[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Rules and Regulations]
[Pages 6294-6305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-00701]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
42 CFR Part 100
RIN 0906-AB01
National Vaccine Injury Compensation Program: Revisions to the
Vaccine Injury Table
AGENCY: Health Resources and Services Administration (HRSA), HHS.
ACTION: Final rule.
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SUMMARY: On July 29, 2015, the Secretary of Health and Human Services
(the Secretary) published in the Federal Register a Notice of Proposed
Rulemaking (NPRM) to amend the regulations governing the National
Vaccine Injury Compensation Program (VICP or program) by proposing
revisions to the Vaccine Injury Table (Table). The Secretary based the
Table revisions primarily on the 2012 Institute of Medicine (IOM)
report, ``Adverse Effects of Vaccines: Evidence and Causality,'' the
work of nine HHS workgroups who reviewed the IOM findings, and
consideration of the Advisory Commission on Childhood Vaccines' (ACCV)
recommendations. The Secretary amends the Table through the changes in
this final rule. These changes will apply only to petitions for
compensation under the VICP filed after this final rule becomes
effective.
DATE: This rule is effective February 21, 2017.
FOR FURTHER INFORMATION CONTACT: Dr. Narayan Nair, Acting Director,
Division of Injury Compensation Programs, Healthcare Systems Bureau,
HRSA, 5600 Fishers Lane, Room 8N146B, Rockville, MD 20857, or by
telephone (855) 266-2427. This is a toll-free number.
SUPPLEMENTARY INFORMATION:
I. Background
The National Childhood Vaccine Injury Act of 1986, title III of
Public Law 99-660 (42 U.S.C. 300aa-10 et seq.), established the VICP, a
Federal
[[Page 6295]]
compensation program for persons thought to be injured by vaccines. The
statute governing the VICP has been amended several times since 1986
and is hereinafter referred to as ``the Act.'' Petitions for
compensation under the VICP are filed in the United States Court of
Federal Claims (Court), with a copy served on the Secretary, who is
designated as the ``Respondent.'' The Court, acting through judicial
officers called Special Masters, makes decisions as to eligibility for,
and the amount of, compensation.
To gain entitlement to compensation under this program, a
petitioner must establish that a vaccine-related injury or death has
occurred, either by proving that a vaccine actually caused or
significantly aggravated an injury (causation-in-fact) or by
demonstrating the occurrence of what is referred to as a ``Table
Injury.'' That is, a petitioner may show that the vaccine recipient
suffered an injury of the type enumerated in the regulations at 42 CFR
100.3--the ``Vaccine Injury Table''--corresponding to the vaccination
in question and that the onset of such injury took place within a time
period also specified in the Table. If so, the injury is presumed to
have been caused by the vaccination and the petitioner is entitled to
compensation (assuming that other requirements are satisfied) unless
the Respondent affirmatively shows that the injury was caused by some
factor other than the vaccination (see 42 U.S.C. 300aa-11(c)(1)(C)(i),
300aa-13(a)(1)(B)), and 300aa-14(a)).
In prior Table revisions, the Secretary determined that the
appropriate framework for making changes to the Table is to make
specific findings as to the illnesses or conditions that can reasonably
be determined, in some circumstances, to be caused or significantly
aggravated by the vaccines under review and the circumstances under
which such causation or aggravation can reasonably be determined to
occur. The Secretary continues this approach through the use of the
2012 IOM report, the work of the nine workgroups who reviewed the IOM
findings, and consideration of the ACCV's recommendations. After
consultation with the ACCV, the Secretary may modify the Table by
promulgating regulations, with notice and opportunity for a public
hearing and at least 180 days of public comment. See 42 U.S.C. 300aa-
14(c) and (d).
II. Summary of the Final Rule
After the IOM released its 2012 report, 9 HHS workgroups comprising
HRSA and Centers for Disease Control and Prevention (CDC) medical staff
reviewed IOM's conclusions for 158 vaccine-adverse events, as well as
any newly published scientific literature not contained in the report,
and developed a set of proposed changes to the Table and its
definitional counterpart, the Qualifications and Aids to Interpretation
(QAI). For the vast majority of the vaccine-adverse event pairs
reviewed (135), the IOM determined that the evidence was inadequate to
accept or reject a causal relationship. Considering the remaining IOM
conclusions and the ACCV Guiding Principles, the Secretary in this
final rule is adopting certain additions or changes to the Table where
the scientific evidence either convincingly supports or favors
acceptance of a causal relationship between certain conditions and
covered vaccines, which are unchanged from the proposed rule. As
required by the Act, the changes in the proposed rule were presented to
the ACCV, which reviewed and concurred with the Table changes set forth
in this final rule.
Additionally, the Secretary, following the recommendation of the
ACCV, is finalizing the Table change, as proposed, to add the injury of
Guillain-Barr[eacute] Syndrome (GBS) for seasonal influenza
vaccinations, which is consistent with the approach taken in the
Countermeasures Injury Compensation Program (CICP). Studies have
demonstrated a causal association between the monovalent 2009 H1N1
vaccine and the 1976 swine flu vaccine and GBS. These causal
associations were the basis of the 2015 decision by the Secretary in
the CICP Pandemic Influenza A Countermeasures Injury Table Final Rule
(80 FR 47411) to include GBS as an injury associated with the 2009 H1N1
influenza. With respect to that vaccine, the Secretary found that there
was compelling, reliable, and valid medical and scientific evidence of
an association between the 2009 H1N1 vaccine and GBS, which is required
to add an injury to the CICP's Injury Table. To date, the H1N1 antigen
has been included in all seasonal influenza vaccines beginning with the
2010-2011 flu season. HHS notes that seasonal influenza vaccine
formulations, unlike other vaccines, include multiple antigens that
change from year-to-year, and enhanced surveillance activities to
detect the incidence of GBS that occurred during the 2009 H1N1 pandemic
may not occur with each virus strain change. In light of this
information and other information as discussed in the proposed rule,
the ACCV recommended that the Secretary add GBS consistent with one of
its Guiding Principles: That where there is credible evidence to both
support and reject a change to the Table, the change should, whenever
possible, be made to the benefit of petitioners.
In addition, in the final rule, the Secretary adopts the proposed
rule's new paragraph (b), Provision that applies to all vaccines
listed. To streamline the Table, this paragraph includes any acute
complication or sequela, including death, of the illness, disability,
injury, or condition listed, as a Table injury (absent an exclusion as
set forth under the QAI) rather than adding the provision to every line
of the Table. To further streamline the Table, the Secretary deleted
redundant wording in the various definitions, particularly with regard
to any references to the presumption of causation, and the importance
of the entire medical record. These elements have been included in
paragraph (b) and are unchanged from the proposed rule. Finally, in
this final rule, the Secretary adopts changes in the proposed rule that
simplify and expand applicability of a provision that previously
applied only to an encephalopathy. This provision, which indicates that
idiopathic conditions do not rebut the Table presumption, now applies
(through inclusion in paragraph (b)), to all injuries, while continuing
to apply to an encephalopathy.
In this final rule, in addition to the changes described in the
proposed rule, the Secretary has made the following non-substantive
changes to the proposed rule for purposes of clarity:
a. Added headings to (c)(2)(ii) and (c)(3)(ii).
b. Moved text from the end of paragraph (c)(3)(ii)(C) to create a
new (c)(3)(ii)(D).
c. Changed paragraphs (c)(11) and (12) by revising the sentence
regarding organs other than the skin by adding ``the'' before ''
disease'', inserting ``and'' after ``organ'', and moving ``, not just
mildly abnormal laboratory values'' to the end of the sentence.
d. Revised paragraph (c)(15)(i) by changing ``nine weeks'' to ``9
weeks''.
e. Changed paragraph (e)(1) (``Coverage Provisions'') for purpose
of clarity and consistency with 42 U.S.C. 300aa-14(c)(4) by adding
``only'' before ``to petitions for compensation.''
