I have been practicing medicine for over 43 years and I’ve
not remembered a time when so many individuals have been so
scared about the lack of influenza vaccine – a vaccine
which under normal circumstances is mediocre at best.
To speak to my competency in discussing the subject of influenza
vaccine, I once held the position of Head of the Influenza
Unit and later Chief, Laboratory of Virology and Rickettsiology,
in the Division of Biologics Standards – the Institute
of the National Institutes of Health which at the time was
responsible for insuring potency and safety of biologic products,
such as vaccines and blood. During a 4 to 5 year period in
the late ‘60's and early ‘70's, there was not a
single lot of influenza vaccine (produced by the 7 commercial
manufacturers at the time) which was released to the public
without my personal signature. Parenthetically, there are now
only 2 inactivated influenza vaccine manufacturers and one
live virus nasal mist vaccine in the United States.
When I assumed the responsibility of influenza vaccine
control, the procedures establishing potency had been
neglected by a
scientist who was both incompetent and totally neglectful
of his duties and responsibilities to the public. I did
the job but I took on the challenge at the insistence of
my direct supervisor who had the faith that I could do
We worked very hard and within one year we standardized the
tests for potency. And it was not too soon because it was 1968
when our country was hit with the so called “Hong Kong” influenza
epidemic. What we went through to get the vaccine manufacturers
to comply to our new standards could be an intriguing subject
of a future expose. Until that time the vaccine manufacturers
were used to have their lots approved without any serious testing
by the Division. Now it was different, and they did not like
it. Enough of my credentials.
Influenza is a very smart virus because it constantly changes
sufficiently enough to guarantee its own survival. This translates
to a situation where individuals experiencing an influenza
outbreak one year would not have the antibodies within their
system to protect them against the next outbreak. This is
much different than with many other viruses, such as measles,
or rubella, where, once one gets the disease, one develops
antibodies and is subsequently protected against reinfection.
It has been the case in the most recent years that new influenza
virus strains emerge in the Far East. This can be appreciated
from looking at the names given to newly emerged strains in
the past: A/Hong Kong; A/Sydney; A/Moscow; A/New Caledonia;
A/Beijing; B/Hong Kong; and the list goes on. The World Health
Organization (WHO) and the Communicable Disease Center (CDC)
in Atlanta monitor the emergence of new strains. Since the
strains emerging in the East do so in one year, it give the
West time to study their antigenicity. If found to be sufficiently
different from the strains causing epidemics in the West, the
new strains are cultivated and included in the vaccine to be
used in the subsequent influenza season. There is time to do
this. A strain of influenza causing an epidemic one year rarely
causes an epidemic the following year.
During this present 2003/2004 influenza season, the vaccine
contained last years strains: A/New Caledonia/20/99(H1NI)-like
virus; A/Moscow/10/99(H3N2)-like virus; and B/Hong Kong/330/2001-like
virus. This might have been useful.
But, something unexpectedly happened. A new mutant emerged
causing the epidemic our country is experiencing at the
present time (the 2003/04 season): A/Fujian/411/2002(H3N2)
Although this A/Fujian strain is quite similar to a strain,
A/Panama(H3N2), contained in the 2002/2003 vaccine, it
is not identical. And we may notice that the experts are
recommendations by saying that the present 2003/2004 vaccine
[containing the A/Moscow(H3N2)] strain might afford a degree
of protection. This indicates to me that they really do
not know. The reason why the A/Fujian strain was not included
in the vaccine this season was because there was not available
a strain which would easily grow in eggs, therefore, not
for vaccine production.
In my opinion, the inactivated influenza vaccine, when
it contains the appropriate and correct strains is mediocre
best in protecting an individual against influenza. I fully
realize that this sounds like heresy, but it is the reality
of the situation. When the vaccine
does not contain the correct
strains – as is the case with the vaccine currently being
used in the United States – it is completely useless. So why are we recommending it? It is simply because we in the
medical profession can not handle not being able to do something.
And so, we are told that the currently used vaccine might do
some good. Physicians, Health Departments, and even that great
amorphous scientific authority, the United States Government,
all chime in together in the chorus recommending people get “the
flu shot.” But the “flu shot” is not without
potential serious side reactions.
A Case in Point: Some years ago, when the epidemic of “Swine” influenza
occurred, the same chorus was chiming. Some authorities believed
that the 1918-19 influenza pandemic which resulted in many
deaths throughout the entire world might have been caused by
a strain of swine influenza virus; others thought it might
have been due to an avian-derived strain – one that might
have come from birds. The medical community (and even our country’s
top scientist, the President of the United States!) recommended
immunization of the entire community – not that there
is ever sufficient vaccine nor the logistics to accomplish
such a feat in the limited time available. I remember that,
at that time, there was similar panic that there might not
be sufficient vaccine to give to the public. But I knew something
that apparently very few who were not directly involved knew
that would influence my decision as to whether I would recommend
the Hong Kong vaccine.
The influenza virus elicits antibodies to the two proteins
contained within it: the hemagglutinin or “H” protein
contained in the virus outer coat and the enzyme neuraminidase
or “N” protein contained within the virus. Note
that each virus strain mentioned earlier has an H1,H2, H3,
N1, N2 as part of its name. For the vaccine to be in any stretch
of the imagination effective, it must be able to elicit antibodies
to both protein. Unfortunately, in the process of adding formalin
(formaldehyde) to inactivate the swine virus for vaccine use,
the neuraminidase protein was destroyed. There was no way that
the vaccine would ever be effective. But, this was all that
we had. So, the recommendations were promulgated. The vaccine
was distributed. Everyone appeared happy. I refused to administer
the vaccine to my patients. Why give an injection of something
which was no good? My patients were happy to follow my advice.
Lo and behold, what we would fear the most happened! One of
the rare side reactions to administrating the inactivated influenza
is the dreaded Guillain-Barre syndrome, an ascending paralysis
starting at the feet and ascending upwards towards the chest
and neck area. If it involves the area higher than the chest,
the intercostal muscles required for breathing would be affected.
Temporary placing someone in an iron lung machine would have
to be necessary in some severe cases. Fortunately, this disease
reverses itself in many patients. Some would recover completely.
Some would be left with residual paralysis. A few would die.
This is quite an unwanted response to receiving a useless vaccine!
Many mothers came to my office thanking me and asking how
I knew. I really did not know. I took the credit anyway.
original Hippocratic Oath, which I took in Medical School
but which has all but been so watered down to adjust to
to be politically correct, states that above all “do
no harm.” There are risks in life. There are risks in
the practice of medicine. Every day we make decisions about
balancing these risks with what we hope to achieve with our
treatment. To have given a useless vaccine with its potential
side reactions seemed, at least to me, to trip the balance
to the do not give side.
With our present situation, to administer the vaccine which
is now on the market – a vaccine which does not contain
the influenza virus strain necessary to protect – appears
to me to be useless and unnecessarily risky.
With regards to attempting to immunize the total population,
this is a sizable feat. With the live polio and live measles
vaccines it took us several years to get 90+% of the population
successfully immunized. With influenza we have a virus which
changes almost every year. Firstly, there is not enough vaccine
manufactured each year; secondly, we have not yet solved
the logistical problem of successfully immunizing 90+%
of the population.
nicola michael c. Tauraso, M.D.
Director, Tauraso Medical Clinic