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