National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 6249-6268 [2021-01211]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Public Health Service

[Federal Register Volume 86, Number 12 (Thursday, January 21, 2021)]
[Rules and Regulations]
[Pages 6249-6268]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-01211]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

42 CFR Part 100

RIN 0906-AB24


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

AGENCY: Public Health Service, Health Resources and Services 
Administration (``HRSA''), Department of Health and Human Services 
(``HHS'' or the ``Department'').

ACTION: Final rule.

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SUMMARY: The Secretary finalizes the proposed rule to amend the Vaccine 
Injury Table (Table) by regulation. This final rule will have effect 
only for petitions for compensation under the National Vaccine Injury 
Compensation Program (VICP) filed after this final rule become 
effective. This final rule does not impact COVID-19 vaccines or PREP 
Act immunity for Covered Persons (as defined in the PREP Act) who 
manufacture, distribute, order, or administer COVID-19 vaccines.

DATES: This final rule is effective on February 22, 2021.

FOR FURTHER INFORMATION CONTACT: Please visit the National Vaccine 
Injury Compensation Program's website, https://www.hrsa.gov/vaccinecompensation/, or contact Tamara Overby, Acting Director, 
Division of Injury Compensation Programs, Healthcare Systems Bureau, 
HRSA, Room 08N146B, 5600 Fishers Lane, Rockville, MD 20857; by email at 
[email protected]; or by telephone at (855) 266-2427.

SUPPLEMENTARY INFORMATION: This is a final rule by which HHS amends the 
provisions of 42 CFR 100.3 by removing Shoulder Injury Related to 
Vaccine Administration, vasovagal syncope, and Item XVII from the 
Vaccine Injury Table.

I. Background and Purpose

    Vaccination is one of the best ways to protect against potentially 
harmful diseases that can be very serious, may require hospitalization, 
or even be deadly. Almost all individuals who are vaccinated have no 
serious reactions.\1\ Nonetheless, in the 1980s, Congress became 
concerned that a small number of children who received immunizations 
had serious reactions to them, and it was not always possible to 
predict which children would have reactions, or what reactions they 
would have.\2\ Claimants alleging vaccine-related injuries in civil 
litigation encountered a time-consuming, expensive, and often 
inadequate system.\3\ Moreover, increased litigation against vaccine 
manufacturers resulted in difficulties in their ability to secure 
affordable product liability insurance, stabilize vaccine prices and 
supply, and enter the market.\4\
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    \1\ National Vaccine Injury Compensation Program, Health 
Resources & Servs. Admin., https://www.hrsa.gov/vaccine-compensation/ (last reviewed Jan. 2020).
    \2\ H.R. Rep. No. 99-908, pt. 1, at 6 (1986). Even though in 
rare instances individuals may have adverse reactions to vaccines, 
the Centers for Disease Control and Prevention (CDC) recommends that 
individuals be vaccinated against a wide range of illnesses and 
diseases. See Recommended Vaccines by Age. Ctrs. for Disease Control 
& Prevention, https://www.cdc.gov/vaccines/vpd/vaccines-age.html 
(last reviewed Nov. 22, 2016).
    \3\ H.R. Rep. No. 99-908, at 6.
    \4\ See id. at 4-6.
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    Therefore, Congress enacted the National Childhood Vaccine Injury 
Act of 1986, title III of Public Law 99--660 (42 U.S.C. 300aa-1 et 
seq.) (``Vaccine Act'' or ``the Act''), which established the National 
Vaccine Injury Compensation Program (VICP). The objectives of the VICP 
are to ensure an adequate supply of vaccines, stabilize vaccine costs, 
and establish and maintain an accessible and efficient forum for 
individuals found to be injured by certain vaccines to be federally 
compensated. Petitions for compensation under the VICP are filed in the 
United States Court of Federal Claims (Court), rather than the civil 
tort system, with a copy served on the Secretary, who is the 
Respondent. The U.S. Department of Justice (DOJ) represents HHS in 
Court, and the Court, acting through judicial officers called Special 
Masters, makes the final decision as to eligibility for, and the type 
and amount of, compensation.
    To gain entitlement to compensation under this Program, a 
petitioner must establish that a vaccine-related injury or death has 
occurred, either by proving that a vaccine actually caused or 
significantly aggravated an injury (causation-in-fact) or by 
demonstrating what is referred to as a ``Table injury.'' That is, a 
petitioner may show that the vaccine recipient (1) received a vaccine 
covered under the Act; (2) suffered an injury of the type enumerated in 
the regulations at 42 CFR 100.3--the ``Vaccine Injury Table'' (Table)--
corresponding to the vaccination in question; and (3) that the onset of 
such injury took place within the time period specified in the Table. 
If so, the injury is presumed to have been caused by the vaccine, and 
the petitioner is entitled to compensation (assuming that other 
requirements are satisfied), unless the respondent affirmatively shows 
that the injury was caused by some factor unrelated to the vaccination 
(see 42 U.S.C. 300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B), and 300aa-
14(a)).
    42 U.S.C. 300aa-14(c) and (e) permit the Secretary to revise the 
Table. The Table currently includes 17 vaccine categories, with 16 
categories for specific vaccines, as well as the corresponding 
illnesses, disabilities, injuries, or conditions covered, and the 
requisite time period when the first symptom or manifestation of onset 
or of significant aggravation after the vaccine administration must 
begin to receive the Table's legal presumption of causation. The final 
category of the Table, ``Item

[[Page 6250]]

XVII,'' includes ``[a]ny new vaccine recommended by the Centers for 
Disease Control and Prevention for routine administration to children, 
after publication by the Secretary of a notice of coverage.'' \5\ Two 
injuries--Shoulder Injury Related to Vaccine Administration (SIRVA) and 
vasovagal syncope--are listed as associated injuries for this category. 
Through this general category, new vaccines recommended by the CDC for 
routine administration to children and subject to an excise tax are 
deemed covered under the VICP prior to being added to the Table as a 
separate vaccine category through Federal rulemaking.
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    \5\ 42 CFR 100.3(a).
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    The Department previously issued a notice of proposed rulemaking 
that proposed to remove SIRVA, vasovagal syncope, and Item XVII from 
the Vaccine Injury Table found at 42 CFR 100.3. The Department did so 
for the reasons set forth in the proposed rule.\6\
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    \6\ See 85 FR 43794 (July 20, 2020) (``proposed rule'').
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    Pursuant to the Vaccine Act, HHS provided the proposed revisions to 
the Vaccine Table to the ACCV.\7\ The ACCV considered the proposed 
changes set forth in the proposed rule on March 6, 2020 and May 18, 
2020. Four members of the ACCV also held a workgroup meeting on April 
3, 2020 to discuss the proposed changes. On July 16, 2020, the proposed 
rule went on public display, with a comment period that ended on 
January 12, 2021.\8\ On November 9, 2020, the Department held a public 
hearing pursuant to 42 U.S.C. 300aa-14(c)(1) via teleconference to 
discuss the proposed rule.\9\
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    \7\ The Department first provided the proposed revisions to the 
Table and requested recommendations and comments by the ACCV on or 
about February 15, 2020.
    \8\ National Vaccine Injury Compensation Program: Revisions to 
the Vaccine Injury Table, 85 FR 43794 (July 20, 2020).
    \9\ https://www.regulations.gov/document?D=HRSA-2020-0002-0373.
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    The Department now finalizes the proposed rule to remove SIRVA and 
vasovagal syncope from the Table found at 42 CFR 100.3(a) and to remove 
the corresponding descriptions of those injuries--``Qualifications and 
Aids to Interpretation'' (QAI)--from 42 CFR 100.3(c). This decision is 
based upon a review of the relevant statutory provisions and the 
scientific literature, as well as the Department's experience since 
SIRVA and vasovagal syncope were added to the Table. The Department 
also finalizes its proposal to remove Item XVII from the Table found at 
42 CFR 100.3(a), because the Department has serious concerns that Item 
XVII is contrary to applicable law, for the reasons set forth below. 
The Department finalizes this final rule for the reasons set forth in 
the proposed rule. This final rule does not impact COVID-19 vaccines or 
PREP Act immunity for Covered Persons (as defined in the PREP Act) who 
manufacture, distribute, order, or administer COVID-19 vaccines.

II. Discussion of, and Response to, Public Comments

    What follows is a summary of the public comments the Department 
received on the notice of proposed rulemaking for this rule, which had 
a comment period that ended on January 12, 2021, and the comments 
received at the public hearing on the proposed rule. The Department 
received 763 comments on the proposed rule. Commenters included 
patients, family and friends of patients, vaccine lawyers, 
rehabilitation counselors, nurses, doctors, legal clinics, law firms, 
law schools, biotech trade associations, pharmacist acclimations, drug 
store associations, and non-profits. The majority of commenters made 
statements in opposition to the proposed rule, although some commenters 
supported the proposed rule.
    The public hearing was conducted on November 9, 2020 from 10:00 
a.m. till 3 p.m. via Adobe connect teleconference. 34 comments were 
provided during the public hearing on the proposed rule. Commenters 
included those who experienced SIRVA injuries, doctors, vaccine 
lawyers, representatives from vaccine legal clinics, law professors, 
representatives from biotechnical associations, and representatives 
from vaccine information associations. All commenters who spoke at the 
public hearing were in opposition to the proposed rule. Below are 
summaries of the comments and the Department's responses.

Section I: Comments Regarding Vaccines in General

    Comment: Many commenters expressed concerns over the safety of 
vaccines in general. Some believe that all chemicals in vaccines are 
harmful to the body and cause bone and organ deterioration. Some 
believe that all vaccines should be stopped entirely. Others called for 
a complete moratorium on vaccines until all negative side effects are 
gone. Some commenters believe that vaccine and pharmaceutical companies 
are evil and have bought the government to push unsafe vaccines. They 
stress that vaccines are useless and unsafe and the very fact that the 
VICP is in existence proves that vaccines are unsafe.
    Response: Vaccines are one of the greatest success stories in 
public health. Through use of vaccines, we have eradicated smallpox and 
nearly eliminated wild polio virus. The number of people who experience 
the devastating effects of preventable infectious diseases like 
measles, diphtheria, and whooping cough is at an all-time low. The 
United States has a long-standing vaccine safety program that closely 
and constantly monitors the safety of vaccines. Before vaccines are 
approved by the Food and Drug Administration (FDA), they are tested and 
studied extensively by scientists to help ensure they are safe and 
effective. After vaccines are approved, a critical part of the vaccine 
safety program is that the Centers for Disease Control and Prevention 
(CDC)'s Immunization Safety Office (ISO) and FDA monitor for possible 
vaccine side effects and conduct studies to determine whether health 
problems are caused by vaccines. CDC's ISO data show that the current 
U.S. vaccine supply is the safest in history.\10\ Also, regulating 
clinical research and reviewing the safety of vaccines are 
responsibilities of the FDA, not the VICP, and changes in vaccine 
research and how vaccines are studied and tested are beyond the scope 
of this final rule.
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    \10\ https://www.cdc.gov/vaccinesafety/ensuringsafety/history/.
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    Comment: Some commenters described bad reactions they, or their 
children, personally experienced from a range of vaccines to argue that 
there should be an end to mandated vaccines for children.
    Response: The Department sympathizes with all those who have 
experienced negative reactions to vaccines. Vaccination is one of the 
best ways to protect against potentially harmful diseases that can be 
very serious, may require hospitalization, or even be deadly. Almost 
all individuals who are vaccinated have no serious reactions.\11\ 
Nonetheless, in the 1980s, Congress became concerned that a small 
number of children who received immunizations had serious reactions to 
them, and it was not always possible to predict which children would 
have reactions, or what reactions they would have.\12\ Therefore, 
Congress enacted the

[[Page 6251]]

National Childhood Vaccine Injury Act of 1986, title III of Public Law 
99-660 (42 U.S.C. 300aa-1 et seq.) (Vaccine Act), which established the 
National Vaccine Injury Compensation Program (VICP). The objectives of 
the VICP are to ensure an adequate supply of vaccines, stabilize 
vaccine costs, and establish and maintain an accessible and efficient 
forum for individuals found to be injured by certain vaccines to be 
federally compensated.
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    \11\ National Vaccine Injury Compensation Program, Health 
Resources & Servs. Admin., https://www.hrsa.gov/vaccine-compensation/ (last reviewed Jan. 2021).
    \12\ H.R. Rep. No. 99-908, pt. 1, at 6 (1986). Even though in 
rare instances individuals may have adverse reactions to vaccines, 
the Centers for Disease Control and Prevention (CDC) recommends that 
individuals be vaccinated against a wide range of illnesses and 
diseases. See Recommended Vaccines by Age. Ctrs. for Disease Control 
& Prevention, https://www.cdc.gov/vaccines/vpd/vaccines-age.html 
(last reviewed Jan. 2021).
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    While the federal government recommends that individuals be 
vaccinated against a wide range of illnesses and diseases, it does not 
mandate them. Each state decides which vaccines are required for 
child's enrollment and attendance at a childcare facility or school in 
that state. Vaccination requirements and allowable exemptions vary by 
state.\13\
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    \13\ More information about state vaccination requirements for 
daycare and school entry can be found at https://www.cdc.gov/vaccines/imz-managers/laws/state-reqs.html (last reviewed Jan. 
2021).
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    Comment: Commenters believe that there should be no vaccines that 
contain metals, formaldehyde, preservatives, fetal tissue, and other 
potentially harmful ingredients to humans.
    Response: That is beyond the scope of this final rule. For more 
information on the contents of vaccines and their safety, please see 
https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/common-ingredients-us-licensed-vaccines.
    Comment: Some commenters believe that vaccines are an attempt to 
supersede their rights as parents, and this regulation should be 
abandoned.
    Response: The federal government is not trying to supersede 
parent's rights. The purpose of vaccines are to eradicate diseases and 
to reduce the number of people who experience the devastating effects 
of preventable infectious diseases like measles, diphtheria, and 
whooping cough. This regulation does not address parents' rights with 
respect to their children.
    Comment: A commenter expressed anger about the Gardasil HPV vaccine 
causing injury and death.
    Response: There is a safe and effective HPV vaccine that can 
prevent the infections that most commonly cause cancer. Gardasil 9 
(human papillomavirus 9-valent vaccine, recombinant; 9vHPV) was 
approved by the FDA for use in 2014. The safety of Gardasil 9 was 
studied in clinical trials with more than 15,000 participants before it 
was licensed and continues to be monitored. Gardasil 9 protects against 
9 types of cancer-causing HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 
58. For more information on the HPV vaccine, side effects, and who 
should and should not receive this vaccine, see https://www.cdc.gov/vaccinesafety/vaccines/hpv-vaccine.html.
    Comment: Some commenters asked to make vaccines optional. They 
believe that vaccines should not be mandated. Commenters believe that 
all vaccines should be voluntary. Many commenters contended that they 
are not. Many expressed a strong desire against being forced to get any 
vaccine, specifically the COVID-19 vaccine.
    Response: State laws establish vaccination requirements for school 
children and some state healthcare workers. Revision of state laws and 
requirements are not within the scope of this final rule.
    Comment: Some commenters expressed concern that their jobs made it 
mandatory to have vaccines. They believe that since their jobs make it 
mandatory, all related injuries should be compensated by the 
government.
    Response: Employment requirements are beyond the scope of this 
final rule.
    Comment: Some commenters believe that all of the studies supporting 
vaccines are biased and created out of fear of the ``vaccine lobby.''
    Response: Vaccines are one of the greatest success stories in 
public health. Through use of vaccines, we have eradicated smallpox and 
nearly eliminated wild polio virus. The number of people who experience 
the devastating effects of preventable infectious diseases like 
measles, diphtheria, and whooping cough is at an all-time low. The 
United States has a long-standing vaccine safety program that closely 
and constantly monitors the safety of vaccines. Before vaccines are 
approved by the Food and Drug Administration (FDA), they are tested and 
studied extensively by scientists to help ensure they are safe and 
effective. After vaccines are approved, a critical part of the vaccine 
safety program is that the Centers for Disease Control and Prevention 
(CDC)'s Immunization Safety Office (ISO) and FDA monitor for possible 
vaccine side effects and conduct studies to determine whether health 
problems are caused by vaccines. CDC's ISO data show that the current 
U.S. vaccine supply is the safest in history.\14\ Also, regulating 
clinical research and reviewing the safety of vaccines are 
responsibilities of the FDA, not the VICP, and changes in vaccine 
research and how vaccines are studied and tested are beyond the scope 
of this final rule.
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    \14\ https://www.cdc.gov/vaccin19esafety/ensuringsafety/history/.
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Section II: COVID-19 Vaccine Comments

