Sensitivity of rapid influenza diagnostic tests
  for novel influenza A (H1N1) virus has been
  estimated at 1070

www.cdc.gov/h1n1flu/guidance/rapid_testing.htm
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Novel H1N1 Influenza Virus 2009

• April 15 first U.S. case confirmed by CDC
  (California)
• June 11 World Health Organization raises
  pandemic level to 6 (first time since 1968)
• June 19 novel H1N1 infections reported by all
  50 states
• June 25 CDC estimates 1 million infections had
  occurred since April
• July-September significantly more influenza
  activity than expected in summer

www.cdc.gov/h1n1flu www.who.int/csr/disease/sw
ineflu/en/index.html
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Pandemic H1N1 InfluenzaSummary of Key
Epidemiologic Findings

• Highest incidence of laboratory-confirmed
  infections in school age children
• Highest hospitalization rates among 0 through 4
  year olds
• 70 of hospitalized cases have an underlying
  medical condition that confers higher risk for
  complications
• Pregnant women are at increased risk of
  complications and death

CDC, unpublished data, 2009
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Pandemic H1N1 InfluenzaSummary of Key
Epidemiologic Findings

• Distribution of cases by age group is markedly
  different compared to seasonal influenza
• Higher proportion of hospitalized cases in
  children and young adults
• Fewest cases but highest case-fatality ratio in
  older adults
• No outbreaks among elderly in long term care
  facilities

CDC, unpublished data, 2009
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Summary of Key Findings from Virologic and
Immunologic Studies

• No significant antigenic changes among pandemic
  influenza A(H1N1) viruses since April 2009
• Cross-reactive antibody to pandemic H1N1 was
  detected among adults participants in vaccine
  studies
• 33 of those 60 years and older
• 0 of children
• Many older adults have evidence of immunity
  presumably based on exposure to similar viruses
  in early 20th century

MMWR 200958(No. 19)521-4
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H1N1 Sept 2009
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Emerg Infect Dis 20061215-22
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Transmission of Pandemic Influenza A (H1N1) Virus
in Healthcare Settings

• Transmission in healthcare settings has been
  reported
• Many HCP with nosocomial H1N1 infection did not
  use appropriate PPE
• Acquisition of pandemic H1N1 virus infection by
  HCP in the community can result in introduction
  to patients in healthcare settings

MMWR 200958641-5
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Influenza A (H1N1) 2009 Monovalent Vaccines
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Influenza Vaccination 2009-2010

• Two different influenza vaccines will be
  available during the 2009-2010 season
• seasonal
• monovalent H1N1
• Vaccination with one will NOT produce immunity to
  the viruses in the other
• Some persons will need BOTH vaccines

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Influenza A (H1N1) 2009 Monovalent Vaccine

• Influenza A (H1N1) 2009 monovalent is NOT an
  experimental or new vaccine
• The vaccines will be produced using the same
  procedures and facilities as seasonal influenza
  vaccines
• Licensure of the vaccines will be based on the
  same standards used for seasonal influenza
  vaccines (i.e., as a strain change)

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Influenza A (H1N1) 2009 Monovalent Vaccine

• Both live attenuated and inactivated vaccine
  formulations are available
• Inactivated vaccine is available in multidose
  vials (with thimerosal) and prefilled syringes
  (preservative-free)
• All vaccines contain egg protein
• Do NOT contain adjuvant
• Children 6 months through 9 years require 2 doses
  separated by 4 weeks

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Pandemic H1N1 Influenza Vaccines Available in
2009-2010
inactivated vaccines approved for children
younger than 4 years all multidose vials contain
thimerosal as a preservative
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Live Attenuated Influenza Vaccine (LAIV)
Indications

• Healthy persons 2 through 49 years of age, and
  includes
• close contacts of persons at high risk for
  complications of influenza (except severely
  immuno-suppressed)
• persons who wish to reduce their own risk of
  influenza
• healthcare personnel

Persons who do not have medical conditions that
increase their risk for complications of
influenza. MMWR 200958 (RR-8)
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Use of LAIV Among Healthcare Personnel

• No instances of transmission of LAIV have been
  reported in the U.S.
• ACIP recommends that LAIV can be given to
  eligible HCWs except those that care for severely
  immuno-suppressed persons (hospitalized and in
  isolation)
• No special precautions are required for HCWs who
  receive LAIV

MMWR 200958 (RR-8)
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Influenza A (H1N1) 2009 Monovalent Vaccine
Distribution

