Compensation for COVID-19 Vaccine Injuries

Compensation for COVID-19 Vaccine Injuries

Compensation for COVID-19 Vaccine Injuries
March 31, 2023
More than 260 million Americans, and billions of people worldwide, have received one or more
doses of a vaccine to protect against Coronavirus Disease 2019 (COVID-19). Most common side
Kevin J. Hickey
effects of COVID-19 vaccines are mild and generally resolve in a few days. In rare instances,
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COVID-19 vaccines can cause serious adverse events.

Hannah-Alise Rogers
Individuals who believe they are injured by COVID-19 vaccines may seek compensation for
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those injuries and associated harms or costs. Absent an applicable federal law, individuals

allegedly injured by a vaccine might seek redress by filing a state tort law claim against the
vaccine manufacturer. However, federal law has two distinct compensation regimes that limit
Erin H. Ward
legal liability for vaccine manufacturers and provide potential compensation—without requiring
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a showing of fault—for individuals harmed by adverse reactions to vaccines.

For injuries and deaths associated with most vaccines recommended by the Centers for Disease

Control and Prevention (CDC) for routine administration in the United States , the National
Vaccine Injury Compensation Program (VICP) may provide compensation. During public health emergencies declared under
the Public Readiness and Emergency Preparedness Act (PREP Act), the Countermeasures Injury Compensation Program
(CICP) may provide compensation for injuries and deaths resulting from the administration of “covered countermeasures,”
which may include vaccines.
The VICP and CICP regimes are similar in some ways, but the programs serve distinct purposes. Compensation through
CICP is generally less comprehensive than through VICP. CICP is a regulatory process administered by the Health Resources
and Services Administration (HRSA), a division of the U.S. Department of Health and Human Services (HHS). CICP
compensation is available only for death or serious injuries resulting from a covered countermeasure. A claimant must
generally file a request form and associated documentation with HRSA within one year of the date that the covered
countermeasure was administered. For injuries not listed by the Secretary of HHS on a Countermeasure Injury Table, the
claimant must demonstrate that the injury was a direct result of the countermeasure’s administration based on compelling
medical and scientific evidence. HRSA makes decisions regarding eligibility and compensation; judicial review is not
available. CICP compensation is limited to reasonable medical expenses, loss of employment income, and a death benefit
when the claimant’s death is a direct result of the administration of a covered countermeasure.
Under the Secretary of HHS’s current PREP Act Declaration for COVID-19, FDA-authorized or -approved COVID-19
vaccines are covered countermeasures. While a PREP Act declaration is in effect, CICP is the sole remedy available for
injuries related to covered countermeasures, so CICP—and not VICP—will apply to injuries resulting from COVID-19
vaccinations while the Declaration remains in effect. Due to COVID-19, the number of CICP claims has increased
dramatically. As of February 1, 2023, CICP has received 11,252 claims alleging injury or death relating to COVID-19
countermeasures. Of those, 8,067 claims (71.7%) relate to COVID-19 vaccines. HRSA has not yet compensated any CICP
claims relating to COVID-19 countermeasures.
When coverage under the PREP Act Declaration for COVID-19 ends, COVID-19 vaccine injuries could be compensated
through VICP, contingent on additional regulatory and statutory changes. To be included in the VICP, (1) the vaccine must
be recommended by the CDC for routine administration to children or pregnant women; (2) the vaccine must be made subject
by act of Congress to the excise tax that funds VICP; and (3) the Secretary of HHS must add the vaccine to the Vaccine
Injury Table, which lists injuries and conditions associated with vaccines covered by VICP. Should all of these changes
occur, COVID-19 vaccines would be covered by VICP.
To receive compensation through VICP for a vaccine-related injury or death, the injured person or their estate must file a
petition with the U.S. Court of Federal Claims, generally within three years of the onset of the first symptom or significant
aggravation of the injury, or within two years of death or four years of the first symptom resulting in death. To receive
compensation, petitioners must show either that they experienced an injury listed in the Vaccine Injury Table within the time
frame specified in the Table, or prove that the vaccine was the “but-for” cause of their injury. Special masters determine
eligibility and compensation; their decisions may be appealed to the U.S. Court of Federal Claims and the U.S. Court of
Appeals for the Federal Circuit. Successful petitioners may receive medical expenses, lost income, a set death benefit, and
reasonable attorneys’ fees and costs. Petitioners who are dissatisfied with the compensation they receive, or whose claims are
delayed, may opt to pursue civil actions in court, subject to certain limitations on vaccine manufacturer liability.
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Contents
The Countermeasures Injury Compensation Program (CICP) ........................................................ 3
Covered Vaccines and Injuries .................................................................................................. 4
Procedure for Obtaining Compensation .................................................................................... 4
Available Compensation ........................................................................................................... 5
Status of Pending CICP Claims for COVID-19 Countermeasures ........................................... 6
The National Vaccine Injury Compensation Program (VICP) ........................................................ 7
Covered Vaccines and Injuries .................................................................................................. 8
Procedure for Obtaining Compensation .................................................................................... 8
Available Compensation .......................................................................................................... 11
Possible Transition of COVID-19 Vaccines from Coverage Under CICP to VICP ....................... 11
Considerations for Congress.......................................................................................................... 13

Appendixes
Appendix. Comparison of Vaccine-Injury Programs: CICP vs. VICP .......................................... 16

Contacts
Author Information ........................................................................................................................ 17

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ore than 260 million Americans have received one or more doses of a Coronavirus
Disease 2019 (COVID-19) vaccine,1 along with billions of people worldwide.2 The
M Food and Drug Administration’s (FDA’s) emergency use authorizations for the Pfizer-
BioNTech, Moderna, Johnson & Johnson, and Novavax COVID-19 vaccines were based on
months-long clinical trials (including safety monitoring) of each vaccine, involving tens of
thousands of participants.3 These trials did not identify any safety concerns that would preclude
emergency use authorization.4 Subsequently, the Pfizer-BioNTech COVID-19 vaccine (later
known as Comirnaty) received full FDA approval as a two-dose primary series for individuals 12
years of age and older,5 and the Moderna COVID-19 vaccine (later known as Spikevax) received
full FDA approval as two-dose primary series for individuals 18 years of age and older.6
Following authorization, the COVID-19 vaccines have been subject to safety monitoring
requirements by FDA and the Centers for Disease Control and Prevention (CDC) to track the
incidence of side effects and detect long-term, rare, or unexpected adverse health events.7 The
most common side effects of COVID-19 vaccines are mild—such as local pain around the
injection site, fatigue, or fever—and usually resolve within a few days.8 As with most vaccines,
however, a small percentage of inoculated individuals experience serious adverse reactions to a
COVID-19 vaccine.9 For example, approximately five people per million receiving mRNA
COVID-19 vaccines experience anaphylaxis, a severe allergic reaction, following vaccination.10
(In part for this reason, the CDC recommends that all individuals be monitored for at least 15
minutes following their vaccinations, and that all vaccination sites have epinephrine available for

