National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table

Published date21 January 2021
Citation86 FR 6249
Record Number2021-01211
SectionRules and Regulations
CourtPublic Health Service
6249
Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
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.
Federal, State, and local officer
designated by or assisting the Captain of
the Port (COTP) Sector Guam in the
enforcement of the safety zone.
(c) Regulations. (1) In accordance with
the general regulations in section
§ 165.23, entry into, transiting, or
anchoring within this safety zone is
prohibited unless authorized by the
COTP or a designated on-scene
representative.
(2) This safety zone is closed to all
persons and vessel traffic, except as may
be permitted by the COTP or a
designated on-scene representative.
(3) The ‘‘on-scene representative’’ of
the COTP is any Coast Guard
commissioned, warrant, or petty officer
who has been designated by the COTP
to act on his or her behalf.
(4) Persons and Vessel operators
desiring to enter or operate within the
safety zone must contact the COTP or an
on-scene representative to obtain
permission to do so. The COTP or an
on-scene representative may be
contacted via VHF Channel 16. Vessel
operators given permission to enter or
operate in the safety zone must comply
with all directions given to them by the
COTP or an on-scene representative.
(d) Enforcement period. This safety
zone will be enforced at a specified date
between February and April. The Coast
Guard will provide advance notice of
enforcement and a broadcast notice to
mariners to inform public of specific
date.
Dated: January 12, 2021.
Christopher M. Chase,
Captain, U.S. Coast Guard, Captain of the
Port, Guam.
[FR Doc. 2021–01084 Filed 1–19–21; 8:45 am]
BILLING CODE 9110–04–P
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.
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
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
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5
42 CFR 100.3(a).
6
See 85 FR 43794 (July 20, 2020) (‘‘proposed
rule’’).
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.
10
http://www.cdc.gov/vaccinesafety/
ensuringsafety/history/index.html.
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
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.
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
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
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.
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
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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).
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).
14
http://www.cdc.gov/vaccin19esafety/
ensuringsafety/history/index.html.
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.
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
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.
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
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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.
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).
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
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
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
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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
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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.
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
Martı
´n Arias, K.H., Fadrique, R., Sa
´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.
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.
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.
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
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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
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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
Martı
´n Arias, K.H., Fadrique, R., Sa
´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.
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
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
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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.
26
80 FR 45137.
27
80 FR 45137. See also IOM Report.
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.
31
42 U.S.C. 300aa–14(c)(1).
32
42 U.S.C. 300aa–14(d).
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.
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.
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.
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.
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
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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).
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
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
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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).
36
See 85 FR 43,796–43,797.
37
See 85 FR 43,796–43,797.
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
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.
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.
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
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See, e.g., https://www.cdc.gov/flu/fluvaxview/
coverage-1718estimates.htm; https://www.cdc.gov/
nchs/data/hus/2018/031.pdf.
39
85 FR 43,798.
40
Or Federal district court if they satisfy the
requirements of 28 U.S.C. 1332 or 28 U.S.C. 1367.
the Table,
38
so it seems unlikely that
this final rule will ‘‘chill’’ vaccine
production.
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.
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
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
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85 FR 43,801 n.33.
42
85 FR 43,801.
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.
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
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.
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See 85 FR 43,796, 43,797.
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.
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).
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
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.
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
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
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85 FR 43,802.
48
85 FR 43,798.
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.
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
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
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49
See 85 FR 43,801–02 (discussing the ACCV’s
comments in depth).
50
85 FR 43,804.
51
See 85 FR 52,136, 52140 (Aug. 24, 2020).
52
See 85 FR 43,796–97.
53
See 85 FR 6294.
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.
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
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
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
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.
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
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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.
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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=i0ad6ad3f000001
733a44933a7bf4372d&startIndex=1&
searchId=i0ad6ad3f000001733a44933a7bf4372d&
kmSearchIdRequested=
False&simpleSearch=False&isAdvanced
SearchTemplatePage=False&
skipSpellCheck=False&isTrDiscoverSearch=False&
thesaurusSearch=False&thesaurusTermsApplied=
False&ancillaryChargesAccepted=False&
proviewEligible=False&eventingTypeOfSearch=
FRM&transitionType=Search&
contextData=%28sc.Search%29.
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.
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
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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
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.
