FMA Pharmacy Course

Florida Medical Association Course
Vaccine
Safety for
Pharmacists
FLORIDA MEDICAL ASSOCIATION

VACCINE SAFETY FOR PHARMACISTS | Continuing Pharmacy Education
Contents
Course Description and ACPE Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Pharmacists’ Role in Immunization. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Immunization Rates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Barriers to Vaccinations. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Vaccine-Preventable Diseases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Overview of Vaccines. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Educational Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Vaccine Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Administering Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Vaccines for Adults. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Summary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Page 2 | FLmedical.org
Continuing Pharmacy Education | VACCINE SAFETY FOR PHARMACISTS
Florida Pharmacists Immunization Course

ACPE UAN #0165-9999-19-096-H06-P
Three (3) Contact Hours
Course Description and Target Audience
Florida Medical Association, Florida Retail Federation and Florida Pharmacy Association collaborated to offer this three-hour
online course to fulfill the continuing education requirement that immunizing pharmacists must meet every two years to maintain
their Florida certification to administer vaccines. This course addresses the safe and effective administration of vaccines with a spe-
cific emphasis on all vaccines listed in the Centers for Disease Control and Prevention and Advisory Committee on Immunization
Practices Adult Immunization Schedule. Influenza. The course also addresses the safe and effective administration of epinephrine
by pharmacists when medically necessary.
Objectives:
Upon completion of this application-based course, learners should be able to:
• Recognize the role that pharmacists can play in the administration of vaccine preventable diseases listed under the Centers for
Disease Control and Prevention (CDC) within the context of current Florida rules and regulations
• Identify the effectiveness of immunizations in the prevention of various diseases
• Identify specific barriers and misconceptions that can result in under-utilization of vaccinations
• Demonstrate effective strategies for communication to dispel and overcome barriers and misconceptions of vaccines
• Recognize side effects associated with vaccines
• Differentiate between live attenuated vaccines and inactivated vaccines
• Provide an overview of each vaccine preventable diseases listed under the CDC
• Recognize patients who are eligible for vaccines listed under the CDC
• Describe the available vaccines used to prevent the spread of disease
• Identify the contraindications or precautions associated with each vaccine
• Demonstrate the appropriate use of vaccinations safely and effectively
• Use proper techniques for administration of vaccines by the intramuscular and subcutaneous routes
• Explain the recommended methods to ensure proper storage and handling of approved vaccines
• Use epinephrine for an allergic reaction and administer appropriately
• Identify signs and symptoms of adverse events and the emergency procedures immunizing pharmacists should be prepared to
implement in order to manage and report adverse events
• Report immunizations, errors, and adverse events in national databases and registries
Faculty/Author:
• Lori L. Alexander, MTPW, ELS, MWC®, Education Director, American Medical Writers Association (AMW@A) and President,
Editorial Rx, Inc., North Fort Meyers, FL
Vaccine Safety Course | Page 3

Disclosure Statement: Instructions for completing this CPE activity

None of the contributors have any relevant financial relation- • Register for the online course as directed. You must provide
ships relevant to the content of this online course. all requested information accurately, particularly date of
birth, as well as the Florida license and NABP numbers so
ACPE Accreditation that credit can be reported properly during the required
The Florida Pharmacy Association is accredited by
time frame. Incorrect or missing information can result in
the Accreditation Council for Pharmacy Education
additional reporting fees and/or the inability to have the
as a provider of continuing pharmacy education.
credit reported to CPE Monitor.
This immunization course is an application based activity. • Pay the required course fee of $75
Initial Release Date: October 24, 2019 • Review the text-based educational monograph and support-
ing resources
Expiration Date: October 24, 2022
• Complete the online post-test with a minimum score of 70%
• Complete the online evaluation
Hardware/Software Requirements:
The completion of this course requires:
» High speed Internet connection
» Turn off Pop-up Blocker – You can add this site as a trusted site and this will enable you to access the course site with Pop-up Blocker enabled.
Adobe has tested Adobe® Flash® Player 9 extensively on the following minimum hardwire configurations:
» Intel® Pentium® II 450MHz or faster processor (or equivalent)
» 128MB of RAM
Recommended hardware for standard and high definition (HD) video playback
The following minimum hardware configurations are recommended for an optimal playback experience:
Resolution Windows
852x480 (480p), 24 fps * Intel Pentium 4 2.33GHz processor (or equivalent)
* 128MB of RAM
* 64MB of VRAM
1,280 x 720 (720p), * Intel Pentium 4 3GHz processor (or equivalent)
24 - 30 fps * 128MB of RAM
* 64MB of VRAM
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24 fps * 128MB of RAM
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Operating Systems and Browsers Flash® Player 9 is supported on the
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Platform Browser
Microsoft® Windows Vista Microsoft Internet Explorer 7, Firefox 2.0
Microsoft Windows XP Microsoft Internet Explorer 6.0 or later, Firefox 1.x, Firefox 2.x
Microsoft Windows Server® 2003 Microsoft Internet 6.0 or later, Firefox 1.x, Firefox 2.x
Introduction
Vaccines have changed the landscape of public health pertussis) or Td (tetanus and diphtheria), hepatitis A and
dramatically. Smallpox, cholera, typhoid, and the plague B, MMR (measles, mumps, and rubella), human papilloma-
were all eliminated by vaccines. In more recent times, virus (HPV), and meningococcal disease.
polio and other diseases have been eradicated in the US
This course addresses the role of pharmacists in immu-
since the introduction of a childhood vaccine program.
nization and the benefits of their involvement in admin-
Despite the effectiveness of vaccines, rates of immu-
istering vaccines. The factors that affect immunization
nization against vaccine-preventable diseases are low,
rates are described, as are evidence-based strategies that
especially among adults. One way to help increase rates is
pharmacists can use to improve these rates. The focus
to expand the pool of vaccine providers; statutes allowing
of the course is on the types of vaccines, the diseases
pharmacists to administer vaccines is an important
they are designed to mitigate, their effectiveness, and
example. In Florida, pharmacists are authorized to give
steps pharmacists must take to ensure the safe storage,
all vaccines listed in the Centers for Disease Control and
handling, and administration of vaccines. With the
Prevention and Advisory Committee on Immunization
convenience of pharmacies in the community, pharma-
Practices Adult Immunization Schedule. This list includes
cists are poised to play a pivotal role in increasing the
vaccines against seasonal influenza, pneumococcal
number of vaccinated people, thus enhancing the health
infection, varicella, zoster, Tdap (tetanus, diphtheria, and
and well-being of the public.

Pharmacists’ Role in Immunization contraindications for vaccines and administer them as appro-
priate. The curriculum for PharmD programs now supports
Pharmacists have played a role in immunization for decades. In
education on increasing immunization rates, identifying and
1997, the American Pharmacists Association issued guidelines
reaching at-risk populations, and helping to decrease the
for pharmacy-based immunization advocacy focused on five
incidences of vaccine-preventable diseases.2
principles: prevention, partnership, quality, documentation,
and empowerment.1 Under prevention, the guidelines state that Pharmacists in all 50 states, as well as Washington DC and
“pharmacists should protect their patients’ health by being Puerto Rico, can administer immunizations in some capacity,
vaccine advocates” and recommend that pharmacists adopt one but the rules and level of autonomy vary across states.9 The
of three levels of involvement in vaccine advocacy:1 authority for pharmacists to provide immunizations follows
• Educator: motivating people to be immunized three primary models: independent, prescription, and pro-
tocol.10 The independent model, used in 17 states, is the least
• Facilitator: hosting others who immunize or serving as a
restrictive. Under this model, pharmacists can independently
depot for vaccine distribution
screen, assess, and give select vaccinations. The prescription
• Immunizer: protecting vulnerable people, consistent with and protocol models are more restrictive. With the prescription
state law model, pharmacists may immunize individuals who have a
As educators, pharmacists can provide recommendations for prescription from a physician for the vaccine. For the protocol
vaccinations by reviewing pharmacy records and prescription model, pharmacists must follow a protocol supported by a
history to identify people at risk for vaccine-preventable private physician, public health official, or state-provided
diseases.2 For example, in one study, the rate of pneumococcal guidance. The protocol outlines the specific vaccines that can
vaccinations increased as pharmacists identified at-risk be given, under what conditions, and with which procedures.10
individuals.3 In a 1-year demonstration project, there was a Florida is one of five states with the protocol model.
15% total increase in the number of influenza, pneumococcal,
In July 2015, Florida House Bill 279 expanded authority of
pertussis, and herpes zoster vaccines; the increase was primar-
pharmacists to allow for the administration of immunizations
ily driven by increases in influenza and pertussis vaccinations.4
and vaccines listed in the Centers for Disease Control and
Just as pharmacists can help enhance adherence to medication,
Prevention (CDC) and Advisory Committee on Immunization
they can help enhance adherence to vaccine recommenda-
Practices (ACIP) Adult Immunization Schedule. This list
tions.5 Pharmacists have facilitated vaccinations by supplying
includes vaccines against seasonal influenza, pneumococcal
vaccine products to health care providers. Surveys have shown
infection, varicella, zoster, Tdap (tetanus, diphtheria, and
that many primary care physicians do not vaccinate patients at
pertussis) or Td (tetanus and diphtheria), hepatitis A and B,
high risk for a vaccine-preventable disease or stock all recom-
MMR (measles, mumps, and rubella), human papillomavirus
mended adult vaccines.6-8 The role of facilitator is waning, but
(HPV), and meningococcal disease. The new Florida law
it is giving way to pharmacists as
also allows pharmacists to give immunizations or vaccines
active immunizers. Now that
recommended by the CDC for international travel. Pharmacists
they have become active
may immunize only individuals 18 years and older. As noted,
immunizers, pharmacists
a vaccine protocol must be set up under a remote supervising
assess patients for
physician. In addition, the Florida law allows pharmacists to
indications and
administer epinephrine in a case of anaphylactic reaction to a
vaccination.
Under the law, a registered pharmacy intern can give these im
munizations with supervision of a pharmacist who is certified
to give immunizations. To become certified, pharmacists
must successfully complete an immunization administration
certification program of no fewer than 20 hours, approved
by the Florida Board of Pharmacy. In addition, during each
subsequent licensure renewal term, the certified pharmacist
must complete a 3-hour course on the safe and effective the country.15 As such, Florida pharmacists are poised to make a
administration of vaccines, including the use of epinephrine substantial contribution to improving immunization rates.
for allergic reactions. This course may be offered only by a
Several studies, including systematic reviews and meta-analy-
statewide professional association of physicians accredited
ses, have shown that rates of vaccination increased when phar-
to provide educational activities designated for AMA PRA
macists were involved in vaccinations across populations.20-26
Category 1 credit™, such as the Florida Medical Association.”
One systematic review, published in 2016, included eight studies
After several state statutes were changed to allow pharmacists designed to evaluate a variety of pharmacy settings (e.g.,
to administer vaccines, researchers found that, between hospitals, community) and vaccines (influenza, zoster, pneumo-
2007 and 2013, the number of influenza vaccinations given in coccal, Tdap, hepatitis A and B, MMR, varicella, meningococcal,
community pharmacies increased from 3.2 to 20.9 million.11 By and HPV). The results indicated that pharmacists as vaccine
2016, approximately 80% of pharmacies provided immunization providers had a significant effect on immunization rates, but
services with at least one vaccine, and pharmacists adminis- the effect varied widely according to the type of vaccine.22 The
tered approximately 25% of all influenza vaccinations.12, 13 In risk ratios ranged from 2.23 (influenza vaccine) to 4.78 (herpes
fact, the leading disease state management service offered zoster vaccine), with an overall risk ratio of 2.95. Another
by pharmacists is now immunizations.14, 15 In 2017, 70% of all systematic review (36 studies) showed an increase in vaccine
pharmacies provided influenza immunizations; in 2018, that coverage when pharmacists were involved in immunizations,
percentage had increased to 76%, and at that time, 69% of all regardless of their role (educator, facilitator, administrator)
pharmacies also offered immunizations other than influenza.15 or the vaccine (e.g., influenza, pneumococcal), compared with
traditional vaccine providers only.23 Pharmacists’ various roles
The results of a 2019 online survey of independent pharmacy in immunization were evaluated in another systematic review
owners show the increasing role of pharmacists in immuniza- (25 studies), and the results were similar: pharmacists had a
tions within the community. Influenza vaccinations continue positive impact on older adults’ access to vaccines, primarily
to be the leading type of vaccine given in the pharmacy setting, pneumococcal and influenza vaccines.24
and herpes zoster and pneumococcal vaccines follow closely
(Table 1).15 The primary benefit of pharmacists as vaccinators is greater
access for the public. Access to vaccines is an established barri-
Table 1: Immunizations Given at Independent Community er to vaccinations and expanding the pool of vaccine providers
Pharmacies 15 can help to increase vaccine coverage. Individuals have said
that they have been satisfied with pharmacist-administered
Percentage (%) of vaccines and prefer a pharmacy setting because of conve-
Type of Vaccination
Pharmacies nience.2, 27 Compared with a traditional setting (e.g., health care
Influenza 90 provider’s office), pharmacies offer advantages such as no visit
Zoster 86 fee, no appointment requirement, less wait time, and extended
Pneumococcal 84 hours. These advantages are important to people. A study of
Tetanus-containing 80 more than 6.2 million vaccinations given by pharmacists at
Hepatitis B 42 Walgreens over a 1-year period showed that approximately 31%
were given during so-called off-clinic hours, with 17% given on
Nearly 310,000 pharmacists are currently employed in more weekends, 10% in the evening, and 3% on holidays.28 The adults
than 67,000 pharmacies in the US.16, 17 With this high number in the study were more likely to be younger, live in an urban
of pharmacies, they can be more convenient than health care area, and be in good health.
providers. For example, more than 90% of people in the US live
within 2 to 5 miles of a community pharmacy.18, 19 As the number Providing vaccines also offers benefits to pharmacists. In
of community pharmacies continues to increase, so does the addition to revenue, relationships with customers are en-
number of pharmacies per capita; in 2015, that number was 2.11 hanced, which can lead them to seek other pharmacy services.15
per 10,000 population, with substantial variation across local As awareness of vaccine services grow, more people in the
areas.18 Florida has the third highest number of pharmacists community will recognize the importance of the pharmacy’s
(20,790) and the fourth highest number of pharmacies (4,549) in role in overall health and well-being.