The modified Table applies only to petitions filed under the VICP
after the effective date of this final rule. Also, petitions must be
filed within the applicable statute of limitations. The general statute
of limitations applicable to petitions filed under the VICP, set forth
in 42 U.S.C. 300aa-16(a),
[[Page 6296]]
continues to apply. However, the statute identifies a specific
exception to this statute of limitations that applies when the effect
of a revision to the Table makes a previously ineligible person
eligible to receive compensation or when an eligible person's
likelihood of obtaining compensation significantly increases. Under
this exception, an individual who may be eligible to file a petition
based on the revised Table may file the petition for compensation not
later than 2 years after the effective date of the revision if the
alleged injury or death occurred not more than 8 years before the
effective date of the revision of the Table (42 U.S.C. 300aa-16(b)).
This is true even if such individual previously filed a petition for
compensation, and is thus an exception to the ``one petition per
injury'' limitation of 42 U.S.C. 300aa-11(b)(2).
For any vaccine-adverse event pairs for which future scientific
evidence develops to support a finding of a causal relationship, the
Secretary will consider future rulemaking to revise the Table
accordingly.
III. Comments and Responses
The NPRM provided a 180-day comment period that resulted in the
receipt of 14 written comments--13 from individuals and one from a
national organization. In addition, a public hearing on the proposed
rule was held on January 14, 2016, during which a representative from
the above mentioned national organization presented comments. The
organization's oral comments were an expansion of the organization's
previously submitted written comments. The Secretary carefully
considered all received comments in the development of this final rule.
Below is a summary of the comments and the Secretary's responses:
Comment: One commenter suggested that vaccines are unsafe,
disagreed with the process for predicting vaccine harm to humans, and
disagreed with the makeup of the ``group assembled to force changes in
this Table,'' calling it a biased group.
Response: The United States has a long-standing vaccine safety
program that closely monitors the safety of vaccines on an ongoing
basis. Before vaccines are approved by the Food and Drug Administration
(FDA), they are tested and studied extensively by scientists to help
ensure they are safe and effective. After vaccines are approved, a
critical part of the vaccine safety program is that the Centers for
Disease Control and Prevention (CDC)'s Immunization Safety Office (ISO)
and FDA monitor for possible vaccine side effects and conduct studies
to determine whether health problems are caused by vaccines. CDC's ISO
data show that the current U.S. vaccine supply is the safest in
history.\1\ Also, regulating clinical research and reviewing the safety
of vaccines are responsibilities of the FDA, not the VICP, and changes
in vaccine research and how vaccines are studied and tested are beyond
the scope of this final rule.
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\1\ http://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html
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As previously indicated, the Table revisions were based primarily
on the 2012 IOM report which was developed after the IOM committee
conducted a comprehensive review of the scientific literature on
vaccines and adverse events. The committee charged with undertaking
this review consisted of 16 members with expertise in the following
fields: Pediatrics, internal medicine, neurology, immunology,
immunotoxicology, neurobiology, rheumatology, epidemiology,
biostatistics, and law. The members of the review committee were
subject to stringent conflict of interest criteria by the IOM. In
addition, the proposed Table changes were developed by HHS workgroups
and reviewed by the ACCV, the membership of which, by statute, reflects
a variety of stakeholders with different perspectives.
Comment: A commenter suggested that shoulder injury related to
vaccine administration (SIRVA) as defined in the QAI is too restrictive
because the recipient's pain and reduced range of motion must be
limited to the shoulder in which the intramuscular vaccine was
administered. The commenter stated that such language was an artificial
and unnecessary qualification, and expressed concern that recipients
who have other symptoms, such as shoulder pain radiating to the neck or
upper back, will not have the benefits of a Table injury. The commenter
suggested that the QAI be expanded to include the shoulder and parts of
the body attributed to that injury.
Response: SIRVA is a musculoskeletal condition caused by injection
of a vaccine intended for intramuscular administration into the
shoulder, and, as its name suggests, the condition is localized to the
shoulder in which the vaccine was administered. In other words, pain in
the neck or back without an injury to the shoulder in which an
individual received a vaccine would not be considered SIRVA. Shoulder
injuries that are not caused by injection occur frequently in the
population. Thus, it is important to have a definition of SIRVA that is
clearly associated with vaccine injection. The portion of the QAI
limiting the pain and reduced range of motion to the shoulder in which
the vaccine was administered is necessary to accurately reflect the
vaccine-associated condition.
Comment: A commenter recommends revising the statute of limitations
for filing complex cases, with additional consideration given to the
aggravation of preexisting conditions not active until post vaccine(s).
Response: Revision of the statute of limitations would require a
statutory amendment and thus is not within the scope of this final
rule.
Comment: A commenter stated that there is a problem with the VICP's
3-year statute of limitations for filing a claim and the military's 5-
year program titled, Temporary Disabled Retirement Listing (TDRL),
where active duty military personnel injured by vaccines are placed.
The commenter stated that the rules need to be amended and/or waivers
granted to military personnel who are severely injured by vaccines so
they can seek compensation for damages.
Response: Amending the Act's statute of limitations is not within
the scope of this final rule.
Comment: A commenter recommended the addition of SIRVA to the
vaccine court [sic]. The commenter also indicated a belief that SIRVA
is due to lack of education on proper injection technique. The
commenter further stated that the CDC should make SIRVA, which the
commenter believes is 100 percent preventable, a priority.
Response: This final rule will add SIRVA as an injury associated
with certain vaccines on the Table. In the VICP, claims are adjudicated
by special masters in the Court. SIRVA prevention activities are not
within the scope of this final rule.
Comment: A commenter recommended that the VICP transfer a fraction
of its compensation responsibilities to pharmaceutical companies, which
would incentivize these companies to develop safer vaccines to avoid
claim compensation.
Response: The source of funding for the VICP is the Vaccine Injury
Compensation Trust Fund (Trust Fund). The Trust Fund is funded by an
excise tax on each dose of vaccines recommended by the CDC for routine
administration to children. To the extent that the commenter is
proposing a change to the funding mechanism for the VICP, effectuating
such a change is beyond the scope of this final rule.
Comment: A commenter agreed with the Secretary's proposal that
SIRVA injuries be added to the Table for the
[[Page 6297]]
measles, mumps, and rubella (MMR) and varicella vaccines that are
currently administered only by percutaneous injection in case an
intramuscular injection is available in the future. The commenter
suggested that the Table make clear that SIRVA only pertains to
intramuscular injection so there is no confusion with respect to
vaccines administered using a different method. The commenter also
suggested that syncope be added as an injury for vaccines that are
administered by jet injectors. The commenter expressed support for the
revision of the Table based on new medical findings and for the
organizational changes to paragraph (b) of the Table.
Response: The Secretary agrees that SIRVA should be an injury
listed on the Table for potential future formulations of MMR and
varicella vaccines that are administered by intramuscular injection,
and, therefore, has added SIRVA to the Table for those vaccines despite
the fact that currently there are no MMR or varicella vaccines that are
administered by intramuscular injection. As such, if an intramuscular
formulation of those vaccines is developed in the future, the Table
will not need to be amended to allow petitioners to potentially meet
the definition for SIRVA in the QAI with respect to those vaccines. The
QAI specifically states that SIRVA is a condition related to
``administration of a vaccine intended for intramuscular administration
in the upper arm.'' Thus, the Secretary believes it is clear that to
meet the definition of SIRVA in the QAI, the vaccine administered must
be one intended for intramuscular injection in the upper arm.
