Post on 23-Jul-2020
10/6/2014
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INFLUENZA: Why Should We Take The Vaccine?
INFLUENZA: Why Should We Take The Vaccine?
J. Milton Gaviria, MD, FACPOctober 17, 2014
DisclosuresI have no relevant commercial relationships to disclose.
Baptist Children’s HospitalBaptist Hospital Doctors Hospital
Baptist Cardiac &Vascular Institute
Homestead Hospital Mariners Hospital
West KendallBaptist Hospital
Baptist Outpatient Services
South Miami Hospital
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OUTLINE
�Influenza Virus
�Epidemiology
�Vaccine Formulations
�Why To Take The Vaccine?
�Adverse Reactions
�Contraindications And Precautions
�Summary
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INFLUNZA VIRUS
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INFLUENZA VIRUS
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INFLUENZA VIRUS
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INFLUENZA VIRUS
� RNA Virus
� High mutation rate
� Antigenic drifts
� Localized outbreaks
� Antigenic shifts
� Associated with:
� Epidemics
� Pandemics
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EPIDEMIOLOGY
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EPIDEMIOLOGY
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EPIDEMIOLOGY
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EPIDEMIOLOGY
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VACCINE FORMULATIONS
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CHOICE OF VACCINE FORMULATION
� Influenza vaccine composition for 2014-2015 season:� (HA) derived from:
� A/California/2009� (H1N1)
� A/Texas/2012� (H3N2)
� B/Massachusetts/ 2012
� B/Brisbane/2008
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VACCINE FORMULATIONS
� Standard-dose inactivated influenza vaccines
� Trivalent
� Quadrivalent
� Subvirion components
� “Split product”
� 15 mcg of HA
� 6m - >65y
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VACCINE FORMULATIONS
� Standard-dose live-attenuated influenza vaccine
� Quadrivalent
� Intranasal
� For healthy nonpregnant adults up to 49 years of age
� 2y – 49y
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VACCINE FORMULATIONS
� High-dose inactivated influenza vaccine
� Trivalent
� 60 mcg of HA
� > 65 years of age
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VACCINE FORMULATIONS
� Intradermal low-dose influenza vaccine
� Trivalent
� 3 mcg of HA
� For individuals age 18 – 64
� Uses an ultra-fine needle
� For needle phobic
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VACCINE FORMULATIONS
� Inactivated influenza vaccine produced in cultured cells
� Trivalent
� Cultured mammalian cells
� > 18 years of age
� Use if egg allergy
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VACCINE FORMULATIONS
� Inactivated influenza vaccine using recombinant DNA technology
� Trivalent
� Recombinant hemagglutinin
� For individuals age 18-49
� Use if egg allergy
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
� Vaccine for Prevention of Mild and Moderate-to-Severe Influenza in Children
� Varsha K Jain, MD, MPH; et al
� New England Journal of Medicine
� December 26th, 2013
� 2013; 369: 2481-91
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WHY TO TAKE THE VACCINE?
� Incidence of influenza among children is high
� Routine vaccination of children against influenza is recommended
� Limited studies on efficacy in children
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WHY TO TAKE THE VACCINE?
� Study Design:
� Phase 3, blind, randomized
� 15 non-US centers (8 countries)
� Goal:
� To assess QIIV efficacy for prevention of influenza A and B
� QIIV Vs HAVV in 1:1
� Influenza-like illness
� Temp >100.4F
� At least one:
� Cough
� Sore throat
� Runny nose
� Nasal congestion
� Diary for 14 days
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WHY TO TAKE THE VACCINE?
