National Vaccine Injury Compensation Program: Revision to Vaccine Injury Table

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration

42 CFR Part 100

National Vaccine Injury Compensation Program: Revision to Vaccine

Injury Table

AGENCY: Health Resources and Services Administration, HHS.

ACTION: Notice of Extension of Public Comment Period.

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SUMMARY: This document affords interested members of the public an

additional 30 days to comment on proposed regulations to amend the

Vaccine Injury Table governing the National Vaccine Injury Compensation

Program (VICP) due to recent publication of a study that may be

relevant to the vaccine injury table.

DATES: Comments must be submitted on or before April 25, 1994.

ADDRESSES: Written comments should be addressed to Fitzhugh Mullan,

M.D., Director, Bureau of Health Professions (BHPr), Health Resources

and Services Administration (HRSA), room 8-05, Parklawn Building, 5600

Fishers Lane, Rockville, MD 20857. All comments received will be

available for public inspection and copying at the Office of Program

Development, BHPr, room 8A-55, Parklawn Building, at the above address

weekdays (Federal holidays excepted) between the hours of 8:30 a.m. and

5 p.m.

FOR FURTHER INFORMATION CONTACT: Geoffrey Evans, M.D., Deputy Director,

Division of Vaccine Injury Compensation, BHPr, (301) 443-6593. David

Benor, Senior Attorney, Office of the General Counsel, (301) 443-2006.

SUPPLEMENTARY INFORMATION: The Agency is publishing this Notice to

afford members of the public an additional 30 days to provide comments

on proposed regulations to amend the Vaccine Injury Table governing the

National Vaccine Injury Compensation Program (hereinafter ``VICP'' or

``Program''). The VICP was established by the National Childhood

Vaccine Injury Act of 1986, Pub. L. 99-660 [42 U.S.C. 300aa-10 et seq.]

(Act), and provides a system of no-fault compensation for certain

individuals who have been injured by specific childhood vaccines.

Petitions for compensation under this Program are filed with the United

States Court of Federal Claims, with a copy served on the Secretary,

who is denominated the ``Respondent.'' The Vaccine Injury Table (Table)

included in the Act establishes presumptions about causation of certain

illnesses and conditions, which are used by the U.S. Court of Federal

Claims to adjudicate petitions.

Under section 312 of the Act, Congress mandated that the Secretary

review the scientific literature and other information on specific

adverse consequences of pertussis and rubella vaccines. In accordance

with the requirements of that law, the Secretary entered into a

contract with the Institute of Medicine (IOM) to perform this review.

The IOM published on August 27, 1991 a report of its review entitled,

``Adverse Effects of Pertussis and Rubella Vaccines'' (hereinafter

``IOM Report.'')

Section 312 also required the Secretary to propose regulations to

amend the Table as a result of such findings. Accordingly, on August

14, 1992, the Assistant Secretary for Health, with the approval of the

Secretary of Health and Human Services (the Secretary) published in the

Federal Register (57 FR 36878) a Notice of Proposed Rulemaking (NPRM)

to amend the Table. The NPRM was issued pursuant to section 2114 of the

Act, which authorizes the Secretary to promulgate regulations to modify

the Table. As required by section 2114(c) of the Act, the Department

provided for a 6-month comment period which closed on February 11,

1993. In addition, on December 3, 1992, the Department held a public

hearing for the purpose of receiving oral testimony on the proposed

rule.

The Agency analyzed the comments received in preparation for

publication of the final rule. During this process, however, the Agency

became aware of the imminent publication of a 10-year follow-up study

to the National Childhood Encephalopathy Study (Madge N., Diamond J.,

Miller D., Ross E., McManus C., Wadsworth J., Yule W. The National

Childhood Encephalopathy Study: A 10-year follow-up. A report of the

medical, social, behavioural and educational outcomes after serious,

acute, neurologic illness in early childhood. Developmental Medicine

and Child Neurology 1993; Supplement No. 68;35(7):1-118; Miller D.L.,

Madge N., Diamond J., Wadsworth J., Ross E. Pertussis immunization and

serious acute neurological illness in children. British medical Journal

1993; 307:1171-1176, hereinafter ``Miller study.''). Because the

National Childhood Encephalopathy Study (NCES) was reviewed initially

by the IOM, and because the Miller study looked specifically at the

relationship between vaccine administration and resulting neurological

damage, the Department determined that it should not proceed with

publication of the final rule until there had been a sufficient

opportunity to consider the conclusions of the new Miller study.

Accordingly, the Department asked the IOM to convene a Committee for

purposes of evaluating the Miller study in light of the conclusions of

its initial report. On March 2, 1994, the Institute of Medicine issued

a report entitled ``DPT Vaccine and Chronic Nervous System Dysfunction:

A New Analysis.''

The Agency has determined that the public should have an additional

30 days to comment on the conclusions of this report prior to

publication of the final rule. Only those comments addressing the

conclusions of this latest IOM report will be considered. Commenters

should address whether the proposed rule should be modified in light of

the conclusions of this latest IOM report. The Department will consider

carefully all comments received, and will address these comments in the

preamble to the final rule.