1 COVID-19 Vaccinations in the United States, CTRS. FOR DISEASE CONTROL & PREVENTION (CDC),
https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total (last visited Jan. 24, 2023).
2 More Than 12.7 Billion Shots Given: Covid-19 Tracker, BLOOMBERG, https://www.bloomberg.com/graphics/covid-
vaccine-tracker-global-distribution/ (last updated Oct. 5, 2022).
3 Letter from FDA to Pfizer Inc., at 1-2 (May 10, 2021), https://www.fda.gov/media/144412/download [hereinafter
Pfizer EUA]; Letter from FDA to ModernaTX, Inc., at 1-2 (Aug. 12, 2021), https://www.fda.gov/media/144636/
download [hereinafter Moderna EUA]; Letter from FDA to Janssen Biotech, Inc., at 1-2 (June 10, 2021),
https://www.fda.gov/media/146303/download [hereinafter J&J EUA]; Novavax COVID-19 Vaccine, Adjuvanted, U.S.
FOOD & DRUG ADMIN., https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-
19/novavax-covid-19-vaccine-adjuvanted (last visited Jan. 24, 2023).
4 Pfizer EUA, supra note 3, at 2; Moderna EUA, supra note 3, at 2; J&J EUA, supra note 3, at 2.
5 See Pfizer-BioNTech COVID-19 Vaccines, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/emergency-
preparedness-and-response/coronavirus-disease-2019-covid-19/pfizer-biontech-covid-19-vaccines (last visited Jan. 24,
2023); see generally CRS Report R46913, FDA Approval of the Pfizer-BioNTech COVID-19 Vaccine: Frequently
Asked Questions, by Kevin J. Hickey, Erin H. Ward, and Agata Bodie.
6 See Moderna COVID-19 Vaccines, U.S. FOOD & DRUG ADMIN., https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/moderna-covid-19-vaccines (last visited Jan. 24, 2023).
7 Ensuring COVID-19 Vaccine Safety in the US, CDC, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/
safety.html (last updated Dec, 22, 2022) (“COVID-19 vaccines are monitored by the most intense safety monitoring
efforts in U.S. history.”); see generally CRS Report R46593, Vaccine Safety in the United States: Overview and
Considerations for COVID-19 Vaccines, by Kavya Sekar and Agata Bodie.
8 Possible Side Effects After Getting a COVID-19 Vaccine, CDC, https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/expect/after.html (last updated Sept. 14, 2022).
9 Selected Adverse Events Reported After COVID-19 Vaccination, CDC, https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/adverse-events.html (last updated Jan. 23, 2023).
10 Id. (“Anaphylaxis after COVID-19 vaccination is rare and has occurred at a rate of approximately 5 cases per one
million vaccine doses administered.”); accord Tom T. Shimabukuro, Matthew Cole & John R. Su, Reports of
Anaphylaxis After Receipt of mRNA COVID-19 Vaccines in the US: December 14, 2020–January 18, 2021, 325 JAMA
1101–02 (Feb. 12, 2021), https://jamanetwork.com/journals/jama/fullarticle/2776557 (reporting rates of 2.5 to 4.7 cases
of anaphylaxis per million doses administered).
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treatment of anaphylaxis.11) Other serious adverse events reported following vaccination, such as
myocarditis and Guillain-Barré Syndrome (GBS), are similarly rare but are associated with some
COVID-19 vaccines in some populations.12 For example, because of the rare risk of thrombosis
with thrombocytopenia syndrome and GBS associated with Johnson & Johnson COVID-19
vaccine, CDC recommends use of mRNA COVID-19 vaccines in preference to the Johnson &
Johnson vaccines for most patients.13
Federal law has two distinct compensation regimes for individuals harmed by adverse reactions to
vaccines. In general, the National Vaccine Injury Compensation Program (VICP) may provide
compensation for injuries or deaths associated with most vaccines routinely administered in the
United States (such as pediatric and seasonal influenza vaccines).14 During certain public health
emergencies, the Countermeasures Injury Compensation Program (CICP) may provide
compensation for injuries and deaths resulting from the administration of “covered
countermeasures,” which may include vaccines, under the Public Readiness and Emergency
Preparedness Act (PREP Act).15
Under the Secretary of Health and Human Services’ (HHS’s) PREP Act Declaration for COVID-
19 (and its amendments), COVID-19 vaccines are considered covered countermeasures within the
PREP Act’s scope.16 As a result, CICP—and not VICP—currently applies to injuries resulting
from COVID-19 vaccinations while the public health emergency persists and the Declaration

11 Interim Considerations: Preparing for the Potential Management of Anaphylaxis After COVID-19 Vaccination,
CDC, https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html (last updated Sept. 2,
2022).
12 See Selected Adverse Events Reported After COVID-19 Vaccination, CDC, https://www.cdc.gov/coronavirus/2019-
ncov/vaccines/safety/adverse-events.html (last updated Jan. 23, 2023); Myocarditis and Pericarditis After mRNA
COVID-19 Vaccination, CDC, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/myocarditis.html (last
updated Sept. 27, 2022); see also Hannah G. Rosenblum et al., Use of COVID-19 Vaccines After Reports of Adverse
Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech
and Moderna): Update from the Advisory Committee on Immunization Practices—United States, July 2021, 70
MMWR 1094–99 (Aug. 13, 2021), https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e4.htm (estimating rates of
Guillain-Barré Syndrome, myocarditis, and other serious adverse events per million vaccine doses administered);
Matthew E. Oster et al., Myocarditis Cases Reported After mRNA-Based COVID-19 Vaccination in the US From
December 2020 to August 2021, 327 JAMA 331 (Jan. 25, 2022).
13 See Sara E. Oliver et al., Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim
Recommendations from the Advisory Committee on Immunization Practices — United States, December 2021, 71
MMWR 90, 94 (Jan. 21, 2022), https://www.cdc.gov/mmwr/volumes/71/wr/mm7103a4.htm.
14 National Vaccine Injury Compensation Program, HEALTH RES. & SERVS. ADMIN. (HRSA), https://www.hrsa.gov/
vaccine-compensation/index.html (last updated Jan. 2023); Covered Vaccines, HRSA, https://www.hrsa.gov/vaccine-
compensation/covered-vaccines/index.html (last updated Jan. 2023) (“The National Vaccine Injury Compensation
Program (VICP) covers most vaccines routinely given in the U.S.”).
15 See Countermeasures Injury Compensation Program (CICP), HRSA, https://www.hrsa.gov/cicp/ (last updated Jan.
2023); Public Readiness and Emergency Preparedness Act, P.L. 109-148, div. C, 119 Stat. 2818 (2005).
16 Fourth Amendment to the Declaration under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19 and Republication of the Declaration, 85 Fed. Reg. 79,190, 79,196 (Dec. 9, 2020)
(“Covered countermeasures [include] any vaccine [used to] prevent, treat, or cure COVID-19.”); Public Readiness and
Emergency Preparedness Act, U.S. DEP’T OF HEALTH & HUMAN SERVS. HHS OFF. OF THE ASST. SEC. FOR
PREPAREDNESS & RESPONSE (HHS ASPR), https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx (last
visited Jan. 25, 2023) (links to the COVID-19 PREP Act Declaration and its ten amendments).
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remains in force.17 Compensation through CICP is generally somewhat more limited than through
VICP.18
This report reviews and compares the compensation regimes available for vaccine-related injuries
under CICP and VICP, and describes the procedures for injured individuals to obtain
compensation under each program. The report concludes with an Appendix that compares the
two regimes.
The Countermeasures Injury Compensation
Program (CICP)
To encourage expeditious development and deployment of medical countermeasures during a
public health emergency, the PREP Act authorizes the Secretary of HHS (the Secretary) to limit
legal liability for losses resulting from the administration of medical countermeasures such as
diagnostics, treatments, and vaccines.19 In a declaration effective February 4, 2020 (the PREP Act
Declaration), the Secretary invoked the PREP Act and declared the spread of COVID-19 to be a
public health emergency warranting liability protections for covered countermeasures (e.g., drugs,
biologics, and medical devices used to diagnose, treat, or prevent COVID-19).20 Pursuant to the
PREP Act Declaration and its subsequent amendments,21 manufacturers, distributors, and health
care providers are generally immune from legal liability (i.e., they cannot be sued for money
damages in court) for losses related to the administration or use of covered countermeasures
against COVID-19.22
In addition to providing immunity from liability, the PREP Act established CICP, a compensation
program for individuals seriously injured or killed as a direct result of the administration or use of
a covered countermeasure.23 CICP is a regulatory process administered by the Health Resources
and Services Administration (HRSA).24 HRSA regulations govern CICP’s procedures and
eligibility determinations.25

