Compensation Programs for COVID-19 Vaccine December 9, 2021
Injuries
Kevin J. Hickey Injuries
March 31, 2023
More than
More than
200260 million Americans, and billions of people worldwide, have received one or more million Americans, and billions of people worldwide, have received one or more
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doses of a vaccine to protect against Coronavirus Disease 2019 (COVID-19). Most common side doses of a vaccine to protect against Coronavirus Disease 2019 (COVID-19). Most common side
Kevin J. Hickey
effects
effects
toof COVID-19 vaccines are mild and generally resolve in a few days. COVID-19 vaccines are mild and generally resolve in a few days.
However, in rare
Erin H. Ward
instances, COVID-19 vaccines can cause serious adverse events. For example, roughly one
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person out of every 200,000 who receives an mRNA-based COVID-19 vaccine experiences a
severe allergic reaction. Other reported serious adverse events, such as myocarditis and Guillain-Barré Syndrome, are rare but may be associated with some COVID-19 vaccines.
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
Individuals who believe they are injured by COVID-19 vaccines may seek compensation for
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those injuries and those injuries and
other associated harms or costs. Absent an applicable federal law, individuals associated harms or costs. Absent an applicable federal law, individuals
allegedly injured by a vaccine might seek redress by 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 filing a state tort law claim against the vaccine manufacturer. However, federal law has two distinct compensation regimes
that limit that limit
Erin H. Ward
legal liability for vaccine manufacturers and provide potential compensation—without requiring legal liability for vaccine manufacturers and provide potential compensation—without requiring
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a showing of a showing of
fault—for individuals harmed by adverse reactions to vaccines.fault—for individuals harmed by adverse reactions to vaccines.
For injuries and deaths associated with most vaccines For injuries and deaths associated with most vaccines
recommended by the Centers for Disease recommended by the Centers for Disease
Control and Prevention (CDC) for routine administration in the United States Control and Prevention (CDC) for routine administration in the United States
(such as pediatric and seasonal influenza vaccines), the National Vaccine Injury Compensation Program (VICP) may provide , the National Vaccine Injury Compensation Program (VICP) may provide
compensation. During public health emergencies declared under the Public Readiness and Emergency Preparedness Act 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 (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. resulting from the administration of “covered countermeasures,” which may include vaccines.
The VICP and CICP regimes are similar
The VICP and CICP regimes are similar
but distinctin some ways, but the programs serve distinct purposes. Compensation through CICP is generally . Compensation through CICP is generally
somewhat more limitedless comprehensive than than
through VICP. CICP is a regulatory process administered by the Health Resources and Services Administration (HRSA), through VICP. CICP is a regulatory process administered by the Health Resources and Services Administration (HRSA),
an agency withina division of the U.S. Department of Health and Human Services (HHS). CICP compensation is available only for death or the U.S. Department of Health and Human Services (HHS). CICP compensation is available only for death or
serious injuries resulting from a covered countermeasureserious injuries resulting from a covered countermeasure
that warrant hospitalization or lead to a significant loss of function or disability. A claimant must generally file a request form and associated documentation with HRSA within one year of the . 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 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 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. on compelling medical and scientific evidence.
Eligibility and compensation decisions are made by HRSAHRSA makes decisions regarding eligibility and compensation; judicial review is ; judicial review is
not available. CICP compensation is limited to reasonable medical expenses, loss of employment income, and a death benefit not available. CICP compensation is limited to reasonable medical expenses, loss of employment income, and a death benefit
in cases wherewhen the claimant’s death is a direct result of the administration the claimant’s death is a direct result of the administration
or use of a covered countermeasure. of a covered countermeasure.
Under the Secretary of HHS’s current PREP Act Declaration for COVID-19, FDA-authorized or -approved COVID-19
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 vaccines are covered countermeasures. While a PREP Act declaration is in effect, CICP is the sole remedy available for
injuries related to covered countermeasures, injuries related to covered countermeasures,
including any covered vaccines. As a result,so CICP—and not VICP—will apply CICP—and not VICP—will apply
to injuries resulting from COVID-19 vaccinations while the to injuries resulting from COVID-19 vaccinations while the
public health emergency persists and the Declaration remains in force. After the termination of the PREP Act public health emergency for COVID-19, COVID-19 vaccine injuries may be 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. compensated through VICP, contingent on additional regulatory and statutory changes.