The Secretary is not aware of any reliable and persuasive evidence
demonstrating that syncope occurs following administration of a vaccine
via a needleless jet device. While it may be plausible for syncope to
occur with this route of administration, given the lack of evidence of
syncope following administration of a vaccine via a needleless jet
device, the Secretary will not include syncope as a Table injury for
vaccines that are administered by a needleless jet device at this time.
However, this does not preclude a claim alleging syncope after the
administration of a vaccine via needleless jet device from being filed
with the program as a non-Table injury.
Comment: One commenter opposed the revision of the Vaccine Injury
Table's QAI for encephalopathy, stating that it is not based on sound
science and that it creates a restrictive and exclusionary guideline
that unfairly discriminates against children and adults born with
certain genes or pre-existing conditions (which may be triggered or
significantly aggravated following vaccination). The commenter further
contends that due to lack of knowledge about biological mechanisms and
high risk factors for vaccine injury, the proposed changes are without
ethical, scientific, or legal justification.
Response: The Secretary respectfully disagrees with the comment
that the revised definition for encephalopathy and the new definition
for encephalitis in the QAI are not based on firm science. The previous
definition of encephalopathy in the QAI was imprecise and did not
include the comprehensive criteria used by medical providers,
particularly specialists, to diagnose encephalopathy or encephalitis.
In addition, the previous QAI did not include any definition for
encephalitis, and, therefore, new and more accurate criteria and
definitions were necessary. To develop precise definitions for the QAI,
an extensive literature search was conducted for reliable, reputable,
evidence-based criteria consistently used by medical specialists in the
fields of infectious disease and neurology. The Secretary also
evaluated information from organizations and publications to formulate
definitions, including those responsible for publishing case
definitions for the Vaccine Adverse Event Reporting System (2002) and
other significant guidelines.
The commenter also stated that the proposed revisions create a
restrictive and exclusionary guideline, unfairly discriminating against
children and adults born with certain genes or pre-existing conditions
which may be triggered or significantly aggravated following
vaccination. The Secretary understands these concerns and agrees that
individuals should not be disqualified from potentially receiving VICP
compensation due to biodiversity and individual susceptibilities.
Certain individuals may not meet the QAI definition, as it is
impossible to develop a scientifically sound definition that allows for
inclusion of every circumstance, particularly those that may arise when
unique and sometimes complex pre-vaccination medical conditions
exist.\2\ However, individuals who do not meet the Table criteria are
not precluded from filing a petition, and may be found entitled to
receive compensation if they demonstrate that their condition was
caused or significantly aggravated by a covered vaccine.
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\2\ 2012 IOM Report, pp. 52, and 82-84.
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Comment: One commenter also noted that, historically, acute and
chronic encephalopathy have been acknowledged as a serious complication
of pertussis, measles and measles containing vaccines, and have been
reported following receipt of other vaccines.
Response: With regard to this comment, it is important to note that
the initial Table and QAI set forth in the 1986 Act reflected
Congress's initial determination of vaccine-related injuries for whole
cell diphtheria, tetanus, and pertussis (DTwP) vaccine, which is no
longer used. Additionally, modifications to the Table and QAI by the
Secretary in 1995 were based on scientific findings--the National
Childhood Encephalopathy Study and its 10-year follow-up study--related
to DTwP vaccine. The IOM committee's conclusions in both 1991 and 1994
were mixed regarding the statistically significant findings of
encephalopathy in these studies. After reviewing the evidence, the
National Vaccine Advisory Committee (NVAC) voted to remove
encephalopathy from the Table. However, in the end, the Secretary, for
both scientific and policy reasons, and with support of the ACCV,
retained the condition on the Table, but clarified the definition of
encephalopathy to make it more clinically precise.
While the initial Table and QAI were based on studies using DTwP
vaccine, the acellular (aP) diphtheria, tetanus, and pertussis (DTaP)
vaccine has been the primary formulation used in the United States
since 1997 when it was recommended for routine use in children younger
than 7 years of age. Current DTaP vaccines were developed because of
concerns of reactogenicity with whole cell pertussis.
To date, no adequate scientific study has been published that
demonstrates a causal relationship between either acellular pertussis
vaccines or MMR vaccines and encephalopathy or encephalitis. As a
result, in its most recent evaluation of adverse events after vaccines
(2012), the IOM found that the evidence was inadequate to accept or
reject a causal association between either acellular pertussis
containing vaccines or MMR vaccines and encephalopathy or encephalitis.
Of the large scale studies that have been conducted on DTaP, none have
shown an increased risk of encephalopathy or encephalitis after
receiving the DTaP vaccine. Furthermore, these studies have
demonstrated a significant reduction in the number of common adverse
events with acellular pertussis, such as crying and fevers, and less
common ones, such as febrile seizures.
[[Page 6298]]
With regard to the MMR vaccine, because natural infection of
measles, mumps and/or rubella virus is thought to lead to neurologic
illness by damaging neurons through direct viral infection and/or
reactivation, it is theorized that the same mechanisms may be
responsible for vaccine-associated encephalopathy and encephalitis.
However, of the studies examined and described by the IOM in its 2012
report, none identified causality between the MMR vaccine and
encephalopathy or encephalitis. Similarly, the IOM concluded that the
mechanistic evidence for an association is weak, based on knowledge
about natural infection and only a few case reports. Accordingly, the
Secretary does not agree that brain inflammation or acute and chronic
encephalopathy have been acknowledged as a serious complication of
either the DTaP or MMR vaccines. However, for the reasons discussed in
the NPRM, the Secretary chose to retain these conditions in the
revisions to the Table and QAI.
Comment: One commenter, when conveying views on acute
encephalopathy as ``one of the most serious complications of
vaccination . . .'' also referenced both encephalitis and
encephalomyelitis in the discussion.
Response: The Secretary would like to clarify that encephalitis and
encephalomyelitis (which is referred to as acute disseminated
encephalomyelitis or ADEM) are distinct conditions. While they share
some clinical characteristics, ADEM is a demyelinating condition with
distinct differences from other types of encephalitis, as demonstrated
on brain magnetic resonance imaging (MRI). The type of encephalitis
that was initially attributed to DTwP was not described as
demyelinating. Although early ADEM may have laboratory and clinical
characteristics similar to acute encephalitis, findings on an MRI are
distinct, with only ADEM displaying evidence of acute demyelination.
For scientific accuracy, we have excluded ADEM from the Table
definition of encephalitis.
Comment: One commenter, while applauding the expansion of the
Vaccine Injury Table and agreeing with the IOM's recommendations,
stated that the Table remains wholly inadequate to properly address
``the widespread epidemic of vaccine adverse events.'' The commenter
stated that the reason for this is that science has been corrupted by
commercial interests, by financial ties between industry, regulators,
and academic institutions and that health care delivery has been
compromised by financial ties between industry, physicians, and their
trade publications.
Response: The Secretary believes that the revisions to the Table
and QAI increase clarity and scientific accuracy regarding those
injuries that will be afforded the Table's presumption of vaccine
causation. As previously indicated, the revisions to the Table and QAI
were based primarily on the 2012 IOM report which was developed after
the IOM committee conducted a comprehensive review of the scientific
literature on vaccines and adverse events. The committee charged with
undertaking this review consisted of 16 members with expertise in the
following fields: pediatrics, internal medicine, neurology, immunology,
immunotoxicology, neurobiology, rheumatology, epidemiology,
biostatistics, and law. The members of the review committee were
subject to stringent conflict of interest criteria by the IOM. In
addition, the proposed Table changes were developed by HHS workgroups
and reviewed by the ACCV, the membership of which, by statute, reflects
a variety of stakeholders with different perspectives.
