Compensation for Vaccine-Related Injuries

November 1980

NTIS order #PB81-163909
Library of Congress Catalog Card Number 80-600187

For sale by the Superintendent of Documents,

U.S. Government Printing Office Washington, D.C. ,20402
PREFAC E

In September 1979, the Office of Technology Assessment published a

report A Review of Selected Federal Vaccine and Immunization Policies. That

report included a chapter that reviewed issues related to legal liability and compensation for vaccine-related injuries. The report noted that all vaccines, even

when properly manufactured and administered, may pose risks to users. Under

the existing legal liability system, persons injured as a result of vaccination must

go to court and establish fault for their injury in order to receive compensation.

To establish fault, the plaintiff (injured person) generally sues one or more of

the participants in the vaccination process (e.g., administers the vaccine). The

report noted that in three major cases in the past 11 years, plaintiffs have won

large judgments against vaccine manufacturers for injuries caused by nondefective and properly administered vaccines. The resulting uncertainty for manufacturers has affected their willingness to produce and supply vaccines.

Because of these problems, OTA suggested that it might be desirable to

establish a federally operated program to compensate vaccinees injured as a

result of being vaccinated in public immunization programs.

Early in 1980, the House Interstate and Foreign Commerce Committee

asked OTA to delineate the specific elements and principles necessary for inclusion in a legislative proposal to implement this option. This memorandum does

not analyze the positives and negatives of establishing such a program. It begins

with the assumption that establishing a compensation program is desirable, and

then discusses the questions that Congress must answer in developing such a

program.

 JOHN H. GIBBONS

Directo r

111
OTA HEALTH PROGRAM STAFF

Joyce C. Lashof, Assistant Director, OTA

Health and Life Sciences Division

H. David Banta, Health Program Manager

Lawrence Miike, Project Director

Pamela Doty, Congressional Fellow

Virginia Cwalina, Administrative Assistant

Shirley Ann Gayheart, Secretary

Nancy L. Kenney, Secretary

ACKNOWLEDGEMENTS

In addition to reviews by the members of the Health Program Advisory

Committee, OTA received reviews of drafts of this technical memorandum from the

following people. These reviewers do not necessarily approve, disapprove, or

endorse the report.

William Foege, M.D.

Director

Center for Disease Control

Atlanta, Georgia

Joel Kavet, D.SC.

Department of Health and Human Services

Washington, D.C.

Hugh Tilson, M.D.

Director

Division of Health Services

Department of Human Resources

State of North Carolina

Richard F. Kingham

Covington & Burling

Washington, D.C.

Kathleen H. Acree, M.D.

Chief

Preventive Medical Services Branch

Department of Health Services

Health and Welfare Agency

State of California

Suzanne Dandoy, M.D., M.P.H.

Director

Department of Health Services

State of Arizona
HEALTH ADVISORY COMMITTEE

C. Frederick Mosteller, Ph.D.

Professor and Chairman

Department of Biostatistics

Harvard University

School of Public Health

Mark Lepper, M.D.

Vice President for

InterInstitutional Affairs

Rush-Presbyterian Medical School

St. Luke’s Medical Center

Lewis H. Butler, L.L.B.

Health Policy Program

School of Medicine

University of California,

San Francisco

Kerr L. White, M.D.

Rockefeller Foundation

Stuart H. Altman, Ph.D.

Dean

Florence Heller School

Brandeis University

Rashi Fein, Ph.D.

Professor of the Economics of Medicine

Center for Community Health

and Medical Care

Harvard Medical School

Kurt Deuschle, M.D.

Professor of Community Medicine

Mount Sinai School of Medicine

Ms. Beverlee Myers

Director

Department of Health Services

State of California

Sidney S. Lee, M.D.

Associate Dean

Community Medicine

McGill University

Melvin A. Glasser, LL.D.

Director

Social Security Department

United Auto Workers

Robert M. Ball

Senior Scholar

Institute of Medicine

National Academy of Sciences

Frederick C. Robbins, M.D.

President

Institute of Medicine

Zita Fearon

Consumer Commission on the

Accreditation of Health Services, Inc.

Mitchell Rabkin, M.D.

General Director

Beth Israel Hospital

vi
—

TABLE OF CONTENTS

I.

II.

III.

IV.

v.

VI.

VII*

Elements of a Vaccine Injury Compensation Program

The Federal Government’s Current Approach to Compensation

Major Arguments For and Against Establishing a Compensation Program

The Types and Estimated Numbers of Vaccine-Related In-juries

Costs of Vaccine Injury Compensation Programs

Current Approaches to Vaccine Injury Compensation

Vaccine Injury Compensation and Future Developments in Vaccines

Exhibit A

Exhibit B

Exhibit C

References

Page

1

13

19

25

53

61

69

75

95

99

105

v i i
List of Tables

—

10

2 .

3 .

40

5.

6.

7.

8.

Reported Reactions to Commonly Used Live Vaccines

Rates of Complication (Per 1000) Following Vaccines

and Natural Diseases

Total Net Doses Distributed, United States, 1974-1978

Estimates of Serious Illness Associated with Immunization Against

the Seven Major Childhood Infectious Diseases (Cases per Year)

Estimated Annual Number of Severe Vaccine Reactions & Associated

Medical Costs

Vaccine Damage Payments Act, Status on 6/20/80

New Vaccines - Expected Development After 1976

Incidence of Certain Causes of Neonatal Sepsis Syndrome

(per 1000 cases)

44

50

51

60

68

72

73

viii
List of Acronyms

CDC :

DHHS :

DHSS :

DT:

DTP :

GAO :

GBS :

MMR:

MR:

OPV :

SIDS :

Td :

TOPV:

Center for Disease Control

Department of Health and Human Services (United States)

Department of Health and Social Security (Great Britain)

Diphtheria toxoid with tetanus toxoid (Pediatric)

Diphtheria and tetanus toxoids with pertussis vaccine

General Accounting Office

Guillain Barre Syndrome

mumps, measles, and rubella vaccines

measles and rubella vaccines

oral polio virus vaccine (see TOPV)

sudden infant death syndrome

tetanus toxoid with diphtheria toxoid (adult)

trivalent oral polio virus vaccine (see OPV)

i x
I. Elements of a Vaccine-Injury Compensation Program

As a result of a previous report on Federal Vaccine and Immunization

Policies, which included an option to compensate persons for injuries resulting

from public immunization programs, the Office of Technology Assessment (OTA) was

requested by the House Committee on Interstate and Foreign Commerce to delineate

the specific elements and principles necessary for inclusion in a legislative

proposal to implement this option. This technical memorandum is OTA’s response

to that request.

Vaccines can cause harm even when properly manufactured, distributed, and

administered. In legal parlance, they are known as “unavoidably dangerous

products,” which are socially-useful but which also are associated with a

statistically small degree of risk.

Typically, adverse vaccine reactions are mild and self-limiting; e.g., a

sore arm or one or two days of fever. Less frequently, transient reactions occur

which are more frightening; e.g., DTP (diphtheria tetanus, and pertussis or

whooping cough) vaccination may be followed by convulsions (1 in 5,000), but

these are reasonably short-lived and leave no permanent brain damage. For an

exceedingly small number of vaccinees, long-lasting or permanent disability and

even death may be the result. For example, live oral polio vaccine carries a 1

in 4,000,000 vaccinations risk of polio disease itself. And a person receiving a

vaccine may develop a very severe allergic reaction (anaphylactic shock) and die

immediately (with an estimated risk of 1 in 10,000,000 vaccinations).

AS there is no one “at fault” for these reactions, the injured vaccinee

would not be able to successfully sue the manufacturer, doctor, or other

defendant in a lawsuit based on negligence; e.g., faulty manufacturing of the

vaccine such that it was contaminated, or faulty vaccination such that a nerve

was damaged by the injection. However, the courts have developed a legal basis

for a potentially successful lawsuit in the doctrines of “informed consent” and

(1)
the “duty to warn. ” Summarily stated, these legal concepts say that: (l)a

person about to be vaccinated should be given a clear explanation of the benefits

of vaccination and of the potential side-effects that might occur; and (2)

someone in the chain from manufacturer to purchaser (such as a state or federal

health agency) to the person who administers the vaccine bears the responsibility

to give that explanation. There has been considerable difficulty in determining

what constitutes an adequate warning and whether or not a truly informed decision

had been made to be vaccinated (the ultimate test of whether the condition had

been satisfied takes place by hindsight in a lawsuit, when the injury has already

occurred and the answer is crucial to the success or failure of the lawsuit).

Furthermore, “informed consent” and the “duty to warn” imply that the potential

vaccinee can refuse the vaccination, but almost all states require that children

receive certain vaccinations as a condition of attending school.

Even if the “duty to warn” had been discharged successfully and adequate

“informed consent” had been given, the injury would not have been averted. The

only result would have been that the economic burden of the injury would be borne

by the injured vaccinee and not shifted toward, for example, the vaccine

manufacturer or the doctor administering the vaccination.

Vaccines may serve two purposes: (1) protection of the individual vaccinee,

and (2) providing “herd immunity,” or protection of the population in which a

high proportion of its individual members has been vaccinated. Herd immunity

occurs because the chances of exposure of unvaccinated individuals to the

infectious agent are greatly diminished and is an important public health concept

because it is a practical impossibility to immunize every individual.

The public health benefits of participating in certain vaccination programs

are not reflected in our country’s present system of handling the problem of

those few individuals who are inevitably harmed as a consequence of that

participation. The injured vaccinee must seek compensation on his or her own

initiative through the judicial system and its emphasis on vaccines as a
3

commercial product. This has led the courts to find ways of compensating the

injured vaccinee within the limits of the judicial approach. Thus, the “duty to

warn” derives from product liability for unavoidably dangerous but socially

useful products, where vaccines are viewed in the same manner as, for example,

dynamite. And “informed consent” originates in the theory of battery, where harm

results from an unconsented touching, as, for example, between agreeing to

participate in a boxing match and being mugged.

Currently, uncertainty over fulfilling the legal duties of an adequate

warning of potential risks and of obtaining “informed consent” to proceed with

vaccination have led to: (1) concern by vaccine manufacturers over their

liability, reflected in difficulty in insuring against such risks and decreased

numbers of manufacturers involved in vaccine research and production, and (2)

difficulties in trying to achieve a balance between giving vaccinees adequate

information on the risks of vaccination and scaring them into not being

vaccinated at all.

How to insure against the risks and how to obtain informed consent have

drawn most of the attention in efforts to address the problem of vaccine-related

injuries and have obscured the primary reason for addressing that problem --

public immunization programs are designed to protect not only the individual

vaccinee but also those who are not vaccinated. Thus, when the vaccinee is

harmed instead of protected, society has the obligation to minimize the

consequences of injury.

California and several countries have, in varying degrees, taken such steps

to minimize those consequences. (see Chapter VI). Generally, these compensation

programs consist of the following elements: (1) the vaccines to be covered, (2)

the injuries to be included, (3) the kinds of compensation, (4) the

administrative mechanisms, and (5) the relationships with existing compensation

programs (lawsuits, social insurance).
4

In California a person who suffers a severe adverse reaction not more than

30 days after any immunization required by state law to be administered to

children under 18 years of age is eligible for reimbursement of medical expenses

Up to $25,000. While reimbursement is without regard to ability to pay, the

state does reserve the right to recover payments from other sources such as

health insurance. The California law does dictate one element of the proof of

causality between a vaccine and an injury by imposing a time limit of 30 days

after immunization, but has left it up to the State Department of Health to

determine which injuries that occur within the 30 day period are the result of

the vaccine. The Department also determines what is a “severe adverse reaction.”

No compensation for economic loss is provided in California, although some

countries do provide such compensation. California has also chosen to protect

persons involved in the immunization programs from lawsuits for vaccine-related

injuries

The

Congress

except in cases of willful misconduct or gross negligence.

following options are grouped according to the five elements that

must address in formulating a vaccine-injury compensation program.

What Vaccines Should Be Covered?

Option 1. Include all vaccines.

Unavoidable injuries occur with all vaccines, although the types of injuries

and their severity may differ among specific vaccines. Thus, all vaccines,

present and future, could be included in a compensation program.

But all drugs have side effects, both mild and severe, as with vaccines. So

a compensation system that includes all vaccines raises the question of why there

should be a distinction between vaccines and all other drugs.

Option 2. Include only vaccines that offer public health protection in

addition to protection of the individual vaccinee.

A public compensation program would be better suited for vaccination
?-i

programs which also protect the public’s

interpretive questions in this approach,

health. There

especially for

may be some difficult

vaccines targeted at

high-risk populations where the total population recommended for vaccination is

substantial. For example, influenza vaccines are targeted at high-risk

populations, but they are presently recommended for approximately 40 million

people; 25 million of whom are 65 years or older.

Option 3. Include only vaccines that are recommended in childhood

immunization programs.

This is the approach commonly used in existing programs. Children would be

the primary beneficiaries (apart from contact cases in adults, e.g., polio), and

public policy might want to pay special attention to this portion of the

population. Also, vaccination is mandatory for attending school in the great

majority of states. As the states vary in the specific immunizations required,

national guidelines will have to be formulated, rather than relying on each

State’s list of mandatory vaccines.

What Injuries Should Be Included?

Including all adverse reactions, from a sore arm to severe, permanent

disability or death, is not a viable option. Not only would the costs be

prohibitive and not subject to reasonable estimates, but the administrative

mechanisms for dealing with claims might quickly be overwhelmed, In addition,

the compensation system need not be an exclusive remedy, nullifying (if at all

possible, subject to judicial review) the injured parties’ right to pursue a

claim through a lawsuit. Injuries that fall below the threshold of entry into

the compensation system still can be pursued in the courts.

The question of what reactions to include is addressed in two parts: (1)

were they caused by vaccination, and (2) how severe must they be to be included?
—

6

Causality

Determining whether or not a particular injury was the result of vaccination

involves establishing a statistical correlation between administration of the

vaccine and the injury in question. What this means in practice is to observe

what injuries occur after vaccination and compare the results to the incidence of

that injury in the unvaccinated population. This is done to separate injuries

that are coincidental with vaccination from those caused by vaccination. The

Center for Disease Control’s monitoring system for vaccine-related injuries

covers the 30 days immediately following vaccination, and the California law

states that injuries must manifest themselves within 30 days. Some

vaccine-related reactions, however, do appear after 30 days.

Option. Whether or not to specify a time period within which the reaction

must occur for inclusion in the program.

Severity

If all vaccine reactions are not to be included, some standard of severity

must be introduced, either explicitly in the legislation or through the

regulations. California defines a severe adverse reaction as one requiring

extensive medical care (as determined through regulations) and manifesting itself

not more than 30 days after the immunization. Recall that California’s

compensation is limited to medical expenses Up to $2s,()()(). In Great Britain, the

compensation system pays a lump-sum of bl0,000 for any disability 80% or greater.

In Denmark, no compensation is

disability between 5 and 50% a

is granted.

payable where the disability is less than 5%; for

lump sum is paid; and for 50% or more an annuity

Thus, the questions on severity of injury that must be resolved depend on

the compensation approach taken. A compensation program limited to reimbursement

of medical expenses need not address questions concerning functional capacity.
Severity of injury can be determined thorough intensity of medical services and

costs of care (including funeral expenses, should death occur). In a

compensation program providing additional economic benefits, the degree of

disability must be specified for determining eligibility and/or for scheduling

the level of payments.

Option 1. Determine severity of injury by the intensity of medical

services.

Option 2. Determine severity of injury by the degree of physical

disability.

These are not mutually exclusive options. For example, option 1 could be

used to determine whether or not medical expenses will be reimbursed. Thus, the

acutely ill person with high medical expenses but who recovers completely would

be covered. For longer-lasting disabilities, however, some type of physical

evaluation system will be needed.

What Kinds of Compensation?

The system would cover, at the minimum, medical costs. The primary question

on medical costs is whether or not there will be limits on the amount dispensed

from the program. California’s approach is to put a limit of $25,000 on medical

expenses covered, and, although it will reimburse regardless of ability to pay,

it reserves the right to recover payment from other sources such as health

insurance.

For medical expenses:

Option. Whether or not to place a limit on reimbursement for medical

expenses for eligible injuries.

Option: Whether medical reimbursement will be “first dollar” coverage or

69-457 0 - 80 - 2 : ?L 3
supplemental insurance.

Economic compensation has typically been in the form of annuities or lump

sum payments for specified degrees of disability. As noted earlier, Great

Britain pays a lump sum of bl0,000 for disabilities 80% or greater. Denmark pays

nothing for disabilities under 5%, a lump sum for disabilities between 5 and 50%,

and an annuity for disabilities 50% or more.

For economic compensation:

Option 1. Provide no compensation beyond reimbursement of medical expenses.

Option 2. Provide compensation only for severe disability.

Option 3. Provide compensation for varying degrees of disability.