In order for VICP to apply to a COVID-19 vaccineTo be included in the VICP, (1) the vaccine must be recommended by the CDC for routine administration to children or pregnant , (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 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 HHS must add the vaccine to the Vaccine Injury Table, which lists injuries and conditions associated with
covered vaccines.
Presuming all of thosevaccines covered by VICP. Should all of these changes changes
occur, COVID-19 vaccines would be covered by VICP.
occur, VICP would apply to COVID-19 vaccine injuries. To receive compensation through To receive compensation through
VICP for a vaccine-related injury or death, the injured person 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, must file a petition with the U.S. Court of Federal Claims,
generally within three years of the generally within three years of the
onset of the first symptom or significant aggravation of the injury, or within two years of first symptom or significant aggravation of the injury, or within two years of
a death or death or
four years of the first symptom resulting in death. To receive compensation, four years of the first symptom resulting in death. To receive compensation,
the injured partypetitioners must show either that must show either that
he or she they experienced an injury listed experienced an injury listed
for the vaccine in the Vaccine Injury Table within the time frame specified in the Table, or in the Vaccine Injury Table within the time frame specified in the Table, or
directly prove that the vaccine prove that the vaccine
caused the injury. Eligibility and compensation determinations are made by a special master in a trial-like proceeding, whichwas 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 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 Federal Circuit. Successful petitioners may receive medical expenses, lost income, a set death benefit, and reasonable
attorneys’ feesattorneys’ fees
and costs. Petitioners who are dissatisfied with the compensation they receive, or whose claims are delayed, may opt to . 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. pursue civil actions in court, subject to certain limitations on vaccine manufacturer liability.
Congressional Research Service
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link to page 19 link to page 20 Compensation Programs for COVID-19 Vaccine Injuries
Contents
The Countermeasures Injury Compensation Program (CICP) ........................................................ 23
Covered Vaccines and Injuries .................................................................................................. 34
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) ........................................................ 67
Covered Vaccines and Injuries .................................................................................................. 78
Procedure for Obtaining Compensation .................................................................................... 8
Available Compensation ........................................................................................................... 9
11
Possible Transition of COVID-19 Vaccines from Coverage Under CICP to VICP ....................... 11 Considerations for Congress.......................................................................................................... 1013
Appendixes
Appendix. Comparison of Vaccine-Injury Programs: CICP vs. VICP .......................................... 1216
Contacts
Author Information ........................................................................................................................ 1317
Congressional Research Service
Congressional Research Service
Compensation Programs for COVID-19 Vaccine Injuries
ore than
ore than
200260 million Americans have received one or more doses of a Coronavirus 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 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-
M Food and Drug Administration’s (FDA’s) emergency use authorizations for the Pfizer-
BioNTech, Moderna,
BioNTech, Moderna,
and Johnson & JohnsonJohnson & Johnson
, and Novavax COVID-19 vaccines were based on months-long COVID-19 vaccines were based on months-long
clinical trials (including safety monitoring) of each vaccine, involving tens of thousands of 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 participants.3 These trials did not identify any safety concerns that would preclude
such authorization.4 (Theemergency use authorization.4 Subsequently, the Pfizer-BioNTech COVID-19 vaccine Pfizer-BioNTech COVID-19 vaccine
subsequently(later known as Comirnaty) received full FDA received full FDA
approval approval as a two-dose primary series for individuals for individuals
16 12 years of age and olderyears of age and older
.5) Post-,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 authorization, the COVID-19 vaccines
have been subject to safety monitoring requirements by FDA and the Centers for Disease Control 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 and Prevention (CDC) to track the incidence of side effects and detect long-term, rare, or
unexpected adverse health events.unexpected adverse health events.
6
7 The most common side effects of COVID-19 vaccines are mild—such as local pain around the The most common side effects of COVID-19 vaccines are mild—such as local pain around the
injection injection
sidesite, fatigue, or fever—and usually resolve within a few days., fatigue, or fever—and usually resolve within a few days.
78 As with most vaccines, As with most vaccines,
however, a however, a
very small percentage of inoculated individuals experience serious adverse reactions small percentage of inoculated individuals experience serious adverse reactions
to a COVID-19 vaccine.to a COVID-19 vaccine.
