Development Course Template
Learning Objectives
Module 4 Overview
On successful completion of this module, you will be able to:




Required Textbook
Discuss the role of healthcare providers as it relates to the safe
administration of vaccines (Level 2 Understand)
Explain the ways in which the Centers for Disease Control monitor
the safety of vaccines in the United States (Level 2 Understand)
Interpret data in order to make informed healthcare decisions
(Level 3 Apply)
Defend your position at it relates to the benefits and risks of
vaccines (Level 5 Evaluate)
Hambrosky, J., Kroger, A., and Wolfe, C. (Eds.) (2015). Epidemiology and
Prevention of Vaccine-Preventable Diseases (13th ed.).
Read and download your book here:
http://www.cdc.gov/vaccines/pubs/pinkbook/index.html
Begin Module.
Module 4
Vaccine Safety and Reporting
Main Content Text
Welcome
Welcome to Module 4! In this module, you will have the opportunity to explore the following topics:
 Immune system and its responses to bacteria and viruses
 Risks and benefits of vaccines
 Current topics in vaccine safety
 The role of the Center for Disease Control in vaccine safety
Tasks
You are required to complete the following tasks:
 Review the Lecture Presentation
 Complete the Required Readings
 Respond to the Discussions
 Submit your Assignment
 Take the Module 4 Quiz
Please see your Syllabus for specific due dates and times.
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Main Content Text
Required Readings
In preparation for this module’s activities, please read the following:
 Epidemiology and Prevention of Vaccine-Preventable Diseases: Chapter 4, “Vaccine Safety”
 Lecture Presentation: Vaccine Safety and Reporting
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Module 4
Lecture Presentation: Vaccine Safety and Reporting
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To understand how and why vaccine reactions occur, it is first necessary to understand how the
immune system helps to protect the body against infection. The immune system is designed to identify
and destroy harmful foreign organisms, called pathogens, from the body and neutralize the toxins, or
poisons, that some bacteria produce.
A doctor vaccinating a small girl 1901.
Attribution: See page for author [CC BY 4.0 (http://creativecommons.org/licenses/by/4.0)], via
Wikimedia Commons.
Vaccines today can prevent diseases from certain pathogens. Vaccine-preventable diseases include
microorganisms such as bacteria or viruses. Bacteria are single-celled life forms that can reproduce
quickly on their own. Viruses are ultramicroscopic infectious agents that replicate themselves only
within the cells of living hosts. Viruses cannot reproduce on their own like bacteria.
Illustration of bacterium.
Attribution: By Mariana Ruiz Villarreal, LadyofHats [Public domain], via Wikimedia Commons.
The immune system responds to bacteria and viruses in a very complex way. It recognizes unique
molecules, called antigens, from bacteria and viruses, and produces antibodies and special white blood
cells, called lymphocytes, that mark the antigens for destruction.
Illustration of lymphocyte.
Attribution: Häggström, Mikael. "Medical gallery of Mikael Häggström 2014". Wikiversity Journal of
Medicine 1 (2). DOI:10.15347/wjm/2014.008. ISSN 20018762. (Image:Lymphocyte_activation.png)
[Public domain], via Wikimedia Commons.
During the primary immune response to the first encounter with a specific pathogen, some
lymphocytes, called memory cells, develop with the ability to confer long-lasting immunity to that
pathogen—often for life. These memory cells recognize antigens on the pathogens they have
encountered before, triggering the immune system to respond faster and more effectively than on the
first exposure.
The goal of all vaccines is to elicit an immune response against an antigen so that when the individual is
exposed to the antigen again, a much stronger secondary immune response will result. Vaccines contain
the same antigens that are found on the pathogens that cause the associated disease, but exposure to
the antigens in vaccines is controlled. By priming the immune system through vaccination, when the
vaccinated individual is later exposed to the live pathogens in the environment, the immune system can
destroy them before they can cause disease.
Illustration of antigen.
Attribution: By Original_antigenic_sin.png: User:DO11.10 derivative work: Hazmat2 [CC BY-SA 3.0
(http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons.
