[Federal Register Volume 60, Number 26 (Wednesday, February 8, 1995)]
[Rules and Regulations]
[Pages 7678-7696]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-2945]
[[Page 7677]]
_______________________________________________________________________
Part V
Department of Health and Human Services
_______________________________________________________________________
Public Health Service
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42 CFR Part 100
National Vaccine Injury Compensation Program Revision of the Vaccine
Injury Table; Final Rule
Federal Register / Vol. 60, No. 26 / Wednesday, February 8, 1995 /
Rules and Regulations
[[Page 7678]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
42 CFR Part 100
RIN 0905-AD64
National Vaccine Injury Compensation Program Revision of the
Vaccine Injury Table
AGENCY: Health Resources and Services Administration, PHS, HHS.
ACTION: Final rule.
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SUMMARY: This final rule amends the existing regulations governing the
National Vaccine Injury Compensation Program (VICP) by adding a new
section regarding the Vaccine Injury Table (Table) to the regulations,
pursuant to section 312 of the National Childhood Vaccine Injury Act of
1986 and section 2114(c) of the Public Health Service Act (the Act).
The VICP provides a system of no-fault compensation for certain
individuals who have been injured by specific childhood vaccines. The
Vaccine Injury Table included in the Act establishes presumptions about
causation of certain illnesses and conditions, which are used by the
Court to adjudicate petitions. The amendments to the Vaccine Injury
Table will affect only those petitions filed for compensation under the
VICP after the effective date of this rule.
EFFECTIVE DATE: This regulation is effective March 10, 1995.
FOR FURTHER INFORMATION CONTACT:
Geoffrey Evans, M.D., Chief Medical Officer and Deputy Director,
Division of Vaccine Injury Compensation, Bureau of Health Professions,
(301) 443-4198, or David Benor, Senior Attorney, Office of the General
Counsel, (301) 443-2006.
SUPPLEMENTARY INFORMATION:
Introduction and Procedural History
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 Vaccine Injury Table (the Table). (A
correction notice to the NPRM was also published on September 11, 1992,
57 FR 41809). The NPRM was issued pursuant to section 2114(c) of the
Act, which authorizes the Secretary to promulgate regulations to modify
the Table.
As stated in the preamble to the proposed rule, under section 312
of the National Childhood Vaccine Injury Act of 1986 (Pub. L. 99-660),
Congress mandated that the Secretary review the scientific literature
and other information on specific adverse consequences of pertussis and
rubella vaccines. The Secretary entered into a contract with the
Institute of Medicine (IOM), as recommended by Congress, to perform
this review. The IOM published a report of its review entitled,
``Adverse Effects of Pertussis and Rubella Vaccines,'' on August 27,
1991 (hereinafter ``IOM Report''). The Public Health Service Task Force
on the VICP evaluated the IOM report and made the initial
recommendations regarding possible revision of the Table.
These recommendations were reviewed by a special subcommittee of
the National Vaccine Advisory Committee (NVAC) (a committee authorized
under section 2105 of the Act). The subcommittee overwhelmingly
endorsed all of the proposed revisions except for the addition of
chronic arthritis to the Table. The full NVAC endorsed the
subcommittee's recommendations for revising the Table.
The Advisory Commission on Childhood Vaccines (ACCV), whose
membership by statutory directive reflects a variety of views relating
to childhood immunizations (authorized under section 2119 of the Act),
considered the NVAC report as well as the PHS Task Force
recommendations. The ACCV deliberations included public policy
considerations, whereas the NVAC charge was to consider only the
scientific issues raised by the existing Table, the recent IOM report,
and other scientific information. The ACCV voted approval of all of the
PHS Task Force recommendations except for the removal of the condition
of Encephalopathy. The ACCV voted unanimously to retain Encephalopathy
on the Table provided the existing definition in the Aids to
Interpretation was clarified. The Secretary proposed changes to the
Table after reviewing the recommendations of these three entities.
As provided by section 2114(c) of the Act, the Department provided
for a 6-month comment period, which closed on February 11, 1993. On
December 3, 1992, the Department held a public hearing for the purpose
of receiving oral testimony on the proposed rule.
During the process of analyzing the comments received in response
to the NPRM, the Agency became aware of the imminent publication of a
10-year follow-up study to the National Childhood Encephalopathy Study
(NCES) (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 Miller study looked specifically at the
relationship between vaccine administration and subsequent 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.'' On March 24, 1994, the Department published a notice
in the Federal Register affording members of the public and additional
30 days to comment on the Miller study and the IOM report. See Federal
Register March 24, 1994, (59 FR 13916).
The Agency also asked a subcommittee of the NVAC to review the
IOM's conclusions regarding the implications of the Miller study. On
March 15, the NVAC subcommittee met to review (among other things) the
Miller study. The subcommittee was composed of members of the NVAC, and
received input from outside experts from the fields of epidemiology,
pediatric infectious disease, and pediatric neurology. The views of the
NVAC are discussed below where relevant.
The ACCV reviewed the IOM report on the Miller study at its
meetings in March and June, 1994. In addition, the ACCV was asked to
provide comments during the additional public comment period. Comments
received from two individual Commission members will be discussed
below. At the June meeting, the Commission discussed in detail the
Miller study and the IOM report. The consensus of the Commission was
that the original table in the statute requires modification to make it
consistent with current medical and scientific knowledge regarding
adverse events associated with certain vaccines. The Commission was
split, however, on the appropriate frame of reference for modifying the
Table. Some [[Page 7679]] Commission members expressed the view that
the starting point for revisions to the Table should be the original
Table in the statute. The other commissioners agreed that the Secretary
should further refine the Table, but that the starting point for
additional revisions should be the modified Table as published in the
NPRM on August 14, 1992.
The Department has listened carefully to the Commissioners'
concerns. After weighing all the varied opinions expressed at the June
meeting, as well as the written comments received from two commission
members, the Department has decided that a final rule which is a
revised and refined version of the proposed rule published in 1992 will
reflect best the scientific evidence. However, in drafting the final
rule, the Department made many of the changes suggested by members of
the Commission. These changes will be explained below. In this regard,
the Department recognizes that one of the objectives of the National
Vaccine Plan, which was released recently by the National Vaccine
Program Office/OASH, is to ensure that the Vaccine Injury Table is
updated periodicall to reflect the latest scientific knowledge. The
final rule is consistent with this goal, as well as the statutory
directive that the Secretary revise the Table.
Although by law the regulation will only affect those petitions
filed after the effective date specified above, the Department
encourages the Special Masters of the U.S. Court of Federal Claims to
apply the scientific findings which form the basis of the revised Table
where appropriate. For instance, in cases where petitioners are
intending to prove causation in fact, the IOM's conclusions regarding
causation may be relevant for consideration by the Special Master. In
addition, the Special Master could find, based on the conclusions of
the IOM, that a particular injury was due to a factor unrelated to
vaccine administration. Prior to promulgation of this rule, several
Special Masters viewed the IOM report as instructive regarding certain
illnesses and conditions and their relationship to vaccine
administration. The Department hopes that the use of the IOM report
continues, and that the findings and conclusions made by the Secretary
in promulgating this rule will be applied by the Masters where the
facts of the case make it appropriate to do so. In some cases, as
explained below, the Secretary's findings as set forth in the NPRM at
57 FR 36879 were not incorporated into the final rule. This decision
does not affect the Secretary's findings and should not deter the
Special Masters from applying the findings where appropriate.
The Department received 41 written comments and five oral comments
on the NPRM, and five comments in response to the Federal Register
Notice to Extend the Public Comment Period (March 24, 1994). Comments
were received from health professional organizations, parent
organizations, medical professionals, attorneys, and the general
public. All comments were carefully considered. The Department's
responses to the comments are discussed below in two separate sections.
Section I discusses the comments addressing legal issues, and Section
II discusses those comments addressing medical issues. The discussion
does not address comments that either generally supported or generally
criticized the proposed Table changes without making a specific point.
In preparing this final rule, the Department also made a number of
changes, both editorial and substantive in nature. The substantive
changes are discussed where appropriate as follows:
I. Legal Issues
The Secretary's Authority To Promulgate the Regulation
Several commenters suggested that the Department had exceeded its
authority in promulgating the regulation. First, commenters argued that
this is a function which belongs to the legislative branch and which
cannot be delegated to the Department based on the Separation of Powers
doctrine. The Department disagrees with this legal argument for several
reasons. In enacting a particular statutory scheme, Congress will often
leave particular gaps with instructions to the Department charged with
executing the statute to promulgate regulations to fill the gaps and
interpret the statutory language. See Chevron v. Natural Resources
Defense Council, Inc., 467 U.S. 837 (1984). In promulgating
regulations, the Department is limited to the authority delegated by
Congress, and is obligated to act consistent with Congressional intent.
See Bowen v. Georgetown University Hospital, 488 U.S. 204 (1988).
Pursuant to these basic principles of administrative law, the Secretary
is promulgating this regulation to amend the Vaccine Injury Table.
The statute explicitly authorizes the Secretary in section 2114(c)
of the Act to modify the Table and states that the ``Secretary may
promulgate regulations to modify * * * the Vaccine Injury Table.'' See
42 U.S.C. 300aa-14(c)(1). The statute further provides that ``a
modification of the Vaccine Injury Table under paragraph (1) may add
to, or delete from, the list of injuries, disabilities, illnesses,
conditions, and deaths for which compensation may be provided, or may
change the time periods for the first symptom or manifestation of the
onset of the significant aggravation of any such injury, disability,
illness, condition, or death.'' See 42 U.S.C. 300aa-14(c)(3). Under
section 312 of Pub. L. 99-660, Congress mandated that the Secretary
review the scientific literature and other information on specific
adverse consequences of pertussis and rubella vaccines. As mandated by
the statute, after completion of this study (undertaken by the
Institute of Medicine), and the consultation required by section
2114(c) of the Act, the Department proposed the revisions to the Table.
In so doing, the Department was acting exactly within the authority
delegated to it by the Congress.
Further, as stated in the preamble to the Notice of Proposed
Rulemaking, the legislative history explains that Congress intended the
Secretary to modify the Table. The Conference Report states as follows:
The Committee recognizes that there is public debate over the
incidence of illnesses that coincidentally occur within a short time
of vaccination. The Committee further recognizes that the deeming of
vaccine-relatedness adopted here may provide compensation to some
children whose illness is not, in fact, vaccine-related. The
Committee anticipates that the research on vaccine injury and
vaccine safety now ongoing and mandated by this legislation will
soon provide more definitive information about the incidence of
vaccine injury and that, when such information is available, the
Secretary or the Advisory Commission on Childhood Vaccines * * * may
propose to revise the Table, as provided below in section 2114
[Initial Table]. Until such time, however, the Committee has chosen
to provide compensation to all persons whose injuries meet the
requirements of the petition and the Table and whose injuries cannot
be demonstrated to be caused by other factors.
See H.R. Rept. 99-908, Part 1, September 26, 1986, page 18 (reprinted
in 1986 U.S. Code Cong. and Admin. News, Vol. 6, page 6359). This
passage indicates that the Department is acting consistent with
Congressional intent.
At least two commenters argued that the Department exceeded its
authority in modifying the ``Qualifications and Aids to
Interpretation'' (Qualifications) found in section 2114(b) of the Act.
This argument, too, is misplaced. First, section 312 requires that the
Secretary make findings regarding which illnesses [[Page 7680]] and
conditions can reasonably be determined to be caused by certain
vaccines. It further requires the Secretary to make findings regarding
``the circumstances under which such causation or aggravation can
reasonably be determined to occur.'' 42 U.S.C. 300aa-1 note. The
purpose of the Qualifications and Aids to Interpretation is to describe
those circumstances under which certain conditions occur. Congress
stated that the Qualifications provide ``various descriptions and
definitions that the Committee intends be used in interpreting the
meaning of the Table.'' See H.R. Rept. 99-908, Part 1, September 26,
1986, page 19 (reprinted in 1986 U.S. Code Cong. and Admin. News, Vol.
6, page 6360). Given that Congress required the Secretary to make
findings regarding the circumstances under which causation can occur,
and that she was then required to promulgate regulations as a result of
such findings, she could not have fulfilled her obligations under
section 312 without modifying the Qualifications as well as the Table
itself.
Moreover, the statutory language and the legislative history quoted
above indicate that the Qualifications must be viewed as part of the
Table. The statute states that ``the following qualifications and aids
to interpretation shall apply to the Vaccine Injury Table in subsection
(a).'' See 42 U.S.C. 300aa-14(b). Thus, Congress intended the Table and
the Qualifications to be viewed as one unit because the Qualifications
explain and clarify the terms of the Table. It stands to reason,
therefore, that if the Table is changed, the Qualifications must be
changed accordingly.
In fact, Congress anticipated that changes to the Table would
require similar changes to the Qualifications and Aids to
Interpretation in order to guarantee that the two sections are
consistent. The statute states that ``if a provision of the table to
which paragraph (1), (2), (3), or (4) [the paragraphs of the
Qualifications and Aids to Interpretation] applies is revised under
subsection (c) or (d), such paragraph shall not apply to such provision
after the effective date of the revision unless the revision specifies
that such paragraph is to continue to apply.'' (42 U.S.C. 300aa-
14(b)(4)). Thus, the Qualifications contained in the original statute
become null and void once that initial Table is changed, unless the
Secretary specifies that they are to apply. Implicit in this authority
is the authority to promulgate by regulation Qualifications applicable
to the revised Table.