Immunization Rates Table 2: Healthy People 2020 Goals for Immunization and Infectious
Diseases29
To help reduce vaccine-preventable disease and
increase immunization rates, target vaccination rates Objective Factor Target
were set in Healthy People 2020 (Table 2).29 Over the
Reduce, eliminate, or » Cases of measles (US- » 30 cases
years, vaccine coverage has improved, but the rates
maintain elimination of acquired)
are still inadequate. Rates vary according to age and cases of vaccine-preventable » Cases of mumps (US- » 500 cases
vaccine. In 2015, the highest rate was associated with diseases acquired)
influenza vaccination among individuals 65 years » Maintain elimination of » 10 cases
and older. The lowest rate was associated with HPV rubella (US-acquired)
vaccination among men, 19 to 26 years old, without re- » Meningococcal disease » 1,094 cases
ported HPV vaccination before age 19 (Table 3).30 Only » New invasive » 31 new
one vaccine, against herpes zoster, met the target set pneumococcal infections cases
in Healthy People 2020.29 Rates have improved; for among adults 65 years
example, during the 2018-2019 flu season, the overall and older
rate of influenza vaccinations among adults was 47.3, Reduce hepatitis A » 0.3 cases
slightly higher than that reported for 2015.31 As with per 100,000
the 2015 rates, the rate was lower for people 18 to 49 Reduce hepatitis B » New infections in adults » 1.5 cases
years of age and was higher for older age-groups 19 years and older per 100,000
(Figure 1 on next page).31 » High-risk populations: » 215 cases
injection drug users
In addition to vaccine and age, rates of vaccination » High-risk populations: men » 45 cases
among adults in the US vary by several other who have sex with men
factors, including sex, race/ethnicity, health status, Increase percentage » Noninstitutionalized » 70%
education level, socioeconomic status, and geographic of children and adults adults 18 years and older
location.26, 30, 32-34 For example, studies have shown that vaccinated annually against » Health care personnel » 90%
rates for influenza, pneumococcal, zoster, tetanus, seasonal influenza » Pregnant women » 80%
and HPV vaccinations are more likely to be higher Increase percentage of » Noninstitutionalized » 90%
for women and for individuals with a higher level of adults vaccinated against adults 65 years and older
education and greater income.33, 34 The likelihood of pneumococcal disease » Noninstitutionalized high- » 60%
vaccination was lower for people with better health, risk adults 18-64 years
a longer time since the last health visit, and difficulty Increase percentage of » 30%
with access to care.33 With regard to race/ethnicity, adults vaccinated against
results have consistently shown that vaccination zoster (shingles)
rates are higher for white individuals than for black, Increase hepatitis B vaccine » 90%
Hispanic, and Asian populations.26, 30, 32 coverage among high-risk
populations: health care
Healthy People 2020 targets for influenza and hepati- personnel
tis B vaccination rates among health care personnel
Increase percentage of » 90%
are 90% each.29 The actual rates have been lower, with health care personnel
rates of 65% to 69% for influenza vaccination and 65% vaccinated annually against
for hepatitis B vaccination.30, 37, 38 These consistently seasonal influenza
low vaccination rates have been addressed by the
Safety Foundation, and the American Pharmacists Association have
CDC and infectious disease societies. Several orga-
adopted policies advocating for mandatory immunization of health care
nizations, including the Infectious Diseases Society
personnel in all settings, including pharmacies.39-41
of America, the Society for Healthcare Epidemiology
of America, the American Academy of Pediatrics, Most health care institutions provide opt-outs for medical, religious, or
American College of Physicians, National Patient philosophical reasons and require that personnel who do not get vaccinated
Table 3: Vaccination Rates by Vaccine and Age in

20153 0
must wear a mask.42 Findings from a systematic review and other studies
have shown that, although mandatory vaccination increases vaccination Vaccine and Age Rate (%)
rates and decreases absenteeism among health care personnel, its effects Influenza
on patient outcomes are still unknown.42-46 ♦ ≥19 yrs. (total) ♦ 44.8%
♦ 19-49 yrs. ♦ 32.5
Vaccination rates also vary considerably by state, and rates are par- ♦ 50-64 yrs. ♦ 48.7
ticularly low in Florida. In an analysis of vaccination rates whereby a ♦ ≥65 yrs. ♦ 73.5
score was given using 18 metrics, Florida received a score of 32.47 of 100, Pneumococcal (ever)
ranking it as 49 of 51 (all states plus Washington DC).47 The state ranked ♦ 19-49 yrs., increased risk ♦ 23
last in vaccination rates among adults and older adults, ranked 49 for ♦ ≥65 yrs. ♦ 63.6
the rate of tetanus vaccinations among adults, and ranked 47 for the rate
Tetanus (in last 10 yrs.)
of zoster vaccination among adults 60 years and older.47 Other research
♦ ≥19 yrs. ♦ 61.6
on state variations in vaccination rates showed that the likelihood of
♦ 19-49 yrs. ♦ 62.1
influenza and Tdap vaccinations was lowest for residents of Florida; ♦ 50-64 yrs. ♦ 64.1
the state was in the bottom quartile for influenza, pneumococcal, Tdap, ♦ ≥65 yrs. ♦ 56.9
and zoster vaccine coverage.33 Clearly, greater advocacy for vaccines is Tetanus including pertussis (in last
needed in the state, and Florida pharmacists have the opportunity to 10 yrs.)
help improve rates in their state. ♦ ≥19 yrs. ♦ 23.1
♦ 19-64 yrs. ♦ 24.7
Barriers to Vaccinations ♦ ≥65 yrs. ♦ 16.5
Barriers to vaccinations in adults are many and range from knowledge Hepatitis A, at least 2 doses (ever)
about vaccines and vaccine-preventable diseases to access to vaccination ♦ ≥19 yrs. ♦ 9.0
(Box 1).38, 48-52 An understanding of the barriers is necessary to develop ♦ 19-49 yrs. ♦ 12.3
strategies to overcome them. ♦ ≥50 ♦ 5.5
Hepatitis B, at least 3 doses (ever)
WHO refers to vaccine hesitancy as one of the top 10 global threats.53 ♦ ≥19 yrs. ♦ 24.6
As defined by WHO, vaccine hesitancy is “the reluctance or refusal to ♦ 19-49 ♦ 32.0
♦ ≥50 yrs. ♦ 16.5
Figure 1: Flu Vaccination Coverage of Adults 18 years and older, Herpes zoster
US, 2010-2019 ♦ ≥60 yrs. ♦ 30.6
♦ 60-64 yrs. ♦ 21.7
80
♦ ≥65 yrs. ♦ 34.2
66.6 66.7 HPV, at least 1 dose (19-26 yrs. old) a
70 64.9 66.2 65.3 .1
65 63.4 68
59.6 ♦ Women ♦ 12.2

♦ Men ♦ 3.3
60
a
Who had no reported HPV vaccination
Percent Vaccinated
47 before age 19 years.

50 45.5 45.1 45.3 43.6
45 . 4
47
.3
42.7 39.
7
43.6 43.3 3
40 42.2 41.7 45.
40.5 41.5
38.8 37 .
1 65+ years
32.7 33.6 9
30 32.3
33.5 34.
30.5 31.1 26.9 50+64 years
28.6
Overall
20
2010-11 2011-12 2012-13 2013-14 2014-15 2015-16 2016-17 2017-18 2018-19 18-49 years
Flu Season

vaccinate despite the availability of vaccines.”53 This hesitancy vaccinations, or they do not understand their risk for a vaccine-
may have its basis in religious or philosophical beliefs or, quite preventable disease. As many as 50% of people are unaware
simply, in fear. Some people’s reluctance to be vaccinated may of the need for a vaccination.49, 50 A recommendation from a
be related to fears about vaccine safety or uncertainty about health care provider has been shown to be a strong predictor
their efficacy. With the advent of the internet, many patients of patient compliance, with up to 73% of unvaccinated people
have turned to various websites for vaccine information, but wanting to talk to their health care provider or pharmacist
the internet is inundated with myths and unreliable informa- about vaccination.38, 49 With more than 50% of health care
tion. Pharmacists can help allay public fears about vaccines by providers reporting that they did not always discuss the
promoting credible information online, such as the following. consequences of missed vaccinations with their patients,38
• Centers for Disease Control and Prevention (CDC): pharmacists can help fill the gap. Several studies have
Vaccines & Immunizations found strategies that pharmacists can use to help increase
vaccination rates.4, 52, 55, 56
• Immunization Action Coalition
• Vaccination forecasting
• American Academy of Family Physicians: Immunizations
• Flyers accompanying prescriptions
• Press releases in local newspapers
Box 1. Barriers to Immunization38, 48-52 • Personalized letter mailed to customers eligible for
vaccine(s)
» Mistrust (pharmaceutical companies, government)
• Personal conversation (face-to-face or by telephone)
» Lack of awareness of need
» Lack of recommendation from a health care Vaccine-Preventable Diseases
provider Smallpox was the first contagious disease to be eradicated by
a vaccine. The vaccine was introduced in the US around 1800,
» Inconvenience/Forgotten
and it was soon followed by vaccines against rabies, diphtheria,
» Fear of side effects (including getting the pertussis, tetanus, tuberculosis, polio, measles, and mumps.48, 57
preventable disease) Widespread use of these vaccines in immunization programs
led to drastic reductions in the number of cases of these
» Dislike of injections
disease. It is estimated that more than 103 million cases of
» Difficult access these contagious diseases have been prevented since the early
1920s.57 Currently, 26 vaccines are available in the US to protect
» Cost/Lack of insurance coverage
against several infectious diseases.58 The focus here is on the
diseases preventable by vaccines that Florida pharmacists can
Providing copious amounts of evidence on vaccine safety administer: seasonal influenza, pneumococcal disease, chicken-
and efficacy usually does little to persuade people with fears. pox, shingles, tetanus, diphtheria, pertussis, hepatitis A and B,
Instead, evidence suggests following these best practices in measles, mumps, rubella, HPV, and meningococcal disease.
developing communications to promote vaccines.54
• Identify target audience and establish trust Influenza
Influenza/pneumonia is among the top 10 leading causes of death
• Give balanced information (both the risks and benefits) in the US.59 Influenza is an RNA virus from the Orthomyxoviridae
• Provide facts before discussing myths family. It is classified as being type A, B, C, or D.60 Influenza types A
• Use visuals and B are the two most important strains for humans; the type C
virus is not associated with severe disease, epidemics, or pandem-
• Test communications before using
ics, and the type D virus is not known to affect humans.61
Another barrier to immunization is unawareness of the
Type A influenza can be further subdivided based on the type
need. Many adults think that healthy people do not need
of surface antigens it expresses, such as hemagglutinin (H) and
Influenza virus is commonly spread by respiratory droplets

introduced into the air by coughing or sneezing. Typically, the
virus is spread from person to person. However, people can also
acquire it by touching something with the virus on it and then
by touching their mouth or nose.60
Secondary bacterial pneumonia is the most common

complication of influenza. Worsening of chronic pulmonary
diseases (including chronic bronchitis) and myocarditis are also
potential complications. Nonrespiratory conditions may also be
complications of influenza. In a study of data for nearly 90,000
adult patients hospitalized with laboratory-confirmed influen-
za, approximately 95% of patients had a respiratory diagnosis
and 47% had a nonrespiratory diagnosis.62 Approximately 5%
neuraminidase (N). The hemagglutinin antigens play a role had only a nonrespiratory diagnosis. The most common acute
in viral attachment, and the neuraminidase antigens aid in diagnoses in these patients were pneumonia (36%), sepsis (23%),
allowing viral penetration into cells. Although there are many and acute kidney injury (20%).62
different subtypes of influenza A viruses, only three hemag-
Influenza is seasonal in the US, with a peak most often in
glutinin (H1, H2, and H3) and two neuraminidase (N1 and N2)
February.60 Older individuals are particularly affected.
subtypes have caused human epidemics.60 Influenza A causes
moderate to severe illness. Influenza carries a substantial burden around the world,
related to both morbidity and mortality and economics. This
Influenza B is not categorized into subtypes, but rather into two
burden varies each year, according to the virus type and sub-
distinct genetic lineages (Yamagata and Victoria).60 Influenza B
type. The CDC estimates that in the 2019-2020 season (October
usually causes milder disease than type A, and mostly affects
1, 2019 to April 4, 2020) in the US, there were 39 to 56 million
children.60
flu-related illnesses, 18 to 26 million medical visits, 410,000 to
The H and N antigens in influenza types A and B continuously 740,000 hospitalizations, and 24,000 to 62,000 deaths.63 These
and gradually change, a process known as antigenic drift. numbers are similar to those for the 2017-2018 flu season, which
Because of these changes, antibodies produced to an influenza had higher numbers than other years since the 2014-2015
virus (either through vaccine or infection) do not protect season (Table 4).64 Researchers using mathematical modeling
against an influenza virus in a later year. As a result, yearly estimated that influenza vaccination in the 2018-2019 flu season
vaccination is recommended, and vaccines are developed to prevented 4.4 million illnesses, 2.3 million medical visits, 58,000
match the currently circulating virus strains.61 hospitalizations, and 3,500 deaths.65
Table 4: Estimated Influenza Disease Burden, by Seasona, 63, 64
Influenza-Related
2019-2020 2018-2019 2017-2018 2016-2017 2015-2016 2014-2015
Outcomes
Symptomatic illnesses 39-56 million 35.5 million 45 million 29 million 24 million 30 million
Medical visits 18-26 million 16.5 million 21 million 14 million 11 million 14 million
Hospitalizations 410,000-740,000 490,600 810,000 500,000 280,000 590,000
Deaths 24,000-62,000 34,200 61,000 38,000 23,000 51,000
Estimates from the 2017-2018 and 2018-2019 seasons are preliminary and may change as data are finalized.
a