Comment: One commenter stated that the Secretary should not make
changes to the Vaccine Injury Table that would make it more difficult
for ``victims'' to be compensated.
Response: The Secretary believes that the revisions to the Table
and QAI set forth in this final rule, such as the addition of injuries,
will make it easier for petitioners alleging injuries that meet the
criteria in the Table and QAI to receive the Table's presumption of
causation (which relieves them of having to prove that the vaccine
actually caused or significantly aggravated the injury). This will make
it easier for such petitioners to receive compensation under the VICP.
Comment: One commenter asked that additional consideration be given
to the human papillomavirus (HPV) vaccination as a cause of postural
orthostatic tachycardia syndrome (POTS), a condition where individuals
can experience fainting and lightheadedness. The commenter also stated
that the ``review period'' should be indefinite for the HPV vaccine.
Response: Like all vaccines used in the United States, HPV vaccines
are required to go through years of safety testing before they are
approved by the FDA. After they are approved and made available to the
public, CDC and FDA continue to evaluate vaccines to ensure their
safety. To date, there is no medical or scientific evidence that the
HPV vaccine causes POTS and safety monitoring has not shown any other
problems. Extending the review period for alleged injuries due to the
HPV vaccine would require a statutory amendment to the Act's statute of
limitations which is not within the scope of the final rule.
Comment: A commenter requested that food allergies be added to the
Table asserting that food proteins that are present in vaccines cause
the development of food allergies. The commenter also requested removal
of the time limit that compensation is not provided for injuries or
death that occurred more than ``8 years before the effective date of
the revision of the Table'' because the commenter believes that ``food
proteins in vaccines have been causing injury for decades.''
Response: The Secretary does not agree that food allergies should
be added to the Table as injuries. HHS conducted a literature search of
the major medical databases for any articles linking the development of
food allergies to vaccinations (81 FR 17423, March 29, 2016). Despite
an extensive search, HHS found no published research addressing any
linkages or potential causality between vaccinations covered by VICP
and the development of food allergies in any population. In addition,
revision of the Act's statute of limitations would require a statutory
amendment and thus is not within the scope of this final rule.
Comment: One commenter suggested that autism spectrum disorders be
added to the Vaccine Injury Table. The commenter also requested removal
of the time limit that compensation not be provided for injuries or
death that occurred more than ``8 years before the effective date of
the revision of the Table'' because the commenter believes that
``bovine milk contaminated vaccines have been causing injury for
decades.''
Response: The Secretary does not agree that autism spectrum
disorders should be added as an injury to the Table. The 2012 IOM
report found that the epidemiologic and mechanistic evidence favored
rejection of a causal relationship between the MMR vaccine and autism.
Moreover, in opinions that were upheld on appeal to the U.S. Court of
Appeals for the Federal Circuit, special masters of the U.S. Court of
Federal Claims held that the MMR, whether administered alone or in
conjunction with thimerosal-containing vaccines, is not a causal factor
in the development of autism or autism spectrum disorders. In addition,
revision of the Act's statute of limitations would require a statutory
[[Page 6299]]
amendment and thus is not within the purview of this final rule.
Comment: One commenter stated that thimerosal (a preservative added
to vaccines) causes nerve damage.
Response: The Secretary disagrees with the comment that thimerosal
in vaccines causes nerve damage to immunized individuals. Currently, no
childhood vaccines used in the U.S. include thimerosal as a
preservative, except for some formulations of influenza vaccine in
multi-dose vials. When exposure to thimerosal occurs through
vaccination, it is at a very low dose, which is readily eliminated from
the body. Thimerosal has been used safely in vaccines since the 1930s.
According to the CDC, scientists have been studying the use of
thimerosal in vaccines for many years. They have not found any evidence
that thimerosal causes any harm. Thimerosal use in medical products has
a record of being very safe. Data from many studies show no evidence of
harm caused by low doses of thimerosal in vaccines.\3\
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\3\ Following are referenced thimerosal studies:
1. Thimerosal Exposure in Infants and Developmental Disorders: A
Retrospective Cohort Study in the United Kingdom Does Not Support a
Causal Association by Nick Andrews et al. Pediatrics. September
2004. Vol 114: pp. 584-591. http://pediatrics.aappublications.org/cgi/content/full/114/3/584.
2. Pervasive Developmental Disorders in Montreal, Quebec,
Canada: Prevalence and Links with Immunizations by Eric Frombonne et
al. Pediatriacs. July 2006. Vol 118: e139-e150. http://pediatrics.aappublications.org/cgi/content/full/118/1/e139.
3. Association between Thimerosal-Containing Vaccine and Autism
by Anders Hviid et al. Journal of the American Medical Association.
October 2003. Vol 290: pp. 1763-1766. http://jama.ama-assn.org/cgi/content/full/290/13/1763.
4. Immunization Safety Review: Vaccines and Autism. Institute of
Medicine. The National Academies Press: 2004. http://www.iom.edu/Reports/2004/Immunization-SafetyReview-Vaccines-and-Autism.aspx.
5. Prenatal and Infant Exposure to Thimerosal from Vaccines and
Immunoglobulins and Risk of Autism by Cristofer Price et al.
Pediatrics. September 2010. Vol 126: pp. 656-664, http://pediatrics.aappublications.org/cgi/reprint peds. 20100309v1.
6. Continuing Increases in Autism Reported to California's
Developmental Services System by Robert Schechter et al. Archives of
General Psychiatry. January 2008. Vol 65: pp. 19-24. http://archpsyc.ama-assn.org/cgi/content/full/65/1/19.
7. Early Thimerosal Exposure and Neuropsychological Outcomes at
7 to 10 Years by William Thompson et al. The New England Journal of
Medicine. September 2007. Vol 357: pages 1281-1292. http://www.nejm.org/doi/pdf/10.1056/NEJMoa071434.
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Economic and Regulatory Impact
Executive Order 12866 directs agencies to assess all costs and
benefits of available regulatory alternatives and, when rulemaking is
necessary, to select regulatory approaches that provide the greatest
net benefits (including potential economic, environmental, public
health, safety, distributive, and equity effects). In addition, under
the Regulatory Flexibility Act, if a rule has a significant economic
effect on a substantial number of small entities the Secretary must
specifically consider the economic effect of a rule on small entities
and analyze regulatory options that could lessen the impact of the
rule.
Executive Order 12866 requires that all regulations reflect
consideration of alternatives, costs, benefits, incentives, equity, and
available information. Regulations must meet certain standards, such as
avoiding an unnecessary burden. Regulations that 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.
The Secretary has determined that no resources are required to
implement the requirements in this rule. Compensation will be made in
the same manner. This final rule only lessens the burden of proof for
potential petitioners. Therefore, in accordance with the Regulatory
Flexibility Act of 1980 (RFA), and the Small Business Regulatory
Enforcement Act of 1996, which amended the RFA, the Secretary certifies
that this rule will not have a significant impact on a substantial
number of small entities.
The Secretary has also determined that this final rule does not
meet the criteria for a major rule as defined by Executive Order 12866
and would have no major effect on the economy or Federal expenditures.
We have determined that the final rule is not a ``major rule'' within
the meaning of the statute providing for Congressional Review of Agency
Rulemaking, 5 U.S.C. 801. Similarly, it will not have effects on State,
local, and tribal governments and on the private sector such as to
require consultation under the Unfunded Mandates Reform Act of 1995.
The provisions of this rule do not, on the basis of family well-
being, affect the following family elements: Family safety; family
stability; marital commitment; parental rights in the education,
nurture and supervision of their children; family functioning;
disposable income or poverty; or the behavior and personal
responsibility of youth, as determined under section 654(c) of the
Treasury and General Government Appropriations Act of 1999.
