Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 6249 

1National Vaccine Injury Compensation Program, 

Health Resources & Servs. Admin., https://

www.hrsa.gov/vaccine-compensation/index.html 

(last reviewed Jan. 2020). 

2H.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). 

3H.R. Rep. No. 99–908, at 6. 4See id. at 4–6. 

Federal, State, and local officer 

designated by or assisting the Captain of 

the Port (COTP) Sector Guam in the 

enforcement of the safety zone. 

(c) Regulations. (1) In accordance with 

the general regulations in section 

§ 165.23, entry into, transiting, or 

anchoring within this safety zone is 

prohibited unless authorized by the 

COTP or a designated on-scene 

representative. 

(2) This safety zone is closed to all 

persons and vessel traffic, except as may 

be permitted by the COTP or a 

designated on-scene representative. 

(3) The ‘‘on-scene representative’’ of 

the COTP is any Coast Guard 

commissioned, warrant, or petty officer 

who has been designated by the COTP 

to act on his or her behalf. 

(4) Persons and Vessel operators 

desiring to enter or operate within the 

safety zone must contact the COTP or an 

on-scene representative to obtain 

permission to do so. The COTP or an 

on-scene representative may be 

contacted via VHF Channel 16. Vessel 

operators given permission to enter or 

operate in the safety zone must comply 

with all directions given to them by the 

COTP or an on-scene representative. 

(d) Enforcement period. This safety 

zone will be enforced at a specified date 

between February and April. The Coast 

Guard will provide advance notice of 

enforcement and a broadcast notice to 

mariners to inform public of specific 

date. 

Dated: January 12, 2021. 

Christopher M. Chase, 

Captain, U.S. Coast Guard, Captain of the 

Port, Guam. 

[FR Doc. 2021–01084 Filed 1–19–21; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Public Health Service 

42 CFR Part 100 

RIN 0906–AB24 

National Vaccine Injury Compensation 

Program: Revisions to the Vaccine 

Injury Table 

AGENCY: Public Health Service, Health 

Resources and Services Administration 

(‘‘HRSA’’), Department of Health and 

Human Services (‘‘HHS’’ or the 

‘‘Department’’). 

ACTION: Final rule. 

SUMMARY: The Secretary finalizes the 

proposed rule to amend the Vaccine 

Injury Table (Table) by regulation. This 

final rule will have effect only for 

petitions for compensation under the 

National Vaccine Injury Compensation 

Program (VICP) filed after this final rule 

become effective. This final rule does 

not impact COVID–19 vaccines or PREP 

Act immunity for Covered Persons (as 

defined in the PREP Act) who 

manufacture, distribute, order, or 

administer COVID–19 vaccines. 

DATES: This final rule is effective on 

February 22, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Please visit the National Vaccine Injury 

Compensation Program’s website, 

https://www.hrsa.gov/ 

vaccinecompensation/, or contact 

Tamara Overby, Acting Director, 

Division of Injury Compensation 

Programs, Healthcare Systems Bureau, 

HRSA, Room 08N146B, 5600 Fishers 

Lane, Rockville, MD 20857; by email at 

vaccinecompensation@hrsa.gov; or by 

telephone at (855) 266–2427. 

SUPPLEMENTARY INFORMATION: This is a 

final rule by which HHS amends the 

provisions of 42 CFR 100.3 by removing 

Shoulder Injury Related to Vaccine 

Administration, vasovagal syncope, and 

Item XVII from the Vaccine Injury 

Table. 

I. Background and Purpose 

Vaccination is one of the best ways to 

protect against potentially harmful 

diseases that can be very serious, may 

require hospitalization, or even be 

deadly. Almost all individuals who are 

vaccinated have no serious reactions.1

Nonetheless, in the 1980s, Congress 

became concerned that a small number 

of children who received 

immunizations had serious reactions to 

them, and it was not always possible to 

predict which children would have 

reactions, or what reactions they would 

have.2 Claimants alleging vaccinerelated injuries in civil litigation 

encountered a time-consuming, 

expensive, and often inadequate 

system.3 Moreover, increased litigation 

against vaccine manufacturers resulted 

in difficulties in their ability to secure 

affordable product liability insurance, 

stabilize vaccine prices and supply, and 

enter the market.4

Therefore, Congress enacted the 

National Childhood Vaccine Injury Act 

of 1986, title III of Public Law 99—660 

(42 U.S.C. 300aa–1 et seq.) (‘‘Vaccine 

Act’’ or ‘‘the Act’’), which established 

the National Vaccine Injury 

Compensation Program (VICP). The 

objectives of the VICP are to ensure an 

adequate supply of vaccines, stabilize 

vaccine costs, and establish and 

maintain an accessible and efficient 

forum for individuals found to be 

injured by certain vaccines to be 

federally compensated. Petitions for 

compensation under the VICP are filed 

in the United States Court of Federal 

Claims (Court), rather than the civil tort 

system, with a copy served on the 

Secretary, who is the Respondent. The 

U.S. Department of Justice (DOJ) 

represents HHS in Court, and the Court, 

acting through judicial officers called 

Special Masters, makes the final 

decision as to eligibility for, and the 

type and amount of, compensation. 

To gain entitlement to compensation 

under this Program, a petitioner must 

establish that a vaccine-related injury or 

death has occurred, either by proving 

that a vaccine actually caused or 

significantly aggravated an injury 

(causation-in-fact) or by demonstrating 

what is referred to as a ‘‘Table injury.’’ 

That is, a petitioner may show that the 

vaccine recipient (1) received a vaccine 

covered under the Act; (2) suffered an 

injury of the type enumerated in the 

regulations at 42 CFR 100.3—the 

‘‘Vaccine Injury Table’’ (Table)— 

corresponding to the vaccination in 

question; and (3) that the onset of such 

injury took place within the time period 

specified in the Table. If so, the injury 

is presumed to have been caused by the 

vaccine, and the petitioner is entitled to 

compensation (assuming that other 

requirements are satisfied), unless the 

respondent affirmatively shows that the 

injury was caused by some factor 

unrelated to the vaccination (see 42 

U.S.C. 300aa–11(c)(1)(C)(i), 300aa– 

13(a)(1)(B), and 300aa–14(a)). 

42 U.S.C. 300aa–14(c) and (e) permit 

the Secretary to revise the Table. The 

Table currently includes 17 vaccine 

categories, with 16 categories for 

specific vaccines, as well as the 

corresponding illnesses, disabilities, 

injuries, or conditions covered, and the 

requisite time period when the first 

symptom or manifestation of onset or of 

significant aggravation after the vaccine 

administration must begin to receive the 

Table’s legal presumption of causation. 

The final category of the Table, ‘‘Item 


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6250 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 

5 42 CFR 100.3(a). 

6See 85 FR 43794 (July 20, 2020) (‘‘proposed 

rule’’). 7The Department first provided the proposed 

revisions to the Table and requested 

recommendations and comments by the ACCV on 

or about February 15, 2020. 

8National Vaccine Injury Compensation Program: 

Revisions to the Vaccine Injury Table, 85 FR 43794 

(July 20, 2020). 

9https://www.regulations.gov/ 

document?D=HRSA-2020-0002-0373. 

10http://www.cdc.gov/vaccinesafety/ 

ensuringsafety/history/index.html. 

11National Vaccine Injury Compensation 

Program, Health Resources & Servs. Admin., 

https://www.hrsa.gov/vaccine-compensation/ 

index.html (last reviewed Jan. 2021). 

12H.R. Rep. No. 99–908, pt. 1, at 6 (1986). Even 

though in rare instances individuals may have 

adverse reactions to vaccines, the Centers for 

Disease Control and Prevention (CDC) recommends 

XVII,’’ includes ‘‘[a]ny new vaccine 

recommended by the Centers for Disease 

Control and Prevention for routine 

administration to children, after 

publication by the Secretary of a notice 

of coverage.’’ 5 Two injuries—Shoulder 

Injury Related to Vaccine 

Administration (SIRVA) and vasovagal 

syncope—are listed as associated 

injuries for this category. Through this 

general category, new vaccines 

recommended by the CDC for routine 

administration to children and subject 

to an excise tax are deemed covered 

under the VICP prior to being added to 

the Table as a separate vaccine category 

through Federal rulemaking. 

The Department previously issued a 

notice of proposed rulemaking that 

proposed to remove SIRVA, vasovagal 

syncope, and Item XVII from the 

Vaccine Injury Table found at 42 CFR 

100.3. The Department did so for the 

reasons set forth in the proposed rule.6

Pursuant to the Vaccine Act, HHS 

provided the proposed revisions to the 

Vaccine Table to the ACCV.7 The ACCV 

considered the proposed changes set 

forth in the proposed rule on March 6, 

2020 and May 18, 2020. Four members 

of the ACCV also held a workgroup 

meeting on April 3, 2020 to discuss the 

proposed changes. On July 16, 2020, the 

proposed rule went on public display, 

with a comment period that ended on 

January 12, 2021.8 On November 9, 

2020, the Department held a public 

hearing pursuant to 42 U.S.C. 300aa– 

14(c)(1) via teleconference to discuss the 

proposed rule.9

The Department now finalizes the 

proposed rule to remove SIRVA and 

vasovagal syncope from the Table found 

at 42 CFR 100.3(a) and to remove the 

corresponding descriptions of those 

injuries—‘‘Qualifications and Aids to 

Interpretation’’ (QAI)—from 42 CFR 

100.3(c). This decision is based upon a 

review of the relevant statutory 

provisions and the scientific literature, 

as well as the Department’s experience 

since SIRVA and vasovagal syncope 

were added to the Table. The 

Department also finalizes its proposal to 

remove Item XVII from the Table found 

at 42 CFR 100.3(a), because the 

Department has serious concerns that 

Item XVII is contrary to applicable law, 

for the reasons set forth below. The 

Department finalizes this final rule for 

the reasons set forth in the proposed 

rule. This final rule does not impact 

COVID–19 vaccines or PREP Act 

immunity for Covered Persons (as 

defined in the PREP Act) who 

manufacture, distribute, order, or 

administer COVID–19 vaccines. 

II. Discussion of, and Response to, 

Public Comments 

What follows is a summary of the 

public comments the Department 

received on the notice of proposed 

rulemaking for this rule, which had a 

comment period that ended on January 

12, 2021, and the comments received at 

the public hearing on the proposed rule. 

The Department received 763 comments 

on the proposed rule. Commenters 

included patients, family and friends of 

patients, vaccine lawyers, rehabilitation 

counselors, nurses, doctors, legal 

clinics, law firms, law schools, biotech 

trade associations, pharmacist 

acclimations, drug store associations, 

and non-profits. The majority of 

commenters made statements in 

opposition to the proposed rule, 

although some commenters supported 

the proposed rule. 

The public hearing was conducted on 

November 9, 2020 from 10:00 a.m. till 

3 p.m. via Adobe connect 

teleconference. 34 comments were 

provided during the public hearing on 

the proposed rule. Commenters 

included those who experienced SIRVA 

injuries, doctors, vaccine lawyers, 

representatives from vaccine legal 

clinics, law professors, representatives 

from biotechnical associations, and 

representatives from vaccine 

information associations. All 

commenters who spoke at the public 

hearing were in opposition to the 

proposed rule. Below are summaries of 

the comments and the Department’s 

responses. 

Section I: Comments Regarding 

Vaccines in General 

Comment: Many commenters 

expressed concerns over the safety of 

vaccines in general. Some believe that 

all chemicals in vaccines are harmful to 

the body and cause bone and organ 

deterioration. Some believe that all 

vaccines should be stopped entirely. 

Others called for a complete moratorium 

on vaccines until all negative side 

effects are gone. Some commenters 

believe that vaccine and pharmaceutical 

companies are evil and have bought the 

government to push unsafe vaccines. 

They stress that vaccines are useless and 

unsafe and the very fact that the VICP 

is in existence proves that vaccines are 

unsafe. 

Response: Vaccines are one of the 

greatest success stories in public health. 

Through use of vaccines, we have 

eradicated smallpox and nearly 

eliminated wild polio virus. The 

number of people who experience the 

devastating effects of preventable 

infectious diseases like measles, 

diphtheria, and whooping cough is at an 

all-time low. The United States has a 

long-standing vaccine safety program 

that closely and constantly monitors the 

safety of vaccines. Before vaccines are 

approved by the Food and Drug 

Administration (FDA), they are tested 

and studied extensively by scientists to 

help ensure they are safe and effective. 

After vaccines are approved, a critical 

part of the vaccine safety program is that 

the Centers for Disease Control and 

Prevention (CDC)’s Immunization Safety 

Office (ISO) and FDA monitor for 

possible vaccine side effects and 

conduct studies to determine whether 

health problems are caused by vaccines. 

CDC’s ISO data show that the current 

U.S. vaccine supply is the safest in 

history.10 Also, regulating clinical 

research and reviewing the safety of 

vaccines are responsibilities of the FDA, 

not the VICP, and changes in vaccine 

research and how vaccines are studied 

and tested are beyond the scope of this 

final rule. 

Comment: Some commenters 

described bad reactions they, or their 

children, personally experienced from a 

range of vaccines to argue that there 

should be an end to mandated vaccines 

for children. 

Response: The Department 

sympathizes with all those who have 

experienced negative reactions to 

vaccines. Vaccination is one of the best 

ways to protect against potentially 

harmful diseases that can be very 

serious, may require hospitalization, or 

even be deadly. Almost all individuals 

who are vaccinated have no serious 

reactions.11 Nonetheless, in the 1980s, 

Congress became concerned that a small 

number of children who received 

immunizations had serious reactions to 

them, and it was not always possible to 

predict which children would have 

reactions, or what reactions they would 

have.12 Therefore, Congress enacted the 


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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 6251 

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). 

13More information about state vaccination 

requirements for daycare and school entry can be 

found at https://www.cdc.gov/vaccines/imzmanagers/laws/state-reqs.html (last reviewed Jan. 

2021). 

14http://www.cdc.gov/vaccin19esafety/ 

ensuringsafety/history/index.html. 

National Childhood Vaccine Injury Act 

of 1986, title III of Public Law 99–660 

(42 U.S.C. 300aa–1 et seq.) (Vaccine 

Act), which established the National 

Vaccine Injury Compensation Program 

(VICP). The objectives of the VICP are to 

ensure an adequate supply of vaccines, 

stabilize vaccine costs, and establish 

and maintain an accessible and efficient 

forum for individuals found to be 

injured by certain vaccines to be 

federally compensated. 

While the federal government 

recommends that individuals be 

vaccinated against a wide range of 

illnesses and diseases, it does not 

mandate them. Each state decides which 

vaccines are required for child’s 

enrollment and attendance at a 

childcare facility or school in that state. 

