Immunization Update 2016 Clinical Learning Day. Tamara Sheffield, MD, MPA, MPH

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1 Immunization Update 2016 Clinical Learning Day Tamara Sheffield, MD, MPA, MPH

2 Disclosure I do not have any relevant financial relationships with any commercial interests I am a Medical Director employed by Intermountain Healthcare

3 Highlighted Vaccines Provider Information Documents Influenza Pertussis Hib HPV Future Recs Zoster Candidate Questions

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5 Provider Information Documents So far, available for: 9vHPV Influenza PCV13 Rotavirus Tdap Go to each individual VIS form found at:

6 Which vaccine preventable disease causes the most deaths annually in U.S. children? 1. Polio 2. Measles 3. Pertussis 4. Meningococcal Meningitis 5. Influenza

7 Which vaccine preventable disease causes the most deaths annually in U.S. children? 1. Polio 2. Measles 3. Pertussis 4. Meningococcal Meningitis 5. Influenza

8 Influenza is a Leading Cause of Vaccine Preventable Deaths in US Children MKT /16

9 Data From the CDC Show That Influenza Deaths Affect All Pediatric Age Groups Reference: 1. Influenza-Associated Pediatric Mortality. Centers for Disease Control and Prevention (CDC) website. Assessed May 11, MKT /16

10 Influenza

11 Influenza Season Season Mild with peak in Feb/March 75% of cases were A 75% of those were H1N Season - Trivalent A/California/7/2009 (H1N1) pdm09-like A/Hong Kong/4801/2014 (H3N2)-like NEW B/Brisbane/60/2008-like (B/Victoria lineage) Season Quadrivalent B/Phuket/3073/2013 (B/Yamagata lineage)

12 How about Egg Allergy? ACIP Recs Remove egg allergy chart 30 minute wait down to 15 minute All products can be used including LAIV** Be able to recognize and treat severe allergic reactions (all allergy symptoms except hives)

13 2 Dose Recommendation for Same as Ages 6 months through 8 years: Give 2 doses one month apart unless child meets criteria for 1 dose Criteria for 1 dose: Previously received 2 doses of seasonal vaccine Doses do not need to have been received in the same season Doses do not need to have been received in consecutive seasons

14 Influenza Vaccines: Available Products Age Type Trade Name Manufacturer 6 mo + IIV4 Fluzone Sanofi 2-49 years LAIV FluMist ** AstraZeneca 3 years + IIV4 Fluarix GSK 3 years + IIV4 FluLaval GSK/ID Bio 18 years + cciiv4 Flucelvax Seqirus 18 years + RIV3 FluBlok Protein Science years IIV4 Fluzone Intradermal Sanofi 65 years + IIV3 Fluzone High-dose Sanofi **CDC has recommended against providing LAIV (FluMist ) for the season

15 FluMist (LAIV) ACIP and AAP s COID Interim Recommendation: LAIV should not be used for the season WHY? (The FDA continues to approve LAIV and has no statement limiting its use not an issue of safety or efficacy, but of clinical effectiveness)

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23 FluMist (LAIV) ACIP and AAP s COID Interim Recommendation: LAIV should not be used for the season WHY? If it isn t the genetic mutation on the stalk, Is it something about LAIV quadrivalent? Is it something about the U.S.? Is it something about H1N1pdm09? We don t know but DoD and AstraZenca seeing problem too

24 FluMist (LAIV) ACIP and AAP s COID Interim Recommendation: LAIV should not be used for the season Because of this recommendation: 1. Most insurance companies are not paying for LAIV 2. The VFC program is not providing LAIV

25 Newly Approved Influenza Vaccines FLUCELVAX QUADRIVALENT (cciiv4) May 2016 FLUAD TM (aiiv3) November 2015 For seniors ages 65+ Adjuvanted with MF-59 Waiting for effectiveness data Currently ordering Fluzone High-dose for seniors Future application is with FDA: FluLaval Quadrivalent TM (IIV4) Different age indication: 6-35 months Different dose: 0.5 ml (2 times Fluzone High-Dose)

26 Supply Concerns - Strategies Order multiple brands Order multiple preparations Central ordering through Supply Chain If you are worried talk to Supply Chain (they have solutions)

27 Pertussis

28 Questions We Hear about Pertussis Why are we seeing so much pertussis? Does vaccine immunity wane quickly? Yes Does Tdap vaccine immunity wane as fast as DTap vaccine immunity? Yes Was DTP a better vaccine than DTaP? Yes/No Are circulating strains mutating (e.g. pertactin deficient strains)? Yes How are we doing with DTaP and Tdap vaccination coverage? Not so good Is Tdap vaccine safe in pregnancy? Yes Should we be giving Tdap boosters? No

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35 Strategy to Combat Pertussis Cocooning not so effective (but still part of the plan) Probably not revaccination So Vaccinate pregnant mothers! ~90% effective in protecting infants <2 months of age, UK Get a better vaccine! Loooong term strategy

36 Hib

37 HIBERIX (GSK) Haemophlius b Conjugate Vaccine (Tetanus Toxoid Conjugate) PRP-T Licensed by FDA in Jan.2016 to use for all doses of the Hib series, not just the booster dose HIBERIX and ActHib both require 4 doses for complete series at 2, 4, 6, and months Only PedvaxHIB (PRP-OMP) requires 3 doses at 2, 4 and months

38 HPV

39 9vHPV Recommendation Routine HPV vaccination of 3 doses starting at 11 or 12 years, as early as 9 years with: Females up to 26 years Males up to 21 years recommended, years permissive for high risk (approved by FDA up to 26 years)

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41 FUTURE: ACIP Considering HPV 2-dose Series Effectiveness of 2-dose schedule may be impacted by dose interval and by recipient age Most studies have (M0,1) or (M0,2) interval and 3-dose is more effective 2016 India study of (M0,6) shows comparable protection to 3-dose schedule Persistence 2- dose vaccination is predicted to reduce HPV-burden of disease substantially and is cost saving if 2-dose protection >20 years

42 FUTURE: ACIP Considering HPV 2-dose Series Draft proposed recommendation: For persons initiating vaccination before their 15 th birthday, recommend 2 doses of HPV. The second dose should be administered 6 to 12 months after the first dose If after 15 th birthday, continue to recommend 3- dose (0, 1-2, and 6 month) schedule Series can have been started with 9vHPV, 4vHPV or 2vHPV

43 Zoster Candidate

44 Adjuvanted Zoster Submitted to FDA for approval, then will need recommendation by ACIP Timing 2017? Disadvantages: 2-dose, separated by 2 months, more reactogenic (local reaction) Advantages: Improved efficacy and persistence of protection

45 Adapted from Healy et al. Vaccine. 2014;32:

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50 Questions

51 Contact Information Tamara Sheffield, MD, MPA, MPH Medical Director, Community Health and Prevention Intermountain Healthcare 36 S. State Street, 21 st Floor Salt Lake City, UT 8411 (801)

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