[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Rules and Regulations]
[Pages 6249-6268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01211]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
42 CFR Part 100
RIN 0906-AB24
National Vaccine Injury Compensation Program: Revisions to the
Vaccine Injury Table
AGENCY: Public Health Service, Health Resources and Services
Administration (``HRSA''), Department of Health and Human Services
(``HHS'' or the ``Department'').
ACTION: Final rule.
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SUMMARY: The Secretary finalizes the proposed rule to amend the Vaccine
Injury Table (Table) by regulation. This final rule will have effect
only for petitions for compensation under the National Vaccine Injury
Compensation Program (VICP) filed after this final rule become
effective. This final rule does not impact COVID-19 vaccines or PREP
Act immunity for Covered Persons (as defined in the PREP Act) who
manufacture, distribute, order, or administer COVID-19 vaccines.
DATES: This final rule is effective on February 22, 2021.
FOR FURTHER INFORMATION CONTACT: Please visit the National Vaccine
Injury Compensation Program's website, https://www.hrsa.gov/vaccinecompensation/, or contact Tamara Overby, Acting Director,
Division of Injury Compensation Programs, Healthcare Systems Bureau,
HRSA, Room 08N146B, 5600 Fishers Lane, Rockville, MD 20857; by email at
vaccinecompensation@hrsa.gov; or by telephone at (855) 266-2427.
SUPPLEMENTARY INFORMATION: This is a final rule by which HHS amends the
provisions of 42 CFR 100.3 by removing Shoulder Injury Related to
Vaccine Administration, vasovagal syncope, and Item XVII from the
Vaccine Injury Table.
I. Background and Purpose
Vaccination is one of the best ways to protect against potentially
harmful diseases that can be very serious, may require hospitalization,
or even be deadly. Almost all individuals who are vaccinated have no
serious reactions.\1\ Nonetheless, in the 1980s, Congress became
concerned that a small number of children who received immunizations
had serious reactions to them, and it was not always possible to
predict which children would have reactions, or what reactions they
would have.\2\ Claimants alleging vaccine-related injuries in civil
litigation encountered a time-consuming, expensive, and often
inadequate system.\3\ Moreover, increased litigation against vaccine
manufacturers resulted in difficulties in their ability to secure
affordable product liability insurance, stabilize vaccine prices and
supply, and enter the market.\4\
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\1\ National Vaccine Injury Compensation Program, Health
Resources & Servs. Admin., https://www.hrsa.gov/vaccine-compensation/index.html (last reviewed Jan. 2020).
\2\ H.R. Rep. No. 99-908, pt. 1, at 6 (1986). Even though in
rare instances individuals may have adverse reactions to vaccines,
the Centers for Disease Control and Prevention (CDC) recommends that
individuals be vaccinated against a wide range of illnesses and
diseases. See Recommended Vaccines by Age. Ctrs. for Disease Control
& Prevention, https://www.cdc.gov/vaccines/vpd/vaccines-age.html
(last reviewed Nov. 22, 2016).
\3\ H.R. Rep. No. 99-908, at 6.
\4\ See id. at 4-6.
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Therefore, Congress enacted the National Childhood Vaccine Injury
Act of 1986, title III of Public Law 99--660 (42 U.S.C. 300aa-1 et
seq.) (``Vaccine Act'' or ``the Act''), which established the National
Vaccine Injury Compensation Program (VICP). The objectives of the VICP
are to ensure an adequate supply of vaccines, stabilize vaccine costs,
and establish and maintain an accessible and efficient forum for
individuals found to be injured by certain vaccines to be federally
compensated. Petitions for compensation under the VICP are filed in the
United States Court of Federal Claims (Court), rather than the civil
tort system, with a copy served on the Secretary, who is the
Respondent. The U.S. Department of Justice (DOJ) represents HHS in
Court, and the Court, acting through judicial officers called Special
Masters, makes the final decision as to eligibility for, and the type
and 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 what is referred to as a ``Table injury.'' That is, a
petitioner may show that the vaccine recipient (1) received a vaccine
covered under the Act; (2) suffered an injury of the type enumerated in
the regulations at 42 CFR 100.3--the ``Vaccine Injury Table'' (Table)--
corresponding to the vaccination in question; and (3) that the onset of
such injury took place within the time period specified in the Table.
If so, the injury is presumed to have been caused by the vaccine, 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 unrelated to the vaccination
(see 42 U.S.C. 300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B), and 300aa-
14(a)).
42 U.S.C. 300aa-14(c) and (e) permit the Secretary to revise the
Table. The Table currently includes 17 vaccine categories, with 16
categories for specific vaccines, as well as the corresponding
illnesses, disabilities, injuries, or conditions covered, and the
requisite time period when the first symptom or manifestation of onset
or of significant aggravation after the vaccine administration must
begin to receive the Table's legal presumption of causation. The final
category of the Table, ``Item
[[Page 6250]]
XVII,'' includes ``[a]ny new vaccine recommended by the Centers for
Disease Control and Prevention for routine administration to children,
after publication by the Secretary of a notice of coverage.'' \5\ Two
injuries--Shoulder Injury Related to Vaccine Administration (SIRVA) and
vasovagal syncope--are listed as associated injuries for this category.
Through this general category, new vaccines recommended by the CDC for
routine administration to children and subject to an excise tax are
deemed covered under the VICP prior to being added to the Table as a
separate vaccine category through Federal rulemaking.
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\5\ 42 CFR 100.3(a).
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The Department previously issued a notice of proposed rulemaking
that proposed to remove SIRVA, vasovagal syncope, and Item XVII from
the Vaccine Injury Table found at 42 CFR 100.3. The Department did so
for the reasons set forth in the proposed rule.\6\
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\6\ See 85 FR 43794 (July 20, 2020) (``proposed rule'').
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Pursuant to the Vaccine Act, HHS provided the proposed revisions to
the Vaccine Table to the ACCV.\7\ The ACCV considered the proposed
changes set forth in the proposed rule on March 6, 2020 and May 18,
2020. Four members of the ACCV also held a workgroup meeting on April
3, 2020 to discuss the proposed changes. On July 16, 2020, the proposed
rule went on public display, with a comment period that ended on
January 12, 2021.\8\ On November 9, 2020, the Department held a public
hearing pursuant to 42 U.S.C. 300aa-14(c)(1) via teleconference to
discuss the proposed rule.\9\
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\7\ The Department first provided the proposed revisions to the
Table and requested recommendations and comments by the ACCV on or
about February 15, 2020.
\8\ National Vaccine Injury Compensation Program: Revisions to
the Vaccine Injury Table, 85 FR 43794 (July 20, 2020).
\9\ https://www.regulations.gov/document?D=HRSA-2020-0002-0373.
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The Department now finalizes the proposed rule to remove SIRVA and
vasovagal syncope from the Table found at 42 CFR 100.3(a) and to remove
the corresponding descriptions of those injuries--``Qualifications and
Aids to Interpretation'' (QAI)--from 42 CFR 100.3(c). This decision is
based upon a review of the relevant statutory provisions and the
scientific literature, as well as the Department's experience since
SIRVA and vasovagal syncope were added to the Table. The Department
also finalizes its proposal to remove Item XVII from the Table found at
42 CFR 100.3(a), because the Department has serious concerns that Item
XVII is contrary to applicable law, for the reasons set forth below.
The Department finalizes this final rule for the reasons set forth in
the proposed rule. This final rule does not impact COVID-19 vaccines or
PREP Act immunity for Covered Persons (as defined in the PREP Act) who
manufacture, distribute, order, or administer COVID-19 vaccines.
II. Discussion of, and Response to, Public Comments
What follows is a summary of the public comments the Department
received on the notice of proposed rulemaking for this rule, which had
a comment period that ended on January 12, 2021, and the comments
received at the public hearing on the proposed rule. The Department
received 763 comments on the proposed rule. Commenters included
patients, family and friends of patients, vaccine lawyers,
rehabilitation counselors, nurses, doctors, legal clinics, law firms,
law schools, biotech trade associations, pharmacist acclimations, drug
store associations, and non-profits. The majority of commenters made
statements in opposition to the proposed rule, although some commenters
supported the proposed rule.
The public hearing was conducted on November 9, 2020 from 10:00
a.m. till 3 p.m. via Adobe connect teleconference. 34 comments were
provided during the public hearing on the proposed rule. Commenters
included those who experienced SIRVA injuries, doctors, vaccine
lawyers, representatives from vaccine legal clinics, law professors,
representatives from biotechnical associations, and representatives
from vaccine information associations. All commenters who spoke at the
public hearing were in opposition to the proposed rule. Below are
summaries of the comments and the Department's responses.
Section I: Comments Regarding Vaccines in General
Comment: Many commenters expressed concerns over the safety of
vaccines in general. Some believe that all chemicals in vaccines are
harmful to the body and cause bone and organ deterioration. Some
believe that all vaccines should be stopped entirely. Others called for
a complete moratorium on vaccines until all negative side effects are
gone. Some commenters believe that vaccine and pharmaceutical companies
are evil and have bought the government to push unsafe vaccines. They
stress that vaccines are useless and unsafe and the very fact that the
VICP is in existence proves that vaccines are unsafe.
Response: Vaccines are one of the greatest success stories in
public health. Through use of vaccines, we have eradicated smallpox and
nearly eliminated wild polio virus. The number of people who experience
the devastating effects of preventable infectious diseases like
measles, diphtheria, and whooping cough is at an all-time low. The
United States has a long-standing vaccine safety program that closely
and constantly monitors the safety of vaccines. 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.\10\ 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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\10\ http://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html.
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Comment: Some commenters described bad reactions they, or their
children, personally experienced from a range of vaccines to argue that
there should be an end to mandated vaccines for children.
Response: The Department sympathizes with all those who have
experienced negative reactions to vaccines. Vaccination is one of the
best ways to protect against potentially harmful diseases that can be
very serious, may require hospitalization, or even be deadly. Almost
all individuals who are vaccinated have no serious reactions.\11\
Nonetheless, in the 1980s, Congress became concerned that a small
number of children who received immunizations had serious reactions to
them, and it was not always possible to predict which children would
have reactions, or what reactions they would have.\12\ Therefore,
Congress enacted the
[[Page 6251]]
National Childhood Vaccine Injury Act of 1986, title III of Public Law
99-660 (42 U.S.C. 300aa-1 et seq.) (Vaccine Act), which established the
National Vaccine Injury Compensation Program (VICP). The objectives of
the VICP are to ensure an adequate supply of vaccines, stabilize
vaccine costs, and establish and maintain an accessible and efficient
forum for individuals found to be injured by certain vaccines to be
federally compensated.
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\11\ National Vaccine Injury Compensation Program, Health
Resources & Servs. Admin., https://www.hrsa.gov/vaccine-compensation/index.html (last reviewed Jan. 2021).
\12\ H.R. Rep. No. 99-908, pt. 1, at 6 (1986). Even though in
rare instances individuals may have adverse reactions to vaccines,
the Centers for Disease Control and Prevention (CDC) recommends that
individuals be vaccinated against a wide range of illnesses and
diseases. See Recommended Vaccines by Age. Ctrs. for Disease Control
& Prevention, https://www.cdc.gov/vaccines/vpd/vaccines-age.html
(last reviewed Jan. 2021).
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While the federal government recommends that individuals be
vaccinated against a wide range of illnesses and diseases, it does not
mandate them. Each state decides which vaccines are required for
child's enrollment and attendance at a childcare facility or school in
that state. Vaccination requirements and allowable exemptions vary by
state.\13\
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\13\ More information about state vaccination requirements for
daycare and school entry can be found at https://www.cdc.gov/vaccines/imz-managers/laws/state-reqs.html (last reviewed Jan.
2021).
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Comment: Commenters believe that there should be no vaccines that
contain metals, formaldehyde, preservatives, fetal tissue, and other
potentially harmful ingredients to humans.
Response: That is beyond the scope of this final rule. For more
information on the contents of vaccines and their safety, please see
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/common-ingredients-us-licensed-vaccines.
Comment: Some commenters believe that vaccines are an attempt to
supersede their rights as parents, and this regulation should be
abandoned.
Response: The federal government is not trying to supersede
parent's rights. The purpose of vaccines are to eradicate diseases and
to reduce the number of people who experience the devastating effects
of preventable infectious diseases like measles, diphtheria, and
whooping cough. This regulation does not address parents' rights with
respect to their children.
Comment: A commenter expressed anger about the Gardasil HPV vaccine
causing injury and death.
Response: There is a safe and effective HPV vaccine that can
prevent the infections that most commonly cause cancer. Gardasil 9
(human papillomavirus 9-valent vaccine, recombinant; 9vHPV) was
approved by the FDA for use in 2014. The safety of Gardasil 9 was
studied in clinical trials with more than 15,000 participants before it
was licensed and continues to be monitored. Gardasil 9 protects against
9 types of cancer-causing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and
58. For more information on the HPV vaccine, side effects, and who
should and should not receive this vaccine, see https://www.cdc.gov/vaccinesafety/vaccines/hpv-vaccine.html.
Comment: Some commenters asked to make vaccines optional. They
believe that vaccines should not be mandated. Commenters believe that
all vaccines should be voluntary. Many commenters contended that they
are not. Many expressed a strong desire against being forced to get any
vaccine, specifically the COVID-19 vaccine.
Response: State laws establish vaccination requirements for school
children and some state healthcare workers. Revision of state laws and
requirements are not within the scope of this final rule.
Comment: Some commenters expressed concern that their jobs made it
mandatory to have vaccines. They believe that since their jobs make it
mandatory, all related injuries should be compensated by the
government.
Response: Employment requirements are beyond the scope of this
final rule.
Comment: Some commenters believe that all of the studies supporting
vaccines are biased and created out of fear of the ``vaccine lobby.''
Response: Vaccines are one of the greatest success stories in
public health. Through use of vaccines, we have eradicated smallpox and
nearly eliminated wild polio virus. The number of people who experience
the devastating effects of preventable infectious diseases like
measles, diphtheria, and whooping cough is at an all-time low. The
United States has a long-standing vaccine safety program that closely
and constantly monitors the safety of vaccines. 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.\14\ 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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\14\ http://www.cdc.gov/vaccin19esafety/ensuringsafety/history/index.html.