17 Frequently Asked Questions, HRSA, https://www.hrsa.gov/cicp/faq (last visited Jan. 25, 2023) (“COVID-19 vaccines
are covered countermeasures under the Countermeasures Injury Compensation Program (CICP), not the National
Vaccine Injury Compensation Program (VICP).”).
18 See Comparison of Countermeasures Injury Compensation Program (CICP) to the National Vaccine Injury
Compensation Program (VICP), HRSA, https://www.hrsa.gov/cicp/cicp-vicp (last updated Apr. 2021); see also infra
“Appendix. Comparison of Vaccine-Injury Programs: CICP vs. VICP.”
19 42 U.S.C. § 247-6d(a)–(b).
20 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against
COVID-19, 85 Fed. Reg. 15,198 (Mar. 17, 2020).
21 See Public Readiness and Emergency Preparedness Act, HHS ASPR, https://www.phe.gov/Preparedness/legal/
prepact/Pages/default.aspx (last visited Jan. 25, 2023) (linking to the COVID-19 PREP Act Declaration amendments).
22 See 42 U.S.C. § 247d-6d(a); see generally PREP Act Q&As, HHS ASPR, https://www.phe.gov/Preparedness/legal/
prepact/Pages/prepqa.aspx. For a detailed discussion of the scope of liability immunity under the PREP Act, see CRS
Legal Sidebar LSB10443, The PREP Act and COVID-19, Part 1: Statutory Authority to Limit Liability for Medical
Countermeasures and CRS Legal Sidebar LSB10730, The PREP Act and COVID-19, Part 2: The PREP Act
Declaration for COVID-19 Countermeasures.
23 42 U.S.C. § 247d-6e; Countermeasures Injury Compensation Program (CICP), HRSA, https://www.hrsa.gov/cicp/
(last updated Jan. 2023).
24 See CICP Frequently Asked Questions, HRSA, https://www.hrsa.gov/cicp/faq/index.html (last visited Jan. 25, 2023).
25 See 42 C.F.R. pt. 110.
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Covered Vaccines and Injuries
Under the PREP Act and the amended PREP Act Declaration, covered countermeasures for
COVID-19 may include drugs, biological products, and medical devices that the FDA approves,
licenses, or authorizes for emergency use “to diagnose, mitigate, prevent, treat, or cure” COVID-
19, or used “to limit the harm that COVID-19 . . . might otherwise cause.”26 For example,
personal protective equipment (PPE) (e.g., respirators), ventilators, therapeutic drugs (e.g.,
Paxlovid), and monoclonal antibody treatments approved or authorized by FDA to treat or
prevent COVID-19 are covered countermeasures under the PREP Act.27 Notably, FDA-authorized
or -approved COVID-19 vaccines—such as those produced by Pfizer, Moderna, Johnson &
Johnson, and Novavax—are covered countermeasures under the PREP Act Declaration.
Under the PREP Act, CICP remedies “shall be exclusive of any other civil action or proceeding”
for injuries directly caused by administering covered countermeasures, with limited exceptions.28
Thus, while the current PREP Act Declaration and public health emergency remain in effect,
CICP is the exclusive remedy for claims within the PREP Act’s scope, including injuries resulting
from COVID-19 vaccinations.29 As discussed below in “Possible Transition of COVID-19
Vaccines from Coverage Under CICP to VICP,” COVID-19-vaccine-related injuries may
eventually be compensable through the VICP after the PREP Act Declaration no longer applies,
contingent on certain statutory and regulatory changes.
CICP compensation is limited to eligible individuals, such as persons injured by countermeasures
or their survivors.30 CICP provides compensation only for death or “serious physical injuries”—
that is, injuries that warrant hospitalization or lead to a significant loss of function or disability.31
Individuals who experience only minor, short-term side effects from a COVID-19 vaccine—such
as mild soreness, headache, or fatigue—would not be eligible for CICP compensation.32
Procedure for Obtaining Compensation
To apply for CICP compensation, a claimant generally must file a request for benefits within one
year of the date the countermeasure was administered.33 (If the Secretary publishes a new
Countermeasure Injury Table, a newly eligible claimant may file within one year after the new

26 Fourth Amendment to the Declaration under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19 and Republication of the Declaration, 85 Fed. Reg. 79,190, 79,196 (Dec. 9,
2020); 42 U.S.C. § 2476d-6d(i)(7).
27 Emergency Use Authorization, FDA, https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-
regulatory-and-policy-framework/emergency-use-authorization#2019-ncov (last updated Jan. 20, 2023) (listing FDA
emergency use authorizations for vaccines, drugs, biologics, and medical devices for use against COVID-19).
28 42 U.S.C. § 247d-6e(d)(4).
29 See id.; see also CICP Frequently Asked Questions, HRSA, https://www.hrsa.gov/cicp/faq/index.html (last visited
Jan. 25, 2023) (“COVID-19 vaccines are covered countermeasures under the Countermeasures Injury Compensation
Program (CICP), not the National Vaccine Injury Compensation Program (VICP).”). The “sole exception” is a claim
for willful misconduct. 42 U.S.C. §§ 247d-6d(d)(1), 247d-6e(d)(4).
30 See 42 C.F.R. § 110.10.
31 See id. § 110.3(z); 42 U.S.C. § 247d-6e(e)(3).
32 Possible Side Effects After Getting a COVID-19 Vaccine, CDC, https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/expect/after.html (last updated Sept. 14, 2022) (describing temporary arm pain, tiredness, muscle pain, fever,
and other “common side effects” of COVID-19 vaccines).
33 42 C.F.R. § 110.42(a).
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Table is established.34) In addition to the request form, claimants may need to submit medical
records and other evidence to establish eligibility.35 If determined to be eligible, claimants may
submit additional documentation to demonstrate the compensation amount.36 Eligibility and
compensation determinations are made by HRSA (exercising power delegated by the Secretary).37
Claimants may seek reconsideration of an adverse eligibility decision by HRSA, but the ultimate
decisionmaking authority lies with the Secretary.38 The PREP Act precludes judicial review of the
Secretary’s eligibility and compensation decisions.39
CICP claimants can prove eligibility for compensation in one of two ways.40 The first applies
only to injuries listed on a Countermeasure Injury Table, which the Secretary must establish by
regulation when compelling medical and scientific evidence shows that administration or use of a
covered countermeasure directly causes particular injuries.41 (The Table established for the H1N1
pandemic influenza vaccine is one example;42 no such table has yet been promulgated for any
COVID-19 countermeasure, including vaccines.) For injuries listed on a Countermeasure Injury
Table, if the claimant can show that the countermeasure recipient’s injury is listed on the Table
and was sustained within the relevant time interval (and meets any other requirements set forth in
the Table), CICP will presume the injury was a direct result of the covered countermeasure.43 For
injuries not on a Countermeasure Injury Table (or outside its scope), the claimant must prove the
non-Table injury was the “direct result” of the countermeasure’s administration based on
“compelling, reliable, valid, medical and scientific evidence” beyond mere temporal
association.44
Available Compensation
Compensation under CICP is limited to (1) reasonable medical expenses (e.g., unreimbursed
hospitalization costs); (2) loss of employment income (e.g., income lost from inability to work
due to disability); and (3) a set death benefit where the death is a direct result of the
administration or use of a covered countermeasure.45 Attorneys’ fees and pain-and-suffering
damages are not available under CICP.46 CICP awards are also subject to various annual and

