Applying the CASE approach to - COVID-19
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COVID-19
VACCINATION
Applying
the CASE
approach to
COVID-19
mRNA vaccine
hesitancy BY ROBERT M. JACOBSON, MD, FAAP,
AND LILA J. FINNEY RUTTEN, PHD, MPH
A
t the time this magazine went to press, the U.S. Food This approach can be usefully applied to adult patients and it
and Drug Administration had authorized two vac- certainly can help with patient hesitancy about the COVID-
cines to prevent COVID-19 infection (with a third 19 mRNA vaccines.
likely to be authorized soon) and the U.S. Advisory Com- CASE stands for corroborate, about me, sci-
mittee on Immunization Practices recommended that all ence and explain/advise. With the CASE approach,
individuals 16 years and older receive a two-dose series of the clinician frames a response to the vaccine-hesitant pa-
either. During the early months of the COVID-19 vaccine tient that corroborates awareness of the patient’s hesitancy
roll-out in the United States, the supply of vaccines available while identifying a shared underlying value or concern.
has been limited. For that reason, the U.S. Advisory Com- Next, the clinician makes an about me statement, describ-
mittee on Immunization Practices recommended that the ing how the clinician went about getting a scientific answer
vaccine be allocated to certain groups of individuals based to the concern. The clinician then summarizes the science
on their occupation, age or health condition. Despite priori- underlying the recommendation and/or explanation ad-
tized availability and expert panel recommendation, some dressing said concerns. Finally, the clinician explains the
individuals express vaccine hesitancy, even those deemed clinician’s advice to the patient.
at higher risk for acquiring the infection and for suffering The CASE approach, while brief, connects the patient
severe infection. to the clinician through the shared value or concern (cor-
Clinicians, particularly primary care clinicians, can expect roborate), recognizes and employs the professional standing
to be contacted by their patients about their concerns and of the clinician (about me), relies on science to address the
hesitation toward COVID-19 vaccines. Patients will look to concern (science) and allows the clinician to reframe the
clinicians for answers to their questions, for reassurance and recommendation addressing the concern of the patient (ex-
for their strong recommendations. plain/advise).
In previous articles in Minnesota Medicine, we have writ- We have identified seven common concerns with the
ten about the use of the CASE approach in addressing vac- available COVID-19 mRNA vaccines authorized for use
cine hesitancy. Alison Tepper Singer, president of the Autism in the United States and created scripts for how clinicians
Science Foundation, developed the CASE approach for clini- might address patients’ questions and hesitancy using the
cians to use with parents in addressing vaccine hesitancy. CASE approach.
16 | MINNESOTA MEDICINE | MARCH/APRIL 2021
COVID-19
VACCINATION
Patient concern #1 sure. But I found very reassuring facts in my readings of the
“The COVID-19 vaccines were rushed through medical literature.”
and only approved with an emergency use
authorization and not a full licensure. We SCIENCE
don’t know yet if they really work or if they “The Food and Drug Administration, or FDA, sped up
are really safe.” its meetings and communications but still required the
manufacturers to go through the entire pre-licensure test-
Clinician case response ing that the FDA requires for all of the vaccines it licenses.
CORROBORATE These vaccines were studied for effectiveness and safety in
“I agree with you that many treatments are too new and placebo-controlled, double-blinded, randomized controlled
under-studied to prescribe. And, as one of your healthcare trials involving tens of thousands of patients. The available
team’s clinicians, I wouldn’t want to recommend a vaccine to vaccines are proven to be effective and safe with data in
you until we have well-established effectiveness and safety tens of thousands of recipients.”
data.”
EXPLAIN/ADVISE
ABOUT ME “It’s because of these very large, well-done safety and ef-
“I, too, was worried at first that these vaccines were emer- ficacy trials that I have the confidence to make a strong
gently authorized and that they may have been authorized for recommendation to you to get the COVID-19 mRNA vaccine
use without all the usual requirements for testing before licen- when it becomes available to you.”
Patient concern #2 Patient concern #3
“I am concerned that the COVID-19 vaccines “COVID-19 vaccines are not required
might cause long-lasting health problems.” vaccines.”
