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IMMUNIZATION AGAINST INFLUENZA IN OLDER ADULTS: REVIEWING THE ACIP
RECOMMENDATIONS

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IMMUNIZATION AGAINST INFLUENZA IN OLDER ADULTS: REVIEWING THE ACIP
RECOMMENDATIONS

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ReachMD Announcer:
You’re listening to ReachMD.

This medical industry feature, titled “Influenza Prevention in Older Adults:
Reviewing the ACIP Recommendations” is sponsored by Seqirus. This program is
intended for healthcare professionals.

Here’s your host, Dr. Charles Turck.

Dr. Turck:
Welcome to ReachMD. I’m Dr. Charles Turck, and joining me to share the rationale
for the latest recommendations for influenza vaccination in older adults is Dr.
Paul Hunter.

Dr. Hunter is an associate professor in the Department of Family Medicine and
Community Health at the University of Wisconsin School of Medicine and Public
Health in Madison. He’s also a former ACIP voting member. Dr. Hunter, welcome to
the program.

Dr. Hunter:
Thank you for having me.

Dr. Turck:
To start us off, Dr. Hunter, why are we particularly concerned about influenza
in adults 65 and older?

Dr. Hunter:
So this is a great starting point because it’s really important to recognize
that older adults are more susceptible to influenza infection—as well as
increased severity of infection—than younger, healthier populations.1 Influenza
also increases the risk of hospitalization2 and disability,3 reduces the quality
of life,3 and increases mortality rate.4,5 And the last thing we should keep in
mind as we dive into our discussion is that adults 65 years and older experience
morbidity and mortality caused by influenza more than any other age group.6

Dr. Turck:
And with this burden in mind, are there vaccines available that can help prevent
influenza in this aging population?

Dr. Hunter:
Yes, so all influenza vaccines available in the United States—except for the
live attenuated influenza vaccines—are licensed for use in adults aged 65 years
and older.7

These include five standard-dose, unadjuvanted, inactivated vaccines; one
high-dose inactivated vaccine; one adjuvanted inactivated vaccine; and one
recombinant vaccine.7

Now adjuvanted and high-dose influenza vaccines, such as FLUAD® Quadrivalent and
Fluzone® High-Dose Quadrivalent, are designed and licensed specifically for
older adults,8,9 but until recently, we didn’t have any formal guidance on which
types of flu vaccines are most effective in older adults.7 And so back in 2019,
the CDC’s Advisory Committee on Immunization Practices, or ACIP for short, set
out to see if they should update the recommendations based on the available
data.

Dr. Turck:
So with that being said, Dr. Hunter, what measures did the ACIP take to
ultimately come up with their recommendations?

Dr. Hunter:
So the ACIP had the goal of answering the following policy question: Do the
relative benefits and harms of higher-dose and adjuvanted vaccines, compared
with one another and with other influenza vaccines, favor the use of any one or
more of these vaccines over other age-appropriate options for people aged 65
years and older?10

To help answer this question, the ACIP’s Influenza Work Group went through the
GRADE process, which stands for Grading of Recommendations, Assessment,
Development, and Evaluations.11 GRADE is transparent framework designed to help
develop and present summaries of evidence, so it provides a systematic approach
for making clinical practice recommendations.11

During the GRADE process, ACIP looked at qualifying studies to see whether
adjuvanted influenza vaccines or higher-dose vaccines serve as better options in
this age group versus standard-dose influenza vaccines.10 Specifically, the
three vaccines looked at were FLUAD® Quadrivalent, Fluzone® High-Dose
Quadrivalent, and Flublok® Quadrivalent.

ACIP focused on critical outcomes, including benefits like prevention of
influenza illness, outpatient and ER visits, hospitalizations, and deaths; along
with harms, including any solicited systemic adverse event with a severity grade
greater than or equal to three and incidence of Guillain-Barré syndrome.10

Lastly, ACIP conducted an Evidence to Recommendations framework, or EtR for
short, which included policy considerations beyond the clinical data of benefit
versus risk.11 This framework helps ensure that all important factors that
determine a recommendation are considered and assessed in a transparent manner.

Dr. Turck:
So between the GRADE and EtR, Dr. Hunter, what kind of studies did the ACIP look
at, and how many did they review?

