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 not want the job but I took on the challenge at the insistence of my direct supervisor who had the faith that I could do the job.

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, mumps 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) strain. 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 hedging their 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 good for vaccine production.

In my opinion, the inactivated influenza vaccine, when it contains the appropriate and correct strains is mediocre at 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. The original Hippocratic Oath, which I took in Medical School but which has all but been so watered down to adjust to our endeavors 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
Frederick, Maryland