Clinician case response Clinician case response
CORROBORATE CORROBORATE
“I share your concern and agree that we must avoid using “It’s true that you are not required to get the COVID-19
pharmaceuticals or biologics that could cause long-lasting mRNA vaccines series.”
health problems—especially when we are only using them for
prevention of a health condition.” ABOUT ME
“As your clinician, I need you to know that I don’t want you
ABOUT ME to get a vaccine because you have to get it. I want you to
“I have learned in my studies as a clinician that vaccines must want to get vaccines that you need, that are effective, that
meet a much higher standard for safety and avoidance of side are safe and that lack competing alternatives.”
effects than medicines used to treat disease once the disease
is present. This is because they are given to so many more SCIENCE
people simply to prevent illness.” “Rather than recommend a vaccine because it is required,
I recommend a vaccine because the studies show that you
SCIENCE are at risk; that, while the masking and social distancing are
“The FDA required that the very large trials of the COVID-19 helpful, they are not enough; and that the vaccine is effec-
mRNA vaccines follow thousands and thousands of vaccine tive in preventing disease and it is safe for you to get. Not all
recipients closely for two months after each dose for safety licensed vaccines meet these standards. The U.S. Advisory
signals. That length of time exceeds the time in which such Committee on Immunization Practices only recommends
safety concerns would show up by two or more weeks.” vaccines that meet the four standards of being safe, effec-
tive, necessary and without reasonable alternatives.”
EXPLAIN/ADVISE
“The safety studies with follow-up for tens of thousands of EXPLAIN/ADVISE
vaccine recipients gives me the confidence to strongly recom- “So, yes, the COVID-19 mRNA vaccines are not required,
mend this vaccine to all of my patients who are now getting but I strongly recommend you get vaccinated. The vac-
invitations to get the vaccine because of their occupation, age cines are effective, safe, necessary and without reason-
or health condition.” able alternatives.”
MARCH/APRIL 2021 | MINNESOTA MEDICINE | 17
COVID-19
VACCINATION
Patient concern #4 Patient concern #5
“I’ve been invited to get “I had a severe allergic reaction—anaphylaxis—to vaccination.
the vaccine, but I don’t I’ve heard of awful allergic reactions to the COVID-19 vaccine.”
have any of the risk
factors for severe COVID- Clinician case response
19. They should save the CORROBORATE
COVID-19 mRNA vaccines “I have close family members who have experienced anaphylaxis with food allergies. I
for others at higher risk.” know it is very frightening and it can be life-threatening. I am sorry that you have had
this experience and I wouldn’t want to put you through that again.”
Clinician case
response ABOUT ME
CORROBORATE “Given both my personal experience and the work I do as a clinician, I read the state-
“I agree with you that we should be ments regarding allergies and the COVID-19 mRNA vaccines published by the U.S.
vaccinating those at highest risk for Advisory Committee on Immunization Practices and the American Academy of Allergy,
infection and complication first.” Asthma & Immunology.”
ABOUT ME SCIENCE
“As your clinician, I’m glad to know “Here is what I learned. If you had an anaphylactic or severe allergic response to a prior
you don’t have a medical condition dose of COVID-19 vaccine, I agree you should not have a second dose without evalu-
that really increases your risk. I have ation by an allergist. For patients who have had anaphylactic or allergic reactions to
read through the published recom- other vaccines, we can explore together with an allergist whether it is safe for you to
mendations from the U.S. Advisory receive the COVID-19 vaccine and how we might best approach receipt of the vaccine
Committee on Immunization Prac- to ensure your safety.”
tices as well as from other national
and state organizations about how EXPLAIN/ADVISE
we need to go about allocating the “That’s why I’m recommending you get the vaccine despite what happened with a previous
vaccines to those who need them non-COVID19 vaccine; just let the staff know and remain 30 minutes under observation.”
most while the vaccines are scarce.”
SCIENCE Patient concern #6
“What I found has convinced me “It’s too expensive. I can’t afford it. With the pandemic I lost
that, first of all, every one of us my job. With my current health insurance, I’ve got a $500
needs vaccination against COVID-19 deductible.”
as we are all at risk, and, second,
distributing the vaccine is fraught Clinician case response
with difficulties. Those getting the CORROBORATE
vaccines serve as examples for oth- “I am sorry to hear about this financial hardship. I can understand why you would want
ers to follow.” to avoid unnecessary expenses and delay those expenses that can wait.”
EXPLAIN/ADVISE ABOUT ME
“That’s why I tell my patients, when “I’ve learned that a big proportion of my patients are in a similar situation as yours be-
you get invited, accept the invitation cause of the pandemic. I investigated the situation about the charges with the vaccines.”
and get the vaccine; don’t delay,
thinking you are doing others a SCIENCE
favor. Those delaying are making “The vaccines that the U.S. government is purchasing will be provided free-of-charge
the distribution more complicated to U.S. residents. Certain vaccine providers may charge an administration fee for giving
by their lack of response to the in- the shot, but individuals can have that fee reimbursed because the Affordable Care Act
vitation and they are inadvertently requires insurance companies to cover approved preventive care.”
setting a bad example. When I got
my invitation, I took the first appoint- EXPLAIN/ADVISE
ment available. That is what I rec- “Given that COVID-19 infection could devastate you financially and the vaccine itself
ommend to you as well.” will be free to you, I recommend you get the vaccine when offered.”
