What is the annual impact?

What do the numbers actually

look like for influenza in the
United States? About 82
million get infected, 65
million have symptoms, 30
million end up with some sort
of medical attention, 200,000
are hospitalized, and 36,000
are dead. Those are big
numbers. Three thousand
Americans die every 10 days
during influenza season in the
United States.

If you look at levels of

influenza vaccine coverage,
and you look at people with
any high-risk condition, we
start at 26%. For pregnant
women, for whom it is
recommended, we're looking
at 13%, and healthcare
workers are in that 40% to
42% range.

There's a disconnect here,

isn't there? The data on
morbidity and mortality of
seasonal influenza are very
clear; they are
unambiguous. The data on
influenza vaccine safety are
clear. The data supporting
influenza vaccine efficacy
exist and are reasonably
clear, so why don't we
believe and act on these
data?

 I'm going to go
through a quick series
of truths for you. The
first truth is that
influenza vaccines are
safe and effective and
every year, even
during times of
"vaccine shortages,"
millions of doses are
wasted. For this year,
the estimate is that 10
to 20 million doses of
vaccine are going to
be wasted.

It is also important to
understand something
about influenza vaccine
efficacy. This vaccine is
designed to prevent
morbidity and mortality; it
is not designed to prevent
a symptom or even
infection per se. It is
"infection permissive", a
simplistic way of saying it.

If you look across studies,

and this is 1 meta-analysis,
the vaccine reduces
hospitalization by 50% to
70%, death by 50% to
85% (50% even in the frail
elderly), illness by 30% to
70%, and lower respiratory
tract involvement by 70%
to 90%.

A couple of years ago I

published a commentary
in Clinical Infectious
Diseases called "If You Could
Halve the Mortality Rate,
Would You Do It?" I wrote it
to my colleagues.

I ask the question because here

are the actual data. Studies
across 3 different geographic
locations. What we see is
consistently about a 50%
decrease in all-cause mortality
-- not a 50% decrease in flu
death, but a 50% decrease in
all-cause mortality. We don't
have very many things like
that in medicine.

The second truth: nearly every

year new indications for
influenza vaccines are added.
As a result, for those of us who
practice clinical medicine it is
impossible to remember them
all. Hence, we get 17%, 20%,
and 40% immunization rates.
There are over 15 current
recommendations.
Approximately two thirds of
the US population already fits
into one of those recommended
areas. I've been pushing for a
universal influenza vaccine
recommendation

Let me take you through some

of the indications, and I don't
mean to say they're brand
new, but recently added
indications. A surprise to
many pregnant women and
their physicians is that
pregnancy is an indication,
not a contraindication, to
receiving influenza vaccine.

Another new indication:

adults and children who
have any conditions
such as cognitive
dysfunction, spinal cord
injury, seizure disorder,
or any neuromuscular
disorder that
compromises
respiratory function or
the handling of
respiratory secretions,
or that can increase the
risk for aspiration.

Persons who live with

or care for persons at
high risk for severe
influenza-related
complications,
including healthy
household contacts,
caregivers of children
age 0 to 59 months, and
healthcare workers.

No one can remember all of

these indications, and we
really do need, I believe, a
universal influenza
immunization
recommendation.

And I'm happy to report that in

February of 2006 I did get a
positive vote on a resolution,
and the Advisory Committee on
Immunization Practices (ACIP)
"signaled its intent to move
toward a universal
recommendation." They next
said that they planned to
implement that in 2013 when
about a quarter of a million
Americans will have died in
that time period, and I was
advised, "Let's be more
moderate about this."

The third truth: influenza

immunization rates can be
increased using methods we
already know work and in
fact, not surprisingly,
requirements are among the
best.

How do we know this? You can't

go to school now unless you get
a vaccine or sign a statement
saying you don't want to get it
for whatever reason. For
healthcare institutions, there are
rules about who has to get
rubella vaccine. All healthcare
workers have to be offered
hepatitis B vaccines and either
accept it or sign an informed
declination. And hepatitis B
immunization rates in healthcare
workers were lower than those
for intravenous drug abusers
until this went into effect. Now, I
personally don't know a
healthcare worker who hasn't
gotten the vaccine. Nationally,
the rates exceed 95%. Standingorder policies work in our
institution, as well as strong
recommendations from a trusted
healthcare provider.

Healthcare worker
immunization rates in many
institutions exceed 95% to
99% for rubella, measles,
mumps, hepatitis B, and
varicella. Some of these are
diseases younger people
haven't seen and won't see, but
we have a requirement for
that. You see influenza
probably every day of
influenza season and we have
no requirement for that, even
for healthcare workers
working in our highest-risk
units in hospitals.