    Comment: Some commenters expressed concern that the proposed rule 
did not add the COVID-19 vaccine to the Table. Some commenters believe 
that the Notice of Proposed Rulemaking would stop the automatic 
addition of the COVID-19 vaccine to the Vaccine Injury Table. Some 
believe the COVID-19 vaccine should be added to the Table to make the 
general public feel better about taking the vaccine; they believe that 
the change in the Table will increase fear of vaccination. Some 
commenters believe that since the COVID-19 vaccine is not included on 
the Table, it is unsafe. Others are concerned that the Government will 
mandate the COVID-19 vaccine, and that the changes to the Table are an 
attempt by the government to shield itself from any responsibility to 
compensate for COVID-19 vaccine related injuries. Other commenters 
asked if someone was injured by the COVID-19 vaccine, how would they be 
compensated.
    Response: This final rule has zero impact on inclusion of the 
COVID-19 vaccine on the Table. The COVID-19 vaccine can separately be 
added to the Table, but the Department needs to follow the process 
specified in 42 U.S.C. 300aa-14(c)-(d) to do so. This includes that the 
ACCV recommend that the COVID-19 vaccine be added, or opine on the 
Department's recommendation to add the COVID-19 vaccine to the Table. 
Prior to COVID-19 vaccines being added to the Table, injuries resulting 
from these vaccines can be compensated under the Countermeasures Injury 
Compensation Program (CICP).
    The CICP is administered by the Health Resources and Services 
Administration, within the Department of Health and Human Services. 
Information about the CICP and filing a claim are available at the 
toll-free number 1-855-266-2427 or the CICP's website, https://www.hrsa.gov/cicp/.
    Comment: Commenters believe that it is suspicious that the 
Administration is trying to remove injuries from the Table ``secretly'' 
during the COVID-19 pandemic. Other commenters suggested that the 
Department should not remove SIRVA from the Table at a time when 
millions more vaccines are being administered against COVID-19.
    Response: The Department respectfully disagrees that injuries are

[[Page 6252]]

being removed from the Table ``secretly.'' The ACCV publicly discussed 
the proposal on March 6, 2020 and May 18, 2020. Recordings of both 
discussions are publicly available at https://www.hrsa.gov/advisory-committees/vaccines/meetings.html. The Department subsequently 
published the Notice of Proposed Rulemaking in the Federal Register and 
provided a 180-day public comment period. It also held a public hearing 
on the proposed rule on November 9, 2020. The fact that the commenters 
were able to comment on the proposed rule indicates that SIRVA and 
vasovagal syncope are not being removed ``secretly.'' This final rule 
has zero impact on the COVID-19 vaccine, which is not currently on the 
Table. Those injured by the COVID-19 vaccine can recover from the CICP 
if they satisfy the statutory and regulatory prerequisites.
    Comment: A commenter expressed anger about the COVID-19 vaccine 
altering the very DNA of its recipient.
    Response: This comment is outside the scope of this rulemaking. The 
Department notes, though, that COVID-19 mRNA vaccines do not affect or 
interact with DNA in any way.\15\
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    \15\ More information about how COVID-19 mRNA vaccines work can 
be found at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines/mrna.html.
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    Comment: Some commenters asked the Department to consider giving 
people stimulus checks in exchange for receiving the COVID-19 vaccine.
    Response: Whether to provide stimulus checks for receiving the 
COVID-19 vaccine is outside the scope of this final rule.
    Comment: One commenter asked the Department to reconsider removing 
SIVRA and vasovagal syncope from the Table because nurses, and those on 
the medical front line, need protection from liability, especially 
considering the overwhelming year they have had due to the COVID-19 
pandemic.
    Response: The Department thanks front-line workers for the 
tremendous work they have done over the past year. This final rule does 
not impact PREP Act immunity for Covered Persons (as defined in the 
PREP Act) who manufacture, distribute, order, or administer COVID-19 
vaccines. Under the PREP Act and the Secretary's March 10, 2020 PREP 
Act declaration, as amended, during the effective period of the 
declaration, Covered Persons are immune from suit and liability (absent 
willful misconduct) under Federal and State law with respect to all 
claims for loss caused by, arising out of, relating to, or resulting 
from the administration to or the use by an individual of a covered 
countermeasure.\16\
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    \16\ 42 U.S.C. 247d-6d; see also Fourth Amendment to the 
Secretary's PREP Act Declaration, 85 FR79,190, 79,195 (Dec. 9, 
2020).
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Section III: General Support for the Proposed Rule

    Comment: Some commenters believe that there is no good rationale to 
include adverse events that are due to the physical administration of 
the vaccine rather than the effects of the contents. Commenters believe 
keeping those events covered by the program actually waters down the 
intent of the program and pulls away resources from the people who were 
actually affected by the vaccines themselves.
    Response: The Department agrees.
    Comment: Some commenters believe that the high number of SIRVA and 
vasovagal syncope cases submitted to the VICP has led to a falsely 
elevated number of reported side effects and reinforcing the ``fear'' 
of receiving vaccines by those who may be uninformed.
    Response: The Department agrees. Since the scientific literature 
indicates that SIRVA and vasovagal syncope results from poor 
vaccination technique and the act of injection, rather than the vaccine 
components, removing SIRVA and vasovagal syncope from the Table would 
more accurately reflect the number of reported side effects actually 
caused by vaccine components. Such claims, which are not associated 
with vaccines or their components, therefore erroneously suggest that 
vaccines are less safe than they in fact are.
    Comment: Some commenters believe that SIRVA and vasovagal syncope 
cases submitted to the VICP has also has contributed to a delayed 
process in awarding monies to those with valid claims related to the 
vaccine itself.
    Response: The Department agrees.
    Comment: Some commenters believe the federal government is not the 
place to lodge a complaint related to the administration of a vaccine. 
The appropriate place to do this is through the traditional court 
system or through practitioner licensing boards. They believe that 
current use and the number of claims for shoulder injury in adults are 
against the intent and spirit of the original law.
    Response: The Department thanks the commenters for these comments. 
It is the Department's belief that Congress intended for the Vaccine 
Act's compensation system to be used for unavoidable injuries and 
illnesses that cannot be predicted in advance and can occur without 
fault. SIRVA and vasovagal syncope are generally not those types of 
injuries or illnesses. With proper injection technique, SIRVA is likely 
preventable. The scientific literature also suggests that those 
administering vaccines can take steps to significantly reduce the 
likelihood of vasovagal syncope.

Section IV: General Concerns

    Comment: Many commenters believed that vaccine or pharmaceutical 
companies should be solely liable for all negative side effects caused 
by their vaccines. They called for the repeal of the laws which grant 
vaccine manufactures immunity.
    Response: The National Childhood Vaccine Injury Act of 1986 was 
passed by Congress. To repeal the Act would require a statutory 
amendment and thus is not within the scope of this final rule.
    Comment: Some commenters fear that the proposed rule will disband 
the entire VICP.
    Response: This final rule is not disbanding the VICP. For the most 
part, this final rule reverts to the status quo as of January 2017. The 
one additional change, removing Item XVII, is being done because the 
Secretary has serious concerns that Item XVII does not comport with 
applicable law. All vaccines currently on the Table, and the vast 
majority of injuries currently on the Table, will remain on the Table 
after this final rule becomes effective.
    Comment: Many commenters stated that the National Vaccine Injury 
Compensation Program covers injuries caused not only by the contents of 
the vaccine, but also the administration of the vaccine. They stated 
that but for the vaccine, there would not be a faulty administration, 
and there would not be a SIRVA injury. Many other commenters stated 
that all injuries, whether caused by the contents of the vaccine or by 
faulty administration of the vaccine, should be covered by the VICP. 
Commenters stated that HHS incorrectly interpreted the Vaccine Act to 
preclude claims involving ``negligence by the vaccine administrator.'' 
This commenter stated that contrary to the HHS interpretation of the 
Act, legislative history shows that Congress expressly indicated that 
it sought to broadly cover all injuries or death associated with 
vaccine administrations.
    Response: The Secretary respectfully disagrees with the comment 
that whether or not SIRVA is caused by faulty administration the VICP 
should cover the injuries. The Department has concluded that the 
Vaccine Act should be read as not applying to cover injuries, like 
SIRVA and vasovagal syncope, which involve negligence by the vaccine

[[Page 6253]]

administrator. The Vaccine Act is ambiguous in how it handles such 
injuries, and in the Department's view there are strong reasons to 
exclude them from coverage under the Act's compensation scheme.
    The Act creates a compensation program ``for a vaccine-related 
injury or death.'' 42 U.S.C. 300aa-11(a)(1). Under the Act, ``only . . 
. a person who has sustained a vaccine-related injury or death'' can 
recover. 42 U.S.C. 300aa-11(a)(9). The Act defines ``[v]accine-related 
injury or death'' as ``an illness, injury, condition, or death 
associated with one or more of the vaccines set forth in the Vaccine 
Injury Table, except that the term does not include an illness, injury, 
condition, or death associated with an adulterant or contaminant 
intentionally added to such a vaccine.'' 42 U.S.C. 300aa-33(5) 
(emphasis added); see also Dean v. HHS, No. 16-1245V, 2018 WL 3104388, 
at * 9 (Fed. Cl. Spec. Mstr. May 29, 2018) (defining ``vaccine'' as 
``any substance designed to be administered to a human being for the 
prevention of 1 or more diseases'') (quoting 26 U.S.C. 4132(a)(2)). 
Thus, the compensation program covers injuries ``associated with'' the 
vaccine itself.
    SIRVA is not a vaccine, and it is not an injury caused by a vaccine 
antigen, but by administration of the vaccine by the health care 
provider. The Department does not think the term ``associated with'' 
was meant to sweep in injuries caused by negligent administration of 
the vaccine. Although the Act permits petitioners to recover for 
Vaccine Table injuries without demonstrating causation in individual 
cases, the term ``associated with'' nevertheless requires that the 
injury, in general, be causally related to the vaccine itself. This is 
clear both from dictionary definitions of ``associated,'' which means 
``related, connected, or combined together'' (Merriam-Webster.com 
Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/associated. Accessed 10 Jul. 2020), and from the text of the 
Act itself, see, e.g., 42 U.S.C. 300aa-22(b)(1) (focusing on injuries 
that ``resulted'' from vaccine side effects); 42 U.S.C. 300aa-
13(a)(1)(B) & (2)(B) (excluding ``trauma'' that has ``no known relation 
to the vaccine involved'').
    Importantly, in the key operative provisions discussed above, the 
phrase ``associated with'' is linked to the vaccine itself, not to the 
technique in administering the vaccine. See Decker v. Nw. Envtl. Def. 
Ctr., 568 U.S. 597, 611 (2013) (in interpreting phrase ``associated 
with industrial activity,'' the key consideration is the scope of 
``industrial activity''; the ``statute does not foreclose a more 
specific definition by the agency'' and ``a reasonable interpretation . 
. . could . . . require the discharges to be related in a direct way to 
operations at `an industrial plant' ''); Chevron, U.S.A., Inc. v. Nat. 
Resources Def. Council, Inc., 467 U.S. 837, 861 (1984) (``[T]he meaning 
of a word must be ascertained in the context of achieving particular 
objectives, and the words associated with it may indicate that the true 
meaning of the series is to convey a common idea.'').
    That basic requirement is not met with SIRVA and vasovagal syncope. 
While the act of being vaccinated may be a but-for cause of those 
injuries, the injury is not associated with the vaccine itself because, 
with proper administration technique, those injuries will not result 
from the vaccine. Rather, SIRVA and vasovagal syncope result from the 
use of improper--that is, negligent--administration technique.
    There are several indicators in the language and structure of the 
Vaccine Act that show it was not meant to cover negligent 
administration of the vaccine.
    First, as the Federal Circuit has explained, troubling issues arise 
if the Act were to apply to ``negligence facially unrelated to the 
vaccine's effects.'' Amendola v. Sec., Dept. of Health & Human Servs., 
989 F.2d 1180, 1187 (Fed. Cir. 1993). It could include, for example, 
``the doctor's negligent dropping of an infant patient'' or use of 
contaminated equipment. Id. at 1186-87. The better reading of the 
statute is that it does not reach this far.
    Second, the definition of vaccine-related injury carves out ``an 
adulterant or contaminant intentionally added to such a vaccine. 42 
U.S.C. 300aa-33(5) (emphasis added). By excluding from the definition 
those injuries associated with an adulterant or contaminant 
intentionally added to the vaccine, Congress indicated its intent to 
permit suit only where the injury was caused by the components of the 
vaccine itself, not individual fault. Relatedly, in the provisions 
setting forth the standard for awarding compensation, Congress 
specified that an award is not appropriate when injury was ``due to 
factors unrelated to the administration of the vaccine,'' and further 
defined that phrase to include ``trauma . . . which have no known 
relation to the vaccine involved.'' 42 U.S.C. 300aa-13(a)(1)(B) & 
(2)(B). In other words, Congress excluded compensation for injuries 
that were not related ``to the vaccine involved.''
    Third, the statutory scheme requires that the patient ``received a 
vaccine set forth in the Vaccine Injury Table,'' 42 U.S.C. 300aa-
11(c)(1)(A), tying compensation to the receipt of a specific listed 
vaccine. See 42 U.S.C. 300aa-11(c)(1)(C)(i) (speaking to an injury 
aggravated ``in association with the vaccine referred to'' on the 
Vaccine Injury Table); 42 U.S.C. 300aa-11(c)(1)(C)(ii)(I) (for 
conditions not on the Vaccine Injury Table, allowing proof that the 
condition ``was caused by a vaccine'' on the Table); 42 U.S.C. 300aa-
11(c)(1)(C)(ii)(II) (same). But negligent administration can occur 
without regard to the specific vaccine and, as noted above, can 
encompass anything from negligent needle placement to ``the doctor's 
negligent dropping of an infant patient.'' Amendola, 989 F.2d at 1186-
87. Congress strongly signaled that it was focused on compensation for 
harm caused by the vaccine by requiring that the Table list the 
vaccines themselves and the types of injuries the vaccines themselves 
would cause.
    Fourth, in the provision preempting state tort liability, Congress 
protected manufacturers from liability when the injury ``resulted from 
side effects that were unavoidable even though the vaccine was properly 
prepared . . .'' 42 U.S.C. 300aa-22(b)(1). This language shows Congress 
wanted to preserve a state tort remedy for certain avoidable injuries, 
such as those caused by negligent vaccine administration. Given that 
the Vaccine Act seeks to replace state tort remedies for the injuries 
it covers, this reinforces the conclusion that the Act does not reach 
SIRVA and vasovagal syncope.
    Fifth, Congress provided for health care providers who administer 
vaccines to record detailed information about the vaccination, 
including the date of administration; the manufacturer; the name of the 
provider; and other identifying information. 42 U.S.C. 300aa-25. This 
information is well suited to a program designed to compensate for 
injuries associated with the vaccine itself, since it provides the key 
details about the vaccine provided and when. But this reporting 
requirement is woefully inadequate if the Program was designed to 
compensate for negligence by the provider, which would require 
maintaining careful records regarding the actual administration of the 
vaccine.
    In setting up the original Vaccine Injury Table, Congress 
referenced conditions ``resulting from the administration of such 
vaccines.'' 42 U.S.C. 300a-14(a). But this phrase was not designed to 
define the scope of the program or the Table; instead, Congress 
directed the Secretary to add conditions