89 For example, approximately For example, approximately
two to five people per million receiving five people per million receiving
mRNA COVID-19 vaccines experience anaphylaxis, a severe allergic reaction, following mRNA COVID-19 vaccines experience anaphylaxis, a severe allergic reaction, following
vaccination.vaccination.
9 (For10 (In part for this reason, the CDC recommends that all individuals be monitored for at least 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 15 minutes following their vaccinations, and that all vaccination sites have epinephrine available
for treatment of anaphylaxis.10) Other serious adverse events reported following vaccination, such as myocarditis and Guillain-Barré Syndrome (GBS), are similarly rare and may be associated with COVID-19 vaccines.11 for
1 1
COVID-19 Vaccinations in the United States, CTRS. FOR DISEASE CONTROL & PREVENTION (CDC), , CTRS. FOR DISEASE CONTROL & PREVENTION (CDC),
https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total (last https://covid.cdc.gov/covid-data-tracker/#vaccinations_vacc-total-admin-rate-total (last
updated Nov. 24, 2021visited Jan. 24, 2023). ).
2
2
More Than 7.7912.7 Billion Shots Given: Covid-19 Tracker, BLOOMBERG, https://www.bloomberg.com/graphics/covid-, BLOOMBERG, https://www.bloomberg.com/graphics/covid-
vaccine-tracker-global-distribution/ (last updated vaccine-tracker-global-distribution/ (last updated
Nov. 24, 2021Oct. 5, 2022). ).
3 Letter from FDA to Pfizer Inc., at 1-2 (May 10, 2021), https://www.fda.gov/media/144412/download [hereinafter
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/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), 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]https://www.fda.gov/media/146303/download [hereinafter J&J EUA]
.
4 Pfizer EUA, supra note 3, at 2; Moderna EUA, supra note 3, at 2; J&J EUA, supra note 3, at 2. 5 Letter from FDA to BioNTech Manufacturing GmbH & Pfizer Inc., at 1 (Aug. 23, 2021), https://www.fda.gov/media/151710/download; 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, 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. , by Kevin J. Hickey, Erin H. Ward, and Agata Bodie.
6
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/, CDC, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/
safety.html (last updated safety.html (last updated
Sept. 28, 2021) (“Millions of people in the United States have received Dec, 22, 2022) (“COVID-19 vaccines COVID-19 vaccines
underare monitored by the most intense safety monitoring the most intense safety monitoring
efforts in U.S. history.”); in U.S. history.”);
see generally CRS Report R46593, CRS Report R46593,
Vaccine Safety in the
United States: Overview and Considerations for COVID-19 Vaccines, by Kavya Sekar and Agata Bodie. , by Kavya Sekar and Agata Bodie.
78 Possible Side Effects After Getting a COVID-19 Vaccine, CDC, https://www.cdc.gov/coronavirus/2019-ncov/ CDC, https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/expect/after.html (last vaccines/expect/after.html (last
visited Nov. 17, 2021).
8updated Sept. 14, 2022).
9 Selected Adverse Events Reported After COVID-19 Vaccination, CDC, https://www.cdc.gov/coronavirus/2019-ncov/, CDC, https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/safety/adverse-events.html (last updated vaccines/safety/adverse-events.html (last updated
Nov. 16, 2021).
9 Id. (“Anaphylaxis, a severe type of allergic reaction, following administration ofJan. 23, 2023).
10 Id. (“Anaphylaxis after COVID-19 vaccination is rare and COVID-19 vaccination is rare and
has occurred has occurred
in approximately 2 to 5 people per million vaccinated in the United Statesat a rate of approximately 5 cases per one million vaccine doses administered.”);.”);
accord Tom T. Tom T.
Shimabukuro, Matthew ColeShimabukuro, Matthew Cole
, & John R. Su, & 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/, 325 JAMA 1101–02 (Feb. 12, 2021), https://jamanetwork.com/journals/
jama/fullarticle/2776557.
10 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 visited Nov. 17, 2021).
11 Myocarditis and Pericarditis After mRNA COVID-19 Vaccination, CDC, https://www.cdc.gov/coronavirus/2019-
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link to page 15 link to page 15 Compensation Programs for COVID-19 