Immunization Update Tamara Sheffield, MD, MPA, MPH

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1 Immunization Update 2015 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 Influenza HPV 9-valent and provider messaging Meningococcal B for high-risk PCV13 for adults

4 Influenza

5 Influenza Season Season Moderately severe season with peak in late December 75% of cases were A-H3N2 99% of Type A were H3N Season - Trivalent A/California/7/(H1N1) pdm09 A/Switzerland/ /2013 (H3N2) NEW (only 24% were matched last season) B/Phuket3073/2013 NEW (B/Yamagata lineage) Season Quadrivalent B/Brisbane/60/2008-like (B/Victoria lineage)

6 Influenza Vaccines: Available Products Everyone over age 6 months for IIV3 (Fluzone ) or IIV4 (Fluzone ) Ages 2-49 years, healthy, non-pregnant for LAIV4 (FluMist ) Ages 3 years and above, IIV4 (Fluarix ) or IIV4 (FluLaval ) Ages 18 and above, cciiv3 (Flucelvax ) Ages years, RIV3 (FluBlok ) Ages years for IIV4 Intradermal (Fluzone ) Ages 65+ years for IIV3 High-dose (Fluzone ) CDC has made no preferences preference for LAIV in children was rescinded

7 Egg Allergic Recombinant DNA Vaccine FluBlok (Protein Sciences Corp) Insect virus (baculovirus) expression vector system and recombinant DNA technology produces hemagglutinin Trivalent inactivated for year olds, 45 micrograms each HA, single dose vial No eggs and no flu virus used, no antibiotics or latex Another advantage is speed of production (gene to production in 21 days) Immunogenic and safe failed to meet criteria in some studies of B type Efficacy against all circulating strains even those not in the vaccine data not shown Short shelf life 16 weeks

8 Influenza Vaccines: ACIP Recommendations February 2015 LAIV preference removed for children ages 2 through 8 years 2 dose recommendation will come out in June

9 LAIV in Children Ages 2-8 years CDC conducted a review of studies comparing efficacy of LAIV compared to IIV in preventing various endpoints that led them to make a preferential recommendation for LAIV in the season

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12 Vaccine Efficacy - LAIV in Children US LAIV3 superior to IIV3 for H1N1pdm09 ( ) US LAIV3 inferior to IIV3 for H1N1pdm09 ( ) US LAIV4 inferior to IIV for H1N1pdm09 ( ) Canada LAIV3 superior to IIV3 for H1N1pdm09 ( ) US LAIV4 superior to IIV for Type B ( ) WHY?

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14 The Rest of the Story Season US LAIV4 inferior to IIV4 for H3N2 ( ) IIV = 33% effective for A/H3N2 LAIV = 16% effective for A/H3N2

15 LAIV in Children Ages 2-8 years Recommendation Either IIV or LAIV is appropriate for healthy children ages 2-8 years who have no contraindications or precautions Do not delay giving vaccine in order to get the right type of vaccine give what you have when the patient is there Contraindications to LAIV Children receiving aspirin containing products History of severe allergic reaction to vaccine or its components Also: immunosuppressed, egg allergy, wheezing, pregnant (not in package insert)

16 HPV Vaccine

17 9-Valent HPV Vaccine (9vHPV) Protocol 001: Conclusions (female ages years) Efficacy HPV types 6, 11, 16, 18: Non-inferior immune response HPV types 31, 33, 45, 52, 58: ~97% reduction in CIN2, VIN2/3, VaIN2/3 disease compared to 4vHPV Safety Generally well tolerated in >15,000 recipients Adverse experiences profile generally comparable between 9vHPV vaccine and 4vHPV vaccine Higher frequency of injection-site AEs with 9vHPV vaccine Most were of mild or moderate intensity Immunobridging study 002: (non-inferior in ages 9-15 years)

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19 9vHPV Benefits 9vHPV vaccine provides an additional 14% reduction in cases of HPV related cervical cancer in females compared to 4vHPV vaccine Although the majority of benefits of 9vHPV is in females, the vaccine is Cost Saving compared to 4vHPV in three models, even in males Cost per QALY< $0 in most scenarios, and at least <$25,000 in all sensitivity analyses

20 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 (off label, FDA up to 15 years)

21 Adolescent Vaccination Coverage United States, MMWR 2014; 63(29);

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23 Clinicians Underestimate the Value Parents Place on HPV Vaccine Adapted from Healy et al. Vaccine. 2014;32:

24 HPV CDC Reasons for Lower Rates Parent does not hear a recommendation by provider Focus on cancer prevention and provide clear recommendation you think it is important Differentiation our messaging Research about the approach we take indicates we should recommend HPV the same way we recommend any other vaccine DON T DIFFERENTIATE Welcome and answer questions, but do not give more information that the parents have asked for - Anne Schuchat, MD, CDC

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27 Messages for parents - HPV 1. Almost everyone gets HPV and HPV can cause a variety of cancers in women and men 2. HPV vaccine is for cancer prevention 3. Provide a strong recommendation for HPV vaccine when patients are 11 or 12 years old 4. Listen carefully to and welcome patient and parent questions, especially about safety

28 Meningococcal B for High-risk

29 MenB Vaccine Recommendation Bexero (2 doses 0 and 1-6 months) or Trumenba (3 doses 0, 2, 6 months) ages 10 and above (off-label; FDA approved for ages years) For those at increased-risk: Complement component deficiency (80,000:6 cases since 2005, none MenB) Asplenia, including sickle cell (100,000:11 cases since 1995, 2 MenB) Microbiologists (100,000:22 cases since 1985 in world, at least 10 MenB) Outbreaks (60,000 in 5 university outbreaks:32 cases since 2009)

30 Special Populations not Included in MenB Recommendation College students (Consider in June 2015 meeting) Travelers (Risk primarily due to other serogroups) Military recruits (DOD says they will not vaccinate)

31 PCV13 for Adults

32 Pneumococcal Vaccine Rule When possible Give PCV13 BEFORE PPSV23 When given first,pvc13 enhances immune response of PPSV23 PPSV23 has the potential to dampen the immune response of PCV13 if given first

33 Spacing of Doses High-risk Children If no previous pneumococcal vaccine One dose PCV13, then PPSV23 at least 8 weeks later (revaccinate with PPSV23 at least 5 years later if indicated) If previous PPSV23 Wait at least 8 weeks after PPSV23 to give one dose of PCV13 Recommended for immunocompromised, asplenia, CSF leak, cochlear implant

34 PCV13 for Seniors New ACIP Recommendation, Aug 2014 If never received a pneumococcal vaccine At age 65 years, give one dose PCV 13 FIRST followed by a dose of PPSV23, one year after PCV13 If received PPSV23 after age 65 yrs (and no PCV13) Give one dose of PCV13 at least one year after PPSV23 If received PPSV23 before age 65 yrs (and no PCV13) Give one dose of PCV13 at age 65, and at least one year after last PPSV23, and give one dose of PPSV23 at least one year after PCV13 and at least 5 years since last PPSV23

35 Your Questions

36 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)