2015 Influenza Update Get Immunized! Presented by Dr. Sheam Bakri, MPH, PharmD and Dr. Paul Mulhausen, MD Moderator: Karen Boland, RN, CIC Objectives • Describe Advisory Committee on Immunization Practices (ACIP), 2015-2016 Recommendations • Discuss types of vaccines available for 2015-2016 • Discuss influenza vaccination rates • Discuss myths about influenza • Present action steps to improve influenza immunization 2 Medication Safety Dr. Sheam Bakri, MPH, PharmD Clinical Pharmacy Specialist Telligen QIN-QIO Email: sheam.bakri@area-d.hcqis.org Phone: 630-928-5849 3 ACIP Recommendations for 2015-2016 Influenza Season • Advisory Committee on Immunization Practices (ACIP) Recommendations*: – All persons aged ≥6 months should receive influenza vaccine annually Either Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccine(IIV) – Children 2 to 8 yrs. may receive either LAIV or IIV – If child (ages 2 to 6) has not received vaccine in past, then give 2 doses (each dose ≥ 4 weeks apart) 8 years is the upper age limit for receipt of 2 doses of influenza vaccine in a previously unvaccinated child *For 4 complete recommendations visit: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6430a3.htm ACIP Recommendations for 2015-2016 Influenza Season • LAIV should not be used in the following populations: – Persons aged <2 years or >49 years – Persons with contraindications listed in the package insert: Children aged 2 through 17 years who are receiving aspirin or aspirin-containing products; Persons who have experienced severe allergic reactions to the vaccine or any of its components, or to a previous dose of any influenza vaccine – Pregnant women – Immunocompromised persons – Persons with a history of egg allergy 5 http://www.cdc.gov/media/releases/2015/s0226-acip.html ACIP Recommendations for 2015-2016 Influenza Season • LAIV continued: – Children aged 2 through 4 years who have asthma history of wheezing in the past 12 months – Persons who have taken influenza antiviral medications within the previous 48 hours – Other underlying medical conditions that might predispose them to complications after wild-type influenza infection – Persons who care for severely immunosuppressed persons who require a protective environment Should avoid contact with such persons for 7 days after receipt http://www.cdc.gov/media/releases/2015/s0226-acip.html 6 Vaccines for 2015- 2016 Influenza Season • • • • • Trivalent vs. Quadrivalent Live vs. Inactivated Egg-based influenza vaccines Cell-based influenza vaccines Recombinant influenza vaccines http://www.cdc.gov/flu/protect/whoshouldvax.htm 7 Vaccines for 2015-2016 Influenza Season • Trivalent vaccines cover: – an A/California/7/2009 (H1N1)pdm09-like virus – an A/Switzerland/9715293/2013 (H3N2)-like virus – a B/Phuket/3073/2013-like virus • Quadrivalent vaccines cover: – – – – an A/California/7/2009 (H1N1)pdm09-like virus an A/Switzerland/9715293/2013 (H3N2)-like virus a B/Phuket/3073/2013-like virus B/Brisbane/60/2008-like virus http://www.cdc.gov/flu/protect/whoshouldvax.htm 8 Inactivated Influenza Vaccine, Trivalent (IIV3) Standard Dose Trade Name 9 Presentation Age Indications Route Afluria® 0.5mL single-dose prefilled syringe, 5.0mL multidose vial ≥9 yrs. IM Fluvirin® 0.5mL single-dose prefilled syringe, 5.0mL multidose vial ≥4 yrs. IM Fluzone® 5.0mL multidose vial ≥6 mos. IM Fluzone HighDose® 0.5mL single-dose prefilled syringe ≥ 65 yrs. IM Inactivated Influenza Vaccine, Quadrivalent (IIV4) Standard Dose Trade Name Presentation Age indications Route Fluarix® Quadrivalent 0.5 mL single dose prefilled syringe ≥ 3 yrs. IM FluLaval® Quadrivalent 5.0mL multidose vial ≥ 3 yrs. IM Fluzone® Quadrivalent 0.25mL single-dose prefilled syringe 6-35 mos. IM 0.5mL single-dose prefilled syringe ≥ 36 mos. IM 0.5 mL single-dose vial ≥ 36 mos. IM 5.0mL multidose vial ≥ 6 mos. IM 0.1 mL single-dose prefilled microinjection system 18 through 64 yrs. ID Fluzone ® Intradermal 10 Quadrivalent Vaccines for 2015-2016 Influenza Season Age specific vaccine information: – Younger than 65 years of age should not receive the high-dose Fluzone® – Younger than 18 years old or older than 64 yrs. not receive