[[Page 6254]]

to the Table if they were ``associated with such vaccines.'' 42 U.S.C. 
300aa-14(e)(1)(B) & (2)(B). And it is telling that Congress included 
nothing similar to SIRVA or other injuries caused by negligent vaccine 
administration in the original Table, rather than injuries associated 
with the vaccine components themselves. Finally, that Congress asked 
the Secretary to ``make or assure improvements'' in the 
``administration'' of vaccines, 42 U.S.C. 300aa-27(a)(2), among many 
areas of improvement in the vaccination process, does not imply that 
the compensation program covers negligent administration.
    Perhaps for some or all of these reasons, state courts have found 
that injuries arising from negligent administration of a vaccine are 
not ``vaccine-related injuries'' under 42 U.S.C. 300aa-33(5), and 
therefore are not preempted by the Vaccine Act. See, e.g., Neddeau v. 
Rite Aid of Conn., 2015 WL 5133151, at *3 (Super. Ct. Conn. July 28, 
2015) (state court action did not allege a ``vaccine-related'' injury 
and therefore was not barred by the Vaccine Act, because plaintiff's 
allegation that the administrator struck the needle too high was an 
allegation that her injuries ``were caused by negligence in the 
physical process of injecting the vaccine, not by the effects of the 
vaccine''); Nwosu ex rel. Ibrahim v. Adler, 969 So. 2d 516, 519 (Ct. 
App. Fla. 2007) (claim arising from a physician's negligent injection 
of a vaccine was not a ``vaccine-related injury,'' and adding that 
``[i]t is true that had the child not been vaccinated, she would not 
have been injured. However, her injury as alleged, does not flow from 
the inoculant injected into her body [so] it is not the type of injury 
covered under the Act'').
    The Table should only include injuries caused by a vaccine or its 
components, not the manner in which the vaccine was administered. Thus, 
a petitioner must have an injury or death ``associated'' with the 
vaccine, not one resulting from poor injection technique or other 
improper administration of the vaccine. The Department believes SIRVA 
and vasovagal claims should not be included on the Table and cannot be 
based on causation in fact, because they are not injuries associated 
with vaccines or their components, nor are they unavoidable injuries or 
illnesses that cannot be predicted in advance, or that can occur 
without fault.
    Comment: Some commenters asked that this final rule be postponed 
until the new administration enters office, arguing that it is unfair 
to change the VICP in the final days of President Trump's 
administration.
    Response: Past practice has often been to finalize rules that are 
ready for finalization without waiting for the incoming Administration 
to take office.\17\ This is consistent with the Department's desire to 
as expeditiously as possible ensure the Table complies with applicable 
law.
---------------------------------------------------------------------------

    \17\ For example, fifty-six (56) new rules were finalized in the 
final two (2) full days of the previous Administration. See Federal 
Register, https://www.federalregister.gov/documents/search?conditions%5Bpublication_date%5D%5Bgte%5D=1%2F18%2F2017&conditions%5Bpublication_date%5D%5Blte%5D=1%2F20%2F2017&conditions%5Btype%5D%5B%5D=RULE.
---------------------------------------------------------------------------

    Comment: Many commenters took issue with the Department's assertion 
in the proposed rule that retaining SIRVA and vasovagal syncope 
injuries on the Table will encourage frivolous petitions for 
compensation and add to DOJ's caseload.
    Response: The proposed rule explained in detail how DOJ's caseload 
has increased since SIRVA and vasovagal syncope were added to the 
Table. DOJ had informed the Department that, out of 2,214 SIRVA claims 
filed since 2017, DOJ had identified 27 cases in which altered medical 
records have been filed, some of which involved changes to the site of 
vaccination.

Section V: SIRVA-Specific Comments

    Comment: Many commenters stated that according to medical 
literature, not all SIRVA is related to improper injection technique, 
and some or all cases of SIRVA result from the antigen itself, not just 
the needle placement in the bursa. These commenters stated that this 
undermines the Department's justification for removing SIRVA from the 
Vaccine Injury Table. They also state that HHS was incorrect to suggest 
that ``there is nearly uniform agreement in the scientific community 
that SIRVA is caused by improper vaccine administration, rather than by 
the vaccine itself.'' Other commenters stated that since medical 
literature is split on the cause of SIRVA, it should be left on the 
table until further research can be done.
    Response: There is nearly uniform agreement in the scientific 
community that SIRVA is caused by improper vaccine administration, 
rather than by the vaccine itself.\18\ Since the 2017 Final Rule was 
promulgated, additional scientific research concluded that subdeltoid 
or subacromial bursitis and other shoulder lesions are ``more likely to 
be the consequence of a poor injection technique (site, angle, needle 
size, and failure to take into account [a] patient's characteristics, 
i.e., sex, body weight, and physical constitution),'' rather than 
``antigens or adjuvants contained in the vaccines that would trigger an 
immune or inflammatory response.'' \19\ The Department has not seen 
compelling peer-reviewed publications, submitted either by the 
commenters or otherwise, that calls into question this conclusion. 
Indeed, SIRVA stands for shoulder injury related to vaccine 
administration.
---------------------------------------------------------------------------

    \18\ See Barnes MG, Ledford C, Hogan K. A ``needling'' problem: 
shoulder injury related to vaccine administration. J Am Board Fam 
Med. 2012 Nov-Dec;25(6):919-22; Cross GB, Moghaddas J, Buttery J, 
Ayoub S, Korman TM. Don't aim too high: Avoiding shoulder injury 
related to vaccine administration. Aust Fam Physician. 2016 
May;45(5):303-6.
    \19\ Mart[iacute]n Arias, K.H., Fadrique, R., S[aacute]inz Gil, 
M., and Salgueiro-Vazquez, M.E., Risk of bursitis and other injuries 
and dysfunctions of the shoulder following vaccinations, Vaccine, 
2017;35:4870-4876. See also Bancsi A, Houle SKD, Grindrod KA. 
Shoulder injury related to vaccine administration and other 
injection site events. Can. Fam. Physician. 2019 Jan;65(1):40-42 
(explaining that SIRVA ``is a preventable occurrence caused by the 
injection of a vaccine into the shoulder capsule rather than the 
deltoid muscle''); Macomb CV, Evans MO, Dockstater JE, Montgomery 
JR, Beakes DE. Treating SIRVA Early With Corticosteroid Injections: 
A Case Series. Mil Med. 2019 Oct 17 (noting that SIRVA does not 
occur unless the vaccine is mistakenly given in the shoulder 
capsule). Another recent study reviewed the Vaccine Adverse Event 
Reporting System (VAERS) database from July 2010 to June 2017 for 
reports of atypical shoulder pain and dysfunction following 
injection of inactivated influenza vaccine (IIV). See B.F. Hibbs, 
C.S. Ng, O. Museru et al., Reports of atypical shoulder pain and 
dysfunction following inactivated influenza vaccine, Vaccine Adverse 
Event Reporting System (VAERS), 2010-2017, Vaccine. The review found 
that, of the 266 reports where contributing factors for the injury 
were reported, 216 (81.2%) described the vaccination as being given 
``too high'' on the arm. Other reports described improper or poor 
administration technique (e.g., bone strikes, ``administered in 
tendon''), uneven position between vaccinator and the patient (e.g., 
vaccinator standing while patient sitting), vaccination needle too 
long, and others (e.g., difficulty injecting vaccine). A small 
minority of reports also indicated the patient had a history of 
thyroid dysfunction or diabetes. It is possible that certain 
injuries characterized as SIRVA occur when an immunologically active 
substance designed to trigger an inflammatory response (i.e., the 
vaccine antigen) is injected into an area where the inflammatory 
response can cause joint damage (i.e., the bursa or tendons) as 
opposed to an area where the inflammatory response will not cause 
joint damage or permanent harm (i.e., the deltoid muscle). Such 
injuries are fairly characterized as resulting from the vaccination 
technique, since they would not have occurred if the injection 
occurred in the proper part of the body.
---------------------------------------------------------------------------

    Comment: Many commenters wrote about their SIRVA injuries and 
experiences with treatment and therapy. Many received or were in the 
process of receiving compensation through the VICP. They stressed the 
pain and suffering they went through due to a badly administered 
vaccine and asked for SIRVA to remain on the Table. They believe they 
deserve just compensation

[[Page 6255]]

for their SIRVA injury through the VICP. These commenters stressed that 
the compensation is needed for treatments, pain and suffering, lost 
wages, and to help cover expenses while they are unable to work. They 
stressed that their SIRVA injuries make employment or career 
advancement extremely difficult, and many could no longer work in their 
chosen fields.
    Response: The Department sympathizes with those who suffered an 
injury, but it is the Department's belief that Congress intended for 
the Vaccine Act's compensation system to be used for unavoidable 
injuries and illnesses that cannot be predicted in advance and can 
occur without fault. SIRVA is generally not that type of injury or 
illness. Moreover, under this final rule, those with SIRVA injuries are 
not barred from suing those who injured them in state court. Those 
injured still have an opportunity to be compensated by the faulty 
party.
    Comment: Many commenters asked what their recourse for SIRVA 
injuries would be if it is removed from the Table. Many other 
commenters believe that removal of SIRVA from the Table will eliminate 
any recourse for patients of improperly administered vaccines.
    Response: Under this final rule, those with SIRVA injuries are not 
barred from suing those who injured them in state court (or in federal 
court if the requirements for diversity jurisdiction under 28 U.S.C. 
1332 are satisfied).
    Comment: Many commenters believe that vaccine administration by 
poorly trained and minimally qualified staff is what leads to a high 
number of SIRVA cases, so the Government should provide more training, 
guidelines, and supervision of medical staff and companies that 
administer vaccines. These commenters suggest mandating more vaccine 
administration training and certification. Some suggested that funds 
from the VICP should be set aside to train providers with the proper 
technique of vaccine administration. They believe that unless there is 
more regulation for continuous training on injection administration, 
SIRVA should not be removed from the table.
    Response: The Department agrees that SIRVA is caused by improper 
vaccine administration. The Department is grateful for the many health 
care professionals and pharmacists who improve public health by 
vaccinating the American public, and does not believe they would 
intentionally administer a vaccine in an improper manner, but the 
Department also wants to incentivize those who administer vaccines to 
do so properly. Doing so will improve public confidence in 
vaccinations. Removing SIRVA from the Table further incentivizes 
learning proper administration technique. The Department agrees that 
proper vaccine administration is critical to ensure that vaccination is 
safe and effective. CDC provides recommendations on vaccine 
administration technique, many of which can be found at https://www.cdc.gov/vaccines/hcp/admin/admin-protocols.html.
    Comment: Some commenters opposed removing SIRVA from the Table, but 
stress that since the injury is caused by faulty administration, the 
person administering the vaccine and causing the injury should be held 
accountable.
    Response: While the Department disagrees with the suggestion to 
keep SIRVA on the Table, the Department understands the desire to hold 
accountable those who cause injury by using faulty administration. If 
those who administer vaccines can be held liable when a patient suffers 
from SIRVA as a result of the administration of the vaccine, those who 
administer vaccines will have greater incentive to use proper injection 
technique. The Department is grateful for the many health care 
professionals and pharmacists who improve public health by vaccinating 
the American public, and does not believe they would intentionally 
administer a vaccine in an improper manner, but awarding no-fault 
compensation from the VICP to those with SIRVA and vasovagal syncope 
claims lessens the incentive to take appropriate precautions. Since 
Vaccine Act proceedings are generally sealed and not made available to 
the public, vaccine administrators may be left unaware that they used 
an improper technique. If SIRVA and vasovagal syncope are included in 
the Table, petitioners will continue to seek to recover from the VICP, 
where they can recover more easily because they need not prove 
causation, rather than from those who failed to properly administer the 
vaccine.
    Comment: A commenter suggested increasing the VICP tax to help 
cover all SIRVA injuries and support more administration training.
    Response: The Department lacks the authority to increase the VICP 
tax, and this is beyond the scope of this final rule.
    Comment: Some commenters threatened that if SIRVA is removed from 
the Table, they will wage a campaign to discourage the public at large 
from receiving flu vaccines.
    Response: Flu vaccines have a good safety record. Hundreds of 
millions of Americans have safely received flu vaccines over the past 
50 years, and there has been extensive research supporting the safety 
of flu vaccines. A flu vaccine is the first and best way to reduce your 
chances of getting the flu and spreading it to others. CDC recommends 
that everyone 6 months of age and older receive a flu vaccine every 
year. More information on the safety of flu vaccines can be found at 
https://www.cdc.gov/flu/prevent/general.htm. The Department anticipates 
that this final rule may result in fewer individuals suffering from 
SIRVA or vasovagal syncope, because it will better incentivize those 
administering vaccines to use proper injection technique.
    Comment: Commenters believe the general public should be better 
informed about the risk of SIRVA. Some suggestions included an ad 
campaign, or informational pamphlets handed out before vaccine 
injection. One commenter suggested that all patients should receive the 
entire list of ingredients of all vaccines before they consent to the 
vaccine.
    Response: All healthcare providers (as defined in the Vaccine Act) 
are required by the Vaccine Act (42 U.S.C. 300aa-26) to give the 
appropriate VIS or Vaccine Information Statement to the patient (or 
parent or legal representative) prior to every administration of 
specific vaccines. A VIS or Vaccine Information Statement is a 
document, produced by CDC, that informs vaccine recipients--or their 
parents or legal representatives--about the benefits and risks of a 
vaccine they are receiving. Such materials shall be revised ``(1) after 
notice to the public and 60 days of comment thereon, and (2) in 
consultation with the Advisory Commission on Childhood Vaccines, 
appropriate health care providers and parent organizations, the Centers 
for Disease Control and Prevention, and the Food and Drug 
Administration.'' 42 U.S.C. 300aa-26(b). Since the aforementioned 
statutory required steps were not taken prior to the proposed rule, the 
commenter's suggestions are outside the scope of this final rule. 
Further information about vaccine ingredients can be found at https://www.cdc.gov/vaccines/vac-gen/additives.htm.
    Comment: Many commenters stress that HHS has drastically changed 
its position since March 21, 2017 when it adopted the Final Rule adding 
SIRVA to the Vaccine Injury Table. Commenters point to past 
Departmental interpretations of SIRVA and vasovagal syncope, and the 
inclusion of these injuries as covered under the VICP. They argue that 
the Department does not have an adequate bases for changing

