Immunization Update 2018

Transcription

1 Immunization Update 2018 Keri Hurley-Kim, PharmD, MPH Assistant Professor, Department of Pharmacy Practice West Coast University School of Pharmacy Conflicts of Interest Keri Hurley-Kim declares no conflicts of interest. Objectives 1. Utilize the CDC immunization schedules to recommend patient-specific vaccines. 2. Review important updates to clinical recommendations for influenza, zoster and other vaccines. 3. Describe key issues involved in compliance with California Business and Professions Code section

2 INFLUENZA UPDATE 2017 / 2018 Influenza Epidemiology H3N2 predominating, high genetic diversity Significantly elevated influenza activity compared to average seasons Average (2009/ /2018) 2009/ /2018 (as of 3/8/18) % of outpatient visits for ILI 5.3% 7.6% 7.5% Influenza-associated hospitalizations (cumulative rate per 100,000) Pneumonia & Influenza mortality (percentage of U.S. 8.7% 8.1% 10.7% deaths at season peak) Influenza-associated pediatric deaths (n) Adjusted overall vaccine ~45 56, , effectiveness (%, 95% CI) [interim estimate] MMWR 59(29); ; MMWR 60(21); ; MMWR 61(22); ; MMWR 62(23); ; MMWR 63(22); ; MMWR 64(21); ; MMWR 65(6); ; MMWR 66(25); ; MMWR 67(6); ; CDC FluView Weekly U.S. Influenza Surveillance Report LAIV4 Update Feb 2018: : Multiple studies demonstrate efficacy comparable to IIV in children and adults 2003: Flumist (LAIV3) introduced *Contained different H1N1 HA vs. standard vaccine June 2014: ACIP recommends preference for LAIV in children 2013: Flumist Quadrivalent (LAIV4) introduced* June 2016: ACIP recommends AGAINST use of LAIV for season Feb 2015: ACIP recommends NO preference for LAIV in children ACIP includes LAIV as an option for season June 2017: Recommendation against LAIV renewed for

3 LAIV4 Update Factors in recommendation to re-include LAIV4 as an option in 2018/ Preliminary efficacy studies immunogenicity + shedding Clinical effectiveness data not yet available 2. Effect of viral interference on low efficacy of LAIV in 2013/2014(?) 3. Potential for vaccine discontinuation if no recommendation Zoster Vaccine Update Recombinant adjuvanted zoster vaccine (RZV, Shingrix ) Zoster vaccine live (ZVL, Zostavax ) Dosing 0.5mL IM x2 at 0 and 2-6mon 0.65mL SQ x1 Contraindications Severe allergy to any vaccine Immunosuppression, pregnancy, severe allergy to any vaccine Zoster Vaccine Update Effectiveness Prevention of herpes zoster RZV ZVL 50-59y 60-69y 70y 50-59y 60-69y 70y 96.6% 97.4% 91.3% 70% ~64% 38% Prevention of post-herpetic neuralgia >90% >90% 88.8% Duration of protection Efficacy >84% after 3 years Efficacy ~33% after 3 years Adverse effects 1. Injection site reaction/pain 2. Myalgia, fatigue, HA, shivering, fever, GI sx Varicella-like rash at injection site (rare), injection site reaction/pain 2. HA -- MMWR 67(3); ; N Engl J Med 2015;372: ; N Engl J Med 2016;375: ; Clin Infect Dis Mar 15;64(6): ; Am J Epidemiol Jan 1;187(1):

4 Zoster Vaccine Update ACIP Recommendations (Oct. 2017) Shingrix is: 1. Preferred over Zostavax Better efficacy, more long-lasting protection 2. Recommended for zoster vaccine naïve adults age 50 yrs and older 3. Recommended for adults age 50 yrs and older who have previously received Zostavax **Likely to be covered by Medicare Part D plans by April 2018 Shingrix reconstitution Lyophilized antigen + adjuvant suspension *Administer within 6 hours after reconstitution Hepatitis B Vaccine Update Recombinant adjuvanted hepatitis B vaccine (HBsAg-1018 HELPISAV-B ) Dosing Adults ( 18y): 0.5mL IMx2 at 0, 1 month Contraindications Immunogenicity (% seroconversion) Severe allergy to any vaccine Potential usefulness as secondary vaccination for non-responders(?) Recombinant hepatitis B vaccines (HBsAg, Engerix-B, Havrix ) Adults ( 20y): 1mL IM x3 at 0, 1, 6 mon Severe allergy to any vaccine Overall DM type 2 CKD* Overall DM type 2 CKD* Safety profile No significant difference in AEs *HEPLISAV dosing in CKD = 3 doses, Engerix-B dosing in CKD = 4 double doses Janssen, et al. Vaccine Feb 11;33(7):833-7; Jackson, et al. Vaccine Jan 29;36(5):

5 Hepatitis B Vaccine Update ACIP Recommendations (Adult) (Feb. 2018) No preference for any FDA approved formulation Any person seeking protection Persons at increased risk of sexual, blood borne exposure MSM Patients <60y with diabetes (permissive recommendation for 60y) ESRD, HIV infection, chronic liver disease* Household or sexual contacts of hep B surface antigen-positive persons Healthcare and public service workers *Including, but not limited to, those with hepatitis C virus [HCV] infection, cirrhosis, fatty liver disease, alcoholic liver disease, autoimmune hepatitis, and an alanine aminotransferase [ALT] or aspartate aminotransferase [AST] level greater than twice the upper limit of normal (updated as of 1/2018) Hepatitis B Vaccine Update ACIP Recommendations (Pediatric) (Jan. 2018) - Universal hepatitis B vaccination within 24 hours of birth (medically stable, >2kg) - Removal of permissive language for delaying birth dose until after hospital discharge - Testing HBsAg-positive pregnant women for hepatitis B virus DNA - Post-vaccination serologic testing for infants whose mother s HBsAg status remains unknown indefinitely - Single dose revaccination for infants born to HBsAgpositive mothers not responding to initial vaccination series California Immunization Registry (CAIR) Currently exists as a regional database As of Aug. 2016, all pharmacy-based immunizations must be reported to CAIR 1. Electronic submission -or- 2. Manual submission Consistent with SB 493-related regulations (B&P code section ) Pharmacies enroll to submit data, then pharmacists enroll to read data Training available via webinar/online videos 5

6 On the horizon What to look out for during the next year Re-evaluation by ACIP of recommendation for PCV13 in patients >65y Potential harmonization of HPV schedules (female, male) Continued surveillance of meningococcal B and potential updated recommendations for men B vaccine use Patient case discussion It is September 2018 and a patient presents to your pharmacy to inquire about the nasal spray flu vaccine. She has heard that it has returned for this season, but is worried because she remembers it wasn t offered the past couple seasons because it did not work well. How would you respond? Patient case discussion You are assessing the vaccine needs of a 55 year old female patient. She tells you that she has not had any vaccines since she was in her 20s except a flu shot most recently about 3 years ago. Her medications are listed below and she does not have any relevant allergies. 1) Metformin 1000mg BID 2) Sitagliptin 100mg daily 3) Lisinopril 20mg daily 4) HCTZ 25mg daily 5) Amlodipine 10mg daily Which four vaccines do you recommend for her today? 6

7 Thank You! Speaker Contact Information: Keri Hurley-Kim, PharmD, MPH West Coast University School of Pharmacy Phone: (323)