According to the results of a systematic review (eight random- As with other respiratory diseases, pneumococcal infections
ized controlled trials), the risk for influenza or influenza-like occur most often during the winter.
illness was lower among older adults who received the influ-
Pneumococcal disease is attributed to an estimated 4 million
enza vaccine than those who did not.66 The findings indicate
illness episodes, 445,000 hospitalizations, and 22,000 deaths
that 30 people would need to be vaccinated to prevent the
each year.71 The overall incidence of the disease is 9.14 per
development of influenza in one person, and 42 would need to
100,00 and increases with age after the 18 to 34 years age-group
be vaccinated to prevent the development of an influenza-like
(Table 5).61 The incidence is highest among individuals 85 years
illness in one person.66
and older (45.4/100,000) The overall death rate is 1.01 per 100,000
In addition to preventing influenza, vaccination is also beneficial and again increases with age, with a rate of 11.4 per 100,000 for
for individuals in whom influenza develops. Researchers people 85 years and older.61
compared outcomes for vaccinated and unvaccinated adults hos-
pitalized for influenza during the 2013-2014 flu season. Vaccinated Table 5: Incidence and Death Rate for Pneumococcal Infections 61
adults were 37% less likely to be admitted to the intensive care
Age Incidence Death Rate
unit and had shorter stays in the intensive care unit compared
(Yrs.) (per 100,000) (per 100,000)
with unvaccinated adults.67 In addition, vaccinated adults were
18-34 2.33 0.08
52% to 79% less likely to die than unvaccinated adults. Overall,
35-49 6.48 0.46
the benefits were greatest for patients 65 years and older.
50-64 14.8 1.47
Influenza is also associated with a significant loss of workplace 65-74 18.0 2.17
productivity68 and economic burden. The average annual cost 75-84 29.0 4.53
of influenza to the health care system and society is estimated >85 45.4 11.4
to be $11.2 billion. Indirect costs accounted for $8.0 billion and
Overall 9.14 1.01
included ill patients who did not receive medical attention,
office-based outpatient visits, emergency department visits, The addition of pneumococcal conjugate vaccines (PCVs)
hospitalizations, deaths, and days of lost productivity.69 7 and 13 in childhood immunization programs not only
reduced infant mortality related to invasive pneumococcal
Pneumococcal Disease disease but also provided secondary herd protection for
Pneumococcal disease is caused by the gram-positive anaerobic unvaccinated adults (Figure 2).61, 72
bacteria Streptococcus pneumoniae.60 S. pneumoniae is a
leading cause of bacterial meningitis and bacteremia and has Figure 2: Effect of Pneumococcal Vaccines in Childhood
Immunization Programs
been identified in 5% to 15% of cases of
community-acquired pneumonia in the US.70 PCV7 introduction PCV17
45
Transmission occurs through direct person- PCV13 non-PCV7
to-person contact via respiratory droplets. 40 Non-Vaccine Type
35
Cases per 100,000 population
PCV13 introduction PCV13 introduction

for children for adults
Figure 2: Rates of invasive pneumococcal disease 30
among adults older than 65 years in the US, 1998-

25
2015. After PCV13 was introduced for children, cases of
invasive pneumococcal disease were reduced through 20
herd protection. In 2007-2008, rates of PCV13-type
invasive pneumococcal disease among adults 65 years 15
of age and older were around 17 cases per 100,000.
In 2014–2015, rates of PCV13-type disease had 10
decreased by 70%. Reprinted from Centers for Disease

5
Control and Prevention. Manual for the Surveillance
of Vaccine-Preventable Diseases. Atlanta, Centers for 0
Disease Control and Prevention. 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 '2011 2012 2013 2014 2015
YEAR
The results of a systematic review (25 studies) showed At one time, nearly all children in the US had chickenpox.
strong evidence of the pneumococcal vaccine being effective In the early 1990s, there was an average of 4 million cases
in preventing invasive pneumococcal disease, especially each year, as well as 10,500 to 13,000 hospitalizations.61 There
among people older than 65 years.73, 74 Evidence also suggests, were approximately 100 to 150 deaths each year; in 1994,
but less strongly, that pneumococcal vaccination is helpful the crude national varicella-related death rate was 0.4 per
in preventing community-acquired pneumonia, providing million population.77 At that time, more than half of varicella-
better outcomes after pneumococcal pneumonia, and related deaths occurred among adults 20 years or older. Low
preventing pneumonia-related deaths.75, 76 nationwide varicella vaccine coverage led to the vaccine being
required for entry into childcare and school in 1999. By 2012,
Chickenpox/Shingles varicella-related outpatient visits and hospitalizations had
Primary infection with the varicella zoster virus, a member of decreased by 84% and 93%, respectively, compared with data
the herpes virus, results in chickenpox. The reactivated latent from the pre-vaccination era.78
form of the virus causes herpes zoster, or shingles.
Currently, varicella most often occurs among adults and older
Chickenpox children and adolescents and often develops in vaccinated
Chickenpox is highly contagious; it is less contagious than individuals. These so-called breakthrough cases are usually
measles, but more contagious than mumps and rubella.60 The much milder.
virus is most commonly transmitted through direct contact
Shingles
with a person with either varicella or shingles. The virus may
Shingles is a painful condition that usually presents as a
also be transmitted through airborne droplets.60 With primary
unilateral vesicular dermatomal rash. The most common
infection, the varicella virus invades epidermal cells, usually
complication is postherpetic neuralgia, or pain in the area of
causing a contagious rash to develop. After the rash develops,
the resolved lesions, which can last up to a year or longer.60
the virus invades sensory nerves located in mucocutaneous
Postherpetic neuralgia will develop in approximately 18% of all
sites and then travels up through the axons to the sensory dor-
adults with shingles and in 33% of those 79 years and older.79
sal root ganglia. Once there, the virus lays dormant (latent) in
neurons.60 The latent virus does not replicate, but it does have Several risk factors for shingles have been identified: immuno-
the ability to become infectious at any time.60 Varicella virus suppression through human immunodeficiency virus/acquired
can become reactivated when the immune system is impaired immune deficiency syndrome, family history, physical trauma,
by aging, immunosuppressive therapy, or some disease states. and older age.80 Age is key; approximately half of all cases
occur in people 60 years and older.38 The prevalence of shingles
The incidence of varicella in the US is highest between March and
is higher among women than men and lower among black
May and lowest between September and November. Once recov-
individuals than white individuals.80, 81
ered, people with chickenpox usually have lifetime immunity.
Approximately 500,000 to one million cases of zoster occur each
Chickenpox typically affects children between the ages of 1
year in the US.60 The overall incidence rate of shingles has been
and 9 years old, but chickenpox can develop in adults who were
reported to be 4.47 per 1,000 person-years, and the rate increases
never infected as a child or who have not received the varicella
with age, from 0.86 per 1,000 person-years for individuals up to
vaccine. Approximately 77% of chickenpox cases occur in
19 years of age to 12.78 for persons 80 years and older (Table 6).81
children 1 to 9 years old; whereas 7% of cases occur in adults (20
The lifetime risk of zoster is estimated at 32%.60
years and older).37, 60
Vaccination against zoster had led to a decline in incidence,
The severity of the condition and complications are more
with greater effectiveness in younger age-groups. The inci-
common among adults, immunocompromised individuals, and
dence decreased by nearly 70% among people 50 to 59 years old,
pregnant women. Severe complications include secondary
by 64% among people 60 to 69 years old, and by 38% in people 70
bacterial infections, pneumonia, cerebellar ataxia, and Reye’s
years and older.38
syndrome.61 Fatality rates increase with age, ranging from 1
per 100,000 for children 1 to 14 years old to 25.2 per 100,000 for
adults 30 to 49 years old.60

Table 6: Incidence Rate of Zoster (Shingles) by to Age 81 especially in older people and those who use illicit drugs.60
Tetanus toxoid was developed in 1924, and immunization was

Incidence Rate
Age-Group (Yrs.) widespread during World War II. The incidence of the disease
(per 1,000 Person-Years)
has declined since the 1940s as a result of not only tetanus
<19 0.86
toxoid-containing vaccines but also better wound care and
20-29 2.74
greater migration from rural to urban areas.61 In the US, 264
30-39 3.64
people were diagnosed with tetanus from 2009 to 2017; most
40-49 4.52 (64%) were 20 to 64 years old and 23% were 65 years or older.61
50-59 6.74 Nineteen of the 264 died.
60-69 9.32
70-79 12.02 Diphtheria
>80 12.78 Diphtheria is a toxin-mediated disease caused by Corynebac-
terium diphtheriae, an aerobic gram-positive bacillus. The
Shingles carries a burden in terms of pain, loss of productivity, infection is transmitted most often through person-to-person
and decreased quality of life. There is an additional financial by respiratory droplets or direct contact with respiratory secre-
burden. The health care costs increase with age, with the tions.60, 61 Diphtheria can involve nearly any mucous membrane,
annual incremental health care costs ranging from $1,201 for and the disease is classified according to its anatomic site:
people 50 to 59 years old (compared with controls) to $3,804 for anterior nasal, pharyngeal and tonsillar, laryngeal, cutaneous,
those 80 years and older.79 Costs for people with postherpetic ocular, and genital. The most common sites are the pharynx
neuralgia are higher, ranging from $4,670 for people 50 to 59 and tonsils. The complications occurring most frequently are
years old to $11,147 for people 80 years and older.79 myocarditis and neuritis.
In the US, diphtheria was once a common cause of illness

Tetanus and death among children but is now rare. A vaccine was
Tetanus is a toxin-mediated disease caused by Clostridium introduced in the 1920s, and it became a universal childhood
tetani, an anaerobic gram-positive, spore-forming bacteria. vaccine in the late 1940s.61 Despite good control in the US, a
The spores of C. tetani are found in soil contaminated with major outbreak of diphtheria occurred in Seattle, Washington,
excrement from animals and humans. The primary transmis- in the 1970s.82 Between 1996 and 2017, 13 cases of respiratory
sion is contaminated wounds and may follow elective surgery, diphtheria were reported; five cases were confirmed and eight
animal bites, burns, deep puncture wounds, and crush wounds. were probable.61 Approximately 92% of these individuals were
Tetanus is the only vaccine-preventable disease that is infec- 15 years or older. Since 2000, five cases have been reported.60
tious but not contagious.60
Tetanus can be categorized as one of three forms: generalized, Pertussis (Whooping Cough)
local, and cephalic. Generalized tetanus is the most common, Pertussis is highly communicable and is caused by the organ-
accounting for 80% of cases.60 Trismus (lockjaw) is the first sign, ism Bordetella pertussis, a small, aerobic gram-negative rod.
and signs follow a descending pattern of rigidity and convulsive The hallmark of pertussis infection is prolonged paroxysmal
spasms of skeletal muscles. Local tetanus is uncommon and cough, usually with an inspiratory whoop.61 Transmission is
is marked by persistent contraction of muscles in the area of most often through contact with respiratory droplets. Older
the injury. This form is milder than generalized tetanus. The individuals are commonly the source of infection for children.60
rare form of the disease is cephalic tetanus, which sometimes
Secondary bacterial pneumonia is the most common complica-
occurs with otitis media.
tion of pertussis, with pneumonia developing in approximately
Presumed risk factors for tetanus are diabetes, a history of 5% of all cases and in nearly 12% of infants younger than 6
immunosuppression, and intravenous drug use.61 Laryngospasm, months old.60 Pneumonia is also the most common cause of
fractures, hypertension and abnormal heart rhythm are poten- pertussis-related deaths.
tial complications of tetanus. Pulmonary embolism may occur
Before the development of a vaccine for pertussis, the disease
was common in childhood and was a substantial cause of death In 2017, the rate was highest in the 30 to 39 years age-group (2.1
among infants and children. The incidence of pertussis fell per 100,000), followed by the 40 to 49 years age-group (1.5 per
from an average of 150 cases per 100,000 between 1922 and 1940 100,000) and 20 to 29 years age-group (1.4 per 100,000).84 The rate
to 0.5 cases per 100,000 in 1976.61 However, the number of cases is higher among men than women (1.4 vs. 0.7 per 100,000) and
began to increase in the 1980s and, in 2012, 48,277 cases were among the white, non-Hispanic population than other racial/
reported in the US. The number of cases has declined since 2012; ethnic groups.84
18,975 cases were reported in 2017. In 2018 and 2019, the number
Overall, in 2017, the reported number of cases was 3,366 and the
had decreased further, to 15,609 and 15,662, respectively. Of the
adjusted number (adjusted to account for underascertainment
cases in 2019, approximately 24% occurred in individuals who
or under-reporting) was 6,700.84 In 2017, the annual incidence
were 20 years and older.83 In that same year, the number of
rate was 1.0 cases per 100,000 population; in Florida, there were
reported cases in Florida was 395, with an incidence of 1.85 per
261 reported cases that year, with an incidence rate of 1.2 per
100,000 population.83
100,000 population.84 This rate was the seventh highest in the
country. The death rate in 2017 was 0.02 per 100,000, with the
Hepatitis A and B
highest rate among individuals 65 years and older (0.09).84
Hepatitis A is caused by hepatitis A virus, a picornavirus
(RNA virus), that is transmitted through the fecal-oral route Hepatitis B is caused by a virus in the Hepadnaviridae family.
and replicates in the liver. Transmission is either through The virus has several antigenic components, including hepatitis
person-to-person contact or ingestion of contaminated food B surface antigen (HBsAg), hepatitis core antigen (HbcAg), and
or water. Children may be a source of infection because they hepatitis B e antigen (HBEAg). The virus is bloodborne and in
are usually asymptomatic, and the disease is undiagnosed. In the US, transmission is primarily sexual contact and perinatal.60
adults, jaundice is the primary clinical sign.
Populations at increased risk for hepatitis B include individuals
Several populations are at increased risk for hepatitis A.84 who have sexual contact with an infected person, men who
have sex with men, injection drug users, and health care
• People who have direct contact with someone with
workers at risk for exposure to blood. Hepatitis B may also
hepatitis A
affect infants born to an infected mother. The most common
• Men who have sex with men risk factors reported in 2017 were injection drug use, multiple
• Users of illegal drugs sex partners, and men who have sex with men.84
• Individuals with clotting factor disorders Infection with hepatitis B is the cause of acute and chronic hepa-
• International travelers, especially those who travel to titis and cirrhosis and of nearly half of all cases of hepatocellular
countries where hepatitis A is endemic cancer. Nearly 11 million (noninstitutionalized) persons in the US
have ever been infected with hepatitis B, and the overall preva-
However, most people infected with hepatitis A report no
lence of chronic hepatitis B infection is 0.3%.85 The prevalence of
risk behaviors or exposures.60 The most common risk factors
chronic hepatitis B is higher in the non-Hispanic black (twofold
reported in 2017 were injection drug use, person-to-person and
to threefold) and non-Hispanic Asian (10-fold) populations.85
foodborne outbreaks, and sexual/household contact with an
individual infected with hepatitis A.84 Before the vaccine against hepatitis B virus became available
in 1982, approximately 200,000 to 300,000 people in the US were
In the pre-vaccine era, the rates of hepatitis A were highest
infected with the virus each year.86 In the first 20 years of the
among children 2 to 18 years old (15 to 20 cases per 100,000).60
vaccine, an estimated 30 million adults (and 40 million infants
The rate of hepatitis A has declined since the routine vaccina-
and children) received the vaccine; the number of cases of
tion of children began in 1996; the rate decreased approximately
hepatitis B dropped to approximately 79,000 cases in 2001.86 The
94% from 1990 to 2009.60 However, since 2014, the rate of
decrease is attributed to both the availability of the vaccine and
reported hepatitis A cases has increased in adults, in part as a
a reduction in increased risk behaviors.
result of outbreaks, primarily involving persons who reported
drug use or homelessness.84 As with hepatitis A, the rate of cases remained lower in children
and adolescents. Between 1990 and 2004, the incidence of acute

