[John M. Neff, M.D.]

[Dr. John Neff:] My name is Dr. John Neff, Assistant Professor of Pediatrics at Johns Hopkins.

It is my feeling that it is no longer necessary to perform routine preschool or infant smallpox vaccinations.

[Samuel Lawrence Katz, M.D.]

I'm Samuel Katz, Professor and Chairman of the Department of Pediatrics at Duke University. 

I believe that our nation's freedom from smallpox rests upon the widespread use of smallpox vaccine.

[Paul F. Wehrle, B.S., M.D.]

I'm Dr. Paul Wehrle. It is my job today to try to resolve these two opposed points of view.

[Music]

[The U.S. Department of Health, Education, and Welfare, Public Health Service, presents T-1678, MCMLXIX]

[A National Medical Audiovisual Center production]

[Concepts and controversies in modern medicine]

[Smallpox Vaccination - Should Our Policy Be Changed?]

[Host:] Welcome to the exploration of concepts and controversies in modern medicine,

one of a series of programs dedicated to examining the uncertain,

candidly recognizing that much of today's teaching is necessarily based upon opinion,

and that the opinions of eminent physicians in a given field vary widely. 

The National Medical Audiovisual Center believes that openly airing such supposing views is a basic responsibility of medical communications. 

Dr. Paul Wehrle, Hastings Professor of Pediatrics at the University Of Southern California School Of Medicine, will act as moderator for this presentation.

[Dr. Paul Wehrle:] For many years the physicians of this country and the workers in public health 

have been emphasizing the need for vaccination for children, 

and particularly infants and preschool children, to provide a basic immunity against smallpox. 

We also have been urging immunization at intervals for particular types of health workers, 

for transportation workers, and at intervals we have also urged reimmunization of all citizens of this country, 

whether they plan international travel or not. 

The immunization against smallpox is the earliest and one of the most effective prophylaxis agents against any of the communicable diseases. 

However, during recent years the ballgame seems to be changed, 

the rules are somewhat different, and perhaps there are differences with respect to some of the threats. 

I would first like to, before getting our combatants into the fray, 

I'd like to first turn to see what's happening with regard to the international picture 

and see what's happening to smallpox on the worldwide scale because I think this is important to us as we develop our story today. 

[World map depicting areas with high rates of smallpox]

As you'll see, in 1945 smallpox was present throughout virtually all of South America. 

In 1945 you will note is the lighter, shaded together with the darker shaded areas spread throughout all of South America, 

throughout all of Africa, through the Middle East, through Southeast Asia, and down including Malaya

and many of the countries in the South Pacific. 

During the next period of time, from 1955 through 1965, 

we see additional changes taking place. 

[World map depicting areas with high rates of smallpox]

Here the earlier period is in lighter color, the subsequent period in darker color, 

and here you see that these areas originally involved very solidly have become substantially smaller,

and I think it's important to note that the areas involved here, 

although they are solidly colored, 

may have some differences with respect to specific areas within those countries where smallpox remains a problem. 

Also, another area that I hope we can point up today is data concerning the risk of vaccination and data 

concerning the possibility of other means of the prevention of smallpox, should it be introduced into this country. 

I think at this time I would like to turn to our first combatant this morning, 

Dr. Neff, and see how he would like to develop his particular position.

[Dr. John Neff:] Well, think that there can be no question now that smallpox vaccination has been the one agent

which has been responsible for eradicating smallpox from large areas of the world. 

But I think there can be no question also that by present-day standards, 

smallpox vaccine, or as a vaccine, is a very poor vaccine. 

And I think for two reasons it's a poor vaccine.

For one reason the duration of immunity that is afforded by the smallpox vaccination is relatively short =

in duration and probably absolute immunity to smallpox from the vaccine is no longer than three years. 

Number two, there are a significant number of complications that are associated with this particular vaccine,

and a significant amount of mortality. 

Now, for a long time in this country we've practiced routine preschool and infant vaccinations

so that within this country about 90 percent of the people have been vaccinated at least one time in their life. 

And it's also true since 1949 there've been no cases of smallpox imported into the United States. 

But for this we've paid a real price. 

Based on surveys that we've done in 1968 and 1963, and review of the death certificates, 

there can be no question that there are at least seven deaths a year as a result of our smallpox vaccination policy. 

