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Influenza Season 2009

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Influenza update for PHNs

Influenza update for PHNs

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  • Some clients might ask why a novel adjuvant was introduced at this timeIt is not completely novel as you saw in the last slide: pre-licensed as “prepandemrix” in all 27 European states, Malaysia and Hong Kong. Using an adjuvanted vaccine allows us to protect ourselves by protecting our neighbors- more antigen is available for other countriesObviously this decision also has humanitarian implications, it is estimated that the US is using 50% of the world antigen supply for this virus due to their decision to use an non-adjuvanted productAn interesting feature of the use of AS03 is that it increases the range of protection in trials- meaning that if there is antigenic drift, immunized persons may still have some protection, this is not seen in antigen only vaccine.Some clients might ask why a novel adjuvant was introduced at this timeIt is not completely novel as you saw in the last slide: pre-licensed as “prepandemrix” in all 27 European states, Malaysia and Hong Kong. Using an adjuvanted vaccine allows us to protect ourselves by protecting our neighbors- more antigen is available for other countriesObviously this decision also has humanitarian implications, it is estimated that the US is using 50% of the world antigen supply for this virus due to their decision to use an non-adjuvanted productAn interesting feature of the use of AS03 is that it increases the range of protection in trials- meaning that if there is antigenic drift, immunized persons may still have some protection, this is not seen in antigen only vaccine.
  • Instructions for mixing and administration of the vaccine:**Do not use larger than a 20 gauge needle to withdraw as this may lead to coring of the stopper, resulting in rubber falling into the vaccine1. Before mixing the two components, both vials should be shaken and inspected visually for any foreign particulate matter and/orAn abnormal physical appearance. In the event of either being observed, discard the vaccine.2. The vaccine is mixed by withdrawing the contents of the vial containing the emulsion(adjuvant) by means of a 20-21 gauge needle and 5 ml or larger syringe (A 3 ml syringe can be used, but care needs to be taken as the plunger is almost fully drawn out from the syringe and may become unstable), and by adding it to the vial containing the antigen suspension.3. After the addition of the emulsion to the suspension, the mixture should be well shaken. Themixed vaccine is a whitish emulsion. In the event of other variation being observed, discard the vaccine.4. The volume of Arepanrix (5 ml) after mixing corresponds to 10 doses of vaccine 5. The vial should be shaken prior to withdrawing each dose6. Each vaccine dose of 0.5 ml is withdrawn into a 25 gauge 1” needle and a 3 ml syringe for injection ( may use 1” 25 gauge needle and 1 ml syringe for those 10 and under)7. After mixing, use the vaccine within 24 hours and do not store above 25°C.
  • Transcript

    • 1. Influenza Season 2009/2010
      Update and Answers to Common Questions
    • 2. Outline of update
      Overview of influenza pattern
      Overview of this years campaign
      Vaccine Details – Seasonal & pH1N1
      Populations and dosages
      Contraindications and Adverse Reactions
      Vaccine Preparation
      Frequently Asked Questions
      Mass Clinics and Ergonomics
    • 3. Current as of October 21, 2009
      3
      Age Distribution
      Seasonal Influenza
      Pandemic Influenza
      Distribution by age group of persons hospitalized with laboratory-confirmed influenza
      ( United States, 2007--08 winter influenza season and April 15--August 11, 2009)
    • 4. Current as of October 21, 2009
      4
      Clinical presentation:
      • pH1N1 symptoms
      • 5. Very similar to seasonal influenza
      • 6. Gastrointestinal symptoms more likely in children
      • 7. Among hospitalized patients
      • 8. Primary viral pneumonia
      • 9. Prolonged ventilatory support
      • 10. Secondary bacterial infections
      Adapted from the Centers for Disease Control and Prevention
    • 11. What vaccines will be available this year?
      In the 2009-10 season,
      • seasonal trivalent influenza vaccine
      • 12. and two pandemic monovalent (H1N1) vaccines will be available.
      • 13. an adjuvanted
      • 14. and a non-adjuvanted H1N1 vaccine
    • Vaccination against seasonal influenza
      • A/Brisbane/59/2007(H1N1), A/Brisbane/10/2007(H3N2) and B/Brisbane/60/2008):
      • 15. Phase 1: Is targeted for those aged 65 years and older and residents of long-term care facilities
      • 16. Phase 2: Include all others (as per the Canadian Immunization Guide), following or concurrently with administration of the A/H1N1 vaccine.
    • H1N1 Vaccine
      Will be available for everyone who needs or wants it and is strongly recommended for:
      • Persons under age 65 with chronic conditions
      • 17. Pregnant women in the second half of pregnancy in communities where pH1N1 influenza is actively circulating.