34 Id. § 110.42(f).
35 See id. § 110.50–110.53; see also Criteria to Demonstrate that a Covered Injury Occurred, HRSA,
https://www.hrsa.gov/cicp/injury-occurred (last updated Dec. 2022).
36 See 42 C.F.R. § 110.60–110.63; see also Countermeasures Injury Compensation Program (CICP) Filing Process,
HRSA, https://www.hrsa.gov/cicp/filing-benefits (last updated Dec. 2022).
37 See 42 C.F.R. § 110.72–110.74.
38 See id. §§ 110.90 (process to request reconsideration of eligibility determinations), 110.91 (“[T]he Secretary may, at
any time, on her own motion or on application, review any determination made under this part [and] may affirm,
vacate, or modify the determination in any manner the Secretary deems appropriate.”).
39 See 42 U.S.C. § 247d-6e(b)(4) (incorporating 42 U.S.C. § 239a(f)(2)); 42 C.F.R. § 110.92 (“[N]o judicial review of
the Secretary’s actions concerning eligibility and benefits determinations under [CICP] is permitted.”).
40 See 42 C.F.R. § 110.20(b)–(c).
41 42 U.S.C. § 247d-6e(5)(A).
42 42 C.F.R. § 110.100.
43 See id. § 110.20(b).
44 See id. § 110.20(c).
45 Id. § 110.2(a).
46 See Comparison of Countermeasures Injury Compensation Program (CICP) to the National Vaccine Injury
Compensation Program (VICP), HRSA, https://www.hrsa.gov/cicp/cicp-vicp (last updated Apr. 2021) (“Attorneys’
fees and costs are not paid by [CICP].”); Nicholas M. Pace, Lloyd Dixon & Bethany Saunders-Medina, The
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lifetime limits. For example, annual lost employment income awards are capped at $50,000 per
year;47 the standard maximum death benefit is the same as that under the Public Safety Officers’
Benefits program (currently $422,035).48
Given the limited number and scope of past PREP Act declarations, CICP has been used
relatively infrequently since the PREP Act’s 2005 enactment prior to the COVID-19 pandemic.49
The majority of the non-COVID-19 CICP claims have been related to alleged injuries from the
H1N1 pandemic influenza vaccine.50 According to HRSA, for FY2010 through FY2023, CICP
received 513 claims unrelated to COVID-19.51 Of these, 40 claims (7.8%) were determined to be
eligible for compensation and 30 claims (5.8%) have been paid out by CICP, amounting to over
$6 million in awards.52 (Ten of the claims determined to be eligible for compensation had no
eligible reported medical expenses or lost employment income.) All but one of the 30 claims
compensated by CICP to date relate to injuries from the H1N1 influenza vaccine.53
Status of Pending CICP Claims for COVID-19 Countermeasures
Due to the COVID-19 pandemic, the number of CICP claims HRSA has received has increased
dramatically. As of February 1, 2023, CICP has received 11,252 claims alleging injury or death
relating to COVID-19 countermeasures, of which 8,067 claims (71.7%) relate to COVID-19
vaccines.54 HRSA has not yet compensated any CICP claims relating to COVID-19
countermeasures. Of the 630 COVID-19 claims in which HRSA has reached a decision on
eligibility, it has denied 609 claims (96.7%) on various grounds, while determining that 21 claims
(3.3%) are eligible for compensation, pending a review of the eligible expenses.55 The remaining
COVID-19 countermeasure claims (approximately 94.4%) are in review or pending review.56
Several COVID-19 emergency appropriations allow the Secretary to transfer funds to the
Covered Countermeasure Process Fund.57 HRSA can use such funds, in addition to prior-year
fund balances, for CICP compensation awards.

Compensation System for Potential Side Effects Is an Important Part of a COVID-19 Vaccine Campaign,
THERANDBLOG (Dec. 18, 2020), https://www.rand.org/blog/2020/12/the-compensation-system-for-potential-side-
effects.html (“The CICP does not provide any compensation for pain, suffering, emotional distress, or similar
damages . . . .”).
47 42 C.F.R. § 110.81(c)(2).
48 Id. § 110.82(b)(1); Benefits by Year: Public Safety Officers’ Benefits Program, U.S. DEP’T OF JUSTICE BUR. OF JUST.
ASSISTANCE, https://psob.bja.ojp.gov/knowledge-base/benefits-by-year/ (last visited Mar. 23, 2023).
49 See Pace et al., supra note 46 (“The NVICP has handled more than 20,000 vaccine injury claims since its inception,
while the CICP, as far as can be determined, has processed about 500 since the law that created the program was
enacted in 2005 [and prior to COVID-19].”).
50 See Bernard Condon & Matt Sedensky, How U.S. Government Will Handle COVID-19 Vaccine Injury Claims Is
Largely a Secret, INS. J., https://www.insurancejournal.com/news/national/2020/12/29/595414.htm (Dec. 29, 2020)
(“[Prior to COVID-19], the vast majority of the claims under [CICP] have stemmed from the H1N1 swine flu vaccine a
decade ago.”).
51 See Countermeasures Injury Compensation Program (CICP) Data, HRSA, https://www.hrsa.gov/cicp/cicp-data (last
updated Mar. 1, 2023) (listing 11,765 total claims, of which 11,252 relate to COVID-19 countermeasures).
52 See id. at tbls. 4 & 5.
53 See id. at tbl. 4. The other claim was for an injury associated with the smallpox vaccine.
54 See id. at tbl. 1.
55 See id. (listing CICP data for COVID-19 claims as of Mar. 1, 2023).
56 See id.
57 See, e.g., Coronavirus Aid, Relief, and Economic Security (CARES) Act, P.L. 116-136, div. B, tit. VIII, 134 Stat.
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The National Vaccine Injury Compensation
Program (VICP)
After the Secretary terminates the PREP Act Declaration for the COVID-19 pandemic, any
injuries or death related to COVID-19 vaccine administration would be addressed in court under
tort law, unless the COVID-19 vaccines are added to VICP.58 VICP provides compensation for
injuries and deaths associated with vaccines that are listed on the Vaccine Injury Table and subject
to an excise tax.59
Congress created the VICP via the National Childhood Vaccine Injury Act of 1986 (NCVIA)
amid concerns that lawsuits against vaccine manufacturers and health care providers alleging
vaccine injuries could deter pharmaceutical innovation, lead to vaccine shortages, and lower
immunization rates.60 Under a typical state tort law framework, an injured person must generally
prove that a vaccine caused the injury and that either the vaccine manufacturer is at fault (e.g.,
negligent, failed to warn adequately) or, under products liability doctrines, that the vaccine was
defective.61 If the person cannot prove one of these elements—for example, if the manufacturer
adequately warned of side effects or it is unclear whether the vaccine caused the injury—the
claimant receives no compensation. If the vaccine manufacturer is found liable, however, it may
be responsible for compensatory damages and potentially punitive damages as determined by a
judge or jury.62 Regardless of the outcome, both sides generally would be responsible for their
own litigation costs.63
The NCVIA created a no-fault alternative compensation program for deaths and injuries caused
by certain vaccines that are recommended by the CDC for routine administration in children or
pregnant women.64 The Program shields vaccine manufacturers from most tort liability for
vaccine-related injuries and deaths, while providing compensation to those injured from a trust
fund funded by excise taxes paid by the vaccine manufacturers.65 By limiting liability exposure
for vaccine manufacturers, expanding the availability of compensation for injured parties, and
lowering the burden of proof, the Program reduces uncertainty for both injured persons and
vaccine manufacturers. From implementation of the Program in 1988 through February 1, 2023,
more than 25,860 petitions for compensation have been filed, of which 21,907 have been
adjudicated, with 9,565 determined to merit compensation.66 The Program has paid out more than