[[Page 6256]]

its interpretation of these injuries. Moreover, the Department has 
concluded that there are strong policy reasons for now removing SIRVA 
from the Table.
    Response: As discussed above, it is the Department's belief that 
vasovagal syncope is not a ``vaccine-related injury'' and therefore 
should not be included on the Table or compensable under the VICP. 42 
U.S.C. 300aa-11, 300aa-14(e), and the inclusion of the injury in 2017 
was incorrect.
    Comment: Many commenters believe that SIRVA should remain on the 
table because ``No evidence has been presented by DHHS justifying the 
removal of these injuries.''
    Response: The scientific literature indicates that SIRVA likely 
results from poor vaccination technique, rather than the vaccine or its 
components alone. The notice of proposed rulemaking that preceded the 
Final Rule characterized SIRVA as an ``adverse event following 
vaccination thought to be related to the technique of intramuscular 
percutaneous injection (the procedure where access to a muscle is 
obtained by using a needle to puncture the skin) into an arm resulting 
in trauma from the needle and/or the unintentional injection of a 
vaccine into tissues and structures lying underneath the deltoid muscle 
of the shoulder.'' \20\ The IOM similarly concluded that ``the 
injection, and not the contents of the vaccine, contributed to the 
development of deltoid bursitis.'' \21\ Indeed, the primary case series 
relied upon by the Department in promulgating the proposed rule and 
Final Rule found that the medical literature supports the possibility 
that SIRVA may result from inappropriate needle length and/or injection 
technique.\22\ There is nearly uniform agreement in the scientific 
community that SIRVA is caused by improper vaccine administration, 
rather than by the vaccine itself.\23\ Since the Final Rule was 
promulgated, additional scientific research concluded that subdeltoid 
or subacromial bursitis and other shoulder lesions are ``more likely to 
be the consequence of a poor injection technique (site, angle, needle 
size, and failure to take into account [a] patient's characteristics, 
i.e., sex, body weight, and physical constitution),'' rather than 
``antigens or adjuvants contained in the vaccines that would trigger an 
immune or inflammatory response.'' \24\
---------------------------------------------------------------------------

    \20\ National Vaccine Injury Compensation: Revision to the 
Vaccine Injury Table (``2015 Proposed Rule''), 80 FR 45132, 45136 
(July 29, 2015) (emphasis supplied); see also Adverse Effects of 
Vaccines: Evidence and Causality (``IOM Report''), at 620, available 
at https://www.nap.edu/catalog/13164/adverse-effects-of-vaccines-evidence-and-causality.
    \21\ IOM Report at 620. SIRVA is a medicolegal term, not a 
medical diagnosis, that is meant to capture a broad array of 
potential shoulder injuries. However the IOM only made findings 
concerning deltoid bursitis.
    \22\ Atanasoff S, Ryan T, Lightfoot R, and Johann Liang R, 2010, 
Shoulder injury related to vaccine administration (SIRVA), Vaccine 
28(51): 8049-52 (recommending that injections avoid the top third of 
the deltoid muscle to avoid shoulder injury).
    \23\ See Barnes MG, Ledford C, Hogan K. A ``needling'' problem: 
Shoulder injury related to vaccine administration. J Am Board Fam 
Med. 2012 Nov-Dec; 25(6):919-22; Cross GB, Moghaddas J, Buttery J, 
Ayoub S, Korman TM. Don't aim too high: Avoiding shoulder injury 
related to vaccine administration. Aust Fam Physician. 2016 May; 
45(5):303-6.
    \24\ Mart[iacute]n Arias, K.H., Fadrique, R., S[aacute]inz Gil, 
M., and Salgueiro-Vazquez, M.E., Risk of bursitis and other injuries 
and dysfunctions of the shoulder following vaccinations, Vaccine, 
2017; 35: 4870-4876. See also Bancsi A, Houle SKD, Grindrod KA. 
Shoulder injury related to vaccine administration and other 
injection site events. Can. Fam. Physician. 2019 Jan; 65(1): 40-42 
(explaining that SIRVA ``is a preventable occurrence caused by the 
injection of a vaccine into the shoulder capsule rather than the 
deltoid muscle''); Macomb CV, Evans MO, Dockstater JE, Montgomery 
JR, Beakes DE. Treating SIRVA Early With Corticosteroid Injections: 
A Case Series. Mil Med. 2019 Oct 17 (noting that SIRVA does not 
occur unless the vaccine is mistakenly given in the shoulder 
capsule). Another recent study reviewed the Vaccine Adverse Event 
Reporting System (VAERS) database from July 2010 to June 2017 for 
reports of atypical shoulder pain and dysfunction following 
injection of inactivated influenza vaccine (IIV). See B.F. Hibbs, 
C.S. Ng, O. Museru et al., Reports of atypical shoulder pain and 
dysfunction following inactivated influenza vaccine, Vaccine Adverse 
Event Reporting System (VAERS), 2010-2017, Vaccine. The review found 
that, of the 266 reports where contributing factors for the injury 
were reported, 216 (81.2%) described the vaccination as being given 
``too high'' on the arm. Other reports described improper or poor 
administration technique (e.g., bone strikes, ``administered in 
tendon''), uneven position between vaccinator and the patient (e.g., 
vaccinator standing while patient sitting), vaccination needle too 
long, and others (e.g., difficulty injecting vaccine). A small 
minority of reports also indicated the patient had a history of 
thyroid dysfunction or diabetes. It is possible that certain 
injuries characterized as SIRVA occur when an immunologically active 
substance designed to trigger an inflammatory response (i.e., the 
vaccine antigen) is injected into an area where the inflammatory 
response can cause joint damage (i.e., the bursa or tendons) as 
opposed to an area where the inflammatory response will not cause 
joint damage or permanent harm (i.e., the deltoid muscle). Such 
injuries are fairly characterized as resulting from the vaccination 
technique, since they would not have occurred if the injection 
occurred in the proper part of the body.
---------------------------------------------------------------------------

    Comment: Some commenters stated that HHS's justification for 
removing SIRVA from the VICP does not comport with best available 
science, because, although HHS correctly states that SIRVA and syncope 
are considered to be adverse injuries following direct trauma from an 
injection point, ``negligent administration'' and ``poor vaccination 
technique'' are not exclusively connected with the onset of SIRVA and 
syncope-related injuries. Commenters stated that the agency did not 
consider that serious injuries may occur following the onset of SIRVA 
or a syncope-related event.
    Response: It is possible that serious injuries may occur following 
the onset of SIRVA or a syncope-related event, but the scientific 
literature suggests such injuries generally result from the act of 
injection, rather than the vaccine or its components. That negligent 
administration or poor vaccination technique may also be connected with 
other injuries does not change the Department's conclusions.
    Comment: Some commenters stated that SIRVA injuries are not as rare 
as the Department states. They state that due to lack of information, 
many SIRVA injuries are not recognized or reported.
    Response: The Department did not state that SIRVA injuries are 
rare.
    Comment: Some commenters argue that medical literature supports 
that SIRVA alone cannot result from negligent administration of a 
vaccine, because these injuries are a combination of both (1) the 
needle placed into the subacromial bursa and (2) the vaccine components 
that are needed to cause the immune response, resulting in SIRVA.
    Response: It is possible that certain injuries characterized as 
SIRVA occur when an immunologically active substance designed to 
trigger an inflammatory response (i.e., the vaccine antigen) is 
injected into an area where the inflammatory response can cause joint 
damage (i.e., the bursa or tendons) as opposed to an area where the 
inflammatory response will not cause joint damage or permanent harm 
(i.e., the deltoid muscle). Such injuries are fairly characterized as 
resulting from the vaccination technique, since they would not have 
occurred if the injection occurred in the proper part of the body.

Section VI: Vasovagal Syncope Specific Concerns

    Comment: Some commenters shared their negative experiences with 
vasovagal syncope. One commenter said he was left alone after receiving 
a vaccine, which resulted in severe injuries to his face and causing 
him to need extensive medical treatment. He stated that the VICP is the 
only recourse to financial compensation for pain and suffering, since 
Texas malpractice laws make it difficult to obtain compensation.
    Response: The Department sympathizes with those who suffered an 
injury, but it is the Department's belief that Congress intended for 
the Vaccine Act's compensation system to be used for unavoidable 
injuries and illnesses

[[Page 6257]]

that cannot be predicted in advance and can occur without fault. 
Vasovagal syncope is generally not that type of injury or illness. 
Scientific and medical literature support the conclusion that syncope 
may be caused by the act of vaccination, but not its contents.\25\ 
Texas state malpractice laws are beyond the scope of this final rule.
---------------------------------------------------------------------------

    \25\ 80 FR 45,137 (The IOM found that one case report suggested 
that ``the injection, and not the contents of the vaccine, 
contributed to the development of syncope''). See also IOM Report at 
18 (``injection of vaccine, independent of the antigen involved, can 
lead to'' syncope); Miller, E. and Woo, E.J. Time to prevent 
injuries from postimmunization syncope, Nursing, 2006 36 (12): 20.
---------------------------------------------------------------------------

    Comment: Some commenters stated that contrary to the Department's 
position that vasovagal syncope is not a vaccine-related injury, the 
IOM found ``sufficient mechanistic evidence supporting the conclusion 
that syncope is `directly related to vaccine administration,' '' and 
that the CDC has reported people fainting after receiving nearly all 
vaccines. While the commenters agree that steps can be taken to reduce 
the risk of syncope, they state that it should remain on the Injury 
Table.
    Response: The IOM found insufficient epidemiologic evidence of an 
association between the injection of a vaccine and syncope, but it 
found sufficient mechanistic evidence supporting the conclusion that 
syncope is ``directly related to vaccine administration.'' \26\ The IOM 
explained that evidence it examined as part of its review suggested 
``that the injection, and not the contents of the vaccine, contributed 
to the development of syncope.'' \27\ In addition, because syncope is 
an injury related solely to the injection of a vaccine, the Department 
did not add syncope to the 2017 revisions to the Table as an injury for 
vaccines that are not administered by injection, such as oral polio and 
rotavirus vaccine.
---------------------------------------------------------------------------

    \26\ 80 FR 45137.
    \27\ 80 FR 45137. See also IOM Report.
---------------------------------------------------------------------------

    Comment: One commenter stated that removing syncope from the table 
would go against three decades of precedent and the weight of the 
medical evidence.
    Response: The Department respectfully disagrees. Vasovagal syncope 
was not added to the Table until 2017. From the inception of the Table 
until 2017, vasovagal syncope is not included.

Section VII: Comments Regarding Item VII

    Comment: Some commenters are concerned that removing Item XVII from 
the Table will remove an avenue to add new vaccines to the Table.
    Response: The Department is removing Item XVII from the table 
because it has serious concerns that Item XVII is contrary to law, 
including the procedures described in the Vaccine Act for amending the 
Table. Specifically, to the extent that Item XVII provides a unilateral 
mechanism for adding injuries and vaccines to the Table, it may be 
inconsistent with the Vaccine Act. The Vaccine Act provides a method 
for adding new vaccines to the Table, and it is far from clear that the 
approach in Item XVII complies with that method. The Vaccine Act 
provides that the Secretary may promulgate regulations to modify the 
Table, but in doing so, he ``shall provide for notice and opportunity 
for a public hearing and at least 180 days of public comment.'' \28\ 
Moreover, the Table cannot be revised unless ``the Secretary has first 
provided to the [ACCV] a copy of the proposed regulation or revision, 
requested recommendations and comments by the [ACCV], and afforded the 
[ACCV] at least 90 days to make such recommendations.'' \29\ Item XVII, 
by contrast, suggests that vaccines are added to the Table once the CDC 
recommends them for routine administration to children and an excise 
tax is imposed, even prior to notice and public comment or comments 
from the ACCV.\30\ This may be inconsistent with the rulemaking 
requirements of the Administrative Procedure Act 5 U.S.C. 553, the 
Regulatory Flexibility Act, 5 U.S.C. 601 et seq., various Executive 
Orders that cabin rulemaking (see, e.g., Executive Order 12866), and 
the Vaccine Act.
---------------------------------------------------------------------------

    \28\ 42 U.S.C. 300aa-14(c)(1).
    \29\ 42 U.S.C. 300aa-14(d).
    \30\ The language in Item XVII also raises Constitutional 
concerns. Item XVII in effect allows CDC to add vaccines to the 
Table so long as the Secretary publishes notice of coverage. The 
Office of Legal Counsel has previously opined that a statute that 
sought to authorize the CDC director to take certain action 
unilaterally was inconsistent with the Executive Powers Clause. 
(Statute Limiting The President's Authority To Supervise The 
Director Of The Centers For Disease Control In The Distribution Of 
An AIDS Pamphlet, 12 U.S. Op. Off. Legal Counsel 47, 48, 1988 WL 
390999, at * 1). For the same reasons, it is not clear that the CDC 
director, as an inferior officer, has the authority to unilaterally 
add vaccines to the Table without the approval of the Secretary.
---------------------------------------------------------------------------

    Moreover, even with the removal of Item XVII, new vaccines may be 
added to the Table under 42 U.S.C. 300aa-14(d), when appropriate.
    Comment: One commenter stated that HHS's argument that Item XVII is 
unlawful is without merit. Article I of the Constitution provides 
Congress the authority to delegate responsibilities to independent 
agencies, and the Vaccine Act expressly provides that HHS shall amend 
the Vaccine Injury Table to include any CDC vaccine recommended for 
routine childhood use within two years. According to this commenter, 
Congress provided the CDC with an autonomous role in the VICP process, 
and its recommendations are separate from administrative action by HHS. 
Therefore, commenters stated that Item XVII is lawful.
    Response: The Vaccine Act provides that the Secretary may 
promulgate regulations to modify the Table, but in doing so, he ``shall 
provide for notice and opportunity for a public hearing and at least 
180 days of public comment.'' \31\ Moreover, the Table cannot be 
revised unless ``the Secretary has first provided to the [ACCV] a copy 
of the proposed regulation or revision, requested recommendations and 
comments by the [ACCV], and afforded the [ACCV] at least 90 days to 
make such recommendations.'' \32\ Item XVII, by contrast, suggests that 
vaccines are added to the Table once the CDC recommends them for 
routine administration to children and an excise tax is imposed, even 
prior to notice and public comment or comments from the ACCV.
---------------------------------------------------------------------------