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Section II: COVID-19 Vaccine Comments
Comment: Some commenters expressed concern that the proposed rule
did not add the COVID-19 vaccine to the Table. Some commenters believe
that the Notice of Proposed Rulemaking would stop the automatic
addition of the COVID-19 vaccine to the Vaccine Injury Table. Some
believe the COVID-19 vaccine should be added to the Table to make the
general public feel better about taking the vaccine; they believe that
the change in the Table will increase fear of vaccination. Some
commenters believe that since the COVID-19 vaccine is not included on
the Table, it is unsafe. Others are concerned that the Government will
mandate the COVID-19 vaccine, and that the changes to the Table are an
attempt by the government to shield itself from any responsibility to
compensate for COVID-19 vaccine related injuries. Other commenters
asked if someone was injured by the COVID-19 vaccine, how would they be
compensated.
Response: This final rule has zero impact on inclusion of the
COVID-19 vaccine on the Table. The COVID-19 vaccine can separately be
added to the Table, but the Department needs to follow the process
specified in 42 U.S.C. 300aa-14(c)-(d) to do so. This includes that the
ACCV recommend that the COVID-19 vaccine be added, or opine on the
Department's recommendation to add the COVID-19 vaccine to the Table.
Prior to COVID-19 vaccines being added to the Table, injuries resulting
from these vaccines can be compensated under the Countermeasures Injury
Compensation Program (CICP).
The CICP is administered by the Health Resources and Services
Administration, within the Department of Health and Human Services.
Information about the CICP and filing a claim are available at the
toll-free number 1-855-266-2427 or the CICP's website, https://www.hrsa.gov/cicp/.
Comment: Commenters believe that it is suspicious that the
Administration is trying to remove injuries from the Table ``secretly''
during the COVID-19 pandemic. Other commenters suggested that the
Department should not remove SIRVA from the Table at a time when
millions more vaccines are being administered against COVID-19.
Response: The Department respectfully disagrees that injuries are
[[Page 6252]]
being removed from the Table ``secretly.'' The ACCV publicly discussed
the proposal on March 6, 2020 and May 18, 2020. Recordings of both
discussions are publicly available at https://www.hrsa.gov/advisory-committees/vaccines/meetings.html. The Department subsequently
published the Notice of Proposed Rulemaking in the Federal Register and
provided a 180-day public comment period. It also held a public hearing
on the proposed rule on November 9, 2020. The fact that the commenters
were able to comment on the proposed rule indicates that SIRVA and
vasovagal syncope are not being removed ``secretly.'' This final rule
has zero impact on the COVID-19 vaccine, which is not currently on the
Table. Those injured by the COVID-19 vaccine can recover from the CICP
if they satisfy the statutory and regulatory prerequisites.
Comment: A commenter expressed anger about the COVID-19 vaccine
altering the very DNA of its recipient.
Response: This comment is outside the scope of this rulemaking. The
Department notes, though, that COVID-19 mRNA vaccines do not affect or
interact with DNA in any way.\15\
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\15\ More information about how COVID-19 mRNA vaccines work can
be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html.
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Comment: Some commenters asked the Department to consider giving
people stimulus checks in exchange for receiving the COVID-19 vaccine.
Response: Whether to provide stimulus checks for receiving the
COVID-19 vaccine is outside the scope of this final rule.
Comment: One commenter asked the Department to reconsider removing
SIVRA and vasovagal syncope from the Table because nurses, and those on
the medical front line, need protection from liability, especially
considering the overwhelming year they have had due to the COVID-19
pandemic.
Response: The Department thanks front-line workers for the
tremendous work they have done over the past year. This final rule does
not impact PREP Act immunity for Covered Persons (as defined in the
PREP Act) who manufacture, distribute, order, or administer COVID-19
vaccines. Under the PREP Act and the Secretary's March 10, 2020 PREP
Act declaration, as amended, during the effective period of the
declaration, Covered Persons are immune from suit and liability (absent
willful misconduct) under Federal and State law with respect to all
claims for loss caused by, arising out of, relating to, or resulting
from the administration to or the use by an individual of a covered
countermeasure.\16\
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\16\ 42 U.S.C. 247d-6d; see also Fourth Amendment to the
Secretary's PREP Act Declaration, 85 FR79,190, 79,195 (Dec. 9,
2020).
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Section III: General Support for the Proposed Rule
Comment: Some commenters believe that there is no good rationale to
include adverse events that are due to the physical administration of
the vaccine rather than the effects of the contents. Commenters believe
keeping those events covered by the program actually waters down the
intent of the program and pulls away resources from the people who were
actually affected by the vaccines themselves.
Response: The Department agrees.
Comment: Some commenters believe that the high number of SIRVA and
vasovagal syncope cases submitted to the VICP has led to a falsely
elevated number of reported side effects and reinforcing the ``fear''
of receiving vaccines by those who may be uninformed.
Response: The Department agrees. Since the scientific literature
indicates that SIRVA and vasovagal syncope results from poor
vaccination technique and the act of injection, rather than the vaccine
components, removing SIRVA and vasovagal syncope from the Table would
more accurately reflect the number of reported side effects actually
caused by vaccine components. Such claims, which are not associated
with vaccines or their components, therefore erroneously suggest that
vaccines are less safe than they in fact are.
Comment: Some commenters believe that SIRVA and vasovagal syncope
cases submitted to the VICP has also has contributed to a delayed
process in awarding monies to those with valid claims related to the
vaccine itself.
Response: The Department agrees.
Comment: Some commenters believe the federal government is not the
place to lodge a complaint related to the administration of a vaccine.
The appropriate place to do this is through the traditional court
system or through practitioner licensing boards. They believe that
current use and the number of claims for shoulder injury in adults are
against the intent and spirit of the original law.
Response: The Department thanks the commenters for these comments.
It is the Department's belief that Congress intended for the Vaccine
Act's compensation system to be used for unavoidable injuries and
illnesses that cannot be predicted in advance and can occur without
fault. SIRVA and vasovagal syncope are generally not those types of
injuries or illnesses. With proper injection technique, SIRVA is likely
preventable. The scientific literature also suggests that those
administering vaccines can take steps to significantly reduce the
likelihood of vasovagal syncope.
Section IV: General Concerns
Comment: Many commenters believed that vaccine or pharmaceutical
companies should be solely liable for all negative side effects caused
by their vaccines. They called for the repeal of the laws which grant
vaccine manufactures immunity.
Response: The National Childhood Vaccine Injury Act of 1986 was
passed by Congress. To repeal the Act would require a statutory
amendment and thus is not within the scope of this final rule.
Comment: Some commenters fear that the proposed rule will disband
the entire VICP.
Response: This final rule is not disbanding the VICP. For the most
part, this final rule reverts to the status quo as of January 2017. The
one additional change, removing Item XVII, is being done because the
Secretary has serious concerns that Item XVII does not comport with
applicable law. All vaccines currently on the Table, and the vast
majority of injuries currently on the Table, will remain on the Table
after this final rule becomes effective.
Comment: Many commenters stated that the National Vaccine Injury
Compensation Program covers injuries caused not only by the contents of
the vaccine, but also the administration of the vaccine. They stated
that but for the vaccine, there would not be a faulty administration,
and there would not be a SIRVA injury. Many other commenters stated
that all injuries, whether caused by the contents of the vaccine or by
faulty administration of the vaccine, should be covered by the VICP.
Commenters stated that HHS incorrectly interpreted the Vaccine Act to
preclude claims involving ``negligence by the vaccine administrator.''
This commenter stated that contrary to the HHS interpretation of the
Act, legislative history shows that Congress expressly indicated that
it sought to broadly cover all injuries or death associated with
vaccine administrations.
Response: The Secretary respectfully disagrees with the comment
that whether or not SIRVA is caused by faulty administration the VICP
should cover the injuries. The Department has concluded that the
Vaccine Act should be read as not applying to cover injuries, like
SIRVA and vasovagal syncope, which involve negligence by the vaccine
[[Page 6253]]
administrator. The Vaccine Act is ambiguous in how it handles such
injuries, and in the Department's view there are strong reasons to
exclude them from coverage under the Act's compensation scheme.
The Act creates a compensation program ``for a vaccine-related
injury or death.'' 42 U.S.C. 300aa-11(a)(1). Under the Act, ``only . .
. a person who has sustained a vaccine-related injury or death'' can
recover. 42 U.S.C. 300aa-11(a)(9). The Act defines ``[v]accine-related
injury or death'' as ``an illness, injury, condition, or death
associated with one or more of the vaccines set forth in the Vaccine
Injury Table, except that the term does not include an illness, injury,
condition, or death associated with an adulterant or contaminant
intentionally added to such a vaccine.'' 42 U.S.C. 300aa-33(5)
(emphasis added); see also Dean v. HHS, No. 16-1245V, 2018 WL 3104388,
at * 9 (Fed. Cl. Spec. Mstr. May 29, 2018) (defining ``vaccine'' as
``any substance designed to be administered to a human being for the
prevention of 1 or more diseases'') (quoting 26 U.S.C. 4132(a)(2)).
Thus, the compensation program covers injuries ``associated with'' the
vaccine itself.
SIRVA is not a vaccine, and it is not an injury caused by a vaccine
antigen, but by administration of the vaccine by the health care
provider. The Department does not think the term ``associated with''
was meant to sweep in injuries caused by negligent administration of
the vaccine. Although the Act permits petitioners to recover for
Vaccine Table injuries without demonstrating causation in individual
cases, the term ``associated with'' nevertheless requires that the
injury, in general, be causally related to the vaccine itself. This is
clear both from dictionary definitions of ``associated,'' which means
``related, connected, or combined together'' (Merriam-Webster.com
Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/associated. Accessed 10 Jul. 2020), and from the text of the
Act itself, see, e.g., 42 U.S.C. 300aa-22(b)(1) (focusing on injuries
that ``resulted'' from vaccine side effects); 42 U.S.C. 300aa-
13(a)(1)(B) & (2)(B) (excluding ``trauma'' that has ``no known relation
to the vaccine involved'').
Importantly, in the key operative provisions discussed above, the
phrase ``associated with'' is linked to the vaccine itself, not to the
technique in administering the vaccine. See Decker v. Nw. Envtl. Def.
Ctr., 568 U.S. 597, 611 (2013) (in interpreting phrase ``associated
with industrial activity,'' the key consideration is the scope of
``industrial activity''; the ``statute does not foreclose a more
specific definition by the agency'' and ``a reasonable interpretation .
. . could . . . require the discharges to be related in a direct way to
operations at `an industrial plant' ''); Chevron, U.S.A., Inc. v. Nat.
Resources Def. Council, Inc., 467 U.S. 837, 861 (1984) (``[T]he meaning
of a word must be ascertained in the context of achieving particular
objectives, and the words associated with it may indicate that the true
meaning of the series is to convey a common idea.'').
That basic requirement is not met with SIRVA and vasovagal syncope.
While the act of being vaccinated may be a but-for cause of those
injuries, the injury is not associated with the vaccine itself because,
with proper administration technique, those injuries will not result
from the vaccine. Rather, SIRVA and vasovagal syncope result from the
use of improper--that is, negligent--administration technique.
There are several indicators in the language and structure of the
Vaccine Act that show it was not meant to cover negligent
administration of the vaccine.
First, as the Federal Circuit has explained, troubling issues arise
if the Act were to apply to ``negligence facially unrelated to the
vaccine's effects.'' Amendola v. Sec., Dept. of Health & Human Servs.,
989 F.2d 1180, 1187 (Fed. Cir. 1993). It could include, for example,
``the doctor's negligent dropping of an infant patient'' or use of
contaminated equipment. Id. at 1186-87. The better reading of the
statute is that it does not reach this far.
Second, the definition of vaccine-related injury carves out ``an
adulterant or contaminant intentionally added to such a vaccine. 42
U.S.C. 300aa-33(5) (emphasis added). By excluding from the definition
those injuries associated with an adulterant or contaminant
intentionally added to the vaccine, Congress indicated its intent to
permit suit only where the injury was caused by the components of the
vaccine itself, not individual fault. Relatedly, in the provisions
setting forth the standard for awarding compensation, Congress
specified that an award is not appropriate when injury was ``due to
factors unrelated to the administration of the vaccine,'' and further
defined that phrase to include ``trauma . . . which have no known
relation to the vaccine involved.'' 42 U.S.C. 300aa-13(a)(1)(B) &
(2)(B). In other words, Congress excluded compensation for injuries
that were not related ``to the vaccine involved.''
Third, the statutory scheme requires that the patient ``received a
vaccine set forth in the Vaccine Injury Table,'' 42 U.S.C. 300aa-
11(c)(1)(A), tying compensation to the receipt of a specific listed
vaccine. See 42 U.S.C. 300aa-11(c)(1)(C)(i) (speaking to an injury
aggravated ``in association with the vaccine referred to'' on the
Vaccine Injury Table); 42 U.S.C. 300aa-11(c)(1)(C)(ii)(I) (for
conditions not on the Vaccine Injury Table, allowing proof that the
condition ``was caused by a vaccine'' on the Table); 42 U.S.C. 300aa-
11(c)(1)(C)(ii)(II) (same). But negligent administration can occur
without regard to the specific vaccine and, as noted above, can
encompass anything from negligent needle placement to ``the doctor's
negligent dropping of an infant patient.'' Amendola, 989 F.2d at 1186-
87. Congress strongly signaled that it was focused on compensation for
harm caused by the vaccine by requiring that the Table list the
vaccines themselves and the types of injuries the vaccines themselves
would cause.
Fourth, in the provision preempting state tort liability, Congress
protected manufacturers from liability when the injury ``resulted from
side effects that were unavoidable even though the vaccine was properly
prepared . . .'' 42 U.S.C. 300aa-22(b)(1). This language shows Congress
wanted to preserve a state tort remedy for certain avoidable injuries,
such as those caused by negligent vaccine administration. Given that
the Vaccine Act seeks to replace state tort remedies for the injuries
it covers, this reinforces the conclusion that the Act does not reach
SIRVA and vasovagal syncope.