      • 18. Children 6 – 59 months of age
      • 19. Persons residing in rural and remote communities
      • 20. Health care workers
      • 21. Household contacts and care providers of infants < 6 months of age and of persons who are immunocompromised
    • Phase 1
      Seasonal vaccine (Oct. 13-mid Nov.) offered to:
      • People 65 years and older
      • 22. & residents of long term care facilities
    • Phase 2A: pH1N1 vaccine Adjuvanted Vaccine (Oct 26)
      In the first week of the program the following groups who are at highest risk will be given priority
      • 1) those under 65 with high-risk medical conditions
      • 23. 2) women in the second half of pregnancy – living in communities where H1N1 virus is actively circulating
      • 24. 3) residents of remote communities where access to timely health care services is very limited.
      Also offer:
      • Seasonal vaccine according to guidelines
    • High Risk Medical Conditions
      • Heart or lung disorders requiring regular care
      • 25. Includes asthma, COPD, or cystic fibrosis
      • 26. Kidney disease, chronic liver disease, hepatitis, diabetes, cancer, anemia or weakened immune system
      • 27. Other conditions causing difficulty breathing , swallowing or risk of choking – ie: severe brain damage, spinal cord injury, seizures or neuromuscular disorders
    • Phase 2b:
      In the second week
      • health care workers
      • 28. children between the ages of 6 months and 4 years (inclusive)
      • 29. household contacts and care providers of infants less than 6 months old
      • 30. people who are immunocompromised of all ages
    • Phase 3
      Thereafter vaccine may be offered to
      everyone else except those aged less than 6 months or those with a contraindication.
      • Healthy children age 5 to 18 years of age
      • 31. First responders (police, firefighters)
      • 32. Poultry and swine workers
      • 33. Healthy adults 19 to 64 years of age
      • 34. Adults 65 years of age and older.
    • H1N1 VACCINE DETAILS
      The two A/H1N1 vaccines contain the A/California/7/2009 (H1N1)v-like antigen, and are:
      • Arepanrix, the adjuvanted A/H1N1 vaccine for all indications except the first half of pregnancy.
      • 35. Influenza A/H1N1 2009 Monovalent vaccine (without adjuvant)
    • Added Notes
      • Only adjuvanted vaccine available until early November. This product should be offered to pregnant women at 20+ weeks gestation at some risk of exposure where A/H1N1 virus is circulating.
      • 36. Pregnant women under 20 weeks gestation who have chronic medical conditions should discuss the risks and benefits of receiving adjuvanted vaccine or waiting until unadjuvanted vaccine is available with their health care provider.
      • 37. Once unadjuvanted vaccine is available it should be preferentially offered throughout pregnancy.
      • 38. There are no known risks of using adjuvanted vaccine in pregnancy, and the recommendation to use unadjuvanted vaccine preferentially is precautionary.
    • Children aged 6 months to less than 3 years
      • Can be offered either adjuvanted or unadjuvanted A/H1N1 vaccine in a two-dose series of 0.25 ml each.
      • 39. Both of the doses should be given with the same product.
      • 40. Unadjuvanted vaccine, when available, may be the preferred option for some parents and providers as this product is formulated in the same manner as seasonal influenza vaccine with which there has been ample experience in young children.
      • 41. It is believed adjuvanted vaccine may be associated with a better immune response, albeit more local and systemic adverse events, as outlined in adverse events
      • 42. Children under 6 months of age
      • 43. Neither vaccine should be given to children younger than 6 months of age.
    • Why use an adjuvant
      • AS03 is approved in 30 countries
      • 44. Safety profileis based on 39,000 subjects who have received A/H5N1avian influenza vaccine, trivalent vaccine, or pH1N1
      • 45. Better immune response with less antigen (3.75 g vs. 15 g)
      • 46. May provide some cross protection in case the virus changes (“drifts”)
      • 47. Faster induction of immune response
      • 48. More immunogenic than regular vaccine formulations in the very young and at older ages
    • Arepanrix, the adjuvanted A/H1N1 vaccine
      • Requires mixing with the adjuvant, a milky white substance in smaller of the two vials, into larger vial containing the antigen.
      • 49. Volume will be 10 doses of 0.5 ml each or 20 doses of 0.25 ml each (for young children).
      • 50. After mixing, record the time and date of mixing onto the vaccine vial; must be used within 24 hours
      • 51. Children 6 months to under 10 years of age should receive two 0.25 ml doses given at least 21 days apart.
      • 52. Those aged 10 and older should receive one 0.5 ml dose.