    \31\ 42 U.S.C. 300aa-14(c)(1).
    \32\ 42 U.S.C. 300aa-14(d).
---------------------------------------------------------------------------

    Comment: One commenter stated that Item XVII does have merit, 
especially because it streamlines the process to allow for quicker 
inclusions of important vaccines. This commenter stated that this is 
especially important and timely due to the impact of the COVID-19 
pandemic and the need to provide quick compensation for COVID-19 
vaccine-related injuries or deaths. Removing Item XVII would just 
frustrate the stated purpose of the Vaccine Act.
    Response: The Department appreciates the desire to quickly add 
vaccines to the Table. However Congress in 42 U.S.C. 300aa-14 specified 
the procedures that must be followed to amend the Table. In addition, 
an excise tax would have to be imposed.
    Comment: A few commenters opposed the removal of the mechanism to 
add vaccines to the Table under item XVII. According to the commenters, 
the proposed rule would stop the automatic addition of COVID-19 and 
other new vaccines to the VICP, which could potentially delay or 
permanently prevent the COVID-19 vaccine from being covered under the 
VICP, and subjecting administrators to lawsuits in the future. 
Commenters suggested that

[[Page 6258]]

this policy change is seemingly at odds with the actions undertaken by 
HHS to expand liability protections for administrators under 
authorities granted in the PREP Act.
    Response: The Department appreciates the desire to quickly add 
vaccines to the Table. However Congress in 42 U.S.C. 300aa-14 specified 
the procedures that must be followed to amend the Table. In addition, 
an excise tax would have to be imposed. During the effective period of 
the Secretary's COVID-19 PREP Act declaration, Covered Persons are 
already immune from suit and liability under Federal and State law with 
respect to all claims for loss caused by, arising out of, relating to, 
or resulting from the administration to or the use by an individual of 
FDA-approved or FDA-licensed COVID-19 vaccines (unless they engage in 
willful misconduct that causes death or serious physical injury). See 
42 U.S.C. 247d-6d.

Section VIII: Miscellaneous Comments

    Comment: A commenter asked that the license for the Hepatitis B 
Vaccine be revoked until further safety studies are done.
    Response: This is beyond the scope of this final rule. For more 
information on the safety of this vaccine, see https://www.cdc.gov/hepatitis/hbv/bfaq.htm#bFAQd04; https://www.cdc.gov/vaccines/hcp/vis/vis-statements/hep-b.html.
    Comment: Some commenters believe that all vaccines should be 
automatically added to the VICP. Other commenters asked for specific 
vaccines to be added to the Table immediately.
    Response: In 42 U.S.C. 300aa-14(c)-(d), Congress specified 
procedures that the Department must follow to add vaccines to the 
Table. In revising the Table, the Department must follow these 
procedures. The Department notes, though, that if a vaccine is in a 
category of vaccines that is already covered by the VICP, then the new 
vaccine product is already covered even before the date of licensure. 
For example, hepatitis B vaccines are covered under the Program under 
Category VIII of the Vaccine Injury Table. If a new hepatitis B vaccine 
is licensed in the U.S., it is already automatically covered under the 
VICP. Adding specific vaccines to the Table in this final rule is 
likely impermissible under the Administrative Procedure Act and the 
logical outgrowth doctrine. Such vaccines could be added in a separate 
rulemaking.
    Comment: Many commenters stressed that vaccines should be changed 
so they do not need to be administered with a shot.
    Response: This is beyond the scope of this final rule.
    Comment: Some commenters believed that any and all mandatory 
vaccines should be covered. Specifically, a commenter expressed her 
anger over a ``mandatory'' TD shot to travel out of the country.
    Response: There are no vaccination requirements for visitors to the 
United States, and U.S. residents traveling abroad do not need any 
vaccines to reenter the United States. Many vaccines are recommend by 
the CDC and primary care doctors when travelling outside the United 
States, but they are not mandatory under federal law.\33\
---------------------------------------------------------------------------

    \33\ For more information on Vaccines recommended for 
international travel: https://wwwnc.cdc.gov/travel/destinations/
traveler/none/united-
states#:~:text=There%20are%20no%20vaccination%20requirements,reenter%
20the%20United%20States. (last viewed Jan. 2021).
---------------------------------------------------------------------------

    Comment: One commenter said it was unfair that the Table does not 
include heart conditions, because they were diagnosed with Pericarditis 
24 hours after receiving the DMMR vaccine.
    Response: To gain entitlement to compensation under the VICP, a 
petitioner must establish that a vaccine-related injury or death has 
occurred, either by proving that a vaccine actually caused or 
significantly aggravated an injury (causation-in-fact) or by 
demonstrating what is referred to as a ``Table injury.'' That is, a 
petitioner may show that the vaccine recipient (1) received a vaccine 
covered under the Act; (2) suffered an injury of the type enumerated in 
the regulations at 42 CFR 100.3--the ``Table''--corresponding to the 
vaccination in question; and (3) that the onset of such injury took 
place within the time period specified in the Table. If so, the injury 
is presumed to have been caused by the vaccine, and the petitioner is 
entitled to compensation (assuming that other requirements are 
satisfied), unless the respondent affirmatively shows that the injury 
was caused by some factor unrelated to the vaccination (see 42 U.S.C. 
300aa-11(c)(1)(C)(i), 300aa-13(a)(1)(B), and 300aa-14(a)). Whether to 
add heart conditions to the Table is beyond the scope of this final 
rule.
    Comment: A commenter expressed concern that CDC guidelines for 
vaccine administration are not followed, which is leading to SIRVA and 
vasovagal syncope. Some commenters believe that pharmacies should not 
be allowed to administer vaccines if injuries such as SIRVA and 
Vasovagal Syncope are occurring.
    Response: The Department is grateful for the many health care 
professionals and pharmacists who improve public health by vaccinating 
the American public, and does not believe they would intentionally 
administer a vaccine in an improper manner, but the Department also 
wants to incentivize those who administer vaccines to do so properly. 
Doing so will improve public confidence in vaccinations. Removing SIRVA 
from the Table further incentivizes learning proper administration 
technique. The Department agrees that proper vaccine administration is 
critical to ensure that vaccination is safe and effective. CDC provides 
recommendations on vaccine administration technique, many of which can 
be found at https://www.cdc.gov/vaccines/hcp/admin/admin-protocols.html. Whether pharmacists should be allowed to vaccinate is 
beyond the scope of this final rule.
    Comment: One commenter believed that instead of removing SIRVA and 
vasovagal syncope from the Table, a new department should be created to 
deal exclusively with injuries caused by vaccine administration.
    Response: Only Congress, not the Department, has the authority to 
create a new department to deal exclusively with injuries caused by 
vaccine administration.
    Comment: One commenter suggested that vaccine companies should be 
mandated to set apart part of their profits to help fund the National 
Vaccine Injury Compensation Program (VICP).
    Response: The source of funding for the VICP is the Vaccine Injury 
Compensation Trust Fund (Trust Fund). The Trust Fund is already funded 
by an excise tax on each dose of vaccines recommended by the CDC for 
routine administration to children. To the extent that the commenter is 
proposing a change to the funding mechanism for the VICP, effectuating 
such a change is beyond the scope of this final rule.
    Comment: Some commenters believed that all those injured should be 
able to go to their local court and file claims.
    Response: Under 42 U.S.C. 300aa-11(a)(2), no person may bring a 
civil action for damages in an amount greater than $1,000 or in an 
unspecified amount against a vaccine administrator or manufacturer in a 
State or Federal court for damages arising from a vaccine-related 
injury or death associated with the administration of a vaccine after 
October 1, 1988, and no such court may award damages in an amount 
greater than $1,000 in a civil action for damages for such a vaccine-
related injury or

[[Page 6259]]

death, unless the person has first filed a petition in the Court. This 
is mandated by statute, and the Department does not have the authority 
to change this.
    Comment: Some commenters believe that removing SIRVA and Vasovagal 
syncope will result in burdensome and time consuming litigation that is 
unfair to those injured since they would have to provide evidentiary 
support in state court. They also believe that the claims will clog up 
federal, state, and local courts. Other commenters suggested that 
removing these injuries from the VICP will lead to claim suppression 
because many individuals will not have the resources to pursue their 
claims in court.
    Response: It is the Department's position that if SIRVA and 
vasovagal syncope were removed from the Table, individuals could still 
file SIRVA and vasovagal syncope claims in state court, or Federal 
district court if they satisfy the requirements of 28 U.S.C. 1332 or 28 
U.S.C. 1367. Once in those court, petitioners would be required to 
prove causation between the manner of administration and the claimed 
injury.
    Further, this final rule is unlikely to unduly burden the civil 
tort system. The Department conducted a search in the WestLaw legal 
database for cases in state court that contained both the terms 
``SIRVA'' and ``vaccine,'' and found only 20 hits, at least two of 
which were cases involving an entity named SIRVA and not the injury. It 
is possible that some additional cases were filed in federal district 
court. Nonetheless, the Department believes based on this data that any 
additional burden on the civil tort system, which would be dispersed 
across States and not concentrated in any one or few States, from 
removing SIRVA and vasovagal syncope from the Table and reverting to 
the status quo as of January 2017 will be minimal.
    Comment: Some commenters worry that removing SIRVA and vasovagal 
syncope from the Table will result in doctors and pharmacists being 
unwilling to administer vaccines because they fear personal liability.
    Response: The Department is grateful for the many health care 
professionals and pharmacists who improve public health by vaccinating 
the American public, and does not believe they would intentionally 
administer a vaccine in an improper manner, but the Department also 
wants to incentivize those who administer vaccines to do so 
properly.\34\ Doing so will improve public confidence in vaccinations. 
Many physicians and pharmacists were willing to administer vaccines 
prior to SIRVA and vasovagal syncope's addition to the Table in 2017. 
In addition, certain pharmacists are already immune from suit and 
liability for claims for loss caused by, arising out of, relating to, 
or resulting from the administration of certain childhood vaccines to 
individuals ages three through 18 for the duration of the Secretary's 
Declaration Under the Public Readiness and Emergency Preparedness Act 
for Medical Countermeasures Against COVID-19.\35\
---------------------------------------------------------------------------

    \34\ See Frakes, M., & Jena, A.B. (2016). Does Medical 
Malpractice Law Improve Health Care Quality?. Journal of public 
economics, 143, 142-158. https://doi.org/10.1016/j.jpubeco.2016.09.002 (Finding ``evidence suggesting that treatment 
quality may improve upon reforms that expect physicians to adhere to 
higher quality clinical standard'').
    \35\ See 85 FR 52,136, 52140 (Aug. 24, 2020).
---------------------------------------------------------------------------

    Comment: Commenters suggest that the tax on flu vaccines that 
sustain the VICP fund should be returned to the doctors, pharmacists, 
and other vaccine administrators so that individuals injured by 
administration can sue the provider directly.
    Response: The source of funding for the VICP is the Trust Fund. The 
Trust Fund is funded by an excise tax on each dose of vaccines 
recommended by the CDC for routine administration to children. To the 
extent that the commenter is proposing a change to the funding 
mechanism for the VICP, effectuating such a change is beyond the scope 
of this final rule.
    Comment: Some commenters asked that all time limits for injuries be 
removed from the VICP.
    Response: Revision of the statute of limitations would require a 
statutory amendment and thus is not within the scope of this final 
rule.
    Comment: Many commenters wrote about their personal negative 
reactions to vaccine components.
    Response: These comments are outside the scope of this rulemaking, 
since the scientific literature indicates that SIRVA and vasovagal 
syncope results from poor vaccination technique and the act of 
injection, rather than the vaccine components.
    Comment: Some commenters asked that vaccine injury reporting be 
significantly improved to reflect all injuries caused by vaccine 
components. Some asked that reporting to the Vaccine Adverse Event 
Reporting System (VAERS) be mandatory. A commenter referenced the 
Harvard Pilgrim Health Care report which found that less than 1 percent 
of vaccine adverse events are reported.
    Response: This final rule concerns the VICP, which is distinct from 
the Vaccine Adverse Event Reporting System. As such, these comments are 
outside the scope of this final rule.
    Comment: Two commenters opposed removing SIRVA from the Table 
because they stated that they have seen compensation greatly help those 
injured by providing resources for rehab treatment.
    Response: The Department sympathizes with those who suffered an 
injury, but it is the Department's belief that Congress intended for 
the Vaccine Act's compensation system to be used for unavoidable 
injuries and illnesses that cannot be predicted in advance and can 
occur without fault. SIRVA is generally not that type of injury or 
illness. Moreover, under this final rule, those with SIRVA injuries are 
not barred from suing those who injured them in state court. Those 
injured still have an opportunity to be compensated.
    Comment: Many commenters believe that the proposed rule changes are 
contrary to the legislative intent behind the creation of the vaccine 
injury compensation program, namely providing fair and prompt 
compensation to those individuals that have suffered well recognized 
injuries related to certain vaccines whilst shielding the 
pharmaceutical and medical industries from significant exposure.
    Response: The Department explained in the proposed rule \36\ and 
elsewhere herein why this final rule is consistent with Congressional 
intent.
---------------------------------------------------------------------------

    \36\ See 85 FR 43,796-43,797.
---------------------------------------------------------------------------

    Comment: Some commenters stated that it was the intention of 
Congress to centralize claims for compensation out of hundreds of tort 
venues to a centralized administrative compensation system, and 
removing SIRVA and vasovagal syncope is contrary to that congressional 
intent.
    Response: The Department explained in the proposed rule \37\ and 
elsewhere herein why this final rule is consistent with Congressional 
intent. SIRVA and vasovagal syncope are not the sorts of injuries that 
Congress intended for inclusion in the Table.
---------------------------------------------------------------------------

    \37\ See 85 FR 43,796-43,797.
---------------------------------------------------------------------------

    Comment: Many commenters believe that the proposed rule change will 
result in exposing pharmaceutical companies to liability and will 
inadvertently ``chill'' vaccine production.
    Response: For the most part, this final rule merely reverts to the 
status quo as of January 2017. In fact, the vaccination rate has gone 
down slightly since SIRVA and vasovagal syncope were added to

[[Page 6260]]

the Table,\38\ so it seems unlikely that this final rule will ``chill'' 
vaccine production.
---------------------------------------------------------------------------

    \38\ See, e.g., https://www.cdc.gov/flu/fluvaxview/coverage-1718estimates.htm; https://www.cdc.gov/nchs/data/hus/2018/031.pdf.
---------------------------------------------------------------------------