Fifth, Congress provided for health care providers who administer
vaccines to record detailed information about the vaccination,
including the date of administration; the manufacturer; the name of the
provider; and other identifying information. 42 U.S.C. 300aa-25. This
information is well suited to a program designed to compensate for
injuries associated with the vaccine itself, since it provides the key
details about the vaccine provided and when. But this reporting
requirement is woefully inadequate if the Program was designed to
compensate for negligence by the provider, which would require
maintaining careful records regarding the actual administration of the
vaccine.
In setting up the original Vaccine Injury Table, Congress
referenced conditions ``resulting from the administration of such
vaccines.'' 42 U.S.C. 300a-14(a). But this phrase was not designed to
define the scope of the program or the Table; instead, Congress
directed the Secretary to add conditions
[[Page 6254]]
to the Table if they were ``associated with such vaccines.'' 42 U.S.C.
300aa-14(e)(1)(B) & (2)(B). And it is telling that Congress included
nothing similar to SIRVA or other injuries caused by negligent vaccine
administration in the original Table, rather than injuries associated
with the vaccine components themselves. Finally, that Congress asked
the Secretary to ``make or assure improvements'' in the
``administration'' of vaccines, 42 U.S.C. 300aa-27(a)(2), among many
areas of improvement in the vaccination process, does not imply that
the compensation program covers negligent administration.
Perhaps for some or all of these reasons, state courts have found
that injuries arising from negligent administration of a vaccine are
not ``vaccine-related injuries'' under 42 U.S.C. 300aa-33(5), and
therefore are not preempted by the Vaccine Act. See, e.g., Neddeau v.
Rite Aid of Conn., 2015 WL 5133151, at *3 (Super. Ct. Conn. July 28,
2015) (state court action did not allege a ``vaccine-related'' injury
and therefore was not barred by the Vaccine Act, because plaintiff's
allegation that the administrator struck the needle too high was an
allegation that her injuries ``were caused by negligence in the
physical process of injecting the vaccine, not by the effects of the
vaccine''); Nwosu ex rel. Ibrahim v. Adler, 969 So. 2d 516, 519 (Ct.
App. Fla. 2007) (claim arising from a physician's negligent injection
of a vaccine was not a ``vaccine-related injury,'' and adding that
``[i]t is true that had the child not been vaccinated, she would not
have been injured. However, her injury as alleged, does not flow from
the inoculant injected into her body [so] it is not the type of injury
covered under the Act'').
The Table should only include injuries caused by a vaccine or its
components, not the manner in which the vaccine was administered. Thus,
a petitioner must have an injury or death ``associated'' with the
vaccine, not one resulting from poor injection technique or other
improper administration of the vaccine. The Department believes SIRVA
and vasovagal claims should not be included on the Table and cannot be
based on causation in fact, because they are not injuries associated
with vaccines or their components, nor are they unavoidable injuries or
illnesses that cannot be predicted in advance, or that can occur
without fault.
Comment: Some commenters asked that this final rule be postponed
until the new administration enters office, arguing that it is unfair
to change the VICP in the final days of President Trump's
administration.
Response: Past practice has often been to finalize rules that are
ready for finalization without waiting for the incoming Administration
to take office.\17\ This is consistent with the Department's desire to
as expeditiously as possible ensure the Table complies with applicable
law.
---------------------------------------------------------------------------
\17\ For example, fifty-six (56) new rules were finalized in the
final two (2) full days of the previous Administration. See Federal
Register, https://www.federalregister.gov/documents/search?conditions%5Bpublication_date%5D%5Bgte%5D=1%2F18%2F2017&conditions%5Bpublication_date%5D%5Blte%5D=1%2F20%2F2017&conditions%5Btype%5D%5B%5D=RULE.
---------------------------------------------------------------------------
Comment: Many commenters took issue with the Department's assertion
in the proposed rule that retaining SIRVA and vasovagal syncope
injuries on the Table will encourage frivolous petitions for
compensation and add to DOJ's caseload.
Response: The proposed rule explained in detail how DOJ's caseload
has increased since SIRVA and vasovagal syncope were added to the
Table. DOJ had informed the Department that, out of 2,214 SIRVA claims
filed since 2017, DOJ had identified 27 cases in which altered medical
records have been filed, some of which involved changes to the site of
vaccination.
Section V: SIRVA-Specific Comments
Comment: Many commenters stated that according to medical
literature, not all SIRVA is related to improper injection technique,
and some or all cases of SIRVA result from the antigen itself, not just
the needle placement in the bursa. These commenters stated that this
undermines the Department's justification for removing SIRVA from the
Vaccine Injury Table. They also state that HHS was incorrect to suggest
that ``there is nearly uniform agreement in the scientific community
that SIRVA is caused by improper vaccine administration, rather than by
the vaccine itself.'' Other commenters stated that since medical
literature is split on the cause of SIRVA, it should be left on the
table until further research can be done.
Response: There is nearly uniform agreement in the scientific
community that SIRVA is caused by improper vaccine administration,
rather than by the vaccine itself.\18\ Since the 2017 Final Rule was
promulgated, additional scientific research concluded that subdeltoid
or subacromial bursitis and other shoulder lesions are ``more likely to
be the consequence of a poor injection technique (site, angle, needle
size, and failure to take into account [a] patient's characteristics,
i.e., sex, body weight, and physical constitution),'' rather than
``antigens or adjuvants contained in the vaccines that would trigger an
immune or inflammatory response.'' \19\ The Department has not seen
compelling peer-reviewed publications, submitted either by the
commenters or otherwise, that calls into question this conclusion.
Indeed, SIRVA stands for shoulder injury related to vaccine
administration.
---------------------------------------------------------------------------
\18\ See Barnes MG, Ledford C, Hogan K. A ``needling'' problem:
shoulder injury related to vaccine administration. J Am Board Fam
Med. 2012 Nov-Dec;25(6):919-22; Cross GB, Moghaddas J, Buttery J,
Ayoub S, Korman TM. Don't aim too high: Avoiding shoulder injury
related to vaccine administration. Aust Fam Physician. 2016
May;45(5):303-6.
\19\ Mart[iacute]n Arias, K.H., Fadrique, R., S[aacute]inz Gil,
M., and Salgueiro-Vazquez, M.E., Risk of bursitis and other injuries
and dysfunctions of the shoulder following vaccinations, Vaccine,
2017;35:4870-4876. See also Bancsi A, Houle SKD, Grindrod KA.
Shoulder injury related to vaccine administration and other
injection site events. Can. Fam. Physician. 2019 Jan;65(1):40-42
(explaining that SIRVA ``is a preventable occurrence caused by the
injection of a vaccine into the shoulder capsule rather than the
deltoid muscle''); Macomb CV, Evans MO, Dockstater JE, Montgomery
JR, Beakes DE. Treating SIRVA Early With Corticosteroid Injections:
A Case Series. Mil Med. 2019 Oct 17 (noting that SIRVA does not
occur unless the vaccine is mistakenly given in the shoulder
capsule). Another recent study reviewed the Vaccine Adverse Event
Reporting System (VAERS) database from July 2010 to June 2017 for
reports of atypical shoulder pain and dysfunction following
injection of inactivated influenza vaccine (IIV). See B.F. Hibbs,
C.S. Ng, O. Museru et al., Reports of atypical shoulder pain and
dysfunction following inactivated influenza vaccine, Vaccine Adverse
Event Reporting System (VAERS), 2010-2017, Vaccine. The review found
that, of the 266 reports where contributing factors for the injury
were reported, 216 (81.2%) described the vaccination as being given
``too high'' on the arm. Other reports described improper or poor
administration technique (e.g., bone strikes, ``administered in
tendon''), uneven position between vaccinator and the patient (e.g.,
vaccinator standing while patient sitting), vaccination needle too
long, and others (e.g., difficulty injecting vaccine). A small
minority of reports also indicated the patient had a history of
thyroid dysfunction or diabetes. It is possible that certain
injuries characterized as SIRVA occur when an immunologically active
substance designed to trigger an inflammatory response (i.e., the
vaccine antigen) is injected into an area where the inflammatory
response can cause joint damage (i.e., the bursa or tendons) as
opposed to an area where the inflammatory response will not cause
joint damage or permanent harm (i.e., the deltoid muscle). Such
injuries are fairly characterized as resulting from the vaccination
technique, since they would not have occurred if the injection
occurred in the proper part of the body.
---------------------------------------------------------------------------
Comment: Many commenters wrote about their SIRVA injuries and
experiences with treatment and therapy. Many received or were in the
process of receiving compensation through the VICP. They stressed the
pain and suffering they went through due to a badly administered
vaccine and asked for SIRVA to remain on the Table. They believe they
deserve just compensation
[[Page 6255]]
for their SIRVA injury through the VICP. These commenters stressed that
the compensation is needed for treatments, pain and suffering, lost
wages, and to help cover expenses while they are unable to work. They
stressed that their SIRVA injuries make employment or career
advancement extremely difficult, and many could no longer work in their
chosen fields.
Response: The Department sympathizes with those who suffered an
injury, but it is the Department's belief that Congress intended for
the Vaccine Act's compensation system to be used for unavoidable
injuries and illnesses that cannot be predicted in advance and can
occur without fault. SIRVA is generally not that type of injury or
illness. Moreover, under this final rule, those with SIRVA injuries are
not barred from suing those who injured them in state court. Those
injured still have an opportunity to be compensated by the faulty
party.
Comment: Many commenters asked what their recourse for SIRVA
injuries would be if it is removed from the Table. Many other
commenters believe that removal of SIRVA from the Table will eliminate
any recourse for patients of improperly administered vaccines.
Response: Under this final rule, those with SIRVA injuries are not
barred from suing those who injured them in state court (or in federal
court if the requirements for diversity jurisdiction under 28 U.S.C.
1332 are satisfied).
Comment: Many commenters believe that vaccine administration by
poorly trained and minimally qualified staff is what leads to a high
number of SIRVA cases, so the Government should provide more training,
guidelines, and supervision of medical staff and companies that
administer vaccines. These commenters suggest mandating more vaccine
administration training and certification. Some suggested that funds
from the VICP should be set aside to train providers with the proper
technique of vaccine administration. They believe that unless there is
more regulation for continuous training on injection administration,
SIRVA should not be removed from the table.
Response: The Department agrees that SIRVA is caused by improper
vaccine administration. The Department is grateful for the many health
care professionals and pharmacists who improve public health by
vaccinating the American public, and does not believe they would
intentionally administer a vaccine in an improper manner, but the
Department also wants to incentivize those who administer vaccines to
do so properly. Doing so will improve public confidence in
vaccinations. Removing SIRVA from the Table further incentivizes
learning proper administration technique. The Department agrees that
proper vaccine administration is critical to ensure that vaccination is
safe and effective. CDC provides recommendations on vaccine
administration technique, many of which can be found at https://www.cdc.gov/vaccines/hcp/admin/admin-protocols.html.
Comment: Some commenters opposed removing SIRVA from the Table, but
stress that since the injury is caused by faulty administration, the
person administering the vaccine and causing the injury should be held
accountable.
Response: While the Department disagrees with the suggestion to
keep SIRVA on the Table, the Department understands the desire to hold
accountable those who cause injury by using faulty administration. If
those who administer vaccines can be held liable when a patient suffers
from SIRVA as a result of the administration of the vaccine, those who
administer vaccines will have greater incentive to use proper injection
technique. The Department is grateful for the many health care
professionals and pharmacists who improve public health by vaccinating
the American public, and does not believe they would intentionally
administer a vaccine in an improper manner, but awarding no-fault
compensation from the VICP to those with SIRVA and vasovagal syncope
claims lessens the incentive to take appropriate precautions. Since
Vaccine Act proceedings are generally sealed and not made available to
the public, vaccine administrators may be left unaware that they used
an improper technique. If SIRVA and vasovagal syncope are included in
the Table, petitioners will continue to seek to recover from the VICP,
where they can recover more easily because they need not prove
causation, rather than from those who failed to properly administer the
vaccine.
Comment: A commenter suggested increasing the VICP tax to help
cover all SIRVA injuries and support more administration training.
Response: The Department lacks the authority to increase the VICP
tax, and this is beyond the scope of this final rule.
Comment: Some commenters threatened that if SIRVA is removed from
the Table, they will wage a campaign to discourage the public at large
from receiving flu vaccines.
Response: Flu vaccines have a good safety record. Hundreds of
millions of Americans have safely received flu vaccines over the past
50 years, and there has been extensive research supporting the safety
of flu vaccines. A flu vaccine is the first and best way to reduce your
chances of getting the flu and spreading it to others. CDC recommends
that everyone 6 months of age and older receive a flu vaccine every
year. More information on the safety of flu vaccines can be found at
https://www.cdc.gov/flu/prevent/general.htm. The Department anticipates
that this final rule may result in fewer individuals suffering from
SIRVA or vasovagal syncope, because it will better incentivize those
administering vaccines to use proper injection technique.
Comment: Commenters believe the general public should be better
informed about the risk of SIRVA. Some suggestions included an ad
campaign, or informational pamphlets handed out before vaccine
injection. One commenter suggested that all patients should receive the
entire list of ingredients of all vaccines before they consent to the
vaccine.
Response: All healthcare providers (as defined in the Vaccine Act)
are required by the Vaccine Act (42 U.S.C. 300aa-26) to give the
appropriate VIS or Vaccine Information Statement to the patient (or
parent or legal representative) prior to every administration of
specific vaccines. A VIS or Vaccine Information Statement is a
document, produced by CDC, that informs vaccine recipients--or their
parents or legal representatives--about the benefits and risks of a
vaccine they are receiving. Such materials shall be revised ``(1) after
notice to the public and 60 days of comment thereon, and (2) in
consultation with the Advisory Commission on Childhood Vaccines,
appropriate health care providers and parent organizations, the Centers
for Disease Control and Prevention, and the Food and Drug
Administration.'' 42 U.S.C. 300aa-26(b). Since the aforementioned
statutory required steps were not taken prior to the proposed rule, the
commenter's suggestions are outside the scope of this final rule.
Further information about vaccine ingredients can be found at https://www.cdc.gov/vaccines/vac-gen/additives.htm.
Comment: Many commenters stress that HHS has drastically changed
its position since March 21, 2017 when it adopted the Final Rule adding
SIRVA to the Vaccine Injury Table. Commenters point to past
Departmental interpretations of SIRVA and vasovagal syncope, and the
inclusion of these injuries as covered under the VICP. They argue that
the Department does not have an adequate bases for changing
[[Page 6256]]
its interpretation of these injuries. Moreover, the Department has
concluded that there are strong policy reasons for now removing SIRVA
from the Table.