Two commenters stated that the regulation exceeded the Department's
authority by attempting to prescribe elements of proof necessary to
prevail in a petition for vaccine compensation. They argued that this
function is reserved to the United States Court of Federal Claims. As
explained above, the Secretary is authorized to revise the
Qualifications as well as the Table. The statute states that the
Secretary may ``add to, or delete from, the list of injuries,
conditions, and deaths for which compensation may be provided or may
change the time periods for the first symptom or manifestation of the
onset or the significant aggravation of any such injury, disability,
illness, condition or death.'' The original Table and Qualifications
delineate those elements which must be proven in order to take
advantage of a presumption of causation.
In this regard, the commenters should understand the function of
the Table. The purpose is not to set forth standards of proof for
establishing causation-in-fact. Rather, the purpose is to set out a
standard for establishing presumed causation, which, absent a finding
of a factor unrelated to the vaccine, will allow a petitioner to
receive compensation without the burden of proving causation for those
conditions included on the Table. Accordingly, the Qualifications
properly set out standards for defining those conditions on the Table.
Petitioners remain free to establish causation in fact by producing
credible scientific information peculiar to their conditions.
Although the commenters assert that the Department is impermissibly
creating elements of proof, the Qualifications as drafted originally
contain numerous requirements that are, in essence, elements of proof.
For example, the paragraph describing the requirements for a `residual
seizure disorder' states the number of seizures which must have
occurred in the year after the vaccine was administered for the
petitioner to be found to have suffered a residual seizure disorder. In
addition, section 2114(b)(3)(A) of the Act describing the definition of
encephalopathy states that ``Encephalopathy usually can be documented
by slow wave activity on an electroencephalogram.'' Similarly, the
revised Qualifications indicate the elements which must be proven to
establish a presumption of causation for those injuries and conditions
listed in the modified Table.
In objecting to this aspect of the Qualifications, the commenters
assume erroneously that the revised Qualifications alter the Special
Master's role in determining whether a Table Injury has been proven.
The Special Master's role is to consider the information contained in
the record, including oral testimony, medical records and medical
opinion. The Master must weigh the evidence, examine the credibility of
the witnesses, reconcile the points of disagreement between the parties
and issue a final decision. The revised Qualifications do not alter
this role. As did the former Qualifications, they require the
petitioner to demonstrate a Table condition by proving that various
events occurred. The Special Master must still analyze the evidentiary
issues which arise in the context of attempting to prove a Table
injury.
The Effect of the Regulation on Other Statutory Sections
One commenter stated that the Qualifications and Aids to
Interpretation are inconsistent with section 2113(b) of the Act, which
permits the Special Master to find that the injury occurred within the
Table period even if the symptoms were not recorded or were incorrectly
recorded in the medical records. The commenter specifically took issue
with the section of the revised Qualifications which states that an
``an acute encephalopathy should be sufficiently severe to require
health care intervention and hospitalization.'' In addition, during the
June 1994 meeting of the ACCV, at least one member of the Commission
objected to this requirement as being overly restrictive because
hospitalization is required. The Commission member voicing this concern
felt that the rule should recognize that not all parents would respond
to a possible encephalopathic event by taking the child to the
hospital.
The revised Qualifications and Aids to Interpretation are not
inconsistent with section 2113(b) of the Act, because the Special
Master may still find that a preponderance of the evidence indicates
that the encephalopathy was severe enough to require medical
intervention or hospitalization, but that because of error or omission
the event was either not recorded or was incorrectly recorded. In
addition, under the revised Qualifications, although medical records
should be provided in most cases, the language ``sufficiently severe''
is meant to be consistent with section 2113(b)(2) of the Act and would
permit a finding in favor of petitioner if the Special Master found
that a preponderance of the evidence indicated that the injury was
sufficiently severe such that medical intervention should have been
sought. [[Page 7681]]
In the Department's view, the original statute does not intend the
Special Master to find that the injury occurred within the Table period
in the absence of any records recording the injury, unless the
petitioner is able to produce clear, cogent, and consistent testimony
to explain the absence of records. The Court has found in favor of
petitioners in the absence of corroborating medical records where the
preponderance of evidence, including oral testimony, demonstrates that
the adverse event occurred within the Table timeframe. The requirement
contained within the revised Aids to Interpretation is meant to include
only those events which are so serious that they require medical
intervention (whether or not medical intervention was actually sought),
and are, therefore, properly referred to as encephalopathies. The
requirement is simply meant to exclude those conditions which are not
serious enough to warrant medical attention. These types of minor
symptoms (e.g., excessive crying, sleepiness) were specifically
excluded from the definition of encephalopathy contained within the
original statute, but have been alleged by some petitioners to be signs
and symptoms of an encephalopathy. The revised Qualifications and Aids
to Interpretation simply seek to make clear the intent of Congress.
The Department recognizes, however, that the language ``should be
sufficiently severe,'' is somewhat confusing. In addition, the
Department recognizes that the phase ``medical intervention and
hospitalization'' is redundant, and open to various interpretations.
Accordingly, the regulatory language in Sec. 100.3(b)(2)(i) as proposed
has been revised to read ``An acute encephalopathy is one that is
sufficiently severe so as to require hospitalization.'' The Department
is making this change in the interests of clarity, consistent with the
explanation articulated above. In order to demonstrate a Table
encephalopathy, the petitioner must prove that the injury was indeed
serious enough to warrant hospitalization, whether or not records of
such hospitalization exist. Certainly, however, contemporaneous medical
records are of extreme importance in proving that a Table injury
occurred.
The Sufficiency of the IOM Report as the Basis for the Changes to the
Vaccine Injury Table
Several commenters stated that the Department relied on
insufficient data in proposing modifications to the Table. These
commenters argued that Congress intended that more definitive
information be available before the Table is revised. The commenters
took issue with both the conclusions of the Institute of Medicine and
the Department's interpretation of those conclusions. Section 312 of
Pub. L. 99-660 (42 U.S.C. 300aa-1, note) required the Secretary to
complete a review of ``all relevant medical and scientific information
regarding the connection between various vaccines and specified adverse
events.'' The Secretary was then required to publish in the Federal
Register findings regarding ``whether each of the illnesses or
conditions set forth in subsection (a) can reasonably be determined in
some circumstances to be caused or significantly aggravated by
pertussis containing vaccines.'' See 42 U.S.C. 300aa-1, note.
Simultaneously, the statute required that the Secretary propose changes
to the Table as a result of the findings.
This language indicates that Congress intended that the Secretary
modify the Table consistent with the conclusions of the review
undertaken by the Institute of Medicine. Nowhere is there a
requirement, however, that the causal connection between the
administration of vaccines and certain adverse events be definite and
conclusive before any changes are made. The IOM concluded that ``the
evidence is insufficient to indicate a causal relation between vaccines
containing pertussis'' and certain adverse events. Because the evidence
was determined as ``insufficient,'' the Department concluded that it
could not ``reasonably determine'' that a causal connection exists, and
the Table is being revised accordingly.
The section of the legislative history cited by the commenter in
support of the objection states that ``the Committee anticipates that
the research on vaccine injury and vaccine safety now ongoing and
mandated by this legislation will soon provide more definitive
information about the incidence of vaccine injury and that, when such
information is available, the Secretary or the Advisory Commission on
Childhood Vaccines (discussed below in section 2119) may propose to
revise the Table as provided below in section 2114.'' This statement
merely indicates a recognition by Congress that the original Vaccine
Injury Table was overinclusive, and that more research would yield more
definitive information. As described in the preamble to the proposed
regulation, and consistent with the statutory requirements, the
findings of the Institute of Medicine represented a comprehensive
review of the existing evidence as well as numerous opportunities for
comment from various experts and members of the public. The systematic
process undertaken by the Department to evaluate the findings of the
IOM demonstrates that the Department reviewed sufficiently the findings
of the IOM and their applicability to the Table. These findings clearly
indicated that the original Table was out of step with the state of
medical knowledge. Accordingly, the Secretary was obliged to propose
revisions. Although the IOM's original conclusion was modified somewhat
in the 1994 report regarding pertussis vaccine and chronic nervous
system damage, the Department has determined that the major changes to
the Table published in the NPRM reflect the IOM's latest conclusions
regarding this difficult issue. Nevertheless, as discussed below, the
final rule reflects some minor changes made to the proposed rule in
light of the Miller study and comments provided to the Department in
connection with this study.
Two commenters felt that the Department had ignored relevant
information in revising the Table. Specifically, they believed that the
Department should have viewed the claims that have either been
compensated or conceded by the Department as proof that the
presumptions conferred by the Table are accurate. However, the fact
that a particular case has either been adjudicated compensable or
conceded by HHS does not imply that a medical conclusion regarding
vaccine-relatedness has been made. The process of deciding claims is
based on whether the claim fits the parameters of the Table, or whether
causation has been proven. Most claims have been adjudicated ``table
cases,'' meaning that the petitioners were afforded the presumption of
causation conferred by the statute. This determination involves an
analysis of various evidentiary and other legal issues, but does not
prove or disprove whether a causal relationship exists in fact between
certain vaccines and adverse events. The outcome of these cases does
not have any bearing on whether the Table should be revised to reflect
the findings of the Institute of Medicine.
One commenter referred to a letter written by the organization
Dissatisfied Parents Together on May 8, 1991, to then Secretary
Sullivan regarding concerns that members of the Immunization Practices
Advisory Committee (ACIP) who have advised pharmaceutical companies, or
conducted research funded by such companies may have a conflict of
interest which precludes their serving [[Page 7682]] on the ACIP. The
Department has determined that this comment is irrelevant as far as the
modification of the Table is concerned. In undertaking its review, the
IOM did not rely on the views of members of the ACIP or the work-
product of that Committee.
The Effect of the Proposed Changes on the Vaccine Injury Compensation
Program
Two commenters suggested that the result of the proposed revisions
would be an increase in the transaction costs of the Program because
many petitioners will pursue their cases by attempting to prove
causation-in-fact. The Department has taken this concern into
consideration and has concluded that the benefits of the proposed
regulation outweigh the possibility of more protracted and complex
hearings. The intent of the regulation is to make the Table consistent
with medical knowledge regarding the relationship between vaccines and
certain adverse events. The Department notes that Congress recognized
that the original Vaccine Injury Table would permit individuals whose
conditions were not related to vaccine administration to be adjudicated
eligible for compensation. If the Table is revised to permit
compensation only in those cases where vaccine relatedness is more
accurately proven, greater resources will be available to compensate
those truly deserving of compensation.
In a similar vein, several commenters expressed concern that the
Department was seeking to prevent children deserving of compensation
from receiving assistance under the Program. In fact, exactly the
opposite is true. The revised Table merely affects the presumption of
causation available to certain petitioners. Petitioners will, of
course, continue to have the option of proving causation by a
preponderance of evidence if they are unable to prove a Table injury.
Moreover, the Department recognizes that there is a desperate need for
parents to obtain resources to cover the significant medical costs of
caring for a sick child. However, the intent of the VICP was to
compensate only those individuals whose injuries are vaccine-related.
The proposed regulation is simply an attempt to come closer to
realizing this goal than was possible with the language of the original
Vaccine Injury Table.
Three commenters suggested that the proposed regulation would
result in an increased number of civil actions filed against vaccine
manufacturers and administrators. In enacting the National Childhood
Vaccine Injury Act, Congress determined that one of the goals of the
Act was to reduce the number of civil actions filed against vaccine
administrators and manufacturers. The other major goal was to provide
compensation to those individuals whose conditions were caused by
vaccines. See H.R. Rept. 99-908, Part 1, September 26, 1986, page 6
(reprinted in 1986 U.S. Code Cong. & Admin News, Vol. 6, page 6347).
The Committee recognized, however, that the Table would possibly
provide compensation to some children whose illnesses are not vaccine-
related, but that further research and modifications to the Table would
result in a more equitable distribution of funds. In balancing these
two Congressional goals, the Department has determined that the
benefits of fulfilling the latter requirement outweigh the risk that an
increased number of civil actions will be filed against vaccine
administrators or manufacturers.
Furthermore, the Department believes that the combined effect of
the IOM's review and this regulatory action may reduce the extent of
tort litigation by giving the courts (and potential plaintiffs weighing
the wisdom of filing suit) definitive guidance as to the state of
scientific knowledge regarding vaccine-related injuries. As causation
must typically be proven in tort actions, the Department believes that
the findings on these issues may well reduce the amount of tort
litigation and may allow easier resolution of any such claims that are
litigated.
II. Medical Issues
The Department's Interpretation of the IOM Report
Six commenters suggested that the Department's findings are a
misinterpretation of the IOM Report. In the Department's view, however,
the proposed changes do reflect accurately the conclusions of the IOM
report.
Both the NPRM and the final rule (with some revisions are discussed
below), reflect most closely the package of recommendations as
developed by the PHS Task Force, reviewed by the NVAC, and endorsed by
the ACCV. The proposed changes are in accordance with the scientific
findings of the IOM Committee. In instances where the IOM found
information suggesting a causal relation and continued effects, the
Department acted to ensure coverage under the Program (e.g., adding
chronic arthritis to the Table). However, where the IOM found that the
evidence did not support a causal relation and continued effects, the
Department removed the legal presumption of causation by removing or
redefining the current injury listed on the Table. The fact that the
proposed revisions received overwhelming approval from three
independent science and health policy committees, and the endorsement
of two national health professionals associations (American Academy of
Pediatrics and American Medical Association), confirms the basic
soundness of the initial proposed revisions.
