kenneth mccall, bspharm, pharmd · virus strains as those in the 2013 –14 vaccine. ......
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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.
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
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
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!
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
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.
25
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
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
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.
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.
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
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