Vaccine Update:
Protecting Our Patients
Thomas P. Lombardi, PharmD, FASHP
Supervisor, Clinical Pharmacy Services
St. Peter’s Hospital, Catholic Health East
&
Senior Adjunct Faculty
Albany College of Pharmacy and Health Sciences
Albany, NY
The information provided in this presentation is the opinion of the author and is not necessarily the opinion of HealthTrust Purchasing Group.
Conflict of Interest
• I sit on the HPG Clinical Executive Group,
however it has not influenced any
discussion as the presentation is not related
to contract items.
Educational Objectives
1. Outline the benefits and controversies of
use of vaccines.
2. Compare and contrast vaccine
recommendations for children and adults
as well as outline the regulatory issues
surrounding vaccinations in today’s
market.
3. Develop an action plan to prevent disease
in the patients using vaccinations.
In 1736 I lost one of my sons a fine boy
of 4 years old, by the Small Pox…I long
regretted bitterly and I still regret that
I had not given it to him by inoculation;
This I mention for the sake of parents ,
who omit that operation on the
supposition that they should never
forgive themselves if a child died under
it; my example showing that the regret
may be the same either way, and that
therefore the safer should be chosen.
Benjamin Franklin
• “Whilst I lived in Dr. Sydenham’s house, I had myself the
Small Pox, and fell ill on the Twelfth Day. In the beginning I
lost twenty two Ounces of Blood [from bloodletting]. He gave
me a Vomit, but I find by Experience Purging much better. I
went abroad, by his Direction, till I was blind, and then took
to my Bed. I had no Fire allowed in my Room, my Windows
were constantly open, my Bed-Clothes were ordered to be
laid no higher than my Waste. He made me take twelve
Bottles of Small Beer, acidulated with Spirit of Vitriol, every
twenty Four hours. I had of this Anomalous Kind [of
smallpox] to a very great Degree, yet never lost my Senses
one Moment.”
• 1684 - Thomas Dover, MB, The Ancient Physician’s Legacy to
His Country
Smallpox
Variolation (Variola virus)
Cowpox (Vaccinia virus)
Notifiable Diseases (U.S.A.)
Disaese
Diphtheria
Measles
Mumps
Pertussis
Paralytic Poliomyelitis
Rubella
CRS
Tetanus
Smallpox
H. influenzae Type b
(<5 yrs)
Menigococcal Disease
Peak of Cases Year of Peak
30,508
1938
763,094
1958
212,932
1964
265,269
1934
21,269
1952
488,796
1964-65
-20,000
1964-65
601
1948
110,672
1920
2003
1
56
231
11,647
0
7
4
20
0
2004
0
37
258
25,827
0
10
0
34
0
Total No. Cases by Year
2005
2006
2007
0
0
0
66
55
43
314
6,584
800
25,616
15,632
8,739
0
0
0
11
11
12
1
1
0
27
41
28
0
0
0
2008
0
140
454
13,278
0
16
0
19
0
2009
0
71
1,991
7,869
0
3
2
18
0
9
29
22
30
35
297
318
325
330
301
% Decrease
from peak
100%
>99%
>99%
>96%
100%
>99%
>99%
>96%
100%
Vaccine Abbreviations
Abbreviation
aP
D
DT
DTaP
DTP
HBIG
HepA
HepB
Hib
IPV
M
MCV4
MMR
MPS4
OPV
PCV-13
PCV-7
PPV-23
R
RV
T (or TT)
Td
Tdap
TIG
TIV
V
VZIG
Vaccine (Biologic)
Accelular Pertussis
Diphtheria Toxoid
Diphtheria, Tetanus Toxoids
Diphtheria, Tetanus Toxoids, acellular Pertussis
Diphtheria, Tetanus Toxoids, Pertussis vaccine
Hepatitis B Immune Globulin
Hepatitis A Vaccine
Hepatitis B Vaccine
Haemophilus influenzae Type B Vaccine
Inactivate Polio Vaccine (Injectable)
Measles or Mumps
Meningococcal Conjugate Vaccine (Menactra)
Measles, Mumps, Rubella
