`Tis the Season - Mayo Clinic the Season - Influenz… · ©2016 MFMER | slide-14 Influenza Update...

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`Tis the Season Influenza and Pneumococcal Vaccine Updates

Alex Quinn, PharmDPGY2 Ambulatory Care ResidentPharmacy Grand RoundsSeptember 20, 2016


Objectives• Identify current influenza and pneumococcal

immunization recommendations

• Explain rationale behind the current recommendations

• Select an appropriate influenza and pneumococcal immunization schedule for patients


Influenza Vaccine


Who should receive the influenza vaccine?

• All persons > 6 months of age without contraindications

Grohskopf LA, et al. MMWR Recomm Rep 2016;65(5):1-56


Types of Influenza Vaccines• Inactivated Influenza Vaccines (IIVs)

• Available as trivalent (IIV3) & quadrivalent (IIV4)

• Recombinant Influenza Vaccine (RIV)• 1 RIV product Flublok

• Live Attenuated Influenza Vaccine (LAIV)• 1 LAIV4 product FluMist Quadrivalent



Influenza Update #1 for 2016-17 Season• Vaccine Composition:

• Trivalent vaccines:• A/California/7/2009 • A/Hong Kong/4801/2014 • B/Brisbane/60/2008

• Quadrivalent vaccines:• All of the above strains plus…• B/Phuket/3073/2013



Influenza Update #2 for 2016-17 Season

• LAIV4 should NOT be used• ACIP interim recommendation

Grohskopf LA, et al. MMWR Recomm Rep 2016;65(5):1-56LAIV4: quadrivalent live attenuated influenza vaccineACIP: Advisory Committee on Immunization Practices


Intranasal Efficacy ConcernsStudy U.S. Influenza

Vaccine EffectivenessNetwork

Department of Defense Laboratory-based Influenza Surveillance

ICICLE Observational Study

Population • 2286 patients • 2 – 17 years • Acute respiratory

illness including cough < 7 days

• Military dependents• 2 – 17 years• Influenza-like illness

• 1012 patients• 2 – 17 years• Febrile acute

respiratory illness with onset < 5 days

Timeframe 11/2/15 – 4/15/16 Not specified 11/30/15 – 4/15/16

Design Test-negative design Test-negative design Test-negative design

Efficacy Results

LAIV4: 3% IIV3/4: 63%

LAIV4: 53%IIV3/4: 66%

LAIV4: 46%IIV: 65%

CDC Web site. Available at: www.cdc.gov/media/releases/2016/s0622-laiv-flu.htmlFlannery B. et al. US Flu VE Network. Available at: http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2016-06/influenza-05-flannery.pdf. Ambrose C. Influenza Clinical Investigation for Children (ICICLE) Study. Available at: http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2016-06/influenza-06-ambrose.pdf.

LAIV4: quadrivalent live attenuated influenza vaccineIIV3/4: trivalent/quadrivalent inactivated influenza vaccineIIV: inactivated influenza vaccine


LAIV vs. IIV Efficacy from US Flu VE Network

-10%

0%

10%

20%

30%

40%

50%

60%

70%

80%

2010 -2011

2011 -2012

2012 -2013

2013 -2014

2014 -2015

2015 -2016

LAIV3LAIV4IIV3IIV3/4

Flannery B. Influenza Division, CDC. Available at: http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2016-06/influenza-07-flannery.pdf.

LAIV3: trivalent live attenuated influenza vaccineLAIV4: quadrivalent live attenuated influenza vaccineIIV3: trivalent inactivated influenza vaccineIIV3/4: trivalent/quadrivalent inactivated influenza vaccine


Conflicting Evidence in Canada • Does vaccinating children & adolescents with LAIV provide

better community protection than IIV?• Design

• Cluster randomized blinded trial • Conducted between October 2012 and May 2015

• Primary endpoint• Reverse transcriptase polymerase chain reaction-confirmed influenza A

or B virus

• Population• 52 Hutterite colonies in Alberta & Saskatchewan, Canada• 1186 Canadians aged 36 months to 15 years received vaccine

Loeb M. et al. Ann Intern Med. Epub 2016 Aug 16: 1-13.LAIV: live attenuated influenza vaccineIIV: inactivated influenza vaccine


Conflicting Evidence in Canada

• Intervention• Randomly assigned, blinded

• Trivalent LAIV or trivalent IIV

• Results• Rate of influenza A or B virus infection:

• LAIV: 5.3%• IIV: 5.2%• Hazard ratio: 1.03 (95% CI 0.85 to 1.24)

• Limitations• Canada using LAIV3• U.S. using LAIV4

Loeb M. et al. Ann Intern Med. Epub 2016 Aug 16: 1-13.LAIV: live attenuated influenza vaccineLAIV3: trivalent live attenuated influenza vaccineLAIV4: quadrivalent live attenuated influenza vaccineIIV: inactivated influenza vaccine


Hypothesis for LAIV4 decreased effectiveness

• Suboptimal vaccine component performance

• Potential interference among live viruses

• More highly vaccinated population

Flannery B. Influenza Division, CDC. Available at: http://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2016-06/influenza-07-flannery.pdf.


