Immunization Update 2017

Transcription

1 Immunization Update 2017 Tamara Sheffield, MD, MPA, MPH November 10, 2017

2 DISCLOSURE: I have no conflicts of interest to disclose I will be discussing off label use I will be discussing an unlicensed vaccine

3 LEARNING OBJECTIVES: PHARMACIST At the conclusion of this activity, pharmacists should be able to successfully: Employ the latest ACIP Immunization Recommendations when delivering services to their clients Describe common errors in vaccine delivery and implement strategies to avoid these errors Locate tools developed to assist Intermountain vaccine providers in administering vaccines in a clinically appropriate manner

4 Impact of Vaccines Hepatitis B Hep B infections have decreased by 90.6% in US since vaccination initiated in 1982 Locally contracted mainly due to injection drug use 95% of new cases are imported Current focus on diabetics age years (only 25% completion of series) they are coming to your pharmacies for their meds and insulin Schille S, Presentation at ACIP Oct 19, 2016

5 Impact of Vaccines Community Immunity Successes Pneumococcal PCV7 Vaccinating children protects adults comparing with Overall 168,000 fewer hospitalizations all ages 555/100,000 fewer for children 360/100,000 fewer for ages /100,000 fewer for ages 85+ Pneumococcal PCV13 (approved 2010) Invasive pneumococcal disease (IPD) rates 33-62% lower in post vaccination period than in pre-pcv13 child vaccine years ( ) in all age groups Rates in seniors have been stable even after introduction of PCV13 in that age group Griffin MR, NEJM 2013;369: (accessed 10/11/17)

6 H= Herd Immunity Threshold

7 IMMUNIZATION RATES Vaccine Pneumococcal Tetanus (any) Tdap Hepatitis B (3 doses) Group 2013 data (%) 2014 data (%) 2015 data (%) % diff from 2014 HR, age Age Age Age Age y/o, total y/o y/o, DM y/o, liver disease Herpes Zoster 60 y/o DM: Diabetes Mellitus; HR: high risk; y/o: years old Slide courtesy of Kathy Povilus, Pharm D, BCACP - modified MMWR Surveillance Summaries/ February 5, 2016 /Vol. 65 / No. 16. MMWR/ February 6, 2015 / Vol. 64 / No. 4, MMWR Surveillance Summaries/ May 5, 2017 / Vol. 66/ No 11, 1 28.

8 Highlighted Topics Influenza Vaccine Errors 2-Dose HPV Meningococcal Future Recs Zoster Yellow fever vaccine access Intermountain protocols and resources

9 INFLUENZA

10 Influenza Season Chart presented at June 2017 ACIP Meeting Season A:H3N2 predominant Had the typical second wave of Type B Vaccine well matched to all 4 strains Season - Trivalent A/Michigan/45/2015 (H1N1) pdm09-like NEW (used in 2017 Southern hemisphere) A/Hong Kong/4801/2014 (H3N2)-like B/Brisbane/60/2008-like (B/Victoria lineage) Season Quadrivalent B/Phuket/3073/2013 (B/Yamagata lineage)

11 You have a 75 year old client wishing to receive an influenza vaccine from you. Which vaccine will potentially provide the greatest protection against contracting influenza? 1. Trivalent High-dose 2. Quadrivalent regular dose

12 You have a 75 year old client wishing to receive an influenza vaccine from you. Which vaccine will potentially provide the greatest protection against contracting influenza? 1. Trivalent High-dose 2. Quadrivalent regular dose

13 Study of high-dose efficacy & Estimation of IIV4 v. IIV3 IIV3-HD compared to IIV3-SD Age 65 years and older Lab confirmed influenza of any subtype 24.2% relative efficacy NEJM 2014; 371: Quadrivalent Vaccine Adds 1 more B type than IIV3 Type B (0-40% - most years 20-25% of circulating virus) Each year 30/70 split of TypeBs circulating Then multiply by vaccine efficacy (40-60%)

14 You have a 75 year old client wishing to receive an influenza vaccine from you. Which vaccine will potentially provide the greatest protection against contracting influenza? 1. Trivalent high-dose 2. Trivalent adjuvanted 3. Quadrivalent Recombinant

15 You have a 75 year old client wishing to receive an influenza vaccine from you. Which vaccine will potentially provide the greatest protection against contracting influenza? 1. Trivalent high-dose 2. Trivalent adjuvanted Don t know 3. Quadrivalent Recombinant Interesting new study

16 Study of Recombinant Influenza Vaccine (RIV4) RIV4-HD compared to IIV4 (standard dose) Age 50 years and older PCR lab-confirmed influenza of any subtype during a mismatch season RIV4 attack rate = 2.2% IIV attack rate = 3.2% 30% lower probability of influenza like illness with RIV4 than with IIV4 Sanofi has purchased Protein Sciences maker of RIV (Flublok) NEJM 2017; 376:

17 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) **CDC has recommended against providing LAIV (FluMist ) for the season MMWR; August 26, 2016;65(5);1-54