Meningococcal Polysaccharide Vaccine 4 (Menomune)
Oral Polio Vaccine
Streptococcus pneumoniae Conjugate Vaccine - 13 valent (Prevnar)
Streptococcus pneumoniae Conjugate Vaccine - 7 valent (Prevnar)
Streptococcus pneumoniae Polysaccharide – 23 valent (Pneumovax)
Rubella
Rotavirus Vaccine
Tetanus Toxoid
Tentanus Booster
Tetanus, reduced Diphtheria, acellular Pertussis (Adacel)
Tentanus Immune Globulin
Trivalent Influenza Vaccine
Varicella Zoster Vaccine
Varicella Zoster Immune Globulin
How many states allow pharmacists to
administer vaccines?
A.20
B.30
C.40
D.50
VAERS
VAERS – On-Line
VAERS – Mail or FAX
Vaccine
Schedules
1. Infants & Children
2. Adolescents
3. Adults
2012 Childhood Immunization Schedule
(0-6 years)
2012 Childhood Immunization Schedule
(7-18 years)
2012 Childhood Immunization Schedule
(0-6 years) – Parent Friendly
2012 Recommended Immunizations for Children from Birth Through 6 Years Old
Birth
HepB
1
month
2
months
4
months
6
months
HepB
12
months
15
months
18
months
19–23
months
RV
RV
RV
DTaP
DTaP
DTaP
Hib
Hib
Hib
Hib
PCV
PCV
PCV
PCV†
IPV
IPV
DTaP
DTaP
IPV
IPV
*
MMR
MMR
Shaded boxes indicate
the vaccine can be
given during shown
age range.
For more information, call toll free
1-800-CDC-INFO (1-800-232-4636)
or visit
http://www.cdc.gov/vaccines
4–6
years
HepB
Influenza (Yearly)
NOTE: If your child misses a
shot, you don’t need to
start over, just go back
to your child’s doctor for
the next shot. The doctor
will keep your child upto-date on vaccinations.
Talk with your doctor if
you have questions.
2–3
years
Varicella
Varicella
§
HepA
FOOTNOTES
† Children 2 years old and older with certain medical conditions may need a dose of pneumococcal vaccine (PPSV) and
meningococcal vaccine (MCV4). See vaccine-specific recommendations at http://www.cdc.gov/vaccines/pubs/ACIP-list.htm.
* Two doses given at least four weeks apart are recommended for children aged 6 months through 8 years of age who
are getting a flu vaccine for the first time.
§
Two doses of HepA vaccine are needed for lasting protection. The first dose of HepA vaccine should be given between
12 months and 23 months of age. The second dose should be given 6 to 18 months later. HepA vaccination may be
given to any child 12 months and older to protect against HepA. Children and adolescents who did not receive the
HepA vaccine and are at high-risk, should be vaccinated against HepA.
See back page
for more
information on
vaccinepreventable
diseases and the
vaccines that
prevent them.
2012 Childhood Immunization Schedule
(7-18 years) – Parent Friendly
2012 Childhood Immunization Schedule
(4 months-18 years) – Catch Up
Interactive Scheduling Tools
Interactive Scheduling Tools
Interactive Scheduling Tools
Differences
•
•
1983 – 7 vaccines in 11 doses
2012 – 16 vaccines in 35-55 doses
•
Additions
– Hepatitis B (3 injections)
– Rotavirus (2-3 oral doses)
– Haemophilus influenzae Type B (4 injections)
– Pneumococcal (4 injections & possible PPSV)
– Influenza
– Varicella (2 injections)
– Hepatitis A (2 injections)
– Human Papilloma Virus (3 injections)
– Meningococcal Vaccine (1 injection)
•
Changes
– DTP to DTaP (1st booster to Tdap)
– OPV to IPV (4 oral doses to 4 injections)
– MMR (1 additional injection)
2012 Adult Immunization Schedule
(By Vaccine & Age)
2012 Adult Immunization Schedule
(By Medical Condition)
Specific Vaccines
•