    Comment: Many commenters stated that there is no data supporting 
the Department's position that the trust fund is running out of money. 
These commenters state that without this data, HHS should not change 
the Vaccine Injury Table.
    Response: SIRVA claims are diminishing the Trust Fund.\39\ The 
Department did not state that the Trust Fund is running out of money. 
The Department is finalizing this final rule for a combination of legal 
and policy reasons explained herein and in the proposed rule, not 
solely because any particular claims are diminishing the Trust Fund.
---------------------------------------------------------------------------

    \39\ 85 FR 43,798.
---------------------------------------------------------------------------

    Comment: Many commenters do not believe that reducing the caseload 
of the VICP is a plausible justification to change the Injury Table. 
Others believe that the VICP should just hire more people to help 
process the caseload.
    Response: The Department is finalizing this final rule for a 
combination of legal and policy reasons explained herein and in the 
proposed rule, not solely because of caseload concerns.
    Comment: Some commenters stated that limiting VICP claims would be 
harmful to families because if individuals and their families are 
inadequately compensated for injuries or death, they can be 
economically harmed. These costs could also be passed on to taxpayers 
when injured individuals and their families are forced to resort to 
extreme measures such as filing for bankruptcy.
    Response: If SIRVA and vasovagal syncope were removed from the 
Table, individuals could still file SIRVA and vasovagal syncope claims 
in state court.\40\
---------------------------------------------------------------------------

    \40\ Or Federal district court if they satisfy the requirements 
of 28 U.S.C. 1332 or 28 U.S.C. 1367.
---------------------------------------------------------------------------

    Comment: Some commenters stated that HHS's interpretation of 
Section 300aa-11(a)(2)(A) of the Vaccine Act is flawed because it 
interprets ``associated with the vaccine'' to mean that the injury must 
come from the vaccine itself instead of from the administration of the 
vaccine. The Department relies on a dictionary definition of 
``associated with'' to conclude that it means ``related, connected, or 
combined together,'' but does not explain why this definition 
forecloses cases in which the vaccine ``combine[s] together'' with its 
administration to bring about the illness. Furthermore, the phrase 
``associated with the administration of the vaccine'' is not qualified. 
Congress could have said ``associated with the non-negligent 
administration of the vaccine'' or ``associated with the proper 
administration of the vaccine.'' Commenters suggested that if (as HHS 
states in the proposed rule) Congress intended to cover only those 
injuries associated with some ``antigen,'' then lawmakers would have 
used that word somewhere in the Act.
    Commenters stated that according to the tort law principles in 
which the Vaccine Act is grounded, ``legal cause'' often implicates the 
combined effects of two or more forces, each constituting a substantial 
factor in bringing about the harm, and imposes liability upon each 
person or thing responsible for those forces. Therefore, consistent 
with tort law principles, a SIRVA claimant can be found to have 
``sustained a vaccine-related injury'' when a third party's negligent 
administration of the vaccine acts concurrently with the contents of 
needle, i.e., the vaccine, which combined effect is in turn a 
substantial factor in bringing about the petitioner's harm. The 
commenter stated that this is consistent with the definition of 
``associated with.''
    Response: Cases where the vaccine ``combine[s] together'' with its 
administration to bring about the illness are fairly characterized as 
resulting from the administration technique, since they would not have 
occurred if the administration were proper. The fact that Congress 
could have said ``non-negligent'' administration of the vaccine or 
``associated with the ``proper'' administration of the vaccine'' does 
not call into question the Department's careful examination of, and 
analysis of, the relevant statutory terms, which is informed by the 
Department's expertise in this subject matter.
    Comment: Some commenters disagree with the Department's reasoning 
that ``associated with'' does not include injuries caused by negligent 
administration of the vaccine. They point to 42 U.S.C. 30aa-11 which 
they contend specifically provides for ``administration'' of the 
vaccine. They state that the Act refers to ``administration of the 
vaccine'' 17 times. Other commenters list prior interpretation of the 
act to be inconsistent with the Department's ``new'' interpretation.
    Response: The Vaccine Act does in certain places refer to 
``administration of'' or the ``administrator'' of the vaccine. But the 
Department thinks that those usages were not meant to suggest the 
Program covers negligence in the administration of the vaccine, but 
served other purposes. At most, these usages render the statute 
ambiguous with respect to needle injuries. In Section 300aa-
11(a)(2)(A), the statute precludes suits against ``a vaccine 
administrator,'' but this reference does not define the scope of the 
compensation program--instead, it protects administrators from suits 
``arising from a vaccine-related injury or death associated with the 
administration of a vaccine.'' This language is not entirely clear, as 
it appears to impose two distinct qualifications that both must be met 
but are worded slightly differently. It may be a belt and suspenders 
approach to ensure that vaccine administrators are protected from tort 
claims like in Amendola, where the vaccine itself was properly 
administered and caused the injury, but the petitioner alleged the 
administrator was negligent in deciding to give the vaccine. See 989 
F.2d at 1186 (holding Vaccine Program does not exclude cases of 
``negligence in deciding, for example, whether to administer an 
otherwise satisfactory vaccine''). The important point is that the 
first qualification--``arising from a vaccine-related injury''--is also 
included here and, Congress defined this requirement to include only 
injuries associated with the vaccine itself. See also 42 U.S.C. 300aa-
11(b)(1)(A) (referencing individuals who ``died as the result of the 
administration of a vaccine'' but only if the individual sustained a 
``vaccine-related injury''). In setting up the original Vaccine Injury 
Table, Congress referenced conditions ``resulting from the 
administration of such vaccines.'' 42 U.S.C. 300a-14(a). But this 
phrase was not designed to define the scope of the program or the 
Table; instead, Congress directed the Secretary to add conditions to 
the Table if they were ``associated with such vaccines.'' 42 U.S.C. 
300aa-14(e)(1)(B) & (2)(B). And it is telling that Congress included 
nothing similar to SIRVA or other injuries caused by negligent vaccine 
administration in the original Table, rather than injuries associated 
with the vaccine components themselves. Finally, that Congress asked 
the Secretary to ``make or assure improvements'' in the 
``administration'' of vaccines, 42 U.S.C. 300aa-27(a)(2), among many 
areas of improvement in the vaccination process, does not imply that 
the compensation program covers negligent administration.
    Furthermore, state courts have found that injuries arising from 
negligent administration of a vaccine are not ``vaccine-related 
injuries'' under 42

[[Page 6261]]

U.S.C. 300aa-33(5), and therefore are not preempted by the Vaccine Act. 
See, e.g., Neddeau v. Rite Aid of Conn., 2015 WL 5133151, at *3 (Super. 
Ct. Conn. July 28, 2015) (state court action did not allege a 
``vaccine-related'' injury and therefore was not barred by the Vaccine 
Act, because plaintiff's allegation that the administrator struck the 
needle too high was an allegation that her injuries ``were caused by 
negligence in the physical process of injecting the vaccine, not by the 
effects of the vaccine''); Nwosu ex rel. Ibrahim v. Adler, 969 So. 2d 
516, 519 (Ct. App. Fla. 2007) (claim arising from a physician's 
negligent injection of a vaccine was not a ``vaccine-related injury,'' 
and adding that ``[i]t is true that had the child not been vaccinated, 
she would not have been injured. However, her injury as alleged, does 
not flow from the inoculant injected into her body [so] it is not the 
type of injury covered under the Act'').
    The Table should only include injuries caused by a vaccine or its 
components, not the manner in which the vaccine was administered. Thus, 
a petitioner must have an injury or death ``associated'' with the 
vaccine, not one resulting from poor injection technique or other 
improper administration of the vaccine.
    Comment: One commenter stated that to the extent that negligence 
may well be a component of some SIRVA injuries, categorically excluding 
these as vaccine-related injuries would make sense only if one could 
show that negligence alone causes SIRVA. The commenter asserts that 
medical literature shows that all SIRVA injuries necessarily involve an 
inflammatory, immune reaction in the deltoid/bursa region. (See 
Vaccine-related Shoulder Discomfort, M. Bordor & E. Montalvo; Shoulder 
injury related to vaccine administration, S. Atanasoff, et al.)
    Response: SIRVA stands for shoulder injury related to vaccine 
administration. The Department does not necessarily agree that the 
scientific literature shows that all SIRVA injuries necessarily involve 
an inflammatory, immune reaction in the deltoid/bursa region. It is 
possible that certain injuries characterized as SIRVA occur when an 
immunologically active substance designed to trigger an inflammatory 
response (i.e., the vaccine antigen) is injected into an area where the 
inflammatory response can cause joint damage (i.e., the bursa or 
tendons) as opposed to an area where the inflammatory response will not 
cause joint damage or permanent harm (i.e., the deltoid muscle). Such 
injuries are fairly characterized as resulting from the vaccination 
technique, since they would not have occurred if the injection occurred 
in the proper part of the body.
    Comment: Some commenters provided critical reviews of the research 
cited by HHS in the proposed rule. One commenter stated that the 
medical and scientific literature cited by the Department is contrary 
to (or at best inconclusive of) the proposition that SIRVA is caused 
solely by the physical conduct attributable to the person administering 
the vaccine.
    Response: The Department respectfully disagrees, and maintains the 
view espoused in the proposed rule. The Department correctly 
characterized the literature in the proposed rule.
    Comment: One commenter stated that HHS wrongfully stated that the 
standard of proof for establishing entitlement of a SIRVA claim is too 
low or lenient, leading to the filing of dubious or frivolous claims 
without providing any evidence of this in the proposed rule. This 
commenter stated that the suspicion of activity is not proper 
justification for the Department's proposed policy change. The 
commenter also stated that the Department's claim that there has been a 
dramatic increase in SIRVA claims is meaningless without context, such 
as an increase in the number of flu vaccines administered from the 
2016/2017 flu season to the 2018/2019 flu season. This commenter also 
pointed out that the there is no evidence that SIRVA claims are 
diminishing the Trust Fund, because according to the US Treasury 
Bulletin for March 2020, the balance of the Trust Fund at the end of FY 
2019 was $3.95 billion, up from $3.85 billion at the end of FY 2018.
    Response: DOJ informs the Department that, as of the time of the 
proposed rule, out of 2,214 SIRVA claims filed since 2017, DOJ had 
identified 27 cases in which altered medical records have been filed, 
some of which involved changes to the site of vaccination. The proposed 
rule noted that the vaccination rate had decreased slightly since SIRVA 
was added to the Table,\41\ yet SIRVA claims have risen dramatically in 
recent years. The Department is finalizing this final rule for a 
combination of legal and policy reasons explained herein and in the 
proposed rule, not solely because any particular claims are diminishing 
the Trust Fund.
---------------------------------------------------------------------------

    \41\ 85 FR 43,801 n.33.
---------------------------------------------------------------------------

    Comment: Some commenters stated that if SIRVA is removed from the 
Vaccine Injury Table, it will have to be covered by malpractice 
insurance, which could unnecessarily drive up the costs of delivering 
vaccines and reduce the number of people willing to administer them.
    Response: It is not clear this was problematic in the United States 
before SIRVA and vasovagal syncope were added to the Table in 2017, and 
the Department has been unable to locate any evidence that insurance 
has materially declined due to the addition of SIRVA and vasovagal 
syncope to the Table. Moreover, the vaccination rate has gone down 
slightly between when SIRVA and vasovagal syncope were added to the 
Table and the time of the proposed rule.\42\
---------------------------------------------------------------------------

    \42\ 85 FR 43,801.
---------------------------------------------------------------------------

    Comment: A commenter asked that if SIRVA and vasovagal syncope are 
removed from the Table, all claims filed before the Final Rule be 
allowed to continue through the National Vaccine Injury Compensation 
Program.
    Response: This final rule applies to claims filed after the 
effective date of this final rule.
    Comment: A commenter stated that in the 34 years since the Vaccine 
Act was passed by Congress, HHS has only ever added to the Injury 
Table, and that it is deeply troubling and potentially against the 
intent of the Act to remove injuries from the Table.
    Response: The Vaccine Act explicitly provides that the Secretary 
can ``delete from'' the list of injuries, disabilities, illnesses, 
conditions, and deaths for which compensation may be provided. 42 
U.S.C. 300aa-14(c)(3). Therefore, this final rule is consistent with 
the statutory text and Congressional intent.
    Comment: Some commenters stated that the Department's contention 
that SIRVA should be removed, in part, because patient records were 
altered in 27 out of 2,214 cases is unsupportable. They state that the 
average fraudulent health care claims, according to the National Health 
Care Anti-Fraud Association, is 3%, which is higher than the reported 
fraud in the SIRVA records, which is 1.2%. One commenter points out 
that, as of January 1, 2020, the Court requires that all medical 
records be certified under the Pre-Assignment Review Order, which 
greatly reduces the chance of fraudulent records.
    Response: DOJ had identified 27 cases in which altered medical 
records have been filed, some of which involved changes to the site of 
vaccination. However, it is possible there were additional instances 
that DOJ did not uncover. The Department is finalizing this final rule 
because of a combination of legal and policy reasons stated herein and 
in the proposed rule, not solely because of fraud.