281, 560–61 (Mar. 27, 2020).
58 42 U.S.C. §§ 300aa-10–300aa-44; 26 U.S.C. §§ 4131, 4132, 9510. See also National Vaccine Injury Compensation
Program, HRSA, https://www.hrsa.gov/vaccine-compensation/index.html (last updated Nov. 2021).
59 42 U.S.C. §§ 300aaa-11–300aa-15; 26 U.S.C. §§ 4131, 4132, 9510; 42 C.F.R. § 100.3; Vaccine Injury Table, HRSA,
https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/vaccine-injury-table.pdf.
60 P.L. 99-660, § 311, 100 Stat. 3758 (1986); see, e.g., S. REP. NO. 99-483, at 2–6 (1986); H. REP. NO. 99-908, at 4–7
(1986).
61 RESTATEMENT (SECOND) OF TORTS § 281; RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY §§ 1, 10. See also
CRS In Focus IF11291, Introduction to Tort Law, by Kevin M. Lewis.
62 RESTATEMENT (SECOND) OF TORTS §§ 901–917.
63 Alyeska Pipeline Serv. Co. v. Wilderness Soc’y, 421 U.S. 240, 247 (1975).
64 42 U.S.C. §§ 300aa-13–300aa-15.
65 Id. §§ 300aa-13–300aa-15, 300aa-21–300aa-22; 26 U.S.C. §§ 4131, 4132, 9510.
66 Data & Statistics, HRSA, https://www.hrsa.gov/sites/default/files/hrsa/vicp/vicp-stats-02-01-23.pdf (last updated
Feb. 1, 2023).
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$4.9 billion in compensation since its inception, and the Trust fund has a current balance of more
than $4.3 billion.67
Covered Vaccines and Injuries
To receive compensation through VICP, the injured person must have received a vaccine that is
(1) recommended by the CDC for routine administration to children or pregnant women,
(2) listed by the Secretary on the Vaccine Injury Table, and (3) subject to an excise tax that funds
the Vaccine Injury Compensation Trust Fund from which compensation is paid.68 The types of
vaccines subject to the excise tax are specified in statute and therefore can be amended only by an
act of Congress.69
To be entitled to VICP compensation, an injured party must first show receipt of a “covered
vaccine.”70 Not every FDA-approved vaccine is covered by VICP. The NCVIA included an initial
Vaccine Injury Table listing vaccines covered by the Program.71 Under the Act, the Secretary may
promulgate regulations to amend the Vaccine Injury Table to include additional vaccines
recommended by the CDC for routine administration to children or pregnant women within two
years of such a recommendation.72
In addition to having received a covered vaccine, the injured party must show either that (1) they
experienced an injury listed for the vaccine in the Vaccine Injury Table and the first symptom of
the onset or significant aggravation of the injury occurred within the timeframe specified in the
Table, or (2) the vaccine more likely than not caused the injury.73 The Vaccine Injury Table allows
injured persons to avoid having to prove a vaccine caused their injuries by allowing them instead
to show they received an injury that has been temporally associated with receipt of a covered
vaccine.74 Individuals who allege vaccine-related injuries not included in the Table, or who allege
a Table injury but experience symptom onset outside of the specified timetable, may still file a
petition. To be entitled to VICP compensation, such individuals are required to prove, by a
preponderance of the evidence, that the vaccine received was the “but-for” cause of the injury.75
Procedure for Obtaining Compensation
To receive VICP compensation, the injured person (or the estate in the case of a death) files a
petition with the U.S. Court of Federal Claims (Claims Court).76 The petition must generally
contain an affidavit and supporting documentation, including relevant medical records, showing
the person:

67 Id. See also Vaccine Injury Trust Fund, Bureau of the Fiscal Service,
https://treasurydirect.gov/ftp/dfi/tfmb/dfivi0223.pdf (Feb. 28, 2023).
68 42 U.S.C. § 300aa-14; 26 U.S.C. §§ 4132, 9510.
69 26 U.S.C. § 4132.
70 42 U.S.C. §§ 300aa-11(c), 300aa-33(5).
71 Id. § 300aa-14(a).
72 Id. § 300aa-14(e).
73 Id. § 300aa-11(c). For more information about OSM proceedings, the adjudication of vaccine petitions, and proving
causation, see CRS In Focus IF12213, The National Vaccine Injury Compensation Program and the Office of Special
Masters, by Hannah-Alise Rogers (last updated Sept. 14, 2022).
74 42 U.S.C. §§ 300a-11, 300aa-14.
75 Id. § 300a-11(c)(1)(C)(ii).
76 Id. § 300aa-11.
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 received a vaccine listed in the Vaccine Injury Table;
 sustained or experienced a significant aggravation of an illness, disability, injury,
or condition either:
 set forth in the Vaccine Injury Table for the particular vaccine, and the
first symptom or manifestation occurred within the required time period;
or
 caused by the vaccine;
 suffered residual effects or complications that lasted for more than six months or
required inpatient hospitalization and surgery, or died; and
 has not collected another award or settlement for the injury or death.77
Petitions for vaccine-related injuries must generally be filed within three years of the first
symptom of the injury or significant aggravation.78 Petitions for vaccine-related deaths must be
filed within two years of the death and within four years of the first symptom or significant
aggravation of the injury from which the death resulted.79 If the Vaccine Injury Table is amended
such that a person qualifies for compensation who previously did not, that person has two years
from when the Table is revised to seek compensation for injuries or deaths that occurred up to
eight years before the Table was revised.80
When a person files a petition with the Claims Court, the clerk of the court forwards the petition
to the Office of Special Masters (OSM), and the chief special master assigns the petition to one of
the eight special masters.81 The court’s guidelines for attorneys practicing in the VICP, referred to
as the Vaccine Rules, require the Secretary to review the petition within 30 days of its filing to
determine whether the record is complete and to determine the government’s position on the
appropriateness of compensation.82 Instead of filing a formal answer to the petition, as would be
required in traditional court proceedings, the Secretary is required to file a report within 90 days
of the petition’s filing outlining any legal and/or factual issues with petitioner’s claim and any
medical conclusions reached by the Secretary’s experts.83 The 90-day period is often extended for
a variety of reasons, for example because more time is needed to file additional medical records,
the special master ordered the petitioner to file an expert report, or the parties wished to discuss
settlement.84
Approximately 60% of compensated petitions are the result of a settlement agreement.85 If the
parties cannot resolve the case via settlement, the special master may hold an evidentiary hearing

77 Id. § 300aa-11(c).
78 Id. § 300aa-16(a).
79 Id.
80 Id. § 300aa-16(b).
81 Id. §§ 300aa-12(c)(1), 300aa-12(d); see also Vaccine Claims/Office of Special Masters, U.S. COURT OF FEDERAL
CLAIMS, https://www.uscfc.uscourts.gov/vaccine-programoffice-special-masters (last visited Nov. 24, 2021).
82 Guidelines for Practice Under the National Vaccine Injury Compensation Program, U.S. COURT OF FEDERAL
CLAIMS, https://www.uscfc.uscourts.gov/sites/default/files/Guidelines-4.24.2020.pdf (revised April 24, 2020).
83 Id.
84 Id.
85 Data & Statistics, HRSA, https://www.hrsa.gov/sites/default/files/hrsa/vicp/vicp-stats-02-01-23.pdf (last visited Feb.
14, 2023). In a settlement agreement, the Secretary agrees to compensate the petitioner without conceding that the
vaccine was responsible for the petitioner’s injuries. Settlements are particularly common for Table injuries. Data &
Statistics, HRSA, https://www.hrsa.gov/sites/default/files/hrsa/vicp/vicp-stats-02-01-23.pdf (last visited Feb. 14, 2023).
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on the petition or issue a ruling based on the administrative record.86 In either case, the assigned
special master issues a decision regarding whether the petitioner is entitled to compensation under
VICP and, if so, how much.87 Vaccine hearings resemble civil trials in that they allow for the
presentation of evidence, including testimony from expert witnesses, but VICP proceedings offer
more flexible, informal procedures to allow for expeditious resolution.88 The special master has
240 days from the date a petition is filed to issue an entitlement decision that includes factual
findings and legal conclusions, though the parties may suspend the proceedings by motion for up
to 150 days if necessary.89
The petitioner has 30 days after the special master issues an entitlement decision to appeal the
decision to the Claims Court.90 The court then has 120 days to uphold the decision, issue its own
decision, or remand to the special master for further proceedings.91 If the parties do not appeal the
special master’s decision within 30 days, or when the Claims Court issues a decision after review,
judgment is entered and the petitioner has 60 days to appeal the judgment to the U.S. Court of
Appeals for the Federal Circuit (Federal Circuit).92 If the parties choose not to appeal the
decision, the judgment becomes final.93
After a final judgment, the petitioner has 90 days to accept or reject the judgment.94 If the
judgment awards compensation and the petitioner chooses to accept the judgment, the petitioner
is entitled to an award of compensation but may not file a civil action for damages related to the
injury or death. If the judgment awards compensation but the petitioner rejects the judgment, the
petitioner is not entitled to any compensation from the VICP but may file a civil action for
damages against the manufacturer.95 Petitioners who do not act to accept or reject the judgment
within 90 days are deemed to have accepted the judgment and are also barred from filing civil
claims.96 A petitioner may also withdraw the petition and file a civil action if the special master
fails to act within 240 days or the Claims Court fails to enter the judgment within 420 days, both
time frames excluding any suspended time.97 (Petitioners may opt not to withdraw their petitions
if they do not want to risk proceeding in civil court.98)
In addition to limiting the availability of civil actions against manufacturers to parties who have
gone through the VICP’s process, the NCVIA imposes certain limitations on vaccine

