1. Immunization Update Amelia Arnold, PharmD
Retail Pharmacy Operations Manager, Community Pharmacies, LP
President-Elect, Maine Pharmacy Association
September 2018

2. Disclosures
I have nothing to disclose concerning possible financial or personal relationships with commercial entities that may have a direct or indirect interest in the subject matter of this presentation.

3. Objectives
Recognize the changes made by the Advisory Committee on Immunization Practices (ACIP) to the 2018 immunization schedules
Discuss ACIP recommendations for use of the new herpes zoster vaccine Shingrix
Describe the available influenza vaccine products and recommendations for the season
List the current influenza antiviral recommendations

4. Disclaimer
All recommendations and data in this slide were developed prior September 22nd, and revolve around CDC and ACIP guidelines
All information in this presentation is subject to change based on new guideline recommendations by the aforementioned governing bodies

5. Flu Shot Options Quadrivalent standard dose
Cell-based technology quadrivalent
Recombinant egg-free quadrivalent
High-dose trivalent
Trivalent with adjuvant
Live-attenuated, inhaled quadrivalent

7. Quad Flu Shot- Examples
Afluria
Fluarix
Flulaval
Fluzone
Agriflu
Flucelvax
Flublok

8. Alternative Delivery System
Uses high pressure, narrow stream of fluid to penetrate the skin instead of a needle
Afluria MDV approved for administration via jet injector

9. Flucelvax® Approved August 2016 0.5 mL given IM in deltoid
Approved for ages 4 years and older
‘Cell-based’ flu vaccine
Original vaccine virus is still grown in eggs, but mass production is performed by growing viruses in animal cells
Flucelvax [Prescribing Information]. Seqirus Inc., Holly Springs, North Carolina. April 2017.

10. Patients with Egg Allergies
Recommendation from ACIP, United States, began in Influenza Season
IIV= Inactivated influenza vaccine
RIV= Recombinant influenza vaccine

11. FluBlok ® FDA approved 2013 0.5 mL given IM in deltoid
Protein Sciences Corp
Quadrivalent
Approved for 18 years and older
Only vaccine that is completely egg free
FluBlok [Prescribing Information]. Protein Sciences Corporation, Meriden, Connecticut. March 2017.

12. Egg-Free Vaccine Effectiveness
FluBlok [Prescribing Information]. Protein Sciences Corporation, Meriden, Connecticut. March 2017.

13. Fluzone® HD FDA approved 2014 0.5 mL given IM in deltoid
Approved for ages 65 and older
Has 4 times the antigen for a higher immune response
High incidence of adverse effects such as pain, erythema, fever, etc.
Fluzone HD [Prescribing Information]. Sanofi Pasteur, Swiftwater, Pennsylvania. July 2017.

14. Comparison of HD vs. Traditional
Fluzone HD [Prescribing Information]. Sanofi Pasteur, Swiftwater, Pennsylvania. July 2017.

15. Fluad ™
FDA approved in 2015
Adjuvanted, inactivated, trivalent vaccine
0.5 mL given IM in deltoid
Approved for 65 years and older
Fluad [Prescribing Information]. Seqirus Inc., Liverpool, United Kingdom. March 2017.

16. Immunology Review: Adjuvant
An adjuvant is an ingredient of a vaccine that helps create a stronger immune response in the patient’s body.
A vaccine made with adjuvants ensures the body produces an immune response strong enough to protect the patient from the germ he or she is being vaccinated against.

17. Fluad ™ A proprietary adjuvant called MF59®
MF59 is an emulsion of the oil squalene, which is a naturally occurring substance in the body
Demonstrated non-inferiority compared to standard trivalent flu shots in a study
Fluad [Prescribing Information]. Seqirus Inc., Liverpool, United Kingdom. March 2017.

18. Fluad ® Studies

19. FluMist® Intranasal, quadrivalent, live flu vaccine
0.2 mL given in each nostril, 0.4 mL total
Approved in healthy, non-pregnant individuals from 2 years to 49 years
Depress plunger in nostril until the dose divider clips stop it, then remove and repeat in second nostril
FluMist [Prescribing Information]. MedImmune, Gaithersburg, MD August 2017.