Influenza Update #3 for 2016-17 Season• History of severe allergic reaction to egg

Symptom Influenza Vaccine Product

Administration Recommendations

Only hivesAny licensed & recommended

influenza vaccine

Supervision NOTrequired

Any symptom other than hives

Any licensed & recommended

influenza vaccine

Vaccinate under the supervision of a

health care provider



Influenza Update #3 for 2016-17 Season

• No longer need to monitor egg-allergic recipients for 30 minutes postvaccination

• Consider monitoring all patients at least 15 minutes postvaccination



Assessment Question #1• What is a potential reason(s) for the decreased

efficacy with LAIV4?

a) Interference amongst vaccine strainsb) Recipient is not inhaling full dosec) Population is more highly vaccinatedd) A & Ce) A, B, & C

LAIV4: quadrivalent live attenuated influenza vaccine


Influenza Vaccine Highlights• Continue recommending influenza vaccine for

• Patients > 6 months of age

• Intranasal flu vaccine is not recommended

• Egg-allergic patients:• Administer under supervision of health care provider

• If history of severe allergic reaction (other than hives)• 30 minute post-vaccination observation no longer required


Pneumococcal Vaccine


Types of Pneumococcal Vaccines

Product PCV13 (Prevnar 13) PPSV23 (Pneumovax 23)Composition 13-valent pneumococcal

conjugate vaccine

Protein Carrier = Diphtheria CRM197

23-valent pneumococcal polysaccharide vaccine

Dose 0.5 mL 0.5 mL

Route IM IM or SC

Preservatives No Yes

Pharmacologic Category

Inactivated vaccine Inactivated vaccine

PCV13 & PPSV23 are NOT interchangeable Clinical Pharmacology Web site. Accessed August 20, 2016.Plosker, GL et al. Drugs (2015)75:1535-1546.Facts & Comparisons Web site. Accessed August 20, 2016.UpToDate Web site. Accessed August 20, 2016.

PCV13: pneumococcal conjugate vaccine (13 valent)PPSV23: pneumococcal polysaccharide vaccine (23 valent)IM: intramuscularSC: subcutaneous


Why do we need to give 2 vaccines?• Polysaccharide antigens are poorly immunogenic in children

< 2 years old

• PCV13 has shown to elicit similar or higher antibody titers compared to PPSV23

• Giving PPSV23 followed by PCV13 has shown lower antibody response than giving PCV13 first

• Potential for broader protection by utilizing both vaccines

MMWR. 2012; 61(40):816-819.Tomczyk S. et al. MMWR. 2014; 63(37):822-825.

PCV13: pneumococcal conjugate vaccine (13 valent)PPSV23: pneumococcal polysaccharide vaccine (23 valent)


Review of CAPiTA Trial• Determine efficacy of pneumococcal conjugate vaccine in

adults > 65 years

• Design• Parallel-group, randomized, placebo-controlled, double-blind trial

• Primary Endpoint• Efficacy of PCV13 in prevention of a 1st episode of confirmed vaccine-

type CAP

• Population• > 65 years of age• Enrolled between 9/15/2008 and 1/30/2010

• Intervention• Randomly assigned 1:1 to receive PCV13 or placebo

Bonten MJM, et al. N Engl J Med. 2015;372:1114-25.CAPiTA: Community-Acquired Pneumonia Immunization Trial in AdultsPCV13: pneumococcal conjugate vaccine (13 valent)CAP: community acquired pneumonia


Review of CAPiTA Trial

49

90

0

10

20

30

40

50

60

70

80

90

100

Number of Confirmed CAP with

vaccine-type strain

PCV13Placebo

P < 0.001

Bonten MJM, et al. N Engl J Med. 2015;372:1114-25.CAPiTA: Community-Acquired Pneumonia Immunization Trial in AdultsPCV13: pneumococcal conjugate vaccine (13 valent)CAP: community acquired pneumonia


Does my patient need a pneumococcal vaccine?• How old are they?

• 19 – 64 years of age• > 65 years of age

• Medical history?• Immunocompetent with specific chronic diseases• Immunocompromised• Functional or anatomic asplenia• Cerebrospinal fluid (CSF) leak • Cochlear implant

• Vaccine naïve?


