Kenneth McCall, BSPharm, PharmD Associate Professor | UNE

Objectives Discuss the gap between current rates and Healthy

People 2020 goals for vaccinations. Categorize each of the CDC recommended flu

vaccines based upon live/inactivated, route, prep., and storage.

Apply new ACIP recommendations and FDA approved indications for pneumococcal, zoster and influenza vaccines.

3

What is the Healthy People 2020 goal for annual influenza vaccination for adults 65 and older?

1%

3%

87%

9% 1. 100% 2. 90% 3. 70% 4. 50%

2014 Recommended Adult Immunization Schedule, by vaccine and age group

www.cdc.gov/vaccines/schedules/hcp/adult.html

Vaccines that might be indicated for adults based on medical and other indications

www.cdc.gov/vaccines/schedules/hcp/adult.html

8

ACIP Recommendations 2014-15 Influenza Season For 2014–15, U.S.-licensed influenza vaccines will contain the same vaccine

virus strains as those in the 2013–14 vaccine. All persons aged ≥6 months should receive influenza vaccine annually. When immediately available, LAIV should be used for healthy children

aged 2 through 8 years who have no contraindications or precautions . If LAIV is not immediately available, IIV should be used.

Persons who care for severely immunosuppressed persons who require a protective environment should not receive LAIV, or should avoid contact with such persons for 7 days after receipt, given the theoretical risk for transmission of the live attenuated vaccine virus.

Persons who report having had reactions to egg involving such symptoms as angioedema, respiratory distress, lightheadedness, or recurrent emesis; or who required epinephrine or another emergency medical intervention, may receive RIV3 if they are aged 18 through 49 years and there are no other contraindications.

MMWR August 15, 2014 / 63(32);691-697

US Influenza Vaccines: 2014 Vaccine Age Group Dosage Schedule Route

Inactivated, Trivalent Standard Dose

6-35 mos 0.25 ml 1 or 2 shots IM 3-8 years 0.5 ml 1 or 2 shots IM >9 years 0.5 ml 1 shot IM

Inactivated, Quadrivalent Standard Dose

3-8 years 0.5 ml 1 or 2 shots IM >9 years 0.5 ml 1 shot IM

Inactivated, Mammalian Trivalent Standard Dose

>18 years 0.5 ml 1 shot IM

Inactivated, Recombinant Trivalent Standard Dose

18-49 years 0.5 ml 1 shot IM

Inactivated, Trivalent High Dose

>65 years 0.5 ml 1 shot IM

Inactivated, Trivalent Intra-dermal

18-64 years 0.1 ml 1 shot ID

Live, Quadrivalent Intranasal

2-8 years 0.2 ml 1 or 2 Nasal 9-49 years 0.2 ml 1 dose Nasal

New Influenza Vaccines: 2014 Fluarix ® (GlaxoSmithKline) – inactivated, quadrivalent vaccine

FDA approved December 2012 People ages 3 years and older

Fluzone® (Sanofi Pasteur) – inactivated, quadrivalent vaccine. FDA approved March 2013 People ages 6 months and older

Flumist® Quadrivalent (MedImmune)– live, attenuated, quadrivalent vaccine FDA approved March, 2012 People ages 2 through 49 years

Flucelvax® (Novartis)– trivalent inactivated vaccine grown in mammalian cells. FDA approved November, 2012 Adults 18 years and older Doesn’t list “severe allergic reaction to egg protein” in the contraindications

Flublok® (Protein Sciences Corp.) – inactivated, trivalent, recombinant vaccine. FDA approved March 2013 People ages 6 months and older Doesn’t list “severe allergic reaction to egg protein” in the contraindications

Which of the following was the predominant flu strain of 2013-14?

