Influenza Virus Vaccine

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Contents 1 More Specific Terms 2 Introduction 3 Indications 4 Contraindications 5 Dosage 6 Pharmacokinetics 7 Adverse-effects 8 Drug-interactions 9 Mechanism-of-action 10 Notes 11 More General Terms 12 Additional Terms 13 References

More Specific Terms

• H5N1 influenza vaccine (avian flu vaccine)

Introduction

• inactivated, egg grown, highly purified vaccine containing 2 influenza A subtypes & one influenza B subtype, updated annually
• the 2010 flu vaccine includes the 2009 H1N1 strain plus two seasonal flu strains
• purified surface antigen
• split virus
• different vaccines for special patient populations [37]
• intradermal vaccine, Fluzone intradermal (available 2011)

Indications

• all persons over 64 years of age (49 years of age [4])

• diminishes risk of hospitalizations for

• heart disease & stroke (20%)
• pneumonia (30%) [8]

• diminishes mortality by 50% (during flu season) [8,10,25]
• any repeat vaccination reduces mortality in patients > 70

• up to 24% [12]
• 10% reduction for 1st vaccination
• patients with chronic illness with most benefit
• no benefit in mortality for patients < 70 [12]

• persons in long-term care facilities [4]
• all children age 6 months to 18 years (to increase herd immunity) [28]
• persons aged 2-64 with chronic disease, especially:

• congestive heart failure
• pulmonary disease
• renal failure
• diabetes
• malignancy
• immunocompromised patients, especially HIV infection
• anemia
• children on long-term aspirin (i.e. juvenile rheumatoid arthritis
• people at risk for aspiration due to: [16]

• seizure disorders
• cognitive dysfunction
• spinal cord injury

• persons who could transmit the disease to high-risk individuals

• health-care workers
• those who provide care for or live with chronically ill patients
• those who work in day-care centers
• household contacts of children < 2 years of age [9]

• all children age 6-59 months [9,10]

• no evidence of benefit in children < 2 years

• pregnant women, 2nd & 3rd trimesters [4,9]
• according FDA's Dr. Karen Midthun: "It is important to get vaccinated every year, even if the strains in the vaccine do not change, because the protection received the previous year will diminish over time and may be too low to provide protection into the next year." ('marketing' or evidence-based medicine?) [39]

Contraindications

• hypersensitivity to eggs, thimerosal or influenza vaccine

• in patients with a positive skin test to egg protein, the influenza virus vaccine can be administered, if necessary, in graded doses
• one of the commonly used graded dose regimens gives 1/10 of the dose followed in 30 minutes by the remaining 9/10 of the dose [36]

• patients with acute febrile illness should delay vaccination
• delay immunization in a patient with active neurologic disease or changing neurological findings
• infants < 6 months of age

• Caution:

• antigenic response may be diminished in patients receiving immunosuppressive agents
• monitor for hypersensitivity, have epinephrine available
• because of potential of febrile reactions, use with caution in patients with a history of febrile seizures
• influenza vaccines from previous seasons must not be used
• safe for asthmatics [5,6]
• considered safe if patients on warfarin, if INR is therapeutic [6]
• use with caution in patients with history of Guillain-Barre syndrome
• Fluarix may contain trace amounts of gentamicin [18]
• Fluzone contains egg protein [34]

• pregnancy-category C (safe during pregnancy [15])
• safety in lactation ?

Dosage

• IM, 15 ug of hemagglutinin per strain ( trivalent vaccine)
• low-dose intradermal injections (20-40% of IM dose) appear effective [13]
  

• Elderly (High-Dose Fluzone HD)

• high-dose vaccine (60 ug hemagglutinin per strain [30], 180 ug [32], 3 strains ?)
  