Through What Administrative Mechanisms?

Addressing this question involves not so much considering a separate set of

options as raising specific issues once choices among the previous options have

been made. These issues arise in two areas: (1) Federal/State relationships,

and (2) the relationships between the compensation program and other federal

health care and income support programs such as Medicare and Social Security. As

we shall see, the more comprehensive the program’s benefits, the more such

specific issues have to be addressed.

First, however, is the question of how to finance the system, and though we

frame it in the form of two options, it seems clear that the first option is most

appropriate.

Option 1. Use general tax revenues, either as part of a federal agency’s

budget or as part of existing federal health insurance programs.

We estimate that, for the seven major childhood vaccines, there are probably

no more than 100 or so injuries occurring annually that result in long-lasting or
permanent disability. If, as some experts allege, the estimates of brain damage

due to pertussis (whooping cough) vaccination are inflated, this estimate might

be lowered by as much as 40 percent. In addition, there are probably another 100

- 250 cases of vaccine-related illnesses serious enough to require some period of

hospitalization, but these estimates may also be inflated. Both the small size

of the vaccine-related injury estimates and the uncertainty over them point to a

flexible financing approach that is administratively simple until actual

experiences can be accumulated.

Option 2. Finance the system through a surcharge on vaccines, including it

as part of the costs of a vaccine.

This would be more appropriate to an approach which used financial

incentives to decrease the incidence of injuries, which is not applicable to the

situation here. In addition, as the Federal and State governments are the

principal purchasers of vaccines, this would be a particularly inefficient method

of financing the system, considering the administrative costs that would be

incurred in putting such a mechanism in place and administering it.

Federal/State Relationships

Two issues are involved here: (1) accommodation with existing California

law, and (2) the apportionment of responsibilities between Federal and State

agencies. On the first issue, Congress may simply want the Federal program to

take precedence. The California law covers vaccines for children under age 18 as

required by State law. These vaccines probably comprise the minimum number of

vaccines that would be covered under a Federal program. If the Federal program

covers less than California’s program, the injured vaccinee could use the

California program as supplemental insurance.

How the States and the Federal government would share responsibilities for a

vaccine-injury compensation program depends a great deal on the benefits
10

included. A program similar to California’s, where only medical expenses are

covered up to a limit ($25,000), could be readily established. For example,

Congress may define a “severe adverse reaction” as one requiring “extensive

medical care as determined through regulations issued by the Secretary of the

Department of Health and Human Services” with or without a specified time period

in which the injury must manifest itself. The States could then establish their

own mechanisms for determining whether a claimant qualifies, subject to final

approval of the Secretary of DHHS.

If the Federal program does not place a limit on reimbursement of medical

expenses, as in the case of long-lasting injuries requiring continued medical

rehabilitative care, then perhaps such benefits might be covered through

Medicare. In this case, the States might be primarily involved in identifying

potential program beneficiaries, with the existing Medicare mechanism used to

determine eligibility.

If economic benefits are also included, the type and method of payment again

would affect the particular Federal and State roles. A lump sum payment might be

administered, as for limited medical benefits, by standards set at the federal

level, with actual determination at the State level subject to Federal review.

Annuity payments for total disability could be merged into Social Security and

its eligibility - determining mechanism used. A workmen’s compensation type

system, however, with different annuities for different degrees of disability,

would be a new experience for Social Security. If the program provides economic

benefits for different degrees of disability, then a program similar to Denmark’s

might be used; i.e., lump sum payments for lesser degrees of disability, and

annuities for disabilities that presently quality for Social Security. Of

course, eligibility requirements (aside from severity of disability) would have

to be changed if the vaccine-injured were to be covered by Social Security.
11

Should the Remedy be Exclusive?

Recall that the primary purpose for establishing a vaccine-injury

compensation program is that, when the vaccinee is harmed instead of protected in

public immunization programs, society has the obligation to minimize the

consequences of injury. Secondary reasons were the vaccine manufacturers’

concerns over their liability and difficulties in trying to give adequate warning

to potential vaccinees and obtaining their informed consent without scaring them

into not being vaccinated at all. Vaccine manufacturers would prefer to have the

compensation system as an exclusive remedy, thereby removing the uncertain legal

status over their liability. Under present arrangements, the Federal government

has assumed the “duty to warn” through the vaccine purchase contracts, but

vaccine manufacturers still can be sued. If they lost the “duty to warn” issue,

only then could they sue the Federal government for breach of contract.

Moreover, claimants can allege both a defect in manufacture and failure of the

duty to warn, and the jury might return a general verdict without specifying

which of the two was the basis for its decision. For these reasons, the

manufacturers would prefer a program similar to the 1976 swine flu legislation,

where all claims had to be filed against the Federal Government, who in turn

could sue the manufacturers if negligence was the basis for injury.

Congress might want to consider similar legislation for the vaccines covered

in a vaccine-injury compensation program. Such an approach, however, would mean

a tradeoff between a claimant’s “day in court” and the benefits of the

compensation program. This would probably mean that the compensation program

would have to include some type of economic benefits in addition to medical

expenses reimbursement. And, since such an approach would be a substitute for

present avenues of compensation instead of being supplemental, more issues must

be addressed and more potential interests accommodated.

As for participation in public immunization programs, we do not know if
either a supplemental or substitution approach will make a difference. The

point, however, is that, in either case, informed consent forms may become less

of a way to avoid liability and truly become what DHHS has labelled them --

“Important Information Forms.”

The remainder of this technical memorandum examines some of the foregoing

issues in more detail and provides the information on which this analysis was

based.
13

II. The Federal Government’s Current Approach to Compensation

The issue of compensation for vaccine related injuries has been brought to

congressional and wider public attention most dramatically in the context of the

Federal Government’s sponsorship of a program of mass immunization against swine

flu in 1976. As is well known, the expected epidemic of A - New Jersey influenza

or “swine flu” never materialized. However, an unexpected association between

swine flu vaccination and a form of paralysis known as Guillain - Barre Syndrome

(GBS) did appear. Although only 420 to 460 cases of GBS developed among 46

million vaccinees, as of May 1980, 3,905 claims for all types of alleged injuries

-- for a total of $3.5 billion in damages -- had been filed. Of these claims,

1,167 progressed to lawsuits; 2,365 claims -- totalling $2.2 billion ‘- had been

denied or withdrawn. Only 267 claims or lawsuits had been administratively

allowed or settled out of court; 774

The swine flu program is widely

inherent in compensating for vaccine

were still pending.

regarded as exemplifying the problems

related injuries via the tort law system.

First, it is clear that most of the claims were trivial at best, mischievous at

worst, and that a great deal of time and money has been wasted on distinguishing

potentially valid claims from frivolous ones. More significantly, P.L. 94-380

(the legislation under which the Federal Government assumed the liability that

would otherwise have remained with the manufacturers of the swine flu vaccine)

did not commit the Government to the principle of compensating victims of

legitimate vaccine related injuries. Rather, under this law the Federal

Government simply assumed the manufacturers’ “duty to warn” potential vaccine

recipients of any known adverse reactions to the vaccine. This did not mean that

the Government thereby assumed an obligation to pay all claims for proven vaccine

injuries. Provided that they are warned of the potential dangers, individuals

who proceed with vaccination do so at their own risk. Conversely, only if the

“duty to warn” were not adequately discharged would the Government be obliged to
14

compensate for vaccine injuries under the legal theory of strict liability in

tort. This fact does not seem to be well understood by the public at large. If

there were no element of negligence present and the “duty to warn” were

adequately discharged, there would be no obligation to provide compensation even

in substantiated cases of vaccine induced injury. Under the Swine Flu Act, the

Government agreed only to accept what otherwise would have been the

manufacturers’ legal liability, and, in prior vaccine injury cases, the courts

have never imposed an “absolute liability” on vaccine manufacturers; i.e.,

liability based simply on a cause-and-effect relationship between vaccination and

injury. “Absolute liability” applied to vaccines could by analogy also apply to

all pharmaceuticals. The

phraseology, “unavoidably

causing adverse reactions

reason is that almost all drugs are, in legal

dangerous products,” as they have the potential

in some people.

for

This confusion over the legal theory of strict liability in tort is

compounded by the Department of Health and Human Services’ (DHHS) decision to go

beyond the bounds of what it is legally required to do and compensate those swine

flu vaccinees who developed the Guillain - Barre paralysis. Actually, DHHS did

not make the decision to honor the GBS claims until June 20, 1978, when then

Secretary Califano issued a statement to that effect.

Many people find it difficult to understand why it has taken so long for the

Government to settle the swine flu injury cases -- particularly the GBS cases.

However, the Government was under no clear legal obligation to pay these claims,

and until June 1978 was unwilling to assume any obligation to compensate beyond

the minimum legal requirements to do so. On purely legalistic grounds, the

Government might well have been able to prevail in court on the GBS question.

The key legal issue was whether or not the Government adequately discharged its

duty to warn vaccine recipients prior to vaccination of potential harmful side

effects, and the Government could have argued that it should not be held
15

accountable for a failure to warn of risks that were unknown at the time.

Moreover, as of early 1977, an informed consent form that did warn of the

possibility of GBS was put into use in the swine flu immunization program. Thus,

the Government could have argued that persons who received swine flu shots after

the new consent form was adopted had been properly warned and therefore had

elected to “assume the risk” of contracting GBS.

Current Federal policy on vaccine related injuries in public immunization

programs is patterned largely on the model provided by the Swine Flu Act. DHHS

is assuming the obligation to warn of side effects from vaccine manufacturers

through the vaccine purchase contracts.

its grant guidelines, that the State and

consent forms, or “Important Information

The assumption by DHHS of the “duty

the vaccine manufacturers, who would not

In addition, DHHS is requiring, through

local health agencies use informed

Forms,” developed by DHHS.

to warn” was done at the insistence of

otherwise have continued to supply

vaccines for public immunization programs. Here again, the only way an injured

vaccinee can legitimately claim a right to compensation is if s/he can prove that

the government’s warning was inadequate. To date, DHHS has pursued a strategy of

developing informed consent statements and procedures for their distribution that

it hopes will meet court tests of their adequacy. Thus, at the present time,

DHHS’S posture is a classical “adversary” stance; i.e., the apparent intent is to

be in a position to go to court and argue that, by signing an informed consent

form, a vaccinee has assumed the risk of injury and is therefore not entitled to

compensation.

Of course, the fact that an adequately warned injured vaccinee cannot

legally claim an entitlement to compensation does not necessarily prevent DHHS

from choosing to provide compensation -- as in the case of GBS from swine flu

vaccination. Exercise of this discretion, however, may put the DHHS in the

position of appearing to act in an arbitrary manner if it chooses to compensate
some individuals or categories of injured individuals, and not others. DHHS has

not issued a clear statement that explains its criteria for deciding when to

allow some claims for compensation and not others.

In trying to resolve the issue of responsibility for the consequences of

non-negligently caused, unavoidable vaccine injuries, the key question arising

out of the swine flu experience would thus appear to be: Should the Government

compensate injured vaccinees, and, if so, on what grounds? A clear delineation

of the valuative criteria underlying any recognition by the Government of an

obligation to provide vaccine injury compensation is an essential element of a

compensation program. It is necessary in order to be able to assure those who

are accorded compensation, those who are denied it, and the public at large, that

compensation decisions have been made fairly rather than capriciously. A clear

statement of principles is also the Government’s best defense against a plethora

of frivolous or invalid claims for compensation. One of the strongest critics of

the swine flu compensation program compared it to a lottery. If this was the

public perception of the program, then it is understandable that the program

might have tended to attract “gamblers” who viewed themselves as having at least

an outside chance to gain and nothing to lose by filing claims for compensation.

In the absence of a compensation system, DHHS is more or less locked into

developing a legal defense around fulfillment of the “duty to warn.” There iS

cause for concern, however, that this defense may not survive court challenges.

First, as a practical matter, the “duty to warn” may not be satisfactorily

discharged in mass immunization programs. A recent GAO Report tends to support

this contention. GAO found that many vaccinees or parents of vaccinees have

problems reading and understanding the forms:

Even though vaccinees are required to sign the information statements or an

accompanying card, we observed, local officials told us, and a CDC study showed

that potential vaccinees may not read or understand the significance of the

statements. Possible explanations for this are (1) apparent public disinterest

in the content of the forms, (2) inadequate attempts by service providers to
explain the importance of the forms, and (3) language barriers.

For example, in one State, the Director of the Bureau of Communicable

Disease Control said that, although signature cards are signed as required, he

doubted that many of the parents whose children are vaccinated in public clinics

read the important information statements. We observed in another State that, in

a 30-minute period, 15 children were vaccinated in a public clinic, but only one

of the accompanying adults read an important information statement. The

statements were available in the vaccination area, but none of the clinic

personnel were attempting to have them read. Nevertheless, the adults were

signing signature cards indicating they had read and understood the statement.

CDC’S field test of the childhood immunization information statements showed

that, for about 20 to 30 percent of the vaccinees, their parents or guardians did

not read the entire statement. Another 12 to 25 percent answered “don’t know”

when asked questions about the disease, the vaccine, and the number of doses and

precautions. Sixty-five percent answered “yes” or “don’t know” when asked if

injectable polio vaccine caused paralysis. Properly constituted injectable polio

vaccine is not thought to cause paralytic reactions; however) paralytic polio has

been associated with oral polio vaccine.

Problems also exist in securing signatures from appropriate parties on the

important information forms (or signature cards). In one State, the signature

cards can be signed by any adult accompanying a child. Some State officials said

that sometimes getting signatures for children coming to public clinics is

difficult because the children are not always accompanied by their parents or

guardian.

Several State officials complained about having to get signatures for each

childhood disease vaccine given rather than by series. They claim that such a

procedure is excessive. An HEW Indian Health Service official told us that

getting necessary adult signatures for each vaccine given to Indian children on

reservations posed a logistical problem. When children arrive at Indian Health

Service clinics for their immunizations, they are not always accompanied by a

parent or guardian. In some cases clinic staff travel many miles on a

reservation to obtain the appropriate signatures (GAO, 1980).

What is a more serious weakness in the Government’s defense strategy is the

contention that a properly warned vaccine recipient has assumed all risks of

injury. Such an argument does not make sense, however, unless the vaccinee can

refuse the vaccine. But vaccination is mandatory in many states for school entry

(which itself is mandatory) and refusing vaccination in these cases is very

difficult.
19

111. Major Arguments For And Against Establishing A Compensation Program

One of the major arguments against a Government-funded vaccine injury

compensation program is also the argument against the current policy in which the

Government has assumed strict liabllity in tort for non-negligently caused

vaccine injuries. The argument is that, because the injuries are foreseeable in

terms of being statistically predictable, the costs of vaccine injuries should be

regarded as among the costs of doing business and therefore should be borne by

the vaccine manufacturers. Those who make this argument can cite the opinion of

the court in the Reyes decision (a vaccine induced polio case). The court noted

a “policy factor” at work and stated:

Statistically predictable as are these rare cases of vaccine-induced polio,

a strong argument can be advanced that the loss ought not to lie where it

falls (on the victim), but should be borne by the manufacturer as a

foreseeable cost of doing business, and passed on in the form of price

increases to his customers (Reyes v. Wyeth Laboratories, 1974).

Here, the court was trying to address compensation for faultless injury through

the existing tort law system, but the judicial aproach to compensation has severe

limitations.

The rationale for compensating victims of vaccine injuries is that such

persons have suffered personal tragedy in the pursuit of a public good. Where

vaccination is mandatory, vaccine injured persons have sustained their injuries

in an effort to comply with the law as well. The purpose of mass immunization

programs is not only to protect each single vaccinated individual from a disease

but also to provide “herd immunity,” a concept which refers to the resistance of

a grouP or population, based on the immunity of a high proportion of individual

members of the group to invasion and spread of an infectious agent. Because of

“herd immunity,” the immunization of the many serves also

are not immunized.

The fact that vaccines also confer benefits on those

to protect the few who

who do not take them
make them into a classic example of what economists term a “collective good.”

Thus, if an ethicist were to argue the case in favor of mandatory vaccination

laws (as is the case in most states), one argument that would probably be made to

justify the coercion is that it prevents “free riding.” Nowhere is this more

starkly evident than in the case of polio vaccination, where, as long as the rate

of immunization among the total population remains sufficiently high to maintain

herd immunity, the chances of contracting polio from the vaccine are likely to be

greater than the chances of contracting polio via natural exposure. Under these

circumstances, those few persons who contract polio from the vaccine can be said

to have made a sacrifice on behalf of society at large.

Judicial doctrines like duty to warn, informed consent, and assumption of

risk, based on paradigms of commercial relations between private

individuals, cannot fully capture the responsibilities that hold between the

individual and society as a whole. They operate capriciously in some cases

to impose unfair costs on manufacturers or the government, in other cases to

leave the entire burden of injury on the individual. In addition, the high

cost of administering compensation rules through the judicial system imposes

unnecessary burdens on plaintiff and defendant alike (Gaskins, 1980).