    • Influenza A/H1N1 2009 Monovalent vaccine (without adjuvant)
      • Available in Nov. Offer to pregnant clients and may also be offered to children under 3 years old.
      • 53. This vaccine is formulated in the same way as Fluviral®, the seasonal trivalent vaccine from GSK.
      • 54. Supplied in cartons of 10 dose vials; record the date of entry on the vial and do not use for more than 28 days.
      • 55. A single 0.5 ml dose should be given to pregnant women; children under 3 years old may receive 2 doses of 0.25 ml each, given at least 21 days apart
    • Co-administration with seasonal flu and pneumococcal vaccines:
      • The A/H1N1 vaccines may be co-administered with seasonal influenza vaccine to people eligible for seasonal influenza vaccine, as well as with pneumococcal vaccines.
      • 56. The A/H1N1 vaccine should be given in a separate limb from that used for other vaccines.
      • 57. Those who do not wish to receive both at the same visit should be advised to receive A/H1N1 vaccine first
    • Current as of October 21, 2009
      20
      Additional recommendations:
      • pH1N1 and seasonal vaccine may be given at the same visit, by separate injection in separate limbs. If PPV23 is given at the same time, it should be given in the same limb as seasonal vaccine.
      • 58. If both seasonal and H1N1 vaccines are given, use separate limbs; give H1N1 vaccine in the non-dominant arm.
      • 59. If the pH1N1 and seasonal influenza vaccines are not given at the same time, they can be given sequentially without regard to interval. People under 65 should receive the pH1N1 vaccine first, if choosing not to receive the two vaccines at the same visit.
    • Current as of October 21, 2009
      21
      Recommendations for dosing of pH1N1 vaccine compared to seasonal influenza vaccine: by age and pregnancy
      *Footnotes on slide # 10
    • 60. Current as of October 21, 2009
      22
      Footnotes to preceding table:
      1. Children aged 6 months to &lt; 3 years can be offered either adjuvanted or unadjuvanted A/H1N1 vaccine in a two dose series. Both of the doses should be given with the same vaccine product. Unadjuvanted vaccine, when available, may be the preferred option for some parents and providers as this product is formulated in the same manner as seasonal influenza vaccine with which there has been ample experience in young children. Although clinical data in this age group are not yet available, it is believed adjuvanted vaccine may be associated with a better immune response, albeit more local and systemic adverse events, as outlined starting slide #25
      2. Seasonal vaccine for children under 9 years old should be given in a two dose series unless the child has received seasonal vaccine in 1 or more prior season.
      3. Pregnant women at 20 weeks or more gestation may receive adjuvanted vaccine early in the pH1N1 vaccine program, at which time unadjuvanted vaccine will not be available. When unadjuvanted vaccine is available, offer it preferentially to pregnant women.
    • 61. NOTE re: pregnancy use:
      • The non-adjuvanted vaccine can be given at any time during pregnancy.
      • 62. There are no data on the use of adjuvanted vaccines for pregnant women. Therefore non-adjuvanted vaccine is recommended preferentially for this group once supplies are available.
      • 63. In the first few weeks of the program only adjuvanted vaccine will be available. National committees have recommended that the adjuvanted vaccine can be given in the second half of pregnancy (≥ 20 weeks gestation) when there is deemed to be a risk of influenza infection, as this outweighs any theoretical safety concerns.
      • 64. Women who have chronic medical conditions that put them at risk of influenza related complications who are in the first half of pregnancy during the weeks when unadjuvanted vaccine is not available should discuss the option of receiving adjuvanted vaccine with their health care provider to consider the benefits and theoretical risks.
      • 65. Vaccines without adjuvants, such as the seasonal influenza vaccine, are safe for pregnant women. The manufacturing process for the Influenza A(H1N1) Monovalent vaccine (without adjuvant) is the same process used for the seasonal influenza vaccine.
    • Adverse events
      Both vaccines are associated with:
      • local site reactions such as pain, redness and swelling at the injection site.
      • 66. Pain at the injection site is very common with the adjuvanted vaccine.
      • 67. Systemic adverse events such as myalgia, headache and fatigue are also reported among recipients, and are more common following the adjuvanted vaccine.
      • 68. Do not report such events as Adverse Events Following Immunization.
      • 69. What adverse events need to be reported? only those adverse events that are medically attended, result in hospitalization, or are severe or unusual.. BCCDC will be reviewing all reported adverse events at least weekly, and serious events daily.
