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influenza virus vaccine, inactivated (Fluogen, Fluzone, Fluvirin, Flushield, Fluarix, Flulaval, Agriflu, Afluria, Flublok Quadrivalent, FluCelVax, Fluad, RIV4)

Indications: 1) all persons >= 6 months of age (ACP, ACIP) [4,152] 2) all persons over 64 years of age (ACIP) [152] a) diminishes risk of hospitalizations for - heart disease & stroke (20%) - reduces risk of cardiovascular events in patients with established cardiovascular disease [4] - reduces mortality in patients with heart failure (RR=0.82) [114] - pneumonia (30%) [8] b) diminishes mortality by 50% (during flu season) [8,10,25] c) 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] - no clear benefit in persons > 65 years of age [125] - high-dose influenza vaccine is recommended for U.S. adults > 65 years, but the evidence is weak [141] 3) persons in long-term care facilities [4] 4) all children age 6 months to 18 years (to increase herd immunity) [28,102] - attenuated influenza vaccine nasal spray (FluMist) 1st line for healthy children 2-8 years of age [68]* - quadrivalent vaccine may be give to children 6 months of age 5) persons aged 2-64 with chronic disease, especially: a) congestive heart failure b) pulmonary disease c) renal failure d) diabetes e) malignancy f) immunocompromised patients, especially HIV infection g) anemia h) children on long-term aspirin (i.e. juvenile rheumatoid arthritis i) people at risk for aspiration due to: [16] - seizure disorders - cognitive dysfunction - spinal cord injury 6) persons who could transmit the disease to high-risk individuals a) health-care workers b) those who provide care for or live with chronically ill patients c) those who work in day-care centers d) household contacts of children < 2 years of age [9] 7) surgical inpatients prior to discharge [87] 8) all children age 6-59 months [9,10] - no evidence of benefit in children < 2 years 9) *live attenuated influenza vaccine (LAIV) is preferred for healthy children 2 to 8 years of age [70] - inactivated influenza vaccine recommmended by American Academy of Pediatrics for 2018-2019 flu season [107,110] 10) pregnant women, 2nd & 3rd trimesters [4,9] - reduces influenza in mothers & their infants (2-4% both) [71] - infants born to mothers who received flu vaccine during pregnancy have a 60% lower risk for influenza or influenza- like illness in the 1st 6 months of life than those born to unvaccinated mothers [90] - does not reduce influenza in infants of HIV+ mothers [71] - reduces risk of stillbirth (3 vs 5 stillbirths per 100,000 pregnancy-days) [88] - reduces influenza-associated hospitalizations & emergency department visits for their infants [150] 11) a new universal vaccine triggers antibodies that bind to the stalk region of the influenza surface protein hemagglutinin [129] 12) 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] * live attenuated vaccine not recommended given low effectiveness against (H1N1)pdm09 viruses during 2013-14 & 2014-2015 seasons [101] Contraindications: 1) hypersensitivity to eggs, thimerosal or influenza vaccine a) Fluzone contains egg protein [34] b) Flublock recommended for patients with egg allergy [58] - egg-free, culture derived vaccine FDA-approved [51] c) in patients with a positive skin test to egg protein, the influenza virus vaccine can be administered, if necessary, in graded doses d) 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 [3] e) may be safely administered to patients with history of hives after exposure to eggs [4] - observe for 30 minutes for signs of adverse reaction [4] f) all available flu vaccines are safe in all egg-allergic patients, regardless if the vaccine may contain residual egg protein [104] 2) patients with acute febrile illness should delay vaccination 3) delay immunization in a patient with active neurologic disease or changing neurological findings 4) infants < 6 months of age * safe & effective to administer Covid-19 vaccine & influenza vaccine at same time [134] * safe & effective to administer RSV vaccine & influenza vaccine at same time [149] Caution: 1) antigenic response may be diminished in patients receiving immunosuppressive agents 2) monitor for hypersensitivity, have epinephrine available 3) because of potential of febrile reactions, use with caution in patients with a history of febrile seizures 4) influenza vaccines from previous seasons must not be used 5) safe for asthmatics [5,6] 6) considered safe if patients on warfarin, if INR is therapeutic [6] 7) use with caution in patients with history of Guillain-Barre syndrome 8) Fluarix may contain trace amounts of gentamicin [18] 9) does not reduce risk