In other words, a judicial approach to compensation would be inequitable and

inefficient. Those successfully seeking compensation through the courts may

receive high monetary awards, while those not seeking judicial recourse would

receive nothing. Yet, even for the successful litigants, actual compensation

would be made several years after the injury, a typical time-table for judicial

resolution.

In addition, the uncertainty of exposure to lawsuits makes it difficult to

predict the expenses of such a compensation approach. Accordingly, manufacturers

and their insurance companies would be likely to determine prices based on a

worse-case estimate. And whatever monies the government would pay out to cover

the potential costs of vaccine injuries would, if paid via the pricing mechanism,

be lost to the government regardless of whether or not these monies were ever

used to pay injury claims.
21

Two arguments are frequently made that suggest that an administrative

compensation program is necessary to maintain the integrity of Federal

immunization programs and to enable these programs to attain their goals.

These arguments are: (1) In the absence of a compensation program for

vaccine injuries, people will refuse in increasing numbers to be immunized. (2)

Vaccine manufacturers are likely to stop producing vaccines unless they can be

assured of protection against financially devastating lawsuits for

non-negligently caused vaccine injuries. A compensation program is therefore

necessary if high rates of immunization are a public policy goal and to provide

vaccine manufacturers with protection.

On the question of whether fear of vaccine injuries has adversely affected

public participation in mass immunization programs, the Opinion Research

Corporation of Princeton, New Jersey, conducted two nationwide telephone surveys

for the Center for Disease Control (CDC) in September 1977 and February 1978, in

each of which more than 2,000 parents and other adults were asked about their

attitudes toward immunization for themselves and their children. 90% of those

interviewed believed generally that vaccinations are moderately to very safe.

Poor, uneducated, low income blacks were, however, significantly more skeptical

about vaccine safety than others. The majority of people (82%) felt that trying

to immunize people by a mass program is an effective way to fight a very

contagious disease. 79% said that they personally would want to be immunized

against a contagious disease such as polio. More specifically, fears concerning

safety were not cited as significant reasons for not having one’s children

immunized, except in the case of the flu vaccines. For Influenza B, 4% of

parents said they would not have their children immunized because they considered

the vaccine unsafe. Another 4% said they would not have their children immunized

against Influenza B because the vaccine would not do any good. The percentages

were the same for the Asian flu vaccine.
22

Not surprisingly, concerns about vaccine safety and efficacy were greatest

in regard to the swine flu vaccine. 17% of parents interviewed in 1977 said they

would not have their children immunized against swine flu; in 1978, this

percentage dropped to 8%. Only 53% of respondents said they would want a flu

shot if there were to be a national immunization program against flu.

Data on public attitudes toward immunization are of added interest because

public health officials have been concerned in recent years about falling

immunization rates in the population as a whole.

...vigilance in maintaining immunization levels has waned and large numbers

of children are not adequately immunized. In 1976, more than a third of all

children under age 15 were not properly protected and the following year

rubella cases increased by 63% measles cases by 39%

by 115 percent (USDHEW, 1979).)

Fears about vaccine safety and efficacy are not the

falling rates. Among interviewees who said they did not

and whooping cough cases

major reasons for the

intend to have their

children immunized, the single major reason given was that they did not believe

vaccination was necessary. For some diseases (measles, rubella, and, especially,

mumps and influenza) the belief that immunization is not necessary seems to be

related to a belief that the disease itself is not serious. In other cases,

(e.g., polio, diphtheria, tetanus) the disease is regarded as very serious, but

highly unlikely to occur. Another opinion survey indicates that people believe

immunizations are now unnecessary because most children’s diseases have been

conquered (Yankelovich et al., 1979). This belief is held by a significant

portion of minority parents, 22% of the minority parents in the survey sample.

The majority (80%) of parents surveyed in the Opinion Research Corporation

study were aware of state laws or regulations requiring children to be immunized.

Most of these (92%) would have their children immunized even if no such

requirements existed. The findings suggest that at least 6% of parents might not

have their children immunized were it not for state laws. 20% of parents were

unaware of state immunization laws although all but 1% lived in states having
such laws.

These findings indicate that DHHS will need to engage in more public

education campaigns in order to meet its announced goal of attaining and

maintaining 90% immunization against the major childhood diseases.

Currently, vaccine manufacturers have agreed to continue to supply vaccines

for government programs, contingent on DHHS’S contractual assumption of the “duty

to warn.” Under the 1976 swine flu legislation, claims of injury have to be

filed exclusively against the Federal Government. Under current contractual

arrangements, however, a manufacturer or other vaccination program participant

can be sued, and the contract only allows the manufacturer to sue the government

if damages were awarded because the government failed in its duty to warn.

Additionally, a plaintiff can allege that an injury resulted either from a defect

in manufacture or from a failure to warn, and a jury might return a general

verdict of liability without specifying the reasons for its decision. For these

and other reasons, vaccine manufacturers still feel vulnerable to lawsuits for

non-negligently caused vaccine injuries and favor a compensation system that

would be the exclusive remedy for persons who allege injuries caused by

participation in public immunization programs (Kingham, 1980). This would be

similar to the 1976 swine flu legislation, where suit had to be brought against

the Federal government, which retained the right to recover damages from program

participants who negligently caused the injury.
25

IV. The Types and Estimated Numbers of Vaccine-Related Injuries

Typically, adverse vaccine reactions are mild and self-limiting, for

example, a sore arm or possibly a fever for a day or two. Less frequently,

transient reactions occur that are more unpleasant and frightening; for example,

some babies (1 in 12,000) display a pattern of abnormal screaming for several

days following DTP vaccination. DTP vaccination may also be followed by

convulsions (1 in 5,000);

these are short-lived and

(but more commonly, adult

however, in the absence of other neurological symptoms,

leave no permanent brain damage. Similarly, children

women) occasionally suffer from temporary arthritis

(less than two weeks) following vaccination against rubella (German measles).

For an exceedingly small number of vaccinees, adverse reactions take the

form of serious illness that result in long-lasting or permanent disability or

even in death. Among the least serious of such reactions are cases of

encephalitis (inflammation of the brain) which require hospitalization but from

which the patient does eventually recover fully. In some cases encephalitis or

some other still rarer neurological disorder results in permanent brain damage.

Brain damage may manifest itself via physical disability (e.g., loss of motor

coordination) but more often takes the.form of mental retardation. Occasionally,

encephalitis or other neurological disorders prove fatal.

Live oral polio vaccine carries a very slight risk of resultant polio

disease (1 in 4,000,000). It is actually more common for polio to occur in

adults who have close contact with young children who have been vaccinated with

live oral polio vaccine. Typically, these adults were never vaccinated against

polio or received less than the full series of live oral polio vaccine in the

days when the three types were administered separately. Apparently, some

individuals are more likely to express paralytic polio reactions to the continued

very low level of virulence in a given virus.
26

Guillain Barre paralysis does not appear to be associated to any significant

degree with vaccines other than A - New Jersey influenza vaccine (i.e., the swine

flu vaccine). A special study carried out by CDC found that the relative risk of

developing GBS within 8 weeks of influenza vaccination during the 1978 - 1979 flu

season was 1.4 per million vaccinees as compared to a non-vaccine-related natural

incidence of 1 per million. In contrast, the incidence rate associated with

swine flu vaccination for the equivalent 8 week period was 6.2 per million.

Similarly, while CDC’S adverse reaction monitoring system has received reports of

GBS occurring within 4 weeks following almost all of the childhood vaccines, the

evidence thus far suggests that these are probably naturally-occurring cases

coincidental with vaccination. One of the difficult decisions that will have to

be made if a compensation program is established is whether or not to extend the

benefit of doubt to such cases and provide compensation. In 1978 - 1979, CDC

received 22 reports of GBS occurring within 4 weeks of vaccination.

Finally, there is a slight risk (estimated at 1 in 10,000,000) that a person

receiving a vaccine may go into anaphylactic shock (a very severe form of

allergic reaction) and die. Almost all such deaths due to anaphylactic shock

would be expected to occur within minutes of vaccination. Less severe

anaphylactic reactions would not normally be expected to have lasting

consequences.

No one really understands why these various adverse vaccine reactions occur.

In many cases the biology of the individual vaccinee appears to play a role.

Some injured vaccinees may have subtle immunological deficiencies; others may be

particularly prone to allergic reactions. On the other hand, certain methods of

culturing viruses for vaccine production seem to be associated with higher rates

of adverse reactions; e.g., dog-kidney versus duck-embryo cultured rubella

vaccines.

Also, it can take years of experience for scientists to determine the proper
27

degree of attenuation (weakening of the virus so that infection is inhibited but

the immunological response is retained) for live viruses that will secure

maximum immunity with a minimum risk of adverse reactions. However, over the

years, continued research on improving vaccines as well as various immunization

policies (such as focusing immunization campaigns on children, who tend to be

less susceptible than adults to adverse vaccine reactions) have resulted in a

lowering of the adverse vaccine reaction rates for most vaccines currently in

wide use.

The major adverse vaccine reactions are described in the following pages

(A.D. Little, 1979). Some of the adverse vaccine reactions described below in

connection with a specific vaccine may occur in connection with other vaccines as

well. Anaphylaxis is an example; it is believed to occur or to have a potential

for occurrence with all vaccines, although it is expected to be more common in

connection with DTP, due to the comparatively less-refined character of pertussis

vaccine.

DTP (Diphtheria/Tetanus/Pertussis) Vaccine

Potential adverse

include: anaphylaxis,

reactions that have been linked to DTP vaccination

convulsions, peripheral mononeuropathy, and encephalitis.

Most of the adverse vaccine reactions associated with DTP vaccine are

attributed to the pertussis (whooping cough) component, as researchers have not

yet succeeded in developing a pertussis vaccine that is as refined as most other

vaccines currently in use.

Anaphylaxis: Anaphylaxis is a form of allergic reaction whose outcome can

range from rapid death to benign local reactions that subside spontaneously.

Most serious reactions occur within 12 hours of exposure; fatal reactions usually

begin within minutes of exposure. Accordingly, a presumptive causal linkage

between the vaccine and severe cases of anaphylaxis should not be too difficult
28

to establish. There is a possibility that in some cases death due to SIDS

(Sudden Infant Death Syndrome) could be mistakenly attributed to DTP induced

anaphylaxis or vice versa.

Anaphylactic reactions to DTP vaccines, and fatal ones in particular, are

quite rare. The most frequently reported outcome is complete recovery.

From the perspective of a compensation system, the most costly potential

outcome is a recovery with brain damage. Although theoretically possible, no

such cases have actually been reported. It is hypothetically possible, however,

that modern resuscitative techniques could result in an improved survival rate at

the expense of brain damage among some percentage of those saved from death.

Medical costs in the event of mild to moderate anaphylaxis would be expected

to be low because no or only brief (l-2 day) hospitalization would

characteristically be required, and long-run effects requiring medical attention

would not be expected. Medical costs associated with death would also be

expected to be low because death, when it occurs, is usually an immediate

reaction.

Convulsions: Convulsions occurring within 48 hours of immunization are

considered most likely to be causally related to vaccination. The frequency of

convulsions following DTP vaccination is uncertain. One set of estimates based

on recent prospective studies gives a range of 1 per 1,000 to 1 per 2,200

vaccinations. Other estimates range from 1 per 3,200 to 1 per 50,000. The

estimate by the Center for Disease Control is 1 in 5,000.

Patterns of convulsive episodes are apparently quite variable. There may be

a single short convulsion , multiple short convulsions over a period of hours to

several days, a prolonged 5-10 minute convulsion, or continued convulsive

activity. Convulsions alone are rarely fatal.
29

In most cases the outcome is complete recovery with medical costs being

primarily a matter of diagnostic tests and follow-up visits for monitoring

purposes. In rare. instances patients may develop chronic epilepsy with or

without mental retardation or become hyperactive and retarded. Should

hyperactivity and/or retardation develop, the need for special education or

long-term care would generate high medical costs.

Encephalitis, Encephalomyelitis and Aseptic Meningitis: These terms refer

to various conditions involving abnormal necrologic function due to inflammation

of the central nervous system. It is thought that such conditions, occurring

within 48 hours of DTP vaccination, have a high probability of being vaccine

related. Some encephalitic reactions are relatively short-lived (36 hours at

most) and always end in complete recovery. These short-lived reactions include

unusual and persistent crying and a syndrome known as “collapse” that is marked

by decreased spontaneous activity, extremely poor fluid intake, lethargy and

pallor. One prospective study of 2,298 children found the incidence of

persistent crying to be 5.9% and of “collapse” to be 0.2%. Medical costs

associated with these types of reactions would be low because patients appear

always to recover without lasting effects and only in the case of the

comparatively infrequent “collapse” syndrome is hospitalization (of about three

days on average) considered warranted. .

There is a

encephalopathic

Conference, CDC

great deal of uncertainty surrounding the incidence of

reactions following DTP immunization. At a 1977 PHS Immunization

officials cited an estimate of 0.009 cases of encephalopathy per

1,000 associated with pertussis vaccination and an incidence of 0.006 per 1,000

of retardation. In 1977, a British commission tentatively concluded that the

risk of brain damage following DTP vaccination was probably about 1 in 300,000.

Good data on the incidence of encephalopathy related to DTP does not appear to be

available. In Britain, where adverse reactions related to pertussis vaccine
30

became a political issue due to the efforts of the Association of Parents of

Vaccine Damaged Children, there has been more attention paid to the question of

the incidence of encephalopathy or other neurological disorders following DTP

vaccination than in the United States. The following quote from an article on

the British controversy both summarizes the available data and the problems with

the data:

Encephalopathy or other serious neurological complications following

whooping cough vaccination have been recorded by several individuals, but to

establish an association between the event and the vaccine is again not

easy. The problem is usually made more difficult because the evaluation of

the illness and the evidence has usually been made in retrospect.... The

available reported information on the frequency of serious neurological

complications of all types following whooping cough vaccine are variable,

and estimates of their frequency have varied from no cases of encephalopathy

in about 19,000 children who were following up in the MRC trials of 1948 and

1957 in the United Kingdom to four or five serious neurological illnesses in

215,000 children inoculated in Sweden in 1955-58 (Malmgren et al.,

reviewing the data of Strom) which gives a rate of 1:50,000 and three cases

of ‘destructive encephalopathy’ between 1959 and 1965 in 516,276 children in

Strom’s second series in Sweden. A guess of 1:10,000 to 1:50,000 which was

based on unconfirmed data from various sources using vaccines which were

available in the UK prior to 1968 was made by Dick. This guess is very

similar to the estimates arrived at by Malmgren et al. and Strom for the

vaccines used in Sweden in the 1960s. Hannik has recorded cases of

encephalopathy associated with quadruple vaccine in the Netherlands, but it

is not possible to calculate the frequency.

No serious neurological complications have been reported in a study

which began in January 1975 and is as yet incomplete and unpublished, in

80,000 children in the North West Thames Region who had recently received a

primary dose of triple vaccine. The number so far studied is too small to

make it possible to draw any sensible conclusion. All of the above studies

except that of Pollock were essentially retrospective.

From personal experience of trying to evaluate retrospectively

neurological complications allegedly associated with the administration of

whooping cough vaccine, perhaps less than 20% of them merit serious

consideration because of inaccurate diagnosis (see also Stephenson and

Ounsted) and of the onset of an event in time which could in no way be

rationally associated with immunization (Dick, 1978).

Occasionally serious encephalitic reactions end in death, typically after a

hospital stay of about 10 days. The medical costs associated with such deaths

would tend to be high because of the lengthy hospitalization and intensive

nursing and physician care during hospitalization. Survival with serious

permanent neurological disability is, of course, costly, both in terms of the
31

lengthy and intensive hospital care involved but even more so because of the need

for intensive rehabilitation therapy, special schooling, and sometimes long-term

institutional care for retardation.

Peripheral mononeuropathy: Peripheral mononeuropathy is a reaction that

affects the peripheral nerves causing disorders of sensation, mobility or

visceral function. Typically the symptoms begin 7-10 days after vaccination, but

the onset of the reaction may range from a few hours to six weeks following

injection.

Patients exhibit weakness in the tendons and often a decreased sense of

touch in the area. The reaction reaches maximum severity within a few days.

Maximum severity may range from a complete paralysis of the affected muscles to a

mild paresis. Most patients make a complete recovery but in a few instances

there may be residual weakness or impairment of movement. The most serious type

of residual impairment that can be anticipated is a “winged scapula” that

diminishes shoulder mobility for life.

Development of mononeuropathy following DTP vaccination seems to be mainly

characteristic of adult males. Of the 21 cases ever reported, only four were

children, the rest were adult males. The main population at risk appears to be

men in military service who undergo strenuous exercise involving possible trauma

to nerves, as well as mutiple immunizations.

