2015 Influenza Update Get Immunized! Presented by Dr. Sheam Bakri, MPH, PharmD and Dr. Paul Mulhausen, MD Moderator: Karen Boland, RN, CIC

2 Objectives Describe Advisory Committee on Immunization Practices (ACIP), Recommendations Discuss types of vaccines available for Discuss influenza vaccination rates Discuss myths about influenza Present action steps to improve influenza immunization

3 Medication Safety Dr. Sheam Bakri, MPH, PharmD Clinical Pharmacy Specialist Telligen QIN-QIO Phone:

4 ACIP Recommendations for 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 complete recommendations visit:

5 ACIP Recommendations for Influenza Season LAIV should not be used in the following populations: –Persons aged 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

6 ACIP Recommendations for 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

7 Vaccines for Influenza Season Trivalent vs. Quadrivalent Live vs. Inactivated Egg-based influenza vaccines Cell-based influenza vaccines Recombinant influenza vaccines

8 Vaccines for Influenza Season Trivalent vaccines cover: –an A/California/7/2009 (H1N1)pdm09-like virus –an A/Switzerland/ /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/ /2013 (H3N2)-like virus –a B/Phuket/3073/2013-like virus –B/Brisbane/60/2008-like virus

9 Inactivated Influenza Vaccine, Trivalent (IIV 3 ) Standard Dose Trade NamePresentationAge 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 High- Dose® 0.5mL single-dose prefilled syringe ≥ 65 yrs.IM

10 Inactivated Influenza Vaccine, Quadrivalent (IIV 4 ) Standard Dose Trade NamePresentationAge indicationsRoute 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 0.5mL single-dose prefilled syringe 0.5 mL single-dose vial 5.0mL multidose vial 6-35 mos. ≥ 36 mos. ≥ 6 mos. IM Fluzone ® Intradermal Quadrivalent 0.1 mL single-dose prefilled microinjection system 18 through 64 yrs.ID

11 Vaccines for 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

12 Inactivated Influenza Vaccine, Trivalent (IIV 3 ) and Quadrivalent (IIV 4 ) 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

13 Inactivated Influenza Vaccine, Trivalent, Cell Culture-Based (ccIIV 3 ) Trade NamePresentationAge IndicationRoute Flucelvax®0.5mL single- dose prefilled syringe ≥ 18yrs.IM

14 Inactivated Influenza Vaccine, Trivalent, Cell Culture-Based (ccIIV 3 ) “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

15 Inactivated Influenza Vaccine, Trivalent, Cell Culture-Based (ccIIV 3 ) 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

16 Live Attenuated Influenza Vaccine, Quadrivalent (LAIV 4 ) Trade NamePresentationAge IndicationsRoute FluMist® Quadrivalent 0.2mL single- dose prefilled intranasal 2-49 yrs.IN

17 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

18 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).

19 Recombinant Influenza Vaccine, Trivalent (RIV 3 ) 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 Trade NamePresentationAge Indications Route FluBlok®0.5mL single- dose vial ≥18 yrs.IM

20 Recombinant Influenza Vaccine, Trivalent (RIV 3 ) 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

21 Recombinant Influenza Vaccine, Trivalent (RIV 3 ) 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

22 Thank You!

23 Telligen QIN-QIO Chief Medical Officer Paul Mulhausen Chief Medical Officer, Telligen QIN-QIO or Phone:

24 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

25 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

26 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.

27 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-the- counter medications

28 The Circulating Viruses that Cause Influenza often change from year-to-year H1N1 A(H3) A(Subtyping not done) B H3N2v FluView -

29 The Flu vaccine is excellent, but not perfect The Influenza Season A/Texas/50/2012 (H3N2) A/California/7/2009 (H1N1) B/Massachusetts/2/2012 B/Brisbane/60/2008-like Influenza Vaccine Mismatch on the Influenza A (H3N2) 12/31/2014

Vaccine worked against well-matched circulating viruses Vaccine Effectiveness (Overall):23% Vaccine Effectiveness (Influenza B Y):55% Vaccine Effectiveness (Influenza B V):63% Vaccine Effectiveness (matched H3N2):43% Vaccine Effectiveness (mismatched H3N2): 9% June 2015 ACIP Meeting-Novel Influenza and Flu -

31 More of Us Can Get the Influenza Vaccination! FluVax View Vaccination Rates Flu Seasons: ;

32 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.”

33 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!

34 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.

35 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!].”

36 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, walk- in 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.

37 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.”

38 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

39 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

40 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

41 Questions/Comments for presenters? Q & A

42 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.

43 THANK YOU! For additional information please visit: htm 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-IL- QIN-8/