20. FluMist®
For flu season, CDC voted to NOT recommend the FluMist vaccine
In February 2018, CDC ACIP voted to recommend FluMist for the flu season

21. FluMist®

22. Strains in 2017-2018 Trivalent formulation:
A/Michigan/45/2015 (H1N1)pdm09-like virus
A/Hong Kong/4801/2014 (H3N2)-like virus
B/Brisbane/60/2008-like (B/Victoria lineage) virus
Additional strain in Quad:
B/Phuket/3073/2013-like (B/Yamagata lineage) virus

23. 2017-2018 Positive Influenza Tests

24. 2017-2018 Positive Influenza Tests

25. So how did the vaccine do?

26. Strains in 2017-2018 Trivalent formulation:
A/Michigan/45/2015 (H1N1)pdm09-like virus
A/Hong Kong/4801/2014 (H3N2)-like virus
B/Brisbane/60/2008-like (B/Victoria lineage) virus
Additional strain in Quad:
B/Phuket/3073/2013-like (B/Yamagata lineage) virus

27. Vaccine Efficacy 2017-2018 Overall efficacy was estimated at 40%
B Strains: 49%
H1N1 Efficacy: 65%
H3N2 Efficacy: 25%

28. 2017-2018 Positive Influenza Tests

29. Effectiveness of Seasonal Flu Vaccines from the 2004-2018 Flu Seasons

30. Strains in
World Health Organization voted on March 1 for the vaccine composition for
Trivalent:
A/Michigan/45/2015 (H1N1)pdm09-like virus
A/Singapore/INFIMH /2016 (H3N2)-like virus
B/Colorado/06/2017-like virus (B/Victoria/2/87 lineage)
In Quad:
B/Phuket/3073/2013-like virus (B/Yamagata/16/88 lineage)

31. What’s the best flu shot?
The one that is available!

32. What happens after you get the flu?

33. Antivirals Can shorten illness by 1 or 2 days
CDC urges consideration of antiviral use for high risk populations
Prevent serious flu complications such as ear infections in children, pneumonia, hospitalization and death in adults

34. “High Risk Populations”
Asthma
Neurological and neurodevelopment conditions
Blood disorders
Chronic lung disease
Endocrine disorder (ex. Diabetes)
Heart disease
Kidney disorders
Liver disorders
Metabolic disorders
BMI >= 40
Adults 65 and older
Children younger than 5 and especially younger than 2
Pregnant women
Women 2 weeks after the end of pregnancy
People with weakened immune system due to disease or medications
American Indians and Alaska Natives
People younger than 19 on long term aspirin therapy
People in nursing facilities and long term care homes

35. Oseltamivir (Tamiflu®)
Available as liquid or capsule
Generic available
Approved for patients 14 days and older for treatment who have had symptoms less than 24 hours
Approved by FDA for prevention in patients 1 year and older
Common adverse reactions: nausea, vomiting, headache, pain
Rare: skin, hypersensitivity and neuropsychiatric events
Tamiflu [Prescribing Information]. Genentech, Inc., South San Francisco, California. June 2016.

36. Oseltamivir (Tamiflu®)
Treatment Dose
Ages 13 years to adult: 75mg twice a day
Pediatric Patients to age 13: based on weight, not to exceed adult dosage
Adjust dose down for renal impairment
Prophylaxis:
Ages 13 years to adult: 75mg once daily for at least 10 days
Ages 1 to 12 years: Based on weight, not to exceed adult dosage
Not approved for <1 year of age
Adjust for renal impairment as needed
Tamiflu [Prescribing Information]. Genentech, Inc., South San Francisco, California. June 2016.

37. Oseltamivir (Tamiflu®)
How supplied:
Available as brand and generic products
75mg capsule
45mg capsule
30mg capsule
Oral suspension 6mg/mL
Tamiflu [Prescribing Information]. Genentech, Inc., South San Francisco, California. June 2016.