And the other question that this brings up, has this really been the reason that we have been free of smallpox? 

If you look carefully in terms of the immunity of the nation, 

you'll find that 80 percent of the population has not been vaccinated within three years

and therefore are not absolutely protected against smallpox,

and 50 percent have not been vaccinated for greater than 15 years

and probably have little or no protection at all from smallpox. 

Whereas the epidemiology of smallpox is such that this can be prevented from entering into our country,

and I think has been, not because our population has been well-vaccinated,

but because our travelers are well-vaccinated. 

And I think that the other thing is that it is a very focal disease

and that secondary cases can be predicted

and they're not going to sweep through the nation as other diseases, perhaps measles or whatnot. 

But it's the secondary cases are very focal and occur in hospital personnel and family contact.

And I think that all we have to do in this country is number one, immunize our travelers

and that will keep smallpox out and number two, identify those risks,

those populations at high-risk and those are your hospital personnel and your family contacts. 

And it is not necessary to perform routine smallpox vaccination.

[Dr. Paul Wehrle:] Thank you Dr. Neff. I think you've summed up the arguments very nicely here 

and I think at this point we should turn to Dr. Sam Katz

and see what he has to say concerning the need to continue our present position.

[Dr. Samuel Katz:] I think that it's important to recall that a little over 30 years ago,

there were at least 15,000 cases of smallpox in the United States. 

And as Dr. Neff has pointed out, we have had none basically over the last 20 years. 

This is an admirable record, and it's one which I think we all wish to persist and defend. 

The question which is basic to this is weighing a known dimension against the conjecture. 

We agree, I think, Dr. Wehrle, Dr. Neff and I, that much of this admirable record stems from the widespread use of vaccine. 

We cannot provide any data on what would happen if we abandoned this widespread immunization program. 

We can look at the experience in other countries. 

In 1948 Great Britain abandoned the legal compulsion of smallpox vaccination.

Over subsequent years they've had hundreds of cases of smallpox, which have resulted from importation,

and in this regard I would disagree with Dr. Neff that the vaccination of our travelers will protect us against importations,

because in most cases, it has not been natives returning to their nation who have brought the initial case,

it has been a native of a country in which the disease remains endemic, as shown on Dr. Wehrle's chart. 

In this regard then, I think we cannot close the door

and rely solely upon the immunization of our travelers. 

I think we have to accept the fact that we can't control a great deal of the population

and that in the jet age it's very simple for a person to be incubating smallpox,

come from Asia, Africa, or Brazil to the United States with no overt disease, 

and introduce the disease within a very short period of time. 

The other feature is, I think our physicians are unable to recognize the disease anymore because we're free of it. 

So this reliance on quick smothering of an outbreak is I think a bit optimistic under present circumstances.

[Dr. Paul Wehrle:] I think that Dr. Katz has summed up very nicely many of the arguments for continuing our present policies

and I think we have several points that we ought to discuss in depth

in order to bring out some of these divergent types of opinions. 

Now, the first question that I think we might bounce around a bit concerns the probability of introducing smallpox

into the United States with our present surveillance systems, with our present levels of immunization and so on. 

And I think the Communicable Disease Center in Atlanta, 

a number of other organizations such as World Health Organization,

the governments and health services of many other countries,

have studied this problem very carefully. 

John, you seem to minimize the risk of bringing smallpox in,

via either Americans abroad or nationals from other countries.

[Dr. John Neff:] Yes, well I think the important point here,

and I would disagree with Dr. Katz,

it's not the nationals of another country, but it's generally the nationals of the country to which smallpox is introduced. 

I think one of the reasons is that smallpox now in the present pattern of eradication

is being driven back into relatively remote areas. 

And it is not the cities and it's not the travelers that have a tendency to come in contact with cases of smallpox, 

and I think that one can look at our own history for the past 20 years.

Our protection has not prevented smallpox from spreading in the United States, 

actually we've never been challenged.

We haven't had an importation into the United States.

[Dr. Paul Wehrle:] How do you know we haven't been challenged?

[Dr. John Neff:] Well, this is a good question. 

I think that we have a very good surveillance system at the CDC, 

at the national CDC, and any suspected case is looked at by a person

who is capable of diagnosing smallpox and differentiating this from chickenpox.