Peripheral neuropathy can also be caused by physical trauma to the affected

areas or by a toxic reaction to heavy metals. It may sometimes be mistaken for

Guillain-Barre syndrome.

Medical costs can be anticipated to be fairly high because recovery is slow

-- 2 to 3 weeks at best and may take up to a year -- and physical therapy is

indicated. In the few instances of permanent disability, vocational counseling

and/or retraining might be necessary.
32

Measles Vaccine

Adverse reactions associated with measles vaccine include: acute aseptic

meningitis and acute encephalitis syndrome.

Acute Aseptic Meningitis and Acute Encephalitis Syndrome: There has been

great difficulty in clearly associating live measles virus vaccine with acute

central nervous system syndromes occurring soon after vaccination. The Center

for Disease Control has, however, adopted the rule of reporting all such

syndromes occurring within 30 days of vaccination as vaccine related. Over the

years since live measles vaccine was introduced, reported rates of

meningoencephalitis have varied between 0.92 and 1.16 cases per million doses of

vaccine dispensed. The reported incidence of measles-vaccine meningoencephalitis

is thus approximately 1,000 times less frequent than the rate associated with

natural measles virus infection. Acording to one published research report

(Landrigan & Witte, 1973), from 1963 through 1971, 84 cases of necrologic

disorders with onset less than 30 days after vaccination were reported in the

United States. 13 cases could be accounted for by causes other than vaccine, and

another 11 were uncomplicated febrile convulsions probably related to

vaccination. One case met the diagnostic criteria for subacute sclerosing

panencephalitis. The remaining 59 showed clinical features of encephalitis or

encephalopathy. The causes of these cases could not be established, but 45 had

onset between 6 and,15 days after vaccination, which suggests a causal

relationship with the vaccine. All 59 cases involved serious neurological

disorders. Five cases were fatal. 26 recovered fully. 19 were left with

residual disability: ataxia in two cases, retardation in 11, learning disability

or hyperkinesis in another 3, seizure disorders in 9, and hemiparesis in 4.

Symptoms of encephalopathic disorders are quite variable and may include

fever, vomiting and seizures, irritability and lethargy, possibly followed by

coma or stupor. For this reason these disorders may readily be confused with a
33

host of other neurological problems or other diseases having similar symptoms.

The illness may last only a few days, followed by complete recovery, or may

be prolonged and severe with residual neurological impairment including

paralysis, epilepsy, and mental retardation. Death occasionally occurs.

In most cases of prolonged severe illness medical costs can be expected to

be high both because of the lengthy hospitalization and the fact that those most

severely afflicted often require intensive life maintenance measures during the

period when cerebral inflammation is at the maximum. Similarly, in cases where

the eventual outcome is death, lengthy hospitalization and heroic life support

measures would lead to high medical costs.

would also be expected to entail high costs

intensive physical therapy and, in the case

care that might be needed.

Mumps Vaccine

Recovery with residual impairment

because of special equipment,

of mental retardation, the long-term

The adverse reaction associated with mumps vaccination is encephalitis.

Encephalitis: Encephalitis following natural mumps infection has been well

documented; accordingly, it was expected that there would be some incidence of

vaccine-induced encephalitis. The incidence of mumps vaccine related

encephalitis has been calculated at 9 cases per million vaccinees, an incidence

rate that might be too low because of underreporting and poor documentation. The

reason for considering this estimate as too low is that the reported incidence of

mumps vaccine related encephalitis contrasts strongly with the reported incidence

of 2,600 cases of encephalitis per million cases of mumps.

Meningoencephalitis, with symptoms including headaches, photophobia, and

stiff neck, appears to be more common than true encephalitis, with symptoms

including confusion, loss of memory, weakness or paralysis and coma in severe
34

cases. Other reported conditions specifically known to have occurred

vaccine associated encephalitis include seizures, dizziness, deafness,

with

cranial

nerve palsies, diplopia, hemiparesis, and optic atrophy. The latency period

between vaccination and onset of the disease appears to range from 1 to 55 days.

Length of illness is expected to last from 4 days in mild cases to six weeks in

severe cases.

In all reported cases of vaccine induced encephalitis in which the outcome

is known, there was recovery. It is generally believed that recovery was

complete, with no residual impairment, although lack of documentation makes this

uncertain; however, wild virus induced encephalitis has not been known to leave

residual effects and, typically, vaccine related side-effects are less severe

than naturally occurring ones. The only lasting impairment that is

hypothetically anticipated as potentially occurring is partial blindness.

Polio Vaccine

Vaccine associated adverse reactions include encephalitis, meningal

encephalitis and encephalopathy without paralysis, and paralytic polio.

Encephalitis, Meningal Encephalitis, and Encephalopathy: The medical

literature on these conditions -- often referred to collectively as “nonparalytic

polio” -- appears to be rather confusing. Cases have been reported of adverse

reactions to both live and killed polio virus vaccines, but descriptions of such

reactions tend to be sparse and lack precision of definition.

Thus, as well-defined clinical syndromes, descriptions of these reactions

must be taken from the pre-vaccine poliomyelitis literature. On such a basis,

these syndromes are described as typically beginning with an acute onset of

fever, headaches, nausea and vomiting, which may be accompanied by pain in the

legs and neck, cough, sore throat, backaches, nasal discharge, drowsiness,

photophobia, convulsions, seizures, frothing at the mouth and constipation. The
35

course of the disease is quite variable and despite the label “nonparalytic

polio” may include muscle weakness or even temporary paralysis as a component.

Typically, the course of the disease is benign though prolonged; symptoms such as

headache and stiff neck may last more than two weeks. Though total recovery is

anticipated in most cases, death can occasionally occur (following about three

weeks hospitalization and use of a respirator to sustain breathing artificially).

In addition, permanent impairment in the form of serious behavioral disturbances,

convulsions or mental retardation can occasionally result. Medical costs in

these instances would be quite high due to the need for special education and

vocational training. Lifetime placement in a residual facility for the

emotionally/behaviorally disturbed or mentally retarded might be necessary.

Paralytic Polio: The occurrence of typical paralytic poliomyelitis

following immunization with live virus vaccine has been documented in four

clinical circumstances: (1) in vaccine recipients, (2) in contacts of vaccine

recipients in the household, (3) in communities where live polio vaccine is being

utilized but where clearcut contact by the afflicted person has not been

demonstrated, and (4) in immunodeficient individuals in all the above categories.

Recent CDC estimates of risk for live polio vaccine induced paralytic polio

in the U.S. are 10/193,000,000 doses of vaccine for recipients and 32/193,000,000

doses of vaccine for contacts. Taken together, these translate, rounded off, to

the 1 in 4,000,000 estimate often cited. The risk for immunodeficient

individuals is estimated at 10,000 times the above risk factors.

Recipient cases occur in children, since the risk of live polio vaccine for

adults was recognized some time ago and its use in adults has been discontinued.

Contact cases, however, are mainly adults in the household, exposed to vaccinated

infants. Cases in adult contacts as well as among the immunodeficient are more

likely to be lethal.
36

Typically, the disease is non-progressive with paralysis limited to the

sites of original involvement. Residual weakness or paralysis of varying degree,

rather than complete recovery, is the rule.

Generally speaking, vaccine association is readily accepted if polio occurs

in a vaccine recipient within 3-60 days of vaccination. There is disagreement as

to the earliest onset, with periods of 4-15 days having been cited. Most cases

occurring before 4-12 days are thought to be due to natural polio, with

vaccination being coincidental.

“Mild polio” is defined as illness requiring less than two weeks hospital

stay, with the outcome being complete recovery or some residual paralysis in one

limb only or a unilateral weakness. “Moderate” polio involves 2 to 3 weeks or

more of hospitalization and permanent limb paralysis in one or multiple limbs.

These cases typically require physical and occupational therapy for 3-6 months to

a year, some home health care for several months, special equipment (wheelchairs,

braces, home modification, etc.) and possibly a short stay (e.g., two months) in

a rehabilitation facility. “Severe” paralytic polio requires a lengthy (2-3

months) acute care hospital stay and leaves a significant handicap, often

affecting respiration. In some cases mechanical assistance to sustain breathing

and other life support measures might be needed. Some of these cases would be

expected to result in death after 2 to 3 months of intensive hospital care or as

long as 2 years in a skilled nursing home. In cases of severe polio not

resulting in death, extensive physical and occupational therapy, home health

services over a period of months to a year or more, special equipment, and 2 to 6

months stay in a rehabilitation facility, would be required. Long-term

institutionalization is, however, not expected to be necessary.

Adverse vaccine reactions associated with rubella vaccine include
37

arthritis/arthralgia, neuritis, and thrombocytopenic purpura.

Arthritis and Arthralgia: Arthritis/arthralgia following rubella

vaccination may take either an acute or chronic form with the former much more

common than the latter. Onset is expected to occur within 60 days of

vaccination. Since the replacement of dog-kidney by duck-embryo vaccine, the

probability of this reaction in children appears to have been all but eliminated.

The population at risk is thus adult women of childbearing age who take the

vaccine primarily in order to guard against birth defects that might be caused by

having rubella during pregnancy. The incidence of rubella associated

arthritis/arthralgia among adult women is rather high; 10% of women 15 to 17

years of age and 43% of women 22 to 41 years of age developed arthritis with the

duck-embryo vaccine. The risk is greater for those individuals with a personal

or family history of arthritis.

The prognosis is almost always excellent in rubella vaccine associated

arthritis. In general there is no need for hospitalization and the period of

disability lasts less than two weeks. Occasionally an acute case might need

surgical intervention and an attendant short hospital stay. In the less frequent

cases of chronic, recurrent disease there may be complete recovery or there may

be a need for surgical intervention with residual impairment. Occasionally,

severe permanent disability may result, necessitating extensive physical or

occupational therapy and lifetime placement in an intermediate care facility. A

more likely occurrence in the case of chronic arthritis would be mild to moderate

recurrent disease in which there would be occasional loss of time from work or

decreased productivity. These outcomes are rare, however, and would be far more

likely to occur in adult women than in children, who are the main population

affected in mass immunization programs.

Neuritis: The incidence of rubella induced neuritis appears to have been

markedly reduced following the replacement of dog-kidney by duck-embryo vaccine.
38

Onset of symptoms has occurred between 7 and 99 days, with the mean interval in

connection with the duck-embryo vaccine being 2 weeks. No cases involving adults

have ever been reported.

There are

so-called “arm

forearm, wrist

two distinct syndromes: (1) brachial radiculoneuritis or the

syndrome” in which the patient awakens at night with pain in the

and hand that lasts 30 to 60 minutes, abating, then recurring a

short time later during the night; and (2) lumbosacral radiculoneuritis or

so-called “catcher’s crouch syndrome” in which the patient has pain in the knees

and walks on the toes with a characteristic crouching gait. Typically the gait

disturbance is worse in the morning and may disappear by noon. In a prospective

study of 32 patients with rubella associated neuropathy, there were 8 children

with the “arm syndrome,” 19 with “catcher’s crouch syndrome,” and 5 mixed cases.

Only 2 cases of “catcher’s crouch syndrome” qualified as severe and recurrent.

Complete recovery is the anticipated outcome in all instances, typically

within 1 to 6 weeks, though in chronic recurrent cases complete recovery may

require as long as 6 months. Hospitalization is not anticipated with the

exception of rare instances of chronic recurrent “arm syndrome” with immobility

of thumb and index finger, in which a brief hospital stay for neurological

testing might be required.

Thrombocytopenic Purpura:

count in the blood, which, as a

Thrombocytopenic purpura refers to a low platelet

naturally occurring complication of rubella, has

been known to lead to gastrointestinal hemorrhages or cerebral hemorrhages, the

latter leading in turn to brain damage. Although these are theorized to be

possible outcomes of a rubella vaccine induced low platelet count, no such case

has ever been documented. Although low platelet count per is thought to be a

fairly common occurrence following rubella vaccination, the actual incidence is

not known, because the condition has no clinical manifestion that would cause the

patient to be given the blood test necessary for detection. The only clinical
manifestations associated with rubella vaccination are red spots, indicating

slight bleeding under the skin.No medical care other than two office visits to

a pediatrician has been required in actual known cases.

Influenza Vaccine

The association between influenza vaccine and Guillain-Barre syndrome came

to light during the 1976 mass immunization campaign against swine flu. It is not

currently known whether Guillain-Barre syndrome is associated with other

influenza vaccines as well.

The latency period is typically 1 to 3 weeks.The first symptom of

Guillain-Barre is muscle weakness followed by progressive paralysis (often

ascending up the torso).Typically the progression of paralysis takes two weeks

but can occur gradually over a period of up to 2 months.Facial weakness and

involvement of cranial nerves takes place in 50 to 80% of cases, especially

vaccine associated cases.Urinary incontinence or retention occurs in 20% of

cases but is transient.From 10% to 25% of patients may have paralysis of

breathing and require artificial respiratory support. Pulmonary complications,

seizures, and residual necrologic defects may occur but, typically> complete

recovery is gradually achieved in one year.Mortality, usually from respiratory

involvement, is approximately 5%.Residual paralysis occurs in 10 to 30% of

cases.

Generally speaking, it is expected that 50 to 60% of Guillain-Barre victims

can return to their normal routine within one year.Approximately 15% will be

completely disabled permanently.Relapses can occur weeks or even years

following the original attack.

The relative risk in swine flu vaccinated persons was found to be 12 times

greater than in unvaccinated persons.All ages were at risk, though the risk was

higher among adults,especially young adults (25-44) and those over 65.The most

F,’j- +; ‘ - ~g - L : II:, 3
40

recent calculation of comparative risk is 6.29 per million among those vaccinated

against swine flu versus 0.58 per million for the unvaccinated poulation (DHEW,

1980).

Even a mild case is estimated to require a minimum of 3 weeks

hospitalization and 3 months of frequent physical therapy following hospital

discharge. Severe cases could require a two month hospital stay on average, up

to six months in a rehabilitation facility, physical and occupational therapy,

nursing care at home, and considerable need for special equipment and home

modifications.

It is important to note, however, that DHHS has agreed to provide

compensation in substantiated cases of GBS following swine flu vaccination and is

in the process of settling these claims. Swine flu vaccine is not now in use and

it appers highly unlikely that it will be in use again in the future.

The significant quesiton is thus whether there is a similar risk of

Guillain-Barre syndrome associated with influenza vaccines currently in use. A

study carried out by CDC in concert with state epidemiologists and the American

Academy of Neurologists has calculated the risk of Guillain-Barre to be 1.4 per

million population with the vaccine used during the 1978-79 influenza season

(DHEW, 1980).

The natural incidence rate of GBS -- that is, non-vaccinated related -- is

about 1 case per 1,000,000. The rate of association between Guillain-Barre

syndrome and influenza vaccines currently in use is quite close to the normal

background incidence, and it is much lower (1.4 per million vs. 6.2 per million)

than the rate of incidence associated with the swine flu mass immunization

campaign.

summary

Estimating the number of serious adverse vaccine reactions that occur
41

annually in the United States cannot be accomplished with absolute certainty.

There are conflicting incidence estimates for the various adverse reactions, and

no one really knows how many doses of vaccine are actually administered (versus

distributed) annually, particularly by private physicians. An often-used

conservative rule of thumb is to estimte one-fourth wastage,

However, OTA has compiled what we believe are reasonable “ballpark”

estimates. Our best estimate of the number of instances of long-lasting

disability due to vaccination of children (diphtheria, pertussis, tetanus, polio,

mumps, measles, and rubella) is that there are unlikely to be more than 200 or so

such cases occurring annually. Also, we suspect that this estimate is likely to

be in error on the high rather than on the low side. The main source of

uncertainty is the incidence rate of brain damage caused by adverse neurological

reactions to the pertussis vaccine or the pertussis component of the DTP vaccine

(See Table 4). In addition, we estimate that there might possibly be as many as

100 - 250 cases of vaccine related illnesses requiring hospitalization but where

the outcome would be full recovery.

Since almost all known adverse reactions to the major childhood vaccines are

extremely rare as naturally occurring, non-vaccine-related illnesses, it would be

feasible to draw up a schedule of adverse reactions (and time periods following

vaccinations) for which the causal role of the vaccine would be assumed and

compensation provided. Proof could be limited to documentation of vaccination

within the alloted time period and diagnosis of the particular illness in

question.