Influenza Vaccine
– High-Dose – Senior Strength
– Intradermal vaccine
– Quadravalent vaccine
•
Pneumococcal Conjugate Vaccine (Prevnar)
– 7 valent
– 13 valent
– What about adults?
•
CMS Core Measure Set
– Influenza Vaccine
– Pneumococcal Vaccine
•
Adolescents – Challenges
– Human Papilloma Virus Vaccine
– Tetanus Toxoid, reduced Diphtheria Toxoid and reduced Pertussis
vaccine (Tdap)
– Meningococcal Vaccine
Influenza
Vaccine
1. High-Dose – Senior Strength
2. Intradermal vaccine
3. Quadravalent vaccine
What percent of healthcare employees
are vaccinated against influenza?
A.20%
B.40%
C.60%
D.80%
2012-2013 Influenza Vaccine
• Selected each year by the Food and Drug
Administration
• Recommended viruses for influenza vaccines for
use in the 2012-2013 northern hemisphere
influenza season
• 15 mcg hemaglutanin per virus
– A/California/7/2009 (H1N1)pdm09-like virus;
– A/Victoria/361/2011 (H3N2)
– B/Wisconsin/1/2010-like
High-Dose Influenza Vaccine
(Senior Strength)
• Inactivated trivalent vaccine containing 60 mcg of
hemagglutinin antigen per influenza vaccine virus
strain (Fluzone High-Dose Senior Strength [Sanofi
Pasteur]) is an alternative inactivated vaccine for
persons aged ≥65 years.
– Persons aged ≥65 years can be administered any
of the standard-dose TIV preparations or
Fluzone High-Dose.
– Persons aged <65 years who receive inactivated
influenza vaccine should be administered a
standard-dose TIV preparation.
• $25.87 vs. $11.93
High-Dose Influenza Vaccine
(Senior Strength)
A (H3N2)
A (H1N1)
B
Geometric Mean Antibody Titers
Fluzone High Dose
Fluzone Vaccine Pre-defined
(N=2,576)
(N=1,275)
Endpoints
609
333
Yes
116
67
Yes
69
52
No
Fluzone High-Dose
(N=2,569-2572)
Fluzone Vaccine
(N=1,258-1,260)
Injection Site
Reactions
Erythema
14.9%
10.8%
Swelling
8.9%
5.8%
Pain
35.6%
24.3%
Systemic Adverse
Events
High-Dose Influenza Vaccine
(Senior Strength)
Headache
16.8%
14.4%
Myalgia
21.4%
18.3%
Malaise
18.0%
14.0%
Fever
3.6%
2.3%
Event
Intradermal Influenza Vaccine
• Licensed by FDA in May 2011
• Sanofi-Pasteur
• Marketed as “You can barely see it. That’s the
point”
• It is NOT Needleless (1.5 mm microneedle)
• Approved only for persons 18 through 64 years of
age
• Dose is 0.1 mL administered by a specially designed
microneedle injector system in the deltoid (not the
forearm)
• Formulated to contain HA (27 mcg) per 0.1 mL dose
of Fluzone formulation (9 mcg of each virus)
• $14.37 vs. $11.93
Intradermal Influenza Vaccine
Intradermal Influenza Vaccine
• Interactive Video
– https://www.vaccineshoppe.com/static/FluID2
/fluid-video-desktop.html
Intradermal Influenza Vaccine
Influenza Strain
A (H1N1)
A (H3N2)
B
Seroconversion Rate (%)
Fluzone
Intradermal
Fluzone
(N=2,573-2,578)
(N=1,283-1,285)
61.2%
60.5%
75.3%
74.8%
46.2%
54.2%
Noninferior
Yes
Yes
Yes
Systemic
Adverse Events
Injection Site
Reactions
Intradermal Influenza Vaccine
Event
Erythema
Induration
Swelling
Pain
Pruritis
Ecchymosis
Headache
Myalgia
Malaise
Shivering
Fever
Fluzone Intrdermal
(N=2,798-2,802)
76%
58%
57%
51%
47%
9%
31%
27%
23%
7%
4%
Fluzone Vaccine
(N=1,392-1,394)
13%
10%
8%
54%
9%
6%
30%
31%
22%
6%
3%
Quadrivalent Influenza Vaccine
• February 2012 FDA approved quadravalent
influenza vaccine
–
–
–
–
•
•
•
•
A/California/7/2009 (H1N1)pdm09-like virus;
A/Victoria/361/2011 (H3N2)
B/Wisconsin/1/2010-like
B/Yamagata/16/88
Indicated 2-49 years