The fourth truth: physicians,

nurses, and the public have
massive misconceptions
about the morbidity and
mortality of influenza. They
have profound and
unfounded fears regarding
the safety of the vaccine, and
these fears I have learned are
emotional and not data
driven. They are anecdotal
and they are persistent, deep
myths in our culture. As a
result, healthcare workers
don't get the vaccine and they
don't give it to their patients.
It would be unusual to make
the decision: "this is not a
good vaccine for me, but I'm
going to recommend it for
my patients." You see the
problem: we've met the
enemy and he is us.

As I've said, about 40%, 42%,

after 26 years of explicit
Centers for Disease Control
and Prevention (CDC)
recommendations, of
healthcare workers get the
influenza vaccine. We're going
to have to make it a
requirement.

Why don't healthcare workers and the

public get this vaccine? A common
reason is that they believe they're not
at risk. We hear this one all the time:
"I never get the flu." Well, you'd be a
very special person if that were true.
Ignorance regarding the risk they
represent to their patients; they don't
realize that the reason for the
recommendation for healthcare
workers isn't so much to protect the
healthy healthcare worker as it is to
protect the compromised patient who
they are privileged to care for.
Other reasons include inappropriate
fear of vaccine side effects and
ignorance about efficacy. Several
surveys show 15% of healthcare
workers are sufficiently needle phobic
that they won't get vaccines. And there
is ignorance about the vaccine itself;
for example, it causes the flu.

So we did a study. Dr. Kristin Nichol

and myself enrolled about 600 people
(300 of them we gave a flu shot, 300
placebo) in a randomized, doubleblind placebo-controlled study. Two
days later, we called them up and
asked them about the kinds of
symptoms people say they get from
the flu shot. Two weeks later, we
crossed them over and gave them
what they hadn't gotten the first time.
Two days after that, we asked them
the same set of questions.
The first question we asked after the
study: what order did you get the
vaccine in? It was a flip of a coin; the
answer was 50/50. Then we did the
analysis on the side effects, and there
was nothing there except for sore arm
in 20% of subjects, which never, in
any of our 600 subjects, prevented
them from doing their activities of
daily living such as going to school or
work. So let's dispel that myth now;
flu vaccine doesn't cause the flu

Guillain-Barr syndrome (GBS)

and swine flu vaccine had a
statistical association with the
1976-1977 vaccine, but this was
not seen in all groups.
Interestingly enough, the
association was not well
documented in the military, and
in Olmsted County, Minnesota,
where I live and where we can
enumerate every single subject
in the county because they only
get their healthcare from us, we
didn't see the association.
A study published in the New
England Journal of Medicine in
1998 looked at the risk of
vaccine-associated GBS in the
1992-1993 flu season and the
1993-1994 season. They
couldn't find any risk in either
season.

When they combined both

seasons, they could not
exclude a risk as low as 1 case
per million doses of vaccine.
Do you put up with the 1 case
of GBS or the hundreds of
thousands of hospitalizations
and tens of thousands of
deaths?
I then wrote another article,
called "Requiring Influenza
Vaccination for Healthcare
Workers: Seven Truths We
Must Accept."

This has gotten a lot of press and it

has done a lot of good because
there are some new standards of
care. What we've been
recommending is that all
healthcare workers with direct
patient care contact should receive
influenza vaccination annually
unless they have a contraindication
or sign an informed declination.
This is supported by CDC,
Infectious Diseases Society of
America (IDSA), Society for
Hospital Epidemiology of America
(SHEA), Association for
Practitioners in Infection Control
(APIC), consumer groups such as
Leapfrog and the National Quality
Forum, US Department of Defense
(DoD), and many different
hospitals and medical systems,
including the American Medical
Association (AMA), American
Nurses Association (ANA),
American Academy of Family
Physicians (AAFP), American
Academy of Pediatrics (AAP), and
the list goes on.

This resulted in a new Joint

Commission Standard, and
I point to the fourth bullet
in bold. This went into
effect in January 2007. You
must now, in a hospital,
evaluate vaccination rates
at the unit level, report
them, and evaluate reasons
for nonparticipation. Then
you have to implement
enhancements to the
program to increase
participation. And what
you're all going to find is
that there are no methods
that will lead to large
increases over a sustained
time period.

The final truth: it makes more

sense, saves lives, prevents
healthcare disruptions and
hospitalization, and saves
money when we prevent
influenza with vaccine.
Prevention always trumps
treatment, and that is
particularly true with
influenza. This too is a
patient safety issue; it
benefits the patient, it
benefits healthcare workers,
and it benefits hospitals and
clinics because they don't
have to close down wards or
transfer patients to other
institutions because they have
too many staff too ill to work

The eleventh commandment:

"Thou shalt get flu vaccine."
Please do and please
encourage your patients to.