of dementia - may increase incidence of dementia in the elderly after a 2-year lag period [142] Pregnancy-category: C (safe during pregnancy [15,85,133]) Influenza vaccination during pregnancy does not harm prenatally exposed children [133] Safety in lactation: ? Benefit/risk: - number needed to treat (NNT) to avoid symptoms - 33 (at best), typically NNT is ~ 100 [74] - NNT = 43 elderly > 65 years of age (range: 16-192) [74] - may reduce major cardiovascular events 3.6% vs 5.6%, NNT=50 [136] - 6.5% vs 11% among those with recent acute coronary syndrome, NNT=22 [136] - may reduce risk of ischemic stroke 5% (raw data), 8-12% (data adjusted for clinical factors) [138] Dosage: - IM, 15 ug of hemagglutinin per strain (trivalent vaccine) - low-dose intradermal injections (20-40% of IM dose) as effective as standard dose intramuscular injections [13,131] - needle-free jet injection as effective as IM injection [67] chronically immunosuppressed solid organ transplant recipients - High-Dose Fluzone HD - seroconversion 78.6% vs 55.8% for standard dose [108] Elderly - High-Dose Flublok. RIV4 (quadrivalent recombinant influenza virus vaccine) - 45 ug of recombinant hemagglutinin per strain - 180 ug of protein per dose [98,148] - gigantic study could not confirm meaningful clinical benefits [148] - High-Dose Fluzone HD - high-dose vaccine (60 ug hemagglutinin per strain [30,69], 180 ug [32], 3 strains ?) - reduces laboratory-confirmed incidence of influenza infection 1.4% vs 1.9% [69] - 0.24 vs 0.35 per 10,000 person-weeks [108] - CDC Advisory Committee on Immunization Practices (ACIP) seems to endorse high-dose Fluzone (HD-IIV3) [44,109] - Fluad combines trivalent influenza virus vaccine (2 influenza A, 1 influenza B hemagglutinins) with an adjuvant, an oil-in-water emulsion of squalene oil [84]; - FDA approval based on immunogenicity & safety - no mention of eliciting IgA - no clinical benefit demonstrated - high-dose trivalent influenza virus vaccine does not reduce all-cause mortality or hospitalizations for cardiac or pulmonary causes compared with standard-dose quadrivalent vaccine in high-risk patients [128] - high-dose quadrivalent influenza vaccine for adults >= 65 years was associated with 23% lower hospitalization rates vs standard dose vaccine [153] - for 2024-25 season ACIP recommends one of 3 vaccines for adults >= 65 years - trivalent high-dose inactivated influenza vaccine (HD-IIV3) - trivalent recombinant influenza vaccine (RIV3) - trivalent adjuvanted inactivated influenza vaccine (aIIV3). Adults & children > 12 years: 1) whole virus, split virus or purified surface antigen 2) one dose 0.5 mL IM 3) do not administer IV 4) if co-administered with Covid-19 vaccine, administer in different limbs if possible* [139] Children* 3-12 years: 1) split virus or purified surface antigen 2) two doses 0.5 mL IM 4 weeks apart (first immunization) Children* 6-35 months of age: 1) split virus or purified surface antigen 2) two doses 0.25 mL IM 4 weeks apart (first immunization) Children 6 months-8 years of age who have never received influenza virus vaccine or who have not received 2 or more doses of influenza virus vaccine since July 2010 should receive two doses IM 4 weeks apart (2012-2013 season) [48] Injection: - split-virus: 5 mL, 0.5 mL prefilled syringe (Fluvirin) - Fluvirin contains trace amounts of thimerosal [43] 2015-16 vaccine: trivalent vaccines will include - A/California/7/2009 (H1N1)-like virus - an A/Switzerland/9715293/2013 (H3N2)-like virus - B/Phuket/3073/2013-like (Yamagata lineage) virus [81] 2015-16 Fluzone Intradermal Quadrivalent vaccine is expected to replace the trivalent Fluzone Intradermal vaccine for adults 18-64 years of age [81] FDA has approved Fluzone High-Dose Quadrivalent for adults >= 65 years available Fall 2020 - contains 2 influenza A & 2 influenza B strains [122] High dose flu vaccine contains 4x more antigen than standard dose - in 2016-2017 when vaccine composition & circulating virus were well matched, both high-dose & standard-dose vaccines provided similar reductions in post-influenza mortality (25-30%) [147] - during other flu seasons, in which vaccine composition & circulating virus were not well matched, post-influenza mortality was ~20& lower with the high-dose vaccine, but this was not a significant difference [147] * High-Dose & adjuvanted inactivated influenza vaccines more likely to cause local reaction [139] FDA has recommended a different composition for the 2016-17 influenza virus vaccine [93] 2018-19 World Health Organization (WHO) recommendations: - A/Michigan/45/2015 (H1N1)pdm09-like