86 Guidelines for Practice Under the National Vaccine Injury Compensation Program, U.S. COURT OF FEDERAL
CLAIMS, https://www.uscfc.uscourts.gov/sites/default/files/Guidelines-4.24.2020.pdf (revised Apr. 24, 2020).
87 42 U.S.C. § 300aa-12.
88 Id. § 300aa-12(d)(3)(B); Vaccine Rules, Appendix B, Rules of the United States Court of Federal Claims, U.S. COURT
OF FEDERAL CLAIMS, https://www.uscfc.uscourts.gov/sites/default/files/20.08.03%20FINAL%20Vaccine%20Rules.pdf
(last updated Aug. 3, 2020).
89 42 U.S.C. § 300aa-12(d)(3). In practice, it takes approximately two to three years for the OSM to adjudicate
petitions, according to HRSA data. See infra note 87, at 7.
90 42 U.S.C. § 300aa-12(e)(1).
91 Id. § 300aa-12(e)(2).
92 Id. § 300aa-12(e)–(f).
93 Id. § 300aa-12(e)(3).
94 Id. § 300aa-21(a)(1).
95 Id. § 300aa-21(a).
96 Id. § 300aa-11(a)(2)(A).
97 Id. § 300aa-21(b).
98 Id.
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manufacturers’ liability in civil proceedings.99 For example, vaccine manufacturers cannot be held
liable for injuries or deaths due to unavoidable side effects from properly prepared vaccines
accompanied by proper directions and warnings.100 Any action that proceeds against a vaccine
manufacturer is tried in three stages: (1) liability, (2) general damages, and (3) punitive
damages.101 Trifurcating the trial in this manner limits the evidence presented to the judge or jury
in the first and second stages to the evidence relevant to each stage of the trial.
Available Compensation
An award for compensation includes:
 actual and reasonably projected unreimbursable expenses resulting from the
vaccine-related injury, including the cost of diagnosis, medical care,
rehabilitation, counseling, vocational training, and custodial care, among others;
 actual and anticipated loss of earnings;
 actual and projected pain and suffering and emotional distress, capped at
$250,000;
 the amount of $250,000, in the case of a vaccine-related death; and
 reasonable attorneys’ fees and other costs associated with proceeding on the
petition.102
The NCVIA authorized appropriations to compensate individuals injured by vaccines
administered before October 1, 1988.103 Compensation for injuries related to vaccines
administered after October 1, 1988, is paid out of the Vaccine Injury Compensation Trust Fund
(Trust Fund).104 Vaccine manufacturers pay into the Trust Fund through excise taxes imposed on
covered vaccines.105 The Trust Fund may only be used to pay for vaccine-related injuries from
vaccines subject to the excise tax at the time of payment, and for certain government
administrative expenses incurred when administering the Program.106 Consequently, only
vaccines subject to the excise tax are included in VICP.
Possible Transition of COVID-19 Vaccines from
Coverage Under CICP to VICP
While they remain covered by the PREP Act Declaration, CICP—not VICP—is the exclusive
remedy for injuries associated with the administration of COVID-19 vaccines.107 As explained in

99 Id. § 300aa-22.
100 Id. § 300aa-22(b).
101 Id. § 300aa-23.
102 Id. § 300aa-15(a)–(e).
103 Id. § 300aa-15(j).
104 Id. § 300aa-15(i)(2); 26 U.S.C. § 9510.
105 26 U.S.C. §§ 4131–4132.
106 Id. § 9510(c).
107 See 42 U.S.C. § 247d-6e(d)(4); CICP Frequently Asked Questions, HRSA, https://www.hrsa.gov/cicp/faq/
index.html (last visited Jan. 25, 2023).
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detail in a separate CRS product,108 the applicable time period for liability immunity under the
PREP Act may depend on the type of countermeasure, the means of distribution, the covered
person who administers the countermeasure, and other factors.109 As a result, when coverage
under the PREP Act Declaration expires depends on the particular context.
For COVID-19 vaccines purchased or distributed by the federal government—which at present
includes all COVID-19 vaccines administered in the United States110—PREP Act coverage
currently extends through October 1, 2024.111 CICP would therefore continue to apply to COVID-
19 vaccine injuries during that period for federally-purchased vaccines.112 However, if COVID-19
vaccines eventually transition to distribution through the private market, PREP Act coverage may
end sooner than October 1, 2024, for those vaccines. Under the current PREP Act Declaration,
PREP Act coverage for COVID-19 countermeasures not related to a federal contract generally
extends through (a) the final day an applicable Declaration of Emergency is in effect, or
(b) October 1, 2024, whichever occurs first.113 The Biden Administration has stated its intention
to terminate the federal public health emergency declared under Section 319 of the Public Health
Service Act on May 11, 2023.114 In light of that decision—unless a state or local emergency
declaration applies or HHS amends the Declaration—PREP Act coverage for some COVID-19
countermeasures may end prior to October 1, 2024.115
When COVID-19 vaccines are no longer covered by the PREP Act, CICP will no longer be an
available remedy for injuries caused by COVID-19 vaccines. At that point, unless the vaccines
are included in VICP, persons injured by COVID-19 vaccine side effects could pursue remedies
under state tort law.
After the expiration of PREP Act coverage, Congress could decide to add COVID-19 vaccines to
the VICP. To accomplish this under existing law, (1) the CDC must recommend the vaccine for
routine administration to children and/or pregnant women; (2) Congress must enact legislation to
apply the excise tax to the vaccine; and (3) the Secretary of HHS must add the vaccine to the
Vaccine Injury Table by publishing a notice of coverage.116 Should all three of these changes
occur, the COVID-19 vaccine would be added to the VICP with coverage effective as of the date
of the enacted tax.117