Route - Intranasal
Dose – standard
Same contraindications
Pneumococcal Conjugate
Vaccine
1. 7 valent
2. 13 valent
3. What about adults?
Pneumococcal Conjugate Vaccine
(Prevnar)
• Pneumovax - Pneumococcal Polysaccharide Vaccine (PPV23)
– 23 strains of pneumococcus
– Infants and small children do not respond to Polysaccharide
vaccines
– Do NOT use in children < 2 years
• Prevnar 7 - Pneumococcal 7-valent Conjugate Vaccine
(Diphtheria CRM197 Protein) (PCV7)
– Used 2000-2010
– 7 strains of Pneumococcus
– Replaced by Prevnar 13
• Prevnar 13 - Pneumococcal 13-valent Conjugate Vaccine
(Diphtheria CRM197 Protein) (PCV13)
– Introduced in 2010
– Indicated children 6 weeks to 5 years
– Should be the standard pneumococcal conjugate vaccine used
Pneumococcal Conjugate Vaccine
(Prevnar)
• Prevnar 13 - Pneumococcal 13-valent Conjugate Vaccine
(Diphtheria CRM197 Protein)
–
–
–
–
–
Approved in 2011
Indicated adults 50 years and older
One dose
Better immunologic response
No different positive effect on disease state demonstrated
– $116.23 vs. $57.94
CMS Core Measure Set
1. Influenza Vaccine
2. Pneumococcal Vaccine
CMS Core Measure Set
• Influenza Vaccine (September 1-April 1)
– Conditions which make a patient eligible for the
influenza vaccine:
• All patients 6 months of age and older
– Contraindications to the influenza vaccine:
• Hypersensitivity to eggs or other components to the
vaccine components
• Patient refuses
• History of Guillain-Barre syndrome within six weeks
after previous influenza vaccination
• Anaphylactic latex allergy (if only product available
contains latex)
• Bone marrow transplant within previous 6 months
CMS Core Measure Set
• Influenza Vaccine
– If any of the following conditions are present,
delay administration and reassess daily. Vaccine
must be administered prior to discharge
•
•
•
•
•
•
•
Temperature exceeding 100.4° F in the prior 24 hours
Less than 24 hours post-op
Currently receiving parenteral IIb-IIIa antagonists
Most recent INR is 3.5 or greater
Most recent PTT is 90 seconds or greater
Most recent platelet count 30,000 or less
For patients in critical care, vaccine administration
should be delayed until patient is stable enough to be
transferred out of critical care
CMS Core Measure Set
• Pneumococcal Vaccine (PPV23)
– Conditions which make a patient eligible for the
Pneumococcal vaccine:
• For all patients 65 years old or older who have never
received the vaccine or the vaccination status cannot
be determined, the vaccine should be offered to the
patient.
CMS Core Measure Set
• Patients between the ages of 6-64 years old should be
assessed for the following conditions:
– Serious long-term health problem with chronic heart or
lung disease, diabetes mellitus, or kidney disease
including nephrotic syndrome
– Compromised immunity such as: Hodgkin’s disease,
leukemia, lymphoma, multiple myeloma, generalized
malignancy, HIV infection or AIDS, organ or bone marrow
transplant, treatment with long-term corticosteroids,
prior treatment with cancer drugs or radiation therapy
– Alcoholism, cirrhosis, or chronic liver disease
– Sickle cell anemia or prior splenectomy
– Cerebrospinal fluid leaks.
– Smokers aged 19 – 64 years
– Patient with asthma
– Diabetes mellitus
– Patient with malpositioned heart
CMS Core Measure Set
• Contraindications to the pneumococcal
vaccine
