Update on Immunizations and the Shingles Vaccine

Transcription

1 Update on Immunizations and the Shingles Vaccine Conflict of Interest Disclosure I have no conflicts of interest to disclose. Sarah Scoular, PharmD., BCPS Annual Meeting 2018 Objectives 1. Describe the 2017/2018 updates for immunizations and apply them to your pharmacy practice. 2. Compare efficacy, safety, cost-effectiveness, storage and administration of zoster vaccine live (ZVL) and recombinant zoster vaccine (RZV). 3. Explain the updated recommendations for vaccination for the prevention of herpes zoster. Dusting Off the Cobwebs with Kahoot! Image: Live Attenuated (LAV): Live pathogens, weakened. Pro: Excellent immune response, continual antigenic stimulation Con: Can cause disease, avoid in pregnancy or in immunocompromised patient populations Examples: Oral Polio vaccine, MMR, Rotavirus, Yellow Fever, Shingles (Zostavax), Varicella Inactivated Whole Cell (Killed Antigen): Microorganisms killed through physical or chemical processes. Pro: No risk of inducing disease, more stable then live attenuated. Con: May not always induce an immune response. Responses do not last as long as LAV response. Examples: Pertussis, Inactivated polio vaccine (IPV) 1

2 Subunit (Purified antigen): Contain killed antigenic parts of the pathogen. Pro: No risk of inducing disease, more stable then live attenuated. Con: Costly to manufacture, no guarantee that the immune response elicited will be appropriate for prevention of disease. Subunit (Purified Antigen) Examples: Protein Subunit: Acellular pertussis (ap), Hepatitis B (HepB) Polysaccharide: Meningococcal, Pneumococcal Conjugate Subunit: Haemophilus influenzae type B (Hib), pneumococcal conjugate (PCV-7, PCV-10, PCV-13), Zoster (Shingrix) Toxoid (Inactivated Toxins): Using the protein-based toxin from the organism as the antigen in the vaccine to elicit an immune response Pro: No risk of inducing disease, antigens are not actively multiplying, excellent stability profile Con: May require several doses Examples: Tetanus toxoid (TT), Diphtheria toxoid (DT and Td) 2017 and 2018 Immunization Updates Image: HepB: Recombivax, Engerix, Twinrix (Hep A +B) Influenza Vaccine: Update for Children 6mo-8yoa Universal hepatitis B (HepB) vaccination within 24 hours of birth for medically stable infants weighing 2,000 grams Single-dose revaccination for infants born to HBsAg-positive women not responding to the initial vaccine series Vaccination for persons with chronic liver disease (HCV, cirrhosis, FLD, ALD, autoimmune hepatitis, ALT or AST > 2 x ULN) MMWR Recomm Rep 2018;67(No. RR-1):1 31. DOI: 2

3 PPSV23 or Pneumovax Recommended for 65 years of age or > and: Adults age years of age with chronic heart disease (CHF and cardiomyopathies, excluding HTN), chronic lung disease (COPD, emphysema, asthma), chronic liver disease, alcoholism, diabetes or who smoke cigarettes HPV Vaccine Recommendations 2016 Population Persons initiating HPV vaccination at ages 9 through 14 years,* except immunocompromised persons Persons initiating HPV vaccination at ages 15 through 26 yearsand immunocompromised personsinitiating HPV vaccination at ages 9 through 26 years Recommended number of HPV vaccine doses Recommended interval between doses 2 0, 6 12 months 3 0, 1 2, 6 months MMWR. 2016;65(49); Meningococcal Meningococcal Serogroups: A, B, C, W-135 and Y Menomune, Menactra, Menveo only cover A, C, W and Y 2 new vaccines approved to cover B: MenB-FHbp (Trumenba ): Three-dose series (0, 1-2, 6 mo) FDA-approved on October 29, 2014 MenB-4C (Bexsero ): Two-dose series (0, 6 mo) FDA-approved on January 23, 2015 Not-interchangeable MMR Vaccine Update: October 2017 Use of a third dose of mumps virus containing vaccine in persons at increased risk for mumps during an outbreak ACIP recommend a routine 2-dose mumps vaccination policy for school-aged children and adults at high risk in 2006 Cases in 2016 (6,369) and 2017 (5,629, preliminary as of December 31) are the highest reported in a decade Egg Allergy is Okay! CDC recommendations : Patients with a history of egg allergy of any severity should receive any licensed, recommended, and age-appropriate influenza vaccine No need to watch them for 30 minutes after! Patients with a history of severe allergic reaction to egg (i.e., any symptom other than hives) should be vaccinated in an inpatient or outpatient medical setting Ann Allergy Asthma Immunol Jan;120(1): doi: /j.anai Administration of influenza vaccines to egg allergic recipients: A practice parameter update Focus on Shingrix (Zoster Vaccine Recombinant, ZVR)! 3