Tables 1-4 summarize the information on vaccine-related injuries.
42

Measles

Mumps

Rubella

Polio

Smallpox

TABLE 1

REPORTED REACTIONS TO COMMONLY USED LIVE VACCINES

(IN ImmUnOlOgiCally NORMAL RECIPIENTS)

Known Probable

Fever Encephalitis

Rash Encephalopathy

Convulsions Subacute Sclerosing

(Primarily Febrile) Panencephalitis (SSPE)

Reye’s Syndrome

Parotitis

Lymphadenopathy

Fever

Rash

Arthralgia

Arthritis

Peripheral Nueitis

Paralytic Polio

Local Infection

(Pustule)

Regional

Lymphadenopathy

Fever

“Toxic” Eruption

Dissemination and

Eczema Vaccinatum

Diphtheria and Local Swelling

Tetanus Toxoids Sterile abscesses

and Pertussis Fever

Vaccine (DTP) Convulsions

Teratogenesis

Teratogenesis

Encephalitis,

Encephalopathy

Possible

Other Necrologic Disorders

-Guillain-Barre Syndrome

-Transverse Myelitis

-Atixia

-Cranial Nerve Paralysis

-Teratogenesis

Encephalitis, Aseptic

Meningitis

Unilateral Nerve Deafness

Allergic Reactions

Rash, Pruritis, Purpura

Reye’s Syndrome

Deafness and Other

Necrologic Disorder:

-Teratogenesis

Thrombocytopenia

Encephalitis, Aseptic

Meningitis

Other Necrologic

Disorder

-Transverse Myelitis

-Guillain-Barre

Syndrome

-Hemiparesis

-Ataxia

-Convulsions

Reye’s Syndrome

Transverse Myelitis

Hemiplegia

Reye’s Sydnrome

Guillain-Barre Syndrome

Teratogeneiss

Encephalopathy Reye’s Syndrome

encephalitis Guillain-Barre Syndrome

Persistent Screaming Peripheral Neuritis
Known

43

TABLE 1 continued

Probable

Tetanus Toxoid and Hypersensitivity

Tetanus-Diphtheria Local Reactions

Toxoids (T,DT, & Td) Fever

Adult Convulsions (Febrile)

Polio Vaccine

Inactivated (IPV)

Influenza Local Reactions

Fever, Malaise

Guillain-Barre Syndrome

Allergic Reactions

Possible

Encephalitis, Aseptic

Meningitis

Other Necrologic Disorders

-Peripheral Neuropathy

-Cranial Nerve Palsy

(Neuritis)

Allergic reactions

Guillain-Barre Syndrome

Teratogenesis

(Neurogenic Tumors)

Peripheral Neuropathy

-Neuritis

Source: Center for Disease Control.
44

TABLE 2

RATES OF COMPLICATION (Per 1000)* FOLLOWING VACCINES AND NATURAL DISEASES

Disease or Vaccine

Complications

Measles

Fever >103°F

Rash

Otitis Media

Pneumonia

(and other resp)

Febrile Convulsions

Encephalitis

(and other necrologic

disorders)

SSPE*(l)

Death

Mumps

Fever >103of —

Parotitis

Orchitis

.

Oophoritis

Pancreatitis

Meningoencephalitis

(& other necrologic

complications)

Deafness

Death

Natural Disease

900-1000

900-1000

25.2-90

38-73

6.9

1-4

.006-.022

0.1-1.0

100-200(?)

500-660

100-250(Males)

+

+

10-150

.005-.07

0.18

Vaccine

60-350

30-100

1.9

.001

.0004-.001

.0002

0-0.2

?

?

.001

(1 case)

Background Rate

(Unknown Cause)

50

0-20

(?)

(?)

0.3

.001-.003

+

Ratio:Disease/Vaccine

2.6-16.7

9-33.3

3.6

1000-4000

6-55

300-5000

.001 500-1000(?)

?

?

?

?

.001-.003 10000-150000

*In the 30 day period following vaccination or onset of natural disease

(1) Occurs 1 month-20 years after measles or vaccine.
45

TABLE 2 Continued

Disease or Vaccine

Complications

Rubella Natural Disease

Lymphadenopathy

Rash

Fever >100oF —

Arthralgia

Arthritis

Peripheral neuritis

Thrombocytopenic

purpura

Encephalitis

(& other necrologic

disorders)

Death

Polio (live vaccine)

Paralytic polio

Death

Smallpox

Fever >101oF —

Toxic eruption

Dissemination

Vaccinia necrosum

Encephalitis,

encephalopathy

Death

500-1000

360-1000

600(est)

250-500

10-300

+

0.3(?)

0.2

0.8

1-1o

0.6-0.8

1000

?

1000

?

1.0

10-300

Vaccine

110-440

10-120

10-40

30-300

1-1oo

.1

+

0.0005

+(2 cases)

0.0002

.00001

20-40(?)

+

.03

.001

.002-.006

.001

(Background Rate

(Unknown Cause)

?

10-40

40

2

?

1.0-3.0

Ratio:Disease/Vaccine

1-9

3-1oo

15-60

1-17

0.1-300

400

5000-50000

60000-80000

25-50(?)

33,333

167-500

10000-300000
46

TABLE 2 Continued

Disease or Vaccine

Complication

Diphtheria

(Pharyngeal)

Fever >1O1o —

Airway obstruction

Myocarditis

Motor paralysis

Anaphylaxis

Natural Disease Vaccine

500-800(?)

Other allergic reactions

Convulsions

Death

Tetanus

Pneumonia

Peripheral or cranial

neuropathy

Myopathy

Fever

Hives or rash

Swollen arm (severe)

Abscess or infection

Death

100(?)

i-t

20-750

+(very rare)

+(rare)

+ 0.014(DT)

18-100

++

+

500

+(5 cases)

70)

20)

jTd

10)

7)

+(rare)

Background Rate

(Unknown Cause) Ratio:Disease/Vaccine
47

TABLE 2 Continued

Disease or Vaccine

Complication

Pertussis

Pneumonia

Convulsions

Encephalopathy

Retardation

Persistent screaming

Hypersensitivity

Death

Influenza A

Fever >1O1o —

Rash

Pneumonia

Myocarditis

Myopathy

Guillain-Barre Syndrome

Death

Influenza B

Fever >1O1o .—

Pneumonia

Reye’s Syndrome

Death

Natural Disease

-1+

8-140

+

1-1o

>800

+

30-200

+

+

+

1.0

>700

30-200

.3-.6

+

Background Rate

Vaccine (Unknown Cause) Ratio:Disease/Vaccine

0.03-0.45

.009

.006

+(very rare)

+(very rare)

0.9-2.0 -tl890-15500

1-100

.005

+

.01

?

1-100

.001

Source: Center for Disease Control
48

Center for Disease Control Notes to Table 1 and 2

Introduction

Reactions following the administration of vaccines have received increased

attention in both the scientific and lay press in recent years. It is important

that vaccine recipients be informed of the possible side effects from vaccines.

Decisions regarding the use of vaccines must take into account several factors in

order to balance the risks associated with the vaccines against the risks of

remaining unvaccinated. If reasonably accurate information regarding the rates

of complications following the vaccine and natural disease, and the risk of

acquiring the natural disease are known, then it is relatively easy to “balance

the risks.” Therefore, we have attempted to compile a tabulation of the rates of

complications occurring after vaccinations and the natural diseases that the

vaccines protect against. We have not attempted to include the important factors

of vaccine efficacy and the risks of acquiring the natural diseases.

Although toxoids (tetanus and diphtheria) are not technically vaccines, we have

included them in this report.

Data Sources

The data in the attached tables have been derived primarily from reports

published in the medical literature. These reports are of 3 general types:

1. Individual case reports of specific disorders noted following the

receipt of a vaccine.

2. Field trials and other studies where vaccinees were actively followed

to determine the rates of disorders.

3. Retrospective studies of specific disorders where a higher rate of

vaccination was noted in persons with the disorder as compared to a

control group.

In addition, we have utilized reports from vaccine manufacturers, practicing

physicians, state and local health departments and other interested parties.

The background rates of disease have been obtained from several different sources

and therefore the numbers vary considerably. Where possible, we have used the

data collected from a control (or placebo) population. Therefore the age of the

population and the case ascertainment were the same for the vaccinated and

unvaccinated populations (for an example see Measles: rash and fever). In some

cases, Particularly with rare disorders, we have had to use other sources such as

community surveys or cases of the disorder reported to CDC that were not

associated with known cases (e.g., encephalitis). Many of the background rates

have been left blank. This does not mean that the disorders do not occur. We

elected to leave blank those disorders where we did not have reliable data and

the rates varied considerably depending upon the factors discussed in the next

section.

Important Qualifications

The rates are not meant to be interpreted (or quoted) as absolute and firmly

established numbers. We are merely trying to provide you with data to help in

balancing the relative risks associated with vaccines and natural diseases.

There are many variables that have been shown to affect the rates of vaccine

reactions:

Vaccinees: age, sex, previous doses of vaccine, allergies, immune

competence
49

Vaccine: culture media,type or strain of organisms, number of organisms,

inactivation process, purification processes, adjuvants,

stabilizers and preservatives

Administration: jet gun vs. needle and syringe, site of injection, tissue

injected (ID,SC, IM or oral)

With regard to most reported reactions, a causal relationship between the vaccine

and the disorder cannot be established with certainty. Most “reactions” also

occur at some low but finite rate in an unvaccinated population and are usually

of unknown cause. Limitations of the individual case investigation or of our

scientific knowledge usually prohibit firm conclusions, often leaving us with a

temporal relationship only.We must decide whether or not the temporal

relationship suggests something other than a coincidental association. With live

vaccines, most reactions occur when the vaccine virus or bacteria has had time to

multiply within the body.This is usually 7-21 days after vaccination.With

killed (inactivated) vaccines,the most common reactions usually occur early,

within the first 24-72 hours.

Some disorders,such as encephalitis following measles vaccine, occur at a rate

that is less than the known background rate in unvaccinated persons. However, a

definite temporal clustering of cases occurs in the 7-15 days after vaccination.

This timing of the reaction, plus the findings noted on post mortem examination

in fatal cases and the occasional isolation of vaccine-like virus from the

cerebrospinal fluid imply that a causal relationship exists with the vaccine.

Other rare disorders,such as peripheral neuritis following rubella vaccine and

Guillain-Barre’ Syndrome following influenza vaccine, were not detected until

mass vaccination programs led to a clustering of cases in localized areas.

Therefore, it is possible that other, as yet unknown, disorders, following

vaccination might be detected under similar circumstances.

Some vaccines were developed and licensed many years ago. For some, we do not

have field trial data which include control groups.Therefore, the rate of

common reactions such as fever following DTP and smallpox vaccines are based on

estimates, and not actual studies.

The early studies on diphtheria toxoid and pertussis vaccines were carried out

using different preparation techniques and potency than are currently in use.

Therefore, those studies are not applicable to what one would expect with today’s

vaccines.

For all of the reasons outlined on the previous pages, we urge you to be very

cautious in the interpretation and use of the data in the accompanying tables.

These data are the best currently available but are rough estimates and are

therefore not intended for publication in the mass media. They are for your use

in anticipating reactions to vaccines and answering questions in a general

manner=
50

I n

I - mm

I n

a )

.

PJ0

C6” m?--l

4“

N

*

*

Inmool n

mho-i m

Omo c o o

-“o” o” N”*” &lam ma3 *

oJof=mm4 c .* .* .

U-J

aJ

G

*

*

c-+

s

:

3

u

c

a)

.

.

‘2

K!

.

*

i i

1+

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9.(

m

5

.5 m

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w

t=! *

*
51

TABLE 4

Estimates of Serious Illness Associated With Immunization

Against the Seven Major Childhood Infectious Diseases

Cases Per Year

Estimated Annual Doses

Illness Incidence Administered on Average Estimate of

or Injury Estimate 1974-1978 (very rough Annual

estimate)* Cases

Encephalitis following

DTP

Brain damage

Peripheral

Mononeuropathy

following DTP Vaccine

Polio contracted from

Polio Vaccine

Encephalitis following

Measles Vaccination

Encephalitis following

Mumps Vaccine

Death Due to

Anaphylactic Shock

(All Vaccines Commonly

Given To Children)

9-20 per million 13.5 million 122-270

Low: 1 in 300,000 (45-81)

doses

(British Royal

Commission Estimate)

High: 6 per million (CDC)

estimate of retardation)

very rare 13.5 million

?

?

probably too

rare for even 1

case annually

1 in 4,000 doses

0.92-1.16 cases per

million doses (based

on doses distributed)

Lowest Estimate:

1 per million

Highest Estimte:

9 per million

(possibly too low)

1 in 10 million doses

18 million 5 (most would be

adult contacts)

9 million doses 8-11 (some of

distributed in 1978 these would

probably result

in permanent

brain damage)

3-4 million

50-60 million

3-4

27-36 (Note:

none are

expected to

leave permanent

brain damage)

5-6

Abased on net doses distributed (Table 3) minus one-quarter wastage.
53

v . Costs of Vaccine Injury Condensation Programs

A compensation program could be designed that would provide compensation to

more vaccine injured persons, at lower average per person cost, and with more of

the money going toward compensation rather than to transaction costs (lawyers’

fees, court costs, administrative overhead, etc.) as compared to the present

system of reliance on tort law. In terms of absolute costs, however, our review

cannot furnish solid assurances that the total costs of a compensation program

would be less than the total costs under a system of continued reliance on tort

law. The reason is that the costs of the tort law approach depend very greatly

on the willingness of the vaccine injured to bring suit and to hold out for a

successful court judgment or a generous out-of-court settlement. To illusrate:

GAO has reported that in 1975 a plaintiff won a suit against the Public Health

Service for vaccine related polio. The original claim was for $7,000,000; the

plaintiff was awarded $1,029,973 plus $3,201 in allowable costs. Clearly, if

each of the 5 cases of vaccine related polio estimated to occur annually were to

result in similar court awards, the costs to the Federal Government would be

substantial. Because manufacturers have been disinclined to release much

information on their legal liabiity, data is not available that would enable us

to calculate what percentage of vaccine related polio cases (or other vaccine

related injuries) results in lawsuits. It is also difficult to predict to what

extent assumption of the manufacturer’s “duty to warn” responsibility will expose

the government to increased lawsuits. However, as of 1979, GAO reported that,

according to Public Health Service records, this one court case represents the

Federal Government’s only payout for vaccine injury compensation for all vaccines

other than swine flu.

Available evidence thus suggests that many injured vaccinees either do not

file suit or settle early for amounts far less than what they might be awarded by

a court. One State health official interview for this study related two
54

anecdotes involving adult contact vaccine related polio. In one case, the

polio-stricken elderly relative of a vaccinated child did not seek any

compensation. In the other case, a young mother who contracted polio from her

vaccinated child reportedly settled for $20,000. In both cases, the injured

person had suffered some degree of permanent paralysis.

Without a special and expensive research project, it would be difficult to

find out in any systematic fashion what actually happens to most vaccine injured

persons, how they cope financially and otherwise, etc. State and Federal health

officials do not follow-up on these cases beyond the requirements of CDC’S

monitoring system, which does not monitor outcomes beyond the four weeks

immediately following vaccination.

We conclude therefore that, unless or until vaccine injured persons begin to

pursue legal remedies more vigorously than they have in the past,

catastrophic-sounding estimates of the Government’s legal liability should be

viewed with skepticism.

Our study has not attempted to estimate total costs of a vaccine injury

compensation program, in large part because such an exercise would be best

carried out after some basic policy decisions have been made. In the following

discussion we will outline some of the major cost-relevant decisions that

be made and some of the factors that might lend support to a given choice

in cost/benefit terms.

need to

viewed

Medical costs are easier to gain a handle on than other costs. DHHS

commissioned a study by the Arthur D. Litle (ADL) management consulting firm of

the costs associated with vaccine related injuries (A.D. Little, 1979). Table 5

lists our best estimates of the number of cases of the most common serious or

potentially serious adverse vaccine reactions likely to occur annually, alonside

ADL’s estimates of the range of medical costs most likely to be associated with
55

such reactions (for children under age one and assuming a discount rate of 2.5%).

Table 5 includes only conditions that are known to result from vaccination

and excludes conditions which have been reported following vaccination but for

which no causal relationships have been established. The ADL study included

several conditions for which causal relationships have not been established (see

exhibit B).

The figures at the high end of the range in Table 5 include estimates of

costs for long-term institutional care in the event of very severe brain damage

or paralysis so extensive as to require mechanical respiratory assistance.

In considering the medical costs associated with vaccine injuries, it is

important to recognize that many injured persons will be covered, in varying

degrees, by existing private medical insurance or government health care

financing programs. In court settlements, such insurance coverage is not taken

into account in determining the size of awards. The reason is that the legal

system is fault-oriented. The logic applied is that the party held to be at

fault in causing the injury should not benefit from the injured party’s foresight

in purchasing insurance. A no-fault compensation system need not adopt such an

approach, however, and could therefore save an unknown (but probably large)

amount by paying only for medical expenditures not covered by the individual’s

existing private insurance or by government program benefits for which the

individual is eligible.