Response: As discussed above, it is the Department's belief that
vasovagal syncope is not a ``vaccine-related injury'' and therefore
should not be included on the Table or compensable under the VICP. 42
U.S.C. 300aa-11, 300aa-14(e), and the inclusion of the injury in 2017
was incorrect.
Comment: Many commenters believe that SIRVA should remain on the
table because ``No evidence has been presented by DHHS justifying the
removal of these injuries.''
Response: The scientific literature indicates that SIRVA likely
results from poor vaccination technique, rather than the vaccine or its
components alone. The notice of proposed rulemaking that preceded the
Final Rule characterized SIRVA as an ``adverse event following
vaccination thought to be related to the technique of intramuscular
percutaneous injection (the procedure where access to a muscle is
obtained by using a needle to puncture the skin) into an arm resulting
in trauma from the needle and/or the unintentional injection of a
vaccine into tissues and structures lying underneath the deltoid muscle
of the shoulder.'' \20\ The IOM similarly concluded that ``the
injection, and not the contents of the vaccine, contributed to the
development of deltoid bursitis.'' \21\ Indeed, the primary case series
relied upon by the Department in promulgating the proposed rule and
Final Rule found that the medical literature supports the possibility
that SIRVA may result from inappropriate needle length and/or injection
technique.\22\ There is nearly uniform agreement in the scientific
community that SIRVA is caused by improper vaccine administration,
rather than by the vaccine itself.\23\ Since the Final Rule was
promulgated, additional scientific research concluded that subdeltoid
or subacromial bursitis and other shoulder lesions are ``more likely to
be the consequence of a poor injection technique (site, angle, needle
size, and failure to take into account [a] patient's characteristics,
i.e., sex, body weight, and physical constitution),'' rather than
``antigens or adjuvants contained in the vaccines that would trigger an
immune or inflammatory response.'' \24\
---------------------------------------------------------------------------
\20\ National Vaccine Injury Compensation: Revision to the
Vaccine Injury Table (``2015 Proposed Rule''), 80 FR 45132, 45136
(July 29, 2015) (emphasis supplied); see also Adverse Effects of
Vaccines: Evidence and Causality (``IOM Report''), at 620, available
at https://www.nap.edu/catalog/13164/adverse-effects-of-vaccines-evidence-and-causality.
\21\ IOM Report at 620. SIRVA is a medicolegal term, not a
medical diagnosis, that is meant to capture a broad array of
potential shoulder injuries. However the IOM only made findings
concerning deltoid bursitis.
\22\ Atanasoff S, Ryan T, Lightfoot R, and Johann Liang R, 2010,
Shoulder injury related to vaccine administration (SIRVA), Vaccine
28(51): 8049-52 (recommending that injections avoid the top third of
the deltoid muscle to avoid shoulder injury).
\23\ See Barnes MG, Ledford C, Hogan K. A ``needling'' problem:
Shoulder injury related to vaccine administration. J Am Board Fam
Med. 2012 Nov-Dec; 25(6):919-22; Cross GB, Moghaddas J, Buttery J,
Ayoub S, Korman TM. Don't aim too high: Avoiding shoulder injury
related to vaccine administration. Aust Fam Physician. 2016 May;
45(5):303-6.
\24\ Mart[iacute]n Arias, K.H., Fadrique, R., S[aacute]inz Gil,
M., and Salgueiro-Vazquez, M.E., Risk of bursitis and other injuries
and dysfunctions of the shoulder following vaccinations, Vaccine,
2017; 35: 4870-4876. See also Bancsi A, Houle SKD, Grindrod KA.
Shoulder injury related to vaccine administration and other
injection site events. Can. Fam. Physician. 2019 Jan; 65(1): 40-42
(explaining that SIRVA ``is a preventable occurrence caused by the
injection of a vaccine into the shoulder capsule rather than the
deltoid muscle''); Macomb CV, Evans MO, Dockstater JE, Montgomery
JR, Beakes DE. Treating SIRVA Early With Corticosteroid Injections:
A Case Series. Mil Med. 2019 Oct 17 (noting that SIRVA does not
occur unless the vaccine is mistakenly given in the shoulder
capsule). Another recent study reviewed the Vaccine Adverse Event
Reporting System (VAERS) database from July 2010 to June 2017 for
reports of atypical shoulder pain and dysfunction following
injection of inactivated influenza vaccine (IIV). See B.F. Hibbs,
C.S. Ng, O. Museru et al., Reports of atypical shoulder pain and
dysfunction following inactivated influenza vaccine, Vaccine Adverse
Event Reporting System (VAERS), 2010-2017, Vaccine. The review found
that, of the 266 reports where contributing factors for the injury
were reported, 216 (81.2%) described the vaccination as being given
``too high'' on the arm. Other reports described improper or poor
administration technique (e.g., bone strikes, ``administered in
tendon''), uneven position between vaccinator and the patient (e.g.,
vaccinator standing while patient sitting), vaccination needle too
long, and others (e.g., difficulty injecting vaccine). A small
minority of reports also indicated the patient had a history of
thyroid dysfunction or diabetes. It is possible that certain
injuries characterized as SIRVA occur when an immunologically active
substance designed to trigger an inflammatory response (i.e., the
vaccine antigen) is injected into an area where the inflammatory
response can cause joint damage (i.e., the bursa or tendons) as
opposed to an area where the inflammatory response will not cause
joint damage or permanent harm (i.e., the deltoid muscle). Such
injuries are fairly characterized as resulting from the vaccination
technique, since they would not have occurred if the injection
occurred in the proper part of the body.
---------------------------------------------------------------------------
Comment: Some commenters stated that HHS's justification for
removing SIRVA from the VICP does not comport with best available
science, because, although HHS correctly states that SIRVA and syncope
are considered to be adverse injuries following direct trauma from an
injection point, ``negligent administration'' and ``poor vaccination
technique'' are not exclusively connected with the onset of SIRVA and
syncope-related injuries. Commenters stated that the agency did not
consider that serious injuries may occur following the onset of SIRVA
or a syncope-related event.
Response: It is possible that serious injuries may occur following
the onset of SIRVA or a syncope-related event, but the scientific
literature suggests such injuries generally result from the act of
injection, rather than the vaccine or its components. That negligent
administration or poor vaccination technique may also be connected with
other injuries does not change the Department's conclusions.
Comment: Some commenters stated that SIRVA injuries are not as rare
as the Department states. They state that due to lack of information,
many SIRVA injuries are not recognized or reported.
Response: The Department did not state that SIRVA injuries are
rare.
Comment: Some commenters argue that medical literature supports
that SIRVA alone cannot result from negligent administration of a
vaccine, because these injuries are a combination of both (1) the
needle placed into the subacromial bursa and (2) the vaccine components
that are needed to cause the immune response, resulting in SIRVA.
Response: It is possible that certain injuries characterized as
SIRVA occur when an immunologically active substance designed to
trigger an inflammatory response (i.e., the vaccine antigen) is
injected into an area where the inflammatory response can cause joint
damage (i.e., the bursa or tendons) as opposed to an area where the
inflammatory response will not cause joint damage or permanent harm
(i.e., the deltoid muscle). Such injuries are fairly characterized as
resulting from the vaccination technique, since they would not have
occurred if the injection occurred in the proper part of the body.
Section VI: Vasovagal Syncope Specific Concerns
Comment: Some commenters shared their negative experiences with
vasovagal syncope. One commenter said he was left alone after receiving
a vaccine, which resulted in severe injuries to his face and causing
him to need extensive medical treatment. He stated that the VICP is the
only recourse to financial compensation for pain and suffering, since
Texas malpractice laws make it difficult to obtain compensation.
Response: The Department sympathizes with those who suffered an
injury, but it is the Department's belief that Congress intended for
the Vaccine Act's compensation system to be used for unavoidable
injuries and illnesses
[[Page 6257]]
that cannot be predicted in advance and can occur without fault.
Vasovagal syncope is generally not that type of injury or illness.
Scientific and medical literature support the conclusion that syncope
may be caused by the act of vaccination, but not its contents.\25\
Texas state malpractice laws are beyond the scope of this final rule.
---------------------------------------------------------------------------
\25\ 80 FR 45,137 (The IOM found that one case report suggested
that ``the injection, and not the contents of the vaccine,
contributed to the development of syncope''). See also IOM Report at
18 (``injection of vaccine, independent of the antigen involved, can
lead to'' syncope); Miller, E. and Woo, E.J. Time to prevent
injuries from postimmunization syncope, Nursing, 2006 36 (12): 20.
---------------------------------------------------------------------------
Comment: Some commenters stated that contrary to the Department's
position that vasovagal syncope is not a vaccine-related injury, the
IOM found ``sufficient mechanistic evidence supporting the conclusion
that syncope is `directly related to vaccine administration,' '' and
that the CDC has reported people fainting after receiving nearly all
vaccines. While the commenters agree that steps can be taken to reduce
the risk of syncope, they state that it should remain on the Injury
Table.
Response: The IOM found insufficient epidemiologic evidence of an
association between the injection of a vaccine and syncope, but it
found sufficient mechanistic evidence supporting the conclusion that
syncope is ``directly related to vaccine administration.'' \26\ The IOM
explained that evidence it examined as part of its review suggested
``that the injection, and not the contents of the vaccine, contributed
to the development of syncope.'' \27\ In addition, because syncope is
an injury related solely to the injection of a vaccine, the Department
did not add syncope to the 2017 revisions to the Table as an injury for
vaccines that are not administered by injection, such as oral polio and
rotavirus vaccine.
---------------------------------------------------------------------------
\26\ 80 FR 45137.
\27\ 80 FR 45137. See also IOM Report.
---------------------------------------------------------------------------
Comment: One commenter stated that removing syncope from the table
would go against three decades of precedent and the weight of the
medical evidence.
Response: The Department respectfully disagrees. Vasovagal syncope
was not added to the Table until 2017. From the inception of the Table
until 2017, vasovagal syncope is not included.
Section VII: Comments Regarding Item VII
Comment: Some commenters are concerned that removing Item XVII from
the Table will remove an avenue to add new vaccines to the Table.
Response: The Department is removing Item XVII from the table
because it has serious concerns that Item XVII is contrary to law,
including the procedures described in the Vaccine Act for amending the
Table. Specifically, to the extent that Item XVII provides a unilateral
mechanism for adding injuries and vaccines to the Table, it may be
inconsistent with the Vaccine Act. The Vaccine Act provides a method
for adding new vaccines to the Table, and it is far from clear that the
approach in Item XVII complies with that method. The Vaccine Act
provides that the Secretary may promulgate regulations to modify the
Table, but in doing so, he ``shall provide for notice and opportunity
for a public hearing and at least 180 days of public comment.'' \28\
Moreover, the Table cannot be revised unless ``the Secretary has first
provided to the [ACCV] a copy of the proposed regulation or revision,
requested recommendations and comments by the [ACCV], and afforded the
[ACCV] at least 90 days to make such recommendations.'' \29\ Item XVII,
by contrast, suggests that vaccines are added to the Table once the CDC
recommends them for routine administration to children and an excise
tax is imposed, even prior to notice and public comment or comments
from the ACCV.\30\ This may be inconsistent with the rulemaking
requirements of the Administrative Procedure Act 5 U.S.C. 553, the
Regulatory Flexibility Act, 5 U.S.C. 601 et seq., various Executive
Orders that cabin rulemaking (see, e.g., Executive Order 12866), and
the Vaccine Act.
---------------------------------------------------------------------------
\28\ 42 U.S.C. 300aa-14(c)(1).
\29\ 42 U.S.C. 300aa-14(d).
\30\ The language in Item XVII also raises Constitutional
concerns. Item XVII in effect allows CDC to add vaccines to the
Table so long as the Secretary publishes notice of coverage. The
Office of Legal Counsel has previously opined that a statute that
sought to authorize the CDC director to take certain action
unilaterally was inconsistent with the Executive Powers Clause.
(Statute Limiting The President's Authority To Supervise The
Director Of The Centers For Disease Control In The Distribution Of
An AIDS Pamphlet, 12 U.S. Op. Off. Legal Counsel 47, 48, 1988 WL
390999, at * 1). For the same reasons, it is not clear that the CDC
director, as an inferior officer, has the authority to unilaterally
add vaccines to the Table without the approval of the Secretary.
---------------------------------------------------------------------------
Moreover, even with the removal of Item XVII, new vaccines may be
added to the Table under 42 U.S.C. 300aa-14(d), when appropriate.
Comment: One commenter stated that HHS's argument that Item XVII is
unlawful is without merit. Article I of the Constitution provides
Congress the authority to delegate responsibilities to independent
agencies, and the Vaccine Act expressly provides that HHS shall amend
the Vaccine Injury Table to include any CDC vaccine recommended for
routine childhood use within two years. According to this commenter,
Congress provided the CDC with an autonomous role in the VICP process,
and its recommendations are separate from administrative action by HHS.
Therefore, commenters stated that Item XVII is lawful.
Response: The Vaccine Act provides that the Secretary may
promulgate regulations to modify the Table, but in doing so, he ``shall
provide for notice and opportunity for a public hearing and at least
180 days of public comment.'' \31\ Moreover, the Table cannot be
revised unless ``the Secretary has first provided to the [ACCV] a copy
of the proposed regulation or revision, requested recommendations and
comments by the [ACCV], and afforded the [ACCV] at least 90 days to
make such recommendations.'' \32\ Item XVII, by contrast, suggests that
vaccines are added to the Table once the CDC recommends them for
routine administration to children and an excise tax is imposed, even
prior to notice and public comment or comments from the ACCV.
---------------------------------------------------------------------------
\31\ 42 U.S.C. 300aa-14(c)(1).
\32\ 42 U.S.C. 300aa-14(d).
---------------------------------------------------------------------------
Comment: One commenter stated that Item XVII does have merit,
especially because it streamlines the process to allow for quicker
inclusions of important vaccines. This commenter stated that this is
especially important and timely due to the impact of the COVID-19
pandemic and the need to provide quick compensation for COVID-19
vaccine-related injuries or deaths. Removing Item XVII would just
frustrate the stated purpose of the Vaccine Act.