virus; - A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus; - B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage); & - B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage) [106] * may be given with other routine childhood immunizations single dose of 0.5 mL if previously immunized [20] vaccination mid-October to mid-November vaccines that do not need to be given annually are in development [50] * Flu Shot Coding. HCPCS/CPT Codes [134] Pharmacokinetics: - 2 weeks for IgG antibodies to develop [44] - elimination: liver Adverse effects: 1) most common (1-10%) a) tenderness, redness or induration at the site of injection b) malaise 2) uncommon (< 1%) - anaphylactoid reactions (generally due to residual egg protein), allergic reactions, fever, hives, angioedema, myalgia, Guillain-Barre syndrome [46], asthma 3) reactions are mild & seldom persist more than 24-48 hours 1) local pain & swelling 2) deltoid or subacromial bursitis (rare) [128] 2) fever & myalgias are infrequent 3) headache 4) other - reports of febrile seizures in children with Fluzone [38] - cranial nerve palsy (Bell's palsy) with high-dose vaccine [69,146] - encephalomyelitis with high-dose vaccine [69] - 849 reports to the vaccine adverse event reporting system in postmarketing surveillance of Floblok Quadrivalent [137] - 810 reported as non-serious yet many allergic reactions reported as non-serious, required interventions to treat a life-threatening event (epinephrine, nebulizers, albuterol, glucocorticoids, supplemental oxygen) - 10 cases of Guillain-Barre syndrome, 5 required mechanical ventilation & 2 people died [137] - no excess risk of thromboembolism [144] - increased risk of ischemic stroke after high-dose vaccine [151] - RR=1.1 if administered alone, RR=1.2-1.3 if administered with bivalent Covid-19 vaccine booster * Covid-19 vaccine booster alone did not increase stroke risk [151] Drug interactions: 1) immunosuppressive agents may diminish immunological response - TNF antagonist adalimumab may not be a problem [22] 2) may increase anticoagulant effect of warfarin 3) may decrease anticonvulsant effect of phenytoin 4) may increase risk of febrile seizures when coadministered with DTaP or PCV13 [92] 5) methotrexate may diminish response to vaccine - hold methotrexate for 1 week after influenza virus vaccine [143] Mechanism of action: 1) vaccines target the globular outer region of the viral hemagglutinin protein a) the outer region or head constantly changes, necessitating different vaccines each year b) producers of annual vaccines do not always accurately predict the dominant circulating strains 2) investigational vaccines target a region in the stem of the hemagglutinin protein, a region that remains largely unchanged [41, 129] 3) intramuscular vaccine induces circulating IgG & IgM; however, the virus replicates in columnar epithelial cells of the respiratory tract - is there an obligatory viremic phase of the virus? - presence of hemagluttin & neuraminidase-specific serum IgG after natural infection would suggest that viremia does occur [62] - natural infection also induces mucosal IgA as well as IgG & IgM [62] - does the vaccine induce T-cell mediated immunity? [62] - does the vaccine induce innate immunity? 4) 2024 flu vaccine (trivalent)* directed at - influenza A(H1N1) virus - influenza A(H3N2) virus - influenza B/Victoria lineage virus [155] * Quadrivalent vaccine no longer produced because influenza B/Yamagata lineage virus stopped circulating during the Covid-19 pandemic [155] Method: 1) inactivated, egg grown, highly purified vaccine containing 2 influenza A subtypes & one influenza B subtype, updated annually 2) the 2010 flu vaccine includes the 2009 H1N1 strain plus two seasonal flu strains 3) purified surface antigen 4) split virus 5) different vaccines for special patient populations [37] 6) intradermal vaccine, Fluzone intradermal (available 2011) 7) Flublock is an egg-free trivalent influenza vaccine made using an insect virus (baculovirus) expression system & recombinant DNA technology [54,58] 8) FluCelVax made in U.S. using cultured dog cells Epidemiology: - 96% of flu viruses in 2014 were influenza A (H3N2) - 67% of circulating influenza A (H3N2) viruses collected in the U.S. in 2014 are antigenically different from the H3N2 virus included in the 2014-2015 vaccine [78,79,80] (also see CDC FluView) - influenza viruses circulating in summer of 2014 are similar to the components of the 2015-2016 influenza virus vaccine & are sensitive to neuraminidase inhibitors [82] - 40% effective in preventing hospitalizations among pregnant women 2010-2016 [112] - 2015-2016 influenza virus vaccine - 51% effective against H1N1 (most cases this season) - 76% against all influenza B viruses - 79% percent against the B/Yamagata [86] - 48% effective against any influenza illness [99] - 2017-2018 influenza virus vaccine - 25% effective against H3N2 (major circulating strain) - 67% effective against H1N1 - 42% effective against influenza B [105] - 2019-2020 vaccine effectiveness has been 47% [116] - influenza A(H1N1)pdm09 major circulating strain - ~45% effective overall. 