• Adults & children > 12 years:

• whole virus, split virus or purified surface antigen
• one dose 0.5 mL IM
• do not administer IV

• Children* 3-12 years:

• split virus or purified surface antigen
• two doses 0.5 mL IM 4 weeks apart (first immunization)

• Children* 6-35 months of age:

• split virus or purified surface antigen
• two doses 0.25 mL IM 4 weeks apart (first immunization)
  

• Injection:

• split- virus: 5 mL, 0.5 mL prefilled syringe (Fluvirin)

• Fluvirin contains trace amounts of thimerosal [43]
  

• * may be given with other routine childhood immunizations single dose of 0.5 mL if previously immunized [20]
  
• vaccination mid-October to mid-November

Pharmacokinetics

• 2 weeks for IgG antibodies to develop [44]
• elimination: liver

Adverse-effects

• most common (1-10%)

• tenderness, redness or induration at the site of injection
• malaise

• uncommon (< 1%)

• anaphylactoid reactions (generally due to residual egg protein), allergic reactions, fever, hives, angioedema, myalgia, Guillain-Barre syndrome, asthma

• reactions are mild & seldom persist more than 24-48 hours

• local pain & swelling
• fever & myalgias are infrequent
• headache

• other

• reports of febrile seizures in children with Fluzone [38]

Drug-interactions

• immunosuppressive agents may diminish immunological response

• TNF antagonist adalimumab may not be a problem [22]

• may increase anticoagulant effect of warfarin
• may decrease anticonvulsant effect of phenytoin

Mechanism-of-action

• vaccines target the globular outer region of the viral hemagglutinin protein

• the outer region constantly changes, necessitating different vaccines each year
• producers of annual vaccines do not always accurately predict the dominant circulating strains

• investigational vaccines target a region in the stem of the hemagglutinin protein, a region that remains largely unchanged [41]

Notes

• breaththrough rate* in patients with COPD is 5% [7]
• benefit moderate if any in elderly [17,27]

• vaccine trials/studies can give the impression of preventing death even when no influenza is in sight [33]

• diminished mortality in patients hospitalized with community-acquired pneumonia [21]
• inactivated vaccine was more efficacious than live- attenuated vaccine in healthy adults [31]
• components of influenza vaccine for the 2011-2012 season unchanged from 2010-2011 season: [39] includes:

• A/California/7/09 ( H1N1)-like virus (the 2009 pandemic virus)
• A/Perth /16/2009 ( H3N2)-like virus
• B/Brisbane/60/2008-like virus

• obesity may decrease vaccine efficacy [45]
  

• * serology-confirmed influenza after vaccination

More General Terms

• vaccine

Additional Terms

• influenza
• live attenuated influenza virus vaccine
• thimerosal; ethylmercurothiosalycilate; thiomersalate; mercurothiolate; merthiolate; merzonin; vitaseptol

