Needle Facts:

Immunization Update

2018Miranda Wilhelm, Pharm.D.

Clinical Associate Professor

SIUE School of Pharmacy

Miranda Wilhelm reports she is a Speaker’s Bureau Member for Merck Vaccines

Disclosures and Conflict of Interest

At the conclusion of the program, the pharmacists will be able to:

1. Discuss the new 2018 Advisory Committee on Immunization Practices (ACIP)

recommendations regarding adult and pediatric immunizations

2. Compare and contrast the safety, efficacy and administration procedures for

the zoster vaccines available

3. Review influenza vaccine considerations in preparation for the 2018-2019

season

4. Analyze a patient’s immunization history to determine vaccine

recommendations based on the appropriate immunization schedule

Pharmacist Objectives

At the conclusion of this program, the pharmacy technician will be able to:

1. Discuss the new 2018 Advisory Committee on Immunization Practices (ACIP)

recommendations regarding adult and pediatric immunizations

2. Compare and contrast the safety, efficacy, and administration procedures for

the zoster vaccines available

3. Review influenza vaccine considerations in preparation for the 2018-2019

season

4. Analyze a patient’s immunization history to determine vaccine

recommendations based on the appropriate immunization schedule

Technician Objectives

Two doses of the MMR vaccine is effective in protecting against mumps in what

percentage of patients?

a) 56%

b) 78%

c) 88%

d) 100%

Pre-Test Question #1

Which of the following patients is a candidate for the Shingrix® vaccine?

a) 45 year old male with hypertension

b) 50 year old female using adalimumab for rheumatoid arthritis

c) 55 year old male who reports receiving the Zostavax® vaccine 1 month ago

d) 60 year old female who reports never receiving Zostavax®

Pre-Test Question #2

Heplisav-B® is a new hepatitis vaccine that is administered on which of the

following schedules?

a) One time dose

b) 0 and 1 month

c) 0, 1 and 6 months

d) 0, 6 months and 1 year

Pre-Test Question #3

Which of the following influenza vaccines exhibited superior efficacy for adults

aged ≥ 65 years?

a) Fluzone High Dose (IIV3-HD)

b) FluMist Quadrivalent (LAIV4)

c) Flucelvax Quadrivalent (ccIIV4)

d) Afluria Quadrivalent (IIV4)

Pre-Test Question #4

Recommendations of the ACIP for Use of a Third Dose of Mumps Virus-

Containing Vaccine in Persons at Increased Risk for Mumps During an Outbreak

Prevention of Hepatitis B Virus Infection in the United States:

Recommendations of the ACIP

Recommendations of the ACIP for Use of Herpes Zoster Vaccines

Recommendations of the ACIP for Use of a Hepatitis B Vaccine with a Novel

Adjuvant

Prevention of Pertussis, Tetanus, and Diphtheria with Vaccines in the United

States: Recommendations of the ACIP

Update: ACIP Recommendations for the Use of Quadrivalent Live Attenuated

Influenza Vaccine (LAIV4) – United States, 2018-2019 Influenza Season

Summary of ACIP Recommendations 2018

Third Dose of Mumps Vaccine

• MMWR, January 12, 2018; 67(1):33-37

Recommendation

• A 3rd dose of mumps vaccine should be administered to those who have previously received 2 doses and are at increased risk of acquiring mumps during an outbreak

Mumps Cases. CDC Website. Available at: https://www.cdc.gov/mumps/outbreaks.html. Accessed 5/11/18.

Mumps Cases. CDC Website. Available at: https://www.cdc.gov/mumps/outbreaks.html. Accessed 5/11/18.

