The document provides an update on the 2009/2010 influenza season and answers common questions about the seasonal and H1N1 vaccines. It outlines the vaccination campaign, including details on the adjuvanted and unadjuvanted H1N1 vaccines, their dosages for different populations, preparation instructions, potential adverse events, and a phased rollout plan prioritizing high-risk groups. Frequently asked questions about the safety of the adjuvanted vaccine for pregnant women are also addressed.

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)

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 infectionsAdapted from the Centers for Disease Control and Prevention

12. and two pandemic monovalent (H1N1) vaccines will be available.

13. an adjuvanted

15. Phase 1: Is targeted for those aged 65 years and older and residents of long-term care facilities

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

23. 2) women in the second half of pregnancy – living in communities where H1N1 virus is actively circulating

25. Includes asthma, COPD, or cystic fibrosis

26. Kidney disease, chronic liver disease, hepatitis, diabetes, cancer, anemia or weakened immune system

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

31. First responders (police, firefighters)

32. Poultry and swine workers

33. Healthy adults 19 to 64 years of age

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.

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

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

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.

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.

56. The A/H1N1 vaccine should be given in a separate limb from that used for other vaccines.

58. If both seasonal and H1N1 vaccines are given, use separate limbs; give H1N1 vaccine in the non-dominant arm.

60. Current as of October 21, 2009 22 Footnotes to preceding table: 1. Children aged 6 months to < 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.

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.

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.

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

74. eggs

75. formaldehyde

76. sodium deoxycholate

77. thimerosal

78. Individuals with serious egg allergies should not be routinely vaccinated with the 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

82. The most current product leaflet will be ‘live’ online at http://www.gsk.ca/english/html/our-products/vaccines-canada.htmlImage courtesy of GSK©

85. 24 hour shelf life after mixingAntigen is clear, in a 10 ml vial

86. Preparation of adjuvanted vaccine

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 contaminationPotential 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.

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

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

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

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®

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.

111. Pregnant women in the second half of pregnancy are among those at highest risk of severe outcomes from the pandemic H1N1 virus.

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

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.