55% among children & adolescents [123] - 2021-2022 vaccine effective against predominant strain H3N2 16% [135] Notes: 1) breakthrough rate* in patients with COPD is 5% [7] 2) 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] - high-dose vaccine 25% more effective than standard dose in elderly [69] - hospitalization 3.4% (high dose) vs. 3.9% (standard dose) over 6 months [100] - 40% of elderly (mean age 69) hospitalized in 2010-2018 with laboratory- confirmed influenza had received annual influenza virus vaccine [132] 3) effectiveness of vaccine questioned [55] - outbreaks may still occur in vaccinated populations [77] 4) diminished mortality in patients hospitalized with community-acquired pneumonia [21] 5) inactivated vaccine is more efficient than live-attenuated vaccine in healthy adults [31] - may not be more efficient in children (see FluMist) 6) components of influenza vaccine for the 2012-2013 season includes: [39,47] - A/California/7/09 (H1N1)-like virus (the 2009 pandemic virus) - A/Perth /16/2009 (H3N2)-like virus - B/Brisbane/60/2008-like virus - A/California/7/2009 (H1N1)-like virus - A/Victoria/361/2011 (H3N2)-like virus - B/Wisconsin/1/2010-like virus 7) Quadrivalent vaccine FDA-approved June 2013 [57] 8) obesity may decrease vaccine efficacy [45] 9) overall level of benefit is modest [49] a) effectiveness of well matched (i.e. good antigenic match of vaccine to seasonal virus) is ~ 60% - 62% in 2013 b) effectiveness of poorly matched vaccine is < 30% c) effectiveness of 2016-2017 vaccine is 48%, 43% against influenza A H3N2 & 73% against influenza B [96] d) consistently poor response in elderly [49] 10) vaccine-induced protection greatest when not vaccinated during the prior 5 years [77] 11) Flublock expires in 16 weeks. [58] 12) flu vaccine reduces cardiovascular risk (2.9% vs 4.7%) in high-risk patients [61] 13) 2 vaccinations in young children is associated with ~80% reduction in flu-related pediatric intensive care unit admissions [65] - a single vaccine is not effective - based on 45 ICU admissions with influenza - 18% of influenza admissions with 2 vaccinations vs 31% of ICU controls & 51% of community controls 14) influenza mortality in children - 26% of influenza-related deaths in vaccinated children - 48% of study group received influenza virus vaccine [97] 15) vaccination rates among healthcare workers [72] & pregnant women could be better [73] 16) may reduce risk of hospitalization for community-acquired pneumonia due to influenza [83] 17) mandatory vaccination of healthcare workers of unknown/ unproven benefit [95] - in states where flu vaccination is mandated or encouraged for hospital employees, fewer respiratory deaths occur [130] 18) 80,000 deaths in U.S. attributed to influenza in 2017-2018 flu season including complications such as MI, stroke, & pneumonia [111] - vaccine 40% effective against circulating strains - 78% of healthcare workers vaccinated 19) yearly vaccination does not reduce effectiveness of vaccine [113] 20) 1st human trial of a universal influenza vaccine (H1ssF_3928) [117] 22) an mRNA vaccine that simultaneously immunizes against all 20 subtypes of flu virus with one injection has been successfully tested in mice & ferrets [140] 23) pediatric waiting room handout to hispanic mothers may increase influenza vaccination rates of their children [118] 24) no adverse outcomes in offspring of mothers who received 2009 H1N1 vaccine by the age 5 years [119] 25) vaccine effectiveness in reducing hospitalizations in the Southern Hemisphere in 2024 was 34% [154] * serology-confirmed influenza after vaccination - a modeling study concludes that early vaccination would save lives & reduce costs in the event of an H7N9 pandemic [66] - the study may overestimate effectiveness of the vaccine

Interactions

drug interactions

Related

influenza live attenuated influenza virus vaccine; LAIV (FluMist, FluMist Quadrivalent) thimerosal; ethylmercurothiosalycilate; thiomersalate; mercurothiolate; merthiolate; merzonin; vitaseptol

Specific

H5N1 influenza vaccine; avian flu vaccine (Audenz) influenza A (H1N1) monovalent vaccine

General

vaccine

References

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Component-of

influenza virus vaccine/live attenuated influenza virus vaccine