School Nurse Update

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School Nurse Update Influenza A (H1N1 2009)
Vaccine Status and Dissemination Plan September
30, 2009
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Purpose

• Provide information on Influenza A (H1N1) 2009
  Monovalent Vaccine and dissemination plan of the
  vaccine

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Overview of Vaccine

• Inactivated Attenuated Vaccine
• Pregnant women
• Healthy infants and children under 6 months-2
  years old
• Persons with chronic health conditions

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Influenza A (H1N1) Monovalent Vaccine

• Live Attenuated Virus Vaccine
• Healthy persons age 2-49 years

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General Information

• It is expected that H1N1 influenza vaccine will
  have a similar safety profile as seasonal
  influenza vaccines
• Produced using the same methods as for seasonal
  influenza formulations
• Immune response similar to seasonal influenza
  vaccines within 8-10 days after a single dose for
  most healthy adults
• Contraindications, precautions, warnings, side
  effects and adverse reactions similar to those
  for seasonal influenza vaccines
• Monitoring for safety will be done by the FDA and
  CDC as with all other vaccines

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Overview of Vaccines

• FDA approval of 4 Vaccines made by
• CSL Limited
• MedImmune, LLC
• Novartis Vaccines and Diagnostics Limited
• Sanofi Pasteur, Inc.
• GlaxoSmithKline-waiting for FDA approval

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CSL FormulationDosage and Administration

• Formulations Latex-Free
• 0.5 mL, PF SDV, pre-filled syringe
• 5 mL MDV contains 10 doses contains
  Thimerosal (24.5 mcg) per dose
• Use for Adults only (18 years and older)
• Single dose - 0.5 mL IM

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Novartis FormulationDosage and Administration

• Formulations
• 0.5 mL, SDV, prefilled syringe (Thimerosal
  trace 0.5 mL/dose)
• 0.5 mL MDV - contains 10 doses contains
  Thimerosal (25.0 mcg) per dose
• Children and Adults
• Children 4-9 years old
• 2 doses 0.5 mL IM injections (1 month interval)
• Children 10-17
• 1 dose 0.5 mL IM injection
• Adults 18 and older
• 1 dose 0.5 mL IM injection

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Sanofi Pasteur FormulationDosage and
Administration

• Formulations Latex Free
• 0.25 mL, single-dose prefilled syringe, PF
• 0.5 mL, single-dose, prefilled syringe PF
• 0.5 mL SDV PF
• 0.5 mL MDV - contains 10 doses Thimerosal
  (25.0 mcg) per dose
• Children and Adults
• Children 6-35 months of age
• 2 doses 0.25 mL IM injections (1 month interval)
• Children 36 months 9 years old
• 2 doses 0.5 mL IM injections (1 month interval)
• Children 10-17
• 1 dose 0.5 mL IM injection
• Adults 18 and older
• 1 dose 0.5 mL IM injection

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MedImmune FormulationDosage and Administration

• Formulations Latex-Free
• 0.2 mL, prefilled single-dose intranasal sprayer
  PF
• Children and Adults
• Children 2-9 years old
• 2 doses 0.2 mL, Intranasal (0.1mL per nostril) 1
  month interval
• Children 10-17
• 1 dose 0.2 mL Intranasal (0.1 mL per nostril)
• Adults 18 49 years old
• 1 dose 0.2 mL Intranasal (0.1mL per nostril)

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Contraindications

• Live Activated Influenza Formulations (MedImmune)
• Hypersensitivity to eggs, egg proteins, gelatin,
  gentamicin, arginine, any component of the
  vaccine or life threatening reactions to previous
  influenza vaccines
• Concomitant Pediatric and Adolescent Aspirin
  Therapy and Reyes Syndrome
• Inactivated Formulations
• Hypersensitivity to eggs, egg proteins, neomycin,
  polymyxin, any component of the vaccine or life
  threatening reactions to previous influenza
  vaccines

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Warnings and Precautions for Live Influenza
Virus Vaccine-MedImmune