[Dr. Samuel Katz:] I can't agree with that now, John.

I think you can be honest about this without denigrating the medical profession. 

We have not had the experience in this country looking at smallpox. 

Even the best physicians acquainted with tropical medicine would be perfectly frank to say that a bad case of chickenpox

is impossible to differentiate from a mild or a more severe case of smallpox. 

I think we can all recall a few years ago when this was exactly what happened,

when a lady from Ghana was thought to have smallpox and actually had Varicella. 

Secondly, that emphasized the fact that our laboratory facilities, 

though they may in rare instances be attuned to this, are not constantly challenged with making the diagnosis of smallpox,

so that there can be confusion even with the laboratory support that's required

for the diagnosis, in a country where smallpox is not occurring. 

So I have no peace of mind about our ability to diagnosis smallpox either clinically or laboratory-wise

at the drop of the hat in New York, San Francisco, Seattle, Boston, any port where the disease might enter tomorrow.

[Dr. Paul Wehrle:] Well, this is certainly an area where I think we might remain far apart.

I wonder if there are a two or three things that we could agree with here now? 

Certainly we haven't had any widespread occurrences, smallpox,

in this country for many years.

We're agreed on this point, we agree. 

Now it's possible that a case or two cases or an occasional case, one or two, three a year,

something like this, may come into the country, may occur without spread, 

could conceivably misdiagnosis. 

[Dr. Samuel Katz:] I would say this again, it's only conjecture, but to me, if I wanted to use such conjecture I would use it to reinforce the concept that 

if this is happening periodically, our level of immunization has been sufficient to dampen the spread of disease. 

I don't like John's use of the word a poor vaccine. 

There are problems with smallpox vaccine. 

I think there is good work going on to improve the vaccine. 

But this business of three years and prevention of disease is one thing,

prevention of death is the other.

You're emphasizing death as your big fear with smallpox vaccine. 

I think you must emphasize death as your fear with the disease. 

Now the mortality rate with importation in Europe has been anywhere from 10 to 40 percent in various outbreaks.

As far as protection from smallpox vaccine is concerned, 

if memory serves me correctly, if you've had immunization even within 20 years,

though you may get disease, there has not been mortality from the disease. 

And I think in the long run that's our best protection, 

is against death from the disease.

[Dr. John Neff:] Well, let me mention something here, 

I think that when you're talking about the death secondary to smallpox vaccine,

that you're talking in the range of seven a year,

which means that over the 20 years that we have been free of smallpox, 

we've had probably in the range of 100 to 200 deaths as the result of the vaccine. 

It would take an awfully large epidemic of smallpox to be able to equal that mortality.

[Dr. Paul Wehrle:] Well John, before we get into that area, let's clear up one or two points where I think we have some real problems. 

One of them is in the area of the real effectiveness of this vaccine,

and Dr. Katz indicated that the immunity as far as death is concerned seems to be pretty solid.

For at least 20 or 25 years after vaccination,

death would be unusual. 

Cases do occur, but there is some protection still conferred. 

After 10, 15, 20 or even 25 years you have a diminished risk of acquiring the disease,

although for three years or something like that it's virtually solid. 

This really is a pretty good vaccine. 

I think what you meant was a poor vaccine in terms of hazards in comparison with benefits in this particular frame,

in this country.

[Dr. John Neff:] Right, and I think if you are just going to look at that aspect alone,

then I think it would be very surprising if this particular vaccine

passed the stringent regulations that we have for a vaccine.

[Dr. Paul Wehrle:] Well, let's look at the deaths that occur. 

It seems to me that as we examine them, and this is from Dr. Neff's own publications, [laughter]

that at least 50 percent of them are in a true sense preventable. 

That is, individuals receive smallpox vaccine for whom we know it is an untoward immunization procedure,

a child with eczema or the sibling of a child with eczema, a patient with a malignancy involving the immune mechanism, 

the patient on immunosuppressant drugs, 

these are patients we know will have trouble with smallpox vaccine, 

these latter ones, or any live virus vaccine. 

This is an accident of medical supervision or of public health supervision. 

I don't think the vaccine should be incriminated on this basis,

rather we should incriminate ourselves as having poor judgment in using it improperly. 

