Hot off the press, What s new for immunizations in 2017?

Transcription

1 Hot off the press, What s new for immunizations in 2017? Jennifer Girotto, PharmD, BCPPS Faculty Disclosure Dr. Girotto has no actual or potential conflicts of interest associated with this presentation. Dr. Girotto will be discussing off label use of immunizations. She will provide information as recommended by the Advisory Committee on Immunization Practices (ACIP)/ Centers for Disease Control and Prevention (CDC). She will also be discussing information on upcoming vaccine recommendations. 1

2 Objectives Explain influenza immunization recommendations for the season Identify recent changes to ACIP vaccination recommendations Discuss new and upcoming vaccines Influenza Vaccine Recommendations and Activity Influenza Activity and Vaccination

3 Influenza Vaccine Components Trivalent and Quadrivalent: A/Michigan/45/2015 (H1N1)pdm09 like virus A/Hong Kong/4801/2014 (H3N2) like virus B/Brisbane/60/2008 like (Victoria lineage) Quadrivalent also includes: B/Phuket/3073/2013 like (Yamagata lineage) Influenza Activity 3

4 Influenza Activity & Vaccine Match? A(H1N1)pdm09 (n=91) All but 1 virus belong to genetic clade 6B.1, same clade as A/Michigan/45/2015, new component for year A(H3N2) (n=415) Multiple clades circulating: 3C.2a, subclade 3C.2a1, and 3C.3a A/Hong Kong/4801/2014 belongs to 3C.2a B/Victoria (n=35) All circulating belong to VIA, same clade as B/Brisbane/60/2008 B/Yamagata (n=124) All circulating belong to Y3 same clade as B/Phuket/3073/2013 4

5 Influenza Activity 5

6 ACIP Influenza Vaccine Recommendations 6

7 All patients 6 months old or greater without contraindication should receive an inactivated influenza vaccine. ACIP Influenza Vaccine Recommendations CDC again does not provide a clear preference for one inactivated influenza vaccine product over another when more than one licensed, recommended product is available 7

8 ACIP Influenza Vaccine Recommendations The live attenuated vaccine is again NOT recommended for any patient. Pediatric Patients Less than 9 years old: If received 2 influenza doses before 7/1/17, only 1 dose needed this season If not received 2 influenza doses before 7/1/17, 2 doses separated by 28 days 9 years old and up: 1 dose this season 8

9 Pregnant Patients ACIP clarified that pregnant women may receive any licensed, recommended, ageappropriate influenza vaccine Elderly Patients Which is best? High dose, attenuated, or maybe even recombinant Lack of comparative efficacy between them MMWR has the data summarized, but has not yet provided a recommendation of one over the other Grohskopf LA, et al. MMWR (30);

10 Elderly Patients 65+ yrs, high dose was superior in 30,000+ twoseason randomized, controlled, double blind trial. 50+ yrs, recombinant quadrivalent was more effective in a single season randomized, controlled, double blind trial comparing RIV4 vs IIV4 (N = 8,604). 65+ yrs small (N=227) observational study, attenuated vs inactivated was more effective against laboratory confirmed influenza. No data are yet available from any randomized studies for aiiv3. Grohskopf LA, et al. MMWR (30); Influenza Vaccine Administration 10

11 Influenza Vaccines Dosing Vaccine Type Age Dosing Intramuscular Standard Dose (both trivalent & quadrivalent) 6 35 months 36 months Fluzone Quadrivalent: 0.25 ml/dose FluLaval Quadrivalent: 0.5 ml/dose ALL ml/dose Intramuscular 65 yrs 0.5 ml/dose High Dose Intradermal yrs 0.1 ml/dose Adapted from Grohskopf LA, et al. MMWR (30); IM Immunization Best Practices Locate deltoid muscle of the upper arm Determine injection site using landmarks Avoid top 1/3 of deltoid In adults, midpoint of deltoid is about 2 inches (2 3 fingers bredth) below the acromion process (bony prominence) and above the armpit in the middle of the arm Have both vaccinator and patient in seated position Have patient lift arm out to the side, placing hand on hip Use appropriate needle size (not too long) the shots.html 11

12 Learning Assessment Mr. Sam is a 75 year old who is here to receive his flu vaccine. Which of the following flu vaccines is/are reasonable for him? A) Fluzone quadrivalent (IIV4) B) Fluzone high-dose (IIV3-HD) C) Adjuvanted influenza vaccine (aiiv3) D) Recombinant influenza vaccin (RIV4) E) Any of the above are acceptable per ACIP Learning Assessment Mr. Sam is a 75 year old who is here to receive his flu vaccine. Which of the following has the strongest evidence to date that it provides better protection for the elderly population? A) Fluzone quadrivalent (IIV4) B) Fluzone high-dose (IIV3-HD) C) Adjuvanted influenza vaccine (aiiv3) D) Recombinant influenza vaccin (RIV4) 12

13 2017 Updated Immunization Recommendations Meningococcal Serotype B Cholera Meningococcal B Vaccination May 2017, MMWR published updated recommendations for the use of MenB-factor H binding protein (FHbp) serogroup B meningococcal vaccine (Trumenba) 13

14 MenFHbp B Duration of Protection and Boosted Response Meningococcal B Vaccination MMWR Summarized recent ACIP votes for meningococcal MenB-FHbp serogroup B vaccination 2 dose series for healthy year old patients during non-outbreak situations 3 dose series for outbreak situation > 10 years old 14