• Children lt 24 months of age
• Pregnancy
• Asthma
• Recurrent wheezing in children lt 5 years
• Guillain-Barré Syndrome
• Altered Immunocompetence
• Allergic reactions

• Chronic medical conditions
• Household contacts and Health Care Workers in
  contact with severely immunocompromised patients
• Limitations of vaccine effectiveness

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Warnings and Precautions for Inactivated
Influenza Vaccine Formulations

• Guillain-Barré Syndrome
• Altered Immunocompetence reduced response
• Management of Allergic Reactions
• Limitations of Vaccine Effectiveness

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Drug Interactions - Antivirals

• Antiviral agents active against Influenza A
  and/or B
• Live Influenza Vaccine Formulations (Med-Immune)
• Should not be given until 48 hours after stopping
  antiviral therapy
• Antivirals for influenza should not be
  administered until 2 weeks after intranasal
  administration (unless medically necessary)

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Drug InteractionsConcurrent Administration with
other Vaccines

• Follow general ACIP recommendations for minimum
  intervals and times for inactivated and live
  virus vaccines (See Pink Book Page 11-14)
• Inactivated 2009 (H1N1) vaccine can be
  administered concurrently with any other vaccine
  including seasonal influenza vaccine
• Live 2009 H1N1 vaccine can be administered at the
  same time as any other live or inactivated
  vaccine EXCEPT seasonal live attenuated influenza
  vaccine
• Recommended interval at least 28 day interval
• Repeat H1N1 dose if interval is 21 days apart

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Common Side Effects

• Inactivated Formulations
• Soreness, redness or swelling at injection site
• Malaise, headache, muscle aches
• Fever

• Live Virus Formulations
• Runny nose
• Nasal congestion
• Sore throat
• Mild fever in children 2-6 years of age

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Adverse Events

• Live Virus Influenza Vaccine Formulations -
  MedImmune
• Hypersensitivity, anaphylactic reaction
• Wheezing in children and adolescents
• Inactivated Influenza Vaccine Formulations
• Hypersensitivity, anaphylactic reaction
• Local reactions soreness at injection site,
  tenderness, pain and swelling

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Vaccine Distribution

• Pre-Registering providers including existing
  providers enrolled in Childrens State Vaccine
  Program
• LHJs will be determining which providers in the
  county will be H1N1 vaccine providers
• Limited distribution sites predetermined by CDC
• Minimum order quantity of 100 doses of vaccine

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Vaccine Management

• Overall vaccine management through IPCP
• LHJs will be determining the best process for
  providers to receive vaccines
• Direct shipment to providers
• Some LHJs will be the distribution site and
  providers will receive vaccine from them in
  smaller quanitites
• Shipped from centralized distribution center
  (McKesson)

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Questions??
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References and Resources

• Use of Influenza A (H1N1) 2009 Monovalent Vaccine
  MMWR August 28, 2009 http//www.cdc.gov/mmwr/previ
  ew/mmwrhtml/rr5810a1.htm?s_cidrr5810a1_e
• ACIP Pink Book http//www.cdc.gov/vaccines/pubs/pi
  nkbook/default.htm
• General Questions and Answers on 2009 H1N1
  Influenza A Vaccine Safety http//www.cdc.gov/h1n1
  flu/vaccination/vaccine_safety_qa.htm
• General Questions and Answers on Thimerosal
  http//www.cdc.gov/h1n1flu/vaccination/thimerosal_
  qa.htm
• General Questions and Answers on Guillain-Barre
  syndrome (GBS) http//www.cdc.gov/h1n1flu/vaccinat
  ion/gbs_qa.htm
• FDA News Release http//www.fda.gov/NewsEvents/New
  sroom/PressAnnouncements/ucm182399.htm
• FDA News Release H1N1 Monovalent Vaccine Package
  Inserts http//www.fda.gov/BiologicsBloodVaccines/
  Vaccines/ApprovedProducts/ucm181950.htm

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