Vaccination requirements and allowable 

exemptions vary by state.13

Comment: Commenters believe that 

there should be no vaccines that contain 

metals, formaldehyde, preservatives, 

fetal tissue, and other potentially 

harmful ingredients to humans. 

Response: That is beyond the scope of 

this final rule. For more information on 

the contents of vaccines and their safety, 

please see https://www.fda.gov/ 

vaccines-blood-biologics/safetyavailability-biologics/commoningredients-us-licensed-vaccines. 

Comment: Some commenters believe 

that vaccines are an attempt to 

supersede their rights as parents, and 

this regulation should be abandoned. 

Response: The federal government is 

not trying to supersede parent’s rights. 

The purpose of vaccines are to eradicate 

diseases and to reduce the number of 

people who experience the devastating 

effects of preventable infectious diseases 

like measles, diphtheria, and whooping 

cough. This regulation does not address 

parents’ rights with respect to their 

children. 

Comment: A commenter expressed 

anger about the Gardasil HPV vaccine 

causing injury and death. 

Response: There is a safe and effective 

HPV vaccine that can prevent the 

infections that most commonly cause 

cancer. Gardasil 9 (human 

papillomavirus 9-valent vaccine, 

recombinant; 9vHPV) was approved by 

the FDA for use in 2014. The safety of 

Gardasil 9 was studied in clinical trials 

with more than 15,000 participants 

before it was licensed and continues to 

be monitored. Gardasil 9 protects 

against 9 types of cancer-causing HPV 

types 6, 11, 16, 18, 31, 33, 45, 52, and 

58. For more information on the HPV 

vaccine, side effects, and who should 

and should not receive this vaccine, see 

https://www.cdc.gov/vaccinesafety/ 

vaccines/hpv-vaccine.html. 

Comment: Some commenters asked to 

make vaccines optional. They believe 

that vaccines should not be mandated. 

Commenters believe that all vaccines 

should be voluntary. Many commenters 

contended that they are not. Many 

expressed a strong desire against being 

forced to get any vaccine, specifically 

the COVID–19 vaccine. 

Response: State laws establish 

vaccination requirements for school 

children and some state healthcare 

workers. Revision of state laws and 

requirements are not within the scope of 

this final rule. 

Comment: Some commenters 

expressed concern that their jobs made 

it mandatory to have vaccines. They 

believe that since their jobs make it 

mandatory, all related injuries should be 

compensated by the government. 

Response: Employment requirements 

are beyond the scope of this final rule. 

Comment: Some commenters believe 

that all of the studies supporting 

vaccines are biased and created out of 

fear of the ‘‘vaccine lobby.’’ 

Response: Vaccines are one of the 

greatest success stories in public health. 

Through use of vaccines, we have 

eradicated smallpox and nearly 

eliminated wild polio virus. The 

number of people who experience the 

devastating effects of preventable 

infectious diseases like measles, 

diphtheria, and whooping cough is at an 

all-time low. The United States has a 

long-standing vaccine safety program 

that closely and constantly monitors the 

safety of vaccines. Before vaccines are 

approved by the Food and Drug 

Administration (FDA), they are tested 

and studied extensively by scientists to 

help ensure they are safe and effective. 

After vaccines are approved, a critical 

part of the vaccine safety program is that 

the Centers for Disease Control and 

Prevention (CDC)’s Immunization Safety 

Office (ISO) and FDA monitor for 

possible vaccine side effects and 

conduct studies to determine whether 

health problems are caused by vaccines. 

CDC’s ISO data show that the current 

U.S. vaccine supply is the safest in 

history.14 Also, regulating clinical 

research and reviewing the safety of 

vaccines are responsibilities of the FDA, 

not the VICP, and changes in vaccine 

research and how vaccines are studied 

and tested are beyond the scope of this 

final rule. 

Section II: COVID–19 Vaccine 

Comments 

Comment: Some commenters 

expressed concern that the proposed 

rule did not add the COVID–19 vaccine 

to the Table. Some commenters believe 

that the Notice of Proposed Rulemaking 

would stop the automatic addition of 

the COVID–19 vaccine to the Vaccine 

Injury Table. Some believe the COVID– 

19 vaccine should be added to the Table 

to make the general public feel better 

about taking the vaccine; they believe 

that the change in the Table will 

increase fear of vaccination. Some 

commenters believe that since the 

COVID–19 vaccine is not included on 

the Table, it is unsafe. Others are 

concerned that the Government will 

mandate the COVID–19 vaccine, and 

that the changes to the Table are an 

attempt by the government to shield 

itself from any responsibility to 

compensate for COVID–19 vaccine 

related injuries. Other commenters 

asked if someone was injured by the 

COVID–19 vaccine, how would they be 

compensated. 

Response: This final rule has zero 

impact on inclusion of the COVID–19 

vaccine on the Table. The COVID–19 

vaccine can separately be added to the 

Table, but the Department needs to 

follow the process specified in 42 U.S.C. 

300aa–14(c)–(d) to do so. This includes 

that the ACCV recommend that the 

COVID–19 vaccine be added, or opine 

on the Department’s recommendation to 

add the COVID–19 vaccine to the Table. 

Prior to COVID–19 vaccines being 

added to the Table, injuries resulting 

from these vaccines can be compensated 

under the Countermeasures Injury 

Compensation Program (CICP). 

The CICP is administered by the 

Health Resources and Services 

Administration, within the Department 

of Health and Human Services. 

Information about the CICP and filing a 

claim are available at the toll-free 

number 1–855–266–2427 or the CICP’s 

website, https://www.hrsa.gov/cicp/. 

Comment: Commenters believe that it 

is suspicious that the Administration is 

trying to remove injuries from the Table 

‘‘secretly’’ during the COVID–19 

pandemic. Other commenters suggested 

that the Department should not remove 

SIRVA from the Table at a time when 

millions more vaccines are being 

administered against COVID–19. 

Response: The Department 

respectfully disagrees that injuries are 


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6252 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 

15More information about how COVID–19 mRNA 

vaccines work can be found at https://www.cdc.gov/ 

coronavirus/2019-ncov/vaccines/different-vaccines/ 

mrna.html. 

16 42 U.S.C. 247d–6d; see also Fourth 

Amendment to the Secretary’s PREP Act 

Declaration, 85 FR79,190, 79,195 (Dec. 9, 2020). 

being removed from the Table 

‘‘secretly.’’ The ACCV publicly 

discussed the proposal on March 6, 

2020 and May 18, 2020. Recordings of 

both discussions are publicly available 

at https://www.hrsa.gov/advisorycommittees/vaccines/meetings.html. 

The Department subsequently published 

the Notice of Proposed Rulemaking in 

the Federal Register and provided a 

180-day public comment period. It also 

held a public hearing on the proposed 

rule on November 9, 2020. The fact that 

the commenters were able to comment 

on the proposed rule indicates that 

SIRVA and vasovagal syncope are not 

being removed ‘‘secretly.’’ This final 

rule has zero impact on the COVID–19 

vaccine, which is not currently on the 

Table. Those injured by the COVID–19 

vaccine can recover from the CICP if 

they satisfy the statutory and regulatory 

prerequisites. 

Comment: A commenter expressed 

anger about the COVID–19 vaccine 

altering the very DNA of its recipient. 

Response: This comment is outside 

the scope of this rulemaking. The 

Department notes, though, that COVID– 

19 mRNA vaccines do not affect or 

interact with DNA in any way.15

Comment: Some commenters asked 

the Department to consider giving 

people stimulus checks in exchange for 

receiving the COVID–19 vaccine. 

Response: Whether to provide 

stimulus checks for receiving the 

COVID–19 vaccine is outside the scope 

of this final rule. 

Comment: One commenter asked the 

Department to reconsider removing 

SIVRA and vasovagal syncope from the 

Table because nurses, and those on the 

medical front line, need protection from 

liability, especially considering the 

overwhelming year they have had due 

to the COVID–19 pandemic. 

Response: The Department thanks 

front-line workers for the tremendous 

work they have done over the past year. 

This final rule does not impact PREP 

Act immunity for Covered Persons (as 

defined in the PREP Act) who 

manufacture, distribute, order, or 

administer COVID–19 vaccines. Under 

the PREP Act and the Secretary’s March 

10, 2020 PREP Act declaration, as 

amended, during the effective period of 

the declaration, Covered Persons are 

immune from suit and liability (absent 

willful misconduct) under Federal and 

State law with respect to all claims for 

loss caused by, arising out of, relating 

to, or resulting from the administration 

to or the use by an individual of a 

covered countermeasure.16

Section III: General Support for the 

Proposed Rule 

Comment: Some commenters believe 

that there is no good rationale to include 

adverse events that are due to the 

physical administration of the vaccine 

rather than the effects of the contents. 

Commenters believe keeping those 

events covered by the program actually 

waters down the intent of the program 

and pulls away resources from the 

people who were actually affected by 

the vaccines themselves. 

Response: The Department agrees. 

Comment: Some commenters believe 

that the high number of SIRVA and 

vasovagal syncope cases submitted to 

the VICP has led to a falsely elevated 

number of reported side effects and 

reinforcing the ‘‘fear’’ of receiving 

vaccines by those who may be 

uninformed. 

Response: The Department agrees. 

Since the scientific literature indicates 

that SIRVA and vasovagal syncope 

results from poor vaccination technique 

and the act of injection, rather than the 

vaccine components, removing SIRVA 

and vasovagal syncope from the Table 

would more accurately reflect the 

number of reported side effects actually 

caused by vaccine components. Such 

claims, which are not associated with 

vaccines or their components, therefore 

erroneously suggest that vaccines are 

less safe than they in fact are. 

Comment: Some commenters believe 

that SIRVA and vasovagal syncope cases 

submitted to the VICP has also has 

contributed to a delayed process in 

awarding monies to those with valid 

claims related to the vaccine itself. 

Response: The Department agrees. 

Comment: Some commenters believe 

the federal government is not the place 

to lodge a complaint related to the 

administration of a vaccine. The 

appropriate place to do this is through 

the traditional court system or through 

practitioner licensing boards. They 

believe that current use and the number 

of claims for shoulder injury in adults 

are against the intent and spirit of the 

original law. 

Response: The Department thanks the 

commenters for these comments. It is 

the Department’s belief that Congress 

intended for the Vaccine Act’s 

compensation system to be used for 

unavoidable injuries and illnesses that 

cannot be predicted in advance and can 

occur without fault. SIRVA and 

vasovagal syncope are generally not 

those types of injuries or illnesses. With 

proper injection technique, SIRVA is 

likely preventable. The scientific 

literature also suggests that those 

administering vaccines can take steps to 

significantly reduce the likelihood of 

vasovagal syncope. 

Section IV: General Concerns 

Comment: Many commenters believed 

that vaccine or pharmaceutical 

companies should be solely liable for all 

negative side effects caused by their 

vaccines. They called for the repeal of 

the laws which grant vaccine 

manufactures immunity. 

Response: The National Childhood 

Vaccine Injury Act of 1986 was passed 

by Congress. To repeal the Act would 

require a statutory amendment and thus 

is not within the scope of this final rule. 

Comment: Some commenters fear that 

the proposed rule will disband the 

entire VICP. 

Response: This final rule is not 

disbanding the VICP. For the most part, 

this final rule reverts to the status quo 

as of January 2017. The one additional 

change, removing Item XVII, is being 

done because the Secretary has serious 

concerns that Item XVII does not 

comport with applicable law. All 

vaccines currently on the Table, and the 

vast majority of injuries currently on the 

Table, will remain on the Table after 

this final rule becomes effective. 

Comment: Many commenters stated 

that the National Vaccine Injury 

Compensation Program covers injuries 

caused not only by the contents of the 

vaccine, but also the administration of 

the vaccine. They stated that but for the 

vaccine, there would not be a faulty 

administration, and there would not be 

a SIRVA injury. Many other commenters 

stated that all injuries, whether caused 

by the contents of the vaccine or by 

faulty administration of the vaccine, 

should be covered by the VICP. 

Commenters stated that HHS incorrectly 

interpreted the Vaccine Act to preclude 

claims involving ‘‘negligence by the 

vaccine administrator.’’ This commenter 

stated that contrary to the HHS 

interpretation of the Act, legislative 

history shows that Congress expressly 

indicated that it sought to broadly cover 

all injuries or death associated with 

vaccine administrations. 

Response: The Secretary respectfully 

disagrees with the comment that 

whether or not SIRVA is caused by 

faulty administration the VICP should 

cover the injuries. The Department has 

concluded that the Vaccine Act should 

be read as not applying to cover injuries, 

like SIRVA and vasovagal syncope, 

which involve negligence by the vaccine 


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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 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]accinerelated 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’’ (MerriamWebster.com Dictionary, MerriamWebster, https://www.merriamwebster.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 vaccinerelated injury carves out ‘‘an adulterant 

or contaminant intentionally added to 

such a vaccine. 42 U.S.C. 300aa–33(5) 

(emphasis added). By excluding from 

the definition those injuries associated 

with an adulterant or contaminant 

intentionally added to the vaccine, 

Congress indicated its intent to permit 

suit only where the injury was caused 

by the components of the vaccine itself, 

not individual fault. Relatedly, in the 

provisions setting forth the standard for 

awarding compensation, Congress 

specified that an award is not 

appropriate when injury was ‘‘due to 

factors unrelated to the administration 

of the vaccine,’’ and further defined that 

phrase to include ‘‘trauma . . . which 

have no known relation to the vaccine 

involved.’’ 42 U.S.C. 300aa–13(a)(1)(B) 

& (2)(B). In other words, Congress 

excluded compensation for injuries that 

were not related ‘‘to the vaccine 

involved.’’ 

Third, the statutory scheme requires 

that the patient ‘‘received a vaccine set 

forth in the Vaccine Injury Table,’’ 42 

U.S.C. 300aa–11(c)(1)(A), tying 

compensation to the receipt of a specific 

listed vaccine. See 42 U.S.C. 300aa– 

11(c)(1)(C)(i) (speaking to an injury 

aggravated ‘‘in association with the 

vaccine referred to’’ on the Vaccine 

Injury Table); 42 U.S.C. 300aa– 

11(c)(1)(C)(ii)(I) (for conditions not on 

the Vaccine Injury Table, allowing proof 

that the condition ‘‘was caused by a 

vaccine’’ on the Table); 42 U.S.C. 

300aa–11(c)(1)(C)(ii)(II) (same). But 

negligent administration can occur 

without regard to the specific vaccine 

and, as noted above, can encompass 

anything from negligent needle 

placement to ‘‘the doctor’s negligent 

dropping of an infant patient.’’ 