hepatitis B decreased 75% overall, with a 94% decrease among In the pre-vaccination era in the US, 90% of people had measles
children and adolescents attributed to an increase in vaccine before the age of 15 years, and an estimated 3 to 4 million cases
coverage. In 2017, rates also decreased for young adults (20 to 29 occurred each year.61 After introduction of a vaccine in 1963, the
years old), again most likely because of childhood vaccination or incidence of measles decreased by more than 95%.60 Low rates
so-called catchup vaccination as adolescents.84 These lower rates continued until a measles resurgence in 1989 to 1991; the cause
offset higher rates among older adults. The rate was highest for of the resurgence was attributed to low vaccination coverage.
individuals 40 to 49 years old (2.5 per 100,000) and 30 to 39 years During that time, 55,622 cases were reported, mostly among
old (2.3 per 100,000). The rate was higher for men than women children younger than 5 years.60 The incidence rates were four to
(1.3 vs. 0.8 per 100,000) and for the white, non-Hispanic (1.1 per seven times higher for black and Hispanic children than non-His-
100,000) and black, non-Hispanic (1.0 per 100,000) populations.84 panic white children.60 By 2000, endemic measles was declared
eliminated (absence of endemic cases for 12 months or more).
Overall, 3.409 cases of hepatitis B were reported in 2017, and the
adjusted number of acute infections was 22,200.84 The incidence From 2001 to 2014, there were 104 outbreaks of measles reported
rate for the US was 1.1, and the rate for Florida (2.8) was the fifth in the US, affecting primarily unvaccinated individuals or those
highest in the country, with 588 cases.84 with an unknown vaccination status.89 The number of cases
reached a high of 667 in 2014 and then remained relatively low
According to data from 2017, the death rates were higher for over the next 3 years (188, 86, and 120 cases) before increasing
individuals 55 years and older compared with younger age- to 375 in 2018.89 In 2019, 1,282 individual cases of measles were
groups and substantially higher for the Asian/Pacific Islander confirmed in 31 states; this number was the highest reported in
population than other racial/ethnic groups. Overall, there were the US since 1992.89 Again, most cases were among people who
1,727 deaths, for a rate of 0.46 per 100,000.84 were not vaccinated against measles.
Measles The vaccination rate for measles in Florida is generally high,

The measles virus is a paramyxovirus (RNA) with one antigenic and as a result, the incidence has been low in the state. From
type. The highly contagious virus is transmitted primarily 2013 to 2017, seven or fewer cases have been reported in Florida;
person-to-person through respiratory droplets; airborne 15 cases were reported in 2018.90
transmission is also possible, especially in closed areas.60 People
A resurgence of measles is occurring worldwide, with a 31%
without immunity who are exposed to the virus have up to a
increase in the number of cases reported worldwide between
90% chance of becoming infected.87
2016 and 2017.91 This high global rate means that US residents
The primary signs of measles is an increasing fever followed traveling outside of the US should make sure they are immu-
by cough and runny nose and a rash that begins on the face nized before traveling.
and upper neck and moves down the body over the course of a
few days.60 Most people with the disease recover after a week. Mumps
However, complications develop in nearly one-third of people Mumps virus is a paramyxovirus and is spread through
with measles; complications are most common in adults 20 airborne droplets or by direct contact with an infected droplet
years or older and children younger than 5 years. Diarrhea, or saliva.60 The most common clinical characteristic is parotitis,
otitis media, and pneumonia are the three most common which may be unilateral or bilateral.
complications; pneumonia accounts for approximately 60% of
Mumps is primarily a childhood disease, but it was the third
measles-related deaths.60 Immunosuppressed individuals are
most common cause of hospitalization for soldiers during
at highest risk for measles-related complications; a high rate of
World War I.60
serious complications and deaths have been reported for people
with human immunodeficiency virus (HIV) infection, cancer, The mumps vaccine was introduced in the US in 1967, and
and solid organ transplant, as well as those receiving high-dose between 1968 and 1985, the reported cases of mumps decreased
glucocorticoids and immunomodulatory therapy.88 from more than 152,000 cases to 2,982 cases.60 A two-dose
vaccine was introduced in 1989, and the number of mumps
Measles occurs most often in late winter and spring.60
cases decreased 99%.92 However, since then, several resurgences
of mumps have occurred, with most outbreaks affecting Human Papillomavirus (HPV)
adolescents and young adults, some of whom had received two HPV is a small DNA virus that infects the epithelium, at the
doses of the vaccine.61 The cause of outbreaks among vacci- basal level.60 The virus is transmitted through direct contact,
nated individuals may be because of declining immunity, and usually sexual, with an infected person.
the ACIP recommended a third dose of a mumps-containing
vaccine for people who had previously received two doses.93 Most HPV infections cause no symptoms, with no resultant
Between January 1 and January 25, 2020, in the US, 70 cases disease. However, infection can lead to much more serious
of mumps were reported to the CDC; the cases were from 16 conditions, depending on the HPV type. Of the more than
states, including Florida.92 Around the globe, mumps is not as 120 HPV types, about 40 types infect the mucosal epithelium,
well controlled as measles and rubella.61 and they are categorized according to their epidemiologic
association with cervical cancer. Types 6 and 11 are low-risk
Rubella types and may cause benign or low-grade cervical cell abnor-
Rubella is also known as German measles but is a virus malities, genital warts, and laryngeal papillomas. Types 16 and
distinct from the measles virus. It is a togavirus, with only one 18 are high-risk (oncogenic) types and may cause low-grade or
antigenic type, and it is characterized by a mild maculopapular high-grade cervical cell abnormalities, the latter of which are
rash. It is transmitted person-to-person through droplets shed precursors to cancer. The high-risk types are found in 99% of
from respiratory secretions of infected persons.60 Rubella is cervical cancers.60
moderately contagious, and the incidence is usually highest in
Anogenital HPV infection is the most common sexually trans-
late winter and early spring.
mitted infection in the US (Table 7).60 Other types of cancers
The rubella virus has been more common in children, with 60% frequently associated with HPV are oropharyngeal, vulvar,
of cases occurring in infants and children up to 14 years old.60 vaginal, penile, and cervical cancer. An estimated 79 million
However, since the elimination of rubella in the US (in 2004), persons are infected with HPV, and an estimated 14 million new
60% of cases have occurred in people 20 to 49 years old.60 HPV infections occur annually.60 About half of the infections
occur in people 15 to 24 years old.
Complications of rubella occur more often in adults than in
children, and arthralgia or arthritis can occur in as many as Nearly all of the two most common types of cervical cancer
70% of women with the disease.60 The virus is particularly worldwide, squamous cell carcinoma and adenocarcinoma, are
dangerous for pregnant women. Miscarriage and fetal death/ caused by HPV. HPV types 16 and 18 are associated with 70% of
stillbirth can occur when rubella infection occurs during these cancers.60 The estimated number of cervical cancers in
pregnancy, especially in the first trimester. In addition,
congenital rubella syndrome, a group of severe birth defects, Human Papillomavirus (HPV)
may also occur.
Before the introduction of a rubella vaccination program in

1969, rubella was a common and widespread infection in the
US. The incidence decreased after routine vaccination, but a
few outbreaks occurred in 1990-1991. By 2004, an expert panel
declared that rubella was no longer endemic in the US. Since
that time, there have been a median of 11 cases each year
between 2005 and 2011.60 Since 2012, all individuals with rubella
had evidence of infection when they were living or traveling
outside the US.94 Despite the eradication of rubella, vaccina-
tion against the virus is especially important for women of
childbearing age and children to ensure the disease remains
eliminated.94

the US in 2020 is 13,800, with 4,290 deaths.95 The age-adjusted Overview of Vaccines
rate of new cases of cervical cancer has decreased considerably
since 1975, from 14.81 to 6.28 per 100,000 in 2017.96 The mortality Vaccination is the primary way to provide active immunity to
rate has also declined during that time, from 5.55 to 2.23 per specific infectious diseases. With active immunity, an antigen
100,000. It’s been noted that increased HPV vaccination in stimulates an individual’s immune system to produce antibod-
adolescence could help prevent a substantial number of ies against the antigen. Passive immunity is transferred by an
cervical cancer cases.97 The economic burden of HPV infection antibody produced by a human or an animal. Sources of passive
is higher than any other sexually transmitted infection, except immunity include blood or blood products, immune globulin,
HIV infection.61 and plasma products. The protection provided by active immu-
nity often lasts a lifetime; protection from passive immunity
Table 7: Percentage of Cancers Associated with HPV 60 typically lasts only a few weeks or months.60 Infection with a
disease can also provide immunity to it.
Type of Cancer Percentage (%)
Anal 90 Types of Vaccines
Oropharyngeal 72 The US Department of Health and Human Services classifies
Vulvar or vaginal 71 vaccines according to four types: live attenuated (live); inacti-
vated; subunit, recombinant, polysaccharide and conjugate; and
Penile 71
toxoid (Box 2).98
Cervical 70
Box 2: Types of Vaccines 98

Meningococcal Infection
Meningococcal disease is a severe and potentially life-threat- Type of Vaccine Specific Vaccines
ening infection caused by Neisseria meningitidis, an aerobic
Live attenuated (live) Measles, mumps, rubella (MMR)
gram-negative bacterium.61 The bacterium can be classified Varicella
into 12 serogroups on the basis of its capsular polysaccharide. Yellow fever
The primary causes of meningococcal disease are serogroups Rotavirus
A, B, C, W, X, and Y. Approximately 40% of cases in the US are Influenza (intranasal)
caused by serogroup B; this serogroup also causes about 60% of Inactivated Hepatitis
cases in children and young adults (younger than 25), whereas Rabies
serogroups C, W, and Y cause about 65% of all cases among Influenza (injection)
people 25 years and older.61 Serogroup A is rare in the US. Subunit, recombinant, Hepatitis B
polysaccharide, conjugate HPV
N. meningitidis is the leading cause of bacterial meningitis and Pertussis
sepsis in the US and can also cause pneumonia and arthritis.60 Pneumococcal disease
Meningeal infection is characterized by a sudden onset of fever, Meningococcal disease
headache, and stiff neck, often with symptoms of nausea, vom- Zoster
iting, photophobia, and altered mental status.60 The bacterium Toxoid Diphtheria
is transmitted primarily by respiratory droplet spread or by Tetanus
direct contact. Its contagiousness is generally limited.
The incidence of meningococcal disease peaked in the late Live Attenuated

1990s and gradually decreased. A vaccine was introduced in A live vaccine is made from a virus (or bacterium) that is
2005, and further decreases have occurred in all age-groups. weakened in a laboratory.60 The weakened virus can still
From 2005 to 2011, the incidence was 0.3 cases per 100,000 replicate, but does not cause disease, although sometimes a
population.60 From 2013 to 2018, there were 10 outbreaks of mild form of the disease may develop. A small dose stimulates a
serogroup B meningococcal disease on college campuses, with person’s immune system to attack the vaccine, and the response
39 cases and two deaths.61 to a live-attenuated vaccine is almost identical to that made
against a natural infectious agent.60 Most live vaccines produce
immunity in patients with one dose.60 Live vaccines are more Effectiveness of Vaccines
immunogenic than inactivated vaccines, and they usually offer The effectiveness of a vaccine is a measure of how well it
lifetime immunity. reduces disease in a real-world population.99 Effectiveness is
different from efficacy, which is determined under optimal
Live viral vaccines include the following.
conditions (a randomized controlled trial) and is the percentage
• Measles, mumps, rubella • Yellow fever
reduction in the incidence of disease in a vaccinated group
(MMR) • Rotavirus compared with a nonvaccinated group. Both are important but
• Varicella • Influenza (intranasal) showing the benefit of vaccines in reducing disease burden is
an integral aspect of promoting immunization and can help
Live vaccines should not be given to individuals who are increase immunization rates. Vaccine effectiveness can also be
immunocompromised because the immune system cannot used to help determine the cost-effectiveness of vaccines. For
mount an effective immune response. As a result, an adverse example, a vaccine is more cost-effective if it reduces a greater
reaction is more likely to develop. proportion of a vaccine-preventable disease. Together, vaccine
Inactivated effectiveness and cost-effectiveness can help improve public
An inactivated vaccine is developed by growing the virus confidence in immunization.
(or bacterium) in culture medium and then inactivating it. Inac- Evidence of vaccine effectiveness is found in the eradication of
tivated vaccines do not replicate and cannot cause the disease smallpox and polio in the US with the introduction of vaccines.
they are designed to protect against. The immune response to In addition, the rates of childhood diseases, such as measles,
an inactivated vaccine is a humoral one, which means little or mumps, and chickenpox have decreased dramatically with the
no cellular immunity results. Thus, immunity is temporary, and advent of routine childhood vaccinations. In 2007, researchers
multiple doses are usually needed for long-term protection. reviewed the effectiveness of several vaccine-preventable
• Inactivated vaccines include hepatitis A, rabies, and diseases and found decreases in the number of cases of 34.1%
influenza. (invasive pneumococcal disease) to 100% (diphtheria) and in the
number of deaths of 25.4% (invasive pneumococcal disease) to
• Inactivated vaccines are recommended for 100% (diphtheria, measles, rubella, and mumps) (Table 8).100
immunocompromised individuals.
Subunit, recombinant, polysaccharide and conjugated Table 8: Effectiveness of Vaccines in Preventing Diseases 100
These vaccines involve the use of a specific piece of a virus (or
bacterium), such as its protein, sugar, or capsid. The advantage Percentage (%) Decrease:
of these vaccines is that they can be given to immunocompro- Pre-vaccine Era and 2006a
mised individuals and others with long-term health issues. The Disease Cases Deaths
primary disadvantage is that they do not provide long-lasting Diphtheria 100 100
protection, and boosters are needed to provide immunity. Measles 99.9 100
Rubella 99.9 100
These vaccines include the following.
Congenital rubella syndrome 99.3 NA
• Hepatitis B • Pneumococcal disease
Mumps 95.9 100
• HPV • Meningococcal disease Tetanus 92.9 99.2
• Pertussis • Zoster Pertussis 92.2 99.3
Hepatitis A 87.0 86.9
Toxoid Varicella 85.0 81.9
Toxoid vaccines are developed from a toxin made by a virus or Hepatitis B (acute) 80.1 80.2
bacterium. As a result, immunity is targeted to the toxin rather
Invasive pneumococcal disease 34.1 25.4
than the entire virus. Immunity is typically not long-lasting,
and booster shots are needed for ongoing protection. Toxoid Reported or estimated cases in 2006; deaths, in 2004.
a
vaccines are given to protect against diphtheria and tetanus.

