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What’s New With Immunizations

2018 Annual Update COURTNEY A. ROBERTSON, PHARMD, BCPS

CLINICAL ASSISTANT PROFESSOR

UNIVERSITY OF LOUISIANA AT MONROE

COLLEGE OF PHARMACY

Disclosures

No financial disclosures to report

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Learning Objectives Pharmacist Objectives:

List important updates to most current vaccine recommendations for adults and children.

Apply recent changes in adult and pediatric immunization schedules to pharmacy practice.

Summarize information regarding newly available vaccines and those in development phases.

Pharmacy Technician Objectives:

Recognize current age-appropriate immunization schedules.

List important updates to most current vaccine recommendations for adults and children.

Summarize information regarding newly available vaccines and those in development phases.

Vaccine-Preventable Diseases

Epidemiology and Prevention of Vaccine-Preventable Diseases. 12th ed.; May 2012 JAMA. 2007;298:2155‒263 MMWR. Weekly / February 10, 2017 /66(05)

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CDC and ACIP – Roles in Immunizations •The Centers for Disease Control and Prevention (CDC) determine childhood and adult immunization schedules based on recommendations from the Advisory Committee on Immunization Practices (ACIP)

•ACIP recommendations consider multiple factors, including disease epidemiology, vaccine safety and efficacy, and economics

•Once approved by the CDC director, ACIP recommendations become agency guidelines on the date published in Morbidity and Mortality Weekly Report (MMWR)

Working To Meet 2020

Goals

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States Authorizing Pharmacists to Administer Influenza Vaccine & Pharmacists Trained to Administer Vaccines Updated December 2017

https://www.pharmacist.com/sites/default/files/files/States_Authorizing_Pharmacists_vs_training_December_2017.pdf

Pharmacists Making a Difference “Five years after national implementation, we estimate that 6.2 million additional influenza immunizations and 3.5 million additional pneumococcal immunizations are attributable to pharmacy-delivered immunization services, each year”

https://www.uspharmacist.com/article/millions-more-get-flu-pneumonia-vaccines-because-of-pharmacy-services/?wc_mid=4:556851&wc_rid=4:5388702

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There’s an App for That…

•Free tool that allows users to identify correct vaccine, dosage, and timing with a few clicks

•Provides the most current version of ◦ Child and adolescent schedules with immunization ◦ Catch-up schedule for children ◦ Adult schedule, including recommendations for adults by age group and by

medical condition ◦ Contraindications and precautions table, with all footnotes that apply to

schedules

•Any changes in the schedules will be released through app updates

•Share content through social media sites

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Childhood Schedule Changes •Medical indications • Information regarding HIV lab parameters and use of live vaccines included in HIV column

• Pneumococcal row clarified that in some situations an additional dose of vaccine may be recommended for children with heart disease/chronic lung disease, chronic liver disease, and diabetes

•MenHibrix® – no longer available; removed from the schedule

•Hepatitis B vaccine – revised footnote information pertaining to infants weighing less than 2 g born to HBsAg-negative mothers • Recommended birth dose of HepB vaccine at chronological age 1 month or at hospital

discharge

Childhood Schedule Changes •Polio vaccine – catch-up schedule modified to clarify recommendations for children 4 years and older and updated guidance for patients receiving oral polio vaccine during series

•Rotavirus vaccine – maximum ages for providing first and last dose of series added to catch-up schedule

•Measles, Mumps, and Rubella vaccine – updated footnote regarding use of a third dose during mumps outbreak • Children 12 months of age and older who have received no more than two doses of mumps-

containing vaccine should receive another dose during outbreak

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Adult Schedule Changes •Measles, Mumps, and Rubella vaccine – administer one dose to adults who previously received two doses or less of mumps-containing vaccine and are identified to be at increased risk during a mumps outbreak

•Zoster vaccines – two vaccines now available; recombinant zoster vaccine (RZV; Shingrix®) and zoster vaccine live (ZVL; Zostavax®) ◦ ZVL has replaced the term HZV (herpes zoster vaccine) used in past schedules

•Meningococcal vaccine – 4-valent meningococcal polysaccharide vaccine (MPSV4) is no longer available; removed from the adult immunization schedule

https://www.cdc.gov/flu/pandemic-resources/1918-commemoration/index.htm

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Influenza Vaccine – Test Your Knowledge A patient walks into the pharmacy and would like you to administer the annual flu vaccine to her 10 year old daughter, Hannah. Hannah is healthy, has no chronic medical conditions, and is up to date on all of her childhood vaccinations. For the upcoming flu season 2018-19, which is the most appropriate vaccine to use according to ACIP recommendations?