Response: The Department appreciates the desire to quickly add
vaccines to the Table. However Congress in 42 U.S.C. 300aa-14 specified
the procedures that must be followed to amend the Table. In addition,
an excise tax would have to be imposed.
Comment: A few commenters opposed the removal of the mechanism to
add vaccines to the Table under item XVII. According to the commenters,
the proposed rule would stop the automatic addition of COVID-19 and
other new vaccines to the VICP, which could potentially delay or
permanently prevent the COVID-19 vaccine from being covered under the
VICP, and subjecting administrators to lawsuits in the future.
Commenters suggested that
[[Page 6258]]
this policy change is seemingly at odds with the actions undertaken by
HHS to expand liability protections for administrators under
authorities granted in the PREP Act.
Response: The Department appreciates the desire to quickly add
vaccines to the Table. However Congress in 42 U.S.C. 300aa-14 specified
the procedures that must be followed to amend the Table. In addition,
an excise tax would have to be imposed. During the effective period of
the Secretary's COVID-19 PREP Act declaration, Covered Persons are
already immune from suit and liability under Federal and State law with
respect to all claims for loss caused by, arising out of, relating to,
or resulting from the administration to or the use by an individual of
FDA-approved or FDA-licensed COVID-19 vaccines (unless they engage in
willful misconduct that causes death or serious physical injury). See
42 U.S.C. 247d-6d.
Section VIII: Miscellaneous Comments
Comment: A commenter asked that the license for the Hepatitis B
Vaccine be revoked until further safety studies are done.
Response: This is beyond the scope of this final rule. For more
information on the safety of this vaccine, see https://www.cdc.gov/hepatitis/hbv/bfaq.htm#bFAQd04; https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-b.html.
Comment: Some commenters believe that all vaccines should be
automatically added to the VICP. Other commenters asked for specific
vaccines to be added to the Table immediately.
Response: In 42 U.S.C. 300aa-14(c)-(d), Congress specified
procedures that the Department must follow to add vaccines to the
Table. In revising the Table, the Department must follow these
procedures. The Department notes, though, that if a vaccine is in a
category of vaccines that is already covered by the VICP, then the new
vaccine product is already covered even before the date of licensure.
For example, hepatitis B vaccines are covered under the Program under
Category VIII of the Vaccine Injury Table. If a new hepatitis B vaccine
is licensed in the U.S., it is already automatically covered under the
VICP. Adding specific vaccines to the Table in this final rule is
likely impermissible under the Administrative Procedure Act and the
logical outgrowth doctrine. Such vaccines could be added in a separate
rulemaking.
Comment: Many commenters stressed that vaccines should be changed
so they do not need to be administered with a shot.
Response: This is beyond the scope of this final rule.
Comment: Some commenters believed that any and all mandatory
vaccines should be covered. Specifically, a commenter expressed her
anger over a ``mandatory'' TD shot to travel out of the country.
Response: There are no vaccination requirements for visitors to the
United States, and U.S. residents traveling abroad do not need any
vaccines to reenter the United States. Many vaccines are recommend by
the CDC and primary care doctors when travelling outside the United
States, but they are not mandatory under federal law.\33\
---------------------------------------------------------------------------
\33\ For more information on Vaccines recommended for
international travel: https://wwwnc.cdc.gov/travel/destinations/
traveler/none/united-
states#:~:text=There%20are%20no%20vaccination%20requirements,reenter%
20the%20United%20States. (last viewed Jan. 2021).
---------------------------------------------------------------------------
Comment: One commenter said it was unfair that the Table does not
include heart conditions, because they were diagnosed with Pericarditis
24 hours after receiving the DMMR vaccine.
Response: To gain entitlement to compensation under the VICP, 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 what is referred to as a ``Table injury.'' That is, a
petitioner may show that the vaccine recipient (1) received a vaccine
covered under the Act; (2) suffered an injury of the type enumerated in
the regulations at 42 CFR 100.3--the ``Table''--corresponding to the
vaccination in question; and (3) that the onset of such injury took
place within the time period specified in the Table. If so, the injury
is presumed to have been caused by the vaccine, 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 unrelated to the vaccination (see 42 U.S.C.
300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B), and 300aa-14(a)). Whether to
add heart conditions to the Table is beyond the scope of this final
rule.
Comment: A commenter expressed concern that CDC guidelines for
vaccine administration are not followed, which is leading to SIRVA and
vasovagal syncope. Some commenters believe that pharmacies should not
be allowed to administer vaccines if injuries such as SIRVA and
Vasovagal Syncope are occurring.
Response: The Department is grateful for the many health care
professionals and pharmacists who improve public health by vaccinating
the American public, and does not believe they would intentionally
administer a vaccine in an improper manner, but the Department also
wants to incentivize those who administer vaccines to do so properly.
Doing so will improve public confidence in vaccinations. Removing SIRVA
from the Table further incentivizes learning proper administration
technique. The Department agrees that proper vaccine administration is
critical to ensure that vaccination is safe and effective. CDC provides
recommendations on vaccine administration technique, many of which can
be found at https://www.cdc.gov/vaccines/hcp/admin/admin-protocols.html. Whether pharmacists should be allowed to vaccinate is
beyond the scope of this final rule.
Comment: One commenter believed that instead of removing SIRVA and
vasovagal syncope from the Table, a new department should be created to
deal exclusively with injuries caused by vaccine administration.
Response: Only Congress, not the Department, has the authority to
create a new department to deal exclusively with injuries caused by
vaccine administration.
Comment: One commenter suggested that vaccine companies should be
mandated to set apart part of their profits to help fund the National
Vaccine Injury Compensation Program (VICP).
Response: The source of funding for the VICP is the Vaccine Injury
Compensation Trust Fund (Trust Fund). The Trust Fund is already 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: Some commenters believed that all those injured should be
able to go to their local court and file claims.
Response: Under 42 U.S.C. 300aa-11(a)(2), no person may bring a
civil action for damages in an amount greater than $1,000 or in an
unspecified amount against a vaccine administrator or manufacturer in a
State or Federal court for damages arising from a vaccine-related
injury or death associated with the administration of a vaccine after
October 1, 1988, and no such court may award damages in an amount
greater than $1,000 in a civil action for damages for such a vaccine-
related injury or
[[Page 6259]]
death, unless the person has first filed a petition in the Court. This
is mandated by statute, and the Department does not have the authority
to change this.
Comment: Some commenters believe that removing SIRVA and Vasovagal
syncope will result in burdensome and time consuming litigation that is
unfair to those injured since they would have to provide evidentiary
support in state court. They also believe that the claims will clog up
federal, state, and local courts. Other commenters suggested that
removing these injuries from the VICP will lead to claim suppression
because many individuals will not have the resources to pursue their
claims in court.
Response: It is the Department's position that if SIRVA and
vasovagal syncope were removed from the Table, individuals could still
file SIRVA and vasovagal syncope claims in state court, or Federal
district court if they satisfy the requirements of 28 U.S.C. 1332 or 28
U.S.C. 1367. Once in those court, petitioners would be required to
prove causation between the manner of administration and the claimed
injury.
Further, this final rule is unlikely to unduly burden the civil
tort system. The Department conducted a search in the WestLaw legal
database for cases in state court that contained both the terms
``SIRVA'' and ``vaccine,'' and found only 20 hits, at least two of
which were cases involving an entity named SIRVA and not the injury. It
is possible that some additional cases were filed in federal district
court. Nonetheless, the Department believes based on this data that any
additional burden on the civil tort system, which would be dispersed
across States and not concentrated in any one or few States, from
removing SIRVA and vasovagal syncope from the Table and reverting to
the status quo as of January 2017 will be minimal.
Comment: Some commenters worry that removing SIRVA and vasovagal
syncope from the Table will result in doctors and pharmacists being
unwilling to administer vaccines because they fear personal liability.
Response: The Department is grateful for the many health care
professionals and pharmacists who improve public health by vaccinating
the American public, and does not believe they would intentionally
administer a vaccine in an improper manner, but the Department also
wants to incentivize those who administer vaccines to do so
properly.\34\ Doing so will improve public confidence in vaccinations.
Many physicians and pharmacists were willing to administer vaccines
prior to SIRVA and vasovagal syncope's addition to the Table in 2017.
In addition, certain pharmacists are already immune from suit and
liability for claims for loss caused by, arising out of, relating to,
or resulting from the administration of certain childhood vaccines to
individuals ages three through 18 for the duration of the Secretary's
Declaration Under the Public Readiness and Emergency Preparedness Act
for Medical Countermeasures Against COVID-19.\35\
---------------------------------------------------------------------------
\34\ See Frakes, M., & Jena, A.B. (2016). Does Medical
Malpractice Law Improve Health Care Quality?. Journal of public
economics, 143, 142-158. https://doi.org/10.1016/j.jpubeco.2016.09.002 (Finding ``evidence suggesting that treatment
quality may improve upon reforms that expect physicians to adhere to
higher quality clinical standard'').
\35\ See 85 FR 52,136, 52140 (Aug. 24, 2020).
---------------------------------------------------------------------------
Comment: Commenters suggest that the tax on flu vaccines that
sustain the VICP fund should be returned to the doctors, pharmacists,
and other vaccine administrators so that individuals injured by
administration can sue the provider directly.
Response: The source of funding for the VICP is the 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: Some commenters asked that all time limits for injuries be
removed from the VICP.
Response: Revision of the statute of limitations would require a
statutory amendment and thus is not within the scope of this final
rule.
Comment: Many commenters wrote about their personal negative
reactions to vaccine components.
Response: These comments are outside the scope of this rulemaking,
since the scientific literature indicates that SIRVA and vasovagal
syncope results from poor vaccination technique and the act of
injection, rather than the vaccine components.
Comment: Some commenters asked that vaccine injury reporting be
significantly improved to reflect all injuries caused by vaccine
components. Some asked that reporting to the Vaccine Adverse Event
Reporting System (VAERS) be mandatory. A commenter referenced the
Harvard Pilgrim Health Care report which found that less than 1 percent
of vaccine adverse events are reported.
Response: This final rule concerns the VICP, which is distinct from
the Vaccine Adverse Event Reporting System. As such, these comments are
outside the scope of this final rule.
Comment: Two commenters opposed removing SIRVA from the Table
because they stated that they have seen compensation greatly help those
injured by providing resources for rehab treatment.
Response: The Department sympathizes with those who suffered an
injury, but it is the Department's belief that Congress intended for
the Vaccine Act's compensation system to be used for unavoidable
injuries and illnesses that cannot be predicted in advance and can
occur without fault. SIRVA is generally not that type of injury or
illness. Moreover, under this final rule, those with SIRVA injuries are
not barred from suing those who injured them in state court. Those
injured still have an opportunity to be compensated.
Comment: Many commenters believe that the proposed rule changes are
contrary to the legislative intent behind the creation of the vaccine
injury compensation program, namely providing fair and prompt
compensation to those individuals that have suffered well recognized
injuries related to certain vaccines whilst shielding the
pharmaceutical and medical industries from significant exposure.
Response: The Department explained in the proposed rule \36\ and
elsewhere herein why this final rule is consistent with Congressional
intent.
---------------------------------------------------------------------------
\36\ See 85 FR 43,796-43,797.
---------------------------------------------------------------------------
Comment: Some commenters stated that it was the intention of
Congress to centralize claims for compensation out of hundreds of tort
venues to a centralized administrative compensation system, and
removing SIRVA and vasovagal syncope is contrary to that congressional
intent.
Response: The Department explained in the proposed rule \37\ and
elsewhere herein why this final rule is consistent with Congressional
intent. SIRVA and vasovagal syncope are not the sorts of injuries that
Congress intended for inclusion in the Table.
---------------------------------------------------------------------------
\37\ See 85 FR 43,796-43,797.
---------------------------------------------------------------------------
Comment: Many commenters believe that the proposed rule change will
result in exposing pharmaceutical companies to liability and will
inadvertently ``chill'' vaccine production.
Response: For the most part, this final rule merely reverts to the
status quo as of January 2017. In fact, the vaccination rate has gone
down slightly since SIRVA and vasovagal syncope were added to
[[Page 6260]]
the Table,\38\ so it seems unlikely that this final rule will ``chill''
vaccine production.
---------------------------------------------------------------------------
\38\ See, e.g., https://www.cdc.gov/flu/fluvaxview/coverage-1718estimates.htm; https://www.cdc.gov/nchs/data/hus/2018/031.pdf.
---------------------------------------------------------------------------
Comment: Many commenters stated that there is no data supporting
the Department's position that the trust fund is running out of money.
These commenters state that without this data, HHS should not change
the Vaccine Injury Table.
Response: SIRVA claims are diminishing the Trust Fund.\39\ The
Department did not state that the Trust Fund is running out of money.
The Department is finalizing this final rule for a combination of legal
and policy reasons explained herein and in the proposed rule, not
solely because any particular claims are diminishing the Trust Fund.
---------------------------------------------------------------------------
\39\ 85 FR 43,798.
---------------------------------------------------------------------------
Comment: Many commenters do not believe that reducing the caseload
of the VICP is a plausible justification to change the Injury Table.
Others believe that the VICP should just hire more people to help
process the caseload.
Response: The Department is finalizing this final rule for a
combination of legal and policy reasons explained herein and in the
proposed rule, not solely because of caseload concerns.
Comment: Some commenters stated that limiting VICP claims would be
harmful to families because if individuals and their families are
inadequately compensated for injuries or death, they can be
economically harmed. These costs could also be passed on to taxpayers
when injured individuals and their families are forced to resort to
extreme measures such as filing for bankruptcy.
Response: If SIRVA and vasovagal syncope were removed from the
Table, individuals could still file SIRVA and vasovagal syncope claims
in state court.\40\
---------------------------------------------------------------------------
\40\ Or Federal district court if they satisfy the requirements
of 28 U.S.C. 1332 or 28 U.S.C. 1367.
---------------------------------------------------------------------------
Comment: Some commenters stated that HHS's interpretation of
Section 300aa-11(a)(2)(A) of the Vaccine Act is flawed because it
interprets ``associated with the vaccine'' to mean that the injury must
come from the vaccine itself instead of from the administration of the
vaccine. The Department relies on a dictionary definition of
``associated with'' to conclude that it means ``related, connected, or
combined together,'' but does not explain why this definition
forecloses cases in which the vaccine ``combine[s] together'' with its
administration to bring about the illness. Furthermore, the phrase
``associated with the administration of the vaccine'' is not qualified.