The effectiveness of the influenza vaccine varies with each reliable storage and temperature monitoring equipment, and
yearly season. In an interim report from the CDC on the 2019- accurate vaccine inventory management.103
2020 flu season, published in February 2020, the overall vaccine
Instances of improper vaccine storage have been reported,
effectiveness for any influenza virus was 45%; effectiveness
and incorrect storage has accounted for at least 10% of
was estimated to be 50% against influenza B/Victoria viruses
vaccine-related errors reported through VAERS.104, 105 In a study
and 37% against influenza A(H1N1)pdm09.101 These interim
of vaccine storage over a 2-week period among participants in
estimates are consistent with those from previous seasons,
the Vaccines for Children program, vaccines were exposed to
which have ranged from 40% to 60% when influenza vaccines
inappropriate temperatures for at least 5 cumulative hours at
were antigenically matched to circulating viruses. Estimated
the facilities of 76% of 45 providers.106
effectiveness varied according to age and influenza strain.
For individuals 50 years and older, vaccine effectiveness was Although research has shown no substantial health risk from
estimated to be 43% (influenza A and B) and 50% (influenza giving vaccines that have been stored outside of recommended
A[H1N1]pdm09); the estimated effectiveness was lower for temperatures,107 such vaccines may have less potency and thus
individuals 18 to 49 years (25% and 5%, respectively).101 not offer full protection. The potential cost is thousands of
dollars in wasted vaccine, as well as the health costs associated
In addition to being effective in preventing disease, adult
with limited protection against vaccine-preventable diseases
vaccination is also cost-effective. Researchers conducting a
and the need for revaccination. In an analysis of 476 reports in
systematic review (78 publications), analyzed studies on the
VAERS regarding vaccines kept at inappropriate temperatures,
cost-effectiveness of influenza (25 studies), pneumococcal (18),
adverse events were reported in 32 (7%); 21 of the 32 adverse
HPV (nine), zoster (seven), tetanus-diphtheria-pertussis (nine)
events were local reactions.107 The vaccines had been kept
hepatitis B  (nine) and multiple vaccines (one).102 Substantial
outside of the recommended temperatures for 15 minutes to 6
cost savings were found across vaccines.
months (median, 51 hours).107 The most common reasons for the
improper storage were lack of vigilance, inadequate training,
Storage and Handling
and equipment failure.
Proper transport, storage, and handling of vaccines are vital
for maintaining the quality of vaccines. Effective cold chain Most vaccines must be refrigerated, and a few must be frozen
management refers to the proper temperature-control of (Table 9).108 For vaccines that are refrigerated, the temperature
vaccines from the point of manufacture to the site of vaccine should be kept at 35° to 46° F from shipping through storage at
administration. Maintaining effective cold chain is a responsi- the pharmacy.103 The ideal temperature is 40° F. For vaccines
bility shared by manufacturers, distributors, and health care that must be kept frozen, the recommended temperature
providers/pharmacists (Figure 3).103 The CDC notes that an range is -58° to +5° F.103
effective cold chain depends on three factors: well-trained staff,
Figure 3: Cold chain Figure 3: The potency of vaccines depends on effective management of the cold chain, which involves commitment from all stakeholders,
from manufacturers to vaccine providers. Once lost, vaccine potency cannot be regained. Reprinted from Centers for Disease Control and
Prevention. Vaccine Storage and Handling Toolkit. US Department of Health and Human Services; 2020.
Vaccine Vaccine Vaccine arrival at Vaccine storage & Vaccine

manufacturing distribution provider facility handling at provider facility administration
Manufacturer Manufacturer/ Provider

responsibility distributor responsibility responsibility
Table 9: Storage Temperatures for Vaccines 103 Box 3: Prevent Storage Errors 108
Refrigerator Freezer
(35° to 46° F) (-58° to +5° F) • Store vaccines in the body of the refrigerator (not
Tdap MMR a in bins on the floor, or in the door)
Hepatitis A MMRV • Place vaccine packages so that air can circulate
Hepatitis B Varicella around the compartment
HPV Zoster (Zostavax)
Influenza • Record temperatures according to recommended
MMRa guidelines
Meningococcal ACWY • Post a “Do Not Unplug” sign next to the electrical
Meningococcal B outlets for the refrigerator and/or freezer
Pneumococcal (PCV13 & PPSV23)
Zoster (Shingrix) • Make sure the door to the storage unit is closed
tightly
May be stored in refrigerator or freezer.
a
• Do not store food and drinks in the vaccine

The best equipment for storing vaccines is a so-called pur- refrigerator
pose-built unit, which is designed to specifically store biologics,
including vaccines.103 Household-grade units are an acceptable
• Take action on temperature excursions
alternative to purpose-built units. However, the freezer compo- • Save temperature logs for at least 3 years
nent of a household-grade unit cannot be used to store frozen
vaccines; a separate freezer unit will be necessary.103 A CDC
Best Practice is to place water bottles in the storage unit, on the
unit; do not store food or drinks. Opening the door frequently
shelf, floor, and door racks. The bottles can help maintain stable
affects the temperature inside the unit.103
temperatures caused by opening and closing the unit doors or a
power failure. Water bottles are not recommended for use with Pharmacies storing vaccines should have a routine storage and
some pharmaceutical-grade or purpose-built units.103 handling plan that provides guidelines on the following.
A temperature monitoring device is required for each vaccine • Ordering and accepting vaccine deliveries
storage unit, and the CDC recommends a digital data logger, • Storing and handling vaccines
which provides the most accurate information on the tempera-
ture in the storage unit.103 Data on storage unit temperatures
• Managing inventory
should be reviewed weekly to identify any problems. • Managing potentially compromised vaccines
A temperature excursion refers to exposure Pharmacies should also have an emergency plan that provides
to a temperature outside the recommended details on a back-up location for storage of vaccines.
range. In cases of temperature excursion, the A back-up generator for maintaining power to
following actions are recommended.60 vaccine storage units is especially important
when there is increased likelihood of
• Store the vaccine properly
power outages, such as hurricane season
• Separate it from other vaccine supplies in Florida.
• Mark “Do NOT Use”
When vaccines are delivered, they
• Contact vaccine manufacturer for guidance should be examined and stored at the
appropriate temperature immediately.
Many storage errors can be prevented by close
Vaccines should be stored in their
attention to recommended guidelines (Box 3).108
original packaging with lids closed
For example, store only vaccines in the storage

until ready for administration. Checking expiration dates contract. These vaccines include the following.
is essential. Pharmacists should ensure that vaccines are
stored with the earliest expiration dates in front, to be used • Pneumococcal polysaccharide
first. In one survey, 16 of 45 providers had expired vaccines.106 • Shingles
Thirteen of the 45 providers stored expired vaccines together • Rabies
with nonexpired vaccines, increasing the risk of mistakenly
administering the expired vaccine.106
• Yellow fever
• Typhoid
Educational Materials • Anthrax
It is vital that every individual understands the benefits and • Cholera
risks of a vaccine before receiving it, not only from an ethical • Japanese encephalitis (Ixiaro)
perspective but also from a legal one. In 1976, the CDC issued
its first Important Information Statement about an influenza Vaccine providers should offer a printed copy of a VIS before
vaccine. In the 44 years since, these statements have trans- vaccination, but the information in the VIS can be distributed
formed into Vaccine Information Statements (VISs), and 28 are to customers in additional ways.
currently available. • Printed copy kept in the pharmacy
VISs are required by law. Under the National Childhood Vaccine • Pharmacy’s computer monitor or other video display (CDC
Injury Act (NCVIA), all vaccine providers are required to give website)
the appropriate VIS to a person (or parent or legal representa- • Individual’s digital device (download from CDC website)
tive) before a vaccine is given, as well as before each dose in a
When a VIS is reviewed in one of these other ways, the phar-
multidose series. As of March 2013, VISs are required under the
macist should still offer a copy of the VIS for the person to take
NCVIA for the following vaccines.
home. However an individual reviews the VIS, pharmacists
• Diphtheria, tetanus, and pertussis-containing vaccines should make sure to ask if he or she has any questions and offer
(DTaP, DT, Td, and Tdap) to explain anything an individual may not understand.
• Haemophilus influenzae type b (Hib)
VISs are available for download from the CDC website. They
• Hepatitis A can be downloaded individually or as a complete set of all 28.
• Hepatitis B The Immunization Action Coalition also has downloadable VISs
• Human papillomavirus (HPV) and offers VISs translated into about 40 languages as well.
Be sure to use the most recent version of an VIS; the Coalition
• Influenza (both inactivated and live, intranasal vaccines) offers an updated list with current dates.109 Pharmacists must
• MMR not make any substantive changes to a VIS but may add the
• MMRV name, address, and contact information of the pharmacy.
• Meningococcal Pharmacists (and all vaccine providers) must document that

• Pneumococcal conjugate (PCV13) an individual received a VIS. The following must be recorded in
the individual’s medical record (which can include an electronic
• Polio medical record), or in a permanent office log.
• Rotavirus • Edition date of the VIS (found on the back at the right
• Varicella bottom corner)
The CDC also encourages the use of VISs for other vaccines • Date the VIS is provided and the vaccine is administered
that are not covered by the NCVIA. If any of these vaccines • Name and title of the person who administers the vaccine
are purchased under a CDC contract, vaccine providers are (and office address)
required to give VISs through a “Duty to Warn” clause in the • Vaccine manufacturer and lot number
In addition to providing VISs, pharmacists can also educate the signs and assess the airway, breathing, circulation, and level of
public about the vital role of vaccines in lowering the risk of consciousness until emergency medical personnel arrive.
disease and about the myths associated with vaccinations. For
The first-line treatment for anaphylactic shock is epinephrine;
example, emphasize that vaccines do not cause the disease they
there are no absolute contraindications and no known equiv-
are designed to prevent.
alent substitute.110 Pharmacists can administer epinephrine to
treat vaccination-related anaphylaxis; epinephrine can be given
Vaccine Safety using a premeasured or prefilled syringe or an autoinjector
The safety of a vaccine is established in clinical trials conducted (Table 10).110 The recommended dose of epinephrine can be given
before the vaccine becomes approved by the US Food and Drug two additional times every 5 to 15 minutes (or sooner as needed)
Administration (FDA) and licensed for use. The adverse events while waiting for emergency medical personnel to arrive.
reported in these trials are documented in the vaccine package
insert. Vaccine safety continues to be monitored through the Pharmacists who provide vaccinations should be certified in
Vaccine Adverse Event Reporting System (VAERS), a national cardiopulmonary resuscitation (CPR).60
passive surveillance system co-administered by the CDC and All adverse reactions to vaccinations should be documented.
the FDA. Reports can be submitted to VAERS from health care For anaphylaxis, record the details of the individual’s reaction;
providers, vaccine manufacturers, and the public. Reports are the vital signs; medications administered, including the time,
classified as nonserious and serious. Among the objectives dosage, response, and the name of the person who administered
of VAERS are to watch for unexpected or unusual patterns the medication; and any other relevant clinical information.110
in adverse event reports and to identify potential patient Report the reaction to VAERS (www.vaers.hhs.gov).
risk factors for particular types of health problems related to
vaccines.61 Vaccine errors can also be reported to VAERS.
Administering Vaccines
Potential Adverse Events Associated with Vaccines Following recommended policies and procedures is necessary
Most adverse events associated with vaccines are minor and to ensure that vaccination is safe and effective. The CDC
are related to the injection site. According to data from VAERS, advises a step-by-step process that includes the following.111
92% of adverse health events related to all vaccinations are
classified as not serious.105 • Review the immunization history
Severe allergic reactions to vaccines are rare, but pharmacists •

Screen for contraindications and precautions
need to prepare for this life-threatening event. Pharmacists •
Educate the person
should have at least three doses of epinephrine available at all •
Prepare for vaccination
times. If an individual has itching and swelling at the injection
site, watch the individual carefully for the development of gen- •
Administer the vaccine
eralized symptoms, which indicate an anaphylactic reaction. •
Avoid errors
The signs and symptoms of anaphylaxis include flushing, facial •
Document the vaccine
edema, generalized urticaria, wheezing, swelling of the mouth
and throat, and difficulty breathing.60 If any of these symptoms Review the Immunization History
occur, ask a colleague to According to American Society of Health-System Pharmacists
call 911 and the individual’s
primary physician. Mon- Table 10: Managing Vaccination-Related Anaphylaxis with Epinephrine 110
itor the individual’s vital
Site of
Dose, Route
Administration
Epinephrine (1 mg/mL) aqueous solution (1:1,000 dilution) 0.3 mg, IM Mid-outer thigh
0.3 to 0.5 mg (0.01