References

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2. Kaiser Permanente Northern California Regional Drug Formulary, 1998
3. Drug Information & Medication Formulary, Veterans Affairs, Central California Health Care System, 1st ed., Ravnan et al eds, 1998
4. Medical Knowledge Self Assessment Program (MKSAP) 11, 14, American College of Physicians, Philadelphia 1998, 2006
5. Journal Watch 21(24):192, 2001 American Lung Association Asthma Clinical Research Centers, NEJM 345:1529, 2001
6. Prescriber's Letter 9(1):5 2002
7. Journal Watch 23(5):41, 2003 Neuzil KM et al, Clin Infect Dis 36:169, 2003
8. Journal Watch 23(9):70, 2003 Nichol KL, Nordin J, Mullooly J, Lask R, Fillbrandt K, Iwane M. Influenza vaccination and reduction in hospitalizations for cardiac disease and stroke among the elderly. N Engl J Med. 2003 Apr 3;348(14):1322-32. PMID: [1]
9. Prescriber's Letter 11(9): 2004 Influenza Virus Vaccine: New Recommendations Detail-Document#: [2] (subscription needed) [3]
10. Journal Watch 24(21):163, 2004 Armstrong BG, Mangtani P, Fletcher A, Kovats S, McMichael A, Pattenden S, Wilkinson P. Effect of influenza vaccination on excess deaths occurring during periods of high circulation of influenza: cohort study in elderly people. BMJ. 2004 Sep 18;329(7467):660. Epub 2004 Aug 15. <PubMed> PMID: [4] <Internet> [5]
11. Prescriber's Letter 11(12): 2004 Detail-Document#: [6] (subscription needed) [7]
12. Journal Watch 24(24):184, 2004 Voordouw AC, Sturkenboom MC, Dieleman JP, Stijnen T, Smith DJ, van der Lei J, Stricker BH. Annual revaccination against influenza and mortality risk in community-dwelling elderly persons. JAMA. 2004 Nov 3;292(17):2089-95. PMID: [8]
13. Journal Watch 25(1):10, 2005 Kenney RT, Frech SA, Muenz LR, Villar CP, Glenn GM. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004 Nov 25;351(22):2295-301. Epub 2004 Nov 25. PMID: [9]
    - Belshe RB, Newman FK, Cannon J, Duane C, Treanor J, Van Hoecke C, Howe BJ, Dubin G. Serum antibody responses after intradermal vaccination against influenza. N Engl J Med. 2004 Nov 25;351(22):2286-94. Epub 2004 Nov 25. PMID: [10]
    - La Montagne JR, Fauci AS. Intradermal influenza vaccination--can less be more? N Engl J Med. 2004 Nov 25;351(22):2330-2. Epub 2004 Nov 25. No abstract available. PMID: [11]
14. Journal Watch 25(8):68, 2005 Jefferson T, Smith S, Demicheli V, Harnden A, Rivetti A, Di Pietrantonj C. Assessment of the efficacy and effectiveness of influenza vaccines in healthy children: systematic review. Lancet. 2005 Feb 26;365(9461):773-80. Review. PMID: [12]
15. Journal Watch 25(11):88, 2005 Munoz FM, Greisinger AJ, Wehmanen OA, Mouzoon ME, Hoyle JC, Smith FA, Glezen WP. Safety of influenza vaccination during pregnancy. Am J Obstet Gynecol. 2005 Apr;192(4):1098-106. PMID: [13]
16. Prescriber's Letter 12(9): 2005 Influenza Update 2005 Detail-Document#: [14] (subscription needed) [15]
    - Harper SA, Fukuda K, Uyeki TM, Cox NJ, Bridges CB; Advisory Committee on Immunization Practices (ACIP), Centers for Disease Control and Prevention (CDC). Prevention and control of influenza. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2005 Jul 29;54(RR-8):1-40. Erratum in: MMWR Morb Mortal Wkly Rep. 2005 Aug 5;54(30):750. <PubMed> PMID: [16] <Internet> [17]
    - specific recommendations for persons displaced by hurricane Katrina [18]
17. Prescriber's Letter 12(9): 2005 Does the Influenza vaccination benefit the elderly Detail-Document#: [19] (subscription needed) [20]
    - Jefferson T, Rivetti D, Rivetti A, Rudin M, Di Pietrantonj C, Demicheli V. Efficacy and effectiveness of influenza vaccines in elderly people: a systematic review. Lancet. 2005 Oct 1;366(9492):1165-74. Epub 2005 Sep 22. Review. PMID: [21]
18. Monthly Prescribing Reference [22]
19. Michele L. Pearson, Carolyn B. Bridges, Scott A. Harper Influenza Vaccination of Health-Care Personnel Recommendations of the Healthcare Infection Control Practices Advisory Committee (HICPAC) and the Advisory Committee on Immunization Practices (ACIP) MMWR February 9, 2006, 55(Early Release);1-16 [23]
20. Prescriber's Letter 13(9): 2006 Updates in Treatment and Prevention of Influenza Detail-Document#: [24] (subscription needed) [25]
    - Prescriber's Letter 14(1): 2007 Influenza Vaccination in Children: Missed Second Doses Detail-Document#: [26] (subscription needed) [27]