108 See CRS Legal Sidebar LSB10730, The PREP Act and COVID-19, Part 2: The PREP Act Declaration for COVID-
19 Countermeasures, by Kevin J. Hickey.
109 See id.; Tenth Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical
Countermeasures Against COVID-19, 87 Fed. Reg. 982, 988 (Jan. 7, 2022) [hereinafter Tenth PREP Act Declaration
Amendment].
110 See CDC COVID-19 Vaccination Program Provider Requirements and Support, CDC, https://www.cdc.gov/
vaccines/covid-19/vaccination-provider-support.html (last updated Oct. 26, 2022).
111 See Hickey, supra note 108; Tenth PREP Act Declaration Amendment, supra note 108, at 988. If COVID-19
vaccines are eventually purchased and distributed through private channels, PREP coverage could potentially terminate
earlier, depending on whether the public health emergency declarations for COVID-19 remain in effect.
112 See HHS, Fact Sheet: COVID-19 Public Health Emergency Transition Roadmap, https://www.hhs.gov/about/news/
2023/02/09/fact-sheet-covid-19-public-health-emergency-transition-roadmap.html (Feb. 9, 2023).
113 See id.; Hickey, supra note 108.
114 See Executive Office of the President, Statement of Administration Policy (Jan. 30, 2023),
https://www.whitehouse.gov/wp-content/uploads/2023/01/SAP-H.R.-382-H.J.-Res.-7.pdf.
115 See HHS Fact Sheet, supra note 112.
116 42 U.S.C. § 300aa-14(e)(2); 42 C.F.R. § 100.3(a)(XVII).
117 42 U.S.C. § 300aa-14(e)(2). Under 42 U.S.C. § 300aa-14(e)(2), when the CDC recommends a new vaccine for
routine administration to children or pregnant women, the Secretary is required to amend the Vaccine Injury Table
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On October 20, 2022, the CDC’s Advisory Committee on Immunization Practices recommended
adding COVID-19 vaccines (specifically, the Pfizer, Moderna, and Novavax vaccines) to the
regular childhood and adult immunization schedules.118 Vaccines added to the regular CDC
immunization schedules are considered recommended for routine use for the purposes of VICP.119
The CDC formally adopted the recommendation on February 10, 2023, when the
recommendation was published in the Morbidity and Mortality Weekly Report.120 This
recommendation triggers a statutory obligation for the Secretary to amend the Table to include the
COVID-19 vaccine; the injuries, conditions, or deaths that are associated with the vaccines; and
the time period in which onset of symptoms or significant aggravation of symptoms must
occur.121 Under the HHS vaccine regulations, the Secretary adds a vaccine to the Table by issuing
a notice of coverage, which generally states that the vaccine is covered by the VICP as of the date
the excise tax applies to the vaccine.122 Any changes made to the Vaccine Injury Table to add
COVID-19 vaccines do not become effective until and unless Congress enacts legislation to
extend the excise tax to the COVID-19 vaccines.123
Considerations for Congress
The inclusion of COVID-19 vaccines in CICP and their possible transition to VICP present
several issues that Congress may consider.
Because of the widespread use of COVID-19 vaccines, HRSA is receiving a volume of claims
under the CICP many times larger than it has received during past public health emergencies. To
date, HRSA has reached decisions on less than 5% of the COVID-19-related claims it has

within two years. 42 U.S.C. § 300aa-14(c) describes the process the Secretary must ordinarily take to revise the Table.
However, under 42 C.F.R. § 100.3(a)(XVII), the Table will immediately include any new vaccine recommended by the
CDC for routine administration to children and/or pregnant women after the Secretary publishes a “notice of coverage”
in the Federal Register. When the Secretary revises the Table under this process, the change takes effect as soon as
Congress enacts the tax. 42 U.S.C. § 300aa-14 note.
118 Press Release, ACIP Immunization Schedule Vote, CDC, https://www.cdc.gov/media/releases/2022/s1020-
immunization-vote.html (Oct. 20, 2022); see also COVID-19 Vaccine: Interim COVID-19 Vaccine Immunization
Schedule for Persons 6 Months of Age or Older, CDC, https://www.cdc.gov/vaccines/covid-19/downloads/COVID-19-
immunization-schedule-ages-6months-older.pdf (Dec. 8, 2022).
119 See, e.g. 62 FR 7685 (Feb. 20, 1997) (Final rule adding hepatitis B vaccine to the Table); 62 FR 52724 (Oct. 9,
1997) (the notice of compensation for hepatitis B); 63 FR 25777 (May 11, 1998) (The final rule adding a date certain
for coverage for hepatitis B vaccine). See also 69 FR 69945 (Dec. 1, 2004), which is the notice of coverage adding
Hepatitis A vaccine to the Table, where the CDC explains, “The two prerequisites for adding Hepatitis A vaccines to
the VICP as covered vaccines as well as to the Table have been satisfied. First, the CDC published its recommendation
that Hepatitis A vaccines be routinely administered to certain children in the October 1, 1999 issue of the Morbidity
and Mortality Weekly Report (MMWR)...” )
For more information on the ACIP and its recommendations, see CRS In Focus IF12317, The Advisory Committee on
Immunization Practices (ACIP), by Kavya Sekar.
120 CDC, Morbidity and Mortality Weekly Report, Advisory Committee on Immunization Practices Recommended
Immunization Schedule for Children and Adolescents Aged 18 Years or Younger – United States, 2023, Feb. 10, 2023,
available at https://www.cdc.gov/mmwr/volumes/72/wr/mm7206a1.htm?s_cid=mm7206a1_w#contribAff (last
accessed Mar. 8, 2023).
121 42 U.S.C. § 300aa-14(e)(2)–(3).
122 See id.; 42 CFR § 100.3(a).
123 See 42 U.S.C. § 300aa-14 note.
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received.124 Congress may wish to consider whether HRSA needs additional authorities or
resources to process these CICP claims expeditiously.
CICP is a more limited program than VICP in several ways. The available compensation is
generally lower, and the standard of proof for non-Table injuries is higher. There are fewer
opportunities for appeal and reconsideration in CICP as judicial review is not available. CICP
claimants have lower rates of success on average as compared to VICP petitioners. Congress may
wish to consider whether barriers to CICP compensation could be lowered, or—as some
observers argue—the law could be changed so that COVID-19 vaccine injury claims could be
brought under VICP.125
CICP has also been criticized for lacking transparency and accountability, and having high
administrative costs relative to the amounts it awards in compensation.126 To some degree, the
high costs may be attributable to the relatively high standard of proof and lower success rates for
CICP claims. Regardless, Congress may consider whether CICP is an efficient way to compensate
these claims, and whether judicial review or greater transparency in HRSA’s decisionmaking
process would improve the Program.
Congress could also choose to implement an entirely new program specifically addressing
compensation for COVID-19 vaccine-related injuries or deaths. Alternatively, Congress could opt
to leave COVID-19 vaccines out of VICP and allow the traditional tort system to address any
vaccine-related injuries after CICP no longer applies.
Covering COVID-19 vaccines under VICP presents issues Congress may wish to consider as
well. As discussed above, VICP awards are funded by an excise tax and the Program may only
compensate injuries resulting from “taxable vaccines” subject to the excise tax.127 “Taxable
vaccines” are defined in the tax code to include vaccines against particular diseases, which does
not include COVID-19.128 Should Congress wish to include COVID-19 vaccines in VICP
following the expiration of coverage under the PREP Act and CICP, it would need to amend the
statute to subject COVID-19 vaccines to this excise tax. Alternatively, to facilitate the process of
adding new vaccines to the Program, Congress could consider subjecting to the tax any vaccine
recommended for routine administration by the CDC.129 Congress could also decide to change
altogether the process outlined above for adding new vaccines to VICP, outline a new program for
compensation for COVID-19 vaccine injuries and deaths,130 or create a new program applicable
only to pandemic vaccines.