• Vaccine will be allocated in proportion to
  population
• Local and state immunization programs will
  identify sites to receive vaccine
• Vaccine will generally be shipped directly to
  sites by a single distributor
• Separate allocation for active duty DOD

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Influenza A (H1N1) 2009 Monovalent Vaccine

• The U.S. Government will pay for the vaccine as
  well as needles, syringes, sharps containers,
  alcohol swabs and record cards
• The currently plan is for public health
  departments to direct the distribution of the new
  vaccine
• Specific Vaccine Information Statements (TIV and
  LAIV) will be available for novel H1N1 vaccine

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Influenza Vaccination 2009-2010

• All persons currently recommended for seasonal
  influenza vaccine, including healthcare personnel
  and persons 65 years of age and older, should
  receive the seasonal vaccine as soon as it is
  available

MMWR 200958(RR-10)
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Goals of the 2009 H1N1 Vaccine Recommendations

• Vaccinate as many as possible as quickly as
  possible
• Focus initial vaccination efforts on groups at
  higher risk for influenza and influenza-related
  complications
• Expand recommendations to include larger
  population groups as supply increases
• Allow for local flexibility because vaccine
  availability and demand for vaccination will vary
  

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ACIP-Recommended Initial Target Groups for H1N1
Monovalent Influenza Vaccine

• Pregnant women
• Household and caregiver contacts of children
  younger than 6 months of age
• Healthcare and emergency medical services
  personnel
• Children from 6 months through 24 years of age
• Persons 25 through 64 years who have high risk
  medical conditions

MMWR 200958 (RR-10)
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ACIP-Recommended Initial Target Groups for H1N1
Monovalent Influenza Vaccine

• Highest priority subgroups
• pregnant women
• persons of any age who live with or care for
  children younger than 6 months of age
• healthcare and emergency services personnel of
  any age with direct patient contact or contact
  with infectious material
• children 6 months through 4 years of age
• children 5 through 18 years of age with chronic
  medical conditions that increase the risk of
  complications of influenza

MMWR 200958 (RR-10)
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Statement endorsed by March of Dimes American
College of Obstetricians and Gynecologists America
n Academy of Pediatrics American Academy of
Family Physicians American College of
Nurse-Midwives Association of Womens Health,
Obstetric, and Neonatal Nurses Infectious Disease
Society for Obstetrics and Gynecology Society of
Maternal-Fetal Medicine
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Joint Statement For Pregnant Women About Influenza

• We strongly recommend all pregnant women receive
  immunization for seasonal flu NOW and H1N1 flu as
  soon as this vaccine becomes available. The
  immunizations pregnant women receive are safe and
  provide flu protection for both themselves and
  their newborns.

www.marchofdimes.com/aboutus/49267_61363.asp Septe
mber 23, 2009
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H1N1 Monovalent Influenza Vaccine

• Healthcare personnel a high priority for both
  seasonal and H1N1 monovalent influenza vaccines
• Facilities must communicate their H1N1 vaccine
  needs to the local public health authority (sole
  source for H1N1 monovalent vaccine)
• Consider providing vaccine for patients if
  feasible

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Healthcare Personnel

• All paid and unpaid persons working in healthcare
  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

MMWR 200958(RR-10)
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Healthcare Personnel

• HCP include (but are not limited to) physicians,
  nurses, nursing assistants, therapists,
  technicians, emergency medical service personnel,
  dental personnel, pharmacists, laboratory
  personnel, autopsy personnel, students and
  trainees, contractual staff, and persons not
  directly involved in patient care but potentially
  exposed to infectious agents that can be
  transmitted to and from HCP (e.g., clerical,
  dietary, housekeeping, maintenance, and
  volunteers)

MMWR 200958(RR-10)
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ACIP Recommendations for H1N1 Monovalent
Influenza Vaccine

• Once vaccination programs and providers are
  meeting the demand for vaccine among the persons
  in the five initial target groups, vaccination
  should be expanded to all persons 25 through 64
  years of age
• Once demand for vaccine among younger age groups
  is being met at the local level, vaccination
  should be expanded to all persons 65 years of age
  and older

This recommendation might need to be reassessed
as new epidemiologic, immunologic, or clinical
trial data warrant and in the context of global
need for vaccine. MMWR 200958(RR-10)
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Influenza A (H1N1) 2009 Monovalent Vaccine

• Seasonal and monovalent H1N1 vaccine availability
  will overlap
• Simultaneous (same visit) administration
• OK for inactivated vaccines
• OK for inactivated and LAIV
• not recommended for LAIV (4 week interval between
  doses)

