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Ped iui rics

VOLUME 49 APRIL 1972 NUMBER 4

COMMENTARIES

THE

END

OF

ROUTINE

SMALLPOX

VACCINATION

IN

THE

UNITED

STATES

1971 was the year in which the Sur-geon General of the United States Public

Health Service, the Redbook Committee of

the American Academy of Pediatrics, and

the Territorial Health Officers agreed that the time had come to discontinue routine primary smallpox vaccination for American children. As a result of this it may also be expected that school vaccination laws pres-ently in effect in some 28 states will soon be repealed or will not be enforced with vigor.

The American pediatrician views these

developments with mixed feelings, since there have been extensive and often spir-ited debates regarding the timing for

dis-continuation of routine smallpox

vaccina-tion. When, at the annual meeting of the

American Pediatric Society in Philadelphia

in 1964, we described the results of a 1-year

survey of the complications of smallpox

vaccination and proposed that routine pri-mary vaccination of American children could be discontinued because the danger of the procedure far outweighed the risk of exposure to disease, a lively discussion en-sued. To the best of my memory, of all the

people who commented following our

pre-sentation, only Dr. Margaret Smith sup-ported our stand. Subsequently, the United

States Public Health Service undertook sev-eral careful and more sophisticated studies to determine the niortality rates following smallpox vaccination and the chance of im-portation of smallpox to this country. They

also reviewed what should be done in the

event importation did occur. In 1971, on the basis of their studies, the United States

Public Health Service was able to

recom-mend that smallpox vaccination in the

United States should be used selectively rather than as a routine procedure.

Imple-mentation of their recommendation should

result in a marked decrease in the number

of vaccinations that are performed at any

age and a subsequent prompt drop in

mor-tality and morbidity.

It has been shown repeatedly that an

ap-preciable number of cases of smallpox must

exist within a country (or area) in order for

it to be the source of exported cases. The mere presence of a few cases is not likely to lead to exportations over long distances.

The World Health Organization has had an

intensive international eradication program.

Since 1964, under the leadership of Dr.

D. A. Henderson, this campaign has made

enormous strides. In 1966, 43 nations had

substantial numbers of cases of smallpox;

by 1970 that number had dropped to 13;

and in 1971 only five nations (Ethiopia,

Su-dan, India, Pakistan, and Indonesia) had a

significant number of cases. During the last

year, smallpox has been essentially

elim-inated as a major problem in the

West-ern Hemisphere through the energetic and

successful eradication program in Brazil,

the last stronghold in the New World.

It is now recommended that the only

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490 END OF VACCINATION

dividuals

( adults

or children) who should receive smallpox vaccination are those who

require it because they will travel to a

country where smallpox is endemic, or be-cause they serve in a health profession and might be early contacts of an imported case

before it has been diagnosed. Health

pro-fessionals should maintain adequate immu-nity because of the experience in Europe

where, over the past 20 years, one half of

all secondary cases were found among doc-tors and nurses.

The often expressed fear that delay in

primary vaccination until adult life would yield a higher rate of complications seems to be unfounded. Although it was formerly believed that the complication rate was two

or three times higher in adults than in

chil-dren, recent careful studies in the United States, where more than a quarter million

primary vaccinations are performed on

adults each year, has disclosed no evidence that the rate of complications is higher in

adults than in infants or children. From a

review of death certificates, only one death was reported in a 9-year period following

adult primary vaccination. Those who are

unduly concerned that primary adult vacci-nation might result in an increased

inci-dence of vaccinia encephalitis should be

aware that the simultaneous use of

vac-cinia-immune gamma globulin at the time

primary vaccination is carried out will sig-nificantly further decrease the incidence of

this rare complication.

Further experience with attenuated vac-cinia (CVI-78) is required to assess its use

prior to standard smallpox vaccination. In

time, vaccination for those select

individu-als who need to be immunized might be a

two-step procedure with attenuated vaccinia

being given first followed by the administra-tion of the standard strain. It is to be

ex-pected that the number of individuals who will need to be vaccinated will decrease

tremendously, probably to less than 250,000

per year. Indeed, if successful eradication

campaigns further reduce the volume of

smallpox abroad, the disease may for all

practical purposes no longer be considered

a problem.

But what if, after 10 or 20 years of the control of smallpox, it should suddenly ap-pear in a virgin population totally

suscepti-ble and with no “herd” immunity?