As far as the children are concerned with eczema, I think we're aware that there are efforts to improve

and to come up with a strain of vaccinia that might not cause eczema vaccinatum. 

But I would again get back to the point of blanketing importations. 

It seems to me that the sort of crash program you have, when suddenly the news hits that a case of smallpox has been imported, 

you're more apt to get poor discrimination in the use of vaccine as you get the panic situation, 

run around and vaccinate everyone who might have been exposed,

seems to me there you're in a situation where you're more likely to immunize the inappropriate individuals

than you are in an ongoing program where good judgment can be encouraged.

[Dr. John Neff:] Well, there are two things that you bring up. 

One is the preventability of the complications.

And Sam, I have taken your stand in the past, that a large number of these complications are preventable. 

But the thing that bothers me is when you actually look at the complications that occur, 

that could be preventable, this has been known a long time, 

that you shouldn't vaccinate a child with eczema or a family contact with eczema, 

yet at the same time between 1963 and 1968 when there's been a lot of publicity, 

you still have the same number of cases of eczema vaccinata. 

The same can be said about vaccinating people with any type of immunological deficiency disease. 

But the difference between '63 and '68 in the data when you would hopefully see a reduction, 

there seems to be no change and it's just an accident, I think, 

of practice that some of these people get vaccinated.

[Dr. Samuel Katz:] Well then, you're willing to take that inevitability of change and bargain that

against the unknown factor of all right, we're defeated, we can't alter that, is what you're saying basically. 

Are you then willing to bargain with the unknown,

which is the only way to prevent those few deaths, which are tragic, I agree, 

but the only way to prevent it is then to take the gamble, which we can't provide any data on, 

of how many cases of smallpox would we have, were we to do away with routine immunization

and how many cases of these same complications would we have in the use of crash program vaccinations?

[Dr. Paul Wehrle:] This brings up a very interesting point

that I think we ought to try to cover in our next session here. 

I think one is why hasn't there been a decrease,

because everyone knows that you shouldn't vaccinate a child with eczema,

and why are we continuing to have this same frequency of involvement here? 

I think another thing that I'd like to see you two spar over is,

is there really a greater risk in vaccinating the individual

who has a primary vaccination as an adolescent or as a young adult?

Because here is another part of the argument and I think an important part. 

If, for example, you're going have an unusually high risk of complications

in vaccinating young adults for overseas travel, for whatever,

then whatever position we take I think has to take that part into consideration.

[Dr. Samuel Katz:] I think your implication, I would accept it to support my argument, [laughter]

we do from the Netherlands, we do from other countries where those complications that are not preventable,

encephalitis would be the one we would say maybe we can prevent eczema vaccinatum. 

We don't know enough about post-vaccine encephalitis to even discuss its pathogenesis.

We don't know how to prevent it. 

We do have at least data which suggest that the older the age group having their primary experience,

the more likely one is to encounter post-vaccinal encephalitis.

I would most certainly use that as an argument in favor of continuing childhood or infant immunizations.

[Dr. John Neff:] Well Sam, I think that you've got to talk about the figures

that come from the United States because there's a tremendous amount of discrepancy in terms of

[Dr. Samuel Katz:] We don't have the data from the United States.

[Dr. John Neff:] Well, I think we do, Sam, to some degree. 

It's true that right now about 90 percent of your adults have been vaccinated so you see very few primary. 

But over the past 20 years since the Second World War,

about 10 percent of your military recruits are primary vaccinees

and this comes to about two million military recruits that have been vaccinated. 

And it happens to be that there have been no reported cases of post-vaccinal encephalitis since the second World War in that group. 

Now it's possible that maybe one or two have been missed,

but you certainly don't have the same type of experience

that they've been having in the Netherlands where one per thousand times

[Dr. Samuel Katz:] What is that data again on how many are truly primary vaccinees?

[Dr. John Neff:] About 10 percent, Sam, 10 to 13 percent.

So that if you work this out over a 20 year period, it comes in the range of 20 million primary vaccinations

in a system where you have pretty good surveillance for complications.

[Dr. Samuel Katz:] I can't quite follow how you're getting 20 million, 

[Dr. John Neff:] I'm sorry, two million. Excuse me, Sam, two million.

[Dr. Samuel Katz:] Yeah, yeah.