This rule is not being treated as a ``significant regulatory
action'' as defined under section 3(f) of Executive Order 12866.
Accordingly, the rule has not been reviewed by the Office of Management
and Budget.
As stated above, this final rule will modify the Vaccine Injury
Table and its Qualifications and Aids to Interpretation based on legal
authority.
Impact of the New Rule
This final rule will have the effect of making it easier for future
petitioners alleging injuries that meet the criteria in the Vaccine
Injury Table to receive the Table's presumption of causation (which
relieves them of having to prove that the vaccine actually caused or
significantly aggravated the injury).
Paperwork Reduction Act of 1995
This final rule has no information collection requirements.
Dated: January 6, 2017.
James Macrae,
Acting Administrator, Health Resources and Services Administration.
Approved: January 9, 2017.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, Immunization.
National Vaccine Injury Compensation Program: Revisions to the Vaccine
Injury Table
Therefore, for the reasons stated in the preamble, the Department
of Health and Human Services amends 42 CFR part 100 as follows:
PART 100--VACCINE INJURY COMPENSATION
0
1. The authority citation for 42 CFR part 100 continues to read as
follows:
Authority: Secs. 312 and 313 of Public Law 99-660 (42 U.S.C.
300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a);
and sec. 13632(a)(3) of Public Law 103-66.
0
2. Revise Sec. 100.3 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 Public Law 99-660, 100 Stat.
3779 (42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health
Service Act, as amended (PHS 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
[[Page 6300]]
injuries, disabilities, illnesses, conditions, and deaths is to occur
after vaccine administration for purposes of receiving compensation
under the Program. Paragraph (b) of this section sets forth additional
provisions that are not separately listed in this Table but that
constitute part of it. Paragraph (c) of this section sets forth the
qualifications and aids to interpretation for the terms used in the
Table. Conditions and injuries that do not meet the terms of the
qualifications and aids to interpretation are not within the Table.
Paragraph (d) of this section sets forth a glossary of terms used in
paragraph (c).
Vaccine Injury Table
------------------------------------------------------------------------
Time period for
first symptom or
Illness, manifestation of
disability, injury onset or of
Vaccine or condition significant
covered aggravation after
vaccine
administration
------------------------------------------------------------------------
I. Vaccines containing tetanus A. Anaphylaxis.... <=4 hours.
toxoid (e.g., DTaP, DTP, DT, B. Brachial 2-28 days (not
Td, or TT). Neuritis. less than 2 days
and not more than
28 days).
C. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
D. Vasovagal <=1 hour.
syncope.
II. Vaccines containing whole A. Anaphylaxis.... <=4 hours.
cell pertussis bacteria,
extracted or partial cell
pertussis bacteria, or specific
pertussis antigen(s) (e.g.,
DTP, DTaP, P, DTP-Hib).
B. Encephalopathy <=72 hours.
or encephalitis.
C. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
D. Vasovagal <=1 hour.
syncope.
III. Vaccines containing A. Anaphylaxis.... <=4 hours.
measles, mumps, and rubella B. Encephalopathy 5-15 days (not
virus or any of its components or encephalitis. less than 5 days
(e.g., MMR, MM, MMRV). and not more than
15 days).
C. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
D. Vasovagal <=1 hour.
syncope.
IV. Vaccines containing rubella A. Chronic 7-42 days (not
virus (e.g., MMR, MMRV). arthritis. less than 7 days
and not more than
42 days).
V. Vaccines containing measles A. 7-30 days (not
virus (e.g., MMR, MM, MMRV). Thrombocytopenic less than 7 days
purpura. and not more than
30 days).
B. Vaccine-Strain
Measles Viral
Disease in an
immunodeficient
recipient.
--Vaccine-strain Not applicable.
virus identified.
--If strain <=12 months.
determination is
not done or if
laboratory
testing is
inconclusive.
VI. Vaccines containing polio A. Paralytic Polio
live virus (OPV).
--in a non- <=30 days.
immunodeficient
recipient.
--in an <=6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
B. Vaccine-Strain
Polio Viral
Infection.
--in a non- <=30 days.
immunodeficient
recipient.
--in an <=6 months.
immunodeficient
recipient.
--in a vaccine Not applicable.
associated
community case.
VII. Vaccines containing polio A. Anaphylaxis.... <=4 hours.
inactivated virus (e.g., IPV).
B. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
C. Vasovagal <=1 hour.
syncope.
VIII. Hepatitis B vaccines...... A. Anaphylaxis.... <=4 hours.
B. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
C. Vasovagal <=1 hour.
syncope.
IX. Haemophilus influenzae type A. Shoulder Injury <=48 hours.
b (Hib) vaccines. Related to
Vaccine
Administration.
B. Vasovagal <=1 hour.
syncope.
X. Varicella vaccines........... A. Anaphylaxis.... <=4 hours.
B. Disseminated
varicella vaccine-
strain viral
disease.
--Vaccine-strain Not applicable.
virus identified.
--If strain 7-42 days (not
determination is less than 7 days
not done or if and not more than
laboratory 42 days).
testing is
inconclusive.
C. Varicella Not applicable.
vaccine-strain
viral
reactivation.
D. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
E. Vasovagal <=1 hour.
syncope.
XI. Rotavirus vaccines.......... A. Intussusception 1-21 days (not
less than 1 day
and not more than
21 days).
XII. Pneumococcal conjugate A. Shoulder Injury <=48 hours.
vaccines. Related to
Vaccine
Administration.
[[Page 6301]]
B. Vasovagal <=1 hour.
syncope.
XIII. Hepatitis A vaccines...... A. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
B. Vasovagal <=1 hour.
syncope.
XIV. Seasonal influenza vaccines A. Anaphylaxis.... <=4 hours.
B. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
C. Vasovagal <=1 hour.
syncope.
D. Guillain- 3-42 days (not
Barr[eacute] less than 3 days
Syndrome. and not more than
42 days).
XV. Meningococcal vaccines...... A. Anaphylaxis.... <=4 hours.
B. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
C. Vasovagal <=1 hour.
syncope.
XVI. Human papillomavirus (HPV) A. Anaphylaxis.... <=4 hours.
vaccines.
B. Shoulder Injury <=48 hours.
Related to
Vaccine
Administration.
C. Vasovagal <=1 hour.
syncope.
XVII. Any new vaccine A. Shoulder Injury <=48 hours.
recommended by the Centers for Related to
Disease Control and Prevention Vaccine
for routine administration to Administration.
children, after publication by
the Secretary of a notice of
coverage.
B. Vasovagal <=1hour.
syncope.
------------------------------------------------------------------------
(b) Provisions that apply to all conditions listed. (1) Any acute
complication or sequela, including death, of the illness, disability,
injury, or condition listed in paragraph (a) of this section (and
defined in paragraphs (c) and (d) of this section) qualifies as a Table
injury under paragraph (a) except when the definition in paragraph (c)
requires exclusion.
(2) In determining whether or not an injury is a condition set
forth in paragraph (a) of this section, the Court shall consider the
entire medical record.
(3) An idiopathic condition that meets the definition of an
illness, disability, injury, or condition set forth in paragraph (c) of
this section shall be considered to be a condition set forth in
paragraph (a) of this section.
(c) Qualifications and aids to interpretation. The following
qualifications and aids to interpretation shall apply to, define and
describe the scope of, and be read in conjunction with paragraphs (a),
(b), and (d) of this section:
(1) Anaphylaxis. Anaphylaxis is an acute, severe, and potentially
lethal systemic reaction that occurs as a single discrete event with
simultaneous involvement of two or more organ systems. Most cases
resolve without sequela. 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. There are no specific
pathological findings to confirm a diagnosis of anaphylaxis.
