OUTLINE INFLUNZAVIRUS...Children, 2010-2012 Jill M. Ferdinands, MD; et al The Journal of Infectious...

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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� Standard-dose inactivated influenza vaccines

� Trivalent

� Quadrivalent

� Subvirion components

� “Split product”

� 15 mcg of HA

� 6m - >65y

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� Standard-dose live-attenuated influenza vaccine

� Quadrivalent

� Intranasal

� For healthy nonpregnant adults up to 49 years of age

� 2y – 49y

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� High-dose inactivated influenza vaccine

� Trivalent

� 60 mcg of HA

� > 65 years of age

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� 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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� Inactivated influenza vaccine produced in cultured cells

� Trivalent

� Cultured mammalian cells

� > 18 years of age

� Use if egg allergy

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� 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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� 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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� 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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� 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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� 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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� 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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� 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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� 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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� 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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� 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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� 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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� 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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� 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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� 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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Influenza Vaccination Coverage

PCR Confirmed Cases

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� 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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� Influenza Vaccination of Pregnant Women and Protection of Their Infants

� Shabir A. Madhi, MD, PhD; et al


� September 4th, 2014

� 2014; 371: 918-31

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� 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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� 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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� 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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� 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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� Efficacy of High-Dose Versus Standard-Dose Influenza Vaccine in Older Adults

� Carlos A. DiasGranados, MD; et al


� August 14th, 2014

� 2014; 371: 635-45

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� Adults >65 years

� Highly vulnerable to influenza complications

� Account for most seasonal influenza-related hospitalizations and death

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� 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


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� 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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OUTLINE INFLUNZAVIRUS...Children, 2010-2012 Jill M. Ferdinands, MD; et al The Journal of Infectious...

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Transcript of OUTLINE INFLUNZAVIRUS...Children, 2010-2012 Jill M. Ferdinands, MD; et al The Journal of Infectious...