0%

98%

0%

2% 1. Type B strain in trivalent vaccine 2. Type B strain not in trivalent vaccine 3. Type A H1N1 strain 4. Type A H3N2 strain

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New Influenza Vaccines: 2013-14 Flumist® Quadrivalent (MedImmune)– live attenuated

vaccine which contains two type A and two type B strains FDA approved March, 2012 People ages 2 through 49 years

Live Attenuated Influenza Vaccine Indication

Healthy people 2 through 49 years of age Contraindications

Pregnant women People who have long-term health problems with: heart disease kidney or liver disease lung disease metabolic disease, such as diabetes asthma anemia, and other blood disorders

Anyone with a weakened immune system Severe egg allergy

20

I pick my nose!

Administration Flumist®: 0.1-mL dose in each nostril Intranasal

21

Which of the following patients is a candidate for the live influenza vaccine?

2%

2%

0%

95%

2% 1. 45 yo man with severe egg allergy 2. 27 yo healthy woman 3. 38 yo man with diabetes 4. 54 yo healthy man 5. 19 yo pregnant woman

Which of the following influenza vaccine(s) is/are preferred for a healthy 7-year-old boy.

20%

20%

20%

20%

20% 1. Fluzone 2. Fluzone ID 3. Flumist 4. Flucelvax 5. 1 and 2

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Methods: Multicenter, randomized, double-blind controlled study HD vaccine (60 mcg of hemagglutinin per strain): N=15,991 SD vaccine (15 mcg of hemagglutinin per strain): N=15,998 Adults 65 years and older. Nursing home residents and

immunocompromised persons were excluded.

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N Engl J Med 2014;371:635-45

Occurrence of laboratory-confirmed influenza following administration of HD and SD influenza vaccines

301

9

223

51

228

8

171

38

0

50

100

150

200

250

300

350

All Strains A/H1N1 A/H3N2 B

SD HD

26

Num

ber

of c

ases

N Engl J Med 2014;371:635-45

Efficacy of HD Vaccine vs. Standard Dose against Laboratory Confirmed Influenza of Any Type

Number (%) of cases IV3-HD: 228/15,990 (1.4%) IV3-SD: 301/15,993 (1.9%)

Relative Efficacy (95% CI) 24.2% (9.7% – 36.5%)

Absolute Efficacy 0.5%

Number Needed to Treat 200

Administration Fluzone HD®: 0.5-mL dose IM - deltoid 1 inch, 25 gauge needle

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Which of the following statements is FALSE when comparing the efficacy of Fluzone HD to Fluzone in adults 65 years or older?

25%

25%

25%

25%1. The relative efficacy of Fluzone HD is

24% > than Fluzone 2. The absolute efficacy of Fluzone HD is

0.5% > than Fluzone 3. These results apply to nursing home

patients 4. The NNT is 200 to avoid one additional

case of influenza

Influenza Vaccines and Age Indications Vaccine Age Indications

6-23m 2-3y 3-17y 18-49y 50-64y 65+y

Inactivated Trivalent (Fluzone©, Afluria©, Fluvirin©)

Inactivated Quadrivalent (Fluarix©, FluLaval©, Fluzone©)

Inactivated Mammalian Trivalent (Flucelvax©)

Recombinant Influeza Vaccine, Trivalent (FluBlok©)

Live Quadrivalent (Flumist©)

Intradermal Trivalent (Fluzone ID©)

High Dose Trivalent (Fluzone HD©)

Indicated for those meeting age requirements and without contraindications

Preferred: Healthy 2-8 yrs

Influenza Vaccine Indications

Vaccine Indication Pregnant Severe Egg Allergy Patients with high

risk medical conditions**

Inactivated Trivalent (Fluzone©, Afluria©, Fluvirin©)

Inactivated Quadrivalent (Fluarix©)

Inactivated Mammalian & Recombinant Trivalent (FluBlok©, Flucelvax©)

Live Quadrivalent (Flumist©)

Intradermal Trivalent (Fluzone ID©)

High Dose Trivalent (Fluzone HD©)

Indicated for individuals meeting age requirements.

contraindicated

**Patients with high risk medical conditions: including immunocompromised, chronic cardiovascular disease, Diabetes Mellitus, pulmonary disease, or metabolic disease.