There are two ways of acquiring immunity to a pathogen:
1. Natural infection
2. Vaccination
Natural infections and vaccines produce a very similar end result: immunity. However, the person who
receives a vaccine does not endure the illness and its potential life-threatening complications. The very
low risk of an adverse event caused by a vaccine greatly outweighs the risk of illness and complications
caused by natural infection.
© Copyright World Health Organization (WHO), 2016. All Rights Reserved.
All images individual attributions provided.
Definitions
Antibodies – A type of protein produced as a primary immune defense.
Antigens –A foreign substance in the body that triggers antibodies.
Immune system - A complex system of organs and processes in the body responsible for fighting
disease. Its primary function is to identify foreign substances in the body (including bacteria, viruses,
fungi, parasites or transplanted organs and tissues) and develop a defense against them. This defense is
known as the immune response.
Immune response - The body's defense against foreign objects or organisms, such as bacteria, viruses,
or transplanted organs or tissue.
Lymphocytes - White blood cells that are part of the immune system. The human body is comprised of
approximately 20% to 40% white blood cells. These cells are important to the immune system because
they determine how the immune system responds to microorganisms and foreign substances.
Pathogens - Any disease-causing substance. Most commonly used for organisms such as bacteria or
viruses and the toxins that they produce.
Priming - The process of artificial induction of immunity in order to protect against infectious disease.
Priming the immune system involves sensitizing or stimulating an immune response with an antigen that
can produce immunity to a disease-causing organism or toxin (poison). Vaccinations involve the
administration of one or more of these antigens, which can be administered in several forms.
Graphic Design Instructions
<insert image V0016682.jpg>
<metadata> A doctor vaccinating a small girl 1901.
Attribution: See page for author [CC BY 4.0 (http://creativecommons.org/licenses/by/4.0)], via
Wikimedia Commons.
<insert image Average_prokaryote_cell-_en.gif>
<metadata> Illustration of bacterium.
Attribution: By Mariana Ruiz Villarreal, LadyofHats [Public domain], via Wikimedia Commons.
<insert image Lymphocyte_activation_simple.png>
<metadata> Illustration of lymphocyte.
Attribution: Häggström, Mikael. "Medical gallery of Mikael Häggström 2014". Wikiversity Journal of
Medicine 1 (2). DOI:10.15347/wjm/2014.008. ISSN 20018762. (Image:Lymphocyte_activation.png)
[Public domain], via Wikimedia Commons.
<insert image Original_antigenic_sin.svg>
<metadata> Illustration of antigen.
Attribution: By Original_antigenic_sin.png: User:DO11.10 derivative work: Hazmat2 [CC BY-SA 3.0
(http://creativecommons.org/licenses/by-sa/3.0)], via Wikimedia Commons.
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Discussion 4.1: Vaccines and Disease
General Discussion Instructions
When posting or responding to a post, try to keep your answers relevant to the particular discussion
string. When you post a comment on the board, please mention the name of the person to whose post
you are responding. This will help keep the discussions organized and help limit reading time as you
engage in the peer discussions.
Discussion Prompt
Take a moment to post to the discussion board addressing the following:
Healthcare providers play an important role in minimizing the risk of adverse effects from vaccination.
According to the Federal Drug Administration and the Centers for Disease Control, certain vaccines
should not be given to certain patients or should be done so only in a controlled environment.
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Provide at least two examples of situations in which a vaccination should be delayed or not
administered.
If you or a close family member needed a particular vaccination but were screened and found
to be at high risk for adverse reaction, what would you do? Would you accept the risk and
vaccinate? Why or why not? Explain your rationale based on the information you have learned
in this module.
ANSWER:
There are several possibilities based on textbook. However, immunocompromised diseases or
conditions and allergic reactions in the patient are the primary reasons to delay or not administer
vaccinations.
Answers will vary.
Discussion Rubric
Grading Rubric
Content/Ideas



