IMMUNIZATION UPDATE 2013
Maine Pharmacy Association
Fall Convention
September 7, 2013
Allison Strobel, PharmD
Assistant Professor Pharmacy Practice
Husson University School of Pharmacy
MPA Board of Directors Member
DISCLOSURE
 I, Allison Strobel, do not have an interest in selling a
technology, program, product, and/or service
 I have no conflicts of interest
LEARNING OBJECTIVES
 Discriminate between the different branded influenza
vaccines based on patient’s characteristics
 Determine in which patient the different pneumococcal
vaccines would be warranted
 Identify the different travel vaccine resources
 Apply principles of travel vaccines to specific patient travel
plans
OUTLINE
 Influenza
 Pneumococcal Disease
 Tdap
 Travel Vaccines
THE LAW – REVISITED
LD 148 “AN ACT TO AMEND THE LAWS
GOVERNING DRUGS AND VACCINES
ADMINISTERED BY PHARMACISTS”
“A pharmacist may not delegate the pharmacist’s
authority to administer drugs or vaccines; except
that a pharmacist licensed under this chapter who
has obtained a certificate of administration
pursuant to section 13832 may delegate the
authority to administer adult vaccines to a
pharmacy intern who is under that
pharmacist’s direct supervision”
INFLUENZA
INFLUENZA VIRUS STRAINS1
 Influenza A virus
 Moderate to severe illness
 All age groups
 Humans and other animals
 Influenza B virus
 Milder disease
 Primarily affects children
 Humans only
 Influenza C virus
 Rarely reported in humans
 No epidemics
2013 – 2014 INFLUENZA VACCINE2,3
A/California/7/2009(H1N1)-like virus
A/Texas/50/2012(H3N2)-like virus*
B/Massachusetts/2/2012-like virus*
 Yamagata lineage
B/Brisbane/60/2008-like virus^
 Victoria lineage
*Different than 2012-2013 vaccine
^Quadrivalent vaccine
EVOLVING INFLUENZA VIRUS –
ANTIGENIC DRIFT4
 Occurs in both type A and type B
 Gradual changes to evade immune system
 Mutations, substitutions, deletions
 Epidemics occur in response to the changes
EVOLVING INFLUENZA VIRUS –
ANTIGENIC SHIFT4
 Occurs in type A
 Sudden, major change in hemagglutinin and/or neuromidiase
 Occasional change
 New subtype
 Little human immunity
 Pandemics occur in response to this change
AVAILABLE INFLUENZA VACCINES
Vaccine (Manufactuerer)
Approved Age Indications
Fluzone (Sanofi Pasteur, Inc) †
≥6 months
Fluvirin (Novartis)
≥4 years
Fluarix (GSK) †
≥3 years
FluLaval (GSK) †
≥18 years
Afluria (CSL Biotherapies)
≥9 years
Agriflu (Novartis)
≥18 years
Fluzone High-Dose (Sanofi Pasteur, Inc)
≥65 years
Fluzone Intradermal (Sanofi Pasteur, Inc)
18-64 years
Flucelvax (Novartis) *
≥18 years
Flublok (Protein Sciences Corp) ^
18-49 years
FluMist (MedImmune)
2-49 years
Adapted from APhA Pharmacy-Based Immunization Delivery April 2013
*cell-cultured
^ recombinant
†available in both trivalent and
quadrivalent
NEW INFLUENZA VACCINES
 Inactivated, quadrivalent vaccine containing two type A and two type B
strains
 Fluarix (GSK) – approved for 3 years and older
 Fluzone (Sanofi Pasteur, Inc) – approved for 6 months and older
 FluLaval (GSK) – approved for 18 years and older
 Inactivated, trivalent vaccine produced by cell culture (mammalian cells)
 Flucelvax (Novartis) – approved for 18 years and older
 Inactivated, trivalent vaccine produced by recombinant technology
 Flublok (Protein Sciences Corporation) – approved for 18-49 years
 Live attenuated, quadrivalent vaccine containing two type A and two