One of the commenters addressing the Miller study suggested that in
light of the 1994 IOM Report, the Department should rescind certain
findings made after release of the 1991 Report and published in the
preamble to the NPRM. In the NPRM, published on August 14, 1992, the
Department made certain findings as required by section 312(b) of Pub.
L. 99-660 (42 U.S.C. 300aa-1 note). The Department has reviewed these
findings again in light of the commenter's concerns, and has determined
that the findings remain valid. In fact, the conclusions of the IOM and
the NVAC subcommittee (discussed below) with respect to pertussis
vaccine and chronic neurological damage confirm the soundness of
findings three and four as listed in the NPRM. These findings read, in
pertinent part, as follows:
3. The evidence is insufficient to indicate a causal relation
between vaccines containing pertussis and: Epilepsy * * * chronic
neurologic damage, * * * learning disabilities and attention-
deficient disorder, * * * or permanent neurologic damage or death
following hypotonic-hyporesponsive episodes.
4. The evidence is consistent with a causal relation between
vaccines containing pertussis and? Acute encephalopathy and shock
and ``unusual shock-like state.''
The recent IOM report was confined to a review of the Miller study, and
is, therefore, limited to the circumstances of that particular study.
Given the conclusions articulated by the IOM and the accompanying
caveats, and the discussion and conclusions of the NVAC subcommittee,
the Department concludes that the findings published with the NPRM
reflect best the state of scientific knowledge. It should be noted
again that in drafting the revised Qualifications and Aids to
Interpretation, the Department decided not to eliminate the presumption
of causation for encephalopathy despite the conclusions of the 1991 IOM
study. Rather, consistent with the recommendation of the ACCV, the
Department included a presumption of vaccine causation for those
individuals who experience an acute encephalopathy within 3 days after
vaccination, who go on to suffer 6 [[Page 7683]] months of residual
effects, and who experience chronic neurological dysfunction. This
presumption is consistent with the IOM's conclusions articulated in its
1994 report.
Four commenters suggested that the IOM's causation category of
``insufficient evidence'' should not be interpreted to mean that DTP
vaccine does not cause the condition. Furthermore, they suggest that
both the IOM and the Department present no data which support the
proposition that acute encephalopathy, subsequent to the receipt of a
pertussis vaccine, has a more benign neurological outcome than acute
encephalopathies from other agents. The Department has considered these
comments but maintains that the IOM report provides a foundational
basis for the proposed changes.
The 1991 IOM report concluded the evidence was insufficient to
indicate a causal relationship between vaccines containing pertussis
and chronic neurological damage for a variety of conditions including
encephalopthy, shock collapse or Hypotonic-Hyporesponsive Episode
(HHE), epilepsy, and other neurologic and non-neurologic disorders.
Comments that expressed concern over this classification focused for
the most part on acute encephalopathy and chronic neurologic damage,
while a few discussed shock-collapse (HHE) or recurrent seizures
(epilepsy). The issue of encephalopathy following pertussis vaccination
is a difficult one. On one hand, in its 1991 Report, the TOM found
evidence ``consistent with a familiar evidence ``consistent with a
causal relation'' for acute encephalopathy, yet on the other hand, it
decided there was ``insufficient evidence'' regarding chronic
nuerologic damage. Due to limitations in the data, the IOM could not
conclude with any certainty whether there is any causal relationship
between pertussis vaccine and shock-collapse (HHE), epilepsy, or any of
the other disorders under this classification category. In its 1994
report addressing the Miller study, the IOM concluded that ``evidence
is insufficient to indicate whether or not DTP increases the overall
risk in shildren of chronic nervous system dysfunction.'' They
concluded further, that the ``balance of evidence is consistent with a
causal relation between DTP and the forms of chronic nervous system
dysfunction described in the NCES in those children who experienced a
serious acute neurological illness within 7 days after vaccine
administration.'' The IOM also concluded, however, that ``the evidence
remains insufficient to indicate the presence or absence of a causal
relation between DTP and chronic nervous system dysfunction under any
other circumstances.'' See 1994 IOM Report, Executive Summary.
Because section 2111(c) of the Act requires that a Petitioner must
show 6 months of residentual effects of a Table injury, a finding of a
relation pertussis-containing vaccines and acute, but not chronically,
does not justify the presumption of causation for long-term neurologic
damage. However, should the evidence show that abnormal neurologic
signs continued beyond the acute state, and therefore the injured
indidivual never returned to a ``normal neurological state,'' than
title may be granted. This conclusion is consistent with the 1994 IOM
report.
The language of section 312 of Pub. L. 99-660 (42 U.S.C. 300aa-1,
note) also supports the Department's conclusion. The IOM determined in
its 1991 report that the evidence is insufficient to support a
conclusion that a causal relationship between DTP vaccine and chronic
neurologic damage exists. The 1994 IOM finding was limited to the
conditions described in the NCES and to those children who experienced
an acute event following vaccination. Therefore, the Department
concluded that it could not ``reasonably determine'' that as a general
rule a causal relationship exists, and the Table is being modified
accordingly. Because section 312 requires such a determination in order
to sustain the presumption of causation, the Department was obligated
to revise the Table consistent with the conclusions of the IOM.
The removal of the legal presumption of causation has been applied
to other conditions in the ``insufficient evidence'' category (i.e.,
HHE and residual seizure disorder). The Department notes, however, that
the removal of a condition from the Table, or the inclusion of a
revised definition thereof, will not necessarily result in compensation
being denied where it would have previously been awarded. Petitioners
may still prevail by providing proof that the vaccine actually caused
the specific injury alleged to have occurred.
Three commenters suggested that the IOM's burden of proof standard
was too high. They suggested that the IOM should develop a confidence
level that is more lenient than 95 percent, particularly when it is
applied to the ``preponderance of the evidence'' burden of proof
standards present in the VICP. After consideration of the process used
by the IOM in developing its report, it is the Department's view that
the IOM's standard was appropriate.
Congress mandated that the IOM review the scientific literature and
other information on specific adverse consequences of pertussis and
rubella vaccines. The Committee was composed entirely of physicians and
scientists, whose task it was to evaluate the literature on adverse
events following these vaccines. Any ``burden of proof'' standard had
to be consistent with the standard applied throughout the science of
epidemiology, policy considerations notwithstanding. It is the
Secretary's responsibility under section 312 of Pub. L. 99-660 (42
U.S.C. 300aa-1, note) to utilize the IOM's conclusions to provide a
better scientific rationale for any presumptions of vaccine causation
under the Program.
Moreover, although the statute requires merely a ``preponderance of
the evidence'' standard in evaluating compensation claims, there is no
requirement that anything other than the standard commonly used among
scientific and medical professionals be applied in re-defining those
conditions which will receive a presumption of causation by use of the
Table. The preponderance of evidence standard is only relevant when a
Master is evaluating a particular case.
One commenter suggested that the IOM conclusions were incorrect
regarding DTP's pathological effects in animals or children. The
commenter stated that the IOM erred in diminishing the importance of,
or incorrectly judged, the conclusions of controlled epidemiologic
studies. Furthermore, the commenter suggested that the IOM Committee
was remiss in its examination of the evidence concerning long-term
sequelae for HHE. Finally, two commenters criticized the IOM because no
original research was done in putting together its conclusions. As
stated above, the Department has considered these comments, but has
determined that the process used by the IOM was appropriate.
The 1991 IOM Committee was made up of 11 experts in infectious
disease, pediatrics, internal medicine, neurology, epidemiology,
biostatistics, decision analysis, immunology and public health. During
the 20 months of their work, approximately 1,400 citations were
reviewed and 5 public meetings were held. No new research was
conducted. Committee members considered new or controversial data and
various points of view and sought to identify gaps in knowledge. The
IOM cited many gaps and limitations of knowledge. Its conclusions were
reached, however, after an exhaustive analysis of the best
epidemiologic data available, and other information.
[[Page 7684]] Congress did not mandate any specific research, but
rather, an extensive review of all the available information on adverse
events.
One commenter suggested the IOM incorrectly judged the conclusions
of the British National Childhood Encephalopathy Study (NCES). Another
commenter stated that the NCES is the only ``suitable'' study that has
been done, and that it concluded that there was a causal relationship
between the DTP vaccine and permanent neurologic injuries. One
commenter also suggested that the NCES proved the onset of a neurologic
disorder, including seizures, within 7 days of a DTP vaccination is
vaccine-related. The Department has reviewed the conclusions of the
NCES in light of these comments, but disagrees for the following
reasons.
The 1991 IOM Report considered carefully the results of the NCES,
which concluded there is an increased risk of acute neurologic illness
(encephalopathy and seizures) within 7 days following DTP immunization,
and that in some instances, this may lead to permanent neurologic
illness. The methods and results of the NCES have been thoroughly
analyzed since publication of the study, which has led to continued
controversy about the study's findings and a reassessment of the role
of pertussis vaccine as a cause of permanent neurologic damage. (IOM
Report, page 99-107)
In its 1991 report, the IOM described potential areas of error and
bias regarding the study's conclusions on acute neurologic illness and
chronic neurologic damage. Regarding acute neurologic illness, the
Committee cited three areas of potential study weakness: case
ascertainment, determination of the onset of illness, and the lack of
control for potential confounding factors. Despite these limiting
factors, the IOM believed that the NCES demonstrated statistical
significance for acute neurologic illness where onset is within 7 days
of DTP vaccination. Their conclusion was based on the fact that only
controlled epidemiological studies can address the relationship between
neurologic illness and vaccine causation. Of the four controlled
studies reviewed (including the NCES), only the NCES demonstrated a
statistically significant risk following DTP vaccine. However, the IOM
noted that the ``total number of cases reported in the other three
studies was consistent with attributable risk found in the NCES,'' and
on this basis concluded the evidence was consistent with a causal
relation between DTP vaccine and acute encephalopathy. (IOM Report,
page 117)
The NCES' conclusion regarding permanent neurologic damage was
viewed differently by the 1991 IOM Committee. The Committee described
concerns over (1) the number and composition of cases on which the
estimates were based and (2) the nature of the relationship between an
episode of acute neurologic illness and subsequent demonstration of
neurologic or developmental abnormalities. Both concerns cast doubt
upon the NCES' conclusion that DTP vaccine causes residual neurologic
injury.
The conclusion regarding permanent injury was based on seven
children who were found to have residual neurologic illness on follow-
up. Since the NCES was published, some of these seven children have
been diagnosed with non-vaccine related conditions. Thus, the risk
estimates are ``very fragile'' at best, since the number of children
with new unexplained neurologic illness was very small. (IOM Report,
page 106).
Similarly, the NCES' conclusions on residual effects begs the
central question of causation. All seven children found to have
``permanent neurologic illness'' on follow-up were presumed to be
normal prior to vaccination. However, no baseline neurologic
examination was performed on any of these children. Additionally, two
of the seven had seizures as their manifestation of acute neurologic
illness within 7 days of DTP vaccination. As the IOM noted, many
experts question whether seizures alone cause neurologic illness, or
rather are the ``markers'' of those children with pre-existing
neurologic disease. (IOM Report, page 107).
As explained above, a follow-up study to the NCES was published by
Miller, et al. in the fall of 1993. The Department asked the IOM to
look at the Miller study's conclusions regarding DTP vaccine and
subsequent neurological damage. The Department then asked a
subcommittee of the National Vaccine Advisory Committee (NVAC) to
review this later IOM report, as well as the Miller study. The NVAC
Subcommittee acknowledged the original NCES (and Miller follow-up) as
the most comprehensive long-term study on this subject to date, yet
noted there are limitations in the data. These include the lack of
neuropathologic studies on case children, the fact that young infants
with pre-existing neurologic disorders (damage) can be normal on
physical examination at the time of immunization, the failure to
exclude alternative etiologic diagnoses, and the non-specific range of
disorders classified by NCES authors under the rubric ``chronic nervous
system dysfunction.'' The subcommittee noted also that the working
definition of ``acute neurologic illness'' used in the NCES is not
consistent with the current medical understanding of acute
encephalopathy as an acute, generalized disorder of the brain. Children
were placed in the NCES case definition who experienced only febrile
seizures, a benign condition known to be triggered by DTP vaccine, yet
never proven to have lasting effects, absent signs of acute
encephalopathy. These limitations disallow definitive causal
conclusions that would necessitate changes to the Secretary's
definition of encephalopathy in the NPRM.
In reviewing the Miller study, the IOM Committee reached three
conclusions:
(a) The evidence is insufficient to indicate whether or not DTP
increases the overall risk in children of chronic nervous system
dysfunction.
(b) The balance of evidence is consistent with a causal relation
between DTP and the forms of chronic nervous system dysfunction
described in the NCES in those children who experienced a serious acute
neurologic illness within 7 days after vaccine.
(c) The evidence remains insufficient to indicate the presence or
absence of a causal relation between DTP and chronic nervous system
dysfunction under any other circumstances.
After extensive review and discussion, the NVAC subcommittee agreed
with the IOM's conclusion that children who experience serious, acute
neurological events after DTP vaccination can go on to exhibit
``chronic nervous system dysfunction.'' The NVAC subcommittee concluded
that despite the conclusions of the Miller study, the information
remains insufficient to accept or reject whether DTP administration
prior to the acute, serious neurologic event influenced the likelihood
of neurologic dysfunction. In order to avoid any confusion on this
point, the Subcommittee approved the following summary statement:
Children immunized with whole-cell DTP vaccines rarely
experience acute, serious neurologic events that require
hospitalization. An important question pertains to the long-term
complications of these events. Among all children hospitalized with
serious neurologic events, irrespective of their etiology or
relationship to DTP, there is a potential for the presence of
neurologic dysfunction when they are evaluated 10 years later.
