Immuniza(on Update Disclosures. Learning Objec(ves 4/9/15

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1 Immuniza(on Update 2015 Jayme Garcia, PharmD Community Pharmacy Resident Smith s Food & Drug Disclosures Dr. Garcia declares no conflicts of interest, real or apparent, and no financial interests in any company, product, or service menaoned in this program, including grants, employment, gibs, and stock holdings. The Utah Pharmacy AssociaAon is accredited by the AccreditaAon Council for Pharmacy EducaAon as a provider of conanuing pharmacy educaaon. Learning Objec(ves At the conclusion of this program, the paracipaang pharmacist or technician will be able to: 1. List vaccinaaons recommended in adulthood by the Advisory CommiMee of ImmunizaAon PracAces (ACIP) and summarize their vaccinaaon schedules. 2. Recognize recent ACIP updates and how they apply to pharmacy pracace. 3. Summarize the influenza season and discuss the changes expected for the upcoming season. 1

2 Key Points New ACIP recommendaaon for pneumococcal New meningococcal type B vaccines approved by the FDA New HPV 9 vaccine approved by the FDA DriBing of the influenza virus and changes in ACIP recommendaaon Measles outbreak in Utah Test Your Knowledge The recently- licensed HPV9 vaccine provides protecaon against: A. 70% of cervical warts B. 80% of cervical warts C. 70% of cervical cancer D. 90% of cervical cancer Test Your Knowledge The current quadrivalent meningococcal vaccine covers all of the following serotypes EXCEPT A. A B. B C. C D. Y 2

3 Test Your Knowledge PCV13 is ACIP recommended for all individuals A years old B. 50 years old C. 60 years old D. 65 years old Test Your Knowledge A 3 year old with no medical condiaons and no respiratory issues needs influenza vaccinaaon. Which is the best opaon for this child? A. LAIV4 quadrivalent live amenuated influenza vaccine B. IIV4 quadrivalent inacavated influenza vaccine C. RIV3 trivalent recombinant influenza vaccine D. No Preference Vaccina(on Coverage Among Adults United States 2013 Vaccine Pneumococcal (PCV13 & PPSV23) Tetanus (1 dose in the past 10 years) Tetanus with pertussis HepaAAs A ( 2 doses) HepaAAs B ( 3 doses) Shingles Human Papilloma Virus ( 1 dose) Coverage 21.2% of adults % of adults % of adults % of adults % of adults % of adults 19 9% of adults 19 25% of adults % of adults % of females % of males

4 Immuniza(on Year in Review ACIP MeeAng June 2014 ACIP MeeAng & Trumenba FDA Approval October 2014 Bexero FDA Approval January 2015 August 2014 ACIP Special Session to discuss PCV13 December 2014 Gardasil 9 FDA Approval February 2015 ACIP MeeAng *NEW 4

5 PCV13 vs PPSV23 PNEUMOCOCCAL VACCINES CAPiTA CAPiTA: Community Acquired Pneumonia ImmunizaAon Trial in Adults Evaluated efficacy of PCV13 for prevenang community- acquired pneumonia (CAP) in 84,496 adults 65 years old Results: 45% efficacy of PCV13 against vaccine- type (CAP) 45% efficacy against vaccine- type non- bacteremic/non- invasive (NB/NI) CAP 75% against vaccine- type invasive pneumococcal disease (IPD) CAPiTA ObjecAves: Prevent PCV13 vaccine type community acquired pneumococcal pneumonia (CAP) Prevent first episode of NB/NI CAP Prevent first episode of IPD 5

6 Work Group Cost analysis applied Cost effecave to add PCV13 or replace PPSV23 Herd Effects 53% reducaon of IPD in PCV13 serotypes 71% reducaon of IPD in PCV7 serotypes ConAnued decline expected Strong evidence of PCV13 effecaveness EsAmates of 86,000 vaccine type CAP hospitalizaaons Pneumococcal Conjugate Vaccine Pneumococcal Conjugate Vaccine PCV13 (Prevnar) ACIP recommends: All infants should be given a primary series of PCV13, at ages 2, 4, and 6 months with a booster at age 12 to 15 months Adults age 19 years and older who have the condiaons specified below and who have not previously received PCV13 should receive one dose of PCV13 Immunocompromising condiaons FuncAonal or anatomic asplenia Cerebrospinal fluid (CSF) leak Cochlear implant Pneumococcal Conjugate Vaccine Pneumococcal Conjugate Vaccine PCV13 (Prevnar) Newest ACIP recommenda(on: Adults age 65 years and older with no previous or unknown history of pneumococcal vaccinaaon Give one dose of PCV13 Medicare Give a follow- up dose of PPSV23 within 6 to 12 months Coverage Adults age 65 years and older who have received one or more doses of PPSV23, but have not received PCV13 Administer one dose of PCV13 at a minimum of one year aber receiving PPSV23 6