Another epinephrine formulation Mid-outer thigh
mg/kg), IM

Box 4: Questions to Identify Adult Candidates for of vaccine for an individual. These questions not only help
Vaccination 112 determine conditions that may make an individual a candidate
for a certain vaccine but also help detect contraindications
to specific vaccines. These questions are usually asked on a
• Are you sick today? printed screening checklist (Box 4),112 which can be obtained
• Do you have allergies to medications, food, a vaccine from the Immunization Action Coalition (www.immunize.org).
component, or latex? Vaccines that are available in prefilled syringes may have
• Have you ever had a serious reaction after receiving a natural rubber latex in the tip caps. Pharmacists should always
vaccination? ask an individual about a latex allergy before preparing to
• Do you have a long-term health problem with heart, lung, vaccinate.
kidney, or metabolic disease (e.g., diabetes), asthma,
Educate the Individual
a blood disorder, no spleen, complement component
As noted earlier, a VIS must be given to the individual before
deficiency, a cochlear implant, or a spinal fluid leak? Are
the vaccine is administered. Be sure to select the most current
you on long-term aspirin therapy? VIS and the one specific to the vaccine. For example, two
• Do you have cancer, leukemia, HIV/AIDS, or any other VISs are available for influenza vaccines, one for inactivated
immune system problem? vaccines and one for the live (intranasal) vaccine.
• Do you have a parent, brother, or sister with an immune
Prepare for Vaccination
system problem?
Safe administration of vaccines depends on some general steps
• In the past 3 months, have you taken medications that and sterile techniques that apply to all vaccines. Regulations
affect your immune system, such as prednisone, other from the Occupational Safety and Health Administration do
steroids, or anticancer drugs; drugs for the treatment not require that gloves be worn.
of rheumatoid arthritis, Crohn’s disease, or psoriasis; or
• Wash your hands with soap and water or an alcohol-based
have you had radiation treatments?
waterless antiseptic hand sanitizer
• Have you had a seizure or a brain or other nervous system
problem?
• Get supplies together (alcohol pads, appropriate needle,
syringe)
• During the past year, have you received a transfusion of
blood or blood products, • Take vaccine out of refrigerator or freezer
• or been given immune (gamma) globulin or an antiviral » Check the label to confirm it is the correct vaccine
drug? » Check the expiration date
• For women: Are you pregnant or is there a chance you The size of the needle is an important factor to consider to
could become pregnant during the next month? avoid injury. The needle should be long enough to reach muscle
• Have you received any vaccinations in the past 4 weeks? mass but short enough to avoid underlying nerve, blood
vessels, or bone.111 A 22- to 25-gauge needle is recommended for
intramuscular (IM) injections, with a needle length of 1 to 1½
inches, depending on the individual’s weight.110, 111 A 5/8-inch
(ASHP) guidelines, pharmacists should review immunization needle can be used for individuals who weigh less than 130 lbs.,
histories to identify vaccination needs.1 When reviewing the but the skin must be stretched flat during the injection.110, 111
history, the pharmacist should always take the opportunity Most vaccines are available in a prefilled syringe. For these
to assess the need for other immunizations. Recommending vaccines, shake the syringe thoroughly, remove the cover from
vaccinations based on this review (vaccine forecasting) has the syringe tip, and attach the needle to the syringe.
been shown to increase immunization rates.2
When using a single-dose (or multidose) vial, remove the plastic
Screen for Contraindications and Precautions
cap and then shake the vial. Clean the stopper with an alcohol
Key questions can help to identify the most appropriate type
pad and let it dry before inserting the needle straight into the
center of the vial stopper to draw up the contents of the vial. Avoid Errors
Errors in vaccination can lead to inadequate protection,
Five vaccines given to adults are available as a powder and
possible injury, additional cost, and inconvenience. Taken
must be reconstituted with a liquid diluent supplied by the
manufacturer in a separate vial. The diluent is typically saline Figure 4: Administering Vaccines to Adults: Dose, Route,
or sterile water. These vaccines are MMR, varicella, zoster, Site, and Needle Size
meningococcal conjugate (Men ACWY), and meningococcal
serogroup B (MenB). You must use the diluent that comes with
vaccine, and not any other saline or sterile water. Intramuscular (IM) injection
Administer the Vaccine
Most adult vaccines are given intramuscularly, and some are
given subcutaneously. One vaccine, the live influenza vaccine,
90 ° angle
is given intranasally. It is best to ask the person to sit down, as
syncope may occur after any type of injection. skin
subcutaneous tissue
For an IM injection, the injection area is the deltoid muscle.110
Wipe the injection area with an alcohol swab, using an outward muscle
spiral motion from the center to a diameter of 2 to 3 inches.
Pinch the injection area and insert the needle at a 90-degree
angle to the skin (Figure 4). Insert the needle to its hub, inject
Subcutaneous (SubCut) injection
the vaccine, and then withdraw the needle quickly.
For subcutaneous injections, a 5/8-inch 23- to 25-gauge 45° angle

needle is recommended. Pinch up the tissue at the back of
the upper arm (the upper-outer triceps muscle) and inject skin
the needle at a 45-degree angle into the fat (Figure 4). Insert subcutaneous tissue
the needle to its hub.110
muscle
With either an IM or subcutaneous injection, discard the used
needle attached to the syringe into a sharps container. Do not
recap the needle. Apply pressure to the injection site with a Intranasal (NAS) administration
cotton ball or gauze. Put an adhesive bandage over the site if of Flumist (LAIV) vaccine
blood is present.
The live flu vaccine is given by the intranasal route. Have the
individual sit in an upright position with the head tilted slightly
back. Gently place a hand behind the back of the person’s head
and insert the tip of the nasal sprayer slightly into one nostril.
A dose-divider clip on the sprayer will allow 0.1 mL of spray.
Remove the clip and repeat administration into the other
nostril. The vaccine does not need to be repeated if the person NOTE: Always refer to the package insert included with each biologic for
sneezes or coughs immediately after the vaccine was given. complete vaccine administration information. CDC’s Advisory Committee
Dispose the nasal sprayer in a sharps container. on Immunization Practices (ACIP) recommendations for the particular
vaccine should be reviewed as well. Access the ACIP recommendations at
For all vaccine administrations, watch for an allergic reaction. www.immunize.org/acip
As noted earlier, pay attention to signs of an allergic reaction,
and follow an emergency plan for this unlikely event. From Immunization Action coalition

VACCINE SAFETY FOR PHARMACISTS | Continuing Medical Education
together, these outcomes can lead to a loss of confidence Box 5: Strategies to Prevent Vaccination Errors 60
among the public which in turn can lead to vaccine hesitancy
in the future. Yet, the number of reported vaccination-related • Review the ACIP immunization schedule carefully
errors has increased. According to data from VAERS, the • Provide ongoing staff training and education
number of errors reported increased from 10 in 2000 to 4,324
• Involve staff in selection of products to be used
in 2013.105 Overall during that timeframe, there were 20,585
vaccination error reports documenting 21,843 errors. • Use standardized ACIP vaccine abbreviations
The most common errors (27%) were categorized as • Keep current reference materials available for staff
inappropriate schedule, and the vaccine most often involved
• Rotate vaccines so those with shortest expiration dates
was the HPV vaccine. Other errors were use of expired
are in front, and check frequently to remove any expired
vaccine and incorrect vaccine given, especially when vaccines
vaccines
had similar antigens (e.g., varicella/zoster, DtaP/Tdap, and
pneumococcal conjugate/polysaccharide). Pharmacists can • Do not store sound-alike and look-alike vaccines next to
help prevent these, and other errors, by following several each other
recommended strategies (Box 5).60 • Color code and label vaccines with type, age, and gender,
if applicable
When an error does occur, be sure to report it to VAERS at
www.vaers.org. • Read labels carefully
» Name of vaccine
Document the Vaccine
After giving a vaccine to an individual, it is important to » Expiration date
document the vaccination in the individual’s record. The • Administer only vaccines that you have prepared
information recorded should include the following.60 • Triple check your work before administering a vaccine
• Date of administration • Avoid interruptions when selecting and preparing

vaccines
• Vaccine type (ACIP abbreviation), route, dose, and site
• Promote a culture that encourages staff to report errors
• Vaccine manufacturer
and be treated fairly
• Vaccine lot number
• Name of person who administered the vaccine From Hamborsky J, Kroger A, Wolfe S, eds. Centers for Disease Control and
Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases,
• Date VIS given to the individual 13th ed, Supplement. Washington, DC: Public Health Foundation; 2017.
• Date printed on VIS

Pharmacists are also encouraged to participate in
vaccines for primarily younger individuals who did not gain
immunization information systems and to send documentation
immunity or receive the vaccine in childhood.
of the immunization to the individual’s primary health care
provider, to enhance continuity of care. Florida pharmacists are allowed to administer all vaccines on
the adult schedule.
Vaccines for Adults
Each year, the ACIP issues the Recommended Adult Immuni-
Influenza Vaccine
The influenza vaccine is recommended for all individuals 6
zation Schedule for the coming year. The schedule includes
months of age or older every year, with the vaccine selected on
charts by age and by health status or personal characteristics,
the basis of age and health status, with few exceptions.113
and notes on recommendations. Pharmacists are encouraged
to review the schedule each year and keep a copy of it in their Several influenza vaccines have been approved for use by the
pharmacy. It can be downloaded here. A CDC Vaccine Sched- FDA.114 No preference has been expressed for one vaccine over
ules app is also available here. Vaccines for adults include another, but each vaccine is licensed with specific indications
season influenza, vaccines targeted to the older population, and according to age and health status. Influenza vaccines are
updated every year to match the virus strains that are expected vaccine for an individual (Table 11).114, 115
to be the predominant circulating strains that year.
The high-dose influenza vaccine is recommended for individual
Types of Influenza Vaccine older than 65. An analysis of seven randomized trials showed
There are two different types of influenza vaccines in the US: that the risk of influenza after vaccination with the high-dose
inactivated and live; the inactivated type has been available vaccine was significantly less for this population than with the
since the 1940s, whereas the live type was introduced in 2003. standard-dose vaccine.116 In addition, the high-dose trivalent
The inactivated vaccine can be used for any individual. The live vaccine provide a better antibody response to influenza than
vaccine is not recommended for pregnant women, immuno- standard-dose trivalent vaccine among adults 65 years and older.117
compromised people, or people with asplenia or complement
deficiences.113 Precautions should be taken for individuals with Pharmacists should consult FDA-approved prescribing
end-stage renal disease (or receiving hemodialysis); heart, lung, information for each year’s influenza vaccines for the most
or chronic liver disease; diabetes, and alcoholism.113 complete and updated information, including (but not limited
to) indications, contraindications, warnings, and precautions.
Influenza vaccines also differ in their formulation. The triva- Package inserts for US-licensed vaccines are available on the
lent form contains three inactivated strains of influenza, two FDA website.
type A strains (A[H1N1] and A[H3N2]) and one type B strain. A
quadrivalent formulation, introduced in the 2013-2014 influenza Timing of Influenza Vaccine
season, contains an additional type B strain to broaden pro- In general, seasonal influenza vaccine should be given as soon as
tection. Typically, trivalent and quadrivalent formulations are it becomes available and ideally by October, although individuals
available each influenza season. Other variations in influenza can receive the vaccine any time during the influenza season.
vaccines are dose (standard and high), route of administration In the 2019-2020 flu season, the CDC and ACIP recommended
(IM, subcutaneous, nasal spray), and base (egg protein or cell). that vaccination be offered by the end of October and warned
All of these factors should be considered when choosing a flu that getting vaccinated early, in July or August, may not provide
Table 11: Approved Influenza Vaccines 114, 115

Age
Vaccine (Mfr) Dose, Route Presentation Notes
Indication
Inactivated
Afluria (Seqirus) >6 mos. 0.5 mL, IM Prefilled syringe; multidose vial (5 mL); jet Quadrivalent
injector (only for adults 18 to 64 years)
Fluarix (GlaxoSmithKline) >6 mos. 0.5 mL, IM Prefilled syringe Quadrivalent
FluLaval (GlaxoSmithKline) >6 mos. 0.5 mL, IM Prefilled syringe Quadrivalent
Flucelvax (Seqirus) >4 yrs. 0.5 mL, IM Prefilled syringe; multidose vial (5 mL) Quadrivalent; cell-based (egg free)
Fluzone (Sanofi Pasteur) >6 mos. 0.5 mL, IM Prefilled syringe; single-dose vial; multidose Quadrivalent
vial (5 mL)
Flublok (Sanofi Pasteur) >18 yrs. 0.5 mL, IM Prefilled syringe Quadrivalent; recombinant (egg-free)
Fluad (Seqirus) >65 yrs. 0.5 mL, IM Prefilled syringe Trivalent; with adjuvant (MF59), to
enhance immune response
Fluzone High-Dose >65 yrs. 0.5 mL, IM Prefilled syringe Trivalent
(Sanofi Pasteur)
Fluvirin (Seqirus) >4 yrs. 0.5 mL, IM Prefilled syringe; multidose vial (5 mL) Trivalent
Live
FluMist (AstraZeneca) 2-49 yrs.a 0.2 mL, NAS Quadrivalent
See text for contraindications.
a

Quadrivalent inactivated influenza vaccines have safety

profiles similar to those of trivalent vaccines. Researchers
reviewed VAERS reports after administration of quadrivalent
and trivalent vaccines from July 1, in 2013, to May 31, 2015.
Among individuals 18 to 64 years old, injection-site pain, pain,
and pain in the extremity were the most common adverse
events for both types of vaccine (Table 12).118 Serious adverse
events occurred in 84 adults (approximately 7%) and included
injection-site reactions, constitutional symptoms, Guillain-Bar-
protection later in the season, especially for older adults.63 ré syndrome, and seizures. There were 19 reports of possible
anaphylaxis; 12 of the cases required epinephrine.118
Education
Two VISs are available for influenza vaccines, one for inactivat-
Table 12: Comparison of Adverse Events after Quadrivalent
ed vaccines and one for the live (intranasal) vaccine. and Trivalent Influenza Vaccines, VAERS 2013-2015 118
Administration
Pharmacists should follow the guidelines for administering
Percentage (%) of Reports
vaccines described earlier. All inactivated influenza vaccines Adverse Event Quadrivalent Trivalent
(N=1,265) (N=3,546)
are given intramuscularly and come in either a prefilled sy-
ringe, a single-dose (0.5 mL) vial, or a multidose (5 mL) vial. The Injection-site pain 16 14
one live influenza vaccine is given intranasally. Because this Pain 15 14
vaccine is live, it has several contraindications and precautions Pain in extremity 13 13
(Box 6).114 Injection-site erythema 12 10
Fever 11 10
Potential Adverse Events
Headache 10 11
Inactivated influenza vaccines are associated with potential
adverse events that are primarily minor and localized. Local re- Dizziness 7 10
actions include soreness, erythema, and induration that usually VAERS = Vaccine Adverse Event Reporting System.
last about 1 to 2 days.60 Fever and myalgia have developed in less
than 1% of vaccinations.60
Box 6: Contraindications and Precautions for Nasal Spray Flu Vaccine 114
Contraindications Precautions
Pregnancy Asthma
History of severe allergic reaction to any component of the vaccine or to a Underlying medical conditions associated with high risk for flu
previous dose of any influenza vaccine complicationsa
Weakened immune system (immunosuppression) Moderate or severe acute illness with or without fever
History of receiving influenza antiviral drugs within the previous 48 hours Guillain-Barré Syndrome within 6 weeks after a previous dose of
influenza vaccine
Caregiving for severely immunocompromised persons who require a
protected environment
a
These conditions include lung disease, heart disease (except isolated hypertension), kidney disease (including diabetes), kidney or liver disorders, and
neurologic/neuromuscular or metabolic disorders.
Pneumococcal Vaccine typically localized. Of 25,168 VAERS reports on PPSV23, 92%