38. Zanamivir (Relenza®) Inhaled powder
Approved for 7 years and older (FDA, CDC), prevention 5 years and older (CDC)
Not recommended for patients with breathing problems like COPD or asthma
Adverse Effects (Treatment):
Sinusitis, dizziness
Adverse Effects (Prophylaxis):
Fever and/or chills, arthralgia and articular rheumatism
Relenza [Prescribing Information]. GlaxoSmithKline, Research Triangle Park, North Carolina. August 2016.

39. Zanamivir (Relenza®)
Relenza [Prescribing Information]. GlaxoSmithKline, Research Triangle Park, North Carolina. August 2016.

40. Zanamivir (Relenza®) How supplied:
Blister for oral inhalation, four 5mg blister on a ROTADISK via DISKHALER
Dosing:
Inhale 10mg twice daily for 5 days
Prophylaxis:
Household: 10mg once daily for 10 days
Community outbreaks: 10mg once daily for 28 days
Relenza [Prescribing Information]. GlaxoSmithKline, Research Triangle Park, North Carolina. August 2016.

41. Peramivir (Rapivab®) Given IV by healthcare provider
Approved for 2 years and older for treatment
Given over 15 to 30 minutes
Dosing:
Ages 13 years to adults- 600mg one time dose
Ages 2 years to 12 years- 12mg/kg up to 600mg
Dose adjustment for creatinine clearance
Adverse Effects:
Diarrhea
Rapivab [Prescribing Information]. BioCryst Pharmaceuticals, Inc., Durham, North Carolina. September 2017.

42. https://www. cdc. gov/flu/professionals/antivirals/summary-clinicians

43. Patient Case
62 year old woman presents to pharmacy to pick up a prescription for oseltamivir 75mg once daily. During counseling the patient discloses that she will be traveling out of state to visit her daughter and grandchildren, who have tested positive today for influenza. What would you tell the patient?
Patient currently taking 25mg HCTZ daily, atorvastatin 40mg daily, Ventolin HFA 2 puffs PRN, and metformin 500mg BID.

44. Questions?

45. Herpes Zoster and Shingrix
Written and Developed by:
Travis Frost Pharm.D. Candidate 2019
University of New England

46. Learning Objectives
Discuss ACIP recommendations for use of the new herpes zoster vaccine Shingrix
Recognize the changes made by the Advisory Committee on Immunization Practices (ACIP) to the 2018 immunization schedules

47. Disclaimer
All recommendations and data in this slide were developed prior September 22nd, and revolve around CDC and ACIP guidelines
All information in this presentation is subject to change based on new guideline recommendations by the aforementioned governing bodies

48. Epidemiology: Shingles
Localized, painful, erupting skin rash resulting from reactivation of latent varicella zoster virus
Risk Factors:1
Immunosuppression
Increasing age
< 1 case per 1000 children
~5 cases per 1000 people years
>15 cases per 1000 people <80 years

49. Presentation and Complications
Pain, burning, numbness
Sensitivity to touch
Postherpetic neuralgia:2
Persistent pain >90 days following resolution of rash
10-18% of patients with shingles over 50 years old will have PHN and this number increases with age
Vision loss
Neurological problems
Encephalitis, facial paralysis, hearing or balance problems
Bacterial Skin infections

50. Shingles vaccine trends (>60 years old)
2015 – 31%2
2016 – 33.4%2

52. Safety of Shingrix

53. Safety data evaluated via 2 placebo-controlled clinical studies (aged 50+)
29,305 patients in total (Study 1: ZOE50, Study 2: ZOE70)
Received either Shingrix or placebo according to a 0 and 2 month schedule
Shingrix (n=14,645)
Saline Placebo (n=14,660)
Mean age of 69 years
74.3% of subjects were white
58% female
Shingrix [Prescribing Information]. GlaxoSmith Kline Biologicals, Rixensart, Belgium