A. Inactivated quadrivalent influenza vaccine (Fluzone®)

B. Live attenuated influenza vaccine (Flumist® nasal spray)

C. Intradermal inactivated influenza vaccine (Fluzone® Intradermal)

D. A or B only

E. Any of the above

2017-18 Influenza Season – Key Facts •Strongest season since the H1N1 pandemic of 2009

•174 flu-related pediatric deaths this season

•30,451 laboratory-confirmed influenza-associated hospitalizations reported through Influenza Hospitalization Network between 10/1/2017 and 4/30/2018 ◦ Data collected from 13 states and represent approximately 9% of the total U.S. population

◦ Cumulative overall rate of 106.6 hospitalizations per 100,000 people in the United States

https://www.cdc.gov/flu/weekly/summary.htm

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2017-18 Influenza Season Peak Activity

https://gis.cdc.gov/grasp/fluview/main.html

Influenza Vaccine Coverage

https://www.cdc.gov/flu/fluvaxview/nifs-estimates-nov2017.htm

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2018-19 Influenza Recommendations •Vaccination is recommended for all persons aged 6 months and older • No preference stated for any influenza vaccine product

•Ideal to vaccinate before flu activity begins; CDC recommends vaccination before October 31st

•Live attenuated influenza vaccine (Flumist® nasal spray) was reinstated as one of the recommended vaccine options for 2018-19 season • Effectiveness against Type A H1N1 viruses unknown

https://www.aap.org/en-us/about-the-aap/aap-press-room/Pages/AAP-Advises-Parents-to-Choose-the-Flu-Shot-For-2018-2019-Flu-Season.aspx

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Influenza Vaccine – Test Your Knowledge A patient walks into the pharmacy and would like you to administer the annual flu vaccine to her 10 year old daughter, Hannah. Hannah is healthy, has no chronic medical conditions, and is up to date on all of her childhood vaccinations. For the upcoming flu season 2018-19, which is the most appropriate vaccine to use according to ACIP recommendations?

A. Inactivated quadrivalent influenza vaccine (Fluzone®)

B. Live attenuated influenza vaccine (Flumist® nasal spray)

C. Intradermal inactivated influenza vaccine (Fluzone® Intradermal)

D. A or B only

E. Any of the above

Herpes Zoster

saintangelandcreative.com

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Herpes Zoster Vaccines 2018 ACIP Recommendations

•Zoster vaccine recombinant (RZV) is recommended for the prevention of herpes zoster and related complications in immunocompetent adults aged ≥50 years

•RZV is recommended in immunocompetent adults who previously received zoster vaccine live (ZVL); RZV should not be administered <2 months after receipt of ZVL

•RZV is preferred over ZVL for the prevention of herpes zoster and related complications

Special Populations

•History of herpes zoster, chronic medical conditions, immunocompromised, varicella zoster virus negative persons

https://www.pharmacist.com/focus-herpes-zoster

Shingrix® Preferred Over Zostavax® •In October 2017, Shingrix®, a recombinant lyophilized varicella zoster virus (RZV) glycoprotein E (gE) antigen vaccine, was approved by the FDA

•Development occurred due to concerns for long-term efficacy and increased incidence of herpes zoster • Shown to reduce the occurrence of shingles by 96.6% in patients aged 50 to 59 years, 97.4%

in patients aged 60 to 69 years, and 91.3% in patients aged ≥70 years compared to about 50% in patients aged ≥60 years with Zostavax®

• Among those aged ≥50 years, vaccine efficacy against postherpetic neuralgia was 91.2% and 88.8% in those aged ≥70 years compared to only 39% with Zostavax®

https://www.cdc.gov/mmwr/volumes/67/wr/mm6703a5.htm https://www.pharmacist.com/focus-herpes-zoster

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Warn Your Patients! •Shingles Vaccines 2018

◦ https://youtu.be/GTDqY8WM-dk

•Shingrix® shown to be very “reactogenic” with pain/swelling at injection site, malaise, aches, and symptoms interfering with daily activities ◦ Incidence much higher most likely due to adjuvant

◦ NEJM Journal Watch blog comment about Shingrix® ◦ “I got my first vaccine last week since I received the live vaccine 15 years ago. I thought the price

would be the most painful component since it isn’t covered by Medicare. I can’t overemphasize how painful that shot was. I could perform most of my daily activities once I was able to put a shirt on. When it came to swimming my daily mile of freestyle which I rarely miss that was delayed for 3 days when I could finally raise my arm.”

https://www.nejm.org/doi/full/10.1056/NEJMoa1501184 https://blogs.jwatch.org/hiv-id-observations/index.php/shingles-vaccine-video-new-name-c-diff-flu-b-rising-pre-valentines-day-id-link-o-rama/2018/02/12/

Vaccine Administration Errors Involving Recombinant Zoster Vaccine — United States, 2017–2018

MMWR Weekly / May 25, 2018 / 67(20);585–586

•During the first four months of monitoring, VAERS received 155 reports involving Shingrix® (RZV) ◦ 13 administration errors (SQ instead of IM)

◦ Inappropriate age

◦ Incorrect VIS

◦ Incorrect storage

◦ Administration of only adjuvant component without reconstitution with vaccine antigen