21. Spaude KA et al, Influenza vaccination and risk of mortality among adults hospitalized with community-acquired pnuemonia. Arch Intern Med 2007, 167:53 PMID: [28]
22. Kaine JL et al, Immune responses following administration of influenza and pneumococcal vaccines to patients with rheumatoid arthritis receiving adalimumab. J Rheumatol 2007, 24:272 PMID: [29]
23. National Influenza Vaccination Week, Nov 2006 [30] and management [31]
24. Fiore AE et al, Prevention and Control of Influenza Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2007 MMWR, 2007 (June 29, 2007) 56:1-54 [32]
25. Nichol KL et al, Effectiveness of influenza vaccine in the community-dwelling elderly. N Engl J Med 357:1373 PMID: [33]
26. Prescriber's Letter 14(11): 2007 Myths about influenza and influenza vaccines Detail-Document#: [34] (subscription needed) [35]
27. Belongia EA and Shay DK. Influenza vaccine for community-acquired pneumonia. Lancet 2008 Aug 2; 372:352. PMID: [36]
28. Prescriber's Letter 15(9): 2008 Update on Influenza 2008-2009 Detail-Document#: [37] (subscription needed) [38]
29. Lexi-Comp Inc. 2009
30. Falsey AR et al Randomized, double-blind controlled phase 3 trial comparing the immunogenicity of high-dose and standard-dose influenza vaccine in adults 65 years of age and older. J Infect Dis 2009 Jul 15; 200:172 PMID: [39]
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32. FDA Press release, Dec 23, 2009 FDA Approves A High Dose Seasonal Influenza Vaccine Specifically Intended for People Ages 65 and Older Accelerated approval process used in vaccine approval [43]
33. Baxter R et al. Evidence of bias in studies of influenza vaccine effectiveness in elderly patients. J Infect Dis 2010 Jan 15; 201:186. PMID: [44]
34. Centers for Disease Control and Prevention (CDC) Licensure of a High-Dose Inactivated Influenza Vaccine for Persons Aged >= 65 Years (Fluzone High-Dose) and Guidance for Use --- United States, 2010 Morbidity and Mortality Weekly Report (MMWR) April 30, 2010 / 59(16);485-486 [45]
35. Prescriber's Letter 17(9): 2010 COMMENTARY: Seasonal Influenza Vaccine: What’s New for 2010-11 GUIDELINES: Prevention and Control of Influenza with Vaccines PATIENT HANDOUT: Common Myths About Flu and the Flu Shot Detail-Document#: [46] (subscription needed) [47]
36. Prescriber's Letter 17(10): 2010 COMMENTARY: Influenza Vaccine and Egg-Allergic Patients GUIDELINES: Prevention and Control of Influenza with Vaccines GUIDELINES: Statement on Seasonal Trivalent Inactivated Influenza Vaccine (TIV) for 2010-2011 Detail-Document#: [48] (subscription needed) [49]
37. Prescriber's Letter 17(12): 2010 Choosing an Influenza Vaccine for Special Patient Populations Detail-Document#: [50] (subscription needed) [51]
38. Fluzone Vaccine Safety: FDA and CDC Update on Fluzone Influenza Vaccine and VAERS Reports of Febrile Seizures in Children January 20, 2011 [52]
39. FDA NEWS RELEASE: July 18, 2011 FDA approves vaccines for the 2011-2012 influenza season [53]
40. Centers for Disease Control and Prevention (CDC). Prevention and control of influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep 2011 Aug 26; 60:1128. PMID: [54]
41. Ekiert DC et al. A highly conserved neutralizing epitope on group 2 influenza A viruses. Science 2011 Aug 12; 333:843 PMID: [55]
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42. Prescriber's Letter 18(10): 2011 Detail-Document#: [58] (subscription needed) [59]
43. Prescriber's Letter 18(12): 2011 Use of Influenza and Pertussis Vaccines in Pregnancy Detail-Document#: [60] (subscription needed) [61]
44. Geriatric Review Syllabus, 7th edition Parada JT et al (eds) American Geriatrics Society, 2010
45. Kim Y-H et al. Diet-induced obesity dramatically reduces the efficacy of a 2009 pandemic H1N1 vaccine in a mouse model. J Infect Dis 2012 Jan 15; 205:244. PMID: [62]
46. National Guideline Clearinghouse
    - Prevention and control of seasonal influenza with vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2010. Centers for Disease Control and Prevention ngc-guideline: [63]
    - Recommendations for prevention and control of influenza in children, 2011-2012. American Academy of Pediatrics ngc-guideline: [64]

influenza virus vaccine, inactivated (Fluogen, Fluzone, Fluvirin, Flushield, Fluarix, Flulaval, Agriflu)