Amendola, 989 F.2d at 1186–87. 

Congress strongly signaled that it was 

focused on compensation for harm 

caused by the vaccine by requiring that 

the Table list the vaccines themselves 

and the types of injuries the vaccines 

themselves would cause. 

Fourth, in the provision preempting 

state tort liability, Congress protected 

manufacturers from liability when the 

injury ‘‘resulted from side effects that 

were unavoidable even though the 

vaccine was properly prepared . . .’’ 42 

U.S.C. 300aa–22(b)(1). This language 

shows Congress wanted to preserve a 

state tort remedy for certain avoidable 

injuries, such as those caused by 

negligent vaccine administration. Given 

that the Vaccine Act seeks to replace 

state tort remedies for the injuries it 

covers, this reinforces the conclusion 

that the Act does not reach SIRVA and 

vasovagal syncope. 

Fifth, Congress provided for health 

care providers who administer vaccines 

to record detailed information about the 

vaccination, including the date of 

administration; the manufacturer; the 

name of the provider; and other 

identifying information. 42 U.S.C. 

300aa–25. This information is well 

suited to a program designed to 

compensate for injuries associated with 

the vaccine itself, since it provides the 

key details about the vaccine provided 

and when. But this reporting 

requirement is woefully inadequate if 

the Program was designed to 

compensate for negligence by the 

provider, which would require 

maintaining careful records regarding 

the actual administration of the vaccine. 

In setting up the original Vaccine 

Injury Table, Congress referenced 

conditions ‘‘resulting from the 

administration of such vaccines.’’ 42 

U.S.C. 300a–14(a). But this phrase was 

not designed to define the scope of the 

program or the Table; instead, Congress 

directed the Secretary to add conditions 


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6254 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 

17For 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. 

18See 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. 

19Martı ́n Arias, K.H., Fadrique, R., Sa ́inz Gil, M., 

and Salgueiro-Vazquez, M.E., Risk of bursitis and 

other injuries and dysfunctions of the shoulder 

following vaccinations, Vaccine, 2017;35:4870– 

4876. See also Bancsi A, Houle SKD, Grindrod KA. 

Shoulder injury related to vaccine administration 

and other injection site events. Can. Fam. 

Physician. 2019 Jan;65(1):40–42 (explaining that 

SIRVA ‘‘is a preventable occurrence caused by the 

injection of a vaccine into the shoulder capsule 

rather than the deltoid muscle’’); Macomb CV, 

Evans MO, Dockstater JE, Montgomery JR, Beakes 

DE. Treating SIRVA Early With Corticosteroid 

Injections: A Case Series. Mil Med. 2019 Oct 17 

(noting that SIRVA does not occur unless the 

vaccine is mistakenly given in the shoulder 

capsule). Another recent study reviewed the 

Vaccine Adverse Event Reporting System (VAERS) 

database from July 2010 to June 2017 for reports of 

atypical shoulder pain and dysfunction following 

injection of inactivated influenza vaccine (IIV). See 

B.F. Hibbs, C.S. Ng, O. Museru et al., Reports of 

atypical shoulder pain and dysfunction following 

inactivated influenza vaccine, Vaccine Adverse 

Event Reporting System (VAERS), 2010–2017, 

Vaccine. The review found that, of the 266 reports 

where contributing factors for the injury were 

reported, 216 (81.2%) described the vaccination as 

being given ‘‘too high’’ on the arm. Other reports 

described improper or poor administration 

technique (e.g., bone strikes, ‘‘administered in 

tendon’’), uneven position between vaccinator and 

the patient (e.g., vaccinator standing while patient 

sitting), vaccination needle too long, and others 

(e.g., difficulty injecting vaccine). A small minority 

of reports also indicated the patient had a history 

of thyroid dysfunction or diabetes. It is possible that 

certain injuries characterized as SIRVA occur when 

an immunologically active substance designed to 

trigger an inflammatory response (i.e., the vaccine 

antigen) is injected into an area where the 

inflammatory response can cause joint damage (i.e., 

the bursa or tendons) as opposed to an area where 

the inflammatory response will not cause joint 

damage or permanent harm (i.e., the deltoid 

muscle). Such injuries are fairly characterized as 

resulting from the vaccination technique, since they 

would not have occurred if the injection occurred 

in the proper part of the body. 

to the Table if they were ‘‘associated 

with such vaccines.’’ 42 U.S.C. 300aa– 

14(e)(1)(B) & (2)(B). And it is telling that 

Congress included nothing similar to 

SIRVA or other injuries caused by 

negligent vaccine administration in the 

original Table, rather than injuries 

associated with the vaccine components 

themselves. Finally, that Congress asked 

the Secretary to ‘‘make or assure 

improvements’’ in the ‘‘administration’’ 

of vaccines, 42 U.S.C. 300aa–27(a)(2), 

among many areas of improvement in 

the vaccination process, does not imply 

that the compensation program covers 

negligent administration. 

Perhaps for some or all of these 

reasons, state courts have found that 

injuries arising from negligent 

administration of a vaccine are not 

‘‘vaccine-related injuries’’ under 42 

U.S.C. 300aa–33(5), and therefore are 

not preempted by the Vaccine Act. See, 

e.g., Neddeau v. Rite Aid of Conn., 2015 

WL 5133151, at *3 (Super. Ct. Conn. 

July 28, 2015) (state court action did not 

allege a ‘‘vaccine-related’’ injury and 

therefore was not barred by the Vaccine 

Act, because plaintiff’s allegation that 

the administrator struck the needle too 

high was an allegation that her injuries 

‘‘were caused by negligence in the 

physical process of injecting the 

vaccine, not by the effects of the 

vaccine’’); Nwosu ex rel. Ibrahim v. 

Adler, 969 So. 2d 516, 519 (Ct. App. Fla. 

2007) (claim arising from a physician’s 

negligent injection of a vaccine was not 

a ‘‘vaccine-related injury,’’ and adding 

that ‘‘[i]t is true that had the child not 

been vaccinated, she would not have 

been injured. However, her injury as 

alleged, does not flow from the 

inoculant injected into her body [so] it 

is not the type of injury covered under 

the Act’’). 

The Table should only include 

injuries caused by a vaccine or its 

components, not the manner in which 

the vaccine was administered. Thus, a 

petitioner must have an injury or death 

‘‘associated’’ with the vaccine, not one 

resulting from poor injection technique 

or other improper administration of the 

vaccine. The Department believes 

SIRVA and vasovagal claims should not 

be included on the Table and cannot be 

based on causation in fact, because they 

are not injuries associated with vaccines 

or their components, nor are they 

unavoidable injuries or illnesses that 

cannot be predicted in advance, or that 

can occur without fault. 

Comment: Some commenters asked 

that this final rule be postponed until 

the new administration enters office, 

arguing that it is unfair to change the 

VICP in the final days of President 

Trump’s administration. 

Response: Past practice has often been 

to finalize rules that are ready for 

finalization without waiting for the 

incoming Administration to take 

office.17 This is consistent with the 

Department’s desire to as expeditiously 

as possible ensure the Table complies 

with applicable law. 

Comment: Many commenters took 

issue with the Department’s assertion in 

the proposed rule that retaining SIRVA 

and vasovagal syncope injuries on the 

Table will encourage frivolous petitions 

for compensation and add to DOJ’s 

caseload. 

Response: The proposed rule 

explained in detail how DOJ’s caseload 

has increased since SIRVA and 

vasovagal syncope were added to the 

Table. DOJ had informed the 

Department that, out of 2,214 SIRVA 

claims filed since 2017, DOJ had 

identified 27 cases in which altered 

medical records have been filed, some 

of which involved changes to the site of 

vaccination. 

Section V: SIRVA-Specific Comments 

Comment: Many commenters stated 

that according to medical literature, not 

all SIRVA is related to improper 

injection technique, and some or all 

cases of SIRVA result from the antigen 

itself, not just the needle placement in 

the bursa. These commenters stated that 

this undermines the Department’s 

justification for removing SIRVA from 

the Vaccine Injury Table. They also state 

that HHS was incorrect to suggest that 

‘‘there is nearly uniform agreement in 

the scientific community that SIRVA is 

caused by improper vaccine 

administration, rather than by the 

vaccine itself.’’ Other commenters stated 

that since medical literature is split on 

the cause of SIRVA, it should be left on 

the table until further research can be 

done. 

Response: There is nearly uniform 

agreement in the scientific community 

that SIRVA is caused by improper 

vaccine administration, rather than by 

the vaccine itself.18 Since the 2017 Final 

Rule was promulgated, additional 

scientific research concluded that 

subdeltoid or subacromial bursitis and 

other shoulder lesions are ‘‘more likely 

to be the consequence of a poor 

injection technique (site, angle, needle 

size, and failure to take into account [a] 

patient’s characteristics, i.e., sex, body 

weight, and physical constitution),’’ 

rather than ‘‘antigens or adjuvants 

contained in the vaccines that would 

trigger an immune or inflammatory 

response.’’ 19 The Department has not 

seen compelling peer-reviewed 

publications, submitted either by the 

commenters or otherwise, that calls into 

question this conclusion. Indeed, SIRVA 

stands for shoulder injury related to 

vaccine administration. 

Comment: Many commenters wrote 

about their SIRVA injuries and 

experiences with treatment and therapy. 

Many received or were in the process of 

receiving compensation through the 

VICP. They stressed the pain and 

suffering they went through due to a 

badly administered vaccine and asked 

for SIRVA to remain on the Table. They 

believe they deserve just compensation 


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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 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 


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6256 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 

20National 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-evidenceand-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). 

23See Barnes MG, Ledford C, Hogan K. A 

‘‘needling’’ problem: Shoulder injury related to 

vaccine administration. J Am Board Fam Med. 2012 

Nov-Dec; 25(6):919–22; Cross GB, Moghaddas J, 

Buttery J, Ayoub S, Korman TM. Don’t aim too high: 

Avoiding shoulder injury related to vaccine 

administration. Aust Fam Physician. 2016 May; 

45(5):303–6. 

24 Martı ́n Arias, K.H., Fadrique, R., Sa ́inz Gil, M., 

and Salgueiro-Vazquez, M.E., Risk of bursitis and 

other injuries and dysfunctions of the shoulder 

following vaccinations, Vaccine, 2017; 35: 4870– 

4876. See also Bancsi A, Houle SKD, Grindrod KA. 

Shoulder injury related to vaccine administration 

and other injection site events. Can. Fam. 

Physician. 2019 Jan; 65(1): 40–42 (explaining that 

SIRVA ‘‘is a preventable occurrence caused by the 

injection of a vaccine into the shoulder capsule 

rather than the deltoid muscle’’); Macomb CV, 

Evans MO, Dockstater JE, Montgomery JR, Beakes 

DE. Treating SIRVA Early With Corticosteroid 

Injections: A Case Series. Mil Med. 2019 Oct 17 

(noting that SIRVA does not occur unless the 

vaccine is mistakenly given in the shoulder 

capsule). Another recent study reviewed the 

Vaccine Adverse Event Reporting System (VAERS) 

database from July 2010 to June 2017 for reports of 

atypical shoulder pain and dysfunction following 

injection of inactivated influenza vaccine (IIV). See 

B.F. Hibbs, C.S. Ng, O. Museru et al., Reports of 

atypical shoulder pain and dysfunction following 

inactivated influenza vaccine, Vaccine Adverse 

Event Reporting System (VAERS), 2010–2017, 

Vaccine. The review found that, of the 266 reports 

where contributing factors for the injury were 

reported, 216 (81.2%) described the vaccination as 

being given ‘‘too high’’ on the arm. Other reports 

described improper or poor administration 

technique (e.g., bone strikes, ‘‘administered in 

tendon’’), uneven position between vaccinator and 

the patient (e.g., vaccinator standing while patient 

sitting), vaccination needle too long, and others 

(e.g., difficulty injecting vaccine). A small minority 

of reports also indicated the patient had a history 

of thyroid dysfunction or diabetes. It is possible that 

certain injuries characterized as SIRVA occur when 

an immunologically active substance designed to 

trigger an inflammatory response (i.e., the vaccine 

antigen) is injected into an area where the 

inflammatory response can cause joint damage (i.e., 

the bursa or tendons) as opposed to an area where 

the inflammatory response will not cause joint 

damage or permanent harm (i.e., the deltoid 

muscle). Such injuries are fairly characterized as 

resulting from the vaccination technique, since they 

would not have occurred if the injection occurred 

in the proper part of the body. 

its interpretation of these injuries. 

Moreover, the Department has 

concluded that there are strong policy 

reasons for now removing SIRVA from 

the Table. 

Response: As discussed above, it is 

the Department’s belief that vasovagal 

syncope is not a ‘‘vaccine-related 

injury’’ and therefore should not be 

included on the Table or compensable 

under the VICP. 42 U.S.C. 300aa–11, 

300aa–14(e), and the inclusion of the 

injury in 2017 was incorrect. 

Comment: Many commenters believe 

that SIRVA should remain on the table 

because ‘‘No evidence has been 

presented by DHHS justifying the 

removal of these injuries.’’ 

Response: The scientific literature 

indicates that SIRVA likely results from 

poor vaccination technique, rather than 

the vaccine or its components alone. 

The notice of proposed rulemaking that 

preceded the Final Rule characterized 

SIRVA as an ‘‘adverse event following 

vaccination thought to be related to the 

technique of intramuscular 

percutaneous injection (the procedure 

where access to a muscle is obtained by 

using a needle to puncture the skin) into 

an arm resulting in trauma from the 

needle and/or the unintentional 

injection of a vaccine into tissues and 

structures lying underneath the deltoid 

muscle of the shoulder.’’ 20The IOM 

similarly concluded that ‘‘the injection, 

and not the contents of the vaccine, 

contributed to the development of 

deltoid bursitis.’’ 21 Indeed, the primary 

case series relied upon by the 

Department in promulgating the 

proposed rule and Final Rule found that 

the medical literature supports the 

possibility that SIRVA may result from 

inappropriate needle length and/or 

injection technique.22 There is nearly 

uniform agreement in the scientific 

community that SIRVA is caused by 

improper vaccine administration, rather 

than by the vaccine itself.23 Since the 

Final Rule was promulgated, additional 

scientific research concluded that 

subdeltoid or subacromial bursitis and 

other shoulder lesions are ‘‘more likely 

to be the consequence of a poor 

injection technique (site, angle, needle 

size, and failure to take into account [a] 

patient’s characteristics, i.e., sex, body 

weight, and physical constitution),’’ 

rather than ‘‘antigens or adjuvants 

contained in the vaccines that would 

trigger an immune or inflammatory 

response.’’ 24

Comment: Some commenters stated 

that HHS’s justification for removing 

SIRVA from the VICP does not comport 

with best available science, because, 

although HHS correctly states that 

SIRVA and syncope are considered to be 

adverse injuries following direct trauma 

from an injection point, ‘‘negligent 

administration’’ and ‘‘poor vaccination 

technique’’ are not exclusively 

connected with the onset of SIRVA and 

syncope-related injuries. Commenters 

stated that the agency did not consider 

that serious injuries may occur 

following the onset of SIRVA or a 

syncope-related event. 