Pneumococcal Vaccines Pneumovax 23®

(PPSV23, pneumococcal polysaccharide vaccine)

• Prevnar 13® (PCV13, pneumococcal conjugate vaccine)

ACIP Recommendations on Pneumococcal Vaccinations in Adults

ACIP Recommendations on Pneumococcal Vaccinations in Adults

Both PCV13 and PPSV23 should be administered routinely in series to all adults aged ≥ 65 years.

Pneumococcal vaccine-naïve persons. Adults aged ≥65 years who

have not previously received pneumococcal vaccine or whose previous vaccination history is unknown should receive a dose of PCV13 first, followed by a dose of PPSV23. The dose of PPSV23 should be given 6–12 months after a dose of

PCV13. If PPSV23 cannot be given during this time window, the dose of

PPSV23 should be given during the next visit. The two vaccines should not be coadministered, and the minimum

acceptable interval between PCV13 and PPSV23 is 8 weeks. MMWR September 19, 2014 / 63 (37)

ACIP Recommendations on Pneumococcal Vaccinations in Adults

Previous vaccination with PPSV23. Adults aged ≥65 years who have previously received ≥1 doses of PPSV23 also should receive a dose of PCV13 if they have not yet received it. A dose of PCV13 should be given ≥1 year after receipt of the most

recent PPSV23 dose. For those for whom an additional dose of PPSV23 is indicated, this

subsequent PPSV23 dose should be given 6–12 months after PCV13 and ≥5 years after the most recent dose of PPSV23.

The recommendations for routine PCV13 use among adults aged ≥65

years will be reevaluated in 2018 and revised as needed. ACIP recommendations for routine use of PCV13 in adults aged ≥19

years with immunocompromising conditions, functional or anatomic asplenia, cerebrospinal fluid leak, or cochlear implants remain unchanged.

MMWR September 19, 2014 / 63 (37)

Pneumococcal vaccine-naïve persons aged > 65 years

*minimum interval between sequential administration of PCV13 and PPSV23 is 8 weeks; PPSV23 can be given later than 6-12 months after PCV13 if this window is missed.

Persons who previously received PPSV23 at age > 65 years

*minimum interval between sequential administration of PCV13 and PPSV23 is 8 weeks; PPSV23 can be given later than 6-12 months after PCV13 if this window is missed.

Persons who previously received PPSV23 before age 65 years who are now aged > 65 years

PPSV23 (Pneumovax®) Age Who receives the vaccine?

≥65 years old

• Vaccination history unclear or never received vaccine before • Revaccinate: If patient received vaccine before the age of 65

and it has been ≥ 5 years since administration

2-64 years old • Chronic cardiovascular disease (CHF, cardiomyopathies) • Chronic pulmonary disease (COPD) • Diabetes mellitus • Alcoholism • Chronic liver disease • Cerebrospinal fluid leaks Re-vaccination after 5 years if: (see figure 1 on next slide)

• functional or anatomic asplenia • Immunocompromising conditions • Chronic kidney disease

19-64 years old • Cigarette smokers • Asthma

ACIP: Pneumococcal. MMWR. http://www.immunize.org/acip/ Accessed 30 July 2014.

Administration Pneumovax® & Prevnar®: 0.5 mL dose 1 inch, 25 gauge needle Intramuscular (IM) - deltoid

CDC: Vaccines and Immunizations. Pneumococcal Disease. http://www.cdc.gov/. Accessed 30 July

What is the Healthy People 2020 goal for pneumococcal vaccination for adults 65 and older?

1%

3%

87%

9% 1. 100% 2. 90% 3. 70% 4. 50%

A 65-year-old man who is pneumonia vaccine naïve. What pneumonia vaccine(s) is/are recommended?