7 Pneumococcal Polysaccharide Vaccine Pneumococcal Polysaccharide Vaccine PPSV23 (Pneumovax) ACIP recommends: All adults age 65 years old Age 2 to 64 years old with the following condiaons*: This subgroup will s(ll need Prevnar + Pneumovax* at age 65 *with a minimum of 5 years between Pneumovax doses CigareMe smokers age 19 years old Chronic cardiovascular disease Chronic pulmonary disease Diabetes mellitus Alcoholism Chronic liver disease Candidate for or recipient of cochlear implant CSF leak FuncAonal or anatomic asplenia Immunocompromising condiaons Solid organ transplant Chronic renal failure or nephroac syndrome California Department of Health PPSV23 Vaccina(on Coverage Among Adults - Utah GOAL = 90% GOAL = 60% 7

8 Pa(ent Case Mrs. Johnson, 66 year old female, new grandmother She presents to your pharmacy today for a Tdap vaccine Her vaccinaaon records indicate that she received PPSV23 9 months ago She has tradiaonal Medicare insurance Should she receive PCV13 today? MENINGOCOCCAL VACCINES Meningococcal Incidence in U.S. 8

9 Meningococcal Meningococcal Quadrivalent Conjugate Vaccine (MCV4) Covers serotypes A, C, W & Y Available formulaaons: Menactra & Menveo Meningococcal Quadrivalent Polysaccharide Vaccine (MPSV4) Covers serotypes A, C, W & Y Available formulaaon: Menomune Preferred for ages 9 months to 55 years Preferred for adults 56 years and older Meningococcal ACIP Recommenda(ons All adults with the following risk factors: Anatomical or funcaonal asplenia Microbiologist who are rouanely exposed to isolates of Neisseria meningiadis Military recruits Travelers to meningococcal disease epidemic areas First- year college student up through age 21 who are living in residence halls MenB Outbreak Meningococcus serogroup B Princeton University 9 cases University of California, Santa Barbara (UCSB) 4 cases 30,000 students vaccinated with Bexero under InvesAgaAonal New Drug (IND) 9

10 Meningococcal B Trumenba (rlp2086) 1st MenB vaccine FDA approved October 2014 Breakthrough therapy status for ages years 3 dose IM series (0, 2, 6 months) Bexero (4cMenB) 2 nd MenB vaccine FDA approved January 2015 Breakthrough therapy status for ages years 2 dose IM series (0 and 1 month) MenB Vaccines Moving Forward Currently, there is no ACIP recommendaaon for rouane MenB vaccinaaon QuesAons to be answered: Timing of MenB vaccinaaon? Should MenB be given with MenACWY? FDA indicaaon? 2% of all meningococcal disease occurs as an outbreak FDA age approval? Most MenB occurs in paaents <1 year old but there is no FDA indicaaon MenB ACIP Recommenda(ons Persons 10 years and older who are at increased risk for MenB infecaon should complete the series: Persistent complement component deficiencies Anatomic or funcaonal asplenia Microbiologists rouanely exposed to isolates of Neisseria meningiadis Persons idenafied to be at increased risk because of MenB outbreaks (i.e. college students) 10

11 HUMAN PAPILLOMA VIRUS (HPV) VACCINES HPV Cancer prevenaon! HPV vaccinaaon protects: Females: cervical, vulvar and vaginal cancer Males: penile cancer Both: anal and oropharyngeal cancer Cervarix (2vHPV) Covers serotypes 16 & 18 Female indicaaon only Gardasil (4vHPV) Covers serotypes 6, 11, 16, 18 HPV Gardasil 9 (9vHPV) FDA approved December 2014 Covers serotypes 6, 11, 16, 18, 31, 33, 45, 52, 58 coverage rates for cervical cancer to 90% SAll covers 90% of genital warts All vaccines administered in a 3 dose series (0, 1-2 and 6 months) 11

12 ACIP HPV Recommenda(on ALL females ages 9-26 years old With rouane HPV vaccinaaon iniaated at years old ALL males ages years old Males ages years old Who did not get any or all doses when they were younger (catch- up) Men who have sex with men Immunocompromised (including HIV) HPV Vaccines Moving Forward Any available HPV vaccine product may be used to conanue or complete the series for females 9vHPV or 4vHPV may be used to conanue or complete the series in males ACIP will meet in June and address the issue of revaccinaaon of paaents who have already received the full 4- valent or 2- valent series Will the availability of Gardasil 9 increase HPV vaccinaaon rates in your pracace?? HPV Vaccina(on Coverage in Utah LOWEST IN THE NATION! GOAL = 80% 12