However, the data are insufficient to accept or reject whether DTP
administration prior to the acute, serious neurologic event
influenced the potential for neurologic dysfunction. See National
Vaccine Advisory Committee (NVAC), Report of the Ad Hoc Subcommittee
on Childhood Vaccines, p.7.
[[Page 7685]] The Agency has reviewed carefully the IOM's
conclusions and the NVAC subcommittee's evaluation of the IOM report,
recognizing that questions will continue regarding DTP vaccine and
chronic nervous system dysfunction. In addition, the Agency has
considered comments provided by three individuals in response to the
March 24, 1994 Federal Register Notice. These commenters suggested that
the Department should retract some of the changes to the Vaccine Injury
Table proposed in 1992, arguing that those changes are not inconsistent
with the 1994 IOM report. The Agency has determined that despite the
uncertainty regarding causation, the final rule is consistent with both
the IOM report and the NVAC subcommittee's conclusions regarding the
Miller study. The final rule permits an individual to receive a
presumption of causation if the DTP vaccine recipient ``manifests,
within the applicable period, an injury meeting the description * * *
of an acute encephalopathy, and then a chronic encephalopathy persists
in such person for more than six months beyond the date of
vaccination.'' See Sec. 100.3(b)(2). Thus, the final rule is consistent
with the IOM's conclusion that some children have been shown to have
experienced an acute encephalopathy following vaccine administration
and then have gone on to develop chronic neurologic dysfunction. See
1994 IOM Report, Executive Summary.
The only circumstances under which a presumption of causation would
not be available to an individual with chronic neurological dysfunction
would be (1) where the child had not experienced an acute
encephalopathy within several days after DTP vaccination, or (2) where
the child experienced an acute encephalopathy within several days of
DTP vaccination, but returned to a normal neurological state, and did
not suffer 6 months of residual effects after the administration of the
vaccine.
The denial of a presumption of causation for the former is
consistent with the IOM's conclusions as articulated in both its 1991
and 1994 reports. The IOM did not conclude that chronic neurological
dysfunction should be presumed to be caused by DTP vaccine in the
absence of an acute encephalopathy that occurs within several days
following vaccination. See 1994 IOM Report at page 10. The IOM stated
the following:
The evidence remains insufficient to indicate the presence or
absence of a causal relation between DTP and chronic nervous system
dysfunction under any other circumstances. That is, because the NCES
is the only systematic study of chronic nervous system dysfunctions
after DTP, the committee can only comment on the causal relation
between DPT and those chronic nervous system dysfunctions under the
conditions studied by the NCES. In particular, it should be noted
that the chronic nervous system dysfunctions associated with DTP
followed a serious acute neurologic illness that occurred in
children within 7 days after receiving DPT. 1994 IOM Report at page
11.
Neither the IOM report nor the Miller study addressed the scenario
where a child would experience an acute encephalopathy within several
days following vaccine administration, would return to a normal
neurological state, but at some point in the future would exhibit signs
of chronic neurological dysfunction. The most recent report by the IOM
does not present any information which warrants a modification of the
presumptions in the final rule. Therefore, the final rule is consistent
with the IOM's conclusions and the NVAC subcommittee's assessment of
those conclusions.
The NVAC subcommittee was also asked to look at whether the
evidence as described in the IOM report would support a conclusion that
the time period in the vaccine injury table for acute encephalopathy
following DTP vaccine should be changed from 3 to 7 days. The
subcommittee concluded that there is presently insufficient information
to justify such a change. The Department has reviewed the conclusions
of the IOM report as well as those of the NVAC subcommittee and has
determined that the rule should not be modified. In this regard, the
Department recognizes that it is accepting the analysis of the NVAC
subcommittee, rather than acting solely on the basis of this particular
statement from the 1994 IOM report. However, it is important to note
that the 1991 IOM report, which included a review of numerous
scientific studies and other medical literature, did not draw any
conclusions regarding the appropriate time period.
In preparing the latest report, the IOM confined its analysis to
the Miller study, which was a follow-up to the original NCES. Given the
limitations of the IOM's conclusions, including the lack of primary
data analysis, as well as the methodologic limitations that have been
noted with regard to the NCES, the NVAC subcommittee determined that
the conclusions of the Miller study with respect to the appropriate
timeframe could not be extended beyond the parameters of this one
particular study. After careful consideration, and recognizing the
extensive expertise of the NVAC subcommittee, the Department has
decided to accept the conclusions of the NVAC subcommittee.
Accordingly, the 3 day timeframe, as originally determined by Congress,
will not be changed. Petitioners may seek to prove causation in fact
for conditions arising between 3 and 7 days after vaccination and may,
of course, introduce the Miller study and the IOM report as evidence
bearing on such an argument.
One commenter suggested that the 1991 IOM report contradicts an
earlier 1985 IOM report which gave risk estimates for reactions
following whole cell pertussis vaccination, and stated that pertussis
vaccine causes permanent neurologic damage.
The 1985 IOM Report focused on building a model to help evaluate
the risks and benefits for existing and new vaccines to allow informed
judgments on priorities for developing new vaccines. In drafting their
conclusions, the 1985 group used informed judgments on vaccine risks,
and the financial benefits of reducing disease. Because of the larger
number of vaccines studied in the 1985 report, the review of the
scientific literature on specific adverse events in this report was far
less extensive than that in the 1991 report.
Analysis of Other Data
Before any changes should be made to the Table, four commenters
suggested that the Vaccine Adverse Events Reporting System (VAERS) data
and/or Vaccine Injury Compensation Program records should be examined
and analyzed. VAERS is a passive reporting system which relies in large
part on reports of events temporally related to vaccine administration.
Therefore, no reliable conclusions about causation could be drawn from
the reported VAERS data without its undergoing substantial analysis.
While the Department recognizes the importance of VAERS, it is
unwilling to overstate its importance by using temporal relationships
to define a new Table.
Further, the IOM's section 312 study involved a thorough review of
scientific and medical information contained in peer reviewed journals.
However, information based on anecdotal reports (e.g., VAERS), or a
series of case reports, such as claims filed under the VICP, has less
certain scientific reliability, and therefore should also not be used
as a basis for revising the Table. Because of the limitations of these
types of evidence, the Department does not concur with this suggested
approach.
The ACCV's Scientific Review Subcommittee reviews cumulative data
[[Page 7686]] collected through the VAERS system at each quarterly
meeting. In December 1992, the Subcommittee wrote the following
concerning: ``VAERS as a means of surveillance of temporally-related
adverse events, has definite limitations and does not allow the
evaluation of possible causal relationships between vaccine
administration and adverse events.'' VAERS's data potentially serve as
a ``signal'' of possible causal relationships, which can then be
investigated through what are termed Large Linked Data Bases (LLDB's).
The Subcommittee encouraged increased utilization of LLDB data because
of its potential for surveillance of adverse events and their possible
causal relationship to vaccine administration.
The Department will monitor future analysis of VAERS and LLDB data.
Should information suggest modifications to the Table, the Department
will publish a new NPRM reflecting this new information with proposals
for change.
One commenter suggested that the Department ignored cases in the
medical literature (and VICP case files) that show a pattern of
increasingly severe reactions after succeeding DTP shots in the same
child. The commenter argued that the IOM Report indicated it would tend
to support the hypothesis of a causal link between pertussis vaccine
and permanent neurologic damage if case histories show such a pattern.
In its analysis, the IOM reviewed case reports and case series
along with controlled epidemiologic studies. It is true that the IOM
suggested that the increasing severity of a reaction following
immunization in the same individual might indicate a causal link to the
vaccine. The Department did not view this hypothesis as strong enough
to warrant a presumption of causation. The results of the 1994 IOM
Report have not changed this conclusion. However, any petitioner who
can demonstrate evidence of progressive or repetitive adverse effects
following vaccination may be eligible for compensation by proving
causation in fact.
Three commenters suggested there should be no changes to the Table
before the section 313 study (of other vaccine risks) is completed. One
commenter suggested specifically that changes to the timeframe under
Residual Seizure Disorder are not appropriate before results of the
section 313 study have been published.
In publishing the final rule, the Department has considered the
effect of the section 313 study. Section 313 of The National Childhood
Vaccine Injury Act of 1986, Pub. L. 99-660, mandated that the Secretary
arrange with the IOM for an additional broad study of the risks
associated with each vaccine set forth in the Table, other than the
vaccines (pertussis and rubella) previously identified in the section
312 study discussed above. The IOM section 313 study, entitled
``Adverse Events Associated with Childhood Vaccines: Evidence Bearing
on Causality,'' was released on September 14, 1993. The study covers
adverse events following these commonly-administered vaccines: measles,
mumps, diphtheria, tetanus, polio, Hemophilus influenza type b, and
Hepatitis B.
On March 15, 1994, a subcommittee of the NVAC met to consider the
section 313 report. The subcommittee was composed of members of the
NVAC and received testimony from outside experts in the fields of
epidemiology, pediatric infectious disease, and pediatric neurology.
The Department determined that the conclusions of the subcommittee
regarding the section 313 report do not provide a basis for changing
the final rule at this time. However, the Department is presently
reviewing the conclusions of the NVAC subcommittee regarding the
section 313 report. It is likely that after this review the Department
will initiate further rulemaking proceedings. The Department has
concluded, however, that there are no compelling reasons which would
justify delaying the promulgation of the final rule pending completion
of that review.
Anaphylaxis
One commenter suggested that the examples of anaphylaxis given by
the IOM do not provide a basis for the proposed revisions.
The IOM examined case reports and epidemiologic studies concerning
anaphylaxis and anaphylactic shock. There was considerable variability
in the onset and clinical signs of what was defined as ``anaphylaxis.''
One ``suspected association'' with pertussis vaccine was a case report
of twins from 1946, both of whom died within 24 hours of pertussis
vaccination (IOM Report, page 146). Forensic examination confirmed
tissue evidence of anaphylaxis. However, both exhibited clinical signs
within 4 hours of vaccination. Other than the 1946 case reports, none
of the other examples of ``anaphylaxis'' cited by the IOM, that began
after 4 hours of vaccination, was associated with permanent injury.
Again, Petitioners may receive compensation under the Program if they
prove their injury was caused by the vaccination, even if the onset was
after the 4 hours specified in the Table.
One commenter noted that the IOM Committee did not address the
timeframe within which to expect anaphylaxis. The commenter suggested
further that the Department should have taken into account the fact
that infants react differently than children and adults.
Although it is true that infants may react differently to illness
or medications, the pediatric literature is clear in stating that
severe anaphylactic reactions occur immediately with antigen exposure
and rarely show their first manifestation after 4 hours.
One commenter suggested that the proposed revision for DTP, MMR and
Polio fail to allow for delayed hypersensitivity.
The medical literature supports the conclusion that the more severe
anaphylactic reactions occur closer in time to the antigen exposure. An
anaphylactic reaction that shows its first manifestation greater than 4
hours after antigen exposure is likely to be a mild reaction and thus
very unlikely to lead to any permanent injury or sequelae. If a
petitioner is injured by a delayed hypersensitivity reaction,
compensation still can be awarded if causation in fact is proven.
One commenter suggested that the changes do not allow for hypoxia,
ischemia, or hypoxia/ischemia, which are common complications of
anaphylaxis and anaphylactoid shock. However, the proposed Table allows
for any sequela whose first sign or clinical manifestation falls within
Table guidelines, as long as the sequela is caused by the Table injury.
Encephalopathy
Much of the discussion of comments related to ``encephalopathy'' is
set forth above under the heading ``The Department's Interpretation of
the IOM Report.'' Set forth below are the remaining issues regarding
encephalopathy.
One commenter suggested that the initial sentence under the
definition of ``encephalopathy'' which states, ``[t]he term
encephalopathy means any acute or chronic significant acquired
abnormality of, or injury to, or impairment of function of the brain,''
is too vague and seems to contradict the more specific definitions
which follow the proposed subparagraphs (i) and (ii).
The Department had proposed to retain the language of the original
Aids to Interpretation to serve as an introduction to the definition of
encephalopathy. The Department agrees that it is imprecise, and that it
tends to differ from the guidance provided in the definitions for acute
and chronic [[Page 7687]] encephalopathy which immediately follow.
Accordingly, the proposed language in Sec. 100.3(b)(2) has been revised
to clarify the definitions for acute and chronic encephalopathy.
Comments concerning the criteria for the diagnosis of acute
encephalopathy (paragraphs (b)(2)(i) (A) and (B)) were offered by three
individuals. One commenter suggested that the criteria for the
diagnosis in the less than 24-month-old age group were too narrow and
restrictive. All three commenters felt there were clinical
inconsistencies in the specific criteria. One commenter felt it was an
unwarranted burden to require two out of three criteria in order to
satisfy the definition of acute encephalopathy (for children 24 months
of age or older). Some members of the ACCV felt that the definition of
acute encephalopathy for children over 24 months implies that a seizure
must last 24 hours to be within the definition. One commenter suggested
the definition was unlike any other employed in medicine or science.
The Department has considered carefully the concerns regarding the
definition of encephalopathy and offers the following responses.
