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Statement by Virginia Apgar, M.D.
Vice President for Medical Affairs
The National Foundation-March of Dimes
Subcommittee on Health
Senate Committee on Labor and Public Welfare
June 30, 1969

The National Foundation-March of Dimes is pleased to have been

invited to present its views on proposals to the Senate for the control of

communicable disease. Our interest in immunization is well known and

extends back to 1938, the year in which The National Foundation was

organized by Franklin D. Roosevelt to lead the fight against poliomyelitis.

During an era in whic-h government support of health research

and development was minimal, The National Foundation was the principal

source for the funding of major advances in virology and immunology which

culminated in the licensure of the Salk vaccine in 1955 and the elimination

of epidemic poliomyelitis as a public health problem in the United States.

Underlying all the developments leading to subsequent virus vaccines were

the laboratory techniques perfected in poliomyelitis vaccine research.

I.

Since 1958 The National Foundation-March of Dimes has been

dedicated to the prevention and amelioration of birth defects which are

this nation's primary problem of child health.

An estimated seven per cent

of the liveborn -- some 250,000 each year -- have defects which are evident

during infancy. Through programs of laboratory and clinical research,

medical care, professional and public education, and community service,

this organization strives to advance the fight against birth defects.

S.1662 addresses itself to the problem of the control through

vaccination of certain communicable diseases of childhood, namely,

poliomyelitis, diphtheria, whooping cough, tetanus, measles and rubella.

S.2264 adds to this list tuberculosis, venereal disease and other

'communicable diseases determined to be of national significance.

With the exception of rubella, existing prophylactic measures have

brought each of the specified diseases under control to varying degrees --

from virtually complete control in the case of poliomyelitis to less-than-

adequate control for tuberculosis, measles and the venereal diseases.

Our particular interest, however, is directed to the prospects for prevention

of rubella, since the recent approval of a vaccine for this disease represents

a significant step forward in the fight against birth defects.

Rubella is usually a mild childhood disease but may cause  serious

defects in the unborn baby when the mother is infected in the early months

of pregnancy. Young children are the principal source of the infection of

pregnant women. Epidemics of rubella occur in the United States at

irregular intervals of 6 to 9 years. The last major epidemic, in 1964,

caused an estimated 50,000 abnormal pregnancies, resulting in some 20,000

live-born babies with birth defects and about 30,000 fetal deaths.

The consequences of rubella in pregnancy are varied and

unpredictable. Spontaneous abortion, stillbirth, live birth with one or

more anomalies, and normal infants are represented in the spectrum.

Virtually every organ may be involved, either temporarily or permanently.

Cooper and Krugman, in a review of 271 abnormal infants followed to age

18 months, found congenital heart disease in 142 (52%), confirmed or

suspected hearing loss in 140 (52%), cataract or glaucoma in 107 (40%),

severe or moderate psychomotor retardation in 65 (24%), and neonatal

thrombocytopenic purpura in 85 (31%). The mortality rate was 13%

(35 infants).

Thousands of victims of congenital rubella from the 1964

epidemic and from subsequent outbreaks of the disease have been cared for

at the 107 Birth Defects Centers supported by the March of Dimes. Many

of these children continue to require intensive medical and educational

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services if they are to realize their full potential.

With widespread immunization of children with the new rubella

vaccine, this tragedy may not be repeated.

In our view, however, there are formidable obstacles to the rapid

and widespread use of the rubella vaccine in time to prevent another wave

of rubella babies which may occur as early as 1970 or 1971.

      Some of these obstacles are educational in nature; others are

fiscal. On the educational side, the idea of vaccinating children against

rubella to protect unborn babies from birth defects will not be easy to

get across.

prevent another epidemic.

itself to render voluntary service when requested by health departments

and medical societies to foster public understanding and acceptance of the

But public understanding is crucial if the vaccine is to

Accordingly, The National Foundation has pledged

vaccine, as supplies become available.

A review article on rubella has been

mailed to 145,000 physicians and other health professionals throughout the

nation, and millions of educational flyers are being readied for widespread

public use.

We are confident that educational measures such as these,

undertaken in cooperation with other voluntary health agencies, organized

medicine and public health departments,  can and will overcome the barriers

to public understanding and acceptance.

As for the fiscal obstacles, however, we are less optimistic.

There are approximately 56 million children aged 1 to 14 in the United States.

This is the target group for rubella immunization.  If 75% of these boys

and girls are to be vaccinated --- and I believe that we can achieve this

level of participation I- some 42 million doses would be required initially.

If as much as half this amount were to be administered on a private,

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fee-for-service basis -- and I personally view this as a probable upper

limit -- then governmental sources will need to furnish at least 20 million

doses to achieve primary protection against another epidemic.

prices, this is equivalent to $30 million, exclusive of necessary laboratory,

surveillance and administrative costs.

At current

In view of the cyclical nature of rubella epidemics and the

consequent need to achieve rapid vaccine coverage, neither of the legislative

proposals under consideration appears to be entirely adequate to meet this

challenge. The appropriations authorized in S. 2264, however, more nearly

approach the requirements.

S. 2264, moreover, would permit expkditious use of rubella vaccine

through the well-established mechanisms of the National Communicable Disease

Center which has proven its competence in earlier programs  authorized under

the Vaccination Assistance Act. The coming rubella epidemic, whether it

strikes next year or the year after, constitutes a real emergency for the

mur'e than 4 million American babies who will be conceived that year.

Under

the circumstances, it would seem ill-advised for the federal government

to approach the problem of rubella prevention along a circuitous route which

involves untried and necessarily slower administrative mechanisms.

In urging your favorable decision on S. 2264, we should like

to call your attention to the need for amendment of the measure to

comprehend the prevention of another disease which constitutes a more

serious threat to children than most of the others included, and for which

there is an effective vaccine. This is hemolytic disease of the newborn

due to Rh in~ompatibility, otherwise known as erythroblastosis fetalis, or

more simply, Rh disease.

Unlike the vaccines for the other diseases, this vaccine prevents,

instead of fostering, immunization, in this case the immunization of Rh

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negative mothers against the Rh positive blood of their unborn babies.

Each year an estimated 250,000 women and their families  in the United States

face the possibility of having an affected child.

Prevention of Rh disease now is possible with the use of a

specially prepared blood fraction known as Rh immune globulin.

product has been available to hospitals since June 1968.

    This

Injected into an

unsensitized Rh negative mother soon after the birth of an Rh positive

baby, the Rh immune globulin effectively prevents her sensitization and

the possible development of the disease in a subsequent Rh positive baby.

About 8.VL of white maternity patients and 4.1% of Negro maternity patients

are candidates for this vaccine.

With optimal use of this vaccine,  the incidence of E& disease

can be expected to decline continuously from year to year,  so that in

20 to 25 years the present pool of sensitized women of childbearing age

will be exhausted, thus eliminating the disease as a public health problem.

      Our surveys of hospitals and our consultations with state public

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health'departments, however, indicate that in many parts of the country

substantially fewer doses of the Rh vaccine are being administered than

are needed to eliminate the disease. While the situation differs from one

community to another, we estimate that nationally about one out of every 4

women who need the vaccine is not receiving it.

The reasons for under-

utilization of this preventive ore varied, but since the vaccine is

relatively expensive, cost may be a serious obstacle for many low and

moderate income families, especially in areas where public programs of

medical assistance are absent or-inadequate to meet this need.

reason, we ask you to consider the inclusion of Rh disease in any

For this

vaccination assistance measure you approve.