Outbreaks

From January 1 to April 21, 2018, 45 states and DC have reported mumps infections in 923 patients to the CDC

2016-17 – outbreak in close-knit community in northwest Arkansas, resulted in nearly 3,000 cases

2015-16 – outbreaks at several university campuses (Iowa and Illinois), each involving several hundred cases

2014 – outbreaks at several university campuses (Ohio), involving over 400 cases

2009-10 – outbreak in close-knit community in New York City, resulted in over 3,000 cases mostly affecting high school-aged students

Vaccine effectiveness

Two doses of MMR vaccine is 88% (range: 66% to 95%) effective against mumps

One dose of MMR vaccine is 78% (range: 49% to 92%) effective against mumps

Mumps

Mumps Cases. CDC Website. Available at: https://www.cdc.gov/mumps/outbreaks.html. Accessed 5/11/18.

Prevention of Hepatitis B Virus

Infection

•MMWR, January 12, 2018; 67(1):1-31

Recommendations

•6 updates are included in this document

Universal hepatitis B vaccination within 24 hours of birth

Removal of language allowing for delay of birth dose until after discharge

Testing HBs-Ag-positive pregnant women for HBV DNA

Postvaccination serologic testing for infants whose mother’s HBs-Ag status is

unknown

Single-dose revaccination for infants born to HBs-Ag-positive mothers not

responding to initial vaccine series

Vaccination for persons with chronic liver disease

Prevention of Hepatitis B Virus Infection

MMWR, January 12, 2018; 67(1):1-31

Use of Herpes Zoster Vaccines

• MMWR, February 6, 2018; 67

Recommendation

• Shingrix is recommended for prevention of herpes zoster in immunocompetent adults aged 50 years and older

• Shingrix is recommended for adults aged 50 years and older that were previously vaccinated with Zostavax

• Shingrix is recommended preferentially over Zostavax

0

20

40

60

80

100

120

50-59 yrs 60-69 yrs 70-79 yrs >= 80 yrs

Zostavax Shingrix

Shingles Vaccine Effectiveness against

Herpes Zoster

Oxman MN, et al. N Engl J Med. 2005 Jun 2;352(22):2271-84.

Harpaz R, et al. MMWR Recomm Rep. 2008 Jun 6;57(RR-5):1-30.

Lal H et. al. N Engl J Med. 2015;372(22):2087–96.

Cunningham AL et al. N Engl J Med. 2016;375(11):1019–32

Age Vaccine Effectiveness against PHN (95% CI)

50 – 59 years 100.0% (40.8% - 100.0%)

60 – 69 years 100.0% (-442.9% - 100.0%)

70 – 79 years 93% (72.4% - 99.2%)

≥ 80 years 71.2% (-51.6% - 97.1%)

OVERALL ≥ 70 years 88.8% (68.7% - 97.1%)

Pooled Data from ZOE-50 & ZOE-70

(RZV – Shingrix)

Lal H et. al. N Engl J Med. 2015;372(22):2087–96.

Cunningham AL et al. N Engl J Med. 2016;375(11):1019–32.

Zostavax

• One-dose

• Live attenuated

• 0.65 mL

• Subcutaneous

• Storage – frozen

• FDA approval 50 years and older

• ACIP approval 60 years and older

Shingrix

• Two-doses

• Non-live, adjuvanted

• 0.5 mL

• Intramuscular

• Storage – refrigerated

• FDA approval 50 years and older

• ACIP approval 50 years and older

Comparison of Zostavax and Shingrix

New Hepatitis B Vaccine

•MMWR, April 20, 2018; 67(15):455-458

Recommendation

•Heplisav-B (Hep-CpG) may be used as a Hepatitis B vaccine in persons aged ≥ 18 years recommended for vaccination against HBV

•Heplisav-B is a 2-dose series administered at 0 and 1 month

Name

Heplisav-B

HBsAg combined with CpG1018 adjuvant (Toll-like receptor 9 agonist [TLR-9])

Indication

For prevention of infection causes by all known subtypes of hepatitis B virus in

adults 18 years of age and older

Dosage and administration

2-dose series, 0.5 mL, administered IM, one month apart

Adverse reactions

Injection site pain (23% - 39%), fatigue (11% - 17%), headache (8% - 17%)

Postmarketing surveillance for increased in cardiovascular events

New Hepatitis B Vaccine

Heplisav-B Package Insert. Dynavax Technologies Corporation. Available at: https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM584762.pdf. Accessed 5/11/18.