The current Qualifications and Aids to Interpretation do not
reflect precisely medical knowledge of the condition
``encephalopathy.'' Many medical experts testifying in proceedings
under the VICP have stated the definition is too vague and needs
clarification. The term ``encephalopathy'' refers generally to a
disturbance of brain function. Clinical definitions vary, as do
opinions on the relationship between encephalopathy and seizures. After
several pages of discussion, the IOM finally defined it as
``encephalopathy, encephalitis, or encephalomyelitis.'' Unfortunately,
this definition is clinically imprecise, and in part circular. While it
may serve to evaluate studies on neurologic disease, it does not impart
guidance to physicians or attorneys on the specific clinical signs of a
child or adult with encephalopathy.
In an effort to define encephalopathy better, the Department used
the definition approved by the ACCV in 1991. The basic criteria were
taken from a peer-reviewed multi-center study assessing adverse events
following immunization in all age groups. (Fenichel GM., Lane DA,
Livengood JR, Horwitz SJ, Menkes JH, Schwartz JF. Adverse events
following immunization: Assessing probability of causation. Pediat
Neurol 1989; 5:287-290) One of its authors, a pediatric neurologist and
former ACCV Chairman, proposed that the Commission use the criteria as
the basic framework to define encephalopathy for purposes of making
changes to the Aids to Interpretation. Following its approval by the
ACCV, additional clarifications were needed to define better clinical
signs in the pre-verbal (less than 24-month) age group, and identify
correctly infants or children who may be experiencing temporary
medication effects, rather than true signs of encephalopathy. The
Department appreciates that the criteria are viewed by some as overly
burdensome. Any clarifications to the definition were for the sole
purpose of allowing non-physicians to identify correctly infants or
children with clinical signs of encephalopathy. However, the ACCV
during its June 1994 meeting suggested that some modifications be made
to the age criteria to reflect the fact that some children under 24
months have more advanced verbal skills. The Department agrees with
this suggestion and has, therefore, changed the age marker from 24 to
18 months for purposes of distinguishing between preverbal and verbal
children. Sec. 100.3(b)(2)(i).
Additionally, the Department agrees that the term ``stupor'' is
imprecise and somewhat restrictive, and has therefore decided to
specify the clinical signs reflective of an acute encephalopathy and
delete the terms ``stupor and coma.'' Acknowledging the difficulty of
defining ``encephalopathy,'' the Department has focused on clinical
criteria that clearly distinguish infants and children with brain
dysfunction from those with transient ``lethargy.'' The diminished
alertness and motor activity, which characterize the lethargic infant
or child, are frequently observed as the physiological response to
fever, infection or other acute illness. The severity and duration of
the behavioral changes differentiate mere lethargy from the more
serious impairment of consciousness that is the hallmark of
encephalopathy (i.e., obtundation, stupor and coma). To provide the
clearest guidance to petitioners' attorneys and the Court, the
Department has added a new paragraph (b)(2)(i)(D) to the section to
identify specific clinical signs constituting ``a significantly
decreased level of consciousness.''
As to concerns articulated by members of the ACCV during the June
1-2, 1994 meeting, the Department did not intend, in listing the signs
for identifying acute encephalopathy in children older than 24 months,
that a ``seizure associated with loss of consciousness'' persist for 24
hours. Rather, the Department intends that in order to be experiencing
an acute encephalopathy a child must experience a significantly altered
mental state or decreased level of consciousness. It is the child's
overall condition which must persist for 24 hours, rather than any one
particular seizure.
One of the ACCV members questioned the Department's decision to use
24 hours, rather than some other period, as the appropriate time period
under the definition of acute encephalopathy. The Department decided to
use 24 hours because this was the marker used in the multi-center study
cited above which established the criteria used by the Department in
drafting the definition of encephalopathy. See Fenichel, et al. The
choice of this time period is also consistent with the way in which
medical professionals gauge and document clinical changes over time.
One commenter suggested there is not a clear distinction between
acute and chronic encephalopathy. In response to this comment, the
Department has added additional language in the final rule for
clarification. For example, the Department revised the introductory
language of Sec. 100.3(b)(2) to make clear that an individual may be
found to have suffered an encephalopathy only if ``such recipient
manifests, within the applicable time period, an injury meeting the
description below of an acute encephalopathy, and then a change in
mental or neurological status persists in such person for more than 6
months beyond the date of vaccination.'' In addition, the Department
added similar language to Sec. 100.3(b)(2)(ii) to clarify the meaning
of chronic encephalopathy.
Two commenters suggested that the term ``neurologically normal''
may be inappropriate because children ``who return to a normal
neurological state after an acute encephalopathy,'' but later develop
signs of a chronic encephalopathy, may easily be misdiagnosed as normal
during this time period. Two commenters questioned whether the
definition ``neurologically normal'' should be based on various testing
criteria (e.g., CT or MRI scans, electroencephalogram (EEG), or lumbar
puncture). The Department has considered these comments and has revised
the first sentence in paragraph (b)(2)(ii) for clarification.
It is expected that any child or adult with a chronic
encephalopathy as a result of a vaccine-related acute encephalopathy
would show evidence of abnormalities in mental or neurological status
in the days to weeks following the vaccination. In the case of an
infant or child, these would be seen as a loss or slowing of
developmental milestones during this time period
[[Page 7688]] following the acute event. Because testing criteria and
the interpretation of results may vary with age group and medical
condition, no additional criteria are suggested for the diagnosis of
chronic encephalopathy. The Department agrees, however, that the Aids
to Interpretation should contain a clear distinction between acute and
chronic encephalopathy. As explained above, additional language has
been added in the final rule for clarification.
Members of the ACCV suggested the phrase ``return to a normal
neurological state'' was too vague, and failed to specify the methods
to be used for gauging a ``normal neurological state.'' These members
also suggested that there might not be any evidence in the medical
records to document this fact. The Department has considered this
suggestion, but has determined that the language in the definition of
chronic encephalopathy need not be changed. It is the Department's
intent that if all other parts of the definition are satisfied, the
presumption remains intact unless there is affirmative evidence that
the child returned to a normal neurological state; such evidence could
consist of documented subjective descriptions of the child's behavior
and development and/or objective findings on physical examinations
performed by physicians in the post-immunization period. Thus, in those
cases where this issue is unclear, or not documented, the presumption
would be that a child whose acute encephalopathy was followed by signs
of a persistent neurologic deficit did not return to a normal
neurological state.
During the June 1-2, 1994 meeting, members of the ACCV also
suggested that parts of the definition of encephalopathy in the
Qualifications and Aids to Interpretation as published in the NPRM were
too restrictive. Specifically, they took issue with the underlined
phrase of the introductory language of Sec. 100.3(b)(2)(i)(D), which
states that ``[t]he following clinical features alone, or in
combination, do not qualify as evidence of an acute encephalopathy or a
significant change in either mental status or level of consciousness as
described above * * *.'' The Department agrees with the commenters and
notes that this language did not reflect accurately the Department's
intent. The point of this language as written in the NPRM was further
to clarify the language as written in the NPRM was further to clarify
the language in the statute, which states that certain signs and
symptoms are compatible with an encephalopathy but ``in and of
themselves are not conclusive evidence of encephalopathy.'' 42 U.S.C.
300aa-14(b)(3)(A). The language in the statute has been interpreted in
many different ways by the Special Masters and has led to results in
some cases which the Department believes are inconsistent with the
medical and scientific literature on this topic. The medical evidence
indicates that certain symptoms do not conclusively establish an
encephalopathy, but instead are merely symptoms that are compatible
with an encephalopathy. Nevertheless, in order to take account of the
concerns of the ACCV, the Department has changed the underlined
language above to ``do not demonstrate.''
One commenter suggested that DTP may aggravate pre-existing genetic
or congenital conditions, and for that matter, other acquired
conditions.
The Department is aware that, in rare instances, a vaccine may
alter the clinical course of a pre-existing condition. Under section
2111(c)(1)(C) of the Act, ``significant aggravation'' of a pre-existing
condition may establish eligibility for compensation provided the
Petitioner is able to demonstrate that a Table injury occurred and that
the prior condition was significantly aggravated during the Table
timeframe, or is able to demonstrate proof of causation in fact.
In considering the comment, the Department realized that there
could be confusion regarding the issue of significant aggravation of
pre-existing conditions. Accordingly, the Department decided to
eliminate the proposed Sec. 100.3(b)(2)(v). Because the statute
includes a definition of ``significant aggravation,'' it is unnecessary
for this term to be defined in the final rule. See 42 U.S.C. 300aa-33;
section 2133 of Act.
As noted above, the Department received five comments in response
to the March 24, 1994, Federal Register notice soliciting comments
regarding the 1994 IOM report. Two comments, one submitted by the
American Academy of Pediatrics, and the other by a vaccine
manufacturer, expressed support for the revised Vaccine Injury Table as
presented in the NPRM. The commenters stated that further revisions to
the proposed Vaccine Injury Table are not warranted based on the
conclusions of the latest IOM review. The Academy of Pediatrics did
suggest, however, that the Table should reflect the ``possibility that
in some children with acute encephalopathy, chronic dysfunction may
subsequently exist, but this is a rare event and the data do not allow
confirmation or rejection of whether this is a direct association.''
The final rule reflects the concern articulated by the Academy. The
revised Table confers a presumption of causation on those individuals
who suffer an acute encephalopathy within 3 days after vaccine
administration, and who then go on to exhibit 6 months of residual
effects, followed by chronic neurological dysfunction.
The other three comments are discussed, where relevant, under the
heading ``The Department's Interpretation of the IOM Report.''
Hypotonic-Hyporesponsive Episode (HHE)
One commenter supported the removal of hypotonic-hyporesponsive
episode (HHE) from the original Table as proposed by stating that HHE
has no long-term effects and does not lead to death; the remaining
commenters were critical of the change. One commenter pointed out that
HHE is a heterogeneous term, which includes features of HHE and
anaphylaxis. It also includes a subset of children with ``unusual
shock-like states'' who have a ``lot-dependent, bimodal, or other form
of onset.'' It was suggested that the Department should give the
benefit of doubt in terms of causation to this group. One commenter
suggested features of collapse are life-threatening. The Department
responds as follows.
Although HHE is not well understood, there are consistent, albeit
rare, clinical signs reported to occur transiently following DTP
immunization. The onset in young infants is usually within 12 hours
following pertussis immunization. Clinical features include pallor,
fever, and decreased activity and responsiveness. Although these
infants may have a significantly decreased activity level and ``shock-
like'' appearance, actual loss of consciousness and hypotension (shock)
have not been demonstrated to occur. Disorders such as anaphylaxis
should easily be distinguishable from shock-collapse or HHE because of
the clearly defined physiologic changes known to occur with
anaphylaxis, which do not occur in HHE. See 1991 IOM Report, 171-186;
Cody CL, Baraff LJ, Cherry JD, March SM, Manclark CR. 1981. Nature and
rates of adverse reactions associated with DTP and DT immunizations in
infants and children. Pediatrics 68:650-660.
The 1991 IOM report found evidence ``consistent with a causal
relation'' between the pertussis vaccine and HHE (shock collapse), but
concluded there was insufficient evidence concerning chronic neurologic
damage. Because there is no proven relationship between HHE and
residual neurologic damage, [[Page 7689]] no purpose is served by
retaining HHE on the Table. Removing HHE as a Table injury places the
burden of proof on the petitioner that an HHE was caused by a vaccine
and that it resulted in death or residual effects lasting at least 6
months.
Additional comments were received in response to the Notice
published on March 24, 1994, requesting comments on the Miller study
and 1994 IOM report. Two commenters argued that the conclusions of this
IOM report are inconsistent with the Department's proposal to remove
HHE from the Vaccine Injury Table. The commenters suggested that
because the Qualifications and Aids to Interpretation include ``loss of
consciousness'' as one of the symptoms of HHE, and because the NCES
would have included a severe shock-collapse resulting in
hospitalization as a serious, acute neurologic illness, it is
appropriate for HHE to continue to receive the presumption of causation
conferred by the Table.
It is important to understand that the Miller study did not purport
to set forth a definition of ``encephalopathy'' for purposes of the
VICP or the Vaccine Injury Table. Rather, it simply defined a set of
conditions which fell under the rubric of ``acute neurologic illness''
that could be studied in relation to the administration of DTP vaccine.
Loss of consciousness is not a recognized sign of HHE (see Cody et
al.), notwithstanding its inclusion in the original statutory
Qualifications and Aids to Interpretation. The Department recognizes
that the 1991 IOM Report included among the symptoms of HHE a loss of
consciousness. However, the Department believes that this simply
reflected some of the case reports in the literature that were reviewed
by the IOM. Given the IOM's statement that the cases reported may
include other conditions, such as anaphylaxis, the Department does not
view the IOM's discussion as a sufficient basis to expand its view of
what properly constitutes HHE. See 1991 IOM Report, p. 171-177. Rather,
children experiencing a loss of consciousness should properly be
considered under the rubric of encephalopathy. Furthermore, there is no
clear evidence that HHE (1) represents acute neurologic dysfunction,
(2) requires medical intervention (although medical consultation is
frequently sought), or (3) leads to any permanent sequelae or death. It
is unlikely that nay of the cases described in the NCES were those of
infants experiencing HHE. In light of these considerations, the
Department concludes that there is an insufficient basis to retain HHE
as a separate category on the Table.
Residual Seizure Disorder
One commenter suggested that some of the seizure classifications
under Residual Seizure Disorder are out of date. They cited the example
of ``grand mal'' seizures which has been dropped from the International
Classification of Diseases. The commenter also questioned the use of
the word ``signs'' in this section. The Department agrees with the
commenter that some of the original seizure terminology has changed
over time. Section 100.3(b)(4) has been revised and the word ``signs''
has been deleted from the text.