the intradermal Fluzone® Quadrivalent •AFLURIA® – Indicated for ≥5 years on package insert ACIP recommends not to be used in children aged 6 months through 8 years due to increased risk of febrile reaction – Available for 18 – 64 yrs. via jet injector – Contains thimerosal 11 Inactivated Influenza Vaccine, Trivalent (IIV3) and Quadrivalent (IIV4) Contraindications: • • • Not recommended for children younger than 6 months People with severe, life-threatening allergies to flu vaccine or any ingredient in the vaccine – Egg protein/ allergy, gelatin, antibiotics, or other ingredients found in vaccine After previous dose of any influenza vaccine Precautions: • • With moderate to severe illness with/without fever History Guillain-Barre syndrome within 6 weeks of influenza vaccine http://www.cdc.gov/flu/about/season/index.htm 12 Inactivated Influenza Vaccine, Trivalent, Cell Culture-Based (ccIIV3) Trade Name Flucelvax® Presentation 0.5mL singledose prefilled syringe Age Indication ≥ 18yrs. http://www.cdc.gov/flu/about/season/index.htm 13 Route IM Inactivated Influenza Vaccine, Trivalent, Cell Culture-Based (ccIIV3) “Cell-based” refers to how the flu vaccine is made • Cell-based flu vaccines are developed through a different manufacturing process – viruses cultured cells of mammalian origin instead of in hens’ eggs • Cell-based flu vaccines are being developed as an alternative to the egg-based manufacturing process • Potentially more flexible than the traditional technology, which relies upon adequate supply of eggs • http://www.cdc.gov/flu/about/season/index.htm 14 Inactivated Influenza Vaccine, Trivalent, Cell Culture-Based (ccIIV3) • A major advantage of cell culture technology includes the potential for a faster start-up of the vaccine manufacturing process in the event of a pandemic. – cells kept frozen and “banked” – assures an adequate supply of cells is readily available for vaccine production – growing the influenza viruses in cell culture for the manufacture of Flucelvax is not dependent on an egg supply • Clinical studies demonstrate that Flucelvax is safe and effective for use in individuals 18 years of age and older • Typical side effects – Pain, redness and soreness at the injection site and headache and fatigue were the most common reactions 15 http://www.cdc.gov/flu/about/season/index.htm Live Attenuated Influenza Vaccine, Quadrivalent (LAIV4) Trade Name FluMist® Quadrivalent Presentation 0.2mL singledose prefilled intranasal Age Indications 2-49 yrs. http://www.cdc.gov/flu/about/season/index.htm 16 Route IN FluMist® Quadrivalent Vaccine • Not recommended for: – Children younger than 2 years – Adults 50 years and older – People with a history of severe allergic reaction to any component of the vaccine or to a previous dose of any influenza vaccine – Those with egg allergies http://www.cdc.gov/flu/about/season/index.htm 17 FluMist® Quadrivalent Vaccine • Not recommended for: – Children or adolescents (2 years through 17 years of age) on long-term aspirin treatment. – Pregnant women – People with weakened immune systems (immunosuppression) – Children 2 years through 4 years who have asthma or who have had a history of wheezing in the past 12 months. – People who have taken antiviral medications within the previous 48 hours. – People who care for severely immunocompromised persons who require a protective environment (or otherwise avoid contact with those persons for 7 days after getting the nasal spray vaccine). http://www.cdc.gov/flu/about/season/index.htm 18 Recombinant Influenza Vaccine, Trivalent (RIV3) Trade Name Presentation FluBlok® 0.5mL singledose vial Age Indications ≥18 yrs. Route IM • Recombinant-based = “egg-free” • approved for use in the U.S. market in 2013 and that involves using recombinant technology • production method does not require an egg-grown vaccine virus and does not use chicken eggs at all in the production process • manufacturers isolate a certain protein from a naturally occurring “wild type" recommended vaccine virus http://www.cdc.gov/flu/about/season/index.htm 19 Recombinant Influenza Vaccine, Trivalent (RIV3) • Proteins are then combined with portions of another