Forth-nately smallpox does not spread as does

chickenpox or measles. Modern techniques

of surveillance, prompt vaccination of

con-tacts, the use of vaccine immune gamma

globulin, and prophylactic use of methisa-zone (Marboran) would make it possible to control smallpox importation adequately. This has already been shown to be an

effec-tive way on a number of occasions. Great

Britain discontinued compulsory vaccina-tion in the 50’s and by 1960 had a

popula-tion in which 90% of the people had not

been immunized or had last been

vacci-nated 10 or more years previously. Despite

this, Great Britain had had no more secon-dary cases than had occurred on the conti-nent where compulsory vaccination has

been continued to the present. In the last 5

years the average importation outbreak in

Europe has resulted in 10 cases. The

num-bers would only have been half as large if

hospital personnel (doctors, nurses, and so

forth) had been adequately protected. In

Great Britain, 13 cases of smallpox were

im-ported from other countries between 1951

and 1970. This gave rise to 103 secondary cases of smallpox with 37 deaths. But dur-ing the same period there were 100 deaths

from smallpox vaccination given in Great

Britain.

The worldwide number of reported cases

has declined in the past 4 years from 131

thousand to 27 thousand. Vaccination

re-quirements for travel have also changed in

some countries. At the present time, in the

United States, evidence of vaccination is

only required of those returning to this

country if the traveler had been in a country reporting to have smallpox in the previous

14 days.

The concept that “herd” immunity in

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COMMENTARIES 491

a modified disease which is quite

infec-tious but much more difficult to diagnose, and that our well-vaccinated infants are not

a numerically important barrier to importa-tions. To have a thoroughly immunized

pop-ulation it would be necessary to vaccinate

and revaccinate more people and at more

frequent intervals than we do now. We can

be said to be well vaccinated but not well immunized.

The fear has been expressed that discon-tinuation of routine primary vaccination of

all children in favor of a policy of

vaccina-tion limited to travelers returning from

areas where smallpox is endemic, and to

doctors and nurses, might result in less

ef-fort by those countries still having the

dis-ease to continue vigorous campaigns of

eradication. On the contrary, I feel that it has been the very success of smallpox

vacci-nation over the years that has made it possi-ble to modify our attitude toward smallpox control in this country, and to concentrate

our financial efforts, and technical and

pro-fessional support, in helping the World

Health Organization and its member

gov-ernments accomplish total eradication

within the next 5 years. This goal is now

within sight. The conquest of this dread

disease would be a wonderful tribute to the

memory of Edward Jenner and to the

inter-national collaboration exemplified by the

WHO eradication campaign. But even if

to-tal eradication is not attainable at this time, the importation of smallpox and the

devel-opment of secondary cases will not result in any more deaths than we suffer from

small-pox vaccination itself. As in all other phases of preventive, diagnostic, and therapeutic

medicine, we must weigh the risk of our

actions against the need to proceed, in

terms of the patients’ welfare.

C. HENRY KEMPE, M.D. Department of Pediatrics

University of Colorado

Medical

Center

4200 East Ninth Avenue

Denver, Colorado 80220

SELECTED BIBLIOGRAPHY

Bauer, 0. J., St. Vincent, L., Kempe, C. H., Young, P. A., and Downie, A. W. : Prophylaxis of small-pox with methisazone. Amer. j. Epidemiol., 90: 130, 1969.

Benenson, A. S.: Possible alternatives to routine smallpox vaccination in the United States. Amer.

J.

Epidemiol., 93 :248, 1971.

Dick, C. : Routine smallpox vaccination. Brit. Med.

J,, 3:163, 1971.

Foege, W. H., Foster, S. 0., and Goldstein,

J.

A.: Current status of global smallpox eradication.

Amer. J. Epidemiol., 93:223, 1971.

Katz, S. L., and Krugman, S.: Smallpox vaccina-tion. New Eng.

J.

Med., 281 :22, 1969.

Katz, S. L.: The case for continuing “routine” childhood smallpox vaccination in the United States. Amer. J. Epidemiol., 93:241, 1971. Kempe, C. H.: Studies on smallpox and

complica-tions of smallpox vaccination. PEDIATRICS, 26:

176, 1960.

Kempe, C. H.: An evaluation of the risks of small-pox vaccination in the United States. Part 2.

J.

Pediat., 67:1017, 1965.

Kempe, C. H., and Benenson, A. S.: Smallpox im-munization in the United States. J.A.M.A., 194: 161, 1965.

Kempe, C. H.: To vaccinate or not. Hospital

Prac-tice, 2:28, 1968.

Kempe, C. H.: Smallpox vaccination of eczema pa-tients with attenuated live virus. Yale J. Biol.

Med., 41:1, 1968.

Kempe, C. H., Fulginiti, V., Minimitani, M., and

Shinefield, H.: Smallpox vaccination of eczema

patients with a strain of attenuated live vaccinia (CVI-78). Pimwriucs, 42:980, 1968.