If you turn around the other way, of course your statistics on the severe complications in childhood amount to about one per million.

[Dr. John Neff:] That's right.

[Dr. Samuel Katz:] And of those, one, we would say 50 percent perhaps are preventable,

so it's a half of one per million which brings it down to probably the same rate

I think you're bargaining for.

[Dr. John Neff:] Well, it's variable. 

I think it's at least a half per million. 

In 1963 there were five post-vaccinal encephalitis for six million primary,

so this is merely one per million primary vaccinations.

[Dr. Paul Wehrle:] And this was for primary, presumably in young age

[Dr. John Neff:] Right.

[Dr. Paul Wehrle:] Individuals, symptoms.

[Dr. John Neff:] Right, particularly.

[Dr. Samuel Katz:] Well, I would certainly submit that we have difficulty in transposing data from one nation to another,

but I'm tremendously impressed with the reliability of the data from the Netherlands with their experience

with armed forces groups who did not have immunization against smallpox in childhood,

and their data is certainly very striking as to the difference in incidence of post-vaccinal

encephalitis when groups in their late teens or early 20s are first immunized. 

I don't know that we have that sort of experience in an ongoing prospective fashion. 

They directed attention to this, as we know Dr. Vandenorder [?] and his associates have followed this carefully. 

I don't know that we've had any such careful surveillance.

[Dr. John Neff:] No, but I think that say, in Great Britain, there has been careful surveillance

and for, their experience is very much analogous to what our experience has been. 

And theirs for revaccinees, uh, for primary vaccinees in the adults 

it's in the range of 2.8 cases of post-vaccinal encephalitis per million,

so this is a little bit more than we have here,

but it's at least in our ballpark rather than the Netherlands. 

So it depends on what countries' data you quote,

and I think that when we're making these decisions you have to look at your own country

and make the decisions as best you can based on our experience.

[Dr. Samuel Katz:] It puts us back in the same place, if we look to our country,

we can only look for conjectures or extrapolations.

We don't have the comparative data. 

I suppose the question we're asking one another is do we want to acquire it?

Are we at a point where we can justify a change which will provide us with the data? 

Are we too concerned about sticking pat the way we are?

Or are we going to get in trouble if we try the other way?

[Dr. Paul Wehrle:] Thank you, Dr. Katz, for summarizing very nicely the various points of view and information

behind the present position regarding the use of this vaccine. 

And thank you, Dr. Neff, for doing a beautiful job

in summarizing the arguments toward changing our position. 

I think that we, in considering the present posture with regard to the use of vaccinia

and the prevention of smallpox as a routine procedure in this country,

must keep these various points that have been very ably presented very firmly in mind. 

One part of the argument revolves around the likelihood of introduction of smallpox cases into this country

and the probability of spread once introduced. 

The data here I think are quite clear, in that it seems unreasonable to assume that this is going to be something

that will be happening frequently in the future. 

However, the chance occurrence still remains a possibility. 

The second area that was brought out, I think very nicely by our combatants, 

is the problem of a risk associated with the use of this most effective vaccine. 

A number of patients have developed,

and they can be expected to continue to develop, serious complications. 

Another considerable risk that I think was very important to bring out is what will happen

if we no longer immunize infants and are immunizing only those 

adults who are involved in international travel

and other situations that might put them at risk. 

Thank you very much for the opportunity to be with you.

[Host:] We thank Dr. Samuel Katz, Dr. John Neff, and Dr. Paul Wehrle

for their interesting analysis of a critical problem in patient care. 

In subsequent programs we shall continue to record 

equally significant concepts and controversies in modern medicine. 

The opinions expressed on this program do not necessarily constitute endorsement

by the Department of Health, Education and Welfare, the Public Health Service, or its constituents.

[Music]

[John M. Neff, M.D., Asst Professor, Department of Pediatrics, Johns Hopkins Hospital]

[Samuel Lawrence Katz, M.D., Professor and Chairman, Department of Pediatrics, Duke University, School of Medicine]

[Paul F. Wehrle, B.S., M.D., Professor and Chairman, Dept. of Pediatrics, University of Southern Calif., Los Angeles, Calif.]

[concepts and controversies in modern medicine]

[The End, T-1678, MCMLXIX]