In assessing the medical costs associated with vaccine injuries, it is also

important to bear in mind that, for certain types of injuries, government (State,

Federal, or both) will likely end up paying most of the bill. Among serious

vaccine injuries, the most common are neurological diseases that can result in

permanent brain damage. Where such brain damage results in mental retardation or

physical disability severe enough to justify long term care in an institution,
56

the costs may be covered by existing government programs. One decision Congress

will need to make is how to relate vaccine injury medical benefits with other

government programs offering medical benefits. One approach would be to pay for

short-term acute medical care and rehabilitation expenses out of funds

specifically set aside to cover the costs of vaccine injuries, but to treat long

term care separately. Under this approach, if, after a certain specified period,

vaccine injured persons required long term care, they could be declared

automatically eligible to have such services paid for under Medicare, without the

individual having to meet the normal eligibility requirements of the program.

Exemption from normal eligibility requirements would protect parents or other

legal guardians of the vaccine injured from a possible obligation to first meet

welfare eligibility criteria before obtaining long term care for a vaccine

injured child.

Estimating nonmedical costs is even more difficult, because more policy

choices are available. One principle which should probably be followed is that

as fault is not at issue, punitive damages are inappropriate and nonmedical

payments should be limited to compensation for economic loss. This woul d

militate against the large “pain and suffering” awards that are frequently given

out in negligence suits.

In the case of the major childhood disease immunization programs, the

vaccine injured are almost always children (the exceptions are adult polio

contact cases), which makes economic loss more difficult to calculate. Since

there is a tendency to view vaccine injury compensation in terms of the swine flu

experience, it is important to understand that the situation of the vaccine

injured in current immunization programs is quite different from that of persons

who developed GBS after having had swine flu shots. Many of the swine flu vaccine

GBS cases were adults who were employed and who were often supporting dependents

as well as themselves. Others fulfilled essential though non-paid economic roles
57

in their families that would be expensive to replace. Moreover, the nature of

GBS is such that, even though a majority of those afflicted eventually do

recover, recovery usually takes several months to a year or more, during which

time the individual is not likely to be able to work or fulfill other

responsibilities. In the case of vaccine injuries associated with such childhood

immunizations as DTP, polio, mumps, measles, and rubella, most of the injured are

children who will have recovered long before reaching the age of self-support.

In some cases, however, these are permanent, highly-disabling injuries. That

these injured persons are most likely to be children poses some difficult

questions. Is it appropriate under such circumstances to try to relate

compensation to the concept of lost earnings? If a child dies as a result of a

non-negligently caused vaccine injury, is there a useful purpose to be served by

paying economic compensation (over and above funeral expenses) to the parents?

●

The same question can be asked about an individual who has suffered severe brain

damage and requires long term institutional care. AS long as this individual

requires long term institutional care and such care is covered by medical

payments, are additional compensation payments of any benefit to that individual?

One of the ironies here is that those children whose injuries are the most

severe may be the least able to benefit from or the least in need of economic, as

distinct from medical, compensation payments. The individual for whom economic

compensation is likely to be most meaningful would seem to be those who are not

so seriously disabled as to require long term institutional care.

In Great Britain (see next chapter) vaccine injured persons who suffer 80%

disability or more are given a flat compensation payment of %10,000 (this is over

and above medical expenses, which are covered by the National Health Service).

In practice, these payments appear to go primarily to the parents to compensate

them for added financial and other strains that a severe vaccine injury imposes

on the family.
58

Thus, rather than award economic compensation solely on the basis of

severity of injury, Congress might wish to approach economic compensation in

terms of such goals as: keep disabled persons at home insofar as possible;

minimize the economic burden of vaccine injuries on families and compensate

parents for the fact that a vaccine injured child may never be able to be wholly

self-sufficient economically and may never be able to live independently of

his/her parents outside an institutional setting.

If these principles were to be followed, this would suggest that no or

comparatively low economic compensation payments be made to institutionalized

persons or to parents in the event of a child’s death. More generous

compensation payments would be made to disabled persons able to function outside

institutions in an effort to keep them outside institutions and to provide the

individual with an alternative or supplement to the conventional social insurance

payments available to disabled persons.

Here again there is a need to consider how disability payments specific to

vaccine injured persons should relate to other benefits available more generally

to disabled persons. One approach would be to establish a compensation schedule

keyed to the extent of disability -- 20%, 30%, 40%, etc. Assessment of percent

disability would be based on the same criteria used to make such determinations

under workmen’s compensation or veterans’ benefits programs. Payments could be

made in the form of periodic payments or in the form of a tax free lump sum

payment. Periodic payments would obviously add more administrative overhead and

create a need for more staff. There is also the problem to consider that there

are not enough vaccine injured persons to justify a full-blown administrative

unit to process such periodic payments. If the periodic payment method is

chosen, vaccine injury disability payment might be grafted onto the existing

Social Security disability benefits payment program. However, Social Security

disability payments are based on total disability. Thus, for ease of
59

integration, economic compensation through Social Security might be limited only

to those totally disabled, with no payment or lump sum payments to those disabled

to a lesser degree (e.g. , see Denmark in the next chapter).

An alternative approach would be to have the size of compensation awards

determined in an individualized manner by a compensation board. Such boards

could be appointed for a term or on an ad hoc basis at the direction of the — —

Secretary of DHHS, or, at the State level, by the State Department of Health, in

the manner of a special commission or panel of consultants. The major advantage

of this method is that it replicates the kind of individualized treatment and

consideration for special circumstances and needs that an individual might obtain

via the courts. Here again, this would add to the administrative costs of the

program, but the small number of severe vaccine injuries that would be

anticipated does make such an approach feasible.
60

TABLE 5

Estimated Annual Number of Severe Vaccine Reactions & Associated Medical Costs

ADL Medical Cost

Adverse Reaction Estimated Range of Annual Cases Estimate Per Case**

Encephalitis* following 122 - 270 (of these, 45 - 81 $2,487 - $170,270

DTP vaccination would be expected to involve

retardation or other brain

damage)

Peripheral Neuropathy <1 $1,443 - $16,018

following DTP

Encephalitis following 6 - 8 (permanent brain damage $1,313 - $247,889

measles vaccination is expected to be quite rare)

Encephalitis* following 3 - 36 $2,167 - $15,123

mumps vaccine

Polio following 5 (most are adult contact cases) $1,766 - $141,055

live oral polio vaccine

Anaphylactic shock 5 - 6 Not calculated (medical

leading to immediate costs minimal if death

death (for all vaccines is immediate)

given to children)

*There is controversy concerning the incidence estimates for these reactions (see previous

chapter)

**For children under age one and assuming a discount rate of 2.5% (A.D. Little, 1979).
61

VI. Current Approaches to Vaccine Injury Compensation

In the U.S., California created an Immunization Adverse Reaction Fund in

1977, and a bill patterned after the California law was introduced in the Rhode

Island legislature in 1979. Six nations provide compensation for vaccine

injuries; Great Britain, Japan, France, West

California

Germany, Switzerland, and Denmark.

Medical, institutional, supportive, and

provided for severe vaccine reactions to any

rehabilitative care are to be

immunization required by state law

to be administered to children under 18 years of age (see Exhibit C). A severe

reaction is defined as one which manifests itself not more than 30 days after the

immunization and requires extensive medical care, as defined by regulation of the

Department of

Expenses

Reimbursement

Health.

will be reimbursed by the State in an amount not to exceed $25,000.

will be made without regard to ability to pay, but the State can

claim any reimbursement for medical expenses from third parties.

An Immunization Adverse Reaction Fund has been created in the State

Treasury, to be administered by the State

The statute also absolves any person

provided the vaccine is required by state

negligence is involved.

Department of Health.

of liability for vaccine injuries,

law and no willful misconduct or gross

To date, only one claim has been filed, alleging polio in an adult male

(Kavet, 1980).

Rhode Island

The bill introduced in the legislature in 1979 is identical to the

California law, except that it also specifies that $50,000 be appropriated for
62

the Immunization Adverse Reaction Fund. This bill has not become law.

Great Britain

The British compensation program is of recent origin, dating from the

Vaccine Damage Payments Scheme of April 6, 1979 (Barnes, 1980). The main impetus

appears to have been the public controversy that had been going on for some years

concerning pertussis (whooping cough) vaccination. No vaccines are compulsory in

Britain, but pertussis and other standard childhood immunizations are recommended

by the National Health Service. In August 1973, the Association of Parents of

Vaccine Damaged Children was formed and began to draw public attention to the

issue of vaccine injury, most especially in relation to pertussis vaccination.

The Association gave testimony to the Royal Commission on Civil Liability and

Compensation for Personal Injury (The Pearson Commission), which was established

to consider the problem. Most of the testimony concerned brain damage alleged to

have resulted from childhood vaccinations. The Association told the Commission

that -- as there was no hope of recovery from injury due to vaccine damage --

normal family life was impossible, holidays were limited, great expense was

incurred (e.g., special education, shoes, clothing and food), and families

sometimes broke up under the strain. The Association had registered 356 alleged

cases of serious vaccine damage, 240 of which they claimed were the result of

whooping cough vaccination.

The Pearson Commission Report noted that the Association’s figures on the

numbers of vaccine damaged children had not been officially confirmed. The

Department of Health and Social Security (DHSS) accepted that severe damage could

occur rarely but underlined the difficulties in establishing clear causal links.

The Joint Committee on Vaccination and Immunization said in its Review of the

Evidence on Whooping Cough Vaccinations that “infants frequently develop

convulsions for the first time in the first two years of life. By chance some of

these will occur shortly after a child has been vaccinated and will be wrongly
attributed to the vaccine. ” In 1976 the British government undertook a National

Childhood Encephalopathy study to address prospectively the causal relationships

among immunization, convulsions and brain damage. Results from this study are

not yet available.

The Pearson Commission also heard testimony from the following groups in

support of vaccine injury compensation: the British Medical Association; the

Royal College of Physicians and Surgeons of Glasgow; the Royal College of

Surgeons, Edinburgh; the Association of the British Pharmaceutical Industry; and

the British Insurance Association. The Standing Medical Advisory Committee of the

Department of Health and Social Security also told the Commission that, in its

view, there was a reasonable case for paying compensation where vaccination was

proven as the cause of the damage.

The British compensation plan provides for the payment of %10,000 (tax free)

to persons who have been severely disabled as a result of vaccination against a

specified disease or to that person’s personal representatives. The diseases

currently specified are diphtheria, tetanus, pertussis, polio, measles, rubella,

tuberculosis, and smallpox. Injuries arising from contact with a vaccine

recipient (e.g., polio, fetal damage) are also eligible for compensation.

Eligibility for compensation is retroactive to 1948. An individual is defined as

“severely disabled” for purposes of vaccine damage compensation if the disability

is 80% or more, a judgment reached by applying the same criteria used by the

industrial injuries compensation scheme.

The initial determination to grant or deny compensation is made by

physicians within the Department of Health and Social Security on behalf of the

Secretary of State. The DHSS Vaccine Damage Payments Unit reviews various

medical records concerning the case, may request a specialist report with respect

to the causal role of the vaccine, or call upon a medical board to give advice

with respect to the extent of the individual’s disability. If a vaccine damage
64

payment is refused because the Secretary of State is not satisfied that the

medical criteria have been met, the claimant may apply for a review of his/her

case by an independent vaccine damage tribunal. Tribunals consist of two

specialists and a lawyer as chairman. The DHSS does not adopt an adversarial

stance on review and does not seek to defend the initial disallowance. The

Department presents the evidence and assists the claimant in presenting his or

her case by assembling and making evidence available, but the burden of proof

rests with the claimant.

The Secretary of State is empowered to reconsider all unfavorable

determinations within 6 years if: (1) there has been a change in circumstance,

or (2) factual ignorance or error was involved in the original determination.

Favorable determinations may be reconsidered at any time if it appears that

factual misrepresentation or failure to disclose was involved. Otherwise, the

decision of the vaccine damage tribunal is conclusive. There is no further right

of appeal except for judical review on a point of law.

Table 6 summarizes the status of claims filed as of June 20, 1980. Recall

that the British system provides for claims retroactive to 1948. About 13% of

the claims reviewed by DHSS (which is all but a handful of the claims filed to

date) received a compensation award on initial determination. Of the claimants

initially denied compensation, 58% requested review by an independent tribunal.

Of the cases thus far reviewed by independent vaccine damage tribunals,

approximately three quarters (73.5%) have been denied compensation upon review as

well.

If these percentages hold constant in the future, we might project that the

British system would end up making compensation payments on 753 out of the 2619

claims filed as of June 1980. This would entail a payout of %7,530,000 for

vaccine injuries covering a 32 year period.
65

Compensation for vaccine injuries covers government subsidized vaccines and

includes a medical allowance, an annuity for persons taking care of individuals

disabled by a vaccine injury, a disability pension, and a funeral grant (Dowdle

et al., 1980).

Reports of vaccine reactions are evaluated by a National Judgment Committee

consisting of twelve physicians and two lawyers appointed by the Minister of

Health and Welfare. Some local governments have their own judgment committees,

so that it would be possible for a person with a vaccine reaction to receive

compensation from either a local government, the national government, or both.

There are no written guidelines. Judgment Committees base their decisions

regarding the validity of claims on available clinical information, the interval

between vaccination and onset of illness, and whether similar adverse reactions

have been reported in the literature.

The Japanese compensation system is of special interest, because influenza

vaccine given to children is covered under Japan’s vaccine injury compensation

program. Statistics are available on the numbers and types of influenza vaccine

related injuries for which compensation has been granted. It is noteworthy that

since 1963, when the earliest claim for an influenza vaccine related injury was

filed, no claims have been made for Guillain-Barre syndrome. Since 1976, in view

of the U.S. experience with swine flu vaccine, a major effort has been made to

identify Guillain-Barre cases related to influenza vaccine. None has been found.

Japan did not mount an immunization campaign against swine flu. The Japanese

experience thus lends support to the thesis that the level of association that

was found between Guillain-Barre syndrome and the swine flu vaccine is not

characteristic of other influenza vaccines.

In Japan annual vaccination against influenza is compulsory for all school
66

children aged 3-18. Children are regarded as the major transmitters of the

virus, and vaccination of school children is designed both to reduce the extent

of influenza epidemics among the population as a whole and to prevent school

closures due to influenza epidemics. In contrast, influenza immunization is not

mandatory for adults nor even reimbursed under either of Japan’s two

government-run or supervised health insurance plans. As a result, adults

suffering influenza vaccine related injuries are not eligible for compensation.

The number of vaccine related injuries per million doses administered

reported to the Tokyo Metropolitan Health Department between 1970-77 was

significantly lower for influenza vaccines (0.8) than for smallpox vaccine (98.4)

or DTP vaccine (13.5). This 0.8 incidence for influenza vaccine adverse

reactions was comparable to that observed for Japanese encephalitis vaccine

(1.3), oral poliovirus vaccine (0.3) and BCG (tuberculosis) vaccine (0.7). This

suggests that a compensation plan including influenza vaccines (other than swine

flu vaccine) would not have a disproportionate effect on the number of claims.

France

Vaccination is compulsory for smallpox, diphtheria, tetanus, polio, and

tuberculosis. Most injuries affect children. The vaccines most frequently

involved in compensation claims are those for smallpox and, to a lesser degree,

tuberculosis. Government compensation is available both to the injured and to

the injured’s parents. Compensation is assessed by a tribunal and covers

established economic and non-economic losses and provides for future support,

taking into account payments under social security schemes. The tribunal has the

discretion to award a lump sum or periodic payments, although a preliminary award

for periodic payments is typically made until the person’s condition has

stabilized.
67

West Germany

smallpox

recommence d.

vaccination is compulsory; other vaccines are officially

Compensation is provided for damage caused by any officially

recommended vaccination, covers medical and other costs, and includes a pension

when earning capacity has been impaired, based on federal invalidity pension

regulations. The probability of a causal relationship is sufficient to establish

a claim.

Switzerland

A federal law on epidemics obliges all cantons to provide free vaccination

against smallpox and other dangerous epidemic diseases. The cantons have the

discretion to make vaccinations compulsory or voluntary. The law also requires

the cantons to compensate for damage caused by compulsory or officially

recommended vaccinations, insofar as the damage is not covered otherwise; e.g.,

by social security payments or private personal insurance.

Denmark

A vaccine injury compensation program covers smallpox, diphtheria,

pertussis, polio, and tuberculosis vaccines. Tetanus is included when it is used

in combination with one of the others. A vaccine injured child receives

compensation for loss of earning capacity when he or she reaches age 15. No

compensation is payable where the disability is less than 5%. For disabilities

between 5 and 50%, a lump sum is paid; and for 50% disability or more, an annuity

is granted.
68

TABLE 6

VACCINE DAMAGE PAYMENTS ACT

STATUS ON 6/20/80*

1. Total number of claims received

2. Disallowed - a. basic conditions (Section 2)

not satisfied

b. medical grounds

3. Awards made on initial consideration

4. Not yet determined

5. Applications for review

60 Determined by tribunalsawards made

disallowance upheld

7. Awaiting consideration by tribunals

2619

76

2192

330

21

1272

129

359

488

784

*covers period from 1948 to 1980

Source: British Department of Health and Social Security
69

VII. Vaccine Injury Compensation and Future Developments in Vaccines

It seems safe to say that, in a decade or less, it will be possible to

offer vaccines against all infectious diseases caused by viruses or

bacteria. Anti-parasite vaccine, pehaps even anti-tumour vaccines, will

also be available. Some may regard such a plain statement as sensational,

some as natural progress (Hennessen, 1978).