– Reported allergy or hypersensitivity to vaccine
– Patient refuses
– Received chemotherapy or radiation therapy
during current admission or less than two weeks
prior
– Bone marrow transplant within previous 12
months
– Received herpes zoster (Zostavax) vaccine
within previous 4 weeks
– Patients 6 years of age who have received a
conjugate vaccine within the previous 8 weeks
CMS Core Measure Set
• If any of the following conditions are present, delay
administration and reassess daily. Vaccine must be
administered prior to discharge
– Temperature exceeding 100.4° F in the prior 24 hours.
– Less than 24-hours post-op
– Pregnant women who have any one of the eligibility conditions
listed above may receive
– the vaccine
– Currently receiving parenteral IIb-IIIa antagonists
– Most recent INR is 3.5 or more
– Most recent PTT is 90 seconds or more
– Most recent platelet count 30,000 or less
– For patients in critical care vaccine administration should be
delayed until patient is stable enough to be transferred out of
critical care
Adolescents - Challenges
1. Human Papilloma Virus Vaccine
2. Tetanus Toxoid, reduced Diphtheria Toxoid
and reduced Pertussis vaccine (Tdap)
3. Meningococcal Vaccine
Human Papillomavirus (HPV)
•
Prevalence/Spread/Natural History
– The most common sexually transmitted infection
• Approximately 20,000,000 currently infected
• Approximately 6,000,000 infected yearly
– Half of those newly infected are 15-24 years of age
– HPV is spread by skin-to-skin contact during sexual activity (does
not require intercourse)
• Most people with HPV have no symptoms
• Approximately 70% of new infections clear within one year,
91% within 2 years
•
Persistent infection with high-risk types (16 and 18) is associated
with increased risk for cancers and pre-cancers
•
Greatest benefit from vaccine if administered before initiation of any
type of sexual activity with another person
Human Papillomavirus (HPV)
HPV Types and Their Associated
Conditions
• HPV 6, 11
– Most common low risk types
– Associated with
• Genital warts
• Recurrent Respiratory Papillomatosis (RRP)
• Low grade intraepithelial dysplasias
• HPV 16, 18
– Most common high-risk types
– Associated with
• Low/high grade intraepithelial dysplasia
• Cervical cancers
• Anal cancers
• Vulvar/vaginal cancers
• Penile cancers
• Oropharyngeal cancers
Estimated Percentage of Cancers
Associated with HPV
HPV Vaccines
• 2 HPV vaccines are licensed by the FDA and recommended by
Centers for Disease Control and Prevention (CDC) and ACIP
– Both vaccines are highly effective against diseases caused
by HPV types 16 and 18
– Both vaccines have been shown to prevent cervical
precancers in women
– Both vaccines are very safe
– Both vaccines are made with the protein outer coat of the
HPV that cannot cause infection
– Both vaccines are given intramuscularly (IM) and require 3
doses
– Vaccine trials have demonstrated immune response
through 6-10 years
HPV Vaccines
HPV Types
Schedule
Manufacturer
Brand Name
Licensed in US
Quadrivalent
(HPV4)
6, 11, 16, 18
0, 2, 6 months
Merck
Gardasil
2006: Females ages 9-26
2009:Males ages 9-26
Bivalent
(HPV2)
16, 18
0, 1, 6 months
GlaxoSmithKline
Cervarix
2009: Females ages 10-25
Comparing the HPV Vaccines
Gardasil (HPV4) (Merck)
•
Indicated for the prevention of
cervical, vulvar, vaginal and anal
cancers, as well as genital warts;