13 INFLUENZA Influenza Hospitaliza(ons in Utah Influenza Drift Influenza Vaccina(on Coverage Among Adults - United States 13

14 Influenza Drim influenza vaccine contains: A/California/7/2009 (H1N1)- like virus A/Texas/50/2012 (H3N2)- like virus B/MassachuseMs/2/2012- like virus Yamagata lineage B/Brisbane/60/2008- like virus INFLUENZA DRIFT! L (H3N2) vaccine strain changed to A/ Switzerland/ /2013 B Yamagata virus strains also changed Trivalent Quadrivalent Vaccine Effec(veness (VE) During , influenza vaccine was only 18% effecave against influenza A H3N2 viruses (95% confidence interval 6%- 29%) During , vaccine relaave effecaveness (RE) favored IIV over LAIV (Flumist) in young children & RE favored LAIV over IIV IIV= Inactivated Influenza Vaccine LAIV= Live Attenuated Influenza Vaccine Flu Season World Health OrganizaAon (WHO) pick for flu season A/California/7/2009 (H1N1)- like virus A/Switzerland (H3N2)- like virus B/Phuket- like virus NEW B/Brisbane/60/2008- like virus NEW Trivalent Quadrivalent 14

15 ACIP Flu Recommenda(on Annual vaccinaaon for all people ages 6 months and older who do not have a contraindicaaon to the vaccine Children 6 months to 8 years of age receiving influenza vaccine for the first Ame should receive two doses at least 4 weeks apart Removed preference for Flumist (LAIV) in children 2-8 years old Influenza Vaccina(on Coverage Among Adults - Utah GOAL = 90% for high risk adults GOAL = 80% GOAL = 90% Needle- Free Injec(on PharmaJet FDA approved to administer Afluria Jet injector that uses unique pressure profile to deliver vaccine IM injecaon for adults years old Eliminates needlesack potenaal 15

16 MEASLES OUTBREAK Measles in Utah January 3 rd, 2015 rash illness in two previously healthy, unimmunized teenaged siblings reported to Utah Department of Health (UDOH) Both visited Disneyland between December 17 th - 19 th, 2014 InfecAous period esamated to be between December 26 th, 2014 and January 4 th, 2015 Voluntary Quaran(ne 269 placed on voluntary quaranane 44% (120) confirmed immune 56% (149) conanued quaranane 56% (83) completed 21 day quaranane 44% (66) did not complete 16

17 Utah Measles Summary 16 exposure events resulang in 376 contacts 269 individuals placed on voluntary quaranane unal immune status confirmed 29 high risk contacts treated with immune globulin 586 doses of MMR vaccines provided 42 symptomaac suspects ruled- out Minimum Es(mated Cost = $115,000 ACIP MMR Recommenda(on All children age months, with a second dose at age 4-6 years Adults with no evidence of immunity should get 1 dose of MMR High risk adults need 2 doses of MMR (0 & 1 month) Healthcare personnel, internaaonal travelers, students at post- high school educaaonal insatuaons and people exposed to a measles outbreak 17

18 Utah Vaccine ExempAons Future Vaccines Ebola GSK and Public Health Agency of Canada/Merck Phase 1 trials completed. Phase 2 & 3 in 2015 Dengue Sanofi Pasteur s ChimericVax- Dengue (Phase 3 trials) PotenAal for domesac and internaaonal traveler use 18

19 Immuniza(on References ImmunizaAon AcAon CoaliAon (IAC) Utah Statewide ImmunizaAon InformaAon System (USIIS) Centers for Disease Control and PrevenAon (CDC) SmartPhone App Pink Book Vaccine InformaAon Statements (VIS) Test Your Knowledge The recently- licensed HPV9 vaccine provides protecaon against: A. 70% of cervical warts B. 80% of cervical warts C. 70% of cervical cancer D. 90% of cervical cancer Test Your Knowledge The current quadrivalent meningococcal vaccine covers all of the following serotypes EXCEPT A. A B. B C. C D. Y 19

20 Test Your Knowledge PCV13 is ACIP recommended for all individuals A years old B. 50 years old C. 60 years old D. 65 years old Test Your Knowledge A 3 year old with no medical condiaons and no respiratory issues needs influenza vaccinaaon. Which is the best opaon for this child? A. LAIV4 B. IIV4 C. RIV3 D. No Preference Need More Informa(on? Jayme Garcia, PharmD PGY1 Community Pharmacy Resident Smith s Food & Drug jayme.johnson@sfdc.com 20