[[Page 6262]]

    Comment: Some commenters stated that removing coverage for SIRVA 
and syncope is inconsistent with the Program's twin purposes of 
creating a simplified means of recovery for those injured by the 
administration of vaccines and providing liability protection to 
vaccine administrators and manufacturers. Commenters state that the 
policy objective is triggered by the immunization and does not vary 
with whether the claimed injury is a consequence of the contents versus 
the administration process.
    Response: The Department agrees that the VICP seeks to create a 
simplified means of recovery and provide certain liability protection 
to vaccine administrators and manufacturers. But it only seeks to do so 
for injuries encompassed by the Vaccine Act. The Act creates a 
compensation program ``for a vaccine-related injury or death.'' 42 
U.S.C. 300aa-11(a)(1). Under the Act, ``only . . . a person who has 
sustained a vaccine-related injury or death'' can recover. 42 U.S.C. 
300aa-11(a)(9). The Act defines ``[v]accine-related injury or death'' 
as ``an illness, injury, condition, or death associated with one or 
more of the vaccines set forth in the Vaccine Injury Table, except that 
the term does not include an illness, injury, condition, or death 
associated with an adulterant or contaminant intentionally added to 
such a vaccine.'' 42 U.S.C. 300aa-33(5) (emphasis added); see also Dean 
v. HHS, No. 16-1245V, 2018 WL 3104388, at * 9 (Fed. Cl. Spec. Mstr. May 
29, 2018) (defining ``vaccine'' as `` `any substance designed to be 
administered to a human being for the prevention of 1 or more diseases' 
'') (quoting 26 U.S.C. 4132(a)(2)). Thus, the compensation program 
covers injuries ``associated with'' the vaccine itself.
    SIRVA is not a vaccine, and it is not an injury caused by a vaccine 
antigen, but by administration of the vaccine by the health care 
provider. The Department does not think the term ``associated with'' 
was meant to sweep in injuries caused by negligent administration of 
the vaccine. Although the Act permits petitioners to recover for 
Vaccine Table injuries without demonstrating causation in individual 
cases, the term ``associated with'' nevertheless requires that the 
injury, in general, be causally related to the vaccine itself. This is 
clear both from dictionary definitions of ``associated,'' which means 
``related, connected, or combined together'' (Merriam-Webster.com 
Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/associated. Accessed 10 Jul. 2020), and from the text of the 
Act itself, see, e.g., 42 U.S.C. 300aa-22(b)(1) (focusing on injuries 
that ``resulted'' from vaccine side effects); 42 U.S.C. 300aa-
13(a)(1)(B) & (2)(B) (excluding ``trauma'' that has ``no known relation 
to the vaccine involved'').
    Importantly, in the key operative provisions discussed above, the 
phrase ``associated with'' is linked to the vaccine itself, not to the 
technique in administering the vaccine. See Decker v. Nw. Envtl. Def. 
Ctr., 568 U.S. 597, 611 (2013) (in interpreting phrase ``associated 
with industrial activity,'' the key consideration is the scope of 
``industrial activity''; the ``statute does not foreclose a more 
specific definition by the agency'' and ``a reasonable interpretation . 
. . could . . . require the discharges to be related in a direct way to 
operations at `an industrial plant' ''); Chevron, U.S.A., Inc. v. Nat. 
Resources Def. Council, Inc., 467 U.S. 837, 861 (1984) (``[T]he meaning 
of a word must be ascertained in the context of achieving particular 
objectives, and the words associated with it may indicate that the true 
meaning of the series is to convey a common idea.'').
    That basic requirement is not met with SIRVA and vasovagal syncope. 
While the act of being vaccinated may be a but-for cause of those 
injuries, the injury is not associated with the vaccine itself because, 
with proper administration technique, those injuries will not result 
from the vaccine. Rather, SIRVA and vasovagal syncope result from the 
use of improper--that is, negligent--administration technique.
    There are several indicators in the language and structure of the 
Vaccine Act that show it was not meant to cover negligent 
administration of the vaccine.\43\
---------------------------------------------------------------------------

    \43\ See 85 FR 43,796, 43,797.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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 disagree with the Department's statement 
that the present regime lessens the incentive of vaccine administrators 
to take appropriate precautions during administration. They state that 
that health care providers, including pharmacists, are highly trained, 
skilled professionals that seek to provide high quality care to their 
patients, and are not likely to be negligent in the care they provide 
because of their knowledge of

[[Page 6263]]

liability protection. Further they list several instances where civil 
action can be filed under the Act (under 42 U.S.C. 300aa-21(a), the 
patient/petitioner may reject the Federal Claims judgment and pursue a 
civil action; the vaccine administered is not listed in the Table; the 
injury sustained is not listed in the Table; the injury/illness did not 
last 6 months). Commenters argue that health care providers are bound 
by their ethical, moral, and legal duties to protect public health and 
no other consideration eliminates or lessens that commitment.
    Response: The Department is grateful for the many health care 
professionals and pharmacists who improve public health by vaccinating 
the American public, and does not believe they would intentionally 
administer a vaccine in an improper manner. The Department has taken 
many steps during the COVID-19 pandemic to increase the universe of 
individuals who can safely vaccinate. Ensuring vaccines are 
administered safely will increase public confidence in vaccinations. 
Since Vaccine Act proceedings are generally sealed and not made 
available to the public, vaccine administrators may be left unaware 
that they used an improper technique.\47\ 42 U.S.C. 300aa-21(a) does 
not materially change the analysis, because there are not many 
instances where an individual would go through the VICP process, fail 
to recover, and then be able to recover in state court. There are also 
not many instances where a petitioner would elect to forgo his or her 
recovery from the VICP to sue in state court, since it is not often 
that an individual could recover more in state court, and there are 
risks inherent in state court litigation.
---------------------------------------------------------------------------

    \47\ 85 FR 43,802.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \48\ 85 FR 43,798.
---------------------------------------------------------------------------

    Comment: Some commenters urge the VICP and the CICP to merge 
together to promote unity and clarity.
    Response: Revision of the formation and organization of the VICP 
and the CICP would require a statutory amendment and thus is not within 
the scope of this final rule.
    Comment: Many commenters stated that patients, healthcare 
providers, vaccine administrators, and vaccine manufactures do not 
support the Notice of Proposed Rulemaking.
    Response: For the legal and policy reasons stated herein and in the 
proposed rule, the Department is finalizing this final rule. The 
Department notes, in addition, that non-SIRVA cases, including those 
filed on behalf of children, are adversely affected as resources are 
stretched or diverted to litigate SIRVA cases.
    Comment: Many commenters state that even before SIRVA was added to 
the Table in 2017, individuals were able to receive compensation from 
the VICP for their SIRVA related injuries. Commenters point to VICP 
cases in which the Vaccine Court held that a causal connection between 
the administration of the vaccine and the consequential injury is 
sufficient proof for an award under the Vaccine Act. Comments stated 
that the Department's change in policy is contrary to the Congressional 
Intent of the Act and would have a devastating effect upon parties' 
ability to recover for their injuries.
    Response: Prior to SIRVA's addition to the Table, SIRVA claims were 
sometimes awarded due to a combination of the government resolving the 
claims without litigating them to conclusion, and public statements by 
the Department suggesting SIRVA was a cognizable injury. The proposal 
to add SIRVA to the Table was in the works for several years before the 
2015 notice of proposed rulemaking was published, and there was a great 
deal of public discussion about it at the ACCV and at the Court of 
Federal Claims' annual judicial conference. The Department has in the 
past not always contested cases alleging injuries that have been 
proposed for addition to the Table if the case as pleaded fulfilled the 
criteria for entitlement to compensation. However, for the reasons 
discussed in the proposed rule and this final rule, including the 
Department's review of the statute and more recent scientific 
literature, the Department no longer believes such claims should be 
included on the Table or can be based on causation in fact, because 
they are not injuries associated with vaccines or their components, nor 
are they unavoidable injuries or illnesses that cannot be predicted in 
advance, or that can occur without fault.
    Comment: Several commenters stated that HHS switched its position 
in this rulemaking without adequately considering the input of the 
Advisory Commission on Childhood Vaccines which unanimously rejected 
the rule change, and without discussing the change with the CDC's 
Advisory Committee for Immunization Practices (ACIP), HHS's own 
National Vaccine Advisory Committee (NVAC), the National Foundation for 
Infectious Disease (NFID), and the Institute of Vaccine Safety at Johns 
Hopkins whose epidemiologists have consulted closely with the Program 
since its inception.
    Response: The Department is grateful to the ACCV for its time spent 
considering the proposed changes and for providing its comments. The 
Department considered the ACCV's

[[Page 6264]]

comments.\49\ However, the Department found the ACCV's comments not 
adequately persuasive. The Department has also considered public 
comments from a wide variety of perspectives during the two public 
hearings and 180-day public comment period on the proposed rule.
---------------------------------------------------------------------------

    \49\ See 85 FR 43,801-02 (discussing the ACCV's comments in 
depth).
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \50\ 85 FR 43,804.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \51\ See 85 FR 52,136, 52140 (Aug. 24, 2020).
---------------------------------------------------------------------------

    Comment: One commenter disagreed with the Department's contention 
that by excluding from the definition those injuries associated with an 
adulterant or contaminant intentionally added to the vaccine, Congress 
intended to permit suit only where the injury was caused by the 
components of the vaccine itself. The commenter states that the 
Department is applying the doctrine of ejusdem generis (i.e., where 
general words follow an enumeration of two or more things, they apply 
only to persons or things of the same general kind or class 
specifically mentioned). However, here, an adulterant and contaminant 
are exceptions instead of enumerations. Therefore, the commenter 
contends that the Department's interpretation of Congress' intent is 
not supported.
    Response: The Department respectfully disagrees. There are several 
indicators in the language and structure of the Vaccine Act that show 
it was not meant to cover negligent administration of the vaccine.\52\
---------------------------------------------------------------------------

    \52\ See 85 FR 43,796-97.
---------------------------------------------------------------------------

    Comment: One commenter stated that the Department mischaracterized 
current SIRVA cases when it said ``petitioners in such cases often 
prevail because of the low burden of proof and because it is not 
necessary to prove causation.'' The commenter said that litigation 
records show complex cases in which the Department of Justice 
``vigorously'' advocated for the DHHS.
    Response: The Department agrees that the Department of Justice 
generally vigorously advocates for the Department. But the burden of 
proof on petitioners is low, and petitioners generally need not prove 
causation.
    Comment: One commenter stated that the proposed rule change may 
disproportionately and severely affect minority communities, since many 
do not have the same access to quality care; the time, energy, and 
know-how to navigate a complex legal system; and the resources to 
access compensation.
    Response: Aiding minority communities was not posited as a reason 
to add SIRVA or vasovagal syncope to the Table when they were added in 
2017.\53\ In any event, this final rule will alleviate the Department's 
significant legal concerns about whether the current Table comports 
with applicable law.
---------------------------------------------------------------------------

    \53\ See 85 FR 6294.
---------------------------------------------------------------------------

    Comment: Some commenters stated that HRSA is attempting to undo the 
lengthy and thorough legal and medical analysis it performed when it 
promulgated the Rule that put both vasovagal syncope and SIRVA on the 
Vaccine Injury Table in 2017.
    Response: This final rule is the product of a lengthy and thorough 
legal and scientific analysis, including an analysis of scientific 
literature published after finalization of the 2017 Final Rule.
    Comment: One commenter argued that the Vaccine Act has a 
subrogation clause which permits the Federal government to seek 
recompense if the VICP compensates a claim, but determines later that a 
health care professional was negligent in administering a vaccine. 
Thus, injury claims resulting from the administration of vaccines 
should still be eligible for VICP compensation.
    Response: This subrogation provision does not properly incentivize 
the vaccine administrator, since it is unlikely that the Federal 
government would assert many claims against administrators, given the 
burden and expense compared to the relatively small potential recovery 
for the Federal government. Individuals would have a greater incentive 
to assert such claims if the administrator were negligent.
    Comment: Some commenters stated that the Department incorrectly 
relies on Amendola v. Sec., Dept. of Health & Human Servs., 989 F.2d 
1180 (Fed. Cir. 1993) to say that issues would arise if the Vaccine Act 
were interpreted to cover injuries caused by negligent administration. 
Commenters contend that the Federal Circuit Judge stated ``Congress 
clearly intended by the amendment to apply the Act to pediatricians who 
administered a vaccine as well as to the manufacture who made it,'' and 
``[w]e see no basis for drawing a bright line that excludes erroneous 
judgment calls by the administrator, as well as negligent 
contamination.'' One commenter concludes that Amendola, in fact, 
confirms that the Vaccine Act protects both vaccine administrators and 
manufactures.
    Response: The Department respectfully disagrees with this 
characterization of Amendola. As the Federal Circuit has explained, 
troubling issues arise if the Act were to apply to ``negligence 
facially unrelated to the vaccine's effects.'' Amendola v. Sec., Dept. 
of Health & Human Servs., 989 F.2d 1180, 1187 (Fed. Cir. 1993). It 
could include, for example, ``the doctor's negligent dropping of an 
infant patient'' or use of contaminated equipment. Id. at 1186-87. The 
better reading of the statute is that it does not reach this far.
    Comment: One commenter argued that the state tort liability 
preemption in Subpart B merely covers the remedies available to 
patients after they have gone through the VICP, not that Congress 
intended to ``preserve a state tort remedy for certain avoidable 
injuries, such as those caused by negligent vaccine administration.''
    Response: Congress protected manufacturers from liability when the 
injury ``resulted from side effects that were unavoidable even though 
the vaccine was properly prepared. . .'' 42 U.S.C. 300aa-22(b)(1). This 
language shows Congress wanted to preserve a

[[Page 6265]]

state tort remedy for certain avoidable injuries, such as those caused 
by negligent vaccine administration. Given that the Vaccine Act seeks 
to replace state tort remedies for the injuries it covers, this 
reinforces the conclusion that the Act does not reach SIRVA and 
vasovagal syncope.
    Comment: One commenter disagreed with the Department's position 
that recordkeeping and reporting requirements are ``woefully inadequate 
if the Program was designed to compensate for negligence by the 
provider,'' since physicians are subject to myriad state laws and 
regulations governing medical records. The commenter stated that 
Congress authorized HHS to promulgate additional recordkeeping 
requirements if need be.
    Response: The text and structure of the Vaccine Act show that it 
was not meant to cover negligent administration of the vaccine. That 
some state laws and regulations govern medical records is besides the 
point.
    Comment: Many commenters argued that this rule is an unconscionable 
attempt to alleviate HHS's backlog of pending cases, and that the 
public would be better served if the Department was to hire additional 
personal to handle case management.
    Response: The Department respectfully disagrees. The Department has 
set forth a series of legal and policy reasons for this final rule both 
herein and in the proposed rule.

III. Statutory Authority

    The primary statutory authority for this rulemaking is 42 U.S.C. 
300aa-14. 42 U.S.C 300aa-14(c)(1) provides that the ``Secretary may 
promulgate regulations to modify in accordance with paragraph (3) the 
Vaccine Injury Table. In promulgating such regulations, he shall 
provide for notice and opportunity for a public hearing and at least 
180 days of public comment.'' 42 U.S.C. 300aa-14(c)(3), in turn, 
provides: ``A modification of the Vaccine Injury Table under paragraph 
(1) may add to, or delete from, the list of injuries, disabilities, 
illnesses, conditions, and deaths for which compensation may be 
provided or may change the time periods for the first symptom or 
manifestation of the onset or the significant aggravation of any such 
injury, disability, illness, condition, or death.''