caused by HPV types 6, 11, 16 and 18
•
No data from vaccine trials on efficacy
against oropharyngeal cancer, penile
cancer or RRP (but HPV 16 known to
cause a subset of head and neck
cancers)
•
3 dose series: administer the second
dose 1-2 months after the first and
the third dose 6 months after the first
dose (at least 24 weeks after the first
dose)
Cervarix (HPV2) (GSK)
•
Indicated for the prevention of
cervical cancer and precancers
caused by HPV types 16 and 18
•
Different adjuvants than
•
3 dose series: administer the
second dose 1 month after the
first and the third dose 6
months after the first dose (at
least 24 weeks after the first
dose)
Gardasil
ACIP Recommendations
•
•
Females
– All 11-12 year olds should receive 3 doses of either HPV vaccine
– Can be given as young as 9 years old
– All 13-26 year olds should get all 3 doses of an HPV vaccine if
they have not yet received them
– There is no maximum interval between doses
– When possible the same brand of HPV vaccine should be used for
the entire vaccination series
Males
– All 11-12 year olds should receive 3 doses of HPV4 vaccine to
protect against genital warts and anal cancers
– Can be given as young as 9 years old
– All 13-21 year olds should get all 3 doses of HPV4 if they have
not yet received them
– Males aged 22-26 years may also be vaccinated
– MSM and immunocompromised males should receive the
vaccine through age 26 years if not already done so
HPV Vaccine Rates
• 2010 NIS Teen Coverage Results Estimated Vaccine
Coverage of 3-Dose HPV Series Completion Among
Adolescents Aged 13 Through 17 Years By
Race/Ethnicity
Total%
United States
White only, non- Black only, nonHispanic
Hispanic%
Hispanic %
(95% CI)
(95% CI)
(95 % CI)
% (95% CI)
69.6(66.8-72.2) 74.7 (71.6-77.5) 65.4 (57.5-72.5) 56.1 (48.5-63.5)
HPV Vaccine Rates
• 2010 NIS Teen Coverage Results Estimated Vaccine
Coverage of 3-Dose HPV Series Completion Among
Adolescents Aged 13 through 17 Years by Poverty
Level and Race/Ethnicity
Total %
(95% CI)
White only,
non-Hispanic %
(95% CI)
Black only, %
(95 % CI)
Hispanic %
(95% CI)
US-National
69.6(66.8-72.2) 74.7 (71.6-77.5) 65.4 (57.5-72.5) 56.1 (48.5-63.5)
At /Above
Poverty
73.2 (70.3-76.0) 74.7 (71.3-77.7) 68.6 (58.7-73.9) 65.0 (55.0-73.9)
Below poverty
57.3 (50.1-64.2) 69.4 (58.6-78.4) 59.4 (45.7-71.9) 49.3 (37.4-61.2)
Unknown
Poverty
68.1 (56.2-78.1) 83.2 (72.9-90.1) NA
NA
HPV Vaccine Safety
• Both vaccines are almost 100% effective in
preventing precancerous cervical cell changes by
the targeted types of HPV
• Both are safe, extensive clinical trials around the
world in tens of thousands of individuals
– As of 9/2011 40 million doses of Gardasil were
administered
– Vaccine Adverse Event Reporting System
(VAERS) received 20,096 reports of adverse
events
– 92% non-serious and 8% serious
HPV Vaccine Safety
•
•
Non-serious events include:
– Redness, pain and swelling at injection site
– Fever, nausea
– Syncope /dizziness
• Recommend sitting/lying during and for 15-20 minutes
after administration
Serious events reported
– Guillain-Barre Syndrome
• no indication of increased rate from Gardasil
– Blood clots
• Generally in those at increased risk (obese, smokers, those
who use oral contraceptive pills)
– Death
• 71 VAERS reports
• No indication that would suggest events were caused by the
vaccine
Tetanus, Diphtheria & Pertussis
•
Tetanus