type B
 FluMist Quadrivalent (MedImmune) – approved for 2-49 years
QUADRIVALENT VS. TRIVALENT:
LOCAL SIDE EFFECTS5
Local Side
Effects
Fluarix
Quadrivalent
N=3,015
Trivalent Influenza Vaccine (TIV)
TIV-1
(B Victoria)
N=1,003
TIV-2
(B Yamagata)
N=607
Pain
36
37
31
Redness
2
2
2
Swelling
2
2
1
QUADRIVALENT VS. TRIVALENT:
SYSTEMIC SIDE EFFECTS5
Systemic Side
Effects
Fluarix
Quadrivalent
N=3,015
Trivalent Influenza Vaccine (TIV)
TIV-1
(B Victoria)
N=1,003
TIV-2
(B Yamagata)
N=607
Muscle Aches
16
19
16
Headache
16
16
13
Fatigue
16
18
15
Arthralgia
8
10
9
GI Symptoms
7
7
6
Shivering
4
5
4
Fever ≥99.5oF
2
1
2
FLUCELVAX VS. COMPARATOR:
LOCAL SIDE EFFECTS6
Local Side Effect
Flucelvax (%)
N=821
Agriflu (%)
N=841
Injection site pain
20
15
Erythema
14
15
Induration
6
6
Swelling
4
4
FLUCELVAX VS. COMPARATOR:
SYSTEMIC SIDE EFFECTS6
Systemic Side Effect
Flucelvax (%)
N=821
Agriflu (%)
N=841
Headache
12
11
Fatigue
11
11
Myalgia
7
8
Malaise
11
11
Chills
4
4
FLUMIST QUADRIVALENT VS. TRIVALENT –
IMMUNE RESPONSE7
 Multicenter, randomized, double-blind study assessing
immunogenicity of FluMist Quadrivalent compared to
FluMist Trivalent
 Children and adolescents 2-17 years: 2,312 subjects
 Adults 18-49 years; 1,800 subjects
 The addition of the second B strain did not result in
immune interference to other strains included in the
vaccine
FLUMIST QUADRIVALENT VS. TRIVALENT :
SIDE EFFECTS IN 2-17 YEARS7
FluMist Quadrivalent
(%)
N=1341
FluMist Trivalent
(%)
N=901
Runny nose/Nasal
congestion
32
32
Headache
13
12
Decreased activity
(lethargy)
10
10
Sore throat
9
10
Decreased appetite
4
5
Fever >100oF
7
5
Side Effect
FLUMIST QUADRIVALENT VS. TRIVALENT :
SIDE EFFECTS IN 18-49 YEARS7
FluMist Quadrivalent
(%)
N=1197
FluMist Trivalent
(%)
N=597
Runny nose/Nasal congestion
44
40
Headache
28
27
Decreased activity (lethargy)
18
18
Sore throat
19
20
Cough
14
13
Muscle aches
10
10
Decreased appetite
6
5
Side Effect
FLUZONE INTRADERMAL8
 Indication
 Persons 18 – 64 years of age
 Dose
 0.1 mL (9mcg hemagglutinin)
 Similar seroprotection rate compared to IM influenza
vaccine
FLUZONE INTRADERMAL VS.
INTRAMUSCULAR ADVERSE EVENTS8
90
80
70
60
50
40
30
20
10
0
ID
9mcg
IM
15mcg
ADVISORY COMMITTEE ON IMMUNIZATION
PRACTICES – RECOMMENDATIONS9
 Annual vaccination of all person 6 months and older against
influenza
 FluMist Qaudrivalent indicated for healthy persons aged 249
 No preference given to once brand name influenza vaccine
over another
 Begin to offer vaccine as soon as supply is available
 Children age 6 months to 8 years should receive 2 doses if
first time receiving the vaccination
 All health care personal should be vaccinated
INTRAMUSCULAR ADMINISTRATION
 Deltoid muscle
 1 inch, 25 gauge needle
INTRANASAL ADMINISTRATION
 0.1 ml dose in each nostril
LIVE ATTENUATED INFLUENZA VACCINE
CONTRAINDICATIONS7
 Pregnant women
 Chronic medical conditions:
 Lung disease (i.e. asthma, COPD)
 Heart disease
 Kidney or liver disease
 Metabolic disease (i.e. diabetes)
 Weakened immune system
 Severe egg allergy
QUESTION 1
Mrs. Jones is a 68 year old female who comes into your pharmacy today
requesting a flu shot. She has no contraindications to receiving the vaccine
today. Of the following influenza vaccines the pharmacy carries, which
vaccine would be appropriate to administer to Mrs. Jones?