18 Age Type Trade Name Manufacturer Influenza Vaccines Available Products 6 mo + IIV4 Fluzone Sanofi 6 mo + IIV4 FluLaval GSK/ID BIo 2-49 years LAIV FluMist ** AstraZeneca 3 years + IIV4 Fluarix GSK 4 years + cciiv4 Flucelvax Seqirus **CDC has recommended against providing LAIV (FluMist ) for the season MMWR; August 26, 2016;65(5);1-54 Updated for unpublished 5 years + IIV3 Afluria Seqirus 5 years + IIV4 Afluria Seqirus 18 years + RIV4 FluBlok Protein Science years IIV4 Fluzone Intradermal 65 years + IIV3 Fluzone Highdose Sanofi Sanofi

19 FluLaval for Infants Approved by FDA FluLaval Quadrivalent TM (IIV4) New age indication, 6 through 35 months Different dose than pediatric Fluzone FluLaval = 0.5 ml Fluzone = 0.25 ml 2017 CPT code determined by dose, not age mL syringe (all ages) mL MVD (all ages) ml syringe (6-35 mo) ml MVD (6-35 mo) FluLaval Package Insert

20 Afluria QIV Approved by FDA as safe and effective Indicated for age 5+ years (as of 8/31/17) Studies on going for age 6 months to 5 years Concerns about fevers and febrile seizures in young children in the TIV formulation (Australia) Resolved fever concern with change in manufacturing process Increased use of TDOC (deoxycholate) splitting agent in both QIV and TIV Reduce lipids connected to mrna fragments Lipids = fevers Grohskopf presentation, ACIP June 2017 Afluria TIV also approved by ACIP down to 5 years Previously ACIP limited it to ages 9 years + because of fevers FDA approval has always been 5 years +

21 FluMist (LAIV) Concerns of Efficacy Heat stability HA activation ph Replicability Grohskopf presentation, ACIP June 2016

22 Documents to assist vaccine providers Influenza Immunization Plan Plan Summary (1pg. 2 side) Table of start and stop times

23 National Vaccine Administration Errors

24 Vaccine Errors Wrong dose or vaccine for age Influenza (0.25mL/0.5mL) DTaP/Tdap Hep A adult and ped Kinrix/ProQuad Wrong interval between doses Wrong diluent Temperature excursions Keeping up with guidelines: New ACIP recommendations 3X per year Storage: Multiple products, diluent not with vaccine, labels, Similar names and colors

25 Vaccine Errors Strategies to avoid errors One dose for Influenza vaccine (0.5mL) Use single dose syringes rather than multi-dose vials Scan vaccine bar code prior to administering icentra prompts Refer to USIIS forecast before administering Registry Import button Keep diluent connected to vaccine icentra removed General influenza choice when ordering

26 9vHPV 2-Dose Original 3-dose recommendation Originally recommended as 3-dose series Any product (2valent, 4valent, 9valent) Interval = 0, 2 months, 6 months For the prevention of cervical, vulvar, vaginal, and anal cancers, precancerous or dysplastic lesions (HPV Types 16, 18, 31, 33, 45, 52, 58) and genital warts (HPV Types 6, 11) MMWR, August 29, 2014, Vo1 63, #RR05

27 9vHPV 2-Dose New ACIP Rec Evidence 1 trial of 9vHPV (girls and boys 9-14 v. females yo) >97.9% seroconverted to all 9 serotypes Non-inferiority criteria met for seroconversion and GMTs GMTs significantly higher for all 9 serotypes in 2-dose 9-14 yo than 3 dose yo 6 additional trials of 4vHPV, 2vHPV immunogenicity non-inferior in 9-14 yo MMWR 2016;65(49);

28 9vHPV 2-Dose New Recommendation A 2-dose series of HPV vaccine will be appropriate if: Initiate first dose before age 15 years If patient is healthy (not immunocompromised) If separation of doses is 6 months (5 months minimum interval) Series can include doses of 2vHPV, 4vHPV or 9vHPV HPV recommended for females 9 to 26 years, males 9-21 years, high risk males 22-26

29 Meningococcal ACYW Menomune MPSV has been discontinued Give high-risk adults age 56 years and older MenACYW conjugate vaccine High risk: Complement component deficient Anatomic or functional asplenia Microbiologists exposed HIV Outbreaks Travel MMWR, March 22, 2013 Vol 62. #RR02 addresses off-label use

30 Meningococcal B New 2-Dose Approved for low risk, BUT---- Still not a general recommendation (Category B) 2 doses for both products Bexero (0, 1 month) Trumenba (0, 6 month) Category B - Individual shared clinical decision, allows for insurance coverage (ACA) Series may be administered to age 16 through 23 years for short-term protection against most strains of serogroup B meningococcal disease Not Category A because of low incidence of disease, lack of efficacy and safety data No herd protection---- High risk and outbreak still need 3 doses of Trumenba (0, 1-2 mo, 6 mo)