Response: It is possible that serious 

injuries may occur following the onset 

of SIRVA or a syncope-related event, but 

the scientific literature suggests such 

injuries generally result from the act of 

injection, rather than the vaccine or its 

components. That negligent 

administration or poor vaccination 

technique may also be connected with 

other injuries does not change the 

Department’s conclusions. 

Comment: Some commenters stated 

that SIRVA injuries are not as rare as the 

Department states. They state that due 

to lack of information, many SIRVA 

injuries are not recognized or reported. 

Response: The Department did not 

state that SIRVA injuries are rare. 

Comment: Some commenters argue 

that medical literature supports that 

SIRVA alone cannot result from 

negligent administration of a vaccine, 

because these injuries are a combination 

of both (1) the needle placed into the 

subacromial bursa and (2) the vaccine 

components that are needed to cause the 

immune response, resulting in SIRVA. 

Response: It is possible that certain 

injuries characterized as SIRVA occur 

when an immunologically active 

substance designed to trigger an 

inflammatory response (i.e., the vaccine 

antigen) is injected into an area where 

the inflammatory response can cause 

joint damage (i.e., the bursa or tendons) 

as opposed to an area where the 

inflammatory response will not cause 

joint damage or permanent harm (i.e., 

the deltoid muscle). Such injuries are 

fairly characterized as resulting from the 

vaccination technique, since they would 

not have occurred if the injection 

occurred in the proper part of the body. 

Section VI: Vasovagal Syncope Specific 

Concerns 

Comment: Some commenters shared 

their negative experiences with 

vasovagal syncope. One commenter said 

he was left alone after receiving a 

vaccine, which resulted in severe 

injuries to his face and causing him to 

need extensive medical treatment. He 

stated that the VICP is the only recourse 

to financial compensation for pain and 

suffering, since Texas malpractice laws 

make it difficult to obtain 

compensation. 

Response: The Department 

sympathizes with those who suffered an 

injury, but it is the Department’s belief 

that Congress intended for the Vaccine 

Act’s compensation system to be used 

for unavoidable injuries and illnesses 


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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 6257 

25 80 FR 45,137 (The IOM found that one case 

report suggested that ‘‘the injection, and not the 

contents of the vaccine, contributed to the 

development of syncope’’). See also IOM Report at 

18 (‘‘injection of vaccine, independent of the 

antigen involved, can lead to’’ syncope); Miller, E. 

and Woo, E.J. Time to prevent injuries from 

postimmunization syncope, Nursing, 2006 36 (12): 

20. 

26 80 FR 45137. 

27 80 FR 45137. See also IOM Report. 

28 42 U.S.C. 300aa–14(c)(1). 

29 42 U.S.C. 300aa–14(d). 

30The language in Item XVII also raises 

Constitutional concerns. Item XVII in effect allows 

CDC to add vaccines to the Table so long as the 

Secretary publishes notice of coverage. The Office 

of Legal Counsel has previously opined that a 

statute that sought to authorize the CDC director to 

take certain action unilaterally was inconsistent 

with the Executive Powers Clause. (Statute Limiting 

The President’s Authority To Supervise The 

Director Of The Centers For Disease Control In The 

Distribution Of An AIDS Pamphlet, 12 U.S. Op. Off. 

Legal Counsel 47, 48, 1988 WL 390999, at * 1). For 

the same reasons, it is not clear that the CDC 

director, as an inferior officer, has the authority to 

unilaterally add vaccines to the Table without the 

approval of the Secretary. 

31 42 U.S.C. 300aa–14(c)(1). 

32 42 U.S.C. 300aa–14(d). 

that cannot be predicted in advance and 

can occur without fault. Vasovagal 

syncope is generally not that type of 

injury or illness. Scientific and medical 

literature support the conclusion that 

syncope may be caused by the act of 

vaccination, but not its contents.25

Texas state malpractice laws are beyond 

the scope of this final rule. 

Comment: Some commenters stated 

that contrary to the Department’s 

position that vasovagal syncope is not a 

vaccine-related injury, the IOM found 

‘‘sufficient mechanistic evidence 

supporting the conclusion that syncope 

is ‘directly related to vaccine 

administration,’ ’’ and that the CDC has 

reported people fainting after receiving 

nearly all vaccines. While the 

commenters agree that steps can be 

taken to reduce the risk of syncope, they 

state that it should remain on the Injury 

Table. 

Response: The IOM found insufficient 

epidemiologic evidence of an 

association between the injection of a 

vaccine and syncope, but it found 

sufficient mechanistic evidence 

supporting the conclusion that syncope 

is ‘‘directly related to vaccine 

administration.’’ 26 The IOM explained 

that evidence it examined as part of its 

review suggested ‘‘that the injection, 

and not the contents of the vaccine, 

contributed to the development of 

syncope.’’ 27 In addition, because 

syncope is an injury related solely to the 

injection of a vaccine, the Department 

did not add syncope to the 2017 

revisions to the Table as an injury for 

vaccines that are not administered by 

injection, such as oral polio and 

rotavirus vaccine. 

Comment: One commenter stated that 

removing syncope from the table would 

go against three decades of precedent 

and the weight of the medical evidence. 

Response: The Department 

respectfully disagrees. Vasovagal 

syncope was not added to the Table 

until 2017. From the inception of the 

Table until 2017, vasovagal syncope is 

not included. 

Section VII: Comments Regarding Item 

VII 

Comment: Some commenters are 

concerned that removing Item XVII from 

the Table will remove an avenue to add 

new vaccines to the Table. 

Response: The Department is 

removing Item XVII from the table 

because it has serious concerns that 

Item XVII is contrary to law, including 

the procedures described in the Vaccine 

Act for amending the Table. 

Specifically, to the extent that Item XVII 

provides a unilateral mechanism for 

adding injuries and vaccines to the 

Table, it may be inconsistent with the 

Vaccine Act. The Vaccine Act provides 

a method for adding new vaccines to the 

Table, and it is far from clear that the 

approach in Item XVII complies with 

that method. The Vaccine Act provides 

that the Secretary may promulgate 

regulations to modify the Table, but in 

doing so, he ‘‘shall provide for notice 

and opportunity for a public hearing 

and at least 180 days of public 

comment.’’ 28 Moreover, the Table 

cannot be revised unless ‘‘the Secretary 

has first provided to the [ACCV] a copy 

of the proposed regulation or revision, 

requested recommendations and 

comments by the [ACCV], and afforded 

the [ACCV] at least 90 days to make 

such recommendations.’’ 29 Item XVII, 

by contrast, suggests that vaccines are 

added to the Table once the CDC 

recommends them for routine 

administration to children and an excise 

tax is imposed, even prior to notice and 

public comment or comments from the 

ACCV.30 This may be inconsistent with 

the rulemaking requirements of the 

Administrative Procedure Act 5 U.S.C. 

553, the Regulatory Flexibility Act, 5 

U.S.C. 601 et seq., various Executive 

Orders that cabin rulemaking (see, e.g., 

Executive Order 12866), and the 

Vaccine Act. 

Moreover, even with the removal of 

Item XVII, new vaccines may be added 

to the Table under 42 U.S.C. 300aa– 

14(d), when appropriate. 

Comment: One commenter stated that 

HHS’s argument that Item XVII is 

unlawful is without merit. Article I of 

the Constitution provides Congress the 

authority to delegate responsibilities to 

independent agencies, and the Vaccine 

Act expressly provides that HHS shall 

amend the Vaccine Injury Table to 

include any CDC vaccine recommended 

for routine childhood use within two 

years. According to this commenter, 

Congress provided the CDC with an 

autonomous role in the VICP process, 

and its recommendations are separate 

from administrative action by HHS. 

Therefore, commenters stated that Item 

XVII is lawful. 

Response: The Vaccine Act provides 

that the Secretary may promulgate 

regulations to modify the Table, but in 

doing so, he ‘‘shall provide for notice 

and opportunity for a public hearing 

and at least 180 days of public 

comment.’’ 31 Moreover, the Table 

cannot be revised unless ‘‘the Secretary 

has first provided to the [ACCV] a copy 

of the proposed regulation or revision, 

requested recommendations and 

comments by the [ACCV], and afforded 

the [ACCV] at least 90 days to make 

such recommendations.’’ 32 Item XVII, 

by contrast, suggests that vaccines are 

added to the Table once the CDC 

recommends them for routine 

administration to children and an excise 

tax is imposed, even prior to notice and 

public comment or comments from the 

ACCV. 

Comment: One commenter stated that 

Item XVII does have merit, especially 

because it streamlines the process to 

allow for quicker inclusions of 

important vaccines. This commenter 

stated that this is especially important 

and timely due to the impact of the 

COVID–19 pandemic and the need to 

provide quick compensation for 

COVID–19 vaccine-related injuries or 

deaths. Removing Item XVII would just 

frustrate the stated purpose of the 

Vaccine Act. 

Response: The Department 

appreciates the desire to quickly add 

vaccines to the Table. However 

Congress in 42 U.S.C. 300aa–14 

specified the procedures that must be 

followed to amend the Table. In 

addition, an excise tax would have to be 

imposed. 

Comment: A few commenters 

opposed the removal of the mechanism 

to add vaccines to the Table under item 

XVII. According to the commenters, the 

proposed rule would stop the automatic 

addition of COVID–19 and other new 

vaccines to the VICP, which could 

potentially delay or permanently 

prevent the COVID–19 vaccine from 

being covered under the VICP, and 

subjecting administrators to lawsuits in 

the future. Commenters suggested that 


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6258 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 

33For more information on Vaccines 

recommended for international travel: https://

wwwnc.cdc.gov/travel/destinations/traveler/none/ 

united-states#:∼:text=There%20are%20no%

20vaccination%20requirements,

reenter%20the%20United%20States. (last viewed 

Jan. 2021). 

this policy change is seemingly at odds 

with the actions undertaken by HHS to 

expand liability protections for 

administrators under authorities granted 

in the PREP Act. 

Response: The Department 

appreciates the desire to quickly add 

vaccines to the Table. However 

Congress in 42 U.S.C. 300aa–14 

specified the procedures that must be 

followed to amend the Table. In 

addition, an excise tax would have to be 

imposed. During the effective period of 

the Secretary’s COVID–19 PREP Act 

declaration, Covered Persons are already 

immune from suit and liability under 

Federal and State law with respect to all 

claims for loss caused by, arising out of, 

relating to, or resulting from the 

administration to or the use by an 

individual of FDA-approved or FDAlicensed 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/visstatements/hep-b.html. 

Comment: Some commenters believe 

that all vaccines should be 

automatically added to the VICP. Other 

commenters asked for specific vaccines 

to be added to the Table immediately. 

Response: In 42 U.S.C. 300aa–14(c)– 

(d), Congress specified procedures that 

the Department must follow to add 

vaccines to the Table. In revising the 

Table, the Department must follow these 

procedures. The Department notes, 

though, that if a vaccine is in a category 

of vaccines that is already covered by 

the VICP, then the new vaccine product 

is already covered even before the date 

of licensure. For example, hepatitis B 

vaccines are covered under the Program 

under Category VIII of the Vaccine 

Injury Table. If a new hepatitis B 

vaccine is licensed in the U.S., it is 

already automatically covered under the 

VICP. Adding specific vaccines to the 

Table in this final rule is likely 

impermissible under the Administrative 

Procedure Act and the logical outgrowth 

doctrine. Such vaccines could be added 

in a separate rulemaking. 

Comment: Many commenters stressed 

that vaccines should be changed so they 

do not need to be administered with a 

shot. 

Response: This is beyond the scope of 

this final rule. 

Comment: Some commenters believed 

that any and all mandatory vaccines 

should be covered. Specifically, a 

commenter expressed her anger over a 

‘‘mandatory’’ TD shot to travel out of the 

country. 

Response: There are no vaccination 

requirements for visitors to the United 

States, and U.S. residents traveling 

abroad do not need any vaccines to 

reenter the United States. Many 

vaccines are recommend by the CDC 

and primary care doctors when 

travelling outside the United States, but 

they are not mandatory under federal 

law.33

Comment: One commenter said it was 

unfair that the Table does not include 

heart conditions, because they were 

diagnosed with Pericarditis 24 hours 

after receiving the DMMR vaccine. 

Response: To gain entitlement to 

compensation under the VICP, a 

petitioner must establish that a vaccinerelated 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 vaccinerelated injury or death associated with 

the administration of a vaccine after 

October 1, 1988, and no such court may 

award damages in an amount greater 

than $1,000 in a civil action for damages 

for such a vaccine-related injury or 


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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 6259 

34See 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’’). 

35See 85 FR 52,136, 52140 (Aug. 24, 2020). 

36See 85 FR 43,796–43,797. 

37See 85 FR 43,796–43,797. 

death, unless the person has first filed 

a petition in the Court. This is mandated 

by statute, and the Department does not 

have the authority to change this. 

Comment: Some commenters believe 

that removing SIRVA and Vasovagal 

syncope will result in burdensome and 

time consuming litigation that is unfair 

to those injured since they would have 

to provide evidentiary support in state 

court. They also believe that the claims 

will clog up federal, state, and local 

courts. Other commenters suggested that 

removing these injuries from the VICP 

will lead to claim suppression because 

many individuals will not have the 

resources to pursue their claims in 

court. 

Response: It is the Department’s 

position that if SIRVA and vasovagal 

syncope were removed from the Table, 

individuals could still file SIRVA and 

vasovagal syncope claims in state court, 

or Federal district court if they satisfy 

the requirements of 28 U.S.C. 1332 or 28 

U.S.C. 1367. Once in those court, 

petitioners would be required to prove 

causation between the manner of 

administration and the claimed injury. 