� Methods:� Influenza confirmed by RT-PCR
� Mod-Severe disease� Temp > 102.2
� Acute otitis media
� Lower respiratory tract illness
� Extrapulmonary complications
� Encephalitis
� Myocarditis
� Efficacy:� Prevent flu A and B
� Prevent mod-severe illness
� Immunogenicity:� Random testing
� Safety data:� Collected adverse events for 7 days after each vaccination
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
� QIIV was efficacious in preventing influenza A and B in children 3 to 8 years of age
� More effective:
� Older children
� Moderate-severe disease
� Influenza A
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
� Effectiveness of Influenza Vaccine Against Life-Threatening RT-PCR-Confirmed Influenza Illness in US Children, 2010-2012
� Jill M. Ferdinands, MD; et al
� The Journal of Infectious Diseases
� September 1st, 2014
� 2014; 210: 674-83
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WHY TO TAKE THE VACCINE?
� Severe influenza: ICU admission or death
� 4%-24% children hospitalized with influenza go to ICU
� 50%-60% children have chronic medical conditions
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WHY TO TAKE THE VACCINE?
� Methods:� Enrolled children 6-17 years from 21 US pediatric ICUs
� Influenza seasons 2010-2011 and 2011-2012
� Cases:� Children admitted with acute severe respiratory illness <7 days and +PCR
� Controls:� ICU: Matched cases who tested –RT-PCR
� Community: Matched children who resided in the same area
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WHY TO TAKE THE VACCINE?
� Results:
� 216 observations
� 44 influenza +
� 172 influenza –
� 93 community –
� At least 1 underlying chronic medical condition
� 55% cases
� 69% ICU controls
0
20
40
60
80
100
120
None
Partial
Full
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
� School-Located Influenza Vaccination Decreases Laboratory-Confirmed Influenza and Improves School Attendance
� Pia S. Pannaraj, MD; et al
� Clinical Infectious Diseases
� August 1st, 2014
� 2014; 59: 325-32
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WHY TO TAKE THE VACCINE?
� School-aged children 5-18 years� Important vectors for community-wide transmission
� Influenza attack rates 30%-50%
� Infected early in the Flu season
� Shed viruses in greater quantities
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WHY TO TAKE THE VACCINE?
� Methods:� Los Angeles County
� 2010-2011 Flu season
� Eight elementary schools (K-6)
� Two noncontiguous(LAC) school districts
� Paired by:� Enrollment size
� Sociodemographic
� Intervention:� 4 schools with on site vaccination from 10/2010 to 12/2010 with either TIIV or LAIV
� Vaccination status recorded in the California immunization registry
� 4 control schools
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WHY TO TAKE THE VACCINE?
� Surveillance:
� Influenza-like illness (ILI)
� Fever >100.4
� Nasal congestion, cough, headache, wheezing, myalgia, sore throat
� Nasopharyngeal swabs for RT-PCR influenza testing
� Outcomes:
� Primary outcome
� Was PCR-confirmed influenza in children from intervention Vs control schools
� Secondary outcome
� Rates of ILI
� Symptoms
� Absenteeism
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WHY TO TAKE THE VACCINE?
Influenza Vaccination Coverage
PCR Confirmed Cases
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
� Findings:� Vaccination resulted in about 60% effectiveness against influenza
� Vaccination of nearly 50% enrollees conferred 54% protection to unvaccinated
� Prevented transmission
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
� Influenza Vaccination of Pregnant Women and Protection of Their Infants
� Shabir A. Madhi, MD, PhD; et al
� New England Journal of Medicine
� September 4th, 2014
� 2014; 371: 918-31
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WHY TO TAKE THE VACCINE?
� Pregnancy and Influenza:
� Higher risk for severe complications
� In 2009 H1N1 pandemic increased maternal and fetal death
� Vaccine coverage not great
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WHY TO TAKE THE VACCINE?
� Methods:� Two double-blind, randomized, placebo-controlled trials
� Soweto, South Africa
� HIV+ 2011 season
� HIV- 2011 & 2012
� TIIV
� Influenza diagnosed by RT-PCR
� Primary objectives:� Evaluate efficacy of TIIV in protecting mother and infant
� Compare seroconversion rates recipients Vs placebo
� Evaluate in HIV+ immunogenicity TIIV
� Secondary objective� Evaluate length of protection
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
� Vaccine efficacy against influenza:
� HIV- women 54.4%
� HIV+ women 70%
� Vaccine immunogenicity (HAI) titer 1:40
� HIV- women 89%
� HIV+ women 59%
� Placebo 30%
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WHY TO TAKE THE VACCINE?