One commenter objected to proposed paragraph (b)(3)(ii) regarding
the 24-hour requirement for separation of seizures under Residual
Seizure Disorder. The commenter disagreed that a 24-hour separation in
seizures makes the diagnosis of recurrent seizures (epilepsy) more
likely, and that seizures occurring on the same day are generally
regarded as part of the same event.
The Department intends that the 24-hour requirement for the
separation of seizures will make it more likely that a Petitioner who
qualifies under Residual Seizure Disorder has a recurring seizure
disorder (epilepsy). The study cited in the NPRM, (Reference: Hauser
WA. et al: Seizure recurrence after a first unprovoked seizure. NEJM
1982; 307(9):522-528), shows that seizures separated by more that 24
hours make a recurrent disorder more likely. Its importance is
underscored by the fact that seizures commonly occur in clusters. For
purposes of predicting recurrence of seizures, those occurring within a
24-hour period are generally viewed as a single event (with the same
cause). It is likely that any petitioner who experiences a vaccine-
related epileptic disorder will still qualify by having further
seizures over the 12-month period specified under the statute. See
section 2114(b)(2)(A) of the Act.
Recognizing the commenter's concerns, and in the interest of
clarity, the Department has modified slightly the definition of a
distinct seizure episode for purposes of this section. The last
sentence of Sec. 100.3(b)(3)(i) now reads, ``A distinct seizure or
convulsion episode is ordinarily defined as including all seizure or
convulsive activity occurring within a 24-hour period, unless competent
and qualified expert neurologic testimony is presented to the contrary
in a particular case.''
Two commenters did not agree with the language in paragraph (b)(4)
that absence (petit mal) epilepsy is not associated with acute
encephalopathy secondary to DTP immunization. Both suggested that the
diagnosis be determined by requiring such a child to have an EEG with
3-per-second spike-and-wave, since it is known that children who have
such minor seizures with different EEG's are often the victims of
severe brain damage and should not be excluded. Finally, it was
suggested that the phrase ``if properly diagnosed'' be used under these
conditions. The Department's response to these comments is as follows.
There is little credible evidence to support the conclusion that
absence (petit mal) epilepsy is associated with acute encephalopathy
following vaccination. It is true, however, that atypical absence and
other forms of spike-and-wave epilepsy may be the sequelae of an acute
encephalophathy, but are not in themselves the features of such.
Following acute encephalopathy, features of atypical absence seizures
may develop months to years later as part of the sequelae to the acute
injury. Other types of staring behavior may constitute seizure activity
associated with an acute encephalopathy, such as an individual with
Herpes simplex type 1 encephalitis. However, these patients typically
present with other clinical signs of acute encephalopathy. (Generalized
Seizures: Absence. In Dreifuss F. (ed): Pediatric Epileptology. Boston,
J. Wright/PSG, 1983, p. 65-91.) It also should be noted that seizures
alone do not constitute an encephalopathy. (1991 IOM Report, page 87).
Requiring EEG confirmation of 3-per-second spike-and-wave to make
the diagnosis of absence (petit) epilepsy may be excessively
restrictive. While patients may have these characteristic EEG findings,
it is neither practical nor advisable to require that the EEG
constitute the basis for diagnosis. Frequently, absence (petit mal)
epilepsy is diagnosed on clinical criteria alone, (i.e., expected age
group, seizure behavior, relationship to hyperventilation and/or
response to ethosuximide therapy). It is therefore impractical to
require EEG confirmation. Furthermore, inserting the phrase ``if
properly diagnosed'' would create confusion as to whether EEG
confirmation is necessary for the diagnosis of this condition.
One commenter suggested it is incorrect to state that petit mal and
absence seizures are the only types of seizure activity with which
staring can be associated. The Department agrees, and did not intend to
imply such in the Preamble to the NPRM. Other [[Page 7690]] conditions
associated with staring, such as atypical absence epilepsy, or various
sequelae to central nervous system injury are noted above in the
Department's response under absence (petit mal) epilepsy.
One commenter suggested that the Department has shown no evidence
that pertussis-related febrile seizures have more benign outcomes than
those induced by other agents. The commenter states that because the
literature shows that a small percentage of children who experience
febrile seizures go on to have permanent problems, the Department's
findings that there is insufficient evidence are erroneous. One
commenter suggested febrile seizures produce brain damage. Another
commenter suggested that not every seizure which is contemporaneous
with a fever is a febrile seizure. The Department agrees in part, and
disagrees in part with these comments for the following reasons.
The term ``febrile seizure'' refers to seizures in infancy or
childhood (between 3 months to 5 years of age) associated with fever,
but without evidence of intracranial infection or other defined cause.
Infants or children who have a pre-existing history of an afebrile
seizure, or recurrent afebrile seizures (epilepsy) are not included in
this category.
While it is true that children with a history of ``febrile
seizures'' may eventually show neurologic deficits, there is no
persuasive experimental or epidemiologic evidence that these deficits
are a result of neurologic injury occurring at the time of the febrile
seizure. Furthermore, there is no evidence that febrile seizures affect
intellectual performance as judged by comparison of affected children
to their siblings. (Consensus Statement. 1980. Febrile seizures: long
term management of children with fever-associated seizures. Pediatrics
66:1009-1012) (Ellenberg JH, Nelson KB. Febrile seizures and later
intellectual performance. Arch Neurol 1978;35:17-21)
Although the IOM concluded ``febrile seizures'' are causally
related to DTP vaccine, most experts believer that febrile seizures do
not cause permanent damage. The clinical courses of children
experiencing febrile seizures following DTP vaccination are
indistinguishable from the clinical courses of children who experience
febrile seizures from other causes. (Hirtz DG, et al. Seizures
following childhood immunizations. J. Pediatr. 1983;314:1085-1088)
While febrile seizures are by their very nature benign, and
therefore not associated with permanent damage, not all seizures
contemporaneous with fever are ``febrile seizures.'' This latter group
of seizures may be the result of pre-existing neurologic disease or
injury, which produces a predisposition to seizure activity with
elevated temperature. Alternatively, one can have an acute
encephalopathy which presents itself as fever and seizures (e.g.,
meningitis). In such a case, the other requisite clinical
manifestations of clinical encephalopathy should be present (i.e.,
diminished consciousness and/or focal or generalized neurologic signs).
One commenter disagreed with the exclusion of infantile spasms. One
commenter noted that the diagnosis for infantile spasms has no
etiological significance. It was suggested there is no medical support
to eliminate this type of seizure disorder from those potentially
compensated. One commenter suggested that it is inappropriate to
exclude infantile spasms, as the U.S. Court of Federal Claims has ruled
that DTP causes infantile spasms. The Department has considered these
comments and offers the following clarification.
The IOM concluded infantile spasms is not casually related to DTP
vaccination. Therefore, there is no basis for a legal presumption of
causation for this condition when it follows DTP vaccination.
Petitioners have the right to prove causation in fact in instances in
which infantile spasms has its onset following immunization.
The U.S. Court of Federal Claims has held that seizures diagnosed
as infantile spasms can be considered a Table injury if the requisite
timeframes are met. The Court has held that the respondent cannot claim
that infantile spasms is a factor unrelated to vaccine administration
unless the precise cause of the infantile spasms can be identified. The
Court's reasoning was based on a technical interpretation of the
statute, and does not purport to be an analysis of the medical issues
involved. Furthermore, the Court's analysis relied, of course, on the
initial Table. It cannot be viewed as relevant to the actual causation
issue which is the basis for revising the Table. See Johnston v.
Secretary of HHS, 22 Cl. Ct. 75 (1990).
Nevertheless, the Department has decided to remove all references
to infantile spasms from the final rule. This decision was made based
purely on procedural grounds. The Department concluded that this issue
is more appropriately addressed in the ``factor unrelated'' section of
the statute (42 U.S.C. 300aa-13(b)), rather than as part of the Vaccine
Injury Table. The decision to revise the rule in this manner does not
affect the Department's findings regarding infantile spasms (based on
the IOM report), nor should it be viewed as inconsistent with the
Department's response to the commenters' concerns. The Department
continues to believe that deciding cases involving infantile spasms,
the Court of Federal Claims should rely heavily on the IOM's conclusion
that the evidence does not indicate a causal relationship between
pertussis vaccine and infantile spasms.
One commenter claims to have concluded ``within medical certainty''
that chronic neurologic damage occurred in children who had acute
afebrile seizures within the timeframes of the current Table of
injuries, and as manifestations of acute encephalopathies. The
commenter does not, however, provide sufficient evidence to justify a
revision of the proposed language.
The IOM concluded that afebrile seizures are not causally related
to DTP vaccine. They considered many studies, including one which
showed that short-lived convulsions, with or without fever, have not
been demonstrated to cause permanent sequelae, regardless of whether
the seizures occur in association with receipt of DTP. vaccine. (IOM
Report p. 118) (Hirtz DG. et al. Seizures following childhood
immunizations. J. Pediatr. 1983; 102:14-18. and Ellenberg JH, Hirtz DG,
Nelson KB. Do seizures in children cause intellectual deterioration?
NEJM 1986; 314:1085-1088) (Ad Hoc Committee for the Child Neurology
Society. Consensus Statement: Pertussis immunization and the central
nervous system. Ann. of Neuro. 1991; 29 (4): 458-460).
The Department also reversed the order of Sec. 100.3(b)(3)(i) and
Sec. 100.3(b)(3)(ii). This change was made to make the order of these
two subparagraphs more logical.
In response to the March 24, 1994, Federal Register Notice
requesting comments on the 1994 IOM Report, two commenters argued that
because seizures were included in the definition of encephalopathy and
chronic nervous system dysfunction used by the NCES, the Department
should not remove residual seizure disorder from the Table.
The Department disagrees with the commenters on this point. As
discussed above, the 1991 IOM report concluded that no causal
relationship can be proven between DTP and afebrile seizures. In its
1994 report, the IOM did not retract any of its 1991 conclusions
regarding DTP and seizure disorders. It merely recognized that the NCES
included seizures as one of those conditions to be monitored or
purposes [[Page 7691]] of tracking long-term dysfunction. This
recognition does not provide any information one way or the other
regarding causation.
Crucial to understanding the Department's response is the knowledge
that the working definition of ``acute neurologic illness'' used in the
NCES is not consistent with the current medical understanding of acute
encephalopathy as an acute, generalized disorder of the brain. Children
were placed in the NCES case definition who experienced only febrile
seizures, a benign condition know to be triggered by DTP vaccine, yet
never proven to have lasting effects absent signs of acute
encephalopathy. Thus, placing seizures in the NCES case definition of
encephalopathy is inconsistent with the current medical understanding
of acute encephalopathy. Moreover, both the IOM and the NVAC
subcommittee agreed that there is no evidence that chronic
encephalopathy in the absence of acute post-immunization encephalopathy
is causally related to the vaccine. Therefore, there is no basis for
providing a legal presumption of vaccine causation for chronic effects
based solely on the occurrence of a seizure following DTP immunization.
There is simply no need for, nor is there medical evidence to support,
a separate presumption for residual seizure disorder in connection with
DTP vaccine.
Sudden Infant Death Syndrome
Two commenters suggested there is not a clear distinction between a
death characterized as Sudden Infant Death Syndrome (SIDS) and one that
is vaccine-related (paragraph (b)(2)(iii) of the NPRM).
The IOM concluded that SIDS is not causally related to DTP vaccine.
This conclusion was based on several controlled epidemiologic studies
involving hundreds of thousands of vaccinations. Although the diagnosis
of SIDS is one of exclusion of other causes, there are specific
guidelines as to the history preceding death, findings on forensic
examination, and the ruling out of other causes by death scene
examination (when possible). Moreover, the possibility that DTP-related
deaths are commonly misclassified as SIDS was also considered by the
IOM Committee. Since there was no evidence of an increased risk of SIDS
following DTP immunization, or of any observable ``pertussis death
syndrome,'' the committee considered that such effects were not
supported by the medical literature. In addition, those studies that
examined infant deaths other than SIDS in relation to DTP vaccine also
demonstrated no excess risk in the post-immunization interval. This
observation argues against the possibility that DTP-related deaths were
missed as a result of their being misclassified as deaths other than
SIDS. (Correspondence from Christopher P. Howson, Ph.D., Project
Director, Committee to Review the Adverse Consequences of Pertussis and
Rubella Vaccines to Dr. George Curlin, Deputy Director, Division of
Microbiology and Infectious Diseases, National Institute of Allergy and
Infectious Diseases: 9/18/91)
Nevertheless, as with infantile spasms, the Department has decided
to remove all references to Sudden Infant Death Syndrome from the final
rule. This decision, too, was made based purely on procedural grounds.
The Department concluded (as with infantile spasms) that this issue is
more appropriately addressed in the ``factor unrelated'' section of the
statute (42 U.S.C. Sec. 300aa-13(b)), rather than as part of the
Vaccine Injury Table. The decision to make this change does not affect
the Department's findings regarding SIDS (based on the IOM report), nor
should it be viewed as inconsistent with the above analysis regarding
the Department's response to the commenters' concerns. The Department
continues to believe that in deciding cases involving SIDS, the Court
of Federal Claims should rely heavily on the IOM's conclusion that the
evidence does not indicate a causal relationship between pertussis
vaccine and SIDS.