Congress could have said ``associated with the non-negligent
administration of the vaccine'' or ``associated with the proper
administration of the vaccine.'' Commenters suggested that if (as HHS
states in the proposed rule) Congress intended to cover only those
injuries associated with some ``antigen,'' then lawmakers would have
used that word somewhere in the Act.
Commenters stated that according to the tort law principles in
which the Vaccine Act is grounded, ``legal cause'' often implicates the
combined effects of two or more forces, each constituting a substantial
factor in bringing about the harm, and imposes liability upon each
person or thing responsible for those forces. Therefore, consistent
with tort law principles, a SIRVA claimant can be found to have
``sustained a vaccine-related injury'' when a third party's negligent
administration of the vaccine acts concurrently with the contents of
needle, i.e., the vaccine, which combined effect is in turn a
substantial factor in bringing about the petitioner's harm. The
commenter stated that this is consistent with the definition of
``associated with.''
Response: Cases where the vaccine ``combine[s] together'' with its
administration to bring about the illness are fairly characterized as
resulting from the administration technique, since they would not have
occurred if the administration were proper. The fact that Congress
could have said ``non-negligent'' administration of the vaccine or
``associated with the ``proper'' administration of the vaccine'' does
not call into question the Department's careful examination of, and
analysis of, the relevant statutory terms, which is informed by the
Department's expertise in this subject matter.
Comment: Some commenters disagree with the Department's reasoning
that ``associated with'' does not include injuries caused by negligent
administration of the vaccine. They point to 42 U.S.C. 30aa-11 which
they contend specifically provides for ``administration'' of the
vaccine. They state that the Act refers to ``administration of the
vaccine'' 17 times. Other commenters list prior interpretation of the
act to be inconsistent with the Department's ``new'' interpretation.
Response: The Vaccine Act does in certain places refer to
``administration of'' or the ``administrator'' of the vaccine. But the
Department thinks that those usages were not meant to suggest the
Program covers negligence in the administration of the vaccine, but
served other purposes. At most, these usages render the statute
ambiguous with respect to needle injuries. In Section 300aa-
11(a)(2)(A), the statute precludes suits against ``a vaccine
administrator,'' but this reference does not define the scope of the
compensation program--instead, it protects administrators from suits
``arising from a vaccine-related injury or death associated with the
administration of a vaccine.'' This language is not entirely clear, as
it appears to impose two distinct qualifications that both must be met
but are worded slightly differently. It may be a belt and suspenders
approach to ensure that vaccine administrators are protected from tort
claims like in Amendola, where the vaccine itself was properly
administered and caused the injury, but the petitioner alleged the
administrator was negligent in deciding to give the vaccine. See 989
F.2d at 1186 (holding Vaccine Program does not exclude cases of
``negligence in deciding, for example, whether to administer an
otherwise satisfactory vaccine''). The important point is that the
first qualification--``arising from a vaccine-related injury''--is also
included here and, Congress defined this requirement to include only
injuries associated with the vaccine itself. See also 42 U.S.C. 300aa-
11(b)(1)(A) (referencing individuals who ``died as the result of the
administration of a vaccine'' but only if the individual sustained a
``vaccine-related injury''). In setting up the original Vaccine Injury
Table, Congress referenced conditions ``resulting from the
administration of such vaccines.'' 42 U.S.C. 300a-14(a). But this
phrase was not designed to define the scope of the program or the
Table; instead, Congress directed the Secretary to add conditions to
the Table if they were ``associated with such vaccines.'' 42 U.S.C.
300aa-14(e)(1)(B) & (2)(B). And it is telling that Congress included
nothing similar to SIRVA or other injuries caused by negligent vaccine
administration in the original Table, rather than injuries associated
with the vaccine components themselves. Finally, that Congress asked
the Secretary to ``make or assure improvements'' in the
``administration'' of vaccines, 42 U.S.C. 300aa-27(a)(2), among many
areas of improvement in the vaccination process, does not imply that
the compensation program covers negligent administration.
Furthermore, state courts have found that injuries arising from
negligent administration of a vaccine are not ``vaccine-related
injuries'' under 42
[[Page 6261]]
U.S.C. 300aa-33(5), and therefore are not preempted by the Vaccine Act.
See, e.g., Neddeau v. Rite Aid of Conn., 2015 WL 5133151, at *3 (Super.
Ct. Conn. July 28, 2015) (state court action did not allege a
``vaccine-related'' injury and therefore was not barred by the Vaccine
Act, because plaintiff's allegation that the administrator struck the
needle too high was an allegation that her injuries ``were caused by
negligence in the physical process of injecting the vaccine, not by the
effects of the vaccine''); Nwosu ex rel. Ibrahim v. Adler, 969 So. 2d
516, 519 (Ct. App. Fla. 2007) (claim arising from a physician's
negligent injection of a vaccine was not a ``vaccine-related injury,''
and adding that ``[i]t is true that had the child not been vaccinated,
she would not have been injured. However, her injury as alleged, does
not flow from the inoculant injected into her body [so] it is not the
type of injury covered under the Act'').
The Table should only include injuries caused by a vaccine or its
components, not the manner in which the vaccine was administered. Thus,
a petitioner must have an injury or death ``associated'' with the
vaccine, not one resulting from poor injection technique or other
improper administration of the vaccine.
Comment: One commenter stated that to the extent that negligence
may well be a component of some SIRVA injuries, categorically excluding
these as vaccine-related injuries would make sense only if one could
show that negligence alone causes SIRVA. The commenter asserts that
medical literature shows that all SIRVA injuries necessarily involve an
inflammatory, immune reaction in the deltoid/bursa region. (See
Vaccine-related Shoulder Discomfort, M. Bordor & E. Montalvo; Shoulder
injury related to vaccine administration, S. Atanasoff, et al.)
Response: SIRVA stands for shoulder injury related to vaccine
administration. The Department does not necessarily agree that the
scientific literature shows that all SIRVA injuries necessarily involve
an inflammatory, immune reaction in the deltoid/bursa region. It is
possible that certain injuries characterized as SIRVA occur when an
immunologically active substance designed to trigger an inflammatory
response (i.e., the vaccine antigen) is injected into an area where the
inflammatory response can cause joint damage (i.e., the bursa or
tendons) as opposed to an area where the inflammatory response will not
cause joint damage or permanent harm (i.e., the deltoid muscle). Such
injuries are fairly characterized as resulting from the vaccination
technique, since they would not have occurred if the injection occurred
in the proper part of the body.
Comment: Some commenters provided critical reviews of the research
cited by HHS in the proposed rule. One commenter stated that the
medical and scientific literature cited by the Department is contrary
to (or at best inconclusive of) the proposition that SIRVA is caused
solely by the physical conduct attributable to the person administering
the vaccine.
Response: The Department respectfully disagrees, and maintains the
view espoused in the proposed rule. The Department correctly
characterized the literature in the proposed rule.
Comment: One commenter stated that HHS wrongfully stated that the
standard of proof for establishing entitlement of a SIRVA claim is too
low or lenient, leading to the filing of dubious or frivolous claims
without providing any evidence of this in the proposed rule. This
commenter stated that the suspicion of activity is not proper
justification for the Department's proposed policy change. The
commenter also stated that the Department's claim that there has been a
dramatic increase in SIRVA claims is meaningless without context, such
as an increase in the number of flu vaccines administered from the
2016/2017 flu season to the 2018/2019 flu season. This commenter also
pointed out that the there is no evidence that SIRVA claims are
diminishing the Trust Fund, because according to the US Treasury
Bulletin for March 2020, the balance of the Trust Fund at the end of FY
2019 was $3.95 billion, up from $3.85 billion at the end of FY 2018.
Response: DOJ informs the Department that, as of the time of the
proposed rule, out of 2,214 SIRVA claims filed since 2017, DOJ had
identified 27 cases in which altered medical records have been filed,
some of which involved changes to the site of vaccination. The proposed
rule noted that the vaccination rate had decreased slightly since SIRVA
was added to the Table,\41\ yet SIRVA claims have risen dramatically in
recent years. The Department is finalizing this final rule for a
combination of legal and policy reasons explained herein and in the
proposed rule, not solely because any particular claims are diminishing
the Trust Fund.
---------------------------------------------------------------------------
\41\ 85 FR 43,801 n.33.
---------------------------------------------------------------------------
Comment: Some commenters stated that if SIRVA is removed from the
Vaccine Injury Table, it will have to be covered by malpractice
insurance, which could unnecessarily drive up the costs of delivering
vaccines and reduce the number of people willing to administer them.
Response: It is not clear this was problematic in the United States
before SIRVA and vasovagal syncope were added to the Table in 2017, and
the Department has been unable to locate any evidence that insurance
has materially declined due to the addition of SIRVA and vasovagal
syncope to the Table. Moreover, the vaccination rate has gone down
slightly between when SIRVA and vasovagal syncope were added to the
Table and the time of the proposed rule.\42\
---------------------------------------------------------------------------
\42\ 85 FR 43,801.
---------------------------------------------------------------------------
Comment: A commenter asked that if SIRVA and vasovagal syncope are
removed from the Table, all claims filed before the Final Rule be
allowed to continue through the National Vaccine Injury Compensation
Program.
Response: This final rule applies to claims filed after the
effective date of this final rule.
Comment: A commenter stated that in the 34 years since the Vaccine
Act was passed by Congress, HHS has only ever added to the Injury
Table, and that it is deeply troubling and potentially against the
intent of the Act to remove injuries from the Table.
Response: The Vaccine Act explicitly provides that the Secretary
can ``delete from'' the list of injuries, disabilities, illnesses,
conditions, and deaths for which compensation may be provided. 42
U.S.C. 300aa-14(c)(3). Therefore, this final rule is consistent with
the statutory text and Congressional intent.
Comment: Some commenters stated that the Department's contention
that SIRVA should be removed, in part, because patient records were
altered in 27 out of 2,214 cases is unsupportable. They state that the
average fraudulent health care claims, according to the National Health
Care Anti-Fraud Association, is 3%, which is higher than the reported
fraud in the SIRVA records, which is 1.2%. One commenter points out
that, as of January 1, 2020, the Court requires that all medical
records be certified under the Pre-Assignment Review Order, which
greatly reduces the chance of fraudulent records.
Response: DOJ had identified 27 cases in which altered medical
records have been filed, some of which involved changes to the site of
vaccination. However, it is possible there were additional instances
that DOJ did not uncover. The Department is finalizing this final rule
because of a combination of legal and policy reasons stated herein and
in the proposed rule, not solely because of fraud.
[[Page 6262]]
Comment: Some commenters stated that removing coverage for SIRVA
and syncope is inconsistent with the Program's twin purposes of
creating a simplified means of recovery for those injured by the
administration of vaccines and providing liability protection to
vaccine administrators and manufacturers. Commenters state that the
policy objective is triggered by the immunization and does not vary
with whether the claimed injury is a consequence of the contents versus
the administration process.
Response: The Department agrees that the VICP seeks to create a
simplified means of recovery and provide certain liability protection
to vaccine administrators and manufacturers. But it only seeks to do so
for injuries encompassed by the Vaccine Act. The Act creates a
compensation program ``for a vaccine-related injury or death.'' 42
U.S.C. 300aa-11(a)(1). Under the Act, ``only . . . a person who has
sustained a vaccine-related injury or death'' can recover. 42 U.S.C.
300aa-11(a)(9). The Act defines ``[v]accine-related injury or death''
as ``an illness, injury, condition, or death associated with one or
more of the vaccines set forth in the Vaccine Injury Table, except that
the term does not include an illness, injury, condition, or death
associated with an adulterant or contaminant intentionally added to
such a vaccine.'' 42 U.S.C. 300aa-33(5) (emphasis added); see also Dean
v. HHS, No. 16-1245V, 2018 WL 3104388, at * 9 (Fed. Cl. Spec. Mstr. May
29, 2018) (defining ``vaccine'' as `` `any substance designed to be
administered to a human being for the prevention of 1 or more diseases'
'') (quoting 26 U.S.C. 4132(a)(2)). Thus, the compensation program
covers injuries ``associated with'' the vaccine itself.
SIRVA is not a vaccine, and it is not an injury caused by a vaccine
antigen, but by administration of the vaccine by the health care
provider. The Department does not think the term ``associated with''
was meant to sweep in injuries caused by negligent administration of
the vaccine. Although the Act permits petitioners to recover for
Vaccine Table injuries without demonstrating causation in individual
cases, the term ``associated with'' nevertheless requires that the
injury, in general, be causally related to the vaccine itself. This is
clear both from dictionary definitions of ``associated,'' which means
``related, connected, or combined together'' (Merriam-Webster.com
Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/associated. Accessed 10 Jul. 2020), and from the text of the
Act itself, see, e.g., 42 U.S.C. 300aa-22(b)(1) (focusing on injuries
that ``resulted'' from vaccine side effects); 42 U.S.C. 300aa-
13(a)(1)(B) & (2)(B) (excluding ``trauma'' that has ``no known relation
to the vaccine involved'').
Importantly, in the key operative provisions discussed above, the
phrase ``associated with'' is linked to the vaccine itself, not to the
technique in administering the vaccine. See Decker v. Nw. Envtl. Def.
Ctr., 568 U.S. 597, 611 (2013) (in interpreting phrase ``associated
with industrial activity,'' the key consideration is the scope of
``industrial activity''; the ``statute does not foreclose a more
specific definition by the agency'' and ``a reasonable interpretation .
. . could . . . require the discharges to be related in a direct way to
operations at `an industrial plant' ''); Chevron, U.S.A., Inc. v. Nat.
Resources Def. Council, Inc., 467 U.S. 837, 861 (1984) (``[T]he meaning
of a word must be ascertained in the context of achieving particular
objectives, and the words associated with it may indicate that the true
meaning of the series is to convey a common idea.'').
That basic requirement is not met with SIRVA and vasovagal syncope.