Dr. Hunter:
Well, there were a lot of them. So the review team started with more than 10,000
studies, analyzed the full text of 3,500 of those, and ended up with 49 studies
presented in the GRADE review at an ACIP meeting in February of 2022.12

These were peer-reviewed studies dating back to 1990 and included randomized
studies, retrospective case-control and cohort studies, and prospective studies.
They excluded things like case series without comparator information, animal
studies, or any study which the entire population fell outside of the age range
of 65 years and older.12 They compared the adjuvanted influenza vaccine FLUAD®
and higher-dose vaccines, Fluzone® high-dose and Flublok® with standard-dose
influenza vaccines and with one another.10

Dr. Turck:
So what conclusions did the work group come to after reviewing the evidence?
Let’s start with the GRADE.

Dr. Hunter:
Okay. Overall, the GRADE showed evidence of benefit favoring adjuvanted and
higher-dose influenza vaccines over standard-dose vaccines for older adults.10
And importantly, there was no strong evidence favoring one over another in
studies providing direct comparisons between these vaccines.10 Now in terms of
overall safety, no results favored one adjuvanted or higher-dose influenza
vaccines over another, nor did they favor them over standard-dose vaccines.10
And finally, limitations include that there were few randomized controlled trial
data representing few influenza seasons, and there were no data reflecting
current quadrivalent formulations, only the previous trivalent formulations.10

Dr. Turck:
And what about the Evidence to Recommendations? Can you walk us through those
conclusions?

Dr. Hunter:
Sure, but before we dive in, I’d like to just remind everyone that the EtR
framework didn’t just look at benefits and harms; it also considered other
domains such as public health importance, resource use, health equity, and
feasibility.7 The ACIP Influenza workgroup concluded that after working through
the EtR that the desirable consequences of this recommendation would outweigh
the undesirable consequences in most settings.7

Now with that being said, after reviewing the EtR framework in June of 2022, the
ACIP voting members voted unanimously in favor of recommending that adults 65
years and older preferentially receive any of the adjuvanted or higher-dose
influenza vaccines, meaning FLUAD® Quadrivalent, Fluzone® High-Dose
Quadrivalent, or Flublok® Quadrivalent.13 I’d like to point out that the large
majority of patients 65 years and older already get adjuvanted or higher-dose
influenza vaccines, so that patient acceptance and feasibility of implementation
in clinical settings is well-established.

If none of these three vaccines is available at an opportunity for vaccine
administration, then any other age-appropriate influenza vaccine should be
used.13

Don’t miss a vaccination. This recommendation was published in CDC’s Morbidity
and Mortality Weekly Report in late August of 2022.

Dr. Turck:
Now we’re almost out of time, Dr. Hunter, but in your opinion, what impact does
this ACIP preferential recommendation have on our aging population?

Dr. Hunter:
Well, from a logistics point of view, having access to multiple vaccines is
better because we’re less concerned about supply issues. You don’t want all of
your eggs in one basket, and given our tight timeline for a vaccination, the
more vaccines and vaccine options we have available, the more people in this
population we can vaccinate, but perhaps most importantly, the ACIP preferential
recommendation designates the use of these adjuvanted or higher-dose vaccines as
the standard of care for older adults, which hopefully will improve equitable
access to appropriate and more effective preventive care.

Dr. Turck:
A great comment for us to think on as we come to the end of today’s program, and
I want to thank my guest, Dr. Paul Hunter, for helping us better understand how
the new ACIP preferential recommendations came to be. Dr. Hunter, it was great
speaking with you today.

Dr. Hunter:
Thank you. It was a pleasure to be here.

Dr. Turck:
I’m Dr. Charles Turck. Before we close, let’s take a moment to review some
important safety information.

ReachMD Announcer:
IMPORTANT SAFETY INFORMATION for FLUAD® (Influenza Vaccine, Adjuvanted) and
FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted)

INDICATIONS AND USAGE

FLUAD® and FLUAD® QUADRIVALENT are inactivated influenza vaccines indicated for
active immunization against influenza disease caused by influenza virus subtypes
A and type B contained in the vaccine. FLUAD® and FLUAD® QUADRIVALENT are
approved for use in persons 65 years of age and older.

This indication is approved under accelerated approval based on the immune
response elicited by FLUAD® and FLUAD® QUADRIVALENT. Continued approval for this
indication may be contingent upon verification and description of clinical
benefit in a confirmatory trial. Data demonstrating a decrease in influenza
disease after vaccination with FLUAD® or FLUAD® QUADRIVALENT is not available.

CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including egg protein,
or after a previous dose of any influenza vaccine.

WARNINGS AND PRECAUTIONS
If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous
influenza vaccination, the decision to give FLUAD® or FLUAD® QUADRIVALENT should
be based on careful consideration of the potential benefits and risks.

Appropriate medical treatment and supervision must be available to manage
possible anaphylactic reactions following administration of the vaccine.

The immune response to FLUAD® or FLUAD® QUADRIVALENT in immunocompromised
persons, including individuals receiving immunosuppressive therapy, may be lower
than in immunocompetent individuals.

Syncope (fainting) may occur in association with administration of injectable
vaccines including FLUAD® and FLUAD® QUADRIVALENT. Ensure procedures are in
place to avoid injury from falling associated with syncope.

ADVERSE REACTIONS
FLUAD® administered by needle and syringe:
The most common (≥10%) local (injection site) adverse reactions observed in
clinical studies were injection site pain (25%) and tenderness (21%).
The most common (≥10%) systemic adverse reactions observed in clinical studies
were myalgia (15%), headache (13%), and fatigue (13%).

FLUAD® QUADRIVALENT administered by needle and syringe:
The most common (≥10%) local and systemic reactions in elderly subjects 65 years
of age and older were injection site pain (16.3%), headache (10.8%) and fatigue
(10.5%).

Other adverse events may occur. For a comprehensive list of local and systemic
adverse reactions, please see full prescribing information.

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1- 855-358-8966 or
VAERS at 1-800-822-7967 and www.vaers.hhs.gov.

Before administration, please see the full Prescribing Information for FLUAD® or
FLUAD® QUADRIVALENT.

FLUAD® and FLUAD® QUADRIVALENT are registered trademarks of Seqirus UK Limited
or its affiliates.

ReachMD Announcer:
This program was sponsored by Seqirus. If you missed any part of this
discussion, visit reachmd.com/industryfeature. This is ReachMD. Be part of the
knowledge.

References:
1. Centers for Disease Control and Prevention. Flu & People 65 Years and Older.
Accessed August 16, 2022. https://www.cdc.gov/flu/highrisk/65over.htm.
2. Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated
hospitalizations in the United States. JAMA. 2004;292(11):1333-1340.
3. McElhaney JE. The unmet need in the elderly: designing new influenza vaccines
for older adults. Vaccine. 2005;23 Suppl 1:S10-S25.
4. Thompson WW, Shay DK, Weintraub E, et al. Mortality associated with influenza
and respiratory syncytial virus in the United States. JAMA. 2003;289(2):179-186.
5. Sprenger MJ, Mulder PG, Beyer WE, Van Strik R, Masurel N. Impact of influenza
on mortality in relation to age and underlying disease, 1967-1989. Int J
Epidemiol. 1993;22(2):334-340.
6. Centers for Disease Control and Prevention. Past Seasons Estimated Influenza
Disease Burden. Accessed April 23, 2021.
https://www.cdc.gov/flu/about/burden/past-seasons.html.
7. National Center for Immunization & Respiratory Diseases. Advisory Committee
on Influenza Practices. Influenza Vaccines for Persons Aged ≥65 Years: Evidence
to Recommend (EtR) Framework. Accessed August 16, 2022.
8. FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly
Springs, NC: Seqirus Inc.; 2020.
9. Fluzone® High-Dose Quadrivalent [package insert]. Swiftwater, PA: Sanofi
Pasteur Inc.; 2019
10. National Center for Immunization & Respiratory Diseases. Advisory Committee
on Influenza Practices. Influenza Vaccines for Older Adults: GRADE Summary.
Accessed August 16, 2022.
11. Centers for Disease Control and Prevention. ACIP Evidence to Recommendation
User’s Guide. Accessed October 17, 2022.
https://www.cdc.gov/vaccines/acip/recs/grade/downloads/acip-evidence-rec-frame-user-guide.pdf.
12. National Center for Immunization & Respiratory Diseases. Advisory Committee
on Influenza Practices. Influenza Vaccines for Older Adults. Accessed October
17, 2022.
13. Grohskopf LA, Blanton LH, Ferdinands JM, et al. Prevention and Control of
Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on
Immunization Practices — United States, 2022–23 Influenza Season. MMWR Recomm
Rep 2022;71(No. RR-1):1–28. DOI: http://dx.doi.org/10.15585/mmwr.rr7101a1

USA-FLUD-22-0050 December 2022

I agree to the terms and conditions

* Host Charles Turck, PharmD, BCPS, BCCCP
* Guest Paul Hunter, MD

Are you up to date on the latest recommendations for influenza vaccination in
older adults from the CDC’s Advisory Committee on Immunization Practices?