Further, this final rule is unlikely to 

unduly burden the civil tort system. The 

Department conducted a search in the 

WestLaw legal database for cases in 

state court that contained both the terms 

‘‘SIRVA’’ and ‘‘vaccine,’’ and found 

only 20 hits, at least two of which were 

cases involving an entity named SIRVA 

and not the injury. It is possible that 

some additional cases were filed in 

federal district court. Nonetheless, the 

Department believes based on this data 

that any additional burden on the civil 

tort system, which would be dispersed 

across States and not concentrated in 

any one or few States, from removing 

SIRVA and vasovagal syncope from the 

Table and reverting to the status quo as 

of January 2017 will be minimal. 

Comment: Some commenters worry 

that removing SIRVA and vasovagal 

syncope from the Table will result in 

doctors and pharmacists being 

unwilling to administer vaccines 

because they fear personal liability. 

Response: The Department is grateful 

for the many health care professionals 

and pharmacists who improve public 

health by vaccinating the American 

public, and does not believe they would 

intentionally administer a vaccine in an 

improper manner, but the Department 

also wants to incentivize those who 

administer vaccines to do so properly.34

Doing so will improve public 

confidence in vaccinations. Many 

physicians and pharmacists were 

willing to administer vaccines prior to 

SIRVA and vasovagal syncope’s 

addition to the Table in 2017. In 

addition, certain pharmacists are 

already immune from suit and liability 

for claims for loss caused by, arising out 

of, relating to, or resulting from the 

administration of certain childhood 

vaccines to individuals ages three 

through 18 for the duration of the 

Secretary’s Declaration Under the Public 

Readiness and Emergency Preparedness 

Act for Medical Countermeasures 

Against COVID–19.35

Comment: Commenters suggest that 

the tax on flu vaccines that sustain the 

VICP fund should be returned to the 

doctors, pharmacists, and other vaccine 

administrators so that individuals 

injured by administration can sue the 

provider directly. 

Response: The source of funding for 

the VICP is the Trust Fund. The Trust 

Fund is funded by an excise tax on each 

dose of vaccines recommended by the 

CDC for routine administration to 

children. To the extent that the 

commenter is proposing a change to the 

funding mechanism for the VICP, 

effectuating such a change is beyond the 

scope of this final rule. 

Comment: Some commenters asked 

that all time limits for injuries be 

removed from the VICP. 

Response: Revision of the statute of 

limitations would require a statutory 

amendment and thus is not within the 

scope of this final rule. 

Comment: Many commenters wrote 

about their personal negative reactions 

to vaccine components. 

Response: These comments are 

outside the scope of this rulemaking, 

since the scientific literature indicates 

that SIRVA and vasovagal syncope 

results from poor vaccination technique 

and the act of injection, rather than the 

vaccine components. 

Comment: Some commenters asked 

that vaccine injury reporting be 

significantly improved to reflect all 

injuries caused by vaccine components. 

Some asked that reporting to the 

Vaccine Adverse Event Reporting 

System (VAERS) be mandatory. A 

commenter referenced the Harvard 

Pilgrim Health Care report which found 

that less than 1 percent of vaccine 

adverse events are reported. 

Response: This final rule concerns the 

VICP, which is distinct from the 

Vaccine Adverse Event Reporting 

System. As such, these comments are 

outside the scope of this final rule. 

Comment: Two commenters opposed 

removing SIRVA from the Table because 

they stated that they have seen 

compensation greatly help those injured 

by providing resources for rehab 

treatment. 

Response: The Department 

sympathizes with those who suffered an 

injury, but it is the Department’s belief 

that Congress intended for the Vaccine 

Act’s compensation system to be used 

for unavoidable injuries and illnesses 

that cannot be predicted in advance and 

can occur without fault. SIRVA is 

generally not that type of injury or 

illness. Moreover, under this final rule, 

those with SIRVA injuries are not barred 

from suing those who injured them in 

state court. Those injured still have an 

opportunity to be compensated. 

Comment: Many commenters believe 

that the proposed rule changes are 

contrary to the legislative intent behind 

the creation of the vaccine injury 

compensation program, namely 

providing fair and prompt 

compensation to those individuals that 

have suffered well recognized injuries 

related to certain vaccines whilst 

shielding the pharmaceutical and 

medical industries from significant 

exposure. 

Response: The Department explained 

in the proposed rule 36 and elsewhere 

herein why this final rule is consistent 

with Congressional intent. 

Comment: Some commenters stated 

that it was the intention of Congress to 

centralize claims for compensation out 

of hundreds of tort venues to a 

centralized administrative 

compensation system, and removing 

SIRVA and vasovagal syncope is 

contrary to that congressional intent. 

Response: The Department explained 

in the proposed rule 37 and elsewhere 

herein why this final rule is consistent 

with Congressional intent. SIRVA and 

vasovagal syncope are not the sorts of 

injuries that Congress intended for 

inclusion in the Table. 

Comment: Many commenters believe 

that the proposed rule change will result 

in exposing pharmaceutical companies 

to liability and will inadvertently 

‘‘chill’’ vaccine production. 

Response: For the most part, this final 

rule merely reverts to the status quo as 

of January 2017. In fact, the vaccination 

rate has gone down slightly since SIRVA 

and vasovagal syncope were added to 


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6260 Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations 

38See, e.g., https://www.cdc.gov/flu/fluvaxview/ 

coverage-1718estimates.htm; https://www.cdc.gov/ 

nchs/data/hus/2018/031.pdf. 

39 85 FR 43,798. 

40Or Federal district court if they satisfy the 

requirements of 28 U.S.C. 1332 or 28 U.S.C. 1367. 

the Table,38 so it seems unlikely that 

this final rule will ‘‘chill’’ vaccine 

production. 

Comment: Many commenters stated 

that there is no data supporting the 

Department’s position that the trust 

fund is running out of money. These 

commenters state that without this data, 

HHS should not change the Vaccine 

Injury Table. 

Response: SIRVA claims are 

diminishing the Trust Fund.39 The 

Department did not state that the Trust 

Fund is running out of money. The 

Department is finalizing this final rule 

for a combination of legal and policy 

reasons explained herein and in the 

proposed rule, not solely because any 

particular claims are diminishing the 

Trust Fund. 

Comment: Many commenters do not 

believe that reducing the caseload of the 

VICP is a plausible justification to 

change the Injury Table. Others believe 

that the VICP should just hire more 

people to help process the caseload. 

Response: The Department is 

finalizing this final rule for a 

combination of legal and policy reasons 

explained herein and in the proposed 

rule, not solely because of caseload 

concerns. 

Comment: Some commenters stated 

that limiting VICP claims would be 

harmful to families because if 

individuals and their families are 

inadequately compensated for injuries 

or death, they can be economically 

harmed. These costs could also be 

passed on to taxpayers when injured 

individuals and their families are forced 

to resort to extreme measures such as 

filing for bankruptcy. 

Response: If SIRVA and vasovagal 

syncope were removed from the Table, 

individuals could still file SIRVA and 

vasovagal syncope claims in state 

court.40

Comment: Some commenters stated 

that HHS’s interpretation of Section 

300aa–11(a)(2)(A) of the Vaccine Act is 

flawed because it interprets ‘‘associated 

with the vaccine’’ to mean that the 

injury must come from the vaccine itself 

instead of from the administration of the 

vaccine. The Department relies on a 

dictionary definition of ‘‘associated 

with’’ to conclude that it means 

‘‘related, connected, or combined 

together,’’ but does not explain why this 

definition forecloses cases in which the 

vaccine ‘‘combine[s] together’’ with its 

administration to bring about the 

illness. Furthermore, the phrase 

‘‘associated with the administration of 

the vaccine’’ is not qualified. Congress 

could have said ‘‘associated with the 

non-negligent administration of the 

vaccine’’ or ‘‘associated with the proper 

administration of the vaccine.’’ 

Commenters suggested that if (as HHS 

states in the proposed rule) Congress 

intended to cover only those injuries 

associated with some ‘‘antigen,’’ then 

lawmakers would have used that word 

somewhere in the Act. 

Commenters stated that according to 

the tort law principles in which the 

Vaccine Act is grounded, ‘‘legal cause’’ 

often implicates the combined effects of 

two or more forces, each constituting a 

substantial factor in bringing about the 

harm, and imposes liability upon each 

person or thing responsible for those 

forces. Therefore, consistent with tort 

law principles, a SIRVA claimant can be 

found to have ‘‘sustained a vaccinerelated 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 ‘‘nonnegligent’’ administration of the vaccine 

or ‘‘associated with the ‘‘proper’’ 

administration of the vaccine’’ does not 

call into question the Department’s 

careful examination of, and analysis of, 

the relevant statutory terms, which is 

informed by the Department’s expertise 

in this subject matter. 

Comment: Some commenters disagree 

with the Department’s reasoning that 

‘‘associated with’’ does not include 

injuries caused by negligent 

administration of the vaccine. They 

point to 42 U.S.C. 30aa–11 which they 

contend specifically provides for 

‘‘administration’’ of the vaccine. They 

state that the Act refers to 

‘‘administration of the vaccine’’ 17 

times. Other commenters list prior 

interpretation of the act to be 

inconsistent with the Department’s 

‘‘new’’ interpretation. 

Response: The Vaccine Act does in 

certain places refer to ‘‘administration 

of’’ or the ‘‘administrator’’ of the 

vaccine. But the Department thinks that 

those usages were not meant to suggest 

the Program covers negligence in the 

administration of the vaccine, but 

served other purposes. At most, these 

usages render the statute ambiguous 

with respect to needle injuries. In 

Section 300aa–11(a)(2)(A), the statute 

precludes suits against ‘‘a vaccine 

administrator,’’ but this reference does 

not define the scope of the 

compensation program—instead, it 

protects administrators from suits 

‘‘arising from a vaccine-related injury or 

death associated with the 

administration of a vaccine.’’ This 

language is not entirely clear, as it 

appears to impose two distinct 

qualifications that both must be met but 

are worded slightly differently. It may 

be a belt and suspenders approach to 

ensure that vaccine administrators are 

protected from tort claims like in 

Amendola, where the vaccine itself was 

properly administered and caused the 

injury, but the petitioner alleged the 

administrator was negligent in deciding 

to give the vaccine. See 989 F.2d at 1186 

(holding Vaccine Program does not 

exclude cases of ‘‘negligence in 

deciding, for example, whether to 

administer an otherwise satisfactory 

vaccine’’). The important point is that 

the first qualification—‘‘arising from a 

vaccine-related injury’’—is also 

included here and, Congress defined 

this requirement to include only injuries 

associated with the vaccine itself. See 

also 42 U.S.C. 300aa–11(b)(1)(A) 

(referencing individuals who ‘‘died as 

the result of the administration of a 

vaccine’’ but only if the individual 

sustained a ‘‘vaccine-related injury’’). In 

setting up the original Vaccine Injury 

Table, Congress referenced conditions 

‘‘resulting from the administration of 

such vaccines.’’ 42 U.S.C. 300a–14(a). 

But this phrase was not designed to 

define the scope of the program or the 

Table; instead, Congress directed the 

Secretary to add conditions to the Table 

if they were ‘‘associated with such 

vaccines.’’ 42 U.S.C. 300aa–14(e)(1)(B) & 

(2)(B). And it is telling that Congress 

included nothing similar to SIRVA or 

other injuries caused by negligent 

vaccine administration in the original 

Table, rather than injuries associated 

with the vaccine components 

themselves. Finally, that Congress asked 

the Secretary to ‘‘make or assure 

improvements’’ in the ‘‘administration’’ 

of vaccines, 42 U.S.C. 300aa–27(a)(2), 

among many areas of improvement in 

the vaccination process, does not imply 

that the compensation program covers 

negligent administration. 

Furthermore, state courts have found 

that injuries arising from negligent 

administration of a vaccine are not 

‘‘vaccine-related injuries’’ under 42 


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41 85 FR 43,801 n.33. 42 85 FR 43,801. 

U.S.C. 300aa–33(5), and therefore are 

not preempted by the Vaccine Act. See, 

e.g., Neddeau v. Rite Aid of Conn., 2015 

WL 5133151, at *3 (Super. Ct. Conn. 

July 28, 2015) (state court action did not 

allege a ‘‘vaccine-related’’ injury and 

therefore was not barred by the Vaccine 

Act, because plaintiff’s allegation that 

the administrator struck the needle too 

high was an allegation that her injuries 

‘‘were caused by negligence in the 

physical process of injecting the 

vaccine, not by the effects of the 

vaccine’’); Nwosu ex rel. Ibrahim v. 

Adler, 969 So. 2d 516, 519 (Ct. App. Fla. 

2007) (claim arising from a physician’s 

negligent injection of a vaccine was not 

a ‘‘vaccine-related injury,’’ and adding 

that ‘‘[i]t is true that had the child not 

been vaccinated, she would not have 

been injured. However, her injury as 

alleged, does not flow from the 

inoculant injected into her body [so] it 

is not the type of injury covered under 

the Act’’). 

The Table should only include 

injuries caused by a vaccine or its 

components, not the manner in which 

the vaccine was administered. Thus, a 

petitioner must have an injury or death 

‘‘associated’’ with the vaccine, not one 

resulting from poor injection technique 

or other improper administration of the 

vaccine. 

Comment: One commenter stated that 

to the extent that negligence may well 

be a component of some SIRVA injuries, 

categorically excluding these as vaccinerelated 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 Vaccinerelated Shoulder Discomfort, M. Bordor 

& E. Montalvo; Shoulder injury related 

to vaccine administration, S. Atanasoff, 

et al.) 

Response: SIRVA stands for shoulder 

injury related to vaccine administration. 

The Department does not necessarily 

agree that the scientific literature shows 

that all SIRVA injuries necessarily 

involve an inflammatory, immune 

reaction in the deltoid/bursa region. It is 

possible that certain injuries 

characterized as SIRVA occur when an 

immunologically active substance 

designed to trigger an inflammatory 

response (i.e., the vaccine antigen) is 

injected into an area where the 

inflammatory response can cause joint 

damage (i.e., the bursa or tendons) as 

opposed to an area where the 

inflammatory response will not cause 

joint damage or permanent harm (i.e., 

the deltoid muscle). Such injuries are 

fairly characterized as resulting from the 

vaccination technique, since they would 

not have occurred if the injection 

occurred in the proper part of the body. 

Comment: Some commenters 

provided critical reviews of the research 

cited by HHS in the proposed rule. One 

commenter stated that the medical and 

scientific literature cited by the 

Department is contrary to (or at best 

inconclusive of) the proposition that 

SIRVA is caused solely by the physical 

conduct attributable to the person 

administering the vaccine. 

Response: The Department 

respectfully disagrees, and maintains 

the view espoused in the proposed rule. 

The Department correctly characterized 

the literature in the proposed rule. 