31 Meningococcal B High Risk, age 10 years and older Category A recommendation Those at high-risk may receive 2 doses of Bexero (0, 1 month) But must still receive 3 doses of Trumenba (0, 1-2 months, 6 month) High risk includes: Asplenia (anatomic) Asplenia (functional, such as sickle cell) Complement component deficiency Microbiologists exposed Outbreak MMWR May 19, 2017:66(19);

32 SHINGLES- HERPES ZOSTER Background: Caused by varicella zoster virus (VZV) o Exclusively human pathogen that affects approx. 98% of US adult population o Reactivation of Chickenpox infection Herpes Zoster ( shingles ) is a localized and painful cutaneous eruption o Vesicular rash across dermatomes of the involved sensory nerve roots o 1 in 3 persons will develop shingles in their lifetime Post Herpetic Neuralgia (PHN) is a common complication of zoster o Can occur up to 6 months after rash and can last months to years o Impacts quality of life (sleep, work, activity), contributes to social withdrawal and depression

33 SHINGRIX HERPES ZOSTER SUBUNIT VACCINE (HZ/su) Investigational herpes zoster subunit vaccine for prevention of herpes zoster and post herpetic neuralgia in adults 50 years Unique ingredient components designed to enhance CD4+ T-cellmediated immune responses and improve vaccine efficacy: o Antigen: varicella zoster virus (VZV) glycoprotein E o Adjuvant system: AS01 B adjuvant Two dose series, separated by 2 months Manufactured by GlaxoSmithKline Lal H, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. NEJM 2015;372: Cunningham AL, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age. NEJM 2016;375: Colindros R. Investigational Herpes Zoster Adjuvanted Subunit (HZ/su) Vaccine: Efficacy in People 70 years and Older. Presented at: ACIP Oct 19.

34 Zostavax Efficacy Merck

35 ZOE-50 Trial HZ/su NEJM May

36 ZOE-70 Trial HZ/su NEJM Sept ,900 participants, mean age 75.6 years Efficacy Age (90.0%) Age 80 + (89.1%) All (89.8%) Pooled ZOE-50 and ZOE-70 (91.3% efficacy) Postherpetic neuralgia (88.8%)

37 Zoster Candidate HZ/su Safety and Duration of Protection Safety No difference from placebo in Severe Adverse Events Local reaction pain, redness, swelling 9.1% Of those who had a first dose Grade 3 reaction 91.4 % received 2 nd dose (local reaction) 89.2% received 2 nd dose (systemic reaction) Efficacy and persistence of protection out to 9 years so far Cellular and humoral immune responses: 3.4 fold titers sustained from years 4 to 9 Colindres, R Presentation at ACIP Feb 2017

38 Professional Resource, Shingles Vaccine: FAQs. Pharmacist s Letter/Prescriber s Letter. Dec CDC. Update on Recommendation for Use of Herpes Zoster Vaccine: Recommendations of the ACIP. MMWR 2014; 63(33): Lal H, et al. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. NEJM 2015;372: Cunningham AL, et al. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age. NEJM 2016;375: COMPARISON Zostavax Shingrix Indication Live vaccine Recommended for prevention of shingles in patients 50 YOA Inactivated vaccine Applied for FDA-approval for prevention of shingles in patients 50 YOA Dosing schedule 1 injection 2 injections, 2-6 months apart Efficacy for HZ 51.3% 91.3% Efficacy for PHN 66.5% 91.2% Duration of HZ efficacy 31.9% after 7 year follow up 87.9% at 4 year follow up Other notes 2 doses may decrease compliance and increase site reactions Manufacturer Merck & Co., Inc. GlaxoSmithKline Inc. HZ = Herpes zoster; PHN = Post herpetic neuralgia; YOA = Years of age; Slide courtesy of Kathy Povlius, Pharm D, BCACP

39 Zoster Candidate HZ/su Summary Submitted to FDA for approval ACIP recommendation planned for October 2017 Age 50 and above Good efficacy and safety when given 5 years after Zostavax Refrigerate, not frozen Not a live vaccine may recommend giving to immunocompromised Preferential recommendation?

40 Yellow Fever Vaccine Access limited during manufacturing plant reconstruction YF-VAX (Sanofi) unavailable until mid-2018 To find sites providing Stamaril (Sanofi) under IND Protocol: Utah: Davis County HD, Passport Health-Midvale, SLCounty HD, University of Utah Travel Clinic,Utah County HD, BYU)

41 Intermountain Healthcare Immunization Resources Located on the Medical Group s Clinical Resources Webpage: Type: IMG in the URL line Also located in the Primary Care Clinical Program Webpage in the topics on the left sidebar Not at Intermountain? Go to or (hcp page)

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43 Intermountain Healthcare Immunization Resources Located on the Medical Group s Clinical Resources Webpage: Type: IMG in the URL line Go to Clinical Resources, then Immunizations Policies, Procedures Vaccine Protocols Links to immunization programs/resources Tools

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48 Questions? Tamara Sheffield, MD, MPA, MPH Medical Director, Community Health and Prevention Intermountain Healthcare 36 S State Street, 21 st Floor Salt Lake City, UT (801) Tamara.Sheffield@imail.org