2. In § 100.3, revise paragraph (a) and
remove paragraphs (c)(10) and (13) and
(e)(8). The revision reads as follows:
§ 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).
T
ABLE
1
TO
P
ARAGRAPH
(a)—V
ACCINE
I
NJURY
T
ABLE
Vaccine Illness, disability, injury or condition covered
Time period for first symptom or
manifestation of onset or of
significant aggravation after
vaccine administration
I. Vaccines containing tetanus tox-
oid (e.g., DTaP, DTP, DT, Td, or
TT).
A. Anaphylaxis ....................................................................................... 4 hours.
B. Brachial Neuritis ................................................................................ 2–28 days (not less than 2 days
and not more than 28 days).
II. Vaccines containing whole cell
pertussis bacteria, extracted or
partial cell pertussis bacteria, or
specific pertussis antigen(s) (e.g.,
DTP, DTaP, P, DTP-Hib).
A. Anaphylaxis ....................................................................................... 4 hours.
B. Encephalopathy or encephalitis ........................................................ 72 hours.
III. Vaccines containing measles,
mumps, and rubella virus or any
of its components (e.g., MMR,
MM, MMRV).
A. Anaphylaxis ....................................................................................... 4 hours.
B. Encephalopathy or encephalitis ........................................................ 5–15 days (not less than 5 days
and not more than 15 days).
IV. Vaccines containing rubella
virus (e.g., MMR, MMRV). A. Chronic arthritis ................................................................................. 7–42 days (not less than 7 days
and not more than 42 days).
V. Vaccines containing measles
virus (e.g., MMR, MM, MMRV). A. Thrombocytopenic purpura ............................................................... 7–30 days (not less than 7 days
and not more than 30 days).
B. Vaccine-Strain Measles Viral Disease in an immunodeficient re-
cipient.
—Vaccine-strain virus identified ............................................................ Not applicable.
—If strain determination is not done or if laboratory testing is incon-
clusive. 12 months.
VI. Vaccines containing polio live
virus (OPV). A. Paralytic Polio.
—in a non-immunodeficient recipient .................................................... 30 days.
—in an immunodeficient recipient ......................................................... 6 months.
—in a vaccine associated community case .......................................... Not applicable.
B. Vaccine-Strain Polio Viral Infection.
—in a non-immunodeficient recipient .................................................... 30 days.
—in an immunodeficient recipient ......................................................... 6 months.
—in a vaccine associated community case .......................................... Not applicable.
VII. Vaccines containing polio inac-
tivated virus (e.g., IPV). A. Anaphylaxis ....................................................................................... 4 hours.
VIII. Hepatitis B vaccines ................ A. Anaphylaxis ....................................................................................... 4 hours.
IX. Haemophilus influenzae type b
(Hib) vaccines. No Condition Specified. ......................................................................... Not applicable.
X. Varicella vaccines ....................... A. Anaphylaxis ....................................................................................... 4 hours.
B. Disseminated varicella vaccine-strain viral disease.
—Vaccine-strain virus identified ............................................................ Not applicable.
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T
ABLE
1
TO
P
ARAGRAPH
(a)—V
ACCINE
I
NJURY
T
ABLE
—Continued
Vaccine Illness, disability, injury or condition covered
Time period for first symptom or
manifestation of onset or of
significant aggravation after
vaccine administration
—If strain determination is not done or if laboratory testing is incon-
clusive. 7–42 days (not less than 7 days
and not more than 42 days).
C. Varicella vaccine-strain viral reactivation .......................................... Not applicable.
XI. Rotavirus vaccines .................... A. Intussusception ................................................................................. 1–21 days (not less than 1 day
and not more than 21 days).
XII. Pneumococcal conjugate vac-
cines. No Condition Specified. ......................................................................... Not applicable.
XIII. Hepatitis A vaccines ................ No Condition Specified. ......................................................................... Not applicable.
XIV. Seasonal influenza vaccines ... A. Anaphylaxis ....................................................................................... 4 hours.
B. Guillain-Barre
´Syndrome ................................................................... 3–42 days (not less than 3 days
and not more than 42 days).
XV. Meningococcal vaccines .......... A. Anaphylaxis ....................................................................................... 4 hours.
XVI. Human papillomavirus (HPV)
vaccines. A. Anaphylaxis ....................................................................................... 4 hours.
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
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jbell on DSKJLSW7X2PROD with RULES

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