Tetanus is an infection caused by bacteria (Clostridium tetani)
usually found in soil, dust and manure. This bacteria enters the
body through an open wound (a cut, puncture, or sore).

Contracting tetanus is very serious. As many as 20% of
unvaccinated individuals infected with Clostridium tetani will
die.

Tetanus is not transmitted person-to-person.

Tetanus has been associated with body piercing.
Tetanus, Diphtheria & Pertussis

Diphtheria (Corynebacterium diphtheriae)

Diphtheria is highly contagious and is spread by coughing and/or
sneezing.

Diphtheria can result in breathing difficulties, paralysis, heart
failure and death.

About 1 out of 10 people who get diphtheria will die.

Cases are extremely rare in the U.S. after the 1970’s due to
aggressive immunization efforts.

Most of these rare, isolated cases were acquired through travel
in incompletely vaccinated or unvaccinated persons.
Tetanus, Diphtheria & Pertussis

Pertussis (Bordetella pertussis)

Pertussis (“whooping cough ”) is highly contagious and spread
by coughing and/or sneezing.

Pertussis causes severe coughing spells which can lead to rib
fractures, pneumonia, seizures and even death.

In 2009, 25% of all pertussis cases reported in the U.S. occurred
among 10 to 19 year olds.

Young children are given a vaccine against diphtheria-tetanuspertussis (DTaP ). However, the protection this vaccine offers
decreases throughout childhood.