General Guidelines

• Adults recommended to receive:• 1 dose of PCV13• 1, 2, or 3 doses of PPSV23

• Ideally PCV13 should be given 1st (when both are indicated)

• Separate PCV13 & PPSV23 by at least 1 year• Exception: separate by at least 8 weeks

• Adults with immunocompromising conditions• Anatomical or functional asplenia• Cerebrospinal fluid leak• Cochlear implant

• Separate PPSV23 doses by at least 5 years

CDC Web site. Adult Immunization Schedule. Available at: https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdf



Pneumococcal Vaccination 19 – 64 Years OldImmune Status Immunocompetent

Risk Factors • Alcoholism• Cardiac: except hypertension• Diabetes• Liver• Pulmonary• Smoking

• Cerebrospinal fluid leak• Cochlear implant

Vaccine Naïve Yes

NoPPSV23 already

givenYes

NoPPSV23 already

given

Vaccine TypePPSV23

No doses needed until

age 65PCV13

PCV131 year after

PPSV23

Interval 8 weeks

Vaccine Type PPSV23

MMWR. 2010;59(34);1102-1106CDC Web site. Adult Immunization Schedule. Available at:www.cdc.gov/vaccines/schedules/hcp/imz/adult-compliant.html. MMWR. 2012;61(40);816-819CDC Web site. Recommended Adult Immunization Schedule. Available at: https://www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdfImmunization Action Coalition Web site. Available at:www.immunize.org/catg.d/p2011.pdfMinnesota Department of Health Web site. Available at: http://www.health.state.mn.us/divs/idepc/diseases/pneumococcal/hcp/pocket.pdf



Pneumococcal Vaccination 19 – 64 Years OldImmune Status Immunocompromised or Functional/Anatomic Asplenia

Vaccine Naïve Yes No1 PPSV23 already given

No2 PPSV23 already given

Vaccine Type PCV13 PCV131 year after PPSV23

PCV131 year after PPSV23

Interval 8 weeks

8 weeks after PCV13and

5 years after PPSV23

Vaccine Type PPSV23 PPSV23

Interval 5 years

Vaccine Type PPSV23

MMWR. 2012;61(40);816-819CDC Web site. Recommended Adult Immunization Schedule. Available at:www.cdc.gov/vaccines/schedules/downloads/adult/adult-combined-schedule.pdfCDC Vaccine Schedules AppMinnesota Department of Health Web site. Available at: http://www.health.state.mn.us/divs/idepc/diseases/pneumococcal/hcp/pocket.pdf



Vaccine Naïve Yes

NoPreviously received PPSV23 at age > 65

NoPreviously received PPSV23 at age < 65

NoPreviously received PCV13 & possibly

PPSV23 at age < 65

Interval NA1 year after

PPSV231 year after

PPSV23

8 weeks after PCV13 and 5 years after

PPSV23

Vaccine Type PCV13 PCV13 PCV13 PPSV23

Interval > 1 year

1 year after PCV13and

5 years after PPSV23

Vaccine Type PPSV23 PPSV23

Pneumococcal Vaccination > 65 Years Old

Tomczyk S et al. MMWR. 2014:63(37);822-825Kobayashi M et al. MMWR. 2015:64(34);944-947MMWR. 2012;61(40);816-819MMWR. 2010;59(34);1102-1106CDC Vaccine Schedules AppMN Department of Health Web site. Available at: http://www.health.state.mn.us/divs/idepc/diseases/pneumococcal/hcp/pocket.pdf



Case for Assessment Questions # 2 & 3• 71 year old male with PMH significant for

GERD, hypertension, migraines, and history of smoking 1 pack per day x20 years (quit 8 years ago). Immunization history: PPSV23 01/2005, influenza vaccine 9/2013, 9/2014, 10/2015, Tdap 7/2011.

PMH: past medical historyGERD: gastroesophageal reflux diseasePPSV23: pneumococcal polysaccharide vaccine (23 valent)Tdap: tetanus toxoid-reduced diphtheria toxoid-acellular pertussis


Assessment Question #2• Does patient qualify for a pneumococcal vaccine?

a) Yes

b) No


Assessment Question #3• What pneumococcal vaccine regimen would

you recommend?a) PCV13 nowb) PPSV23 now, followed by PCV13 in 9/2017c) PPSV23 now, followed by PCV13 in

9/2017, then PPSV23 in 9/2022d) PCV13 now, followed by PPSV23 in

9/2017



Pneumococcal Vaccine Highlights• Vaccination sequence & timing dependent upon:

• Age• Medical history• Pneumococcal vaccine history

• Adults recommended to receive:• 1 dose of PCV13• Up to 3 doses of PPSV23

• Interval either 8 weeks, 1 year, or 5 years



Questions & Discussion


`Tis the Season Influenza and Pneumococcal Vaccine Updates

Alex Quinn, [email protected]

`Tis the Season - Mayo Clinic the Season - Influenz… · ©2016 MFMER | slide-14 Influenza Update...

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