18 | MINNESOTA MEDICINE | MARCH/APRIL 2021COVID-19
VACCINATION
Patient concern #7
“I’m pregnant, and I’ve been told I
should talk to my healthcare provider
before I get the vaccine. I think I
should refuse. What do you think?”
Clinician case response The case for CASE
CORROBORATE Addressing COVID-19 vaccine hesitancy with your patients can be chal-
“I understand why you are concerned. During your lenging and stressful. Through clinical practice and research, we know that
pregnancy you take special care not to take over- patients look to their primary care providers for recommendations about
the-counter medicines or eat certain foods. You vaccination. The CASE method provides a structured means to organize your
want to be as careful as possible.” thoughts and express yourself in terms of your compassion for your patient,
your role as the patient’s trusted health care provider, and your understand-
ABOUT ME ing of the science. We recommend familiarizing yourself with the common
“And, as your healthcare provider, I am glad that patient concerns about COVID-19 vaccination and practicing use of the
you came to me with this concern. I’ve investigated CASE method to improve your ability to address these concerns with your
how we should discuss the benefits and risks.” patients. MM
Robert M. Jacobson, MD, is a professor of pediatrics and the medical director for the
SCIENCE immunization program for Primary Care in Southeast Minnesota at Mayo Clinic. Lila J.
“In your situation, you are a front-line essential Finney Rutten, PhD, MPH, is a professor of health services research and a population health
scientist in the Department of Family Medicine at Mayo Clinic.
worker and therefore at higher risk for exposure.
Every day, despite the precautions you and other This work was supported in whole by the National Cancer Institute of the National Institutes
healthcare providers are taking, you run the risk of of Health under award number R01CA217889. The content is solely the responsibility of the
authors and does not necessarily represent the official views of the National Institutes of
getting COVID-19 infection. Furthermore, pregnant Health.
individuals are at five times the risk for complica-
tions as others of the same age. While it is true
R E F E R E N C E S
that the pre-licensure trials of the first two mRNA
vaccines did not include pregnant individuals, Dooling K, Marin M, Wallace M, et al. The Advisory Committee on Immunization Practices’ Updated
Interim Recommendation for Allocation of COVID-19 Vaccine — United States, December 2020. MMWR
that does not mean that we do not know anything Morb Mortal Wkly Rep 2021;69:1657-1660.
about these vaccines and pregnancy. First of all, Jacobson RM, Van Etta L, Bahta L. The C.A.S.E. Approach: Guidance for Talking to Vaccine-Hesitant Parents.
Minn Med. Apr 2013;96(4):49-50.
the available COVID-19 vaccines are not live-viral
Jacobson RM. Making the C.A.S.E. for the Human Papillomavirus Vaccine: How to Talk to Parents and
vaccines. They are mRNA vaccines. The mRNA Adolescents. Minn Med. Feb 2014;97(2):38-42.
acts locally at the injection site in the muscle cells Jacobson RM, Finney Rutten LR. Parents’ Hesitance about HPV: Using the CASE Approach to Address their
Concerns. Minn Med. Feb 2019;102(1):24-27.
and then is quickly digested. The vaccine does not
Oliver S, Gargano J, Marin M, et al. The Advisory Committee on Immunization Practices’ Interim
travel through the rest of the body.” Recommendation for Use of Moderna COVID-19 Vaccine — United States, December 2020. MMWR Morb
Mortal Wkly Rep 2021;69:1653-1656.
Oliver S, Gargano J, Marin M, et al. The Advisory Committee on Immunization Practices’ Interim
EXPLAIN/ADVISE
Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020.
“Weighing the risks and benefits in your situation, MMWR Morb Mortal Wkly Rep 2020;69:1922-1924.
I recommend that you get the vaccine now that it Singer, Alison. 2010. Making the CASE for Vaccines: Communicating about Vaccine Safety. Virtual
Immunization Communication Network (VICNetwork). URL: http://www.vicnetwork.org/2010/09/22/
has been made available.” making-the-case-for-vaccine/. Last accessed January 31, 2021.
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