Please See

Important Safety Information

* Video

Immunization Against Influenza in Older Adults: Reviewing the ACIP
Recommendations

* Audio

Immunization Against Influenza in Older Adults: Reviewing the ACIP
Recommendations

* Podcast

Immunization Against Influenza in Older Adults: Reviewing the ACIP
Recommendations

* Transcript
* Transcript PDF

1
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* email

* SPONSORED BY

* OVERVIEW

It’s important to recognize that older adults are more susceptible to
influenza infection—as well as increased severity of infection—than younger,
healthier populations.1 Fortunately, there are vaccines available that can
help prevent influenza in this aging population. But do the relative benefits
and harms of higher-dose and adjuvanted vaccines, compared with one another
and with other influenza vaccines, favor the use of any one or more of these
vaccines over other age-appropriate options for people 65 and older?2
That's the exact question the CDC’s Advisory Committee on
Immunization Practices (ACIP) sought to answer and what Dr. Charles Turck
discusses with Dr. Paul Hunter, Associate Professor in the Department of
Family Medicine and Community Health at the University of Wisconsin School of
Medicine and Public Health.

References:
1. Centers for Disease Control and Prevention. Fly & People 65 Years and
Older. Accessed August 16, 2022. https://www.cdc.gov/flu/highrisk/65over.htm.
2. National Center for Immunization & Respiratory Diseases. Advisory
Committee on Influenza Practices. Influenza Vaccines for Older Adults: GRADE
Summary. Accessed August 16, 2022.

USA-FLUD-22-0056 December 2022

* FLUAD® AND FLUAD® QUADRIVALENT (INFLUENZA VACCINE, ADJUVANTED)

IMPORTANT SAFETY INFORMATION

INDICATIONS AND USAGE
FLUAD® and FLUAD® QUADRIVALENT are inactivated influenza vaccines indicated
for active immunization against influenza disease caused by influenza virus
subtypes A and type B contained in the vaccine. FLUAD® and FLUAD®
QUADRIVALENT are approved for use in persons 65 years of age and older.

This indication is approved under accelerated approval based on the immune
response elicited by FLUAD® and FLUAD® QUADRIVALENT. Continued approval for
this indication may be contingent upon verification and description of
clinical benefit in a confirmatory trial. Data demonstrating a decrease in
influenza disease after vaccination with FLUAD® or FLUAD® QUADRIVALENT is not
available.

CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including egg
protein, or after a previous dose of any influenza vaccine.

WARNINGS AND PRECAUTIONS
If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous
influenza vaccination, the decision to give FLUAD® or FLUAD® QUADRIVALENT
should be based on careful consideration of the potential benefits and risks.

Appropriate medical treatment and supervision must be available to manage
possible anaphylactic reactions following administration of the vaccine.

The immune response to FLUAD® or FLUAD® QUADRIVALENT in immunocompromised
persons, including individuals receiving immunosuppressive therapy, may be
lower than in immunocompetent individuals.

The most common (≥10%) systemic adverse reactions observed in clinical
studies were myalgia (15%), headache (13%), and fatigue (13%).

FLUAD® QUADRIVALENT administered by needle and syringe:
The most common (≥ 10%) local and systemic reactions in elderly subjects 65
years of age and older were injection site pain (16.3%), headache (10.8%) and
fatigue (10.5%).

Other adverse events may occur. For a comprehensive list of local and
systemic adverse reactions, please see full prescribing information.

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1- 855-358-8966 or
VAERS at 1-800-822-7967 and www.vaers.hhs.gov.

Before administration, please see the full Prescribing Information for FLUAD®
or FLUAD® QUADRIVALENT.

FLUAD® and FLUAD® QUADRIVALENT are registered trademarks of Seqirus UK
Limited or its affiliates.

RECOMMENDED

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Heart Failure Grand Rounds: 3 Things You Need to Know About Cardiac
Contractility Modulation

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Schedule17 May 2023
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