Foster SL. CDC’s ACIP recommends LAIV for 1018-19 flu season. Pharmacy Today. April 2018.

Prevention of Pertussis, Tetanus and Diphtheria

•MMWR, April 27, 2018; 67(2):1-44

Recommendation

•Does not contain new recommendations

•Summarizes all previously published ACIP recommendations regarding prevention and control of pertussis, tetanus and diphtheria

Use of LAIV4 in the 2018-2019 Influenza Season

• MMWR, June 8, 2018; 67 922):643-645

Recommendation

• LAIV4 is an option for the 2018-2019 influenza season if age and medical condition appropriate

• ACIP will continue to review data concern vaccine efficacy

In February 2018, ACIP voted to include LAIV in the 2018-2019 influenza

vaccine recommendations

Not included in 2016-2017 and 2017-2018 seasons due to concerns of vaccine

effectiveness

Manufacturer changed the H1N1 strain included in the vaccine

Now = A/Slovenia

Previous = A/Bolivia

Data

Clinical trial in 200 US children 2 to 4 years of age

A/Slovenia strain demonstrated higher seroconversion rates than A/Bolivia strain

It’s Back! ACIP Approves Use of LAIV

ACIP: LAIV OK to Use During 2018-2019 Flu Season. AAFP Website. Available at: https://www.aafp.org/news/health-of-the-public/20180226acipmtg-laiv.html. Accessed 5/4/18.

ACIP recommends LAIV for 2018-2019 influenza season. APhA Website. Available at: https://pharmacist.com/article/acip-recommends-laiv-2018-19-influenza-season. Accessed 5/4/18.

Influenza season is October to May and commonly peaks in January to

February

Annual influenza vaccination is recommended for all persons 6 months of age

and older

Influenza

https://www.cdc.gov/flu/weekly/#modalIdString_CDCTable_0

Inactivated Influenza Vaccine (IIV)

• Quadrivalent inactivated influenza vaccine (IIV4)

• Trivalent inactivated influenza vaccine (IIV3)

• Cell cultured inactivated influenza vaccine (ccIIV4)

• Adjuvanted inactivated influenza vaccine (aIIV3)

Recombinant hemagglutinin Influenza Vaccine (RIV)

• Quadrivalent recombinant hemagglutinin influenza vaccine (RIV4)

• Trivalent recombinant hemagglutinin influenza vaccine (RIV3)

Live-attenuated Influenza Vaccine (LAIV)

• Quadrivalent live-attenuated influenza vaccine (LAIV4)

MMWR, August 25, 2017; 66(2): 1-22.

Efficacy of HD-IIV3 vs SD-IIV3

RCT in 2009-2010 - primary outcome not evaluable due to emergence of H1N1pdm09 pandemic

RCT in 2011-2012 and 2012-2013 – HD-IIV3 exhibited superior efficacy over SD-IIV3 for adults ≥ 65 years

Efficacy of aIIV3 vs SD-IIV3

Nonramdomized, observation, prospective test negative case-control – aIIV3 exhibited superior relative effectiveness

No data are yet available from studies comparing the efficacy of HD-IIV3, aIIV3 and RIV4

The lack of comparative data prevent recommending one of these vaccines over another for this population

Efficacy of Influenza Vaccines in Older

Adult Patients

Grohskopf L, et al. MMWR, August 25, 2017, 66(2); 1–20.