    • Current as of October 21, 2009
      25
      Serious Adverse Events (SAE) after seasonal influenza vaccines:
      • SAE profile of seasonal influenza vaccine
      • 70. Anaphylaxis (1 per 1 million doses given)
      • 71. Guillain-Barré syndrome (GBS) (1 per 1 million doses given)
      * These data represent an average of SAEs that have occurred in BC with annual influenza vaccination campaigns since 2004
    • 72. Current as of October 21, 2009
      26
      Common adverse events with H1N1 AS03 vaccine
    • 73. Current as of October 21, 2009
      27
      Contraindications to receipt of influenza vaccine:
      • History of anaphylactic reaction to a previous dose of influenza vaccine or to the following vaccine components:
      • 74. eggs
      • 75. formaldehyde
      • 76. sodium deoxycholate
      • 77. thimerosal
      • 78. Individuals with serious egg allergies should not be routinely vaccinated with the influenza vaccine.
      • 79. If at high risk of complications of influenza, such people should be evaluated by an allergy specialist. If such an evaluation is not possible, the risk of an allergic reaction to the vaccine must be weighed against the risk of influenza disease.
    • Current as of October 21, 2009
      28
      Contraindications to receipt of influenza vaccine, continued:
      • History of Guillain-Barré syndrome within 8 weeks of a prior dose of influenza vaccine
      • 80. Age under 6 months old
      *Latex hypersensitivity is NOT a contraindication to either adjuvanted or unadjuvanted pH1N1 vaccine because the stopper is butyl rubber, latex free
    • 81. Current as of October 21, 2009
      29
      Adjuvanted pH1N1 vaccine
      • Vaccine will be distributed from GSK in 500 dose ‘shoebox’ containing 2x25 vial boxes of adjuvant, and 50 vial box of antigen
      • 82. The most current product leaflet will be ‘live’ online at http://www.gsk.ca/english/html/our-products/vaccines-canada.html
      Image courtesy of GSK©
    • 83. Preparation of Adjuvanted H1N1
      Arepanrix: Adjuvanted pH1N1 vaccine
      • utilizes a novel GlaxoSmithKline proprietary adjuvant called AS03
      • 84. adjuvant stimulates immune response to the antigen for better antibody response
    • Preparation
      Adjuvant is milky white, in 3 ml vial
      • Requires mixing prior to administration
      • 85. 24 hour shelf life after mixing
      Antigen is clear, in a 10 ml vial
    • 86. Preparation of adjuvanted vaccine
    • 87. Current as of October 21, 2009
      33
      Withdrawing adjuvant: use care
      • Adjuvant vial may contain overfill – draw up all
      • 88. Vials when mixed may contain – up to 12 ml
      • 89. Will not affect amount of antigen per dose
      • 90. Use all of contents
      • 91. If using 3 cc syringe for adjuvant, use care to avoid pulling out plunger because of overfill
      • 92. If this happens dispose of contents to avoid contamination
      Potential errors in mixing and administering adjuvanted pH1N1 vaccine:
    • 93. Current as of October 21, 2009
      34
      Potential errors in mixing and administering adjuvanted pH1N1 vaccine:
      Antigen only is injected: this does NOT constitute a dose.
      Antigen and adjuvant from separate shoeboxes are used: It is
      preferable to use antigen and adjuvant from one “shoebox”; however, there is no scientific reason why adjuvant from one shoebox cannot be used to mix with antigen from another; record the lot number of each component antigen AND adjuvant.
      Please report errors to your local health unit. Errors will be collated centrally to identify common misunderstandings and improve instructional materials to prevent future errors.
    • 94. Lot Numbers
      Each vaccine dose is related to 3 lot numbers:
      • One for adjuvant – on vial
      • 95. One for antigen – on vial
      • 96. One for the mixture of both – on box
      • 97. found on the “shoe box” outer carton containing 500 doses OR on the outer label of the bubble pack containing 10 doses
      • 98. Community Providers will be Recording EITHER both adjuvant and antigen lot number OR outer (combination) lot number in provider record
      • 99. For iPHIS Record combination lot number only
    • 100. Lot number of combination product will be on outer label only
    • 101. Current as of October 21, 2009
      38
      Reporting of number of persons immunized each week:
      Reporting of the number of people immunized each week will be conducted from all clinics administered by public health and First Nations community health immunization service providers
      Check with your local health unit on how to report
      Private providers (e.g., in workplace settings) should check with local health unit about reporting back requirements
      Doses given by physicians will be estimated through MSP billing claims
    • 102. Key Messages:
      • Both seasonal and pandemic vaccine will be available
      • 103. • The pandemic vaccine will be freely available to all; it is strongly recommended for those
      • 104. • Influenza vaccines will provide protection against the pH1N1 virus, expected to predominate, and the seasonal trivalent viruses which may also be circulating
      • 105. • Pneumococcal vaccine is strongly encouraged for the usual risk groups; these include people ≥65 years of age and those less than 65 years of age with chronic conditions. Pneumococcal infections are a known complication of both seasonal and pandemic influenza.