IV. Statutory and Regulatory Requirements

A. Executive Orders 12866, 13563, and 13771: Regulatory Planning and 
Review

    E.O. 12866 and E.O. 13563 direct agencies to assess all costs and 
benefits of available regulatory alternatives and, if regulation is 
necessary, to select regulatory approaches that maximize net benefits 
(including potential economic, environmental, public health and safety 
effects, distributive impacts, and equity). E.O. 13563 supplements and 
reaffirms the principles, structures, and definitions governing 
regulatory review as established in E.O. 12866, which emphasizes the 
importance of quantifying both costs and benefits, of reducing costs, 
of harmonizing rules, and of promoting flexibility.
    Executive Order 12866 requires that all regulations reflect 
consideration of alternatives, of costs, of benefits, of incentives, of 
equity, and of available information. Regulations must meet certain 
standards, such as avoiding an unnecessary burden. Regulations that are 
``significant'' because of cost, adverse effects on the economy, 
inconsistency with other agency actions, effects on the budget, or 
novel legal or policy issues require special analysis. The Department 
anticipates that the final rule will save limited compensation funds 
under the National Vaccine Injury Compensation Program. Specifically, 
it will reduce the amount of program funds spent on program 
administration, reduce the amount of funds paid out to those with SIRVA 
or vasovagal syncope claims, and ensure that funds awarded from the 
VICP are awarded to individuals whose claims arise from vaccine-related 
injuries, which is consistent with the original intent of the VICP. 
Moreover, the Department anticipates that the final rule may result in 
fewer individuals suffering from SIRVA or vasovagal syncope, because it 
will better incentivize those administering vaccines to use proper 
injection technique. If those who administer vaccines can be held 
liable when a patient suffers from SIRVA or vasovagal syncope as a 
result of the administration of the vaccine, those who administer 
vaccines will have greater incentive to use proper injection technique. 
In addition, the final rule may also limit the ability of those opposed 
to vaccinations to cite to the high number of SIRVA awards to 
misleadingly suggest that vaccines are less safe than they truly are.
    The Department considered, as an alternative to the proposed rule 
and this final rule, issuing a notice of proposed rulemaking that would 
revise the definition of SIRVA so that those with true shoulder 
injuries were able to recover while reducing the number of less 
appropriate claims. However, the Department concluded that removing 
SIRVA from the Table is preferable. If SIRVA is removed from the Table, 
those with actual SIRVA injuries would still be able to recover in 
state court. Removal is preferable to redefining SIRVA, because it 
better addresses the vaccine hesitancy concern, is more in line with 
the Vaccine Act and Congressional intent, and incentivizes learning and 
utilizing proper administration technique. Indeed, because Vaccine Act 
proceedings are generally sealed and not made available to the public, 
vaccine administrators often are left unaware that they used an 
improper technique.
    The Department also considered, as alternatives to this final rule, 
not removing one or more of (1) SIRVA, (2) vasovagal syncope, or (3) 
Item XVII from the Table. For the reasons discussed herein and in the 
proposed rule, the Department rejected these alternatives.
    Section 3(f) of Executive Order 12866 defines a ``significant 
regulatory action'' as an action that is likely to result in a rule (1) 
having an annual effect on the economy of $100 million or more in any 
one year, or adversely or materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order. A regulatory impact 
analysis must be prepared for major rules with economically significant 
effects ($100 million or more in any one year), and a ``significant'' 
regulatory action is subject to Office of Management and Budget (OMB) 
review. As discussed below regarding the anticipated effects, these 
changes are not likely to have economic impacts of $100 million or more 
in any one year, and therefore do not meet the definition of 
``economically significant'' under Executive Order 12866. OMB has 
waived review over this final rule.

[[Page 6266]]

B. Economic and Regulatory Impact

    In accordance with the Regulatory Flexibility Act of 1980 (RFA), 
and the Small Business Regulatory Enforcement Act of 1996, which 
amended the RFA, the Secretary certifies that this rule will not have a 
significant impact on a substantial number of small entities. Between 
FY 2017 and FY 2019, the VICP on average paid out $30,893,481.90 per 
year to petitioners alleging SIRVA claims. The VICP on average paid out 
$124,489.56 per year to petitioners alleging vasovagal syncope claims. 
When this final rule goes into effect, the Department anticipates that 
small entities will not actually pay these amounts, because fewer SIRVA 
and vasovagal syncope claims would be filed if petitioners had to prove 
causation. In addition, vaccines are often administered by non-small 
entities, so even if total amounts paid approximated the amounts paid 
on average between FY 2017 and FY 2019, claims against small entities 
would be less. It is the Department's belief that should the amounts 
paid equal the amounts annually paid out of the VICP between FY 2017 
and FY 2019, and such claims are paid in full by small entities, these 
amounts will not constitute a significant impact on a substantial 
number of small entities for purposes of the RFA.
    Section 202 of the Unfunded Mandates Reform Act of 1995 (Unfunded 
Mandates Act) (2 U.S.C. 1532) requires that covered agencies prepare a 
budgetary impact statement before promulgating a rule that includes any 
Federal mandate that may result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of $100 
million in 1995 dollars, updated annually for inflation. Currently, 
that threshold is approximately $154 million. If a budgetary impact 
statement is required, section 205 of the Unfunded Mandates Act also 
requires covered agencies to identify and consider a reasonable number 
of regulatory alternatives before promulgating a rule. The Department 
has determined that this final rule will not result in expenditures by 
State, local, and tribal governments, or by the private sector, of $154 
million or more in any one year. Accordingly, the Department has not 
prepared a budgetary impact statement or specifically addressed the 
regulatory alternatives considered.
    The provisions of this rule will also not negatively affect family 
well-being or the following family elements: family safety; family 
stability; marital commitment; parental rights in the education, 
nurture and supervision of their children; family functioning; 
disposable income or poverty; or the behavior and personal 
responsibility of youth, as determined under section 654(c) of the 
Treasury and General Government Appropriations Act of 1999.
    On January 30, 2017, the White House issued Executive Order 13771 
on Reducing Regulation and Controlling Regulatory Costs. Section 2(a) 
of Executive Order 13771 requires an agency, unless prohibited by law, 
to identify at least two existing regulations to be repealed when the 
agency publicly proposes for notice and comment or otherwise 
promulgates a new regulation. In furtherance of this requirement, 
section 2(c) of Executive Order 13771 requires that the new incremental 
costs associated with new regulations shall, to the extent permitted by 
law, be offset by the elimination of existing costs associated with at 
least two prior regulations. This final rule partially repeals prior 
regulations and is not expected to increase incremental costs, so it is 
not anticipated to be a regulatory or deregulatory action under 
Executive Order 13771.
    As stated above, this final rule modifies the Vaccine Injury Table 
to ensure that the Table complies with applicable law, the Table is 
consistent with medical and scientific literature, those administering 
vaccines have additional incentive to use proper injection technique, 
and the VICP has sufficient funds to adequately compensate those 
injured by vaccines listed in the Table.

C. Executive Order 12988: Civil Justice Reform

    The agency has reviewed this rule under Executive Order 12988 on 
Civil Justice Reform and has determined that this final rule complies 
with this Executive Order.

V. Summary of Impacts

    This final rule has the effect of removing injuries from the Table 
that are not encompassed by the provisions of the Vaccine Act and that 
are reducing the pool of funds available to those injured by vaccines 
or vaccine components. It therefore aligns the Table with the 
Department's understanding of Congress' intent and public policy in 
favor of compensating those harmed by injuries associated with the 
vaccine or vaccine components, and particularly children who have 
suffered such harm. The rule also has the effect of ensuring that the 
limited compensation resources available under the National Vaccine 
Injury Compensation Program are provided to those with vaccine-related 
injuries or deaths. In addition, because of the large volume of SIRVA 
claims, removing SIRVA from the Table will reduce the amount of program 
funds spent on program administration and ensure that funds awarded 
from the VICP are awarded to individuals whose claims arise from 
vaccine-related injuries, which is consistent with the Department's 
interpretation of the original intent of the VICP.
    The final rule also better incentivizes those who administer 
vaccines to use proper injection technique. It may also help correct 
misleading and erroneous suggestions that vaccines are not safe. 
Because COVID-19 and the COVID-19 vaccines are not currently on the 
Table, the Department does not believe this rule will have an impact on 
patients with COVID-19 or the COVID-19 vaccines.
    Moreover, the rule is unlikely to unduly burden the civil tort 
system. The Department conducted a search in the WestLaw legal database 
for cases in state court that contained both the terms ``SIRVA'' and 
``vaccine,'' and found only 20 hits, at least two of which were cases 
involving an entity named SIRVA and not the injury.\54\ It is possible 
that some additional cases were filed in federal district court. 
Nonetheless, the Department believes based on this data that any 
additional burden on the civil tort system, which will be dispersed 
across States and not concentrated in any one or few States, from 
removing SIRVA and vasovagal syncope from the Table and reverting to 
the status quo as of January 2017 will be minimal.
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    \54\ https://1.next.westlaw.com/Search/Results.html?query=%22sirva%22%20%26%20%22vaccine%22&jurisdiction=ALLSTATES&saveJuris=False&contentType=CASE&querySubmissionGuid=i0ad6ad3f000001733a44933a7bf4372d&startIndex=1&searchId=i0ad6ad3f000001733a44933a7bf4372d&kmSearchIdRequested=False&simpleSearch=False&isAdvancedSearchTemplatePage=False&skipSpellCheck=False&isTrDiscoverSearch=False&thesaurusSearch=False&thesaurusTermsApplied=False&ancillaryChargesAccepted=False&proviewEligible=False&eventingTypeOfSearch=FRM&transitionType=Search&contextData=%28sc.Search%29.
---------------------------------------------------------------------------

A. Executive Order 13132--Federalism

    HHS has reviewed this final rule in accordance with E.O. 13132 
regarding federalism and has determined that it does not have 
``federalism implications.'' This final rule will not ``have 
substantial direct effects on the States, or on the relationship 
between the national government and the States, or on the distribution 
of power and

[[Page 6267]]

responsibilities among the various levels of government.''

B. Collection of Information

    The Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)) (PRA) 
requires that OMB approve all collections of information by a federal 
agency from the public before they can be implemented. This final rule 
is projected to have no impact on current reporting and recordkeeping 
burden, as the amendments finalized in this rule will not impose any 
data collection requirements under the PRA.

List of Subjects in 42 CFR Part 100

    Biologics, Health insurance, Immunization.

    Accordingly, 42 CFR part 100 is amended as set forth below:

PART 100--VACCINE INJURY COMPENSATION

0
1. The authority citation for 42 CFR part 100 continues to read as 
follows:

    Authority: Secs. 312 and 313 of Public Law 99-660 (42 U.S.C. 
300aa-1 note); 42 U.S.C. 300aa-10 to 300aa-34; 26 U.S.C. 4132(a); 
and sec. 13632(a)(3) of Public Law 103-66.


0
2. In Sec.  100.3, revise paragraph (a) and remove paragraphs (c)(10) 
and (13) and (e)(8). The revision reads as follows:


Sec.  100.3  Vaccine injury table.

    (a) In accordance with section 312(b) of the National Childhood 
Vaccine Injury Act of 1986, title III of Public Law 99-660, 100 Stat. 
3779 (42 U.S.C. 300aa-1 note) and section 2114(c) of the Public Health 
Service Act, as amended (PHS Act) (42 U.S.C. 300aa-14(c)), the 
following is a table of vaccines, the injuries, disabilities, 
illnesses, conditions, and deaths resulting from the administration of 
such vaccines, and the time period in which the first symptom or 
manifestation of onset or of the significant aggravation of such 
injuries, disabilities, illnesses, conditions, and deaths is to occur 
after vaccine administration for purposes of receiving compensation 
under the Program. Paragraph (b) of this section sets forth additional 
provisions that are not separately listed in this Table but that 
constitute part of it. Paragraph (c) of this section sets forth the 
Qualifications and Aids to Interpretation for the terms used in the 
Table. Conditions and injuries that do not meet the terms of the 
Qualifications and Aids to Interpretation are not within the Table. 
Paragraph (d) of this section sets forth a glossary of terms used in 
paragraph (c).

             Table 1 to Paragraph (a)--Vaccine Injury Table
------------------------------------------------------------------------
                                                         Time period for
                                                        first symptom or
                                                        manifestation of
                                 Illness, disability,      onset or of
            Vaccine               injury or condition      significant
                                        covered            aggravation
                                                         after  vaccine
                                                         administration
------------------------------------------------------------------------
I. Vaccines containing tetanus  A. Anaphylaxis........  <=4 hours.
 toxoid (e.g., DTaP, DTP, DT,
 Td, or TT).
                                B. Brachial Neuritis..  2-28 days (not
                                                         less than 2
                                                         days and not
                                                         more than 28
                                                         days).
II. Vaccines containing whole   A. Anaphylaxis........  <=4 hours.
 cell pertussis bacteria,
 extracted or partial cell
 pertussis bacteria, or
 specific pertussis antigen(s)
 (e.g., DTP, DTaP, P, DTP-Hib).
                                B. Encephalopathy or    <=72 hours.
                                 encephalitis.
III. Vaccines containing        A. Anaphylaxis........  <=4 hours.
 measles, mumps, and rubella
 virus or any of its
 components (e.g., MMR, MM,
 MMRV).
                                B. Encephalopathy or    5-15 days (not
                                 encephalitis.           less than 5
                                                         days and not
                                                         more than 15
                                                         days).
IV. Vaccines containing         A. Chronic arthritis..  7-42 days (not
 rubella virus (e.g., MMR,                               less than 7
 MMRV).                                                  days and not
                                                         more than 42
                                                         days).
V. Vaccines containing measles  A. Thrombocytopenic     7-30 days (not
 virus (e.g., MMR, MM, MMRV).    purpura.                less than 7
                                                         days and not
                                                         more than 30
                                                         days).
                                B. Vaccine-Strain
                                 Measles Viral Disease
                                 in an immunodeficient
                                 recipient.
                                --Vaccine-strain virus  Not applicable.
                                 identified.
                                --If strain             <=12 months.
                                 determination is not
                                 done or if laboratory
                                 testing is
                                 inconclusive.
VI. Vaccines containing polio   A. Paralytic Polio....
 live virus (OPV).
                                --in a non-             <=30 days.
                                 immunodeficient
                                 recipient.
                                --in an                 <=6 months.
                                 immunodeficient
                                 recipient.
                                --in a vaccine          Not applicable.
                                 associated community
                                 case.
                                B. Vaccine-Strain
                                 Polio Viral Infection.
                                --in a non-             <=30 days.
                                 immunodeficient
                                 recipient.
                                --in an                 <=6 months.
                                 immunodeficient
                                 recipient.
                                --in a vaccine          Not applicable.
                                 associated community
                                 case.
VII. Vaccines containing polio  A. Anaphylaxis........  <=4 hours.
 inactivated virus (e.g., IPV).
VIII. Hepatitis B vaccines....  A. Anaphylaxis........  <=4 hours.
IX. Haemophilus influenzae      No Condition            Not applicable.
 type b (Hib) vaccines.          Specified..
X. Varicella vaccines.........  A. Anaphylaxis........  <=4 hours.
                                B. Disseminated
                                 varicella vaccine-
                                 strain viral disease.
                                --Vaccine-strain virus  Not applicable.
                                 identified.

[[Page 6268]]

 
                                --If strain             7-42 days (not
                                 determination is not    less than 7
                                 done or if laboratory   days and not
                                 testing is              more than 42
                                 inconclusive.           days).
                                C. Varicella vaccine-   Not applicable.
                                 strain viral
                                 reactivation.
XI. Rotavirus vaccines........  A. Intussusception....  1-21 days (not
                                                         less than 1 day
                                                         and not more
                                                         than 21 days).
XII. Pneumococcal conjugate     No Condition            Not applicable.
 vaccines.                       Specified..
XIII. Hepatitis A vaccines....  No Condition            Not applicable.
                                 Specified..
XIV. Seasonal influenza         A. Anaphylaxis........  <=4 hours.
 vaccines.
                                B. Guillain-            3-42 days (not
                                 Barr[eacute] Syndrome.  less than 3
                                                         days and not
                                                         more than 42
                                                         days).
XV. Meningococcal vaccines....  A. Anaphylaxis........  <=4 hours.
XVI. Human papillomavirus       A. Anaphylaxis........  <=4 hours.
 (HPV) vaccines.
------------------------------------------------------------------------


Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2021-01211 Filed 1-19-21; 8:45 am]
BILLING CODE 4165-15-P