(2) Encephalopathy. A vaccine recipient shall be considered to have
suffered an encephalopathy if an injury meeting the description below
of an acute encephalopathy occurs within the applicable time period and
results in a chronic encephalopathy, as described in paragraph (d) of
this section.
(i) Acute encephalopathy. (A) For children less than 18 months of
age who present:
(1) Without a seizure, an acute encephalopathy is indicated by a
significantly decreased level of consciousness that lasts at least 24
hours.
(2) Following a seizure, an acute encephalopathy is demonstrated by
a significantly decreased level of consciousness that lasts at least 24
hours and cannot be attributed to a postictal state--from a seizure or
a medication.
(B) For adults and children 18 months of age or older, an acute
encephalopathy is one that persists at least 24 hours and is
characterized by at least two of the following:
(1) A significant change in mental status that is not medication
related (such as a confusional state, delirium, or 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) The following clinical features in themselves do not
demonstrate an acute encephalopathy or a significant change in either
mental status or level of consciousness: Sleepiness, irritability
(fussiness), high-pitched and unusual screaming, poor feeding,
persistent inconsolable crying, bulging fontanelle, or symptoms of
dementia.
(D) Seizures in themselves are not sufficient to constitute a
diagnosis of encephalopathy and in the absence of other evidence of an
acute encephalopathy seizures shall not be viewed as the first symptom
or manifestation of an acute encephalopathy.
(ii) Exclusionary criteria for encephalopathy. Regardless of
whether or not the specific cause of the underlying condition, systemic
disease, or acute event (including an infectious organism) is known, an
encephalopathy shall not be considered to be a condition set forth in
the Table if it is shown that the encephalopathy was caused by:
(A) An underlying condition or systemic disease shown to be
unrelated to the vaccine (such as malignancy, structural lesion,
psychiatric illness, dementia, genetic disorder, prenatal or
[[Page 6302]]
perinatal central nervous system (CNS) injury); or
(B) An acute event shown to be unrelated to the vaccine such as a
head trauma, stroke, transient ischemic attack, complicated migraine,
drug use (illicit or prescribed) or an infectious disease.
(3) Encephalitis. A vaccine recipient shall be considered to have
suffered encephalitis if an injury meeting the description below of
acute encephalitis occurs within the applicable time period and results
in a chronic encephalopathy, as described in paragraph (d) of this
section.
(i) Acute encephalitis. Encephalitis is indicated by evidence of
neurologic dysfunction, as described in paragraph (c)(3)(i)(A) of this
section, plus evidence of an inflammatory process in the brain, as
described in paragraph (c)(3)(i)(B) of this section.
(A) Evidence of neurologic dysfunction consists of either:
(1) One of the following neurologic findings referable to the CNS:
Focal cortical signs (such as aphasia, alexia, agraphia, cortical
blindness); cranial nerve abnormalities; visual field defects; abnormal
presence of primitive reflexes (such as Babinski's sign or sucking
reflex); or cerebellar dysfunction (such as ataxia, dysmetria, or
nystagmus); or
(2) An acute encephalopathy as set forth in paragraph (c)(2)(i) of
this section.
(B) Evidence of an inflammatory process in the brain (central
nervous system or CNS inflammation) must include cerebrospinal fluid
(CSF) pleocytosis (>5 white blood cells (WBC)/mm\3\ in children >2
months of age and adults; >15 WBC/mm3 in children <2 months of age); or
at least two of the following:
(1) Fever (temperature >= 100.4 degrees Fahrenheit);
(2) Electroencephalogram findings consistent with encephalitis,
such as diffuse or multifocal nonspecific background slowing and
periodic discharges; or
(3) Neuroimaging findings consistent with encephalitis, which
include, but are not limited to brain/spine magnetic resonance imaging
(MRI) displaying diffuse or multifocal areas of hyperintense signal on
T2-weighted, diffusion-weighted image, or fluid-attenuation inversion
recovery sequences.
(ii) Exclusionary criteria for encephalitis. Regardless of whether
or not the specific cause of the underlying condition, systemic
disease, or acute event (including an infectious organism) is known,
encephalitis shall not be considered to be a condition set forth in the
Table if it is shown that the encephalitis was caused by:
(A) An underlying malignancy that led to a paraneoplastic
encephalitis;
(B) An infectious disease associated with encephalitis, including a
bacterial, parasitic, fungal or viral illness (such as herpes viruses,
adenovirus, enterovirus, West Nile Virus, or human immunodeficiency
virus), which may be demonstrated by clinical signs and symptoms and
need not be confirmed by culture or serologic testing; or
(C) Acute disseminated encephalomyelitis (ADEM). Although early
ADEM may have laboratory and clinical characteristics similar to acute
encephalitis, findings on MRI are distinct with ADEM displaying
evidence of acute demyelination (scattered, focal, or multifocal areas
of inflammation and demyelination within cerebral subcortical and deep
cortical white matter; gray matter involvement may also be seen but is
a minor component); or
(D) Other conditions or abnormalities that would explain the
vaccine recipient's symptoms.
(4) Intussusception. (i) For purposes of paragraph (a) of this
section, intussusception means the invagination of a segment of
intestine into the next segment of intestine, resulting in bowel
obstruction, diminished arterial blood supply, and blockage of the
venous blood flow. This is characterized by a sudden onset of abdominal
pain that may be manifested by anguished crying, irritability,
vomiting, abdominal swelling, and/or passing of stools mixed with blood
and mucus.
(ii) For purposes of paragraph (a) of this section, the following
shall not be considered to be a Table intussusception:
(A) Onset that occurs with or after the third dose of a vaccine
containing rotavirus;
(B) Onset within 14 days after an infectious disease associated
with intussusception, including viral disease (such as those secondary
to non-enteric or enteric adenovirus, or other enteric viruses such as
Enterovirus), enteric bacteria (such as Campylobacter jejuni), or
enteric parasites (such as Ascaris lumbricoides), which may be
demonstrated by clinical signs and symptoms and need not be confirmed
by culture or serologic testing;
(C) Onset in a person with a preexisting condition identified as
the lead point for intussusception such as intestinal masses and cystic
structures (such as polyps, tumors, Meckel's diverticulum, lymphoma, or
duplication cysts);
(D) Onset in a person with abnormalities of the bowel, including
congenital anatomic abnormalities, anatomic changes after abdominal
surgery, and other anatomic bowel abnormalities caused by mucosal
hemorrhage, trauma, or abnormal intestinal blood vessels (such as
Henoch Scholein purpura, hematoma, or hemangioma); or
(E) Onset in a person with underlying conditions or systemic
diseases associated with intussusception (such as cystic fibrosis,
celiac disease, or Kawasaki disease).
(5) Chronic arthritis. Chronic arthritis is defined as persistent
joint swelling with at least two additional manifestations of warmth,
tenderness, pain with movement, or limited range of motion, lasting for
at least 6 months.
(i) Chronic arthritis may be found in a person with no history in
the 3 years prior to vaccination 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
between 7 and 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; and
(C) Medical documentation of an antibody response to the rubella
virus.
(ii) 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 idiopathic
arthritis, systemic lupus erythematosus, systemic sclerosis, mixed
connective tissue disease, polymyositis/determatomyositis,
fibromyalgia, 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, blood disorders, or arthralgia (joint pain), or joint
stiffness without swelling.