    • Frequently asked questions
      There have been many questions by pregnant women – “should I get the vaccine now or wait for the unadjuvanted vaccine?”
      The adjuvanted vaccine : no clinical trials conducted or completed in pregnancy or young children, respectively.
      The unadjuvanted vaccine: Formulated same manner as standard Fluviral® seasonal influenza vaccine made by GSK and used in BC each year
    • 106. Current as of October 21, 2009
      41
      What is the preservative used in the adjuvanted and non-adjuvanted vaccine?
      Both vaccines in 10 dose vials; therefore a preservative is needed to maintain sterility after vial entry
      Both contain thimerosal as a preservative
      In each 0.5 ml dose of the vaccine:
      Adjuvanted: 5 gthimerosal
      Unadjuvanted: 50 gthimerosal, the same as in a 0.5 ml dose of Fluviral®
    • 107. Mature minor consent
      • We already have policies and procedures to cover mature minor consent – for school imms
      • 108. Effort is made to seek parental or guardian consent prior to immunization.
      • 109. Children under the age of 19 who are able to understand the risks and benefits may consent to or refuse immunizations, regardless of the parent’s or guardian’s wishes.
      • 110. It is recommended that parents/guardians and their minor children discuss immunizations beforehand, and ask the nurse any questions
    • Why the focus on Pregnant women and the H1N1 vaccine
      • Pregnant women and new mothers are at higher risk of complications from the H1N1 flu virus.
      • 111. Pregnant women in the second half of pregnancy are among those at highest risk of severe outcomes from the pandemic H1N1 virus.
      • 112. Since B.C. is experiencing epidemic levels of the H1N1 virus now, pregnant women in second half of pregnancy are advised not to wait until November for unadjuvanted vaccine, but to get immunized now with the adjuvanted version.
    • Who is recommended to get vaccine for H1N1
      • It is strongly recommended that the following people receive the pH1N1 vaccine:
      • 113. Children and adults under 65 years old with certain medical conditions, including:
      • 114. Heart or lung disorders that require regular medical care including asthma, chronic obstructive pulmonary disease, or cystic fibrosis.
      • 115. Kidney disease, chronic liver disease including hepatitis, diabetes, cancer, anemia, or weakened immune systems.
      • 116. Those with health concerns causing difficulty breathing, swallowing, or a risk of choking on food or fluids, including persons with severe brain damage, spinal cord injury, seizures or neuromuscular disorders.
      • 117. Pregnant women
      • 118. Children 6 months to 5 years of age
      • 119. Persons residing in remote and isolated settings and communities
      • 120. Health care workers
      • 121. Household contacts and care providers of children under 6 months of age or those with weakened immune systems.
      • 122. All others are recommended to receive the pH1N1 vaccine:
      • 123. Children 5-18 years of age
      • 124. First responders (police and firefighters)
      • 125. Poultry and swine workers
      • 126. Adults 19-64 years of age
      • 127. Adults 65 years of age and over
    • I have already had pH1N1 infection do I still need to get vaccinated?
      • The vaccine is not recommended for those who had lab-confirmed pH1N1 they will have acquired natural immunity.
      • 128. Give pH1N1 vaccine to individuals whose infection was not laboratory-confirmed. Testing these individuals now is NOT indicated.
    • Autoimmune disorders & Adjuvant
      • Since the squalene contained in AS03 is designed to improve the immune response to the vaccine, there are some theoretical concerns that it may provoke a hyperactive immune response.
      • 129. Animal studies have shown that arthritis can result when undiluted squalene is injected in large amounts into rats’ tails or joints.
      • 130. This has not been observed in clinical trials of human subjects.
      • 131. As well, another squalene containing adjuvant, MF59, has been used in >40 million recipients of the seasonal influenza vaccine called Fluad® (Novartis®) marketed in Europe and approved for use in elderly individuals, without observed excess rates of autoimmune diseases.
    • pH1N1 web sites
      Federal level information, Canada wide epidemiology, planning
      Provincial information on disease, BC vaccine roll out plan
      http://www.bccdc.ca
      Provides up to date provincial information, epidemiology, links to other resources
      http://www.ImmunizeBC.ca
      Immunization specific information- appropriate for patients
      Provincial Health Officer’s H1N1 Site for the Physicians of B.C. http://www.hls.gov.bc.ca/pho/physh1n1.html