virus that grows well in insect cells • This “recombinant” vaccine virus is then mixed with insect cells and allowed to replicate • Flu protein is harvested from cells and purified • Recombinant flu vaccine is the only 100% egg-free vaccine on the U.S. market http://www.cdc.gov/flu/about/season/index.htm 20 Recombinant Influenza Vaccine, Trivalent (RIV3) • Process can produce vaccine in the shortest amount of time – not dependent on an egg supply or limited by the selection of vaccine viruses that are adapted for growth in eggs • Precaution with moderate to severe illness with/without fever – History Guillain-Barre syndrome within 6 weeks of influenza vaccine http://www.cdc.gov/flu/about/season/index.htm 21 Thank You! 22 Telligen QIN-QIO Chief Medical Officer Paul Mulhausen Chief Medical Officer, Telligen QIN-QIO Email: pmulhausen@telligen.com or Paul.mulhausen@hcqis.org Phone: 515-440-8504 23 Influenza (“The Flu”) • Influenza is the most frequent cause of death from a vaccine-preventable illness in the United States. • Influenza is highly contagious and attacks the body’s airways. • Incubation is from 1-4 days after exposure. • Signs and Symptoms include Fever Nasal congestion Headache Runny Nose Dry cough Muscle aches Sore throat 24 http://www.cdc.gov Influenza (“The Flu”) • Each year, 5% - 20% of the U.S. population develops influenza – 200,000 hospitalizations – 36,000 influenza-associated pulmonary and cardiac deaths each year • In outbreaks, as many as 10% to 40% of people are attacked by the virus 25 http://www.cdc.gov Influenza is spread by air droplets and hands. • The influenza virus is spread from person to person! • The viruses are spread mainly by large-particle respiratory droplets: cough, sneeze, or talk. • People infected with influenza start being contagious one day prior to showing signs or symptoms. 26 http://blogs.cdc.gov/niosh-science-blog/2013/01/15/catchingtheflu/ Preventing the Flu! • Vaccination remains the single best way to prevent the flu! – Reduce flu illnesses, – Reduce doctors' visits, – prevent flu-related hospitalizations and deaths. • Vaccination reduces the need to use antibiotics and over-thecounter medications http://www.cdc.gov 27 The Circulating Viruses that Cause Influenza often change from year-to-year 2012-2013 2013-2014 2014-2015 2009 H1N1 A(H3) A(Subtyping not done) B H3N2v 28 FluView - http://gis.cdc.gov/grasp/fluview/fluportaldashboard.html The Flu vaccine is excellent, but not perfect The 2014-2015 Influenza Season Mismatch on the Influenza A (H3N2) 2014-2015 Influenza Vaccine • • • • 12/31/2014 29 A/Texas/50/2012 (H3N2) A/California/7/2009 (H1N1) B/Massachusetts/2/2012 B/Brisbane/60/2008-like 2014-2015 Vaccine worked against well-matched circulating viruses • • • • • 2014-2015 Vaccine Effectiveness (Overall): 2014-2015 Vaccine Effectiveness (Influenza B Y): 2014-2015 Vaccine Effectiveness (Influenza B V): 2014-2015 Vaccine Effectiveness (matched H3N2): 2014-2105 Vaccine Effectiveness (mismatched H3N2): 23% 55% 63% 43% 9% June 2015 ACIP Meeting-Novel Influenza and Flu https://www.youtube.com/watch?v=iYwm6qId4-k 30 More of Us Can Get the Influenza Vaccination! Vaccination Rates Flu Seasons: 2013-2014; 2014-15 FluVax View http://www.cdc.gov/flu/fluvaxview/nifs-estimates-nov2014.htm 31 Why don’t our patients get the influenza vaccination? • Underestimate the Impact of Influenza: “It’s just the flu, what’s the big deal?” • Underestimate the prevention power of the vaccination: “last year, the flu shot didn’t even work!” • Expense: “I can’t afford it!” • Underestimate need for annual vaccination: “I got the shot last year.” • Concern about the risks of the vaccination: “My friend took the flu shot and it gave her the flu. Plus it has mercury in it.” “Vaccines are dangerous!” • Concern about discomfort: “I hate shots.” • “I didn’t know I needed it. My doctor didn’t say anything.” 