15 Cholera Vaccine CVD 103-HgR Recommended for adults years from the US who are traveling to an area of active cholera transmission. Active cholera transmission is an area with endemic or epidemic cholera caused by toxigenic Vibrio cholerae O1. It is not recommended for those who are not traveling to an area with active transmission. ( wwwnc.cdc.gov/travel/ ) Cholera Vaccine Live oral vaccine shed in stool 11% in 7 days post vaccination. Efficacy 90.3% at 10 days, 79.5% at 3 months Contraindicated in allergy Pregnancy risk vs benefit should be considered. Increased risk of severe cholera disease, no data on safety although not absorbed, theoretical concern that baby could be exposed via delivery. Immunocompromised risk vs benefit uncertain, prior vaccine had lower seroconversion in HIV positive patients but not an increased risk of adverse effects 15

16 Upcoming Vaccines & Changes to Vaccine Recommendations October ACIP Meeting Zoster subunit inactivated vaccine HEPLISAV-B Mumps vaccine 16

17 Herpes Zoster Subunit Vaccine Subunit inactivated vaccine Lyophilized varicella zoster virus glycoprotein E mixed with ASO1 B adjuvant suspension Comes as 2 vials, both should be stored in the refrigerator and protected from light Once reconstituted use immediately or store in refrigerator for up to 6 hours 2 dose (0 and 2-6 months) 0.5 ml intramuscular administration Herpes Zoster Vaccines: Efficacy Prevention of herpes zoster years HZ/su 96.6% ( ) vs ZVL 70% (54-81) years HZ/su 97.4% ( ) vs ZVL 64% (56-71) years HZ/su 91.3% ( ) vs ZVL 41% (28-52) >/= 80 years HZ/su 91.4% ( ) vs ZVL 18% ( ) Number needed to treat with HZ/su 50 years + to prevent 1 case:

18 Herpes Zoster Vaccines: Efficacy Prevention of post herpetic neuralgia HZ/su >/= 50 years 91.2% ( ) vs ZVL years 65.7% (20-87) >/= 70 years HZ/su 88.8% ( ) vs ZVL 66.8% (43-81) Number needed to treat with HZ/su 50 years + to prevent 1 case: Herpes Zoster Vaccines: Efficacy Duration of protection After 4 years: HZ/su > 85% vs ZVL </= 40% 18

19 Herpes Zoster Subunit Vaccine Serious adverse events Serious adverse event: 12.6% HZ/su vs 13% placebo Serious adverse event considered related to vaccine: 0.1% HZ/su; 0.1% placebo HZ/su had higher rates of grade 3 reactions: injection site reaction (9.4 vs 0.3%) and systemic reaction (10.8% vs 2.4%) Herpes Zoster Subunit Vaccine Overall reported adverse reactions within 7 days Pain 70 88% Myalgia % Fatigue 37 57% Headache 29 51% (more common dose 2) Swelling 23 31% Shivering 20 36% (more common dose 2) Fever 14 28% Nausea, vomiting, diarrhea, or abdominal pain 14 24% Redness % Optic ischemic neuropathy reported in 3 of 17,000 patients who received vaccination. Uncertain association 19

20 Herpes Zoster Vaccine Cost Effectiveness vs No Vaccine Cost effectiveness (cost per quality adjusted life year) by age group: years: HZ/su $46,824 vs ZVL $85, years: $25,683 vs ZVL $54, years: $11,561 vs ZVL $58, years: $9,739 vs ZVL $137, years: $27,310 vs ZVL $364, years and up: HZ/su $30,797 ACIP Vote for Zoster Subunit Vaccine Recommended for prevention of herpes zoster and related complications for Immunocompetent adults 50 years and older Immunocompetent adults who previously received Zostavax Recommended as preferred vaccine over Zostavax for the prevention of herpes zoster and related complications AAFP News. 20

21 Zoster Subunit Vaccine Coverage To be determined: When Medicare will begin covering this If Medicare will cover 2 doses within 1 year GSK website to provide updates as available: e/us/en/brands/shingrix/pi/coverage.html Phone number for questions CPT and ICD-10 Codes available at: e/us/en/brands/shingrix/pi/coding.html AAFP News. Learning Assessment Mr. Kline, a 55 year old comes into your pharmacy to pick up his generic Lipitor. While there he asks you if he should receive the zoster vaccine. Which vaccine(s) would he be recommended to receive (Once published in the MMWR)? A) One dose of ZVL B) One dose of HZ/su C) Two doses of HZ/su D) Either A or B E) Either A or C 21

22 Mumps Mumps Vaccine Voted to recommended a 3 rd dose of MMR vaccine during mumps outbreaks to increase protection Recommended not routinely but in cases when the public health department identifies there is an outbreak or exposure AAFP News. 22

23 Learning Assessment Tammy is a 19 year old patient that is up to date on her vaccines. She is currently a freshman in college. She heard that she should get a 3rd dose of MMR to protect her from mumps. Which of the following is true? A) She should receive a 3rd dose of MMR as she is at risk being a college student B) She does not currently need a 3rd dose of MMR as there is not any specific outbreaks that she has been a exposed C) She should have received any needed doses as a child, so would not need to be considered for MMR today HEPLISAV-B 23

24 HEPLISAV-B New hepatitis B vaccine approved for adults Dosed as ml doses given over 1 month (vs 3 doses over 6 months) Adjuvanted with 3 mg of toll like receptor 9 agonist 1018 Higher seroprotection response rates (vs Energix-B) in nondiabetic adults (96% vs 84%) as well as those with diabetes (90% vs 65%), obesity (95% vs 75%) and in those who smoke (96% vs 79%) In one study, the number of patients with myocardial infarction was higher in the HEPLISAV-B group. Although not seen in other studies, it will be monitored post-marketing ACIP did not vote because the vaccine was not yet approved at the meeting. Will vote on its role in Feb 2018 meeting. Questions 24