Routine pneumococcal vaccine should be given to immunocom- were nonserious; 86% of the reports were associated with an
petent individuals 65 years and older. It is also recommended adult 19 years or older. The most common nonserious adverse
for adults 19 to 64 years old who have certain medical condi- events in adults were all related to the injection site: erythema
tions or who smoke. These medical conditions include chronic (32%), pain (27%), and swelling (23%).119 Usually these reactions
heart, lung, or liver disease, or diabetes. The vaccine is also are mild and resolve in less than 48 hours. Of the serious events,
recommended for adults 19 years or older who are immuno- fever was the most common (39%) event among adults.119 There
compromised.113 were 62 reports of death in adults; evaluation of the deaths
showed no evidence of a causal association with the vaccine.
Types of Vaccines Other adverse events, such as fever and myalgias are rare.
There are currently two types of pneumococcal vaccine:
pneumococcal conjugate vaccine (PCV13; Prevnar 13 Varicella Vaccine
[Pfizer]) and pneumococcal polysaccharide vaccine (PPSV23, The varicella vaccine is recommended for adults who have
Pneumovax23 [Merck]). never had chickenpox or received chickenpox vaccine.113
Contraindications and Precautions Types of Vaccine
Both pneumococcal vaccines are contraindicated in individuals Varivax (Merck) is a live vaccine.
who have had a severe allergic reaction (e.g., anaphylaxis) to
any component of the vaccine or any diphtheria toxoid-contain- Contraindications and Precautions
ing vaccine (Prevnar13).114 Varicella vaccination is contraindicated in the following
situations.113
For Pneumovax23, use caution and appropriate care for
individuals with severely compromised cardiovascular and/or
• Pregnancy
pulmonary function in whom a systemic reaction would pose a • Immunocompromised status

significant risk. • HIV infection, with a CD4 count of less than 200 mL
Timing of Pneumococcal Vaccination • Blood dyscrasias, leukemia, lymphomas, or malignant
The timing of pneumococcal vaccine for adults is complex, with neoplasms affecting bone marrow or the lymphatic system
many factors involved. Pharmacists are encouraged to review • Prolonged, high-dose systemic immunosuppressive therapy
medical information and algorithms for administration of the (2 weeks or more), including large doses of oral steroids or
vaccines on the CDC website. In brief, one dose of PCV13 is other immunosuppressive therapy
recommended for adults 19 years or older with certain medical
conditions who have not previously received PCV13. One dose
• Transfusion of blood products (such as whole blood, plasma,
or immune globulin) during the previous 3 to 11 months,
of PPSV23 is recommended for adults 65 years or older, regard-
depending on dosage)
less of previous history of pneumococcal vaccination. Once a
dose of PPSV23 is given at age 65 years or older, no additional • Family history (first-degree relatives) of congenital heredi-
doses of PPSV23 should be given. tary immunodeficiency (unless person has been determined
to be immunocompetent)
Education
Two VISs are available, one for PCV13 and one for PPSV23. • History of anaphylactic/anaphylactoid reaction to gelatin,
neomycin, or any other component of the vaccine
Administration
• Moderate or severe concurrent illness
Both pneumococcal vaccines are given intramuscularly;
Pneumovax23 may also be given subcutaneously. The dose is Timing of Varicella Vaccination
0.5 mL. The vaccines are available as prefilled syringes, and Varicella vaccination includes two doses, given at least 28 days
Pneumovax23 is also available as single-dose or multidose vials. apart.
Potential Adverse Events Education

Adverse events associated with the pneumococcal vaccine are A VIS on the varicella vaccine is available. Individuals given the

varicella vaccine should be told that they should not receive an The vaccine is also contraindicated for people with an allergy to
antibody-containing product for 2 weeks after the vaccination. any components within the vaccine, which includes neomycin
or gelatin.
Administration
The varicella vaccine is given subcutaneously at a dose of 0.5 Shingrix can be given to adults older than 50 regardless of
mL. The vaccine must be reconstituted with the accompanying chronic medical conditions or treatment with immunosuppres-
sterile diluent and given immediately thereafter. sive therapy.
Potential Adverse Events Timing of Zoster Vaccination

A total of 25,306 adverse events were reported to VAERS from Both zoster vaccines are given in a two-dose series, with the
1995 through 2005. Of those reports, 2,781 were nonserious in second dose given 2 to 6 months after the first. The minimum
adults 18 years and older who had received varicella alone (with interval is 4 weeks.
no other vaccine).120 The most common adverse events were
rash, fever, and injection-site reaction; however, the data for Education
Two VISs are available, one for the live vaccine (Zostrix) and
adults and children were not separated.
one for the recombinant vaccine (Shingrix).
Zoster Vaccine Administration

The ACIP recommends the zoster vaccine for immunocompe- Zostavax is given subcutaneously in two 0.65-mL doses. The
tent people 50 years or older.113 vaccine should be reconstituted and given immediately thereaf-
ter, as the potency of the vaccine decreases after 30 minutes.
Types of Vaccine
Two zoster vaccines are available: Zostavax (Merck), a live Shingrix is given intramuscularly in two 0.5-mL doses. Among
vaccine, and Shingrix (GlaxoSmithKline), an adjuvanted recom- errors of administration reported to VAERS, incorrect route
binant vaccine. Zostavax is recommended for people 60 years was the most common error (approximately 76%), with
or older, and Shingrix is recommended for people 50 years and Shingrix given intramuscularly.121
older. The ACIP recommends Shingrix as the preferred zoster
vaccine.113 Potential Adverse Events
The safety profiles of the two zoster vaccines in use are
Contraindications and Precautions similar to those for the vaccines found in clinical trials before
Zostavax is not recommended for pregnant women or for peo- licensure. From May 1, 2006, to January 31, 2015, 23,092 adverse
ple with severe immunocompromising conditions (including events associated with Zostavax were reported to VAERS.122 Of
HIV infection with a CD4 count of less than 200 cells per mL). these reports, 96% were classified as nonserious. Most (68%)
Immunocompromising conditions include the following. of the events occurred among individuals who were 60 years
• Leukemia, lymphomas, or other malignant neoplasms or older. Among adults 50 years or older, the most common
affecting the bone marrow or lymphatic system (People adverse events were injection-site erythema, zoster, and
with one of these diseases in remission who have not injection-site swelling (Table 13).122 Among the serious reports,
received chemotherapy or radiation for at least 3 months the most common events were herpes zoster (29%), pain (18%),
can be vaccinated.) and rash (16%).122 There were 36 reports of anaphylaxis, with the
episode occurring 10 minutes to 3 days after vaccination. Eleven
• AIDS or other clinical manifestations of HIV
of the episodes were confirmed, for a rate of 0.5 report per
• Treatment with high-dose corticosteroids (more than 20 mg million doses distributed.
per day of prednisone or equivalent) lasting at least 2 weeks
During the first 8 months of Shingrix in use, 4,381 adverse events
• Immunosuppressive treatments, such as methotrexate,
were reported to VAERS, 3% (130) of which were classified as
chemotherapy, recombinant human immune mediators,
serious. Approximately one-third of events occurred in people
and immune modulators, especially the antitumor necrosis
who were 60 to 69 years old. The most common events were fever
factor agents, adalimumab, infliximab, and etanercept
and pain and erythema at the injection site (Table 13).121
Table 13: Nonserious Adverse Events Related to Zoster Contraindications and Precautions
Vaccines Reported to VAERS 121, 122 Tdap is contraindicated for individuals with encephalopathy
that is not due to another identifiable cause within 7 days after
Event Percentage (%) a previous dose of a pertussis-containing vaccine (Table 14).123
Zostavax (n=23,092) Because this contraindication is associated with the pertussis
Injection-site erythema 27 component, individuals can receive Td instead.
Injection-site swelling 17
Both Tdap and Td are contraindicated for people who have had
Zoster 16
a severe allergic reaction after a previous dose or to a compo-
Rash 13 nent of the vaccine.
Erythema 13
Injection-site pain 12 Tdap should be used with caution in people who have a progres-
Pruritus 11 sive neurologic disorder (until the condition has stabilized).
Tdap and Td should be used with caution in people with a his-
Pain 11
tory of Guillain-Barré syndrome that occurred within 6 weeks
Injection-site warmth 10
after a dose of a tetanus toxoid-containing vaccine, a history of
Injection-site pruritus 10 a severe local reaction (Arthus reaction) after a previous dose of
Shingrix (n=4,381) tetanus or diphtheria toxoid-containing vaccine, or a moderate
Fever 24 or severe acute illness with or without fever.123
Injection-site pain 23
Tenivac and Decavac are contraindicated for people who have
Injection-site erythema 20
had a severe allergic reaction (e.g., anaphylaxis) to a previous
Pain 20
dose of the vaccine or any other tetanus- or diphtheria
Chills 19
toxoid-containing vaccine or any component of the vaccine.
Headache 17 Both vaccines should also be used with caution in people with
Fatigue 16 a history of Arthus-type hypersensitivity reactions after a pre-
Pain in extremity 16 vious dose of tetanus or diphtheria toxoid–containing vaccines.
Injection-site swelling 13 For these people, vaccination should be deferred until at least
Myalgia 12 10 years after the last tetanus toxoid-containing vaccine.123
VAERS = Vaccine Adverse Event Reporting System. Timing of Vaccination

Adults who did not receive Tdap on or after age 11 years should
Tdap and Td Vaccines
The ACIP recommends the Tdap vaccine for all adults who did
not receive the vaccine on or after the age of 11 years. Pregnant
women should receive Tdap during each pregnancy, preferably
at 27 to 36 weeks of gestation.113
Types of Vaccine
There are two Tdap vaccines for use in adults: Boostrix
(GlaxoSmithKline) and Adacel (Sanofi Pasteur); the primary
difference between the two is the indicated age. Boostrix is
indicated for all ages over 10 years, whereas Adacel is indicated
only up to age 64 years.58
The vaccines available to protect against tetanus and diphtheria

(Td) are Tenivac (Sanofi Pasteur) and Decavac (Sanofi-Pasteur).

Table 14: Contraindications and Precautions for Tdap and Td Vaccines 123
Contraindications Precautions
Tdap
Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to Progressive or unstable neurologic disorder, uncontrolled seizures,
a vaccine component or progressive encephalopathy until a treatment regimen has been
established and the condition has stabilizeda
Encephalopathy (e.g., coma, decreased level of consciousness, or Guillain-Barré syndrome <6 weeks after a previous dose of tetanus
prolonged seizures) not attributable to another identifiable cause, toxoid–containing vaccine
within 7 days after a previous dose of DTP, DTaP, or Tdap
History of Arthus-type hypersensitivity reactions after a previous dose of
tetanus or diphtheria toxoid–containing vaccinesb
Moderate or severe acute illness with or without fever
Td
Severe allergic reaction (e.g., anaphylaxis) after a previous dose or to Guillain-Barré syndrome <6 weeks after a previous dose of tetanus
a vaccine component toxoid–containing vaccine
History of Arthus-type hypersensitivity reactions after a previous dose of
tetanus or diphtheria toxoid–containing vaccinesb
Moderate or severe acute illness with or without fever
a
These precautions are related to the pertussis components of the Modified from Liang J, Tiwari T, Moro P, et al. Prevention of pertussis, tetanus, and
vaccine. diphtheria with vaccines in the US: recommendations of the Advisory Committee on
b
Defer vaccination until at least 10 years after the last tetanus tox- Immunization Practices (ACIP). MMWR Recomm Rep. 2018;67(2):1-44.
oid-containing vaccine.
receive one dose of Tdap and then a dose of Td or Tdap every 10 through December 2018; these reports all affected people 65
years. Individuals with an unknown or incomplete history of years or older. Six percent (104) of the reports were serious.125
completing a three-dose Tdap series should receive at least one The most common adverse events were localized to the
dose of Tdap followed by one dose of Td or Tdap at least 4 weeks injection site: erythema (26%), pain (19%), and swelling (18%).
later and third dose of Td or Tdap 6 to 12 months after the last Td or Other erythema accounted for 18% of the reports.125 No deaths
Tdap dose. Tdap is preferred as the first dose but can be substituted were attributed to the vaccine.
for any Td dose. Td or Tdap should be given every 10 years.
Hepatitis A and B Vaccines
Adacel can be given as a booster starting at 8 years after a previ-
The ACIP recommends Hepatitis A vaccination for people
ous dose of Tdap. It can also be given for wound management
with HIV infection (regardless of CD4 count), people with
as early as 5 years after a previous dose of Tdap or another
chronic liver disease, and men who have sex with men. The
tetanus toxoid-containing vaccine.
vaccine should also be given to anyone at risk for infection with
Education hepatitis A (Box 7).113
VISs are available for Tdap and Td.
Hepatitis B vaccination is recommended for people with HIV
Administration infection (regardless of CD4 count), end-stage renal disease
All four vaccines are given as an IM injection, at a dose of 0.5 mL. (or receiving hemodialysis), chronic liver disease, or diabetes;
They are available in prefilled syringes and single-dose vials. health care personnel; and men who have sex with men.
Potential Adverse Events Vaccination against either virus may be given to pregnant
Studies after licensure of Tdap vaccines have shown that the women if they are at risk for infection or severe outcome from
vaccines are safe for adolescents and adults.124 A total of 1,798 infection during pregnancy.
adverse event reports were sent to VAERS from September 2010
Box 7: Risk Factors for Hepatitis A or B 113 Twinrix) or to any vaccine components (yeast [Recombivax HB,
Engerix B, Heplisav-B, Twinrix] or neomycin [Twinrix]).114
Hepatitis A Hepatitis B
Timing of Hepatitis Vaccines
Chronic liver disease Chronic liver disease
All hepatitis vaccines are given as a two- or three-dose series at
HIV infection HIV infection
established intervals (Table 15).113 For people traveling to coun-
Men who have sex with men Sexual exposure risk (including
tries where hepatitis A or B is endemic (high or intermediate),
men who have sex with men)
it is best to receive all doses at least 2 weeks before potential
Injection or non-injection drug Current or recent injection drug
exposure to the virus.114 If that is not possible, at least one dose
use use
should be received.
Persons experiencing Incarcerated persons
homelessness Education
Work with hepatitis A virus in Percutaneous or mucosal risk for VISs are available for hepatitis A and for hepatitis B.
research lab exposure to blood
Administration
Travel in countries with high or Travel in countries with high or
All hepatitis vaccinations are given intramuscularly (Table 15).
intermediate endemic hepatitis A intermediate endemic hepatitis B
Heplisav and Twinrix are available in prefilled syringes
Close, personal contact with
only; the others are available as both prefilled syringes and
international adoptee
single-dose vials. Hepatitis vaccines are available in pediatric
doses, so pharmacists should double-check the vial to ensure
Types of Vaccines that it is the correct one for an adult.
Six hepatitis vaccines are available, two for hepatitis A, three
for hepatitis B, and one for a combination of hepatitis A and B Potential Adverse Events
(Table 15).114 A survey was done of VAERS reports after single-antigen
hepatitis B or hepatitis B-containing vaccinations (January
Contraindications and Precautions 2005 to December 2015). Of the 20,231 reports, 5,867 (29%) were
Hepatitis vaccines are contraindicated in anyone who has had a for individuals older than 18 years. The most common adverse
severe allergic reaction (e.g., anaphylaxis) after a previous dose of a events after single-antigen hepatitis B vaccination were
hepatitis A-containing vaccine (Havrix, Vaqta, Twinrix) or hepatitis dizziness and nausea (8.4% each); fever (23%) and injection-site
B-containing vaccine (Recombivax HB, Engerix B, Heplisav-B, erythema (11%) were the most common events after hepati-
tis-containing vaccines.126
Table 15: Vaccines for Hepatitis A and B 114
Indicated Initial Dose,
Vaccine (Mfr) Booster Dose Type of Vaccine
Ages Route
Hepatitis A
Havrix (GSK) ≥12 mos. 1 mL, IM 1 mL, 6-12 mos. after initial dose Inactivated
Vaqta (Merck) ≥12 mos. 1 mL, IM 1 mL, 6-18 mos. after initial dose Inactivated
Hepatitis B
Recombivax HB (Merck) ≥20 yrs. 1 mL, IM 1 mL, at 1 and 6 mos. Recombinant
Energix-B (GSK) ≥20 yrs. 1 mL, IM 1 mL, at 1 and 6 mos. Recombinant
Heplisav-B (Dynavax) ≥18 yrs. 0.5 ml, IM 0.5 mL, 1 mos. after initial dose Recombinant, adjuvanted
Combination
Twinrix (GSK) ≥18 yrs. 1 mL, IM Standard dosing: 1 mL, at 1 and 6 mos. Recombinant
Accelerated dosing: 1 mL 7 and 21-30 days after
initial dose and at 1 mos.
GSK = GlaxoSmithKline, IM = intramuscular.