(6) Brachial neuritis. This term is defined as dysfunction limited
to the upper extremity nerve plexus (i.e., its trunks, divisions, or
cords). A deep, steady, often severe aching pain in the shoulder and
upper arm usually heralds onset of the condition. The pain is
[[Page 6303]]
typically followed in days or weeks by weakness in the affected upper
extremity muscle groups. Sensory loss may accompany the motor deficits,
but is generally a less notable clinical feature. Atrophy of the
affected muscles may occur. The neuritis, or plexopathy, may be present
on the same side or on the side opposite the injection. It is sometimes
bilateral, affecting both upper extremities. A vaccine recipient shall
be considered to have suffered brachial neuritis as a Table injury if
such recipient manifests all of the following:
(i) Pain in the affected arm and shoulder is a presenting symptom
and occurs within the specified time-frame;
(ii) Weakness;
(A) Clinical diagnosis in the absence of nerve conduction and
electromyographic studies requires weakness in muscles supplied by more
than one peripheral nerve.
(B) Nerve conduction studies (NCS) and electromyographic (EMG)
studies localizing the injury to the brachial plexus are required
before the diagnosis can be made if weakness is limited to muscles
supplied by a single peripheral nerve.
(iii) Motor, sensory, and reflex findings on physical examination
and the results of NCS and EMG studies, if performed, must be
consistent in confirming that dysfunction is attributable to the
brachial plexus; and
(iv) No other condition or abnormality is present that would
explain the vaccine recipient's symptoms.
(7) Thrombocytopenic purpura. This term is defined by the presence
of clinical manifestations, such as petechiae, significant bruising, or
spontaneous bleeding, and by a serum platelet count less than 50,000/
mm\3\ with normal red and white blood cell indices. Thrombocytopenic
purpura does not include cases of thrombocytopenia associated with
other causes such as hypersplenism, autoimmune disorders (including
alloantibodies from previous transfusions) myelodysplasias,
lymphoproliferative disorders, congenital thrombocytopenia or hemolytic
uremic syndrome. Thrombocytopenic purpura does not include cases of
immune (formerly called idiopathic) thrombocytopenic purpura that are
mediated, for example, by viral or fungal infections, toxins or drugs.
Thrombocytopenic purpura does not include cases of thrombocytopenia
associated with disseminated intravascular coagulation, as observed
with bacterial and viral infections. Viral infections include, for
example, those infections secondary to Epstein Barr virus,
cytomegalovirus, hepatitis A and B, human immunodeficiency virus,
adenovirus, and dengue virus. An antecedent viral infection may be
demonstrated by clinical signs and symptoms and need not be confirmed
by culture or serologic testing. However, if culture or serologic
testing is performed, and the viral illness is attributed to the
vaccine-strain measles virus, the presumption of causation will remain
in effect. Bone marrow examination, if performed, must reveal a normal
or an increased number of megakaryocytes in an otherwise normal marrow.
(8) Vaccine-strain measles viral disease. This term is defined as a
measles illness that involves the skin and/or another organ (such as
the brain or lungs). Measles virus must be isolated from the affected
organ or histopathologic findings characteristic for the disease must
be present. Measles viral strain determination may be performed by
methods such as polymerase chain reaction test and vaccine-specific
monoclonal antibody. If strain determination reveals wild-type measles
virus or another, non-vaccine-strain virus, the disease shall not be
considered to be a condition set forth in the Table. If strain
determination is not done or if the strain cannot be identified, onset
of illness in any organ must occur within 12 months after vaccination.
(9) Vaccine-strain polio viral infection. This term is defined as a
disease caused by poliovirus that is isolated from the affected tissue
and should be determined to be the vaccine-strain by oligonucleotide or
polymerase chain reaction. Isolation of poliovirus from the stool is
not sufficient to establish a tissue specific infection or disease
caused by vaccine-strain poliovirus.
(10) Shoulder injury related to vaccine administration (SIRVA).
SIRVA manifests as shoulder pain and limited range of motion occurring
after the administration of a vaccine intended for intramuscular
administration in the upper arm. These symptoms are thought to occur as
a result of unintended injection of vaccine antigen or trauma from the
needle into and around the underlying bursa of the shoulder resulting
in an inflammatory reaction. SIRVA is caused by an injury to the
musculoskeletal structures of the shoulder (e.g. tendons, ligaments,
bursae, etc.). SIRVA is not a neurological injury and abnormalities on
neurological examination or nerve conduction studies (NCS) and/or
electromyographic (EMG) studies would not support SIRVA as a diagnosis
(even if the condition causing the neurological abnormality is not
known). A vaccine recipient shall be considered to have suffered SIRVA
if such recipient manifests all of the following:
(i) No history of pain, inflammation or dysfunction of the affected
shoulder prior to intramuscular vaccine administration that would
explain the alleged signs, symptoms, examination findings, and/or
diagnostic studies occurring after vaccine injection;
(ii) Pain occurs within the specified time-frame;
(iii) Pain and reduced range of motion are limited to the shoulder
in which the intramuscular vaccine was administered; and
(iv) No other condition or abnormality is present that would
explain the patient's symptoms (e.g. NCS/EMG or clinical evidence of
radiculopathy, brachial neuritis, mononeuropathies, or any other
neuropathy).
(11) Disseminated varicella vaccine-strain viral disease.
Disseminated varicella vaccine-strain viral disease is defined as a
varicella illness that involves the skin beyond the dermatome in which
the vaccination was given and/or disease caused by vaccine-strain
varicella in another organ. For organs other than the skin, the disease
must be demonstrated in the involved organ and not just through mildly
abnormal laboratory values. If there is involvement of an organ beyond
the skin, and no virus was identified in that organ, the involvement of
all organs must occur as part of the same, discrete illness. If strain
determination reveals wild-type varicella virus or another, non-
vaccine-strain virus, the viral disease shall not be considered to be a
condition set forth in the Table. If strain determination is not done
or if the strain cannot be identified, onset of illness in any organ
must occur 7- 42 days after vaccination.
(12) Varicella vaccine-strain viral reactivation disease. Varicella
vaccine-strain viral reactivation disease is defined as the presence of
the rash of herpes zoster with or without concurrent disease in an
organ other than the skin. Zoster, or shingles, is a painful,
unilateral, pruritic rash appearing in one or more sensory dermatomes.
For organs other than the skin, the disease must be demonstrated in the
involved organ and not just through mildly abnormal laboratory values.
There must be laboratory confirmation that the vaccine-strain of the
varicella virus is present in the skin or in any other involved organ,
for example by oligonucleotide or polymerase chain reaction. If strain
determination reveals wild-type
[[Page 6304]]
varicella virus or another, non-vaccine-strain virus, the viral disease
shall not be considered to be a condition set forth in the Table.
(13) Vasovagal syncope. Vasovagal syncope (also sometimes called
neurocardiogenic syncope) means loss of consciousness (fainting) and
postural tone caused by a transient decrease in blood flow to the brain
occurring after the administration of an injected vaccine. Vasovagal
syncope is usually a benign condition but may result in falling and
injury with significant sequela. Vasovagal syncope may be preceded by
symptoms such as nausea, lightheadedness, diaphoresis, and/or pallor.
Vasovagal syncope may be associated with transient seizure-like
activity, but recovery of orientation and consciousness generally
occurs simultaneously with vasovagal syncope. Loss of consciousness
resulting from the following conditions will not be considered
vasovagal syncope: organic heart disease, cardiac arrhythmias,
transient ischemic attacks, hyperventilation, metabolic conditions,
neurological conditions, and seizures. Episodes of recurrent syncope
occurring after the applicable time period are not considered to be
sequela of an episode of syncope meeting the Table requirements.