i. Fluzone prefilled syringe
ii. Fluarix (quadrivalent) prefilled syringe
iii. Fluzone High-Dose
iv. Flu-Mist
a. i, ii
b. ii, iii
c. i, ii, iii
d. i, ii, iii, iv
QUESTION 2
Jimmy is a 9 year old boy who comes in today with his mother. Mrs. J
would like to have Jimmy receive his influenza vaccine today at your
pharmacy. After screening you find he has mild asthma and seasonal
allergies. Which of the vaccines would be appropriate for Jimmy?
a.
Fluzone Intradermal
b.
Fluarix (quadrivalent)
c.
Flu-Mist
d.
Fluzone High-Dose
PNEUMOCOCCAL DISEASE
PNEUMOVAX23 – PPSV2310
 Recommended for all patients over the age of 65
 Before 65 years if patient has chronic conditions
 Chronic illness (diabetes, heart disease, lung disease)
 Asplenia
 Immunocompromised
 Cochlear implant
 Smokers
 Protects against 23 serotypes; 11 are unique
 Improves patient outcomes if pneumococcal pneumonia
develops
PREVNAR13 – PCV1311,12
 Indicated for children 6 weeks to 5 years
and adults over
50 years
 Not recommended by ACIP for routine use in adults
 Main place in therapy is for immunocompromised adults
 Asplenia
 CSF leaks
 Cochlear implants
 Protects against 13 serotypes; 1 is unique
DOSING SCHEDULE12
PPSV naïve patients
PCV13
PPSV23
8 weeks
PPSV23 (PPSV23 after age 65)
≥5 years
Prior PPSV23 vaccination
≥5 years
PPSV23
PCV13
≥1 year
≥8 weeks
PPSV23
PPSV3
≥5 years
PPSV23
PPSV23 (PPSV23 after age 65)
PCV13 (PPSV23 after age 65)
≥1 year
PPSV23 (PPSV23 after age 65)
≥5 years
Adapted from APhA Pharmacy-Based Immunization Delivery April 2013
PCV13
≥1 year
ADVISORY COMMITTEE ON IMMUNIZATION
PRACTICES – RECOMMENDATIONS12,13
 Vaccinate all people over 65 years old
 Vaccinate earlier if:
 19-64 years: smoke, asthma
 ≥2 years: chronic illness
 If second dose is needed
 Minimum of 5 years between doses
 First dose given before 65th birthday
 Not recommending Prevnar13 for routine use
 Immunocompromised patients can receive one dose
QUESTION 3
Stacy is a 55 year old female who has COPD (quit smoking 2 years ago
upon diagnosis), hypertension, and hyperlipidemia. Her current medications
include Spiriva, HCTZ, lisinopril, and Crestor. Which of the following
immunizations would Stacy be indicated for?
a.
PREVNAR13
b.
Pneumovax
c.
Fluzone
d.
A and C only
e.
B and C only
f.
All three are indicated
TETANUS, DIPHTHERIA,
ACELLULAR PERTUSSIS
TDAP – VACCINE14
 Boostrix (GSK) approved for ≥10 years
 Adacel (Sanofi Pasteur) approved for ages 11-64
 Replaces one tetanus booster
 Timing
 Administer regardless of last Td vaccine
WHAT’S NEW?15
 October 2012 updated ACIP recommendation
 Vaccinate women during each pregnancy
 Third trimester preferred (after 30 weeks)
 Possible adverse events
 Increased injection site pain
 Arthus reactions, whole arm swelling
 Don’t forget about the fathers!