If, in fact, there is likely to be an explosive increase in the number of

vaccines available in the next decade, how might these new developments in

vaccines affect a vaccine injury compensation program?

Table 7 lists the vaccines expected to be developed after 1976.

Most of the vaccines currently being researched are targeted at diseases

that are moderately contagious at most. 1 The major exceptions are syphilis and

gonorrhea. This reflects the fact that major epidemic diseases affecting the

U.S. population have been controlled via existing vaccines, other public health

measures, and the generally high standard of living enjoyed by most Americans.

Most of the vaccines currently being researched are thus being targeted for use

among specialized “high risk” populations.

Annual influenza vaccination is presently recommended for approximately 40

million people, 25 million of whom are 65 years of age or older (Foege, 1980).

Thus, although influenza immunization is recommended primarily for high risk

populations, it nevertheless qualifies as being widely recommended and used.

The target population for a hepatitis B vaccine encompasses health care and

laboratory personnel; staff and residents of institutions for the mentally

retarded and other large semi-closed institutions; patients on maintenance

hemodialysis; patients requiring repeated blood transfusions or ministration of

blood products; patients undergoing treatment with immune suppressive or

cytotoxic drugs; and patients with malignant diseases and disorders associated

with depression of immune response (Plotkin, 1978). Pseudomonas vaccine is even

more of a vaccine targeted at a specific population, as these bacteria cause
70

problems only in persons who are susceptible to them because of other health

problems.

What this means is that for many of the vaccines that might be expected to

be developed in the next 10 years, the decision to be vaccinated or not will be

much more of a private decision taken in consultation with one’s physician, which

will involve balancing the risks versus benefits for that particular individual.

There are, however, some potential candidates for mass immunization programs

among vaccines currently being researched. Vaccines to protect against the

bacterial agents that cause meningitis and otitis (a type of ear infection) in

children are cases in point. The bacterial agents in question are streptococci,

meningococci B&C, pneumococci (approximately 8 strains) and H. influenza. Of

these, meningococci C and H. influenza are the most readily spread from person

to person, though relative to other contagious diseases they are only moderately

contagious. At present vaccines against meningococci C and H. influenza that

are effective in adults and older children have been developed. Meningococcal

vaccine has been used successfully against small scale outbreaks of meningitis

among specific at risk populations such as soldiers. Most of the serious,

lasting damage done by these bacterial organisms occurs, however, in children

under age 5. For example, with H. influenza meningitis, approximatley 10% of

those affected die; 30% suffer neurological damage. Thus, the benefits of a mass

immunization program against these bacteria would only occur if a safe and

effective vaccine could be developed for use in infants. Existing vaccines do

not produce sufficient levels of immunity in children under age two, however.

Apparently the immune system is still maturing in infancy with respect to these

antigens. Whether or not vaccines against the bacteria that cause meningitis and

otitis will become serious candidates for use in mass immunization programs thus

depends on solving the problem of how to provide effective immunizations against

these bacteria in infants.
A vaccine against chickenpox (varicella) has not yet been developed but is

anticipated. This is a common childhood disease which, in the present state of

knowledge, does not appear to have the same potential for the serious

complications associated with measles, mumps and rubella. Should a disease that

is highly unpleasant but seems to run its course in a short time without

fatalities or residual disability be made the target of a mass immunization

campaign? As the vaccine has not yet been developed, no one can know what the

adverse side-effects of such a vaccine might be. Serious adverse reactions to a

vaccine tend to be the same as the serious complications of the disease itself,

so we might anticipate that a chicken pox vaccine would be quite safe. This does

not, however, fully answer the question whether an unpleasant but largely benign

disease should be made the target of a mass immunization effort.

Another potential candidate for a mass immunization program is a vaccine

against cytomegalovirus. Mass immunization against cytomegalovirus in young

girls, in later childhood just before puberty, might will prevent considerable

mental retardation, since cytomegalovirus is the most common congenital infection

(Table 8). The infant born with intra-uterine infection suffers brain damage in

10-30% of cases (Zuckerman, 1978).

Finally, gonorrhea and syphilis are obvious candidates for mass immunization

programs, should effective vaccines become available.

69-457 0 - 80 - 6 : QL 3
.

72

Table 7

New Vaccines - Expected Development After 1976

Vaccinees Bacteria Toxoids Virus Other

Children Meningococci B.

Meningococci A - B

Polyv. pneumococci

H. influenza

Caries

Trachoma

Bact. enterotoxoids

Pseudomonas

Cholera-toxoids

Gonococci

Syphilis

Rocky Mountain Spotted Fever

Adults

Herpes simplex 1 - 2

Cytomegalo

Varicella/Zoster

Rota

Influenza, inactivated Parasites

Influenza, live, att. Tumour

Resp. synctytial

Parainfluenza 1 - 3

Hepatitis A - B

Sources: Hennessen, 1978 and Foege, 1980.
73

Table 8

Incidence of Certain Causes of Neonatal Sepsis Syndrome

(per 1000 cases)

Bacterial 1.0-3.5

Cytomegalovirus 5-20

Rubella 0.25-5

Toxoplasma 0.75-1.3

Herpes virus 0.03-0.3

Syphilis 0.1-0.2

Source: Plotkin, 1978.
74

1. This discussion is based on Hennessen, 1978, and discussions with NIH

scientists involved in vaccine research; Drs. John LaMontague, James Hill,

and Milton Puziss,
75

EXHIBIT A

Surveillance of Illnesses Following Immunization

1978-1979

Majorie P. Pollack, M.D.

Center for Disease Control

April 14, 1980
77

Surveillance of Illnesses Following Immunization

1978-1979

Vaccines are recommended and administered to millions of individuals every

year on the presumption that the benefits far outweigh the risks. In the

risk-benefit equation, the benefits may be easily defined--vaccinations can and

do prevent serious diseases. On the risk side of the equation are the adverse

reactions to vaccination. Since some adverse effects may occur very rarely, it

is often difficult to recognize their relationship to vaccination and to estimate

the rate at which they occur. Additionally, many events reported to occur

following receipt of vaccine may not be related directly to the vaccine.

Continuing evaluation of the balance of risks and benefits requires the

surveillance of reactions following vaccination.

A formal monitoring system has been developed by the Immunization Division,

Bureau of State Services, Center for Disease Control. This system collects

information from vaccinees who report any illness requiring medical attention

during the 30-day period following receipt of vaccine. Reports are made to local

and State health departments and are then forwarded to CDC for collation. The

system was instituted on a pilot basis in several States early in 1978 and

formalized nationwide in October 1978. While reporting of illness following

vaccination is now mandatory from all Federally funded Immunization Projects, it

is still voluntary from the private sector. Figure 1 is a copy of the form

presently used, entitled “Report of Illness Following Vaccination.” This form is

triplicate, but the top sheet (shown in Figure 1) is the only copy which contains

patient identifying information. This copy is retained locally. This form

requests specific information on the individual who experienced an illness

following receipt of vaccine. Additional information that will be requested on

future forms is the patient’s immunization history prior to the dose in question.

The diagnoses and symptomatology described in the section “Brief description of
78

illness” are coded in accordance with the International Classification of

Disease, ninth revision, Clinical Modification (lCD 9-CM).

As of December 31, 1979, a total of 1,440 adverse events following

vaccination have been reported. Table 1 shows the number of reports received by

CDC, comparing the calendar year 1978 with 1979. Both the absolute number of

reports received, and the number of areas reporting increased in 1979, reflecting

the gradual implementation of the surveillance system. In 1979, 11.1 percent of

reports came from vaccine administered in the private sector, as compared with

9.5 percent in 1978. Fourteen reports concern vaccine administered-by military

providers. Table 2 shows the number of reports of adverse events following

vaccination by antigen administered, comparing 1978 with 1979. The vaccine most

frequently reported to be associated temporally with adverse events was DTP,

followed by OPV and MMR. This parallels vaccine practices, with DTP being

administered most frequently, followed by OPV.

Table 3 shows the breakdown of reports received by vaccine combinations

administered in 1978 and 1979. Of the 514 reports of illnesses following receipt

of OPV, only 26 followed the administration of OPV alone. Three hundred

thirty-two individuals received DTP simultaneously with OPV, 31 received Td with

OPV, 50 received DTP and MMR with OPV, and 14 received Td and MMR with OPV. This

simultaneous administration of multiple antigens makes it difficult to assess the

role of individual antigens in the etiology of adverse events following

immunization.

Table 4 shows the breakdown of reports received, by clinical illness and

vaccine type, for the combined period 1978 and 1979. It should be noted that an

event following the simultaneous administration of two vaccines is shown in both

vaccine columns. Thus, all 193 local reactions reported following receipt of OPV

represent individuals receiving OPV simultaneously with a parenterally

administered vaccine--i.e, DTP, Td, and/or MMR. Additionally, an individual
79

having a local reaction at the site of injection could also have had a convulsive

episode and thus would be shown in both rows in the table. The clinical illness

titles represent composites of symptoms based on the ICD9-CM coding system. The

bottom line of the table, labeled “Total Number of Individuals Involved”

represents the number of individuals reported to have had adverse events

following the receipt of each type of vaccine.

For all vaccine types except MMR, the most frequently reported adverse

events are local reactions. These represent approximately 40 percent of the

reports received overall, decreasing from 45 percent of reports in 1978 to 38

percent in 1979. This decrease may reflect improved functioning of the system,

since the guidelines for implementation of the surveillance system discourage the

reporting of local reactions except when there is an increased frequency noted.

The next most frequently reported adverse events were, fever--unaccompanied

by other systemic or localizing signs--and rash. In the cumulative file, these

two symptoms account for 32 percent of all reports received. If local reactions,

fever-only, and rash are considered minor symptoms, then 72 percent of all

adverse events reported were minor.

Arthritis and/or arthralgia accounted for 52 percent of all reports of

illnesses following receipt of rubella vaccine. All 24 reports involved

individuals over age 20 years--a finding consistent with the increased frequency

in adults reported in the literature.

Tables 5-9 are estimates of age specific rates of illnesses reported

following receipt of vaccine in the public sector in 1979. They are expressed as

the number of reports per million doses of vaccine administered. Tables 7-9

include reports relating to all vaccines containing the specific antigen

mentioned. The bottom line of each table gives the overall rate of reporting

individuals experiencing any adverse event following the receipt of the specific
80

vaccine.

In Table 5 we see the age-specific rates of illnesses following receipt of

DTP. Local reactions were most frequently reported, with an increasing rate with

increasing age. Febrile convulsions were most frequent in the 1- to 4-year-old

age group.

Table 6 shows the age-specific rates of illnesses following receipt of adult

Td vaccine. There is a trend of increasing rates with increasing age. Local

reactions in the greater than 20-year-old age group were reported at a rate

10-fold greater than that reported in the 5- to 9-year-old age group. This trend

is consistent with reports in the literature of an increased incidence of local

reactions following Td correlated with previous immune status.

Table 7 shows age-specific illness rates following receipt of mumps antigen

containing vaccines. All reports of encephalopathy were following receipt of

MMR.

Table 8 shows age-specific rates of illness following receipt of measles

antigen containing vaccines. There is a decreasing rate of febrile illnesses with

increasing age.

Table 9 shows the age-specific illness rates following receipt of rubella

antigen containing vaccines. The rates of illnesses seen in the greater than

20-year-old age group are much higher than those seen in the younger age groups.

In March of 1979, the Tennessee Department of Health reported that four

infants died suddenly in the 24-hour period following receipt of DTP vaccine. An

extensive investigation neither established nor refuted a causal relationship A

review of the surveillance file for 1978 and 1979 revealed that 43 reports of

sudden deaths in infancy in the 30 days following receipt of DTP vaccine had been

received. Figure 2 shows the number of cases of sudden death following receipt
81

of DTP by month of occurrence for the period May 1978 through December 1979.

Twenty-five of the 43 deaths (58 percent) had autopsy findings consistent with

sudden infant death syndrome (SIDS). Ten (or 23 percent) of the deaths occurred

in March. This coincides both with the investigation of the cluster in Tennessee

and with the usual seasonal incidence of SIDS.

The age range of the cases was 6 weeks to 13 months, with a mean of 304

months and a median of 2 months. The male to female ratio was 1.6 to 1.

Following receipt of DTP; the range was from several hours to 28 days, with

a mean of 5.4 days and a median of 1.5 days.

Of the 43 deaths reported, 28 different lots of vaccine from four different

manufacturers were involved. Only one lot was reported to have more than two

deaths; this

percent) had

immunization

was the lot involved in the Tennessee cluster. Thirty-six (84

received OPV simultaneously with DTP. Of the 30 infants where the

history was known, 73 percent had received their first dose, 20

percent their second dose, and 7 percent their third dose.

The 43 sudden deaths following receipt of DTP have similar age, sex, and

seasonal characteristics as reported for SIDS. The usual age at vaccination with

DTP coincides with the peak incidence of SIDS. The high proportion of reported

deaths that occurred within 24 hours of receipt of vaccine may reflect recall

bias, as people are more likely to attribute causality to events occurring

shortly before an unexpected and unexplained death.

The maintenance of a surveillance system to monitor

receipt of vaccines has three main roles. The first and

adverse events

most important

following

role of

the system is to learn about previously unrecognized vaccine reactions of low

incidence that might surface after wide-scale vaccine use, e.g., Guillaip-Barre

syndrome following swine influenza vaccine program.
A second role of the system is to maintain a vigilance for clustering of

vaccine reactions following the administration of a specific lot of vaccine. For

example, the clustering of sterile abscesses following two lots of Sclavo DTP

which resulted in the recall of the lot.

A third role is to refine estimates of the occurrence of known vaccine

reactions. In the past, there had been problems in the ascertainment of both the

frequency of reactions following vaccination and the number of doses of vaccine

actually administered. Until recently, determination of the frequency of

reactions was dependent upon vaccine field trials and sporadic reports to the

Bureau of Biologics (BOB) at FDA, the vaccine manufacturers, and public health

centers. The present surveillance system permits continuing estimation of this

frequency--albeit an underestimate due to the relative passive nature of the

system. The data reported do not establish causality or lack of causality

between an adverse event and the immunization received. The system does

highlight areas in which there is a need for special studies to determine

causality.
83

FIGURE 1

DEPARTMENT OF HEALTH, EDUCATION, AND WELFARE

PUBLIC HEALTH SERVICE

Form AvProveC

OMB No. 68-R 1661

CENTER FOR DISEASE CONTROL

ATLANTA, GEORGIA 30333 REPORT OF ILLNESS FOLLOWING VACCINATION

Patient Name: IPhona:

1- Z

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I i

Patient Addr- 1 1 I l - l I 1 I

— I I I I I

a.c. exe. num.

‘

ataOf Birth:m cm m

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ate: 

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County of Restdence:

Dateof Report: ~] IT] ~ [

M o Day V r .

Patient’s Physician: Phone:

111111111111 1

— —

a.c. exe. num.

Physician’s Address:

Parwn Making Report: Phone:

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— —

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--at

e:

m m m Provider: O Public❑ ;ivate ~M!litary ~ Other

M o , Day Yr.

Name of Provider:

lelow, enter all vaccines given on the above date.

Vaccine: ● 1 ● 2 # 3 * 4

Type

Manufacturer

Lot Number

Roum

Method

Site

‘

n

”

t D a

”’m m m Dmqwmsis :

M o , Oay Y r .

Brief Description of Illness:

‘“=’itdiz’’’’n yes EINO ❑ ’nk ‘

fy6Name0fHmpita ”

Laboratory Results:

Previous Illness or ReactIon to Vaccination: ❑ yes cl NO ❑ lun k ‘

e d

’

c a

’ ’

o n s

’

aken: ❑ lyes ❑ NO clun k

History of Convulsions in Patient:

c l

y

” c l

NO ❑ u n ’

History of Convulsions in Family: ❑ l’es cl NO ❑ u ” k

Descrtba:

‘

ate :m m m ❑ Recovered ❑ partalRecoverYn lllDDeat h

M o . Day Vr.