4 Shingrix and Zostavax : The fall out Cher you ve been replaced Introducing the Newer, Cooler Kid on the Block Shingrix (GSK) Approved 10/20/17 for the prevention of herpes zoster in immunocompetent adults aged 50 years including patients who previously received Zostavax 2 doses (0.5 ml each), administered intramuscularly, 2 6 months apart The Older, Lamer Kid on the Block: Zostavax (Merck) Approved 2006 for the prevention of herpes zoster in immunocompetent adults aged 50 years, recommended by ACIP for age 60 years Single 0.65 ml subcutaneous injection Shingrix : ZOE-50: Randomized, doubleblind, multinational study immunocompetent adults 50 years of age (mean age 62.3 years) Patients were randomized in a 1:1 ratio to receive 2 IM doses of Shingrix or placebo separated by 2 months with a mean follow-up of 3.2 years Overall efficacy was 97.2% (95% CI , P <0.001) with no significant difference in vaccine efficacy among the 50-59, 60-69, and 70 years age groups (96.6%, 97.4%, and 97.7% respectively) N EnglJ Med. 2015;372: ZOE-70: Randomized, double-blind study immunocompetent adults 70 years of age (mean age 75.6 years) Efficacy of 89.9% (95% CI , P<0.001). With no significant difference in vaccine efficacy among the and 80 years age groups. Vaccine efficacy for Postherpetic neuralgia of 91.2% (95% CI , P<0.001). No cases of postherpetic neuralgia were observed in patients <70 years of age in the vaccine group. N EnglJMed. 2016;375: Grupping K, et al. Immunogenicity and safety of the HZ/su adjuvanted herpes zoster subunit vaccine in adults previously vaccinated with a live attenuated herpes zoster vaccine Open-label, multicenter study: Patients 65 years of age who had received Zostavax 5 years previously vs. Zostavax - naïve patients. 430 patients received 2 doses of Shingrix 2 months apart Primary objective: compare the humoral immune responses 1 month after dose 2 of the vaccine between the two groups. J Infect Dis. 2017;216:

5 Grupping K, et al. Non-inferiority met if the upper limit of the 95% CI of the adjusted antiglycoprotein E geometric mean concentration (GMC) ratio of nonvaccinated group over Zostavax -vaccinated group was <1.5. The adjusted GMC ratio between the two study groups was 1.04 (95% CI ) Incidence of local, systemic and grade 3 reactions was similar between the groups. Pain and fatigue were the most common reactions reported after Shingrix administration. Efficacy of Zoster Vaccine Live (ZVL) Two randomized clinical trials and seven observational studies were reviewed to evaluate the performance of a single dose of ZVL in preventing herpes zoster Efficacy was 70% (95% CI = 54 81) in persons aged years Efficacy was 64% (95% CI = 56 71) in persons aged 60 years Efficacy was 38% (95% CI = 54 81) in persons aged 70 years J Infect Dis. 2017;216: Comparing the Two: Efficacy Age Shingrix Zostavax Persons aged % 70% Persons aged 60 years 97.4%, 64% Persons aged 70 years (pooled data from ZOE 50 and ZOE %, 38% Comparing the Two: Adverse Effects Shingrix Zostavax Pain 78% Erythema 38.1% Myalgia 44.7% Fatigue 44.5% Headache 37.7% Shivering 26.8% Swelling 25.9% Fever 20.5% GI symptoms 17.3% Pain 34-54% Erythema 36-48% Swelling 26-40% Headache 1-9% Shingrix [package insert]. Research Triangle Park, NC: GlaxoSmithKline Biologicals; Zostavax [package insert]. Whitehouse Station, NJ: Merck & Co., Inc;2017. Cost Effectiveness and Storage Under most assumptions, vaccination with RZV prevented more disease at lower overall costs than did vaccination with ZVL The numbers of persons needed to be vaccinated with RZV to prevent one case of herpes zoster and one case of postherpetic neuralgia are and , respectively Storage: Shingrix (between 36 F and 46 F) Zostavax (between -58 F and +5 F) And the Winner is October 2017 ACIP meeting recommendations 1. RZV is recommended for immunocompetent adults aged 50 years (14 voted in favor, 1 opposed) 2. RZV is recommended for immunocompetent adults previously vaccinated with ZVL (12 voted in favor, 3 opposed) 3. RZV is preferred over ZVL (8 voted in favor, 7 opposed) 5

6 Considerations for Shingrix in Special Populations Persons with a history of herpes zoster: Adults with a history of herpes zoster should receive RZV. If a patient is experiencing an episode of herpes zoster, vaccination should be delayed until the acute stage of the illness is over and symptoms abate. Persons with chronic medical conditions. Adults with chronic medical conditions (e.g., chronic renal failure, diabetes mellitus, rheumatoid arthritis, and chronic pulmonary disease) should receive RZV. Considerations for Shingrix in Special Populations: Immunocompromised persons: ACIP recommends the use of RZV in persons taking low-dose immunosuppressive therapy (e.g., <20 mg/day of prednisone or equivalent) Immunocompromised persons and those on moderate to high doses of immunosuppressive therapy were excluded from the efficacy studies (ZOE-50 and ZOE-70) ACIP has not made recommendations regarding the use of RZV in these patients. Final Kahoot! - For all the Marbles! Case: Your favorite 82 year old patient, Mabel comes to see you. She just read in the paper something about a new vaccine for shingles and is wondering if she should get it. She takes 5mg of prednisone per day for her COPD and per her profile she received Zostavax two years ago. What do you recommend for cute, little, old Miss Mabel? What to do with Vaccine Hesitant Martha, Mabel s older, wiser sister? Vaccine Hesitancy The Why s Religious Personal Beliefs or Philosophical Reasons Safety Concerns Desire for Additional Education! Vaccine Hesitancy Communication tools to improve vaccine compliance: Pivot to disease severity and education Acknowledge the motivation/value, not the concern Make it Personal Make vaccination the default 6

7 Questions? Contact: 7