Tuberous Sclerosis Complex
One commenter suggested that the proposed revisions do not take
into account the condition of tuberous sclerosis complex (TSC), which
some believe can be aggravated by DTP vaccine. Since DTP vaccine can
cause fevers which trigger seizures, there remains a question whether
someone with TSC would have a worse outcome as a result of a seizure
following a DTP shot. One commenter suggested that infantile spasms is
frequently associated with TSC and the U.S. Court of Federal Claims has
found compensable infantile spasms cases that manifested after DTP
vaccine. The Department provides the following clarification regarding
the effect the new Table will have on individuals with TSC.
TSC is a genetic disorder manifested chiefly as mental deficiency,
epilepsy and skin lesions. Seizures occur in 80-90 percent of
individuals with tuberous sclerosis. This disorder frequently presents
in infancy, commonly in the form of infantile spasms. Some petitioners
have argued that administration of a DTP vaccine can significantly
aggravate a case of TSC.
The Act provides two avenues of proof in order to establish
eligibility for compensation. A petitioner is afforded a presumption of
causation if he/she can establish that an injury listed in the Table
occurred within the specified time period. Otherwise, the petitioner
may argue that an injury occurred which is not listed in the Table, but
which was nonetheless caused by the vaccine. The TSC cases presented to
the Court, some petitioners who sought to establish a Table case argued
that the child experienced seizures within 3 days of receipt of a
vaccine and that this event significantly aggravated the pre-existing
TSC. Some petitioners who were unable to establish Table cases argued
that although the child did not sustain an injury listed in the Vaccine
Injury Table, the vaccine nonetheless was the cause-in-fact of the
aggravation of the underlying Tuberous Sclerosis. In either case, the
petitioner had the burden of proving that the clinical course of the
pre-existing condition had been significantly aggravated. Typically,
petitioners presented expert testimony to support this theory.
The revisions to the Vaccine Injury Table do not, by and large,
change the petitioner's burden of proof in TSC cases. The only
difference is that there is not a presumption of causation for residual
seizure disorders for DTP vaccine. As explained in the preamble to the
NPRM, and reiterated here, the IOM concluded that there is no causal
relation between pertussis vaccine and afebrile seizures. However, to
receive a presumption of causation, petitioners may still argue that an
encephalopathy (as defined in the revised Qualifications) occurred
within 3 days of vaccine administration and that this encephalopathy
significantly aggravated the pre-existing Tuberous Sclerosis. In
addition, petitioners may continue to argue that the vaccine was the
cause-in-fact of the aggravation of the TSC. As far as infantile spasms
is concerned, the Department has removed all references to this
condition from the final rule as explained above. Therefore,
petitioners have available to them the same avenues of proof open to
individuals with other types of seizures.
One commenter noted that MMR frequently triggers epilepsy in
children with TSC. The same analysis as above applies. Here, the
petitioner may take advantage of the presumption of causation if he or
she is able to prove either a Table encephalopathy, or a Table residual
seizure disorder, and that that injury significantly aggravated the
underlying TSC. If the evidence does [[Page 7692]] not demonstrate that
the case meets the requirements of the Table, the case will be
evaluated based on a causation theory.
Diphtheria/Tetanus Vaccines (DT, TD, TT)
One commenter suggested that making changes to non-pertussis
components based on studies of pertussis vaccine is inappropriate.
Although the section 312 study (``IOM Report'') did not
specifically study the non-pertussis antigens of DTP vaccine (i.e.,
diphtheria, tetanus), most individuals receiving pertussis antigen,
also were given these antigens. Therefore, some inferential data is
present. Moreover, studies reveal little evidence that these antigens
are causally related to the injuries currently listed in the Table
under DTP, other than Anaphylaxis. In the section 313 study, the IOM
concluded that the evidence favored rejection of a causal relation
between DT/Td/TT and encephalopathy. After review of the section 313
Report, the Department may promulgate additional changes to the Table.
MMR Vaccines
One commenter suggested that the requirement for at least 5 days of
viral replication is inappropriate. One commenter suggested that the
changes for encephalopathy are wrong because there is a broad spectrum
of severity. Sequelae may occur after less serious acute
encephalopathy. The proposed changes would exclude all but the most
severe acute encephalopathies from the Table. The Department has
considered these comments, but has concluded that the medical evidence
supports the proposed changes.
Since viral replication is required for a viral vaccine-associated
encephalopathy, a window for the expected time of onset is appropriate.
The onset of vaccine-related illness following MMR (or any of its
components) is generally from 7 to 14 days, thus a time interval of 5
to 15 days would be all-inclusive. Any acute encephalopathy of unknown
cause, regardless of severity or duration, that occurs during the 5 to
15 day time frame would be eligible for the Table presumption, provided
the child or adult has continued evidence of ``chronic
encephalopathy.'' The 1991 NVAC Subcommittee felt there was strong
support in the literature to narrow the timeframe as above. Some felt
Residual Seizure Disorder should be removed from the Table based on the
lack of evidence for causation in the current medical literature. This
was not done because it went significantly beyond the scope of changes
proposed by the PHS Task Force. However, at that time, the Subcommittee
recognized additional changes may be forthcoming once the section 313
study results are published and have been reviewed. Since the
Subcommittee's original discussion on this issue, the IOM issued its
section 313 report. The IOM concluded for both encephalopathy and
residual seizure disorder that the evidence is inadequate to accept or
reject a causal relation. After review of the 313 Report, the
Department may promulgate additional changes to the Table based on this
conclusion.
One commenter suggested that the evidence for an association
between rubella vaccine and chronic arthritis is inconclusive. The
section 312 IOM Committee concluded that the evidence is ``consistent
with a causal relation'' between the currently used rubella vaccine (RA
27/3) and chronic arthritis in adult women, although the evidence is
limited in scope and confined to reports from one institution. To
establish this biologically plausible relation more firmly, the
Committee expressed the need for prospective, double-blind, controlled
trials in which individuals are followed for at least 12 months after
vaccination with attempts to isolate and identify rubella virus. At
least one medical research center is pursuing this research to try and
obtain better data on causation.
Many investigators still view the evidence as inconclusive with
regard to chronic arthritis. However, the IOM's finding justifies the
inclusion of chronic arthritis on the Vaccine Injury Table since there
is biologic plausibility of causation, and the term ``chronic
arthritis'' is defined as effects lasting greater than 6 months. In
this instance, the IOM is stating there is ``consistent'' evidence for
both acute onset and residual effects lasting greater than 6 months.
Previously described changes for Table injuries under DTP involved
conditions (i.e., HHE and Residual Seizure Disorder) that the IOM did
not view as having strong evidence for both acute and chronic effects.
Although the Department added chronic arthritis to the Table,
guidelines written into the Aids to Interpretation will preclude
patients with pre-existing conditions or other non-vaccine related
musculoskeletal disorders from being legally presumed to have a
vaccine-related injury. As information from prospective studies becomes
available, modifications may be made to the Table or Aids to
Interpretation based on this data.
Polio Vaccines
Two commenters suggested that Inactivated Polio Vaccine (IPV),
known as the Salk vaccine, may be proven to be causally related to
poliomyelitis. The IOM evaluated the relationship between polio
vaccines and adverse events in its section 313 study. Except for the
1955 incident with inadequate inactivation of live polio virus in the
Cutter Company supply of IPV, there have been no serious adverse events
causally tied to this vaccine. Since the ``Cutter Incident,'' when
manufacturing and testing difficulties were identified and corrected,
the safety of released inactivated Poliovirus vaccine has been assured.
(See IOM Section 313 Report at 188,; see also Bodian, D., et al.
Interim Report, Public Health Service Technical Committee on
Poliomyelitis Vaccine. JAMA:1444-7, 1955) Furthermore, no serious side
effects of currently available inactivated poliovirus vaccines have
been documented. (Report of the Committee on Infectious Diseases,
American Academy of Pediatrics 1991:389) Because these earlier problems
have been cured, and there is no current evidence bearing on a causal
relationship, the section 313 study does not discuss specifically the
connection between IPV and poliomyelitis. Therefore, there is no
evidence of a causal relationship which would justify adding
poliomyelitis to the Table for IPV.
Other Changes
At the meeting on June 1-2, 1994, members of the ACCV suggested
that the definition of ``sequela'' imposes a higher burden of proof
than that required by the statute. The Department disagrees that the
definition affects the burden of proof, but agrees that the definition
as written should be simplified. Accordingly, the definition in
Sec. 100.3(b)(5) has been modified to read as follows: ``The term
sequela means a condition or event which was actually caused by a
condition listed in the Vaccine Injury Table.'' This definition is
consistent with current scientific understanding that in order for a
subsequent event to be considered a sequela of an initial event, there
must be a causal relationship between the two.
Technical Changes
First, in publishing the NPRM, the Department inadvertently
misquoted the statutory introduction to the Vaccine Injury Table.
Accordingly, the introductory paragraph of Sec. 100.3(a) now reads as
follows: ``In accordance with section 312(b) of the National Childhood
Vaccine Injury Act of 1986, [[Page 7693]] title III of Pub. L. 99-660
(42 U.S.C. 300aa-note) and section 2114(c) of the Public Health Service
Act (42 U.S.C. 300aa-14(c)), the following is a table of vaccines, the
injuries, disabilities, illnesses, conditions, and deaths resulting
from the administration of such vaccines, and the time period in which
the first symptom or manifestation of onset or of the significant
aggravation of such injuries, disabilities, illnesses, conditions, and
deaths is to occur after vaccine administration for purposes of
receiving compensation under the Program:''
Second, we are revising Sec. 100.3(c), entitled ``Effective date
provisions.'', to change the term ``United States Claims Court''
wherever it appears to read ``United States Court of Federal Claims'',
in accordance with section 902(b) of title IX, Pub. L. 102-572, the
Federal Courts Administration Act of 1992 (See 106 Stat. 4516).
In addition, the Department is making a technical change to the
existing regulations (42 CFR part 100) by revising the currently
codified acronym used to refer to the National Vaccine Injury
Compensation Program from ``NVIC'' to ``VICP'' wherever it appears
under part 100. ``VICP'' has been used for the entire history of the
program to avoid confusion with the parents' advocacy group known as
the National Vaccine Information Center (NVIC), Dissatisfied Parents
Together (DPT).
Since these changes are of a technical nature, the Secretary has
determined pursuant to 5 U.S.C. 553 and departmental policy that it is
unnecessary and impractical to follow proposed rulemaking procedures.
Economic Impact
The NPRM preamble erred in not explaining that this rule will not
have a significant impact on a substantial number of small businesses
because it will have only small effects, and those primarily on
individuals. Attorneys, while small entities within the meaning of the
Act, will still be awarded costs and fees for cases they bring on a
reasonable basis. The reduced number of vaccine cases brought will be
negligible measured against overall business opportunities for lawyers.
Therefore, SBA is incorrect in saying that a regulatory flexibility
analysis is required. Therefore, the Secretary certifies that this
final rule will not have a significant economic impact on a substantial
number of small entities.
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, of costs, of benefits, of incentives, of
equity, and of available information. Regulations must meet certain
standards, such as avoiding unnecessary burden. Regulations which are
``significant'' because of cost, adverse effects on the economy,
inconsistency with other agency actions, effects on the budget, or
novel legal or policy issues, require special analysis.
As stated above, this final regulation modifies the Vaccine Injury
Table based on legal authority, and under that authority the Court will
award such fees and costs as appropriate under the law. As such, the
regulation would have little direct effect on the economy or on Federal
or State expenditures. For the same reasons, the Secretary has also
determined that this is not a ``significant'' rule under Executive
Order 12866.
Effect of the New Rule
The NPRM failed to explain the effect of the rule for individuals
who were not eligible to file petitions based on the original Vaccine
Injury Table, but who may be eligible to file petitions based on the
revised Table. The Act permits such individuals to file a petition for
such compensation not later than 2 years after the effective date of
the revision if the injury or death occurred no more than 8 years
before the effective date of the revision of the Table. See 42 U.S.C.
300aa-16(b). As part of the Omnibus Reconciliation Act of 1993,
Congress amended this section to permit individuals to file claims
within this 2-year period, even if they had already filed a claim
involving a particular vaccine, but only if the Table revision will
``significantly increase the likelihood of obtaining compensation.''
See Pub. L. 103-66, sec. 13632(a)(1). (August 10, 1993). For example,
this amendment would permit an individual whose claim alleging vaccine-
related arthritis had been dismissed by the Claims Court to file a new
claim for the same vaccine-related injury, if the individual can show
that the addition of arthritis to the Table as a rubella vaccine-
related condition has significantly increased the likelihood of
obtaining compensation. The Department believes that the amendment
would not permit someone who had had a claim for an alleged vaccine-
related encephalopathy subsequent to DTP vaccine to refile a claim that
had been dismissed by the Claims Court, as the changes in the Table
related to DTP and encephalopathy do not appear to significantly
increase the likelihood of obtaining compensation.
Possible Effect on Other Legislation
This rule will not have an effect on the Vaccines for Children
Program, implemented by the Centers for Disease Control and Prevention
under section 1928 of the Social Security Act, as enacted by section
13631 of the Omnibus Budget Reconciliation Act of 1993 (Pub. L. 103-66,
August 10, 1993). This section provides for the establishment of a
program to distribute free vaccines to all vaccine-eligible children,
as defined by this section. The final rule modifies the existing
Vaccine Injury Table, a mechanism by which compensation is awarded to
individuals who have been found to have suffered from vaccine-related
injuries. Because the two authorities are not related, the publication
of this rule should not have any impact on the Vaccines for Children
Program.