Organization

Meets minimum
word requirement
Includes supporting
details, and relates
to course content
Includes content
from both the
course materials
and library as well
as the internet


Presents ideas
presented in clear,
logical manner
Includes a strong
thesis
Includes both facts
and opinions
supported by peer
review research
Timeline


Student
posted
initial post
by
Wednesday
of each
week
Two or more
additional
posts are
made by
Sunday
11:59 p.m.
PST


Writing
Mechanics/Style
Contains correct
grammar, spelling,
punctuation, and
sentence structure
Provides sources
when using nonoriginal material
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Discussion 4.2: Public Confidence in Immunization Safety
General Discussion Instructions
When posting or responding to a post, try to keep your answers relevant to the particular discussion
string. When you post a comment on the board, please mention the name of the person to whose post
you are responding. This will help keep the discussions organized and help limit reading time as you
engage in the peer discussions.
Discussion Prompt
Take a moment to post to the discussion board addressing the following:
Maintaining public confidence in immunizations is critical for the continued decline of contagious
diseases in the United States and in the world. In recent years, there have been concerns about the
safety of certain vaccines being administered to children. These concerns have led some parents to
delay or refuse to vaccinate their children.
 Provide two examples of such instances, either in the United States or in another country.
 Explain how the Center for Disease Control (CDC) or World Health Organization (WHO) handled
these concerns.
 Provide your own recommendations as to how the situation(s) could have been prevented.
 Explain your rationale.
ANSWER:
Answers will vary. However, the following instances are mentioned in this module’s readings:
 Whole-cell Pertussis vaccine and Pertussis increase (2010)
 MMR vaccine and Measles increase (2008)
Discussion Rubric Template
Grading Rubric
Content/Ideas


Meets minimum word
requirement
Answer is focused,
addresses the question
with supporting details,
and relates to course
content
Organization