The Department is not able to reproduce herein the entire study for

review by the public. Set forth below, however, is the Executive

Summary of the report containing the IOM's conclusions. Copies of the

full report can be obtained by contacting the National Academy of

Sciences, 2101 Constitution Avenue, NW., Washington, DC 20077-5576.

Executive Summary

An Institute of Medicine (IOM) committee recently concluded that

the evidence is consistent with a causal relation between vaccination

with DPT and acute encephalopathy (IOM, 1991), and the excess risk was

estimated to range from 0 to 10.5 per million DPT immunizations.

However, the same IOM committee also concluded that the evidence was

insufficient to indicate a causal relation between DPT and permanent

neurologic damage (IOM, 1991). In fact, the relation between DPT and

chronic nervous system dysfunction had not been studied in a rigorous

scientific manner until recently. Because the evidence has been so

limited, the appearance of a single new report, a 10-year follow-up to

the National Childhood Encephalopathy Study (NCES, Miller et al.,

1993), prompted the U.S. Public Health Service to ask IOM to convene

the Committee to Study New Research on Vaccines with the charge of

studying the new data and, if warranted, reevaluating the causal

relation between DPT and chronic nervous system dysfunction.

The NCES reported that the occurrence of hospitalization for

serious neurologic disorders among 2- to 35-month-old children is very

strongly related to the occurrence of death or nervous system

dysfunction (neurologic, behavioral, educational, motor, sensory, or

self-care impairment) up to 10 years (Madge et al., 1993; Miller et al.

1993). Children who experienced the rare but serious acute neurologic

disorder within 7 days after receiving DPT were no more or less likely

to experience documented chronic nervous system dysfunction or to have

died within 10 years of the acute disorder than children who had not

received DPT within 7 days prior to the onset of the disorder. There

were no special characteristics associated with the acute or chronic

nervous system illnesses linked to DPT exposure.

The NCES did not investigate the possibility of a direct relation

between DPT and chronic nervous system dysfunction, that is, in the

absence of a serious acute neurologic illness that occurs within 7 days

after receiving DPT. The NCES provides data only on the limited case of

a possible relation between DPT and chronic nervous system dysfunction

in those children in whom a serious acute neurologic illness followed

DPT vaccination within 7 days.

The committee posits three possible scenarios whereby the acute

neurologic illnesses that follow DPT might be related to chronic

nervous system dysfunction.

1. DPT administration might cause serious acute neurologic illness

and subsequent chronic dysfunction in children who might not have

otherwise experienced either an acute neurologic illness or chronic

dysfunction in the absence of DPT.

2. DPT might trigger (and thereby be an immediate or proximate

cause) an acute neurologic illness and subsequent chronic dysfunction

in children with underlying brain or metabolic abnormalities. Such

children might experience acute neurologic illness and subsequent

chronic dysfunction in association with some trigger other than DPT.

3. DPT might cause an acute neurologic illness in children with

underlying brain or metabolic abnormalities that would themselves

eventually have led to chronic dysfunction even in the absence of an

acute neurologic illness.

The Committee believes its conclusions take into account the fact

that the data do not support any one of these scenarios over the

others. Because the NCES did not (and probably could not) rule out the

possibility that only children with underlying brain or metabolic

abnormalities react to stimuli such as DPT with acute neurologic

illness, and no other studies establish or rule out such a possibility,

the committee concludes that the evidence is insufficient to indicate

whether or not DPT increases the overall risk in children of chronic

nervous system dysfunction.

The NCES data are consistent with the possibility that some

children without underlying brain or metabolic abnormalities might

experience serious, acute neurologic illness within 7 days after

receiving DPT and that acute neurologic illness will have chronic

nervous system sequelae. The NCES data also are consistent with the

possibility that some children with underlying brain or metabolic

abnormalities (which foster a ``triggering'' by DPT of an acute

neurologic illness) might go on to develop chronic nervous system

dysfunction due to a DPT-triggered acute illness. Therefore, the

committee concludes that the balance of evidence is consistent with a

causal relation between DPT and the forms of chronic nervous system

dysfunction described in the NCES in those children who experience a

serious, acute neurologic illness within 7 days after receiving DPT

vaccine. This serious, acute neurologic response to DPT is a rare

event. The excess risk has been estimated to range from 0 to 10.5 per

million immunizations (IOM, 1991). The evidence does not ``establish''

or ``prove'' a causal relation. The evidence remains insufficient to

indicate the presence or absence of a causal relation between DPT and

chronic nervous system dysfunction under any other circumstances. That

is, because the NCES is the only systematic study of long-term

dysfunctions after DPT, the committee can only comment on the causal

relation between DPT and those long-term dysfunctions under the

conditions studied by the NCES. In particular, it should be noted that

the long term dysfunctions associated with DPT followed a serious acute

neurologic illness that occurred in children within 7 days after

receiving DPT.

Dated: March 18, 1994.

Ciro V. Sumaya,

Administrator.

[FR Doc. 94-6858 Filed 3-23-94; 8:45 am]

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