54. Adverse Reactions 7 Days Post Dose
% of recipients experiencing AR(s)
Shingrix [Prescribing Information]. GlaxoSmith Kline Biologicals, Rixensart, Belgium

55. Adverse Reactions 7 Days Post Dose
% of recipients experiencing AR(s)
Shingrix [Prescribing Information]. GlaxoSmith Kline Biologicals, Rixensart, Belgium
Zostavax [Prescribing information]. Merck & Co., INC., Whitehouse Station, NJ. 2018
Fluarix [Prescribing Information]. GlaxoSmith Kline Biologicals, Dresden, Germany, April 2018.

56. Safety Trails for Shingrix 30 Days Post Last Vaccination
Serious Adverse Events (SAEs), defined by the FDA as
Any adverse drug event occurring at any dose that in the opinion of the investigator or sponsor results in death, a life threatening adverse drug experience, inpatient hospitalization, (or prolonging of existing hospitalization by > 24 hours, or a substantial disruption of the ability to conduct normal life functions
Shingrix
Placebo
10.1%
10.4%
Shingrix [Prescribing Information]. GlaxoSmith Kline Biologicals, Rixensart, Belgium

57. Effectiveness of Shingrix

58. Effectiveness4

59. Vaccine Effectiveness % Comparison Over Time4
NNT
Herpes Zoster: 11-17
PHN:
(Zostavax)
(Shingrix)

60. Comparison Between Zostavax and Shingrix During First 4 Years Post Exposure4

61. Questions to consider:
What should I do if a patient waits longer than 6 months to get the second dose?
 How long after a person received Zostavax—the shingles vaccine in use since —should I wait to give Shingrix?
How long after a person received chickenpox vaccine should I wait to give Shingrix?
Can I give Shingrix with other adult vaccines?
Can a pregnant patient receive Shingrix?

62. Updates to Vaccination Schedules

63. Summary of Changes5 Tdap or Td
“Td/Tdap” ”Tdap or Td” (i.e. 1 dose Tdap, then Td booster every 10 years)
MMR
“Administer 1 dose of MMR to adults who previously received ≤2 doses of mumps- containing vaccine and are identified by a public health authority to be at increased risk during a mumps outbreak.
The text in the indication bar for Figure 1 for MMR has been changed to “1 or 2 doses depending on indication (if born in 1957 or later).”

64. Summary of Changes5
HPV
Changed from 3 doses, to 2-3 based on age of patient when initiation of vaccine series
MenACWY
MPSV4 (meningococcal vaccine) is no longer available, thus removed from the guideline

65. Supplemental Materials

66. 2017 Adult Guidelines By Age6

67. 2018 Adult Guidelines By Age with Highlights7

68. 2017 Adult Guidelines Based on Disease State6

69. 2018 Adult Guidelines Based on Disease State7

70. References
CDC.gov.Morbidity and Mortality Weekly Report (MMWR). Recommendations of the Advisory Committee on Immunization Practices for Use of Herpes Zoster Vaccines. Published Feb Accessed Sept. 10, 2018.
Institute for Quality and Efficiency in Health Care. Shingles. Published April Accessed Sept. 10, 2018.
CDC.gov.Herpes Zoster. Shingles Surveillance . Published Feb Accessed Sept. 12, 2018.
CDC.gov. Considerations for the use of herpes zoster vaccines. [online] CDC. Available at: Published Nov Accessed Sept 12, 2018.
CDC.gov. Immunization Schedules. Published April Accessed Sept. 11, 2018.
Immunize.org..Recommended Adult Immunization Schedule United States, [online] Available at: Published Accessed Sept. 12, 2018
Cdc.gov. Recommended Immunization Schedule for Adults Aged 19 Years or Older, United States, [online] Available at: Published Accessed Sept. 12, 2018.

71. Travis Frost Pharm.D. Candidate 2019 University of New England
Questions?
Travis Frost Pharm.D. Candidate 2019
University of New England