•Shingrix® should be given intramuscularly in two doses

•The second dose should be administered 2 to 6 months after the first

•Zostavax®(ZVL) should be given subcutaneously in one dose

https://www.jwatch.org/fw114210/2018/05/25/after-clinician-errors-cdc-reminds-providers-proper?query=pfwTOC&jwd=000012902133&jspc= https://www.cdc.gov/mmwr/volumes/67/wr/mm6720a4.htm

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Key Differences between Herpes Zoster Vaccines

https://www.pharmacist.com/focus-herpes-zoster

https://www.cdc.gov/mmwr/volumes/67/wr/mm6720a4.htm#T1_down

Shingrix® Demand Outpaces Supply May 1, 2018

◦ CDC states providers should expect ordering limits and shipping delays through end of June

◦ GSK is working to make more doses available

◦ Shingrix® vaccination recommendations remain the same regardless of shortages

CDC Update June 2018 ◦ “Due to high levels of demand for GSK’s Shingrix vaccine, GSK has implemented order limits

and providers have experienced shipping delays. It is anticipated these order limits and shipping delays will continue throughout 2018. In response, GSK has increased the US supply available for 2018 and plans to release doses to all customer types on a consistent and predictable schedule for the rest of 2018. Overall, the supply of Shingrix during 2018 is sufficient to support the vaccination of more patients during 2018 than were vaccinated against shingles during 2017.” https://www.cdc.gov/vaccines/hcp/clinical-resources/shortages.html#note4

https://www.pharmacist.com/article/shingrix-demand-outpaces-supply

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A patient was inadvertently given RZV by the subcutaneous rather than the intramuscular route. Does the dose need to be repeated?

RZV has been shown to be immunogenic when given by the subcutaneous route. A dose erroneously given by this route does not need to be repeated.

http://www.immunize.org/askexperts/experts_zos.asp

Hepatitis B Vaccine •11/09/2017: FDA approved HEPLISAV-B®, a recombinant adjuvanted Hepatitis B vaccine for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older

•HEPLISAV-B® is the first new hepatitis B vaccine in the United States in more than 25 years and the only two-dose hepatitis B vaccine for adults

https://www.cdc.gov/vaccines/acip/recs/grade/hepb.html

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Mumps and New Recommendations • Mumps outbreaks still occur in

highly vaccinated US communities, especially in close contact settings

• Recent increase from 229 cases in 2012 to 6,366 cases in 2016

• 2 doses of mumps vaccine = 88% effective at preventing disease; 1 dose = 78% effective

• Studies have shown 78% lower risk of mumps with 3-dose regimen

• ACIP recommends third dose to all persons previously vaccinated with 2-dose series at increased risk due to an outbreak

https://www.cdc.gov/mumps/outbreaks.html

Developing one vaccine is estimated to cost $200 million and at least 10 years

Innovators are thinking outside the syringe for new ways of developing, shipping, storing, and administering vaccines

In the last 20 years, over 21 million hospitalizations and 732,000 deaths could have been saved by existing vaccines in the US alone

http://www.phrma.org/sites/default/files/pdf/Vaccines_2013.pdf http://innovations.clevelandclinic.org/Summit/Top-10-Medical-Innovations/Top-10-for-2018/6-Next-Generation-Vaccine-Platforms.aspx

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Immunization for the Ages IN LOUISIANA

Influenza vaccine:

-may be administered without a Rx to anyone ≥ 7 years

-may be administered with a Rx to anyone ≥ 3 years

ANY vaccine:

-may be administered without a Rx to anyone ≥ 17 years

THINGS TO REMEMBER

Documentation is required for ALL vaccines administered, update BLS every 2 years and send to LABP, 1 hour Immunization-related CE per year, OSHA/Bloodborne Pathogen training, sign up for LINKS

•From 2010 to 2016 influenza seasons, there were 128-223 shoulder injury reports in 130 million doses

•Best strategy to minimize injury = maintain same level as patient and target lower two-thirds of the deltoid muscle

https://www.cdc.gov/vaccines/hcp/infographics/you-call-the-shots-intramuscular-flu-vaccination.html https://www.uspharmacist.com/issue/may-2018

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Document in LINKS and VAERS

In-depth demonstration of the two methods for submitting VAERS report electronically

https://www.youtube.com/watch?v=9IVCzQFOhew

References •Centers for Disease Control and Prevention

◦ Vaccines and Immunizations - http://www.cdc.gov/vaccines/index.html

◦ ACIP Vaccine-Specific Recommendations - http://www.cdc.gov/vaccines/hcp/acip-recs/index.html

◦ Immunization Schedules for Health Care Professionals - http://www.cdc.gov/vaccines/schedules/hcp/index.html

◦ Vaccination Coverage Rates and Data/NIS - http://www.cdc.gov/vaccines/imz-managers/coverage/index.html

•American Pharmacists Association

◦ APhA Pharmacy-Based Immunization Delivery Certificate Training Program, 14th edition -http://www.pharmacist.com/immunization-center

•Mospan, C. New Vaccines and Immunization Schedule Changes. https://www.uspharmacist.com/issue/may-2018

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Questions