32 Influenza Vaccination Myth Busters! • Flu vaccine gives you the flu – Busted! • CDC mandates that everyone has to get a flu shot. It’s the law – Busted! • You don’t need to get the flu vaccine every year – Busted! • Pregnant women should not get the annual flu vaccine – Busted! • Children should not get the flu vaccine each year – Busted! • It’s better to get the flu than to get the flu vaccine – Busted! • http://www.cdc.gov/flu/about/qa/misconceptions.htm#misconception 33 What can you do in your care setting to break down barriers to influenza vaccination • Provide a strong, intentional message recommending the vaccination. • Build systematic reminders into clinic workflow • Standing orders for vaccination of all eligible patients. • Message the safety of the vaccine while empathically recognizing the concerns raised by patients • Message the potential to protect loved ones by blocking transmission • Ask about barriers and take time to address knowledge gaps. 34 Examples from the field of Telligen partners • "I can respect that decision [to not get the Flu Shot] for you yourself, but please consider how it is a very responsible thing to do for those around you; for instance, you can actually carry the flu, and without even knowing it, spread it to someone else--and some others can get hit very hard with it [yes, I do even share that "tens of thousands die of the flu every year," but I know that number has been put into question!].” 35 More examples from the Field of Telligen partners • “In my experience the more convenient it is for a patient to receive vaccine the more likely they will get it. We have used drive thru vaccination clinics, walkin vaccination clinics. Sending reminders and calling to bring people in helps. “ • Allow the nurse to advocate and provide vaccine • Standing orders so nurses can administer the vaccine without a doctor order. 36 Another example from the field of Telligen partners • “Once patients start to get the vaccine they will get it in subsequent years because they note how healthy they remain during the winter. The problem is how to make a person a ‘believer’ initially. Testimonials from peers helps.” 37 Clean Hands Save Lives! • Hand-washing prevents illness and the spread of germs to others. • Live Influenza virus can transfer from nonporous surfaces to hands for 24 h and from tissues to hands for 15 min. • Hand-washing reduces the total rate of respiratory illnesses • Hand sanitation using 95% ethanol, kills influenza viruses on the hands. Clinical Infectious Diseases 2003; 37:1094–1101 38 http://www.cdc.gov Knowledge Sharing • Everyone 6 months of age and older should be vaccinated if they have no contraindications (if contraindicated speak with healthcare provider about alternatives) • Get vaccinated as soon as vaccine available • It is possible to get a respiratory virus other than flu during flu season- similar symptoms • Influenza virus spread through droplets • Influenza virus can survive on surfaces between 2 and 8 hours • Persons can be contagious 1 day before symptoms appear and up to 7 days after 39 What can we all do? • Get influenza vaccine as soon as possible • Avoid contact with sick people, limit your contact with others when you are sick • Wash your hands frequently • Cover your nose and mouth with a tissue when you cough or sneeze, then immediately wash your hands • Be aware of touching your eyes, nose or mouth, avoid spreading germs • Clean commonly touched or exposed surfaces often(workspaces, door knobs, faucets, handles, etc.) • Use alcohol based hand rubs 40 Q&A Questions/Comments for presenters? 41 Summary • Getting the influenza vaccine decreases likelihood of getting the flu and, although not perfect, offers the best opportunity for protection against influenza. • There are a number of reasons that people choose not to receive the seasonal influenza vaccination. A variety of strategies can be used to successfully overcome the barriers and optimize use of the influenza vaccine to fight influenza. 42 THANK YOU! For additional information please visit: http://www.cdc.gov/flu/about/season/flu-season-20152016.htm 43 This material was prepared by Telligen, the Medicare Quality Improvement Organization for Colorado, under contract with the Centers for Medicare & Medicaid Services (CMS), an agency of the U.S. Department of Health and Human Services. The contents presented do not necessarily reflect CMS policy. 11SOW-ILQIN-8/2015-11174