MMWR 200958 (RR-10)
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Vaccination of Persons with Previous
Influenza-Like Illness (ILI)

• Previous ILI confirmed by RT-PCR as pandemic
  H1N1
• Vaccination with monovalent H1N1 vaccine not
  necessary this year
• Previous ILI NOT confirmed by RT-PCR as pandemic
  H1N1
• Vaccinate if indicated

reverse transcriptase polymerase chain reaction
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Interim Guidance for Pneumococcal Polysaccharide
Vaccine (PPSV) During H1N1 Pandemic

• Use of PPSV among people without current
  indications for vaccination is not recommended at
  this time
• This recommendation may be revised as the
  epidemiology and clinical presentation of
  pandemic influenza A (H1N1) virus infection as
  well as the frequency and severity of secondary
  pneumococcal infections are better understood

www.cdc.gov/h1n1flu/guidance/ppsv_h1n1.htm
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Interim Guidance for Pneumococcal Polysaccharide
Vaccine (PPSV) During H1N1 Pandemic

• Single dose of PPSV for
• all people 65 years and older
• persons 2 through 64 years of age at high-risk
• 19 years and older who smoke or have asthma
• Place emphasis on vaccinating people aged less
  than 65 years who have established high-risk
  conditions because
• PPSV coverage among this group is low
• people in this group appear to be overrepresented
  among severe cases of pandemic H1N1 influenza
  infection

www.cdc.gov/h1n1flu/guidance/ppsv_h1n1.htm
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Novel H1N1 Influenza Vaccine Safety Monitoring

• CDC will use the Vaccine Adverse Event Reporting
  System (VAERS) and the Vaccine Safety Datalink
  system
• CDC will increase the capacity of VAERS
• CDC will set up an intensive surveillance system
  for Guillian- Barre' syndrome (GBS)

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H1N1 Antiviral Treatment and Chemoprophylaxis

• The virus is susceptible to neuraminidase
  inhibitors oseltamivir (Tamiflu) and zanamivir
  (Relenza)
• Treatment (5 days) recommended for severely ill
  persons and those at high risk for complications
  (children younger than 5 years, persons 65 years
  and older, pregnant women)
• Chemoprophylaxis (10 days) recommended for high
  risk contacts

www.cdc.gov/h1n1flu/recommendations.htm
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Revised Antiviral GuidanceSeptember 2009

• Treatment recommendations unchanged
• Use oseltamivir or zanamivir (98 circulating
  viruses are 2009 H1N1)
• Options to reduce treatment delays provided
• Discuss treatment plan with higher risk patients
  now
• Triage (office and telephone) for higher risk
• Empiric treatment if influenza suspected dont
  wait for testing
• Limit use of postexposure prophylaxis, and
  consider education / early treatment as
  alternative

www.cdc.gov/h1n1flu/recommendations.htm
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Infection Control Recommendations for Persons
with H1N1 Infection

• Surgical mask when outside room
• Standard and contact precautions plus eye
  protection
• Fit-tested N95 respirator for all HCP entering
  room
• Continue isolation precautions for 7 days from
  symptom onset or until resolution of symptoms
  whichever is longer

as of 5/13/09. Recommendations are currently
being revised www.cdc.gov/h1n1flu/guidelines_inf
ection_control.htm
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Management of Healthcare Personnel with Febrile
Respiratory Illness

• Symptomatic HCP should not report to work or
  cease patient care activities if at work
• Exclude from work for 7 days or until symptoms
  have resolved, whichever is longer
• Asymptomatic HCP with unprotected exposure to
  H1N1 may continue to work if started on antiviral
  prophylaxis

as of 5/13/09. Recommendations are currently
being revised www.cdc.gov/h1n1flu/guidelines_inf
ection_control.htm
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Revised Infection Control Guidance

• Criteria for identification of suspected
  influenza patients
• Recommended time away from work for HCP
• Changes to isolation precautions based on tasks
  and anticipated exposures
• Changes to guidance on use of respiratory
  protection

anticipated release in September-October 2009
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www.cdc.gov/h1n1flu/guidelines_infection_control.h
tm
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CDC Vaccines and ImmunizationContact Information

• Telephone 800.CDC.INFO
• (for patients and parents)
• Email nipinfo_at_cdc.gov
• (for providers)
• Website www.cdc.gov/vaccines/
• CDC H1N1 www.cdc.gov/h1n1flu/