10/6/2014. INFLUENZA: Why Should We Take The Vaccine? OUTLINE INFLUNZA VIRUS INFLUENZA VIRUS INFLUENZA VIRUS

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1 INFLUENZA: Why Should We Take The Vaccine? Baptist Hospital Baptist Children s Hospital Doctors Hospital J. Milton Gaviria, MD, FACP October 17, 2014 Homestead Hospital Mariners Hospital Baptist Cardiac & Vascular Institute Disclosures I have no relevant commercial relationships to disclose. West Kendall Baptist Hospital Baptist Outpatient Services South Miami Hospital 2 OUTLINE INFLUNZA VIRUS Influenza Virus Epidemiology Vaccine Formulations Why To Take The Vaccine? Adverse Reactions Contraindications And Precautions Summary 3 4 INFLUENZA VIRUS INFLUENZA VIRUS 5 6 1

2 INFLUENZA VIRUS EPIDEMIOLOGY RNA Virus High mutation rate Antigenic drifts Localized outbreaks Antigenic shifts Associated with: Epidemics Pandemics 7 8 EPIDEMIOLOGY EPIDEMIOLOGY 9 10 EPIDEMIOLOGY

3 CHOICE OF VACCINE FORMULATION Influenza vaccine composition for season: (HA) derived from: A/California/2009 (H1N1) A/Texas/2012 (H3N2) B/Massachusetts/ 2012 B/Brisbane/2008 Standard-dose inactivated influenza vaccines Trivalent Quadrivalent Subvirion components Split product 15 mcg of HA 6m - >65y Standard-dose live-attenuated influenza vaccine Quadrivalent Intranasal For healthy nonpregnant adults up to 49 years of age 2y 49y High-dose inactivated influenza vaccine Trivalent 60 mcg of HA > 65 years of age Intradermal lowdose influenza vaccine Trivalent 3 mcg of HA For individuals age Uses an ultra-fine needle For needle phobic Inactivated influenza vaccine produced in cultured cells Trivalent Cultured mammalian cells > 18 years of age Use if egg allergy

4 Inactivated influenza vaccine using recombinant DNA technology Trivalent Recombinant hemagglutinin For individuals age Use if egg allergy 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, ; 369: Incidence of influenza among children is high Routine vaccination of children against influenza is recommended Limited studies on efficacy in children 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 Methods: Influenza confirmed by RT-PCR Mod-Severe disease Temp > 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

5 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

6 Effectiveness of Influenza Vaccine Against Life-Threatening RT-PCR- Confirmed Influenza Illness in US Children, Jill M. Ferdinands, MD; et al The Journal of Infectious Diseases September 1st, ; 210: Severe influenza: ICU admission or death 4%-24% children hospitalized with influenza go to ICU 50%-60% children have chronic medical conditions Methods: Enrolled children 6-17 years from 21 US pediatric ICUs Influenza seasons and 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 Results: 216 observations 44 influenza influenza 93 community At least 1 underlying chronic medical condition 55% cases 69% ICU controls None Partial Full School-Located Influenza Vaccination Decreases Laboratory-Confirmed Influenza and Improves School Attendance Pia S. Pannaraj, MD; et al Clinical Infectious Diseases August 1st, ; 59:

7 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 Methods: Los Angeles County 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 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 Influenza Vaccination Coverage PCR Confirmed Cases Findings: Vaccination resulted in about 60% effectiveness against influenza Vaccination of nearly 50% enrollees conferred 54% protection to unvaccinated Prevented transmission

8 Influenza Vaccination of Pregnant Women and Protection of Their Infants Shabir A. Madhi, MD, PhD; et al New England Journal of Medicine September 4th, ; 371: Pregnancy and Influenza: Higher risk for severe complications In 2009 H1N1 pandemic increased maternal and fetal death Vaccine coverage not great Methods: Two double-blind, randomized, placebocontrolled trials Soweto, South Africa HIV season HIV & 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 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%

9 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% 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, ; 371: Adults >65 years Highly vulnerable to influenza complications Account for most seasonal influenzarelated hospitalizations and death Methods: Phase IIIB-IV, multicenter, randomized, doubleblind, activecontrolled Participants: 65 years or older 126 centers USA and Canada 9/2011 thru 5/2013 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

10 ADVERSE REACTIONS 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 Immunogenicity: HAI antibody titers and seroprotection rates 28 days after vaccination were significantly higher for TIIV-HD ADVERSE REACTIONS 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 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 CONTRAINDICATONS AND PRECAUTIONS 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

11 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 SUMMARY High-priority populations in vaccine campaigns: High-risk individuals Close contacts of high-risk individuals Healthcare workers SUMMARY SUMMARY