While the act of being vaccinated may be a but-for cause of those
injuries, the injury is not associated with the vaccine itself because,
with proper administration technique, those injuries will not result
from the vaccine. Rather, SIRVA and vasovagal syncope result from the
use of improper--that is, negligent--administration technique.
There are several indicators in the language and structure of the
Vaccine Act that show it was not meant to cover negligent
administration of the vaccine.\43\
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\43\ See 85 FR 43,796, 43,797.
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Comment: Many commenters stated that the proposed rule is not
supported by the cited financial concerns; that SIRVA payouts in the
last three years only account for 1% of the $4 billion life-to-date
total that the program has paid for claims for all injuries. They
contend that the fund has enough money to support SIRVA claims. Other
commenters pointed out that the awards paid out on an annual basis has
substantially decreased, while the fund has increased in size. Some
commenters contend that financial concerns is not a proper basis to
remove an injury from the Table.
Response: The Department is finalizing this final rule for a
combination of legal and policy reasons explained herein and in the
proposed rule, not solely because any particular claims are diminishing
the Trust Fund.
Comment: Many commenters stated that the Department should not move
forward with this final rule since the ACCV voted against the rule
changes.
Response: The Department is grateful to the ACCV for its time spent
considering the proposed changes and for providing its comments.
However, the Department found the ACCV's comments not adequately
persuasive.\44\ For reasons stated herein and in the proposed rule, the
Department believes that credible scientific and medical evidence
supports this final rule.
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\44\ See 85 FR 43,801-43,802 for a detailed discussion of why
the Department did not find the ACCV's comments to be adequately
persuasive.
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Comment: Some commenters stated that removing SIRVA and vasovagal
syncope from the Table will have the negative effective of reducing the
amount of providers who are willing to administer vaccinations, thereby
lowering the overall number of people vaccinated. A few commenters also
stated that the legislative history of the Vaccine Act shows that
Congress took steps to provide protections for healthcare providers.
These commenters suggest that removing SIRVA from the Vaccine Injury
Table would be contrary to Congressional intent and undercut key
purposes of the Vaccine Act.
Response: The Department respectfully disagrees. The Department has
been unable to locate any evidence that premiums have materially
declined due to the addition of SIRVA and vasovagal syncope to the
Table. Moreover, the vaccination rate has gone down slightly since
SIRVA and vasovagal syncope were added to the Table.\45\ In addition,
certain pharmacists are already immune from suit and liability for
claims for loss caused by, arising out of, relating to, or resulting
from the administration of certain childhood vaccines to individuals
ages three through 18 for the duration of the Secretary's Declaration
Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19.\46\
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\45\ See, e.g., https://www.cdc.gov/flu/fluvaxview/coverage1718estimates.htm; https://www.cdc.gov/nchs/data/hus/2018/031.pdf.
\46\ See 85 FR 52,136, 52140 (Aug. 24, 2020).
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Comment: Some commenters disagree with the Department's statement
that the present regime lessens the incentive of vaccine administrators
to take appropriate precautions during administration. They state that
that health care providers, including pharmacists, are highly trained,
skilled professionals that seek to provide high quality care to their
patients, and are not likely to be negligent in the care they provide
because of their knowledge of
[[Page 6263]]
liability protection. Further they list several instances where civil
action can be filed under the Act (under 42 U.S.C. 300aa-21(a), the
patient/petitioner may reject the Federal Claims judgment and pursue a
civil action; the vaccine administered is not listed in the Table; the
injury sustained is not listed in the Table; the injury/illness did not
last 6 months). Commenters argue that health care providers are bound
by their ethical, moral, and legal duties to protect public health and
no other consideration eliminates or lessens that commitment.
Response: The Department is grateful for the many health care
professionals and pharmacists who improve public health by vaccinating
the American public, and does not believe they would intentionally
administer a vaccine in an improper manner. The Department has taken
many steps during the COVID-19 pandemic to increase the universe of
individuals who can safely vaccinate. Ensuring vaccines are
administered safely will increase public confidence in vaccinations.
Since Vaccine Act proceedings are generally sealed and not made
available to the public, vaccine administrators may be left unaware
that they used an improper technique.\47\ 42 U.S.C. 300aa-21(a) does
not materially change the analysis, because there are not many
instances where an individual would go through the VICP process, fail
to recover, and then be able to recover in state court. There are also
not many instances where a petitioner would elect to forgo his or her
recovery from the VICP to sue in state court, since it is not often
that an individual could recover more in state court, and there are
risks inherent in state court litigation.
---------------------------------------------------------------------------
\47\ 85 FR 43,802.
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Comment: One commenter who serves on the Advisory Commission on
Childhood Vaccines stated that a representative from HHS should have
come to talk to the Commission about the proposed rule. This commenter
stated that additional evidence should have been provided by HHS at the
May 2020 meeting of the Commission, but HHS was not involved in the
meeting. The commenter stated that it was the responsibility of HHS to
provide sufficient evidence to justify its recommendation, not the job
of the Commission to provide sufficient evidence to support its
rejection. Another commenter stated that by not adopting the
recommendation of the Commission, HHS risks undermining the integrity
of the Federal Advisory Committee Act (FACA) process and the
willingness of qualified experts to serve on such committees.
Response: The proposal provided to the ACCV before the May 2020
meeting, which synthesized the views of many within the Department, was
the Department's best explanation for why it was proposing the changes
to the Table. The Department's proposed regulation provided to the ACCV
provided ample scientific and legal justification. The Department is
grateful to the ACCV for its time spent considering the proposed
changes and for providing its comments, but it would raise
constitutional concerns if a federal Agency had to accept the
recommendations of a FACA.
Comment: A few commenters stated that there is no evidence to
support that the Department's position that ``SIRVA petitions are
likely to unnecessarily risk reductions in the funding available for
children and others who sustain unavoidable vaccine-related injury or
death'' because the taxes collected by vaccine manufacturers and paid
into the Trust Fund have exceeded outflows for every year except Fiscal
Year 2013. Commenters also stated that this reasoning ignores the fact
that some SIRVA claims involve children.
Response: It stands to reason that if large sums are paid to SIRVA
petitioners, that risks reducing funding available for others who
sustain unavoidable vaccine-related injuries or deaths. At the time of
the proposed rule, over 99.2% of SIRVA cases (3,034 out of 3,057) filed
since FY 2010 were filed by adults.\48\
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\48\ 85 FR 43,798.
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Comment: Some commenters urge the VICP and the CICP to merge
together to promote unity and clarity.
Response: Revision of the formation and organization of the VICP
and the CICP would require a statutory amendment and thus is not within
the scope of this final rule.
Comment: Many commenters stated that patients, healthcare
providers, vaccine administrators, and vaccine manufactures do not
support the Notice of Proposed Rulemaking.
Response: For the legal and policy reasons stated herein and in the
proposed rule, the Department is finalizing this final rule. The
Department notes, in addition, that non-SIRVA cases, including those
filed on behalf of children, are adversely affected as resources are
stretched or diverted to litigate SIRVA cases.
Comment: Many commenters state that even before SIRVA was added to
the Table in 2017, individuals were able to receive compensation from
the VICP for their SIRVA related injuries. Commenters point to VICP
cases in which the Vaccine Court held that a causal connection between
the administration of the vaccine and the consequential injury is
sufficient proof for an award under the Vaccine Act. Comments stated
that the Department's change in policy is contrary to the Congressional
Intent of the Act and would have a devastating effect upon parties'
ability to recover for their injuries.
Response: Prior to SIRVA's addition to the Table, SIRVA claims were
sometimes awarded due to a combination of the government resolving the
claims without litigating them to conclusion, and public statements by
the Department suggesting SIRVA was a cognizable injury. The proposal
to add SIRVA to the Table was in the works for several years before the
2015 notice of proposed rulemaking was published, and there was a great
deal of public discussion about it at the ACCV and at the Court of
Federal Claims' annual judicial conference. The Department has in the
past not always contested cases alleging injuries that have been
proposed for addition to the Table if the case as pleaded fulfilled the
criteria for entitlement to compensation. However, for the reasons
discussed in the proposed rule and this final rule, including the
Department's review of the statute and more recent scientific
literature, the Department no longer believes such claims should be
included on the Table or can be based on causation in fact, because
they are not injuries associated with vaccines or their components, nor
are they unavoidable injuries or illnesses that cannot be predicted in
advance, or that can occur without fault.
Comment: Several commenters stated that HHS switched its position
in this rulemaking without adequately considering the input of the
Advisory Commission on Childhood Vaccines which unanimously rejected
the rule change, and without discussing the change with the CDC's
Advisory Committee for Immunization Practices (ACIP), HHS's own
National Vaccine Advisory Committee (NVAC), the National Foundation for
Infectious Disease (NFID), and the Institute of Vaccine Safety at Johns
Hopkins whose epidemiologists have consulted closely with the Program
since its inception.
Response: The Department is grateful to the ACCV for its time spent
considering the proposed changes and for providing its comments. The
Department considered the ACCV's
[[Page 6264]]
comments.\49\ However, the Department found the ACCV's comments not
adequately persuasive. The Department has also considered public
comments from a wide variety of perspectives during the two public
hearings and 180-day public comment period on the proposed rule.
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\49\ See 85 FR 43,801-02 (discussing the ACCV's comments in
depth).
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Comment: A few commenters stated that they believe the reason for
HHS's policy change is to reduce the Department's workload, which has
increased due to the large number of SIRVA cases. Commenters stated
that workload concerns are not a valid reason for making a policy
change. Some commenters added that the change would not actually make
the system more efficient, but would rather shift the burden of SIRVA
cases to the civil tort system.
Response: The Department has set forth herein and in the proposed
rule a series of legal and policy reasons for finalizing this final
rule. The Department believes based on the examined data that any
additional burden on the civil tort system, which would be dispersed
across States and not concentrated in any one or few States, from
removing SIRVA and vasovagal syncope from the Table and reverting to
the status quo as of January 2017 will be minimal.\50\
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\50\ 85 FR 43,804.
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Comment: One commenter warned that this rule could result in the
increase in the cost of vaccines, as more medical providers are exposed
to liability.
Response: With respect to SIRVA and vasovagal syncope, this final
rule will revert to the status quo as of January 2017. In addition,
certain pharmacists are already immune from suit and liability for
claims for loss caused by, arising out of, relating to, or resulting
from the administration of certain childhood vaccines to individuals
ages three through 18 for the duration of the Secretary's Declaration
Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19.\51\
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\51\ See 85 FR 52,136, 52140 (Aug. 24, 2020).
---------------------------------------------------------------------------
Comment: One commenter disagreed with the Department's contention
that by excluding from the definition those injuries associated with an
adulterant or contaminant intentionally added to the vaccine, Congress
intended to permit suit only where the injury was caused by the
components of the vaccine itself. The commenter states that the
Department is applying the doctrine of ejusdem generis (i.e., where
general words follow an enumeration of two or more things, they apply
only to persons or things of the same general kind or class
specifically mentioned). However, here, an adulterant and contaminant
are exceptions instead of enumerations. Therefore, the commenter
contends that the Department's interpretation of Congress' intent is
not supported.
Response: The Department respectfully disagrees. There are several
indicators in the language and structure of the Vaccine Act that show
it was not meant to cover negligent administration of the vaccine.\52\
---------------------------------------------------------------------------
\52\ See 85 FR 43,796-97.
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Comment: One commenter stated that the Department mischaracterized
current SIRVA cases when it said ``petitioners in such cases often
prevail because of the low burden of proof and because it is not
necessary to prove causation.'' The commenter said that litigation
records show complex cases in which the Department of Justice
``vigorously'' advocated for the DHHS.
Response: The Department agrees that the Department of Justice
generally vigorously advocates for the Department. But the burden of
proof on petitioners is low, and petitioners generally need not prove
causation.
Comment: One commenter stated that the proposed rule change may
disproportionately and severely affect minority communities, since many
do not have the same access to quality care; the time, energy, and
know-how to navigate a complex legal system; and the resources to
access compensation.
Response: Aiding minority communities was not posited as a reason
to add SIRVA or vasovagal syncope to the Table when they were added in
2017.\53\ In any event, this final rule will alleviate the Department's
significant legal concerns about whether the current Table comports
with applicable law.
---------------------------------------------------------------------------
\53\ See 85 FR 6294.
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Comment: Some commenters stated that HRSA is attempting to undo the
lengthy and thorough legal and medical analysis it performed when it
promulgated the Rule that put both vasovagal syncope and SIRVA on the
Vaccine Injury Table in 2017.
Response: This final rule is the product of a lengthy and thorough
legal and scientific analysis, including an analysis of scientific
literature published after finalization of the 2017 Final Rule.
Comment: One commenter argued that the Vaccine Act has a
subrogation clause which permits the Federal government to seek
recompense if the VICP compensates a claim, but determines later that a
health care professional was negligent in administering a vaccine.
Thus, injury claims resulting from the administration of vaccines
should still be eligible for VICP compensation.
Response: This subrogation provision does not properly incentivize
the vaccine administrator, since it is unlikely that the Federal
government would assert many claims against administrators, given the
burden and expense compared to the relatively small potential recovery
for the Federal government. Individuals would have a greater incentive
to assert such claims if the administrator were negligent.
Comment: Some commenters stated that the Department incorrectly
relies on Amendola v. Sec., Dept. of Health & Human Servs., 989 F.2d
1180 (Fed. Cir. 1993) to say that issues would arise if the Vaccine Act
were interpreted to cover injuries caused by negligent administration.
Commenters contend that the Federal Circuit Judge stated ``Congress
clearly intended by the amendment to apply the Act to pediatricians who
administered a vaccine as well as to the manufacture who made it,'' and
``[w]e see no basis for drawing a bright line that excludes erroneous
judgment calls by the administrator, as well as negligent
contamination.'' One commenter concludes that Amendola, in fact,
confirms that the Vaccine Act protects both vaccine administrators and
manufactures.
Response: The Department respectfully disagrees with this
characterization of Amendola. As the Federal Circuit has explained,
troubling issues arise if the Act were to apply to ``negligence
facially unrelated to the vaccine's effects.'' Amendola v. Sec., Dept.
of Health & Human Servs., 989 F.2d 1180, 1187 (Fed. Cir. 1993). It
could include, for example, ``the doctor's negligent dropping of an
infant patient'' or use of contaminated equipment. Id. at 1186-87. The
better reading of the statute is that it does not reach this far.