Comments

Record additional comments on a separate page and attach to this form,

I

Thls report IS authorized by law (42 (JSC 247b; 42 c F R 51 b). Its subm Ission Is needed to monitor possible rea CtlOn S to VaCClnat iOn and iS

voluntary except w hen required as a :ondtt 10 n of immu nlzat Ion grant awards. I

CDC 10.365-79 REPORTING AGENCY COPY
—

84

.s

‘s

‘6

‘5
85

Table 1

Number of Reports Received

1978 and 1979*

Number of Reports

Number of Areas Reporting

Number received vaccine from:

Public Provider

Private Provider

Military Provider

1978 1979 Total

486 954 1,400

33 48 48

320 747 1,067

46 106 152

3 11 14

*As of February 15, 1980
86

Table 2

DTP

TOPV

Td - Adult

Influenza

Mumps

Rubella

Tetanus toxoid

M-R

Measles

Smallpox

Typhoid

DT - Pediatric

Cholera

Yellow Fever

Pneumovax

Rabies - DEV

Rabies - HRIG

Tuberculosis

IPV

Number of Reports Received by Antigen

Administered in Decreasing Order

1978 and 1979*

1978 1979 Total

230

141

80

42

69

9

14

4

18

40

3

2

8

0

0

2

0

0

0

0

462

373

144

123

97

43

32

31

28

25

16

9

8

6

5

3

1

1

1

0

692

514

224

165

166

52

46

35

46

65

19

11

16

6

5

5

1

1

1

0

*Reports received as of February 15, 1980
87

Table 3

Immunizations Received by Individuals

Reported to Have Illnesses in the 30 days

Following Receipt of Vaccine - 1978 and 1979*

Single Antigen Only 1978 1979

DTP 130 143

59 92

Influenza 66 96

Td 11 79

Rubella 8 30

Mumps 5 17

Measles 30 19

TOPV 10 16

MR 6 9

Two Antigens

DTP & OPV

Td & TOPV

DTP & MMR

OPV & MMR

MR & Mumps

Td & Mumps

OPV & Mumps

Td & MR

Measles & Rubella

Td & Measles

Td & MMlt

DTP & Mumps

DTP & MR

OPV & Measles

OPV & MR

OPV & Rubella

69-457 0 - 80 - 7 : QL, 3

76

9

4

2

3

1

1

2

1

1

1

1

256

22

5

6

5

2

2

2

1

1

Total

293

151

162

90

38

22

49

26

15

332

31

9

8

5

3

3

3

2

2

1

1

1

1

1

1
88

Three Antigens

OPV & DTP & MMR

Td&OPV&M R

OPV & DTP & Mumps

Td & OPV & Measles

Td&OPV&MM R

OPV & DTP & MR

Td & OPV & Mumps

DTP & OPV & Measles

Td & OPV & Rubella

DTP & Mumps & MR

OPV & Measles & Mumps

Table 3 Continued

1978

13

7

1

4

2

2

1

2

2

1979 Total

37

7

10

2

3

3

1

1

1

50

11

6

5

5

2

2

2

1

1

*For those reports where full immunization histories are knon.
89

Table 4

Clinical Illnesses Reported to Have Occurred in the 30-day Period

Following Immunization by Vaccine Received -

1978 & 1979

Vaccine Type

Clinical Illness DTP

Local Reactions

Fever-- only

Rash

Allergic Reactions

Anaphylaxis

Arthritis and/or

Arthralgia

Convulsions-Febrile

Convulsions--Non-febrile

Encephalopathy

Guillain Barre

Syndrome (GBS)

Reye’s Syndrome

Paralysis--non GBS

Other necrologic Symptoms

Sudden Infant Death

Syndrome (SIDS)

Deaths from All Causes

Total number of

Individuals Involved

346

88

90

29

13

52

18

11

3

5

44

28

44

692

OPV

193

73

82

30

19

41

15

9

6

6

41

25

34

513

35

29

105

9

7

33

8

8

4

2

33

2

224

Td

106

12

20

5

8

1

6

1

3

1

6

162

Rubella

55

33

8

5

1

9

4

7

17

7

159

15

12

11

3

2

1

1

3

1

5

1

1

52

13

3

14

4

24

1

1

3

46

MR

7

5

13

3

2

1

4

1

6

1

1

45

Measles

22

7

22

3

2

2

4

2

3

1

1

7

2

65
90

Table 5

Age Specific Reports of Illness in the 30 Days

Following Receipt of DTP Administered in the Public Sector

Expressed as Cases Per Million Doses Administered-1979

Age (in years)

Clinical Illness

Local Reactions

Fever--Only

Rash

Allergic Reactions

Convulsions--Febrile

Convulsions--non-Febrile

Encephalopathy

Other Necrologic symptoms

SIDS

Deaths

Any reaction

<1

20.4

9.1

11.5

1.6

400

2.4

0.8

2.4

6.3

9.1

58.8

1-4

24.4

9.2

9.6

3.2

12.3

2.3

0.9

4.6

0.5

0.5

62.5

5-9

3003

12.7

8.4

4.2

3.2

58.8

All Ages

25.0

10.8

10.5

2.8

6.7

2.1

0.7

3.7

300

4.2

62.5
91

Table 6

Age Specific Reports of Illness in the 30 Days

Following Receipt of Td Administered in the Public Sector

Expressed as Cases Per Million Doses Administered-1979

Age (in years)

Clinical Illness 5-9

Local Reactions

Fever--Only

Rash

Convulsions-Febrile

Convulsions --non-febrile

Encephalopathy

Other Necrologic symptoms

Anv reaction .

12.7

2.1

17.8

10-14

1106

1.9

3.9

1.9

1.0

20.4

15-19

18.9

2.5

1.3

103

2.5

1.3

27.8

>20

166.7

4 0 9

14.7

409

4.9

200.0

All Ages

27.8

2.7

4.3

003

1.7

0.3

0.7

38.5
92

Table 7

Age Specific Rates of Reported Illnesses in the 30 Days

Following Receipt of Mumps* Administered in the Public Sector

1979 Expressed as Cases Per Million Doses Administered

Age (in years)

Reactions

Local Reactions

Fever--Only

Rash

Allergic Reactions

Convulsions-Febrile

Convulsions-Non-feb.

Encephalopathy

Other Necrologic

Symptoms

Any reaction

1-4

c 1

13.1

28.4

3.5

1.4

3.5

007

7.6

21.4

9.6

6.0

2.4

14.4

10-14

16.9

1001

3.4

3.4

10.1

23.6

15-19

8.0

8.0

8.0

>20

121.6

121.6

All Ages

1003

11.4

20.5

2.2

0.7

1.8

0.7

6.2

19.8

*For all mumps containing vaccines (mUmPS + MMR)
93

Table 8

Age Specific Rates of Reported Illnesses in the 30 Days

Following Receipt of Measles* Administered in the Public Sector

1979 Expressed as Cases Per Million Doses Administered

Age ( i n years)

Reaction 1-4

Local Reactions 10.0

Fever-- only 10.7

Rash 30.7

Allergic Reactions 2.9

Anaphylaxis

Convulsions--Febrile 10.7

Convulsions--Non-Feb. 3.6

Encephalopathy 0.7

Other Necrologic

Symptoms 7.9

Any reaction 65.7

5-9

8.9

7.4

3.0

1.5

1.5

22.2

10-14

10.0

2.9

10.0

2.9

1.4

1.4

2.9

1.4

7.5

31.4

15-19

8.9

2.2

4.5

2.2

29.0

>20

41.7

125.0

All Ages

10.4

7.3

18.9

2.1

0.3

5.2

2.8

0.9

5.5

48.6

*For all measles containing vaccines (measles + MR + MMR)
.

94

Table 9

Age Specific Rates of Reported Illnesses in the 30 Days

Following Receipt of Rubella* Administered in the Public Sector

1979 Expressed as Cases Per Million Doses Administered

Age (in years)

Reaction 1-4 5-9 10-14

Local Reactions 9.3 8.4 11.9

Fever-- only 12.2 8.4 2.4

Rash 29.5 3.4 7.1

Allergic Reactions 2.9 1.7 2.4

Arthritis and/or

Arthralgia 0.7 1.7

Convulsions--Febrile 10.8 2.4

Convulsions--Non-feb. 3.6 2.4

Encephalopathy 0.7

Other necrologic

symptoms 7.2 1.7 9.5

Any reaction 65.4 23.6 30.9

*For all rubella containing vaccines (rubella + MR + MMR)

15-19

10.9

10.9

5.5

43.8

>20

158.6

238.0

39.7

515.6

793.2

All Ages

12.2

9.1

23.2

3.0

6 . 5

6 . 1

3.0

0.8

6.1

51.7
95

EXHIBIT B

Ranges of Direct, Indirect, and Total Cost by Medical Event
97

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99

Exhibit C

California Law on Vaccine In-jury Compensation

and

Rhode Island Legislative Proposal on Vaccine Injury Compensation
101

California Health and Safety Code

ARTICLE 14.5

Immunization Reactions

(Added by Stats 1977 ch 1097 1.)

 429.35 Medical etc., care for reactions by minors: Claims reimbursement, and

subrogation: Creation of Immunization Adverse Reaction Fund

 429.36 Liability for injuries caused by acts or omissions in administration of

vaccine or other immunizing agent

($429.35. Medical, etc., care for reactions by minors: Claims, reimbursement,

and subrogation: Creation of Immunization Adverse Reaction Fund

It is the intent of the Legislature to provide for care, including medical,

institutional, supportive, and rehabilitative care, necessitated because of

severe adverse reaction to any immunization required by state law to be

administered to children under 18 years of age.

As used in this article, a severe adverse reaction is one which manifests itself

not more than 30 days after the immunization and requires extensive medical care,

as defined by regulation of the department.

Medical expenses shall be reimbursed by the state department in an amount not to

exceed twenty-five thousand dollars ($25,000).

Eligibility for reimbursement under this section shall be limited to persons

requiring extensive medical care, as defined by the state department pursuant to

this section. Such reimbursement shall be made without regard to ability to pay

and neither the parents nor the estates of such persons shall be liable for

repayment to the state of any portion of the amounts reimbursed pursuant to this

article.

The state department shall, by regulation, establish procedures for processing

claims pursuant to this section.

Whenever reimbursement is provided for medical expenses under this article, the

state shall be subrogated to the rights of the person receiving reimbursement of

medical expenses for any amounts due to or recoverable by such person from third

parties. The subrogation shall be for an amount equal to any claim reimbursed

under this article.

There is hereby created in the State Treasury the Immunization Adverse Reaction

Fund, which shall be administered by the State Department of Health and is

appropriated without regard to fiscal years.

Reimbursements made pursuant to this article shall be made from the Immunization

Adverse Reaction Fund.

ff 429.36 Liability for in-juries caused by acts or omissions in administration of

vaccine or other immunizing agent.

No person shall be liable for any injury caused by an act or omission in the

administration of a vaccine or other immunizing agent to a minor, including the

residual effects of the vaccine or immunizing agent, if such immunization is

required by state law and the act or omission does not constitute willful

misconduct or gross negligence.
102

79-s 77

Introduced bySenators Federico, Flynn and O’Neill

Ordered Printed bySenate

Referred toSenate Committee on Special Legislation

Date PrintedJanuary 10, 1979

State of Rhode Island and Providence Placations

JANUARY

An Act Pertaining to “Immunization

SESSION, A. D. 1979

Reactions’ t.

It is enacted by the General Assembly as follows:

Section 10 Title 16 of the general laws entitled “Education” is hereby

amended by adding thereto the following chapter:

“CHAPTER 16-21.2

“Immunization Reactions

“16-21.2-1. LEGISLATIVE INTENT. -- It is the intent of the legislature to

provide for care, including medical,, institutional, supportive, and

rehabilitative care, necessitated because of severe adverse reaction to any

immunization required by state law to be administered to children under eighteen

(18) years of age.

‘16-21.2-2. REACTION DEFINED. -- As used in this chapter, a severe

adverse reaction is one which manifests itself not more than thirty (30) days

after the immunization and requires extensive medical care, as defined by

regulation of the department of health.

“16-21.2-3. REIMBURSEMENT -- MEDICAL EXPENSES. -- Medical expenses shall

be reimbursed by the state in an amount not to exceed twenty-five thousand

dollars ($25,000).

Eligibility for reimbursement under this section shall be limited to persons

requiring extensive medical care, as defined by the health department pursuant to

this section. Such reimbursement shall be made without regard to ability to pay

and neither the parents nor the estates of such persons shall be liable for

repayment to the state of any portion of the amounts reimbursed pursuant to this

chapter.

The health department shall, by regulation, establish procedures for

processing claims pursuant to this section

Whenever reimbursement is provided for medical expenses under this article,

the state shall be subrogated to the rights of the person receiving reimbursement

of medical expenses for any amounts due to or recoverable by such person from

third parties. The subrogation shall be for an amount equal to any claim

reimbursed under this chapter.
103

There is hereby created in the state treasury the immunization adverse

reaction fund, which shall be administered by the department of health and is

appropriated without regard to fiscal years. Reimbursments made pursuant to this

article shall be made from the immunization adverse reaction fund.

“16-21.2-4. PERSONS LIABLE. -- No persons shall be liable for any injury

caused by an act or omission in the administration of a vaccine or other

immunizing agent to a minor, including the residual effects of the vaccine or

immunizing agent, if such immunization is required by state law and the act or

omission does not constitute willful misconduct or gross negligence.”

Sec. 2. The sum of fifty thousand dollars ($50,000) is hereby appropriated

from the general fund to the immunization adverse reaction fund for the purposes

of this chapter.

Sec. 3. This act shall take effect upon passage.
104

79-s7 7

EXPLANATION

By the Legislative Council

Under existing law, there is no state program which provides for medical or

institutional care or indemnification expressly for children who suffer an

adverse reaction to a required immunization. Also, nothing in present law

exempts physicians and surgeons from liability for damages caused by negligent

acts or omissions in the administration of immunizing agents, except with respect

to prescribed participation in the National Influenza Program of 1976.

This act would require the Department of Health to reimburse the medical

expenses incurred for a child under the age of 18 as a result of a severe

reaction to a state-required immunization, as specified. Such reimbursement

would not exceed $25,000, would be made without regard to ability to pay, and

would be made without requirement of repayment.

This act would subrogate the state to the rights of the person receiving

reimbursement for medical expenses to the extent of any reimbursement provided.

This act would exempt a person from liability for injury caused by acts or

omissions, not constituting gross negligence or willful misconduct, in

connection with the administration of an immunization required by state law.

This act would appropriate $50,000 to the Immunization Adverse Reaction

Fund, a continuously appropriated fund created by the act to carry out the

provisions of the bill requiring indemnification for medical expenses.
105

References

Barnes, J., 1980, communication with the Office of Technology Assessment from the

British Department of Health and Social Security.

Dick, G., 1978, “The Whooping Cough Vaccine Controversy” in New Trends and

Developments in Vaccines, ed. A. Voller and H. Friedman (University Park Press:

Baltimore).

Dowdle, W.R., et al. , 1980, “Japanese Influenza Immunization Program,” Journal of

Infectious Disease 141:258-264 (February).

Foege, W.H., 1980, communication with the Office of Technology Assessment from

the Director, Center for Disease Control, Atlanta, Georgia.

Gaskins, R., 1980, “Equity in Compensation: The Case of Swine Flu,” Hastings

Center Report, February, pp. 5-8.

General Accounting Office, June 6, 1980, “Discussion of Selected Issues Affecting

Federal Immunization Activities.”

Hennessen, W., “New Developments in Vaccines,” in New Trends and Developments in

Vaccine, ed. A. Voller and H. Friedman (University Park Press: Baltimore) p. 7.

Kavet, J., 1980, communication with the Office of Technology Assessment from the

Office of Policy, Research, Statistics, and Technology, Assistant Secretary for

Health, U.S. Department of Health and Human Services.

Kingham, R.F., September 1980, communication with the Office of Technology

Assessment from Covington & Burling, counsel for Merck & Co., Inc.

Landrigan, P., and Witte, J., 1973, “Necrologic Disorders Following Live Measles

- Virus Vaccination,” Journal of the American Medical Association 223: 1459-1462

(March).

Little, A.D., 1979, “Estimated Economic Costs of Selected Medical Events Known or

Suspected to be Related to the Administration of Common Vaccines,” under contract

to the National Center for Health Services Research, Department of Health and

Human Services.

Plotkin, S.A., 1978, “Pediatric Vaccines,” in New Trends and Developments in

Vaccines, ed. A. Voller and H. Friedman (University Park Press: Baltimore) pp.

19-28.

Reyes v. Wyeth Laboratories, 498 F. 2d 1264 (5th Circuit 1974), at 1294.

U.S. Department of Health, Education, and Welfare, public Health Service, Healthy

People: the Surgeon General’s Report on Health Promotion and Disease Prevention

(Washington, D.C.: U.S. Gov’t Printing Office, 1979).

Yankelovich, Skelley and White, 1978-1979, Family Health in an Era of Stress, The

General Mills American Family Report.

Zuckerman, A.J., “Development with Hepatitis B Vaccines,” in New Trends and

Developments in Vaccines, ed. A. Voller and H. Friedman (University Park Press:

Baltimore) pp. 171-178.