TIMING AND SPACING OF VACCINES1
 Administer all indicated vaccines in the same visit
 Individual vaccines in separate syringes injected at separate sites
 Live vaccines are separated by 28 days if not administered
at the same visit
 Inactivated vaccines do not have a minimum interval
between administration if not administered at the same visit
 Vaccine Series:
 Increasing the interval between doses does not weaken immune response
 Decreasing the interval between doses may weaken immune response and
vaccine’s protection
VACCINES TYPES1
 Live Attenuated
 Intranasal influenza, herpes zoster, measles, mumps, rubella, varicella,
rotavirus, oral typhoid capsules, yellow fever
 Inactivated
 Intramuscular influenza, pneumococcal, tetanus, diphtheria,
pertussis, human papillomavirus, hepatitis A and B, meningococcal,
Haemophilus influenzae type B, inactivated poliovirus, rabies,
intramuscular typhoid
TRAVEL VACCINES16
IMPORTANCE
 Travelers can become infected while in a different country
and may not develop symptoms until they return home
 Introduction of pathogens into new climates can have
devastating effects
 Small pox introduction to North America
 Syphilis introduction to Europe
 Recent transmission of region specific diseases
 Severe Acute Respiratory Syndrome (SARS) – 2003
TYPES OF TRAVELERS
Vacation
Business
Mission
Visiting Friends and Family
TRAVEL MEDICINE IS AN ART OF
MANAGING A PERSON’S RISK, NOT
ELIMINATING IT
AVAILABLE RESOURCES
 CDC’s Travelers’ Health (http://wwwnc.cdc.gov/travel/)
 CDC Health Information for International Travel, The Yellow Book
(http://wwwnc.cdc.gov/travel/page/yellowbook-home-2014)
 International Society of Travel Medicine (http://www.istm.org/)
 The American Society of Tropical Medicine and Hygiene
(www.astmh.org//)
 Travel Software
 Shoreland Travax (http://www.shoreland.com/)
 Travel+Care International (http://www.travelcare.com/en/index.cfm)
 Tropimed (http://www.tropimed.com/en/index.html#&panel1-1)
VACCINE PREVENTABLE DISEASE
 Typhoid
 Hepatitis A and B
 Japanese Encephalitis
 Meningococcal Diseaseᴽ
 Rabies
 Poliomyelitis (adult booster)
 Tuberculosis*
 Yellow Feverᴽ
 Cholera*
*Available in other countries
ᴽRequired to enter country
TYPHOID
 Life-threatening febrile illness cause by Salmonella enterica
serotype Typhi
 Transmitted by fecal-oral route
 Consuming contaminated water or food
 Incubation period of 6-30 days before gradual onset of
symptoms
 Fever and fatigue, headache, malaise, anorexia
 Recommended for
 Highest risk: Southern Asia; visiting family and friends
 High risk: East/Southeast Asia, the Caribbean, Africa, Central/South America
 Food and water precautions should still be followed
TYPHOID – VACCINE
Vivotif
 Oral live attenuated
vaccine
 4 dose series
 One capsule every other day 1
hour before a meal
 Restart regimen if more than
48 hours between doses
 Keep refrigerated
 Complete one week
before exposure
 Booster after 5 years
 Minimum age: 6 years
 Common adverse effects
 Abdominal discomfort
TYPHOID – VACCINE
Typhim Vi
 Capsular polysaccharide vaccine
 One dose at least 2 weeks before exposure
 Booster after 2 years
 Minimum age: 2 years
 Common adverse effects
 Headache, injection site reactions
JAPANESE ENCEPHALITIS
 Transmitted by infected mosquitoes
 Acute encephalopathy is a classic symptom
 Recommended if traveling to agricultural portions of Asia
 High risk: visiting family and friends
 Mosquito bite precautions
 Considerations
 Low overall risk of transmission
 Destination and length of stay
 Cost
JAPANESE ENCEPHALITIS – VACCINE
 Ixiaro, JE-Vax (no longer available)
 Approved for 17 years or older
 2 dose series
 0, 28 days
 Complete 1 week before travel
 Booster after 12 months
 Common adverse effects
 Injection site pain and tenderness
 Fatigue, headache, influenza-like illness
 Contraindicated with hypersensitivity to protamine sulfate
RABIES
 Transmitted through animal bite
 Incubation period is 1-3 months post exposure
 Symptom development results in death within 7-14 days
 Prevention with vaccine prior to or post bite exposure is
key for survival
 Consider vaccination when:
 Prevalence in visiting country is high
 Unknown availability of post-exposure antirabies biologics
 Unknown duration of stay
RABIES – VACCINE
 Imovax, RabAvert
 3 dose series
 0, 7, 21-28 days
 Must complete ALL 3 doses prior to travel
 No booster for pre-exposure vaccination
 Common adverse effects
 Injection site reactions, headache
HEPATITIS A
 Fecal-oral transmission
 Virus levels peak 1-2 weeks before abrupt symptom onset
 Fever, malaise, anorexia, nausea, abdominal discomfort
 Disease usually resolves within 2 months
 Recommended if traveling outside the US regardless of
destination
 Highest risk: developing counties; visiting family and friends
HEPATITIS A – VACCINE
 Havrix, Vaqta
 Twinrix (combination with Hepatitis B)
 Standard 2 dose series
 0, 6-12 months (Havrix)
 0, 6-18 months (Vaqta)
 No Booster
 Common adverse effects
 Injection site pain, headache
HEPATITIS B
 Transmitted through infected bodily fluid
 Virus incubation is usually 90 days before symptom on set
 Malaise, fatigue, anorexia, nausea, vomiting, abdominal pain, jaundice
 Acute or chronic infection
 Recommended for travel to high chronic endemic areas
 High risk: Africa and Asia; missionaries
HEPATITIS B – VACCINE
 Recombivax-HB, Engerix-B
 Twinrix (Combination with Hepatitis A)
 Standard 3 dose series
 0, 1, 6 month
 Accelerated series
 0, 1, 2 months; 12 months (Engerix-B)
 0, 7, 21-30 days; 12 months (Twinrix)
 Common adverse effects
 Injection site pain, fever
MENINGOCOCCAL DISEASE
 Required immunization with the quadrivalent vaccine before
attending Hajj in Saudi Arabia
 2000 outbreak of Neisseria meningitidis serogroup W-135
 “Meningitis belt” in sub-Saharan Africa
 Incubation is generally 1-14 days before onset of sudden
symptoms
 Headache, fever, stiffness of neck, possible altered mental status
MENINGOCOCCAL –VACCINE
 Menactra, Menveo, Menomune
 One dose series
 Menactra and Menveo administered IM
 Menomune admistered SQ
 Booster every 5 years if at continued risk
 Protective antibody levels occurs 7-10 days after vaccination
 Common adverse effects
 Injection site pain and redness
 Menactra contraindicated in natural rubber latex allergy
POLIO17
 Fecal-oral transmission
 Global Polio Eradication Initiative
 “As of August 20, 2013 192 polio cases have been reported
from the three remaining endemic countries: Afghanistan,
Nigeria, and Pakistan”
 In 2012 there were five countries with endemic polio (wildtype): Afghanistan, Chad, Niger, Nigeria, and Pakistan
POLIO – VACCINE
 Inactivated Polio Vaccine (IPV)
 Standard 3 dose series
 0, 4-8 weeks, 6-12 months (after second dose)
 Single adult booster dose if needed
 Common adverse effects
 Injection site pain and redness
 Oral Polio Vaccine (OPV) no longer available
 Vaccine-associated paralytic poliomyelitis (VAPP)
YELLOW FEVER
 Transmitted by infected mosquito
 High viremia shortly before fever and for 3-5 days after
onset of symptoms
 Influenza-like illness before decompensation
 Required for entrance into specific countries in sub-Saharan
Africa and tropical South America
 Immunizer needs special certificate obtained from state
medical director
 23 vaccination sites available in Maine
YELLOW FEVER – VACCINE
YF-Vax
 Live-attenuated vaccine
 One dose very 10 years
 Rare serious adverse events
 Hypersensitivity and yellow fever vaccine-associated neurologic disease
 Considered valid after 10 days post vaccination per
International Health Regulations
 Documented on International Certificate of Vaccination or
Prophylaxis
OTHER TRAVEL HEALTH CONCERNS
 Malaria
 Travelers’ Diarrhea
 Altitude Illness/Acute Mountain Sickness
 Jet Lag
 Motion Sickness
 UTI
 Yeast Infections
QUESTION 4
You have decided to start a travel health clinic in your
pharmacy. Which of the following is/are a good resource to
help you determine which vaccines are needed for a person
traveling outside of the United States?
a.
The Pink Book
b.
CDC website
c.
The Yellow Book
d.
CDC Vaccine Schedule
QUESTION 5
Bobby and Sue are planning their honeymoon to India (staying at higher end
hotels in populated cities traveling to popular tourist destinations) and have
come to you today to see what vaccines they will need. Both Bobby and Sue
are up-to-date with standard recommended vaccines. After entering the travel
destination into the CDC Traveler’s Health; the following are possible vaccines:
Hepatitis A and B, Japanese Encephalitis, Malaria prophylaxis, Polio, Rabies,
Typhoid, and Yellow Fever. Which vaccines do you recommend?
i. Hepatitis A
v. Polio
ii. Hepatitis B
vi. Rabies
iii. Japanese Encephalitis
vii. Typhoid
iv. Malaria prophylaxis
viii.Yellow Fever
a.
i, ii, iv, v
b.
i, iv, vii
c.
i, ii, iv, vii, viii
d. All of the vaccines are recommended
SUMMARY
 FluMist is available only in quadrivalent formulation
 Fluzone, Fluarix, FluLaval available in either quadrivalent or
trivalent formulations
 ACIP does not recommend one influenza vaccine over the
either for persons eligible for specific vaccine
 Pneumovax should be administered to anyone who is
eligible
 ACIP recommends Prevnar only for immunocompromised
patients
 Travel medicine is a unique area pharmacists can have an
impact in and there are multiple resources to aid in the
decision of which vaccine to give when
REFERENCES
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
Epidemiology and Prevention of Vaccine-Preventable Diseases; 12th Edition. Available at
http://www.cdc.gov/vaccines/pubs/pinkbook/index.html
Recommended composition of influenza virus vaccines for use in the 2013-2014 northern hemisphere influenza season.
World Health Organization. Available at
http://www.who.int/influenza/vaccines/virus/recommendations/2013_14_north/en/index.html
Influenza Virus Vaccine for the 2013-2014 Season. U.S. Food and Drug Administration. Available at
http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/postmarketactivities/lotreleases/ucm343828.htm
How the Flu Virus Can Change: “Drift” and “Shift” Centers for Disease Control and Prevention. Available at
http://www.cdc.gov/flu/about/viruses/change.htm
Fluarix[package insert]. GlaxoSmithKline Inc;2013
Flucelvax[package insert]. Novartis Vaccines and Diagnostics Inc;2013
FluMist Quadrivalent [package insert]. MedImmune Inc; 2012.
Arnou R, Eavis, P, et.al. Immunogenicity, large scale safety and lot consistency of an intradermal influenza vaccine in
adults aged 18-60 years; Randomized, controlled phase III trial. Human Vaccins. 2010;6:346-54
Summary Recommendations: Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory
Committee on Immunization Practices – United States, 2013-14. Centers for Disease Control and Prevention.
Available at http://www.cdc.gov/flu/professionals/acip/2013-summary-recommendations.htm
Pneumovax23 [package insert]. Merck Sharp & Dohme Corp.]2013
Prevnar [package insert]. Wyeth Pharmaceutical Divison]2010
Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 2012;61(40):816-819
Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 1997;46(R-8):1-28
Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 2011;60(01):13-15
Centers for Disease Control and Prevention (CDC). MMWR Recomm Rep. 2013;62(07):131-135
CDC Health Information for International Travel; 2014 Edition. Available at
http://wwwnc.cdc.gov/travel/page/yellowbook-home-2014
Updates on CDC’s Polio Eradication Efforts. Centers for Disease Control and Prevention. Available at
http://www.cdc.gov/polio/updates/
QUESTIONS