� Vaccine efficacy against influenza� Infants not exposed to HIV 45.6%
� Infants exposed to HIV no protection
� Vaccine immunogenicity (HAI) titer 1:40� HIV-unexposed newborns 70%
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WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
� Efficacy of High-Dose Versus Standard-Dose Influenza Vaccine in Older Adults
� Carlos A. DiasGranados, MD; et al
� New England Journal of Medicine
� August 14th, 2014
� 2014; 371: 635-45
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WHY TO TAKE THE VACCINE?
� Adults >65 years
� Highly vulnerable to influenza complications
� Account for most seasonal influenza-related hospitalizations and death
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WHY TO TAKE THE VACCINE?
� Methods:
� Phase IIIB-IV, multicenter, randomized, double-blind, active-controlled
� Participants:
� 65 years or older
� 126 centers USA and Canada
� 9/2011 thru 5/2013
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� Allocation:
� Assigned 1:1 ratio TIIV-SD or TIIV-HD
� Participants contacted from Jan to end of Apr for symptoms
� Diagnosis made with PCR and HAI assay to identify antigenic strain
� HAI titers after 28 days
WHY TO TAKE THE VACCINE?
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WHY TO TAKE THE VACCINE?
� Efficacy:
� Influenza
� TIIV-HD 1.4%
� TIIV-SD 1.9%
� TIIV-HD = 24.2%
� Safety:
� At least one adverse event
� TIIV-HD 8.3%
� TIIV-SD 9.0%
� TIIV-HD RR 0.92
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� Immunogenicity:
� HAI antibody titers and seroprotection rates 28 days after vaccination were significantly higher for TIIV-HD
ADVERSE REACTIONS
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ADVERSE REACTIONS
� Inactivated Flu Vaccines
� Standard dose:� Generally well tolerated
� Arm soreness 64%� Slight increase risk of Guillain-Barre Sx less than that the health risk posed by influenza
� Oculorespiratory Sx
� Inactivated Flu Vaccines
� High-dose:� Gastrointestinal complaints� Vomiting
� Diarrhea
� Intradermal:� Higher injection site reactions� Swelling, erythema
� Pruritus� No pain
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ADVERSE REACTIONS
� Live-attenuated Flu Vaccine
� Generally well tolerated
� Most common side effects:
� Rhinorrhea
� Nasal congestion
� Headache
� Sore throat
� Live-attenuated Flu Vaccine
� Three million people have got the vaccine
� Anaphylaxis 7
� Guillain-Barre Sx 2
� Bell’s palsy 1
� Asthma exacerbation 8
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CONTRAINDICATONS AND PRECAUTIONS
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CONTRAINDICATONS AND PRECAUTIONS
� Flu vaccine contraindicated:
� Prior severe allergic reaction
� Guillain-Barre Sx within 6 weeks from prior vaccine
� Recommendations for individuals with egg allergy
� Live-attenuated contraindicated:
� Immunosuppressed
� Chronic debilitating conditions
� Guillain-Barre Sx
� Pregnant women
� Adults > 50
� Egg allergy
� Safety not evaluated
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SUMMARY
� Influenza is a global potentially fatal illness
� Influenza virus has high mutation rate leading to epidemics/pandemics
� Annual influenza vaccination is an important public health measure
� In 2010 the ACIP recommended Flu vaccine to all individuals 6 months and older
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SUMMARY
� High-priority populations in vaccine campaigns:
� High-risk individuals
� Close contacts of high-risk individuals
� Healthcare workers
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SUMMARY
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SUMMARY
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