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

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

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.

.

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.

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.

scientists involved in vaccine research; Drs. John LaMontague, James Hill,

and Milton Puziss,