(14) Immunodeficient recipient. Immunodeficient recipient is
defined as an individual with an identified defect in the immunological
system which impairs the body's ability to fight infections. The
identified defect may be due to an inherited disorder (such as severe
combined immunodeficiency resulting in absent T lymphocytes), or an
acquired disorder (such as acquired immunodeficiency syndrome resulting
from decreased CD4 cell counts). The identified defect must be
demonstrated in the medical records, either preceding or postdating
vaccination.
(15) Guillain-Barr[eacute] Syndrome (GBS). (i) GBS is an acute
monophasic peripheral neuropathy that encompasses a spectrum of four
clinicopathological subtypes described below. For each subtype of GBS,
the interval between the first appearance of symptoms and the nadir of
weakness is between 12 hours and 28 days. This is followed in all
subtypes by a clinical plateau with stabilization at the nadir of
symptoms, or subsequent improvement without significant relapse. Death
may occur without a clinical plateau. Treatment related fluctuations in
all subtypes of GBS can occur within 9 weeks of GBS symptom onset and
recurrence of symptoms after this time-frame would not be consistent
with GBS.
(ii) The most common subtype in North America and Europe,
comprising more than 90 percent of cases, is acute inflammatory
demyelinating polyneuropathy (AIDP), which has the pathologic and
electrodiagnostic features of focal demyelination of motor and sensory
peripheral nerves and nerve roots. Another subtype called acute motor
axonal neuropathy (AMAN) is generally seen in other parts of the world
and is predominated by axonal damage that primarily affects motor
nerves. AMAN lacks features of demyelination. Another less common
subtype of GBS includes acute motor and sensory neuropathy (AMSAN),
which is an axonal form of GBS that is similar to AMAN, but also
affects the sensory nerves and roots. AIDP, AMAN, and AMSAN are
typically characterized by symmetric motor flaccid weakness, sensory
abnormalities, and/or autonomic dysfunction caused by autoimmune damage
to peripheral nerves and nerve roots. The diagnosis of AIDP, AMAN, and
AMSAN requires:
(A) Bilateral flaccid limb weakness and decreased or absent deep
tendon reflexes in weak limbs;
(B) A monophasic illness pattern;
(C) An interval between onset and nadir of weakness between 12
hours and 28 days;
(D) Subsequent clinical plateau (the clinical plateau leads to
either stabilization at the nadir of symptoms, or subsequent
improvement without significant relapse; however, death may occur
without a clinical plateau); and,
(E) The absence of an identified more likely alternative diagnosis.
(iii) Fisher Syndrome (FS), also known as Miller Fisher Syndrome,
is a subtype of GBS characterized by ataxia, areflexia, and
ophthalmoplegia, and overlap between FS and AIDP may be seen with limb
weakness. The diagnosis of FS requires:
(A) Bilateral ophthalmoparesis;
(B) Bilateral reduced or absent tendon reflexes;
(C) Ataxia;
(D) The absence of limb weakness (the presence of limb weakness
suggests a diagnosis of AIDP, AMAN, or AMSAN);
(E) A monophasic illness pattern;
(F) An interval between onset and nadir of weakness between 12
hours and 28 days;
(G) Subsequent clinical plateau (the clinical plateau leads to
either
stabilization at the nadir of symptoms, or subsequent improvement
without significant relapse; however, death may occur without a
clinical plateau);
(H) No alteration in consciousness;
(I) No corticospinal track signs; and
(J) The absence of an identified more likely alternative diagnosis.
(iv) Evidence that is supportive, but not required, of a diagnosis
of all subtypes of GBS includes electrophysiologic findings consistent
with GBS or an elevation of cerebral spinal fluid (CSF) protein with a
total CSF white blood cell count below 50 cells per microliter. Both
CSF and electrophysiologic studies are frequently normal in the first
week of illness in otherwise typical cases of GBS.
(v) To qualify as any subtype of GBS, there must not be a more
likely alternative diagnosis for the weakness.
(vi) Exclusionary criteria for the diagnosis of all subtypes of GBS
include the ultimate diagnosis of any of the following conditions:
chronic immune demyelinating polyradiculopathy (CIDP), carcinomatous
meningitis, brain stem encephalitis (other than Bickerstaff brainstem
encephalitis), myelitis, spinal cord infarct, spinal cord compression,
anterior horn cell diseases such as polio or West Nile virus infection,
subacute inflammatory demyelinating polyradiculoneuropathy, multiple
sclerosis, cauda equina compression, metabolic conditions such as
hypermagnesemia or hypophosphatemia, tick paralysis, heavy metal
toxicity (such as arsenic, gold, or thallium), drug-induced neuropathy
(such as vincristine, platinum compounds, or nitrofurantoin),
porphyria, critical illness neuropathy, vasculitis, diphtheria,
myasthenia gravis, organophosphate poisoning, botulism, critical
illness myopathy, polymyositis, dermatomyositis, hypokalemia, or
hyperkalemia. The above list is not exhaustive.
(d) Glossary for purposes of paragraph (c) of this section--(1)
Chronic encephalopathy. (i) A chronic encephalopathy occurs when a
change in mental or neurologic status, first manifested during the
applicable Table time period as an acute encephalopathy or
encephalitis, persists for at least 6 months from the first symptom or
manifestation of onset or of significant aggravation of an acute
encephalopathy or encephalitis.
(ii) Individuals who return to their baseline neurologic state, as
confirmed by clinical findings, within less than 6 months from the
first symptom or manifestation of onset or of significant aggravation
of an acute encephalopathy or encephalitis 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 or encephalitis.
(2) Injected refers to the intramuscular, intradermal, or
[[Page 6305]]
subcutaneous needle administration of a vaccine.
(3) Sequela means a condition or event which was actually caused by
a condition listed in the Vaccine Injury Table.
(4) Significantly decreased level of consciousness is indicated by
the presence of one or more of the following clinical signs:
(i) Decreased or absent response to environment (responds, if at
all, only to loud voice or painful stimuli);
(ii) Decreased or absent eye contact (does not fix gaze upon family
members or other individuals); or
(iii) Inconsistent or absent responses to external stimuli (does
not recognize familiar people or things).
(5) Seizure includes myoclonic, generalized tonic-clonic (grand
mal), and simple and complex partial seizures, but not absence (petit
mal), or pseudo seizures. Jerking movements or staring episodes alone
are not necessarily an indication of seizure activity.
(e) Coverage provisions. (1) Except as provided in paragraph
(e)(2), (3), (4), (5), (6), (7), or (8) of this section, this section
applies only to petitions for compensation under the program filed with
the United States Court of Federal Claims on or after February 21,
2017.
(2) Hepatitis B, Hib, and varicella vaccines (Items VIII, IX, and X
of the Table) are included in the Table as of August 6, 1997.
(3) Rotavirus vaccines (Item XI of the Table) are included in the
Table as of October 22, 1998.
(4) Pneumococcal conjugate vaccines (Item XII of the Table) are
included in the Table as of December 18, 1999.
(5) Hepatitis A vaccines (Item XIII of the Table) are included on
the Table as of December 1, 2004.
(6) Trivalent influenza vaccines (Included in item XIV of the
Table) are included on the Table as of July 1, 2005. All other seasonal
influenza vaccines (Item XIV of the Table) are included on the Table as
of November 12, 2013.
(7) Meningococcal vaccines and human papillomavirus vaccines (Items
XV and XVI of the Table) are included on the Table as of February 1,
2007.
(8) Other new vaccines (Item XVII of the Table) will be included in
the Table as of the effective date of a tax enacted to provide funds
for compensation paid with respect to such vaccines. An amendment to
this section will be published in the Federal Register to announce the
effective date of such a tax.
[FR Doc. 2017-00701 Filed 1-18-17; 8:45 am]
BILLING CODE 4160-15-P