Comment: One commenter stated that 

HHS wrongfully stated that the standard 

of proof for establishing entitlement of 

a SIRVA claim is too low or lenient, 

leading to the filing of dubious or 

frivolous claims without providing any 

evidence of this in the proposed rule. 

This commenter stated that the 

suspicion of activity is not proper 

justification for the Department’s 

proposed policy change. The 

commenter also stated that the 

Department’s claim that there has been 

a dramatic increase in SIRVA claims is 

meaningless without context, such as an 

increase in the number of flu vaccines 

administered from the 2016/2017 flu 

season to the 2018/2019 flu season. This 

commenter also pointed out that the 

there is no evidence that SIRVA claims 

are diminishing the Trust Fund, because 

according to the US Treasury Bulletin 

for March 2020, the balance of the Trust 

Fund at the end of FY 2019 was $3.95 

billion, up from $3.85 billion at the end 

of FY 2018. 

Response: DOJ informs the 

Department that, as of the time of the 

proposed rule, out of 2,214 SIRVA 

claims filed since 2017, DOJ had 

identified 27 cases in which altered 

medical records have been filed, some 

of which involved changes to the site of 

vaccination. The proposed rule noted 

that the vaccination rate had decreased 

slightly since SIRVA was added to the 

Table,41 yet SIRVA claims have risen 

dramatically in recent years. The 

Department is finalizing this final rule 

for a combination of legal and policy 

reasons explained herein and in the 

proposed rule, not solely because any 

particular claims are diminishing the 

Trust Fund. 

Comment: Some commenters stated 

that if SIRVA is removed from the 

Vaccine Injury Table, it will have to be 

covered by malpractice insurance, 

which could unnecessarily drive up the 

costs of delivering vaccines and reduce 

the number of people willing to 

administer them. 

Response: It is not clear this was 

problematic in the United States before 

SIRVA and vasovagal syncope were 

added to the Table in 2017, and the 

Department has been unable to locate 

any evidence that insurance has 

materially declined due to the addition 

of SIRVA and vasovagal syncope to the 

Table. Moreover, the vaccination rate 

has gone down slightly between when 

SIRVA and vasovagal syncope were 

added to the Table and the time of the 

proposed rule.42

Comment: A commenter asked that if 

SIRVA and vasovagal syncope are 

removed from the Table, all claims filed 

before the Final Rule be allowed to 

continue through the National Vaccine 

Injury Compensation Program. 

Response: This final rule applies to 

claims filed after the effective date of 

this final rule. 

Comment: A commenter stated that in 

the 34 years since the Vaccine Act was 

passed by Congress, HHS has only ever 

added to the Injury Table, and that it is 

deeply troubling and potentially against 

the intent of the Act to remove injuries 

from the Table. 

Response: The Vaccine Act explicitly 

provides that the Secretary can ‘‘delete 

from’’ the list of injuries, disabilities, 

illnesses, conditions, and deaths for 

which compensation may be provided. 

42 U.S.C. 300aa–14(c)(3). Therefore, this 

final rule is consistent with the statutory 

text and Congressional intent. 

Comment: Some commenters stated 

that the Department’s contention that 

SIRVA should be removed, in part, 

because patient records were altered in 

27 out of 2,214 cases is unsupportable. 

They state that the average fraudulent 

health care claims, according to the 

National Health Care Anti-Fraud 

Association, is 3%, which is higher than 

the reported fraud in the SIRVA records, 

which is 1.2%. One commenter points 

out that, as of January 1, 2020, the Court 

requires that all medical records be 

certified under the Pre-Assignment 

Review Order, which greatly reduces 

the chance of fraudulent records. 

Response: DOJ had identified 27 cases 

in which altered medical records have 

been filed, some of which involved 

changes to the site of vaccination. 

However, it is possible there were 

additional instances that DOJ did not 

uncover. The Department is finalizing 

this final rule because of a combination 

of legal and policy reasons stated herein 

and in the proposed rule, not solely 

because of fraud. 


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

44See 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. 

45See, e.g., https://www.cdc.gov/flu/fluvaxview/ 

coverage1718estimates.htm; https://www.cdc.gov/ 

nchs/data/hus/2018/031.pdf. 

46See 85 FR 52,136, 52140 (Aug. 24, 2020). 

Comment: Some commenters stated 

that removing coverage for SIRVA and 

syncope is inconsistent with the 

Program’s twin purposes of creating a 

simplified means of recovery for those 

injured by the administration of 

vaccines and providing liability 

protection to vaccine administrators and 

manufacturers. Commenters state that 

the policy objective is triggered by the 

immunization and does not vary with 

whether the claimed injury is a 

consequence of the contents versus the 

administration process. 

Response: The Department agrees that 

the VICP seeks to create a simplified 

means of recovery and provide certain 

liability protection to vaccine 

administrators and manufacturers. But it 

only seeks to do so for injuries 

encompassed by the Vaccine Act. The 

Act creates a compensation program 

‘‘for a vaccine-related injury or death.’’ 

42 U.S.C. 300aa–11(a)(1). Under the Act, 

‘‘only . . . a person who has sustained 

a vaccine-related injury or death’’ can 

recover. 42 U.S.C. 300aa–11(a)(9). The 

Act defines ‘‘[v]accine-related injury or 

death’’ as ‘‘an illness, injury, condition, 

or death associated with one or more of 

the vaccines set forth in the Vaccine 

Injury Table, except that the term does 

not include an illness, injury, condition, 

or death associated with an adulterant 

or contaminant intentionally added to 

such a vaccine.’’ 42 U.S.C. 300aa–33(5) 

(emphasis added); see also Dean v. 

HHS, No. 16–1245V, 2018 WL 3104388, 

at * 9 (Fed. Cl. Spec. Mstr. May 29, 

2018) (defining ‘‘vaccine’’ as ‘‘ ‘any 

substance designed to be administered 

to a human being for the prevention of 

1 or more diseases’ ’’) (quoting 26 U.S.C. 

4132(a)(2)). Thus, the compensation 

program covers injuries ‘‘associated 

with’’ the vaccine itself. 

SIRVA is not a vaccine, and it is not 

an injury caused by a vaccine antigen, 

but by administration of the vaccine by 

the health care provider. The 

Department does not think the term 

‘‘associated with’’ was meant to sweep 

in injuries caused by negligent 

administration of the vaccine. Although 

the Act permits petitioners to recover 

for Vaccine Table injuries without 

demonstrating causation in individual 

cases, the term ‘‘associated with’’ 

nevertheless requires that the injury, in 

general, be causally related to the 

vaccine itself. This is clear both from 

dictionary definitions of ‘‘associated,’’ 

which means ‘‘related, connected, or 

combined together’’ (MerriamWebster.com Dictionary, MerriamWebster, https://www.merriamwebster.com/dictionary/associated. 

Accessed 10 Jul. 2020), and from the 

text of the Act itself, see, e.g., 42 U.S.C. 

300aa–22(b)(1) (focusing on injuries that 

‘‘resulted’’ from vaccine side effects); 42 

U.S.C. 300aa–13(a)(1)(B) & (2)(B) 

(excluding ‘‘trauma’’ that has ‘‘no 

known relation to the vaccine 

involved’’). 

Importantly, in the key operative 

provisions discussed above, the phrase 

‘‘associated with’’ is linked to the 

vaccine itself, not to the technique in 

administering the vaccine. See Decker v. 

Nw. Envtl. Def. Ctr., 568 U.S. 597, 611 

(2013) (in interpreting phrase 

‘‘associated with industrial activity,’’ 

the key consideration is the scope of 

‘‘industrial activity’’; the ‘‘statute does 

not foreclose a more specific definition 

by the agency’’ and ‘‘a reasonable 

interpretation . . . could . . . require 

the discharges to be related in a direct 

way to operations at ‘an industrial 

plant’ ’’); Chevron, U.S.A., Inc. v. Nat. 

Resources Def. Council, Inc., 467 U.S. 

837, 861 (1984) (‘‘[T]he meaning of a 

word must be ascertained in the context 

of achieving particular objectives, and 

the words associated with it may 

indicate that the true meaning of the 

series is to convey a common idea.’’). 

That basic requirement is not met 

with SIRVA and vasovagal syncope. 

While the act of being vaccinated may 

be a but-for cause of those injuries, the 

injury is not associated with the vaccine 

itself because, with proper 

administration technique, those injuries 

will not result from the vaccine. Rather, 

SIRVA and vasovagal syncope result 

from the use of improper—that is, 

negligent—administration technique. 

There are several indicators in the 

language and structure of the Vaccine 

Act that show it was not meant to cover 

negligent administration of the 

vaccine.43

Comment: Many commenters stated 

that the proposed rule is not supported 

by the cited financial concerns; that 

SIRVA payouts in the last three years 

only account for 1% of the $4 billion 

life-to-date total that the program has 

paid for claims for all injuries. They 

contend that the fund has enough 

money to support SIRVA claims. Other 

commenters pointed out that the awards 

paid out on an annual basis has 

substantially decreased, while the fund 

has increased in size. Some commenters 

contend that financial concerns is not a 

proper basis to remove an injury from 

the Table. 

Response: The Department is 

finalizing this final rule for a 

combination of legal and policy reasons 

explained herein and in the proposed 

rule, not solely because any particular 

claims are diminishing the Trust Fund. 

Comment: Many commenters stated 

that the Department should not move 

forward with this final rule since the 

ACCV voted against the rule changes. 

Response: The Department is grateful 

to the ACCV for its time spent 

considering the proposed changes and 

for providing its comments. However, 

the Department found the ACCV’s 

comments not adequately persuasive.44

For reasons stated herein and in the 

proposed rule, the Department believes 

that credible scientific and medical 

evidence supports this final rule. 

Comment: Some commenters stated 

that removing SIRVA and vasovagal 

syncope from the Table will have the 

negative effective of reducing the 

amount of providers who are willing to 

administer vaccinations, thereby 

lowering the overall number of people 

vaccinated. A few commenters also 

stated that the legislative history of the 

Vaccine Act shows that Congress took 

steps to provide protections for 

healthcare providers. These commenters 

suggest that removing SIRVA from the 

Vaccine Injury Table would be contrary 

to Congressional intent and undercut 

key purposes of the Vaccine Act. 

Response: The Department 

respectfully disagrees. The Department 

has been unable to locate any evidence 

that premiums have materially declined 

due to the addition of SIRVA and 

vasovagal syncope to the Table. 

Moreover, the vaccination rate has gone 

down slightly since SIRVA and 

vasovagal syncope were added to the 

Table.45 In addition, certain pharmacists 

are already immune from suit and 

liability for claims for loss caused by, 

arising out of, relating to, or resulting 

from the administration of certain 

childhood vaccines to individuals ages 

three through 18 for the duration of the 

Secretary’s Declaration Under the Public 

Readiness and Emergency Preparedness 

Act for Medical Countermeasures 

Against COVID–19.46

Comment: Some commenters disagree 

with the Department’s statement that 

the present regime lessens the incentive 

of vaccine administrators to take 

appropriate precautions during 

administration. They state that that 

health care providers, including 

pharmacists, are highly trained, skilled 

professionals that seek to provide high 

quality care to their patients, and are not 

likely to be negligent in the care they 

provide because of their knowledge of 


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47 85 FR 43,802. 48 85 FR 43,798. 

liability protection. Further they list 

several instances where civil action can 

be filed under the Act (under 42 U.S.C. 

300aa–21(a), the patient/petitioner may 

reject the Federal Claims judgment and 

pursue a civil action; the vaccine 

administered is not listed in the Table; 

the injury sustained is not listed in the 

Table; the injury/illness did not last 6 

months). Commenters argue that health 

care providers are bound by their 

ethical, moral, and legal duties to 

protect public health and no other 

consideration eliminates or lessens that 

commitment. 

Response: The Department is grateful 

for the many health care professionals 

and pharmacists who improve public 

health by vaccinating the American 

public, and does not believe they would 

intentionally administer a vaccine in an 

improper manner. The Department has 

taken many steps during the COVID–19 

pandemic to increase the universe of 

individuals who can safely vaccinate. 

Ensuring vaccines are administered 

safely will increase public confidence in 

vaccinations. Since Vaccine Act 

proceedings are generally sealed and not 

made available to the public, vaccine 

administrators may be left unaware that 

they used an improper technique.47 42 

U.S.C. 300aa–21(a) does not materially 

change the analysis, because there are 

not many instances where an individual 

would go through the VICP process, fail 

to recover, and then be able to recover 

in state court. There are also not many 

instances where a petitioner would elect 

to forgo his or her recovery from the 

VICP to sue in state court, since it is not 

often that an individual could recover 

more in state court, and there are risks 

inherent in state court litigation. 

Comment: One commenter who 

serves on the Advisory Commission on 

Childhood Vaccines stated that a 

representative from HHS should have 

come to talk to the Commission about 

the proposed rule. This commenter 

stated that additional evidence should 

have been provided by HHS at the May 

2020 meeting of the Commission, but 

HHS was not involved in the meeting. 

The commenter stated that it was the 

responsibility of HHS to provide 

sufficient evidence to justify its 

recommendation, not the job of the 

Commission to provide sufficient 

evidence to support its rejection. 

Another commenter stated that by not 

adopting the recommendation of the 

Commission, HHS risks undermining 

the integrity of the Federal Advisory 

Committee Act (FACA) process and the 

willingness of qualified experts to serve 

on such committees. 

Response: The proposal provided to 

the ACCV before the May 2020 meeting, 

which synthesized the views of many 

within the Department, was the 

Department’s best explanation for why 

it was proposing the changes to the 

Table. The Department’s proposed 

regulation provided to the ACCV 

provided ample scientific and legal 

justification. The Department is grateful 

to the ACCV for its time spent 

considering the proposed changes and 

for providing its comments, but it would 

raise constitutional concerns if a federal 

Agency had to accept the 

recommendations of a FACA. 

Comment: A few commenters stated 

that there is no evidence to support that 

the Department’s position that ‘‘SIRVA 

petitions are likely to unnecessarily risk 

reductions in the funding available for 

children and others who sustain 

unavoidable vaccine-related injury or 

death’’ because the taxes collected by 

vaccine manufacturers and paid into the 

Trust Fund have exceeded outflows for 

every year except Fiscal Year 2013. 

Commenters also stated that this 

reasoning ignores the fact that some 

SIRVA claims involve children. 

Response: It stands to reason that if 

large sums are paid to SIRVA 

petitioners, that risks reducing funding 

available for others who sustain 

unavoidable vaccine-related injuries or 

deaths. At the time of the proposed rule, 

over 99.2% of SIRVA cases (3,034 out of 

3,057) filed since FY 2010 were filed by 

adults.48

Comment: Some commenters urge the 

VICP and the CICP to merge together to 

promote unity and clarity. 