A/Michigan/45/2015 (H1N1)pdm09-like virus

A/Singapore/INFIMH-16-0019/2016 (H3N2)-like virus

B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage)

Additional strain for quadrivalent vaccines

B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage)

Recommended Influenza Vaccine Composition 2018-2019

Recommended composition of influenza virus vaccines for use in the 2018-2019 northern hemisphere influenza season. World Health Organization Website. Available at:

http://www.who.int/influenza/vaccines/virus/recommendations/2018_19_north/en/. Accessed 5/1/18.

https://www.cdc.gov/flu/weekly/#modalIdString_CDCTable_0

https://www.cdc.gov/flu/weekly/#modalIdString_CDCTable_0

https://www.cdc.gov/flu/weekly/#modalIdString_CDCTable_0

https://www.cdc.gov/flu/weekly/#modalIdString_CDCTable_0

https://www.cdc.gov/flu/weekly/#modalIdString_CDCTable_0

Two doses of the MMR vaccine is effective in protecting against mumps in what percentage of patients?

a) 56%

b) 78%

c) 88%

d) 100%

According to the CDC, two doses of the vaccine are 88% (range: 66% to 95%) effective at protecting against mumps; one dose is 78% (range: 49% to 92%) effective. Studies have shown that the MMR vaccine protects against currently circulating mumps strains.

Post-Test Question #1

Which of the following patients is a candidate for the Shingrix® vaccine?

a) 45 year old male with hypertension

b) 50 year old female using adalimumab for rheumatoid arthritis

c) 55 year old male who reports receiving the Zostavax® vaccine 1 month ago

d) 60 year old female who reports never receiving Zostavax®

Shingrix® is indicated for prevention of herpes zoster in immunocompetent

adults aged 50 years and older AND for individuals within that age group that

were previously vaccinated with Zostavax® as long as the minimum interval (8

weeks) has been met.

Post-Test Question #2

Heplisav-B® is a new hepatitis vaccine that is administered on which of the

following schedules?

a) One time dose

b) 0 and 1 month

c) 0, 1 and 6 months

d) 0, 6 months and 1 year

The recommended administration schedule for Heplisav-B® is 0 and 1 months.

This is a new adjuvanted hepatitis B vaccine indicated for patients 18 years of

age and older.

Post-Test Question #3

Which of the following influenza vaccines exhibited superior efficacy for adults

aged ≥ 65 years?

a) Fluzone High Dose (IIV3-HD)

b) FluMist Quadrivalent (LAIV4)

c) Flucelvax Quadrivalent (ccIIV4)

d) Afluria Quadrivalent (IIV4)

HD-IIV3 when compared to SD-IIV3 exhibited superior efficacy in a large

(N=31,989), two-season randomized, controlled, double-blind trial and might

provide better protection than SD-IIV3 for this age group.

Post-Test Question #4

A third dose of mumps containing vaccine may be administered during an outbreak to those who have previously received 2 doses

Shingrix is recommended, preferentially, for prevention of herpes zoster in immunocompetent adults aged 50 years and older AND for individuals within that age group that were previously vaccinated with Zostavax

Shingrix is 97.2% effective in preventing shingles and 88.8% effective in preventing posterpetic neuralgia

LAIV has been recommended by the ACIP to be included as an influenza vaccine for the 2018-2019 season

Heplisav-B is a new 2 dose series hepatitis B vaccine administered at 0 and 1 month for those 18 years and older

HD-IIV3 exhibited superior efficacy over SD-IIV3 and might provide better protection for patients ≥ 65 years of age

Take Home Points

Immunization Action Coalition

www.immunize.org

Advisory Committee on Immunization Practices

www.cdc.gov/vaccines/acip/index.html

Centers for Disease Control and Prevention Vaccines and Immunizations

www.cdc.gov/vaccines/index.html

Be FLUent

www.pharmacist.com/befluent

CDC Weekly US Influenza Surveillance Report

www.cdc.gov/flu/weekly/index.htm

Resources & References

Needle Facts:

Immunization Update

2018Miranda Wilhelm, Pharm.D.

Clinical Associate Professor

SIUE School of Pharmacy

miwilhe@siue.edu