Paperwork Reduction Act of 1980
This final rule has no information collection requirements.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, Immunization.
Dated: November 16, 1993.
Philip R. Lee,
Assistant Secretary for Health.
Approved: November 9, 1994.
Donna E. Shalala,
Secretary.
Accordingly, 42 CFR part 100 is amended as set forth below.
PART 100--VACCINE INJURY COMPENSATION
1. The authority citation for part 100 is revised to read as
follows:
Authority: Sec. 215 of the Public Health Service Act (42 U.S.C.
216); sec. 2115 of the PHS Act, 100 Stat. 3767, as amended (42
U.S.C. 300aa-15); Sec. 100.3, the Vaccine Injury Table, issued under
sec. 312 of Pub. L. 99-660, 100 Stat. 3779 (42 U.S.C. 300aa-1 note)
and sec. 2114(c) of the PHS Act (42 U.S.C. 300aa-14(c)).
2. Section 100.1 is revised to read as follows:
Sec. 100.1 Applicability.
This part applies to the National Vaccine Injury Compensation
Program (VICP) under subtitle 2 of title XXI of the Public Health
Service (PHS) Act.
3. The first sentence in Sec. 100.2 is revised to read as follows:
Sec. 100.2 Average cost of a health insurance policy.
For purposes of determining the amount of compensation under the
VICP, section 2115(a)(3)(B) of the PHS Act, 42 U.S.C.
300aa.15(a)(3)(B), provides that certain individuals are entitled to
receive an amount reflecting [[Page 7694]] lost earnings, less certain
deductions. * * *
4. Section 100.3 is added to read as follows:
Sec. 100.3 Vaccine injury table.
(a) In accordance with section 312(b) of the National Childhood
Vaccine Injury Act of 1986, title III of Pub. L. 99-660, 100 Stat. 3779
(42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health
Service Act (42 U.S.C. 300aa-14(c)), the following is a table of
vaccines, the injuries, disabilities, illnesses, conditions, and deaths
resulting from the administration of such vaccines, and the time period
in which the first symptom or manifestation of onset or of the
significant aggravation of such injuries, disabilities, illnesses,
conditions, and deaths is to occur after vaccine administration for
purposes of receiving compensation under the Program:
Vaccine Injury Table
----------------------------------------------------------------------------------------------------------------
Time period for first symptom or
manifestation of onset or of
Illness, disability, injury or condition covered significant aggravation after
vaccine administration
----------------------------------------------------------------------------------------------------------------
I. DTP; P; DT; Td; or Tetanus Toxoid; or in any combination with Polio; or
any Other Vaccine Containing Whole Cell Pertussis Bacteria, Extracted or
Partial Cell Pertussis Bacteria, or Specific Pertussis Antigen(s):
A. Anaphylaxis or anaphylactic shock..................................... 4 hours.
B. Encephalopathy (or encephalitis)...................................... 72 hours.
C. Any sequela (including death) of an illness, disability, injury, or Not applicable.
condition referred to above which illness, disability, injury, or
condition arose within the time period prescribed.
II. (a). Measles, mumps, rubella, or any vaccine containing any of the
foregoing as a component:
A. Anaphylaxis or anaphylactic shock..................................... 4 hours.
B. Encephalopathy (or encephalitis)...................................... 5-15 days (not less than 5 days
and not more than 15 days) for
measles, mumps, rubella, or any
vaccine containing any of the
foregoing as a component.
C. Residual seizure disorder in accordance with subsection (b)(3)........ 5-15 days (not less than 5 days
and not more than 15 days) for
measles, mumps, rubella, or any
vaccine containing any of the
foregoing as a component.
D. Any sequela (including death) of an illness, disability, injury, or Not applicable.
condition referred to above which illness, disability, injury, or
condition arose within the time period prescribed.
II. (b). In the case of measles, mumps, rubella (MMR), measles, rubella (MR)
or rubella vaccines only:
A. Chronic arthritis..................................................... 42 days.
B. Any sequela (including death) of an illness, disability, injury, or Not applicable.
condition referred to above which illness, disability, injury, or
condition arose within the time period prescribed.
III. Polio Vaccine (other than Inactivated Polio Vaccine):
A. Paralytic Polio
In a non-immunodeficient recipient................................... 30 days.
In an immunodeficient recipient...................................... 6 months.
In a vaccine associated community case............................... Not applicable.
B. Any acute complication or sequela (including death) of an illness, Not applicable.
disability, injury, or condition referred to above which illness,
disability, injury, or condition arose within the time period prescribed.
IV. Inactivated Polio Vaccine:
A. Anaphylaxis or anaphylactic shock..................................... 4 hours.
B. Any acute complication or sequela (including death) of an illness, Not applicable.
disability, injury, or condition referred to above which illness,
disability, injury, or condition arose within the time period prescribed.
----------------------------------------------------------------------------------------------------------------
(b) Qualifications and aids to interpretation. The following
qualifications and aids to interpretation shall apply to the Vaccine
Injury Table in paragraph (a) of this section:
(1) Anaphylaxis and anaphylactic shock. For purposes of paragraph
(a) of this section, Anaphylaxis and anaphylactic shock mean an acute,
severe, and potentially lethal systemic allergic reaction. Most cases
resolve without sequelae. Signs and symptoms begin minutes to a few
hours after exposure. Death, if it occurs, usually results from airway
obstruction caused by laryngeal edema or bronchospasm and may be
associated with cardiovascular collapse. Other significant clinical
signs and symptoms may include the following: Cyanosis, hypotension,
bradycardia, tachycardia, arrhythmia, edema of the pharynx and/or
trachea and/or larynx with stridor and dyspnea. Autopsy findings may
include acute emphysema which results from lower respiratory tract
obstruction, edema of the hypopharynx, epiglottis, larynx, or trchea
and minimal findings of eosinophilia in the liver, spleen and lungs.
When death occurs within minutes of exposure and without signs of
respiratory distress, there may not be significant pathologic findings.
(2) Encephalopathy. For purposes of paragraph (a) of this section,
a vaccine recipient shall be considered to have suffered an
encephalopathy only if such recipient manifests, within the applicable
period, an injury meeting the description below of an acute
encephalopathy, and then a chronic encephalopathy persists in such
person for more than 6 months beyond the date of
vaccination. [[Page 7695]]
(i) An acute encephalopathy is one that is sufficiently severe so
as to require hospitalization.
(A) For children less than 18 months of age who present without an
associated seizure event, an acute encephalopathy is indicated by a
significantly decreased level of consciousness lasting for at least 24
hours. Those children less than 18 months of age who present following
a seizure shall be viewed as having an acute encephalopathy if their
significantly decreased level of consciousness persists beyond 24 hours
and cannot be attributed to a postictal state (seizure) or medication.
(B) For adults and children 18 months of age or older, an acute
encephalopathy is one that persists for at least 24 hours and
characterized by at least two of the following:
(1) A significant change in mental status that is not medication
related; specifically a confusional state, or a delirium, or a
psychosis;
(2) A significantly decreased level of consciousness, which is
independent of a seizure and cannot be attributed to the effects of
medication; and
(3) A seizure associated with loss of consciousness.
(C) Increased intracranial pressure may be a clinical feature of
acute encephalopathy in any age group.
(D) A ``significantly decreased level of consciousness'' is
indicated by the presence of at least one of the following clinical
signs for at least 24 hours or greater (see paragraphs (b)(2)(i)(A) and
(b)(2)(i)(B) of this section for applicable timeframes):
(1) Decreased or absent response to environment (responds, if at
all, only to loud voice or painful stimuli);
(2) Decreased or absent eye contact (does not fix gaze upon family
members or other individuals); or
(3) Inconsistent or absent responses to external stimuli (does not
recognize familiar people or things).
(E) The following clinical features alone, or in combination, do
not demonstrate an acute encephalopathy or a significant change in
either mental status or level of consciousness as described above:
Sleepiness, irritability (fussiness), high-pitched and unusual
screaming, persistent inconsolable crying, and bulging fontanelle.
Seizures in themselves are not sufficient to constitute a diagnosis of
encephalopathy. In the absence of other evidence of an acute
encephalopathy, seizures shall not be viewed as the first symptom or
manifestation of the onset of an acute encephalopathy.
(ii) Chronic Encephalopathy occurs when a change in mental or
neurologic status, first manifested during the applicable time period,
persists for a period of at least 6 months from the date of
vaccination. Individuals who return to a normal neurologic state after
the acute encephalopathy shall not be presumed to have suffered
residual neurologic damage from that event; any subsequent chronic
encephalopathy shall not be presumed to be a sequela of the acute
encephalopathy. If a preponderance of the evidence indicates that a
child's chronic encephalopathy is secondary to genetic, prenatal or
perinatal factors, that chronic encephalopathy shall not be considered
to be a condition set forth in the Table.
(iii) An encephalopathy shall not be considered to be a condition
set forth in the Table if in a proceeding on a petition, it is shown by
a preponderance of the evidence that the encephalopathy was caused by
an infection, a toxin, a metabolic disturbance, a structural lesion, a
genetic disorder or trauma (without regard to whether the cause of the
infection, toxin, trauma, metabolic disturbance, structural lesion or
genetic disorder is known). If at the time a decision is made on a
petition filed under section 2111(b) of the Act for a vaccine-related
injury or death, it is not possible to determine the cause by a
preponderance of the evidence of an encephalopathy, the encephalopathy
shall be considered to be a condition set forth in the Table.
(iv) In determining whether or not an encephalopathy is a condition
set forth in the Table, the Court shall consider the entire medical
record.
(3) Residual Seizure Disorder. (i) A petitioner may be considered
to have suffered a residual seizure disorder for purposes of paragraph
(a) of this section, if the first seizure or convulsion occurred 5-15
days (not less than 5 days and not more than 15 days) after
administration of the vaccine and 2 or more additional distinct seizure
or convulsion episodes occurred within 1 year after the administration
of the vaccine which were unaccompanied by fever (defined as a rectal
temperature equal to or greater than 101.0 degrees Fahrenheit or an
oral temperature equal to or greater than 100.0 degrees Fahrenheit). A
distinct seizure or convulsion episode is ordinarily defined as
including all seizure or convulsive activity occurring within a 24-hour
period, unless competent and qualified expert neurological testimony is
presented to the contrary in a particular case.
(ii) For purposes of paragraph (a) of this section, a petitioner
shall not be considered to have suffered a residual seizure disorder,
if the petitioner suffered a seizure or convulsion unaccompanied by
fever (defined as a rectal temperature equal to or greater than 101.0
degrees Fahrenheit or an oral temperature equal to or greater than
100.0 degrees Fahrenheit) before the fifth day after the administration
of the vaccine involved.
(4) Seizure and convulsion. For purposes of paragraphs (b) (2) and
(3) of this section, the terms, ``seizure'' and ``convulsion'' include
myoclonic, generalized tonic-clonic (grand mal), and simple and complex
partial seizures. Absence (petit mal) seizures shall not be considered
to be a condition set forth in the Table. Jerking movements or staring
episodes alone are not necessarily an indication of seizure activity.
(5) Sequela. The term ``sequela'' means a condition or event which
was actually caused by a condition listed in the Vaccine Injury Table.
(6) Chronic Arthritis. (i) For purposes of paragraph (a) of this
section, chronic arthritis may be found in a person with no prior
history of arthropathy (joint disease) on the basis of:
(A) Medical documentation, recorded within 30 days after the onset,
of objective signs of acute arthritis (joint swelling) that occurred
within 42 days after a rubella vaccination; and
(B) Medical documentation (recorded within 3 years after the onset
of acute arthritis) of the persistence of objective signs of
intermittent or continuous arthritis for more than 6 months following
vaccination.
(ii) For purposes of paragraph (a) of this section, the following
shall not be considered as chronic arthritis: Musculoskeletal disorders
such as diffuse connective tissue diseases (including but not limited
to rheumatoid arthritis, juvenile rheumatoid arthritis, systemic lupus
erythematosus, systemic sclerosis, mixed connective tissue disease,
polymyositis/dermatomyositis, necrotizing vasculitis and vasculopathies
and Sjogren's Syndrome), degenerative joint disease, infectious agents
other than rubella (whether by direct invasion or as an immune
reaction), metabolic and endocrine diseases, trauma, neoplasms,
neuropathic disorders, bone and cartilage disorders and arthritis
associated with ankylosing spondylitis, psoriasis, inflammatory bowel
disease, Reiter's syndrome, or blood disorders.
(iii) Arthralgia (joint pain) or stiffness without joint swelling
shall not be viewed as chronic arthritis for purposes of paragraph (a)
of this section.
(c) Effective date provisions. The Table of Injuries set forth in
paragraph [[Page 7696]] (a) of this section applies to petitions for
compensation under the Program filed with the United States Court of
Federal Claims on or after March 10, 1995. The Qualifications and Aids
to Interpretation set forth in paragraph (b) of this section apply to
petitions filed with the United States Court of Federal Claims on or
after March 10, 1995. The petitions for compensation filed with the
United States Court of Federal Claims before March 10, 1995 shall be
governed by section 2114(a) (initial ``Table'') and section 2114(b)
(initial ``Qualification and Aids to Interpretation'') of the Public
Health Service Act as in effect on February 8, 1995.
[FR Doc. 95-2945 Filed 2-7-95; 8:45 am]
BILLING CODE 4160-15-M