Lane, J. M., Ruben, F. L., Neff, J. M., Millar, J. D.: Complications of Smallpox

Vaccina-tion, 1968. National Surveillance in the United

States. New Eng. J. Med., 281:12-1-1208, 1969.

Lane, J. M., Ruben, F. L., Abrutyn, E., and Millar,

J. D.: Deaths attributable to smallpox

vaccina-tion. 1959-1966, 1968. J.A.M.A., 212:441, 1970. Lane, J. M., Ruben, F. L., Neff, J. M., et al: Com-plications of smallpox vaccination, 1968. II. Re-suits of ten statewide surveys J. Inf. Dis., 122:

303, 1970.

Lane, J. M., and Millar, J. D.: Risks of smallpox vaccination in the United States. Amer. J. Epi-demiol., 93:238, 1971.

(4)

492 HEXACHLOROPHENE

Neff, J. M., Lane, J. M., Pert, J. H., et al.: Compli-cations of smallpox vaccination. I. National sur-vey in the United States, 1963. New Eng. J. Med., 276:125, 1967.

Neff, J. M., Levine, R. H., Lane, J. M., Ager, E. A., Moore, H., Rosenstein, B. J., Millar, J. D.,

and Henderson, B. A.: Complications of small-pox vaccination, United States, 1963. II. Results

obtained by four statewide surveys. PEDIATRICS,

39:916, 1967.

Neff, J. M.: The case for abolishing routine child-hood smallpox vaccination in the United States. Amer. J. Epidemiol., 93:245, 1971.

Public Health Service Recommendation on Small-pox Vaccination. Morbidity and Mortality: 20:

339, 1971.

HEXACHLOROPH

ENE

Y

ET another chemical widely used by the

population has been discovered to be

potentially dangerous. Hexachlorophene was first synthesized in 1939 and found to have both bactericidal and fungicidal prop-erties, but its toxicity has only been appre-ciated in the last few years. Probably the

most alarming aspects are that the chemical is not only neurotoxic but is also readily

ab-sorbed from the skin.

Although muscle twitching and coma

were observed 3 years ago in burn patients treated with hexachlorophene, these

obser-vations were not actually responsible for

the recent toxicity studies which have

fo-cused attention on this subject and raised many important questions. These studies, begun in 1970 at the FDA Division of Pesti-cide Chemistry and Toxicology in Atlanta, were related to the use of hexachlorophene as a fungicide on citrus fruits and a number

of vegetables, including cucumbers, toma-toes, and potatoes. Rats fed

hexachioro-phene daily developed cerebral edema and

cystic spaces in the white matter of the

brain and spinal cord. The findings were

presented at the Society of Toxicology

meeting in March of 1971 and the implica-tions immediately became apparent, partic-ularly for the newborn. Blood levels were

determined in infants given daily baths

with hexachlorophene in a 3% emulsion

and reported in the Lancet in August 1971.

In some cases these levels were nearly 50%

of those associated with neurotoxicity in the

rats which had been fed the chemical.

The FDA immediately notified the

Academy Committee on the Fetus and

Newborn of these developments and

pro-posed a warning statement. The initial reac-tion of the Committee at its meeting in Oc-tober of 1971 was that more information

was needed and the experiments in rats

might not be relevant to the human. Conse-quently the Committee did not agree to

en-dorse the statement at that time.

Shortly thereafter, results of testing the effect of skin washing with

hexachloro-phene in newborn monkeys became

avail-able. The animals were washed daily with

one teaspoonful of a detergent containing 3% hexachlorophene which was subsequent-ly washed off. After 90 days all of six ani-mals showed extensive lesions in the brain and spinal cord, and two had papilledema.

No lesions were detected in five control

animals. The experiments left a number of

questions unanswered. The amount of

hexachiorophene used in the small animals,

which weighed only approximately 400 gm

at birth, was proportionally greater per unit of body surface than is customarily used in

the human infant. There might be

differ-ences in absorption due to the number of

sweat glands in the skin of the monkey,

some of the chemical might have been

licked from the skin, and there also might

have been difficulties in washing the

ma-terial off because of hair. There was no

indication as to how rapidly these lesions

developed nor whether they might be

(5)

1972;49;489

Pediatrics

C. Henry Kempe

THE END OF ROUTINE SMALLPOX VACCINATION IN THE UNITED STATES

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(6)

1972;49;489

Pediatrics

C. Henry Kempe

THE END OF ROUTINE SMALLPOX VACCINATION IN THE UNITED STATES

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the World Wide Web at:

The online version of this article, along with updated information and services, is located on

American Academy of Pediatrics. All rights reserved. Print ISSN: 1073-0397.

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