25%

25%

25%

25% 1. Pneumovax only 2. Prevnar only 3. Both; Pneumovax prior to Prevnar 4. Both; Prevnar prior to Pneumovax

Clinical Presentation of Herpes Zoster1–3

Abnormal Skin Sensations Headache

Photophobia Malaise

Unilateral Dermatomal Rash Maculopapules/Vesicles

Altered Sensitivity to Touch Unbearable Itching

Cessation of New Vesicles Pustulation Scabbing

Cutaneous Healing

Neurologic Cutaneous Ophthalmic

Visceral (rare)

Prodrome Acute HZ Rash Evolution of Rash Complications?

Pain (varying severity)

“Aching”, “burning”, “stabbing”, “shock-like” 1. Oxman MN. In: Arvin AM et al, eds. Varicella-Zoster Virus: Virology and Clinical Management. Cambridge, UK: Cambridge

University Press; 2000:246–275. 2. Weaver BA. J Am Osteopath Assoc. 2007;107(suppl 1):S2–S7. 3. Harpaz R et al. MMWR Morb Mortal Wkly Rep. 2008;57(RR-5):1–30.

© Phototake. © Dr. P. Marazzi / Photo Researchers, Inc.

Herpes Zoster Rash Follows a Dermatomal Distribution

© Phototake.

ZOSTAVAX® (Zoster Vaccine Live)

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Zoster Vaccine Indication ACIP recommends routine vaccination of all persons aged

>60 years with 1 dose of zoster vaccine. NEW FDA LABELING: “ZOSTAVAX is a live attenuated

virus vaccine indicated for prevention of herpes zoster (shingles) in individuals 50 years of age and older.”

Persons who report a previous episode of zoster and persons with chronic medical conditions can be vaccinated unless those conditions are contraindications or precautions.

Zoster vaccination is not indicated to treat acute zoster.

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Recommendations of the Advisory Committee on Immunization Practices (ACIP) http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5705a1.htm?s_cid=rr5705a1_e

Zostavax® [package insert]. Whitehouse Station, NJ: Merck; April 2011.

Efficacy of ZOSTAVAX® (Zoster Vaccine Live) on Incidence of Herpes Zoster in Adults Aged 50–59 Years

Based on the results of the ZOSTAVAX Efficacy and Safety Trial (ZEST)1,a

aStudy Design for ZEST: In the ZOSTAVAX Efficacy and Safety Trial, efficacy was evaluated in a placebo-controlled, double-blind study of ZOSTAVAX. 22,439 subjects 50 to 59 years of age were randomized to receive a single dose of either ZOSTAVAX (n=11,211) or placebo (n=11,228) and were monitored for the occurrence of shingles for a median of 1.3 years postvaccination (range, 0 to 2 years). 1. Schmader KE et al. Clin Infect Dis. 2012;54:922–928.

99

30

Placebo (n=11,228)

ZOSTAVAX (n=11,211)

Num

ber

of Z

oste

r C

ases

70%

in subjects 50–59 [95% CI: 54–81]

ACIP Recommendations for Use of ZOSTAVAX® (Zoster Vaccine Live): Adults Aged 50–59 Years1

ACIP=Advisory Committee on Immunization Practices. 1. Harpaz R et al. MMWR. 2011;60:1528.

Adults Aged 50–59 Years With: Consider Vaccination

Preexisting chronic pain, severe depression, or other comorbid conditions Inability to tolerate treatment medications because of hypersensitivity or interactions with other chronic medications

Occupational considerations

ZOSTAVAX is FDA approved for use in patients 50 years and older The ACIP has clarified that despite the absence of an ACIP recommendation,

providers may consider the following factors when deciding whether to administer ZOSTAVAX among certain patients aged 50–59 years:

Administration Zostavax: 0.65-mL dose (reconstituted) SQ – upper, outer tricep 5/8 inch, 25 gauge needle

55

Which of the following statements is FALSE regarding the administration of Zostavax by trained individuals in Maine?

25%

25%

25%

25% 1. A pharmacist or intern may administer Zostavax to a 61-year-old patient

2. A pharmacist or intern may administer Zostavax to a 51-year-old patient

3. Interns can not administer Zostavax 4. A pharmacist may administer Zostavax

to a 41-year-old patient pursuant to a Rx