124 See Countermeasures Injury Compensation Program (CICP) Data, HRSA, https://www.hrsa.gov/cicp/cicp-data
(last updated Feb. 1, 2023).
125 See, e.g., Maryanne Demasi, COVID-19: Is the US Compensation Scheme for Vaccine Injuries Fit for Purpose?,
377 BMJ 1, 2 (Apr. 19, 2022) (citing stakeholders urging changes in law to compensate all COVID-19 vaccine injury
claims through VICP).
126 See Junying Zhao et al., Reforming the Countermeasures Injury Compensation Program for COVID-19 and
Beyond: An Economic Perspective, 9 J.L. & BIOSCI. 1 (2022).
127 See 26 U.S.C. §§ 4131, 9510(c).
128 Id. § 4132(a).
129 H.R. 3656, the Vaccine Access Improvement Act of 2021 (117th Cong.), introduced on June 1, 2021, proposed
amendments to the Internal Revenue Code (26 U.S.C. § 4132(a)(1)) to automatically subject to the excise tax any
vaccine the Secretary adds to the Vaccine Injury Table.
130 H.R. 5687, the Backing the Independent Decisions of Employees Against Nefarious Mandates Act of 2021, (117th
Cong.), introduced on October 21, 2021, proposed to authorize a private right of action in federal district court for
employees who suffer a vaccine-related injury or death as a result of receiving a COVID-19 vaccine that is mandated
by their employer.
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Should Congress add COVID-19 to the excise tax and COVID-19 vaccines become covered by
VICP, processing COVID-19 vaccine claims under the VICP may present other issues, absent
further congressional action. For example, the NCVIA caps the number of special masters who
may adjudicate petitions at eight.131 Petitioners being able to file VICP petitions for injuries
related to COVID-19 vaccines would likely result in a substantial increase to the OSM caseload,
which has already grown in recent years. For example, in Fiscal Year (FY) 2021, vaccine petition
filings increased by 72.6% over FY2020, and there have been more than 1,000 petitions filed in
the Program every year since FY2015.132 As of September 30, 2022, there are currently more than
3,800 pending vaccine petitions.133 Congress may wish to amend the NCVIA to increase both the
number of special masters who may adjudicate petitions as well as the OSM budget, so as to
accommodate additional court staff.134
In light of the potential increased caseload if COVID-19 vaccines are added to VICP, Congress
could also consider increasing the staffing and resources of both the Department of Justice, which
litigates VICP petitions on behalf of the government, and HRSA, which provides medical experts
and administrative support to review the petitions and medical records filed to determine the
government’s position on petitioner’s entitlement to compensation.135According to HRSA, a
backlog of cases awaiting review began in FY2017, and it currently takes the agency
approximately 12 months to conduct its initial review of each petition,136 delaying the processing
of petitions and the OSM’s adjudications.

131 42 U.S.C. § 300aa-12(c)(1).
132 Data & Statistics, HRSA, https://www.hrsa.gov/sites/default/files/hrsa/vicp/vicp-stats-02-01-23.pdf (last visited
Feb. 14, 2023).
133 Statistical Case Report for the Fiscal Year October 1, 2021 – September 30, 2022, COURT OF FEDERAL CLAIMS,
https://www.uscfc.uscourts.gov/sites/default/files/AOstats-2022.pdf (last visited Feb. 14, 2023).
134 H.R. 3655, the Vaccine Injury Compensation Modernization Act, (117th Cong.), introduced on June 1, 2021,
proposed to amend the Public Health Service Act to establish a minimum of 10 special masters. The bill also proposed
to increase compensation for pain, suffering, and death, and would have lengthened the statute of limitations for filing
vaccine petitions from 36 months to five years.
135 Fiscal Year 2024 Justification of Estimates for Appropriations Committees, HEALTH RES. & SERVS. ADMIN.,
https://www.hrsa.gov/sites/default/files/hrsa/about/budget/budget-justification-fy2024.pdf, at 462 (last visited Mar. 29,
2023). Advisory Commission on Childhood Vaccines, U.S. Dept. Health & Human Servs.,
https://www.hrsa.gov/sites/default/files/hrsa/advisory-committees/vaccines/accv-recommendation-funding-support-
vicp-09-12-2022-sge-signature-508.pdf, at 1 (last visited Mar. 29, 2023).
136 Id. at 445.
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Appendix. Comparison of Vaccine-Injury Programs:
CICP vs. VICP
Countermeasures Injury
Vaccine Injury Compensation Program

Compensation Program (CICP)
(VICP)
Scope of Coverage
“Covered countermeasures” under the
“Covered Vaccines” are those recommended
PREP Act, such as pandemic and
by CDC for routine administration to children
epidemic products used to treat,
or pregnant women, subject to a federal excise
mitigate, prevent, or cure COVID-19
tax, and added to the Vaccine Injury Table
(e.g., vaccines, PPE, treatments)
Covered Injuries
Death, or serious physical injury that
Death or an il ness, injury, or condition that
(1) warrants hospitalization or (2) leads
lasted more than six months or required
to a significant loss of function or
inpatient hospitalization and surgical
disability
intervention and was associated with one or
more vaccines in the Vaccine Injury Table
(unless the cause was an adulterant or
contaminant that was intentionally added to
the vaccine)
Process for
Administrative Process: file request form Judicial Process (“vaccine court”): file a petition
Obtaining
and supporting documentation with
in the U.S. Court of Federal Claims
Compensation
CICP to prove eligibility and
compensation amounts
Available Benefits
Reasonable medical expenses, lost
Non-reimbursed expenses related to the injury
employment income, and death benefits
for the diagnosis, medical care, and various
rehabilitation and recovery services; lost
employment income; pain, suffering, and
emotional distress damages; death benefits;
attorney’s fees
Unavailable Benefits
Attorneys’ fees, pain-and-suffering
Punitive or exemplary damages
damages, punitive damages
Benefit Caps
$50,000/year for lost employment
$250,000 for death; $250,000 for pain and
income; lifetime cap for lost income
suffering and emotional distress
(except for permanent disability); and
standard death benefit of $389,825.45
for FY2022
Filing Deadlines
Within one year of administration of
For injuries, within three years of the onset of
covered countermeasure (or within one
the first symptom; for deaths, within two years
year of the issuance of an amended
of the death and four years of the onset of the
Countermeasure Injury Table)
first symptom
Standard of Proof
Must show the injury (1) meets the
Must show the injured person (1) received a
requirements on a Countermeasure
vaccine on the Vaccine Injury Table;
Injury Table; or (2) was a direct result of
(2) sustained or significantly aggravated an
the administration or use of a covered
il ness, disability, injury, or condition, or died;
countermeasure
(3) the il ness, disability, injury, condition, or
death is either listed in the Vaccine Injury
Table in association with the vaccine and
occurred within a set time period as specified
in the Table or was caused by the vaccine;
(4) suffered the effects for more than six
months or required inpatient hospitalization
and surgery or died; and (5) has not previously
col ected an award for the injury or death
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Compensation Programs for COVID-19 Vaccine Injuries

Countermeasures Injury
Vaccine Injury Compensation Program

Compensation Program (CICP)
(VICP)
Initial
CICP (as delegate of the Secretary of
U.S. Court of Federal Claims special master
Decisionmaker
HHS)
Appeals & Judicial
Claimant may seek reconsideration of
Parties may seek review of special master
Review
CICP decision to a qualified independent
eligibility decision by U.S. Court of Federal
panel within 60 days; no further judicial
Claims within 30 days of decision; parties may
or administrative review
seek review by the U.S. Court of Appeals for
the Federal Circuit within 60 days of final
judgment; claimant may accept the judgment
or reject it, in which case they could file a tort
claim against the manufacturer with certain
limitations
Funding Source
Emergency appropriations to Covered
Vaccine Injury Compensation Trust Fund
Countermeasure Process Fund
based on excise tax of $0.75 per dose on
“taxable vaccines”
Number of Claims
Non-COVID-19 claims (2010–2023):
24,441 petitions as of 10/1/2021, of which
Processed
513 claims, of which 40 were
20,300 have been adjudicated: 11,947 were
determined eligible and 30 compensated
determined ineligible and 8,353 compensated
(6%)
(41%)
COVID-19 countermeasure claims (as of
March 1, 2023): 11,252 claims, of which
8,067 (72%) allege injuries from COVID-
19 vaccines; of the 630 claims reviewed
for CICP eligibility, 21 (3.3%) have been
held eligible for compensation; most
claims (94%) remain in or pending
review
Process for Adding
Scope of “covered countermeasures” is
Secretary of HHS may add vaccines to the
New Vaccines
determined by Secretary of HHS’s PREP
Vaccine Injury Table that are (1) subject to the
Act declarations (within statutory limits)
excise tax; and (2) recommended by the CDC
for routine administration to children or
pregnant women
Source: 42 U.S.C. §§ 300aa-10–300aa-34; 42 U.S.C. § 247d-6d to -6e; 42 C.F.R. pt. 110; HRSA; CRS.

Author Information

Kevin J. Hickey
Erin H. Ward
Legislative Attorney
Legislative Attorney

Hannah-Alise Rogers

Legislative Attorney

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Compensation Programs for COVID-19 Vaccine Injuries

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Congressional Research Service
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