Response: Revision of the formation 

and organization of the VICP and the 

CICP would require a statutory 

amendment and thus is not within the 

scope of this final rule. 

Comment: Many commenters stated 

that patients, healthcare providers, 

vaccine administrators, and vaccine 

manufactures do not support the Notice 

of Proposed Rulemaking. 

Response: For the legal and policy 

reasons stated herein and in the 

proposed rule, the Department is 

finalizing this final rule. The 

Department notes, in addition, that nonSIRVA cases, including those filed on 

behalf of children, are adversely affected 

as resources are stretched or diverted to 

litigate SIRVA cases. 

Comment: Many commenters state 

that even before SIRVA was added to 

the Table in 2017, individuals were able 

to receive compensation from the VICP 

for their SIRVA related injuries. 

Commenters point to VICP cases in 

which the Vaccine Court held that a 

causal connection between the 

administration of the vaccine and the 

consequential injury is sufficient proof 

for an award under the Vaccine Act. 

Comments stated that the Department’s 

change in policy is contrary to the 

Congressional Intent of the Act and 

would have a devastating effect upon 

parties’ ability to recover for their 

injuries. 

Response: Prior to SIRVA’s addition 

to the Table, SIRVA claims were 

sometimes awarded due to a 

combination of the government 

resolving the claims without litigating 

them to conclusion, and public 

statements by the Department 

suggesting SIRVA was a cognizable 

injury. The proposal to add SIRVA to 

the Table was in the works for several 

years before the 2015 notice of proposed 

rulemaking was published, and there 

was a great deal of public discussion 

about it at the ACCV and at the Court 

of Federal Claims’ annual judicial 

conference. The Department has in the 

past not always contested cases alleging 

injuries that have been proposed for 

addition to the Table if the case as 

pleaded fulfilled the criteria for 

entitlement to compensation. However, 

for the reasons discussed in the 

proposed rule and this final rule, 

including the Department’s review of 

the statute and more recent scientific 

literature, the Department no longer 

believes such claims should be included 

on the Table or can be based on 

causation in fact, because they are not 

injuries associated with vaccines or 

their components, nor are they 

unavoidable injuries or illnesses that 

cannot be predicted in advance, or that 

can occur without fault. 

Comment: Several commenters stated 

that HHS switched its position in this 

rulemaking without adequately 

considering the input of the Advisory 

Commission on Childhood Vaccines 

which unanimously rejected the rule 

change, and without discussing the 

change with the CDC’s Advisory 

Committee for Immunization Practices 

(ACIP), HHS’s own National Vaccine 

Advisory Committee (NVAC), the 

National Foundation for Infectious 

Disease (NFID), and the Institute of 

Vaccine Safety at Johns Hopkins whose 

epidemiologists have consulted closely 

with the Program since its inception. 

Response: The Department is grateful 

to the ACCV for its time spent 

considering the proposed changes and 

for providing its comments. The 

Department considered the ACCV’s 


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49See 85 FR 43,801–02 (discussing the ACCV’s 

comments in depth). 

50 85 FR 43,804. 

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

52See 85 FR 43,796–97. 

53See 85 FR 6294. 

comments.49 However, the Department 

found the ACCV’s comments not 

adequately persuasive. The Department 

has also considered public comments 

from a wide variety of perspectives 

during the two public hearings and 180- 

day public comment period on the 

proposed rule. 

Comment: A few commenters stated 

that they believe the reason for HHS’s 

policy change is to reduce the 

Department’s workload, which has 

increased due to the large number of 

SIRVA cases. Commenters stated that 

workload concerns are not a valid 

reason for making a policy change. 

Some commenters added that the 

change would not actually make the 

system more efficient, but would rather 

shift the burden of SIRVA cases to the 

civil tort system. 

Response: The Department has set 

forth herein and in the proposed rule a 

series of legal and policy reasons for 

finalizing this final rule. The 

Department believes based on the 

examined data that any additional 

burden on the civil tort system, which 

would be dispersed across States and 

not concentrated in any one or few 

States, from removing SIRVA and 

vasovagal syncope from the Table and 

reverting to the status quo as of January 

2017 will be minimal.50

Comment: One commenter warned 

that this rule could result in the increase 

in the cost of vaccines, as more medical 

providers are exposed to liability. 

Response: With respect to SIRVA and 

vasovagal syncope, this final rule will 

revert to the status quo as of January 

2017. In addition, certain pharmacists 

are already immune from suit and 

liability for claims for loss caused by, 

arising out of, relating to, or resulting 

from the administration of certain 

childhood vaccines to individuals ages 

three through 18 for the duration of the 

Secretary’s Declaration Under the Public 

Readiness and Emergency Preparedness 

Act for Medical Countermeasures 

Against COVID–19.51

Comment: One commenter disagreed 

with the Department’s contention that 

by excluding from the definition those 

injuries associated with an adulterant or 

contaminant intentionally added to the 

vaccine, Congress intended to permit 

suit only where the injury was caused 

by the components of the vaccine itself. 

The commenter states that the 

Department is applying the doctrine of 

ejusdem generis (i.e., where general 

words follow an enumeration of two or 

more things, they apply only to persons 

or things of the same general kind or 

class specifically mentioned). However, 

here, an adulterant and contaminant are 

exceptions instead of enumerations. 

Therefore, the commenter contends that 

the Department’s interpretation of 

Congress’ intent is not supported. 

Response: The Department 

respectfully disagrees. There are several 

indicators in the language and structure 

of the Vaccine Act that show it was not 

meant to cover negligent administration 

of the vaccine.52

Comment: One commenter stated that 

the Department mischaracterized 

current SIRVA cases when it said 

‘‘petitioners in such cases often prevail 

because of the low burden of proof and 

because it is not necessary to prove 

causation.’’ The commenter said that 

litigation records show complex cases in 

which the Department of Justice 

‘‘vigorously’’ advocated for the DHHS. 

Response: The Department agrees that 

the Department of Justice generally 

vigorously advocates for the 

Department. But the burden of proof on 

petitioners is low, and petitioners 

generally need not prove causation. 

Comment: One commenter stated that 

the proposed rule change may 

disproportionately and severely affect 

minority communities, since many do 

not have the same access to quality care; 

the time, energy, and know-how to 

navigate a complex legal system; and 

the resources to access compensation. 

Response: Aiding minority 

communities was not posited as a 

reason to add SIRVA or vasovagal 

syncope to the Table when they were 

added in 2017.53 In any event, this final 

rule will alleviate the Department’s 

significant legal concerns about whether 

the current Table comports with 

applicable law. 

Comment: Some commenters stated 

that HRSA is attempting to undo the 

lengthy and thorough legal and medical 

analysis it performed when it 

promulgated the Rule that put both 

vasovagal syncope and SIRVA on the 

Vaccine Injury Table in 2017. 

Response: This final rule is the 

product of a lengthy and thorough legal 

and scientific analysis, including an 

analysis of scientific literature 

published after finalization of the 2017 

Final Rule. 

Comment: One commenter argued 

that the Vaccine Act has a subrogation 

clause which permits the Federal 

government to seek recompense if the 

VICP compensates a claim, but 

determines later that a health care 

professional was negligent in 

administering a vaccine. Thus, injury 

claims resulting from the administration 

of vaccines should still be eligible for 

VICP compensation. 

Response: This subrogation provision 

does not properly incentivize the 

vaccine administrator, since it is 

unlikely that the Federal government 

would assert many claims against 

administrators, given the burden and 

expense compared to the relatively 

small potential recovery for the Federal 

government. Individuals would have a 

greater incentive to assert such claims if 

the administrator were negligent. 

Comment: Some commenters stated 

that the Department incorrectly relies on 

Amendola v. Sec., Dept. of Health & 

Human Servs., 989 F.2d 1180 (Fed. Cir. 

1993) to say that issues would arise if 

the Vaccine Act were interpreted to 

cover injuries caused by negligent 

administration. Commenters contend 

that the Federal Circuit Judge stated 

‘‘Congress clearly intended by the 

amendment to apply the Act to 

pediatricians who administered a 

vaccine as well as to the manufacture 

who made it,’’ and ‘‘[w]e see no basis for 

drawing a bright line that excludes 

erroneous judgment calls by the 

administrator, as well as negligent 

contamination.’’ One commenter 

concludes that Amendola, in fact, 

confirms that the Vaccine Act protects 

both vaccine administrators and 

manufactures. 

Response: The Department 

respectfully disagrees with this 

characterization of Amendola. As the 

Federal Circuit has explained, troubling 

issues arise if the Act were to apply to 

‘‘negligence facially unrelated to the 

vaccine’s effects.’’ Amendola v. Sec., 

Dept. of Health & Human Servs., 989 

F.2d 1180, 1187 (Fed. Cir. 1993). It 

could include, for example, ‘‘the 

doctor’s negligent dropping of an infant 

patient’’ or use of contaminated 

equipment. Id. at 1186–87. The better 

reading of the statute is that it does not 

reach this far. 

Comment: One commenter argued 

that the state tort liability preemption in 

Subpart B merely covers the remedies 

available to patients after they have 

gone through the VICP, not that 

Congress intended to ‘‘preserve a state 

tort remedy for certain avoidable 

injuries, such as those caused by 

negligent vaccine administration.’’ 

Response: Congress protected 

manufacturers from liability when the 

injury ‘‘resulted from side effects that 

were unavoidable even though the 

vaccine was properly prepared. . .’’ 42 

U.S.C. 300aa–22(b)(1). This language 

shows Congress wanted to preserve a 


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state tort remedy for certain avoidable 

injuries, such as those caused by 

negligent vaccine administration. Given 

that the Vaccine Act seeks to replace 

state tort remedies for the injuries it 

covers, this reinforces the conclusion 

that the Act does not reach SIRVA and 

vasovagal syncope. 

Comment: One commenter disagreed 

with the Department’s position that 

recordkeeping and reporting 

requirements are ‘‘woefully inadequate 

if the Program was designed to 

compensate for negligence by the 

provider,’’ since physicians are subject 

to myriad state laws and regulations 

governing medical records. The 

commenter stated that Congress 

authorized HHS to promulgate 

additional recordkeeping requirements 

if need be. 

Response: The text and structure of 

the Vaccine Act show that it was not 

meant to cover negligent administration 

of the vaccine. That some state laws and 

regulations govern medical records is 

besides the point. 

Comment: Many commenters argued 

that this rule is an unconscionable 

attempt to alleviate HHS’s backlog of 

pending cases, and that the public 

would be better served if the 

Department was to hire additional 

personal to handle case management. 

Response: The Department 

respectfully disagrees. The Department 

has set forth a series of legal and policy 

reasons for this final rule both herein 

and in the proposed rule. 

III. Statutory Authority 

The primary statutory authority for 

this rulemaking is 42 U.S.C. 300aa–14. 

42 U.S.C 300aa–14(c)(1) provides that 

the ‘‘Secretary may promulgate 

regulations to modify in accordance 

with paragraph (3) the Vaccine Injury 

Table. In promulgating such regulations, 

he shall provide for notice and 

opportunity for a public hearing and at 

least 180 days of public comment.’’ 42 

U.S.C. 300aa–14(c)(3), in turn, provides: 

‘‘A modification of the Vaccine Injury 

Table under paragraph (1) may add to, 

or delete from, the list of injuries, 

disabilities, illnesses, conditions, and 

deaths for which compensation may be 

provided or may change the time 

periods for the first symptom or 

manifestation of the onset or the 

significant aggravation of any such 

injury, disability, illness, condition, or 

death.’’ 

IV. Statutory and Regulatory 

Requirements 

A. Executive Orders 12866, 13563, and 

13771: Regulatory Planning and Review 

E.O. 12866 and E.O. 13563 direct 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). E.O. 13563 supplements 

and reaffirms the principles, structures, 

and definitions governing regulatory 

review as established in E.O. 12866, 

which emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. 

Executive Order 12866 requires that 

all regulations reflect consideration of 

alternatives, of costs, of benefits, of 

incentives, of equity, and of available 

information. Regulations must meet 

certain standards, such as avoiding an 

unnecessary burden. Regulations that 

are ‘‘significant’’ because of cost, 

adverse effects on the economy, 

inconsistency with other agency actions, 

effects on the budget, or novel legal or 

policy issues require special analysis. 

The Department anticipates that the 

final rule will save limited 

compensation funds under the National 

Vaccine Injury Compensation Program. 

Specifically, it will reduce the amount 

of program funds spent on program 

administration, reduce the amount of 

funds paid out to those with SIRVA or 

vasovagal syncope claims, and ensure 

that funds awarded from the VICP are 

awarded to individuals whose claims 

arise from vaccine-related injuries, 

which is consistent with the original 

intent of the VICP. Moreover, the 

Department anticipates that the final 

rule may result in fewer individuals 

suffering from SIRVA or vasovagal 

syncope, because it will better 

incentivize those administering 

vaccines to use proper injection 

technique. If those who administer 

vaccines can be held liable when a 

patient suffers from SIRVA or vasovagal 

syncope as a result of the administration 

of the vaccine, those who administer 

vaccines will have greater incentive to 

use proper injection technique. In 

addition, the final rule may also limit 

the ability of those opposed to 

vaccinations to cite to the high number 

of SIRVA awards to misleadingly 

suggest that vaccines are less safe than 

they truly are. 

The Department considered, as an 

alternative to the proposed rule and this 

final rule, issuing a notice of proposed 

rulemaking that would revise the 

definition of SIRVA so that those with 

true shoulder injuries were able to 

recover while reducing the number of 

less appropriate claims. However, the 

Department concluded that removing 

SIRVA from the Table is preferable. If 

SIRVA is removed from the Table, those 

with actual SIRVA injuries would still 

be able to recover in state court. 

Removal is preferable to redefining 

SIRVA, because it better addresses the 

vaccine hesitancy concern, is more in 

line with the Vaccine Act and 

Congressional intent, and incentivizes 

learning and utilizing proper 

administration technique. Indeed, 

because Vaccine Act proceedings are 

generally sealed and not made available 

to the public, vaccine administrators 

often are left unaware that they used an 

improper technique. 

The Department also considered, as 

alternatives to this final rule, not 

removing one or more of (1) SIRVA, (2) 

vasovagal syncope, or (3) Item XVII from 

the Table. For the reasons discussed 

herein and in the proposed rule, the 

Department rejected these alternatives. 