Comment: One commenter argued that the state tort liability
preemption in Subpart B merely covers the remedies available to
patients after they have gone through the VICP, not that Congress
intended to ``preserve a state tort remedy for certain avoidable
injuries, such as those caused by negligent vaccine administration.''
Response: Congress protected manufacturers from liability when the
injury ``resulted from side effects that were unavoidable even though
the vaccine was properly prepared. . .'' 42 U.S.C. 300aa-22(b)(1). This
language shows Congress wanted to preserve a
[[Page 6265]]
state tort remedy for certain avoidable injuries, such as those caused
by negligent vaccine administration. Given that the Vaccine Act seeks
to replace state tort remedies for the injuries it covers, this
reinforces the conclusion that the Act does not reach SIRVA and
vasovagal syncope.
Comment: One commenter disagreed with the Department's position
that recordkeeping and reporting requirements are ``woefully inadequate
if the Program was designed to compensate for negligence by the
provider,'' since physicians are subject to myriad state laws and
regulations governing medical records. The commenter stated that
Congress authorized HHS to promulgate additional recordkeeping
requirements if need be.
Response: The text and structure of the Vaccine Act show that it
was not meant to cover negligent administration of the vaccine. That
some state laws and regulations govern medical records is besides the
point.
Comment: Many commenters argued that this rule is an unconscionable
attempt to alleviate HHS's backlog of pending cases, and that the
public would be better served if the Department was to hire additional
personal to handle case management.
Response: The Department respectfully disagrees. The Department has
set forth a series of legal and policy reasons for this final rule both
herein and in the proposed rule.
III. Statutory Authority
The primary statutory authority for this rulemaking is 42 U.S.C.
300aa-14. 42 U.S.C 300aa-14(c)(1) provides that the ``Secretary may
promulgate regulations to modify in accordance with paragraph (3) the
Vaccine Injury Table. In promulgating such regulations, he shall
provide for notice and opportunity for a public hearing and at least
180 days of public comment.'' 42 U.S.C. 300aa-14(c)(3), in turn,
provides: ``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 or the significant aggravation of any such
injury, disability, illness, condition, or death.''
IV. Statutory and Regulatory Requirements
A. Executive Orders 12866, 13563, and 13771: Regulatory Planning and
Review
E.O. 12866 and E.O. 13563 direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts, and equity). E.O. 13563 supplements and
reaffirms the principles, structures, and definitions governing
regulatory review as established in E.O. 12866, which emphasizes the
importance of quantifying both costs and benefits, of reducing costs,
of harmonizing rules, and of promoting flexibility.
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 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 Department
anticipates that the final rule will save limited compensation funds
under the National Vaccine Injury Compensation Program. Specifically,
it will reduce the amount of program funds spent on program
administration, reduce the amount of funds paid out to those with SIRVA
or vasovagal syncope claims, and ensure that funds awarded from the
VICP are awarded to individuals whose claims arise from vaccine-related
injuries, which is consistent with the original intent of the VICP.
Moreover, the Department anticipates that the final rule may result in
fewer individuals suffering from SIRVA or vasovagal syncope, because it
will better incentivize those administering vaccines to use proper
injection technique. If those who administer vaccines can be held
liable when a patient suffers from SIRVA or vasovagal syncope as a
result of the administration of the vaccine, those who administer
vaccines will have greater incentive to use proper injection technique.
In addition, the final rule may also limit the ability of those opposed
to vaccinations to cite to the high number of SIRVA awards to
misleadingly suggest that vaccines are less safe than they truly are.
The Department considered, as an alternative to the proposed rule
and this final rule, issuing a notice of proposed rulemaking that would
revise the definition of SIRVA so that those with true shoulder
injuries were able to recover while reducing the number of less
appropriate claims. However, the Department concluded that removing
SIRVA from the Table is preferable. If SIRVA is removed from the Table,
those with actual SIRVA injuries would still be able to recover in
state court. Removal is preferable to redefining SIRVA, because it
better addresses the vaccine hesitancy concern, is more in line with
the Vaccine Act and Congressional intent, and incentivizes learning and
utilizing proper administration technique. Indeed, because Vaccine Act
proceedings are generally sealed and not made available to the public,
vaccine administrators often are left unaware that they used an
improper technique.
The Department also considered, as alternatives to this final rule,
not removing one or more of (1) SIRVA, (2) vasovagal syncope, or (3)
Item XVII from the Table. For the reasons discussed herein and in the
proposed rule, the Department rejected these alternatives.
Section 3(f) of Executive Order 12866 defines a ``significant
regulatory action'' as an action that is likely to result in a rule (1)
having an annual effect on the economy of $100 million or more in any
one year, or adversely or materially affecting a sector of the economy,
productivity, competition, jobs, the environment, public health or
safety, or state, local or tribal governments or communities (also
referred to as ``economically significant''); (2) creating a serious
inconsistency or otherwise interfering with an action taken or planned
by another agency; (3) materially altering the budgetary impacts of
entitlement grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raising novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order. A regulatory impact
analysis must be prepared for major rules with economically significant
effects ($100 million or more in any one year), and a ``significant''
regulatory action is subject to Office of Management and Budget (OMB)
review. As discussed below regarding the anticipated effects, these
changes are not likely to have economic impacts of $100 million or more
in any one year, and therefore do not meet the definition of
``economically significant'' under Executive Order 12866. OMB has
waived review over this final rule.
[[Page 6266]]
B. Economic and Regulatory Impact
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. Between
FY 2017 and FY 2019, the VICP on average paid out $30,893,481.90 per
year to petitioners alleging SIRVA claims. The VICP on average paid out
$124,489.56 per year to petitioners alleging vasovagal syncope claims.
When this final rule goes into effect, the Department anticipates that
small entities will not actually pay these amounts, because fewer SIRVA
and vasovagal syncope claims would be filed if petitioners had to prove
causation. In addition, vaccines are often administered by non-small
entities, so even if total amounts paid approximated the amounts paid
on average between FY 2017 and FY 2019, claims against small entities
would be less. It is the Department's belief that should the amounts
paid equal the amounts annually paid out of the VICP between FY 2017
and FY 2019, and such claims are paid in full by small entities, these
amounts will not constitute a significant impact on a substantial
number of small entities for purposes of the RFA.
Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded
Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a
budgetary impact statement before promulgating a rule that includes any
Federal mandate that may result in the expenditure by State, local, and
tribal governments, in the aggregate, or by the private sector, of $100
million in 1995 dollars, updated annually for inflation. Currently,
that threshold is approximately $154 million. If a budgetary impact
statement is required, section 205 of the Unfunded Mandates Act also
requires covered agencies to identify and consider a reasonable number
of regulatory alternatives before promulgating a rule. The Department
has determined that this final rule will not result in expenditures by
State, local, and tribal governments, or by the private sector, of $154
million or more in any one year. Accordingly, the Department has not
prepared a budgetary impact statement or specifically addressed the
regulatory alternatives considered.
The provisions of this rule will also not negatively affect family
well-being or 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.
On January 30, 2017, the White House issued Executive Order 13771
on Reducing Regulation and Controlling Regulatory Costs. Section 2(a)
of Executive Order 13771 requires an agency, unless prohibited by law,
to identify at least two existing regulations to be repealed when the
agency publicly proposes for notice and comment or otherwise
promulgates a new regulation. In furtherance of this requirement,
section 2(c) of Executive Order 13771 requires that the new incremental
costs associated with new regulations shall, to the extent permitted by
law, be offset by the elimination of existing costs associated with at
least two prior regulations. This final rule partially repeals prior
regulations and is not expected to increase incremental costs, so it is
not anticipated to be a regulatory or deregulatory action under
Executive Order 13771.
As stated above, this final rule modifies the Vaccine Injury Table
to ensure that the Table complies with applicable law, the Table is
consistent with medical and scientific literature, those administering
vaccines have additional incentive to use proper injection technique,
and the VICP has sufficient funds to adequately compensate those
injured by vaccines listed in the Table.
C. Executive Order 12988: Civil Justice Reform
The agency has reviewed this rule under Executive Order 12988 on
Civil Justice Reform and has determined that this final rule complies
with this Executive Order.
V. Summary of Impacts
This final rule has the effect of removing injuries from the Table
that are not encompassed by the provisions of the Vaccine Act and that
are reducing the pool of funds available to those injured by vaccines
or vaccine components. It therefore aligns the Table with the
Department's understanding of Congress' intent and public policy in
favor of compensating those harmed by injuries associated with the
vaccine or vaccine components, and particularly children who have
suffered such harm. The rule also has the effect of ensuring that the
limited compensation resources available under the National Vaccine
Injury Compensation Program are provided to those with vaccine-related
injuries or deaths. In addition, because of the large volume of SIRVA
claims, removing SIRVA from the Table will reduce the amount of program
funds spent on program administration and ensure that funds awarded
from the VICP are awarded to individuals whose claims arise from
vaccine-related injuries, which is consistent with the Department's
interpretation of the original intent of the VICP.
The final rule also better incentivizes those who administer
vaccines to use proper injection technique. It may also help correct
misleading and erroneous suggestions that vaccines are not safe.
Because COVID-19 and the COVID-19 vaccines are not currently on the
Table, the Department does not believe this rule will have an impact on
patients with COVID-19 or the COVID-19 vaccines.
Moreover, the rule is unlikely to unduly burden the civil tort
system. The Department conducted a search in the WestLaw legal database
for cases in state court that contained both the terms ``SIRVA'' and
``vaccine,'' and found only 20 hits, at least two of which were cases
involving an entity named SIRVA and not the injury.\54\ It is possible
that some additional cases were filed in federal district court.
Nonetheless, the Department believes based on this data that any
additional burden on the civil tort system, which will be dispersed
across States and not concentrated in any one or few States, from
removing SIRVA and vasovagal syncope from the Table and reverting to
the status quo as of January 2017 will be minimal.
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\54\ https://1.next.westlaw.com/Search/Results.html?query=%22sirva%22%20%26%20%22vaccine%22&jurisdiction=ALLSTATES&saveJuris=False&contentType=CASE&querySubmissionGuid=i0ad6ad3f000001733a44933a7bf4372d&startIndex=1&searchId=i0ad6ad3f000001733a44933a7bf4372d&kmSearchIdRequested=False&simpleSearch=False&isAdvancedSearchTemplatePage=False&skipSpellCheck=False&isTrDiscoverSearch=False&thesaurusSearch=False&thesaurusTermsApplied=False&ancillaryChargesAccepted=False&proviewEligible=False&eventingTypeOfSearch=FRM&transitionType=Search&contextData=%28sc.Search%29.
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A. Executive Order 13132--Federalism
HHS has reviewed this final rule in accordance with E.O. 13132
regarding federalism and has determined that it does not have
``federalism implications.'' This final rule will not ``have
substantial direct effects on the States, or on the relationship
between the national government and the States, or on the distribution
of power and
[[Page 6267]]
responsibilities among the various levels of government.''
B. Collection of Information
The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) (PRA)
requires that OMB approve all collections of information by a federal
agency from the public before they can be implemented. This final rule
is projected to have no impact on current reporting and recordkeeping
burden, as the amendments finalized in this rule will not impose any
data collection requirements under the PRA.
List of Subjects in 42 CFR Part 100
Biologics, Health insurance, Immunization.
Accordingly, 42 CFR part 100 is amended as set forth below:
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. In Sec. 100.3, revise paragraph (a) and remove paragraphs (c)(10)
and (13) and (e)(8). The revision reads 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
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).
Table 1 to Paragraph (a)--Vaccine Injury Table
------------------------------------------------------------------------
Time period for
first symptom or
manifestation of
Illness, disability, onset or of
Vaccine injury or condition significant
covered aggravation
after vaccine
administration
------------------------------------------------------------------------
I. Vaccines containing tetanus A. Anaphylaxis........ <=4 hours.
toxoid (e.g., DTaP, DTP, DT,
Td, or TT).
B. Brachial Neuritis.. 2-28 days (not
less than 2
days and not
more than 28
days).
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 or <=72 hours.
encephalitis.
III. Vaccines containing A. Anaphylaxis........ <=4 hours.
measles, mumps, and rubella
virus or any of its
components (e.g., MMR, MM,
MMRV).
B. Encephalopathy or 5-15 days (not
encephalitis. less than 5
days and not
more than 15
days).
IV. Vaccines containing A. Chronic arthritis.. 7-42 days (not
rubella virus (e.g., MMR, less than 7
MMRV). days and not
more than 42
days).
V. Vaccines containing measles A. Thrombocytopenic 7-30 days (not
virus (e.g., MMR, MM, MMRV). purpura. less than 7
days and not
more than 30
days).
B. Vaccine-Strain
Measles Viral Disease
in an immunodeficient
recipient.
--Vaccine-strain virus Not applicable.
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).
VIII. Hepatitis B vaccines.... A. Anaphylaxis........ <=4 hours.
IX. Haemophilus influenzae No Condition Not applicable.
type b (Hib) vaccines. Specified..
X. Varicella vaccines......... A. Anaphylaxis........ <=4 hours.
B. Disseminated
varicella vaccine-
strain viral disease.
--Vaccine-strain virus Not applicable.
identified.
[[Page 6268]]
--If strain 7-42 days (not
determination is not less than 7
done or if laboratory days and not
testing is more than 42
inconclusive. days).
C. Varicella vaccine- Not applicable.
strain viral
reactivation.
XI. Rotavirus vaccines........ A. Intussusception.... 1-21 days (not
less than 1 day
and not more
than 21 days).
XII. Pneumococcal conjugate No Condition Not applicable.
vaccines. Specified..
XIII. Hepatitis A vaccines.... No Condition Not applicable.
Specified..
XIV. Seasonal influenza A. Anaphylaxis........ <=4 hours.
vaccines.
B. Guillain- 3-42 days (not
Barr[eacute] Syndrome. less than 3
days and not
more than 42
days).
XV. Meningococcal vaccines.... A. Anaphylaxis........ <=4 hours.
XVI. Human papillomavirus A. Anaphylaxis........ <=4 hours.
(HPV) vaccines.
------------------------------------------------------------------------
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-01211 Filed 1-19-21; 8:45 am]
BILLING CODE 4165-15-P