Presents ideas in clear,
logical manner
Writing Mechanics/Style


Contains correct grammar,
spelling, punctuation, and
sentence structure
Provides sources when
using non-original material
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Assignment: Benefits and Risks of Vaccines Infographic
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Instructions
In this assignment, you will create an infographic on the benefits and risks of vaccines. The main idea or
question that your infographic should answer is this: Do the benefits of vaccination outweigh the
potential risks?
Your infographic must include content based on facts from reputable websites, government agencies,
and institutions. Review the grading rubric to ensure you have met the requirements prior to submitting
your work.
You may choose to use a common program such as Word or PowerPoint to create your assignment.
There are also several free tools available on the Internet to help you create your infographic. You can
use any of the following free tools or another of your choosing:
 https://www.easel.ly/
 http://piktochart.com/
 https://infogr.am/
 http://visual.ly/
What is an Infographic?
If you are not sure what an infographic is, here are a few examples:
 https://www.unicefusa.org/stories/champions-children-main-page/impact-yoursupport/emergency-support/infographic-thinking-big
 http://www.behance.net/gallery/Vaccine-Infographic/2878481
 http://www.vaxnorthwest.org/about-vaccines--2/vaccine-achievements
Submit Your Assignment
When you have completed your assignment please upload it using the attachment button and submit
your work for grading.
Option 1:
Optional assignment is to have students conduct a peer review of the infographics prior to submission
for grading.
Option 2:
The instructor may want to assign ½ of the class to defend a pro-vaccine stance and the other ½ an antivaccine stance.
Infographic Grading Rubric
Metrics
Main Idea
Details
Content
Accuracy/Sources
Graphics/Relevance
4
Excellent
3
Needs some
improvement
2
Needs significant
improvement
1
Poor
The topic and
messages of the
infographic are clear
and easily
understood.
Details (including
labels) support the
main idea without
distracting with
clutter.
At least four
accurate
facts/concepts are
displayed in the
infographic.
The graphics used
represent
information
appropriately.
Topic and main ideas
are clear.
Topic is given but
main ideas are
unclear or lacking.
Topic and/or main
ideas are absent or
very unclear.
Detail is added to
support each main
idea with minimal
clutter.
Three accurate facts
are displayed.
More detail is
needed for
understanding. Some
details are
distracting.
Two accurate facts
are displayed.
Very little detail is
provided for the
main ideas and
understanding is
limited.
Fewer than two
accurate facts are
displayed.
Most graphics
represent the
information
appropriately.
All graphics relate to
the topic but do not
represent
appropriately.
Graphics do not
relate to the topic.
Mechanics/Grammar
Capitalization and
punctuation are
correct throughout.
There are no
grammatical
mistakes.
TOTAL
There is one error in
capitalization or
punctuation.
There is one
grammatical
mistake.
There are two errors
in capitalization or
punctuation.
There are two
grammatical
mistakes.
There are more than
two errors in
capitalization or
punctuation.
There are more than
two grammatical
mistakes.
/20
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Main Content Text:
Further Study
The following articles, websites, and videos provide an opportunity to further study this week’s topics.
These are reading recommendations and represent optional materials for this module.
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Learn more about the CDC’s Vaccine Safety Datalink (VSD) here:
http://www.cdc.gov/vaccinesafety/ensuringsafety/monitoring/vsd/
Explore the ethical issues surrounding vaccination at History of Vaccines created by The College
of Physicians of Philadelphia: http://www.historyofvaccines.org/content/articles/ethicalissues-and-vaccines
Read “Current Controversies in the USA Regarding Vaccine Safety” from Medscape, a part of
WebMD Health Professional Network here: www.medscape.com/viewarticle/722174
Watch “Is Natural Infection Better Than Vaccination” from The Children’s Hospital of
Philadelphia: https://www.youtube.com/watch?v=xBAac0JVm9c
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Quiz: Vaccine Safety
Instructions
This quiz consists of five questions and covers the material found in the readings and lecture for this
module. You will have one opportunity to take this quiz.
1.
2.
3.
True or False: Vaccines generate an immune response in the body.
True or False: Vaccines are regulated from development, to licensure, to use, and national
regulatory authorities play an important role in this process.
M/C (Select all that apply): In the United States, vaccines are licensed and monitored by which
organizations?
a. Food and Drug Administration (FDA)
b. Vaccine Adverse Event Reporting (VAERS)
c. Center for Disease Control (CDC)
4.
5.
d. Vaccine Safety Datalink (VSD)
e. All of the above
M/C (Select all that apply): The purpose of the National Childhood Vaccine Injury Act is to:
a. Cover the costs of recommended childhood vaccines
b. Require healthcare providers to report adverse health events following vaccinations
c. Collect reports of vaccine adverse events
d. Enforce vaccine storage rules and spacing of vaccine doses
e. All of the above
M/C (Select all that apply): Which of the following programs does the Center for Disease
Control (CDC) have in place to capture reporting data in regards to the adverse effects of
vaccinations?
a. Vaccine Adverse Event Reporting System (VAERS)
b. Vaccine Safety Datalink (VSD)
c. Clinical Immunizations Safety Assessment (CISA)
d. Vaccine Injury Compensation Program (VICP)
e. All of the above
ANSWERS
1. True
2. True
3. A & C
a.
4.
5.
B&C
a.
Rationale: The FDA licences vaccines and the facilities that produce vaccines. The CDC
provides vaccine safety information to health care providers, parents, and the general
population, as well as monitors adverse events related to vaccination. VAERS is a
system used by the FDA and CDC to monitor the safety of vaccines. The VSD is a
system established by the CDC.
Rationale: The National Childhood Vaccine Injury Act mandates that healthcare
providers who administer vaccines and vaccine manufacturers report adverse health
events following vaccinations. These reports are collected through the Vaccine
Adverse Event Reporting System (VAERS).
E
a.
Rationale: All of the programs are currently administered or co-administered by the
CDC.
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Attributions
David Schauer & Edward DeLong, 20.106J / 1.084J Systems Microbiology, Fall 2006. (Massachusetts
Institute of Technology: MIT OpenCourseWare), http://ocw.mit.edu (Accessed June 20, 2016).
License: Creative Commons BY-NC-SA.
Hambrosky, J., Kroger, A., and Wolfe, C. (Eds.) 2015. Epidemiology and Prevention of VaccinePreventable Diseases (13th ed.).
World Health Organization. (2013). Vaccine Safety Basics. http://www.who.int (Accessed June 20,
2016).
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End Module.