Section 3(f) of Executive Order 12866 

defines a ‘‘significant regulatory action’’ 

as an action that is likely to result in a 

rule (1) having an annual effect on the 

economy of $100 million or more in any 

one year, or adversely or materially 

affecting a sector of the economy, 

productivity, competition, jobs, the 

environment, public health or safety, or 

state, local or tribal governments or 

communities (also referred to as 

‘‘economically significant’’); (2) creating 

a serious inconsistency or otherwise 

interfering with an action taken or 

planned by another agency; (3) 

materially altering the budgetary 

impacts of entitlement grants, user fees, 

or loan programs or the rights and 

obligations of recipients thereof; or (4) 

raising novel legal or policy issues 

arising out of legal mandates, the 

President’s priorities, or the principles 

set forth in the Executive Order. A 

regulatory impact analysis must be 

prepared for major rules with 

economically significant effects ($100 

million or more in any one year), and 

a ‘‘significant’’ regulatory action is 

subject to Office of Management and 

Budget (OMB) review. As discussed 

below regarding the anticipated effects, 

these changes are not likely to have 

economic impacts of $100 million or 

more in any one year, and therefore do 

not meet the definition of 

‘‘economically significant’’ under 

Executive Order 12866. OMB has 

waived review over this final rule. 


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54https://1.next.westlaw.com/Search/

Results.html?query=%22sirva%22%20%

26%20%22vaccine%22&

jurisdiction=ALLSTATES&saveJuris=False&

contentType=CASE&

querySubmissionGuid=i0ad6ad3f000001

733a44933a7bf4372d&startIndex=1&

searchId=i0ad6ad3f000001733a44933a7bf4372d&

kmSearchIdRequested=

False&simpleSearch=False&isAdvanced

SearchTemplatePage=False&

skipSpellCheck=False&isTrDiscoverSearch=False&

thesaurusSearch=False&thesaurusTermsApplied=

False&ancillaryChargesAccepted=False&

proviewEligible=False&eventingTypeOfSearch=

FRM&transitionType=Search&

contextData=%28sc.Search%29. 

B. Economic and Regulatory Impact 

In accordance with the Regulatory 

Flexibility Act of 1980 (RFA), and the 

Small Business Regulatory Enforcement 

Act of 1996, which amended the RFA, 

the Secretary certifies that this rule will 

not have a significant impact on a 

substantial number of small entities. 

Between FY 2017 and FY 2019, the 

VICP on average paid out 

$30,893,481.90 per year to petitioners 

alleging SIRVA claims. The VICP on 

average paid out $124,489.56 per year to 

petitioners alleging vasovagal syncope 

claims. When this final rule goes into 

effect, the Department anticipates that 

small entities will not actually pay these 

amounts, because fewer SIRVA and 

vasovagal syncope claims would be 

filed if petitioners had to prove 

causation. In addition, vaccines are 

often administered by non-small 

entities, so even if total amounts paid 

approximated the amounts paid on 

average between FY 2017 and FY 2019, 

claims against small entities would be 

less. It is the Department’s belief that 

should the amounts paid equal the 

amounts annually paid out of the VICP 

between FY 2017 and FY 2019, and 

such claims are paid in full by small 

entities, these amounts will not 

constitute a significant impact on a 

substantial number of small entities for 

purposes of the RFA. 

Section 202 of the Unfunded 

Mandates Reform Act of 1995 

(Unfunded Mandates Act) (2 U.S.C. 

1532) requires that covered agencies 

prepare a budgetary impact statement 

before promulgating a rule that includes 

any Federal mandate that may result in 

the expenditure by State, local, and 

tribal governments, in the aggregate, or 

by the private sector, of $100 million in 

1995 dollars, updated annually for 

inflation. Currently, that threshold is 

approximately $154 million. If a 

budgetary impact statement is required, 

section 205 of the Unfunded Mandates 

Act also requires covered agencies to 

identify and consider a reasonable 

number of regulatory alternatives before 

promulgating a rule. The Department 

has determined that this final rule will 

not result in expenditures by State, 

local, and tribal governments, or by the 

private sector, of $154 million or more 

in any one year. Accordingly, the 

Department has not prepared a 

budgetary impact statement or 

specifically addressed the regulatory 

alternatives considered. 

The provisions of this rule will also 

not negatively affect family well-being 

or the following family elements: family 

safety; family stability; marital 

commitment; parental rights in the 

education, nurture and supervision of 

their children; family functioning; 

disposable income or poverty; or the 

behavior and personal responsibility of 

youth, as determined under section 

654(c) of the Treasury and General 

Government Appropriations Act of 

1999. 

On January 30, 2017, the White House 

issued Executive Order 13771 on 

Reducing Regulation and Controlling 

Regulatory Costs. Section 2(a) of 

Executive Order 13771 requires an 

agency, unless prohibited by law, to 

identify at least two existing regulations 

to be repealed when the agency publicly 

proposes for notice and comment or 

otherwise promulgates a new regulation. 

In furtherance of this requirement, 

section 2(c) of Executive Order 13771 

requires that the new incremental costs 

associated with new regulations shall, to 

the extent permitted by law, be offset by 

the elimination of existing costs 

associated with at least two prior 

regulations. This final rule partially 

repeals prior regulations and is not 

expected to increase incremental costs, 

so it is not anticipated to be a regulatory 

or deregulatory action under Executive 

Order 13771. 

As stated above, this final rule 

modifies the Vaccine Injury Table to 

ensure that the Table complies with 

applicable law, the Table is consistent 

with medical and scientific literature, 

those administering vaccines have 

additional incentive to use proper 

injection technique, and the VICP has 

sufficient funds to adequately 

compensate those injured by vaccines 

listed in the Table. 

C. Executive Order 12988: Civil Justice 

Reform 

The agency has reviewed this rule 

under Executive Order 12988 on Civil 

Justice Reform and has determined that 

this final rule complies with this 

Executive Order. 

V. Summary of Impacts 

This final rule has the effect of 

removing injuries from the Table that 

are not encompassed by the provisions 

of the Vaccine Act and that are reducing 

the pool of funds available to those 

injured by vaccines or vaccine 

components. It therefore aligns the 

Table with the Department’s 

understanding of Congress’ intent and 

public policy in favor of compensating 

those harmed by injuries associated 

with the vaccine or vaccine 

components, and particularly children 

who have suffered such harm. The rule 

also has the effect of ensuring that the 

limited compensation resources 

available under the National Vaccine 

Injury Compensation Program are 

provided to those with vaccine-related 

injuries or deaths. In addition, because 

of the large volume of SIRVA claims, 

removing SIRVA from the Table will 

reduce the amount of program funds 

spent on program administration and 

ensure that funds awarded from the 

VICP are awarded to individuals whose 

claims arise from vaccine-related 

injuries, which is consistent with the 

Department’s interpretation of the 

original intent of the VICP. 

The final rule also better incentivizes 

those who administer vaccines to use 

proper injection technique. It may also 

help correct misleading and erroneous 

suggestions that vaccines are not safe. 

Because COVID–19 and the COVID–19 

vaccines are not currently on the Table, 

the Department does not believe this 

rule will have an impact on patients 

with COVID–19 or the COVID–19 

vaccines. 

Moreover, the rule is unlikely to 

unduly burden the civil tort system. The 

Department conducted a search in the 

WestLaw legal database for cases in 

state court that contained both the terms 

‘‘SIRVA’’ and ‘‘vaccine,’’ and found 

only 20 hits, at least two of which were 

cases involving an entity named SIRVA 

and not the injury.54 It is possible that 

some additional cases were filed in 

federal district court. Nonetheless, the 

Department believes based on this data 

that any additional burden on the civil 

tort system, which will be dispersed 

across States and not concentrated in 

any one or few States, from removing 

SIRVA and vasovagal syncope from the 

Table and reverting to the status quo as 

of January 2017 will be minimal. 

A. Executive Order 13132—Federalism 

HHS has reviewed this final rule in 

accordance with E.O. 13132 regarding 

federalism and has determined that it 

does not have ‘‘federalism 

implications.’’ This final rule will not 

‘‘have substantial direct effects on the 

States, or on the relationship between 

the national government and the States, 

or on the distribution of power and 


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responsibilities among the various 

levels of government.’’ 

B. Collection of Information 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3507(d)) (PRA) requires that 

OMB approve all collections of 

information by a federal agency from the 

public before they can be implemented. 

This final rule is projected to have no 

impact on current reporting and 

recordkeeping burden, as the 

amendments finalized in this rule will 

not impose any data collection 

requirements under the PRA. 

List of Subjects in 42 CFR Part 100 

Biologics, Health insurance, 

Immunization. 

Accordingly, 42 CFR part 100 is 

amended as set forth below: 

PART 100—VACCINE INJURY 

COMPENSATION 

■ 1. The authority citation for 42 CFR 

part 100 continues to read as follows: 

Authority: Secs. 312 and 313 of Public Law 

99–660 (42 U.S.C. 300aa–1 note); 42 U.S.C. 

300aa–10 to 300aa–34; 26 U.S.C. 4132(a); and 

sec. 13632(a)(3) of Public Law 103–66. 

■ 2. In § 100.3, revise paragraph (a) and 

remove paragraphs (c)(10) and (13) and 

(e)(8). The revision reads as follows: 

§ 100.3 Vaccine injury table. 

(a) In accordance with section 312(b) 

of the National Childhood Vaccine 

Injury Act of 1986, title III of Public Law 

99–660, 100 Stat. 3779 (42 U.S.C. 

300aa–1 note) and section 2114(c) of the 

Public Health Service Act, as amended 

(PHS Act) (42 U.S.C. 300aa–14(c)), the 

following is a table of vaccines, the 

injuries, disabilities, illnesses, 

conditions, and deaths resulting from 

the administration of such vaccines, and 

the time period in which the first 

symptom or manifestation of onset or of 

the significant aggravation of such 

injuries, disabilities, illnesses, 

conditions, and deaths is to occur after 

vaccine administration for purposes of 

receiving compensation under the 

Program. Paragraph (b) of this section 

sets forth additional provisions that are 

not separately listed in this Table but 

that constitute part of it. Paragraph (c) 

of this section sets forth the 

Qualifications and Aids to 

Interpretation for the terms used in the 

Table. Conditions and injuries that do 

not meet the terms of the Qualifications 

and Aids to Interpretation are not 

within the Table. Paragraph (d) of this 

section sets forth a glossary of terms 

used in paragraph (c). 

TABLE 1 TO PARAGRAPH (a)—VACCINE INJURY TABLE

Vaccine Illness, disability, injury or condition covered 

Time period for first symptom or 

manifestation of onset or of 

significant aggravation after 

vaccine administration 

I. Vaccines containing tetanus toxoid (e.g., DTaP, DTP, DT, Td, or 

TT).

A. Anaphylaxis ....................................................................................... ≤4 hours. 

B. Brachial Neuritis ................................................................................ 2–28 days (not less than 2 days 

and not more than 28 days). 

II. Vaccines containing whole cell 

pertussis bacteria, extracted or 

partial cell pertussis bacteria, or 

specific pertussis antigen(s) (e.g., 

DTP, DTaP, P, DTP-Hib).

A. Anaphylaxis ....................................................................................... ≤4 hours. 

B. Encephalopathy or encephalitis ........................................................ ≤72 hours. 

III. Vaccines containing measles, 

mumps, and rubella virus or any 

of its components (e.g., MMR, 

MM, MMRV).

A. Anaphylaxis ....................................................................................... ≤4 hours. 

B. Encephalopathy or encephalitis ........................................................ 5–15 days (not less than 5 days 

and not more than 15 days). 

IV. Vaccines containing rubella 

virus (e.g., MMR, MMRV).

A. Chronic arthritis ................................................................................. 7–42 days (not less than 7 days 

and not more than 42 days). 

V. Vaccines containing measles 

virus (e.g., MMR, MM, MMRV).

A. Thrombocytopenic purpura ............................................................... 7–30 days (not less than 7 days 

and not more than 30 days). 

B. Vaccine-Strain Measles Viral Disease in an immunodeficient recipient.

—Vaccine-strain virus identified ............................................................ Not applicable. 

—If strain determination is not done or if laboratory testing is inconclusive.≤12 months. 

VI. Vaccines containing polio live 

virus (OPV).

A. Paralytic Polio.

—in a non-immunodeficient recipient .................................................... ≤30 days. 

—in an immunodeficient recipient ......................................................... ≤6 months. 

—in a vaccine associated community case .......................................... Not applicable. 

B. Vaccine-Strain Polio Viral Infection.

—in a non-immunodeficient recipient .................................................... ≤30 days. 

—in an immunodeficient recipient ......................................................... ≤6 months. 

—in a vaccine associated community case .......................................... Not applicable. 

VII. Vaccines containing polio inactivated virus (e.g., IPV).A. Anaphylaxis ....................................................................................... ≤4 hours. 

VIII. Hepatitis B vaccines ................ A. Anaphylaxis ....................................................................................... ≤4 hours. 

IX. Haemophilus influenzae type b 

(Hib) vaccines.

No Condition Specified. ......................................................................... Not applicable. 

X. Varicella vaccines ....................... A. Anaphylaxis ....................................................................................... ≤4 hours. 

B. Disseminated varicella vaccine-strain viral disease.

—Vaccine-strain virus identified ............................................................ Not applicable. 


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TABLE 1 TO PARAGRAPH (a)—VACCINE INJURY TABLE—Continued 

Vaccine Illness, disability, injury or condition covered 

Time period for first symptom or 

manifestation of onset or of 

significant aggravation after 

vaccine administration 

—If strain determination is not done or if laboratory testing is inconclusive.7–42 days (not less than 7 days 

and not more than 42 days). 

C. Varicella vaccine-strain viral reactivation .......................................... Not applicable. 

XI. Rotavirus vaccines .................... A. Intussusception ................................................................................. 1–21 days (not less than 1 day 

and not more than 21 days). 

XII. Pneumococcal conjugate vaccines.No Condition Specified. ......................................................................... Not applicable. 

XIII. Hepatitis A vaccines ................ No Condition Specified. ......................................................................... Not applicable. 

XIV. Seasonal influenza vaccines ... A. Anaphylaxis ....................................................................................... ≤4 hours. 

B. Guillain-Barre ́ Syndrome ................................................................... 3–42 days (not less than 3 days 

and not more than 42 days). 

XV. Meningococcal vaccines .......... A. Anaphylaxis ....................................................................................... ≤4 hours. 

XVI. Human papillomavirus (HPV) 

vaccines.

A. Anaphylaxis ....................................................................................... ≤4 hours. 

Alex M. Azar II, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2021–01211 Filed 1–19–21; 8:45 am] 

BILLING CODE 4165–15–P 


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