MMR Vaccine Potential Adverse Events

MMR vaccination is recommended for all people with no From January 1, 2003, through July 31, 2013, 3,175 adverse events
evidence of immunity to measles, mumps, or rubella. Evidence among adults 19 years and older were reported to VAERS. The
of immunity includes born before 1957, documentation of most common events among the nonserious reports were fever,
receipt of MMR vaccine, laboratory evidence of immunity or rash, pain, and arthralgia (Table 16).127 Five percent (168) of the re-
disease. The MMR vaccine is contraindicated for pregnant ports were serious. Among the serious reports, the most common
women, immunocompromised individuals, and people with adverse events were fever, headache, asthenia, and hypoesthesia.
HIV infection and a CD4 count less than 200/μL.113
Table 16: Adverse Events Associated with MMR II in VAERS,
Vaccination is also recommended for people at high risk for any 2003-2015 127
of the diseases covered by the vaccine. These high-risk people
include health care personnel, college students, international Event Percentage (%)
travelers, and nonpregnant women of childbearing age who Nonserious reports (n=3007)
do not have evidence of immunity to rubella. Pregnant women Fever 19
who have no evidence of immunity to rubella should receive Rash 17
one dose of the vaccine after pregnancy, before discharge from Pain 13
the health care facility where she gave birth. Arthralgia 13
Types of Vaccine Serious reports (n=168)
MMR II (Merck) is the live vaccine used for individuals 12 Fever 24
months of age and older. Another live vaccine (Proquad; Merck) Headache 21
is also available but is indicated only for children 12 months to Asthenia 19
12 years old. Hypoesthesia 19
Arthralgia 18
Contraindications and Precautions
In addition to the health statuses already noted, MMR II is also Pain 16
contraindicated for people with moderate or severe febrile illness Dyspnea 16
or active untreated tuberculosis.114 The vaccine should be used VAERS = Vaccine Adverse Event Reporting System.
with caution for individuals with a history of febrile seizures or
thrombocytopenia or with anaphylaxis or immediate hypersen-
HPV Vaccine
sitivity after eating eggs.114 Immune globulins and other blood
Vaccination against HPV is recommended for all adults
products should not be given concurrently with MMR II.
through age 26 years. Vaccination is recommended to begin
Timing of Vaccination at the age of 9 years, but if the three-dose series was not given
Two doses of MMR vaccine are recommended for prevention of in adolescence, vaccination can be completed or can start in
mumps in adults at high risk (as defined earlier). The vaccines adulthood. Vaccination for adults 27 through 45 years can
should be given at least 4 weeks apart.113 All other adults born be discussed through shared clinical decision-making.113 For
during or after 1957 without other evidence of immunity should pregnant women, vaccination should be delayed until after
be vaccinated with one dose. In 2017, the ACIP approved a third pregnancy.
dose of MMR II during a mumps outbreak.
Types of Vaccine
Education Gardasil 9 (Merck) is now the only HPV vaccine available in the
A VIS is available for the MMR vaccine. US. It is a nine-valent recombinant vaccine indicated for both
sexes, 9 to 45 years old.
Administration
MMR II is given subcutaneously, at a dose of 0.5 mL. The Contraindications and Precautions
vaccine must be reconstituted with the accompanying sterile Contraindications to HPV vaccines include hypersensitivity to
diluent and given immediately thereafter. any components (which includes yeast).114
Timing of HPV Vaccination Meningococcal B vaccine is recommended for individuals

Gardasil 9 is given in a series of three doses at 0, 2, and 6 with HIV infection (regardless of CD4 count), anatomical or
months.114 functional asplenia (including sickle cell disease), persistent
complement component deficiency, or complement inhibitor
Education
(e.g., eculizumab, ravulizumab) use. Among pregnant women,
A VIS is available for HPV vaccine.
the vaccine should be delayed until after pregnancy unless
Administration the woman is at increased risk for meningococcal disease and
HPV vaccine is given intramuscularly, at a dose of 0.5 mL. The vaccination benefits outweigh potential risks.113
vaccine is available in prefilled syringes or single-dose vials.
Types of Vaccines
Potential Adverse Events There are five meningococcal vaccines, three against sero-
In a study of VAERS reports from June 2006 through December groups A, C, Y, and W, and two against serogroup B (Table 17).114
31, 2008, 3,958 reports were on individuals 18 to 26 and 274, on One of the three meningococcal ACWY vaccines was approved
individuals older than 26 years.128 Among the individuals 18 to by the US FDA in May 2020 and provides an option for adults
26 years old, 93% of the reports were nonserious; among the older than 55 years. Menveo is a live vaccine.
individuals older than 26 years, 94% were nonserious. The most
Contraindications and Precautions
common adverse events overall (all ages) were syncope (15%),
Contraindications to the meningococcal vaccines include
dizziness (14%), nausea (9%), and headache (8%).128
severe allergic reaction to any components of the vaccines.
The decision to give Menactra should consider the potential
Meningococcal Vaccine benefits and risks for people previously diagnosed with
ACIP recommends meningococcal ACWY vaccine for individ- Guillain-Barré syndrome, as they may be at increased risk of
uals with HIV infection (regardless of CD4 count), anatomical the syndrome after receiving the vaccine.
or functional asplenia (including sickle cell disease), persistent
complement component deficiency, or complement inhibitor Timing of Meningococcal Vaccination
(e.g., eculizumab, ravulizumab) use. The vaccine is also rec- Meningococcal ACWY vaccines are given as an initial dose, and
ommended for first-year college students to live in residential a booster can be given at least 4 years later if a risk for menin-
housing (in not vaccinated earlier), military recruits, and people gococcal disease is still present.113 Meningococcal B vaccines
traveling to countries with hyperendemic or epidemic menin- are given as a series of two doses, with the second dose 1 month
gococcal disease.113 later (Bexsero) or 6 months later (Trumenba).114
Bacteria neisseria meningitidis

Education level of education, and socioeconomic status. In general, rates

Two VISs are available, one for meningococcal ACWY and one are higher among women, white individuals, and people with
for meningococcal B. higher education levels and socioeconomic status. Pharmacists
should help enhance awareness and education of vaccines over-
Administration
all in their community, with increased efforts targeting groups
All meningococcal vaccines are given intramuscularly, at a
for whom immunization rates are lower. Studies have shown
dose of 0.5 mL. Menveo is provided in two vials that must be
that a recommendation from a health care provider is a strong
combined immediately before the vaccine is given. Menactra
predictor of receiving a vaccine, yet about half of providers
and is MenQuadfi are available in single-dose vials, and Bexsero
report not discussing the consequences of missed vaccinations
and Trumenba are available as prefilled syringes.
with their patients. This gap can be filled by pharmacists, and
Potential Adverse Events multiple studies have shown that pharmacists are beneficial in
According to data collected in VAERS from January 1, 2020, improving vaccination rates. Pharmacists should also draw on
through December 31, 2005, 379 reports represented adults evidence-based strategies to address barriers to immunization,
(18 years and older). The most common adverse events were such as vaccine forecasting, press releases in newspapers, flyers
injection-site erythema (14%), fever (14%), injection-site swelling with prescriptions, and personal conversations with customers.
(13%), headache (12%), and injection-site pain (11%).129 Syncope
Among all states, Florida ranks low in vaccination rates, but
was reported in 6%.
high in the number of pharmacies and pharmacists. This
unique situation creates an opportunity for pharmacists to
Summary become vaccine champions and help increase rates by height-
Vaccines can help the public stay healthier and avoid several ening awareness, advocating for vaccinations, and providing
contagious and/or infectious diseases. However, many adults vaccines to adults.
do not take advantage of this simple step toward avoiding vac-
cine-preventable diseases. Immunization rates vary by many
factors, including age, sex, the specific vaccine, race/ethnicity,
Table 17: Vaccines against Meningococcal Disease 114

Indicated Initial Dose,
Vaccine (Mfr) Booster Dose
Ages Route
Serogroups A, C, Y, W-135
Menveo (GSK) 2 mos.-55 yrs. 0.5 mL, IM 0.5 mL may be given to adults at continued risk for meningococcal disease
if at least 4 years since first dose of a meningococcal (serogroups A, C, Y,
W-135) conjugate vaccine
Menactra (Sanofi Pasteur) 9 mos.-55 yrs. 0.5 mL, IM 0.5 mL may be given to adults at continued risk for meningococcal disease
if at least 4 years since first dose of a meningococcal (serogroups A, C, Y,
MenQuadfi (Sanofi 2 yrs. and older 0.5 mL, IM 0.5 mL may be given to adults at continued risk for meningococcal disease
Pasteur) if at least 4 years since first dose of a meningococcal (serogroups A, C, Y,
Serogroup B
Bexsero (Novartis) 10-25 yrs. 0.5 mL, IM 0.5 mL, 1 mos. later
Trumenba (Wyeth) 10-25 yrs. 0.5 mL, IM 0.5 mL, at 1-2, and 6 mos. OR
0.5 mL at 0 and 6 mos.a
GSK = GlaxoSmithKline, IM = intramuscular.

a
If the second dose is given earlier than 6 months after the first dose, a third dose should be given at least 4 months after the second dose.
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Florida Pharmacists Immunization Course

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Disclosure Statement: Instructions for completing this CPE activity

Vaccine Safety Course | Page 5

Vaccine Safety Course | Page 7

Table 3: Vaccination Rates by Vaccine and Age in

47 before age 19 years.

Vaccine Safety Course | Page 9

Influenza virus is commonly spread by respiratory droplets

Secondary bacterial pneumonia is the most common

Table 4: Estimated Influenza Disease Burden, by Seasona, 63, 64

Vaccine Safety Course | Page 11

PCV13 introduction PCV13 introduction

among adults older than 65 years in the US, 1998-

decreased by 70%. Reprinted from Centers for Disease

Vaccine Safety Course | Page 13

Tetanus toxoid was developed in 1924, and immunization was

In the US, diphtheria was once a common cause of illness

Vaccine Safety Course | Page 15

Measles The vaccination rate for measles in Florida is generally high,

Before the introduction of a rubella vaccination program in

Vaccine Safety Course | Page 17

Box 2: Types of Vaccines 98

The incidence of meningococcal disease peaked in the late Live Attenuated

vaccines are given to protect against diphtheria and tetanus.

Vaccine Safety Course | Page 19

Vaccine Vaccine Vaccine arrival at Vaccine storage & Vaccine

Manufacturer Manufacturer/ Provider

• Do not store food and drinks in the vaccine

Vaccine Safety Course | Page 21

• Meningococcal Pharmacists (and all vaccine providers) must document that

Severe allergic reactions to vaccines are rare, but pharmacists •

0.3 to 0.5 mg (0.01

Vaccine Safety Course | Page 23

For subcutaneous injections, a 5/8-inch 23- to 25-gauge 45° angle

Vaccine Safety Course | Page 25

• Date of administration • Avoid interruptions when selecting and preparing

• Date printed on VIS

Table 11: Approved Influenza Vaccines 114, 115

Vaccine Safety Course | Page 27

Quadrivalent inactivated influenza vaccines have safety

Pneumococcal Vaccine typically localized. Of 25,168 VAERS reports on PPSV23, 92%

pulmonary function in whom a systemic reaction would pose a • Immunocompromised status

Potential Adverse Events Education

Vaccine Safety Course | Page 29

Potential Adverse Events Timing of Zoster Vaccination

Zoster Vaccine Administration

VAERS = Vaccine Adverse Event Reporting System. Timing of Vaccination

The vaccines available to protect against tetanus and diphtheria

Vaccine Safety Course | Page 31

GSK = GlaxoSmithKline, IM = intramuscular.

Vaccine Safety Course | Page 33

MMR Vaccine Potential Adverse Events

Timing of HPV Vaccination Meningococcal B vaccine is recommended for individuals

Bacteria neisseria meningitidis

Vaccine Safety Course | Page 35

Education level of education, and socioeconomic status. In general, rates

Table 17: Vaccines against Meningococcal Disease 114

GSK = GlaxoSmithKline, IM = intramuscular.

References 15. National Community Pharmacists Association. 2019 NCPA Digest.

Vaccine Safety Course | Page 37