It is very important that adolescents receive the Tdap booster
dose for longer protection, and avoid spreading to others,
especially infants.
Pertussis by Age Group
Increased Incidence of Pertussis?
• Pertussis is very contagious
• Individuals with pertussis can be contagious for up
to three weeks
• Pertussis can be difficult to diagnose and treat
especially in older adolescents and adults
• After beginning treatment for pertussis, individuals
remain contagious for five days
• Immunity from prior vaccination wanes
Tdap Vaccines
Manufacturer
Licensed in US
Boostrix
GlaxosmithKline
Approved for persons
10-64 years of age
Adacel
Sanofi Pasteur
Approved for persons
11-64 years of age
Tdap Recommendations
• A single dose of Tdap (Boostrix or Adacel) is
recommended for:
– Adolescents 11-18 years of age (preferably at 11
or 12 years of age)
– Adults 19-64 years of age
– Children 7-10 years of age who are not fully
vaccinated against pertussis (having received
fewer than 4 doses of DTaP, or having received 4
doses of DTaP, but the last dose was prior to age
4 years)
– Adults 65 years of age or older who have or
anticipate having close contact with an infant
less than 12 months of age
Tdap Safety
• Contraindications
– Severe allergic reaction to vaccine component or following
a prior dose
– Encephalopathy not due to another identifiable cause
occurring within 7 days after vaccination with a pertussiscontaining vaccine
• Precautions
– History of Guillain-Barre Syndrome within 6 weeks after a
previous dose of tetanus-containing vaccine
– Progressive neurologic disorder until the condition has
stabilized
– History of severe local reaction following a prior dose of a
tetanus and/or diphtheria toxoid-containing vaccine (i.e.
extensive limb swelling)
– Moderate or severe acute illness
Tdap Safety
• NOT a Contraindication or Precaution
• Certain conditions following DTaP vaccine:
– Temperature of 1050 F or higher
– Collapse/shock-like state
– Persistent crying
– Convulsions with or without fever
Meningococcal Disease
•
•
•
Neisseria meningitidis
How meningococcal disease develops
– Direct contact with oral secretions
– Colonization of the nose and throat
– Bacteria cross protective lining and enter blood stream
Risk Factors for Meningococcal Disease
– Terminal complement deficiency
– Asplenia
– Weakened immune system
– Household exposure
– Crowding
– Other respiratory tract Infections
– Active and passive smoking
Meningococcal Disease
•
Meningitis
– Most common pathologic
presentation
– Secondary result of
hematogenous
dissemination
– Clinical findings
• Fever
• Headache
• Stiff neck
– Laboratory Findings
• CSF pleocytosis
(predominately polys)
• CSF glucose low, protein
high
•
Meningococcemia
– Fulminant presentation
• CASE-FATALITY OF 1530%
• DEATH OFTEN IN 12-48
HOURS
– Result of substantial
endotoxemia
– Clinical findings
• Petechial/purpuric rash
• Hypotension
• Disseminated
intravascular
coagulopathy
• Multi-organ failure
Incidence by Age
1.4
1.2
Serogroup C
Rate per 100,000
1
0.8
Serogroup Y
0.6
0.4
0.2
0
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26
Age (year)
Incidence by Year
Rate per 100,000
0.5
0.4
B
C
Y
0.3
0.2
0.1
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008
Quadravalent Meningococcal
Conjugate Vaccine (MCV4)
Menactra
N. Meningiditis
serogroups
Conjugated component
Manufacturer
Licensed in US
Menveo
A, C, Y and
A, C, Y and
W-135 capsular
W-135 capsular
polysaccharide antigens polysaccharide antigens
Diphtheria
CRM197
Toxoid Protein
Sanofi Pasteur
Novartis
2005;persons 2-55 yrs. 2010;persons 11-55 yrs.
Quadravalent Meningococcal
Conjugate Vaccine (MCV4)
• Administer MCV4 at age 11 or 12 years with a
booster dose at 16 years of age
• Administer 1 dose at age 13 through 15 years if not
previously vaccinated
• For persons vaccinated at age 13 through 15 years,
a one-time booster dose is recommended,
preferably at or after 16 through 18 years of age
(minimal interval of 8 weeks)
• Healthy persons who received their first routine
dose of meningococcal conjugate vaccine at or
after age 16 years do not need a booster dose
• DATA INDICATES THAT PROTECTION WANES
WITHIN 5 YEARS AFTER VACCINATION
U.S. Average Annual Number of
Cases of Meningococcal Disease
Age Group
11-14 yrs
15-18 yrs
19-22 yrs
Total (11-22 yrs)
2000-2004
46
106
62
214
2005-2009
12
77
52
141
Percent
Change
-74%
-27%
-16%
-34%
Useful Websites
•
•
•
•
•
•
•
•
•
•
•
Center for Disease Control and Prevention (CDC)
– http://www.cdc.gov/
www.flu.gov
– http://www.cdc.flu.gov
CDC – Advisory Committee on Immunization Practices (ACIP)
– http://www.cdc.gov/nip/ACIP/default.htm
CDC – ACIP – Vaccine Information Sheets
– http://www.cdc.gov/nip/publications/vis/
Food and Drug Administration (FDA)
– http://www.fda.gov/
FDA – Center for Biologic Research (CBER)
– http://www.fda.gov/cber/index.html
FDA – CBER – Biologic Product Shortages
– http://www.fda.gov/cber/shortage/shortage.htm
Morbidity and Mortality Weekly Report (MMWR)
– http://www.cdc.gov/mmwr/weekcvol.html
Pediatric and Adolescent Schedules
– http://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html
Adult Schedules
– http://www.cdc.gov/vaccines/schedules/hcp/adult.html
WHO recommendations for Influenza Vaccine 2013
– http://www.who.int/influenza/vaccines/virus/recommendations/201202_recom
mendation.pdf
Questions
Thomas P. Lombardi, PharmD, FASHP
Supervisor, Clinical Pharmacy Services
St. Peter’s Hospital
&
Senior, Adjunct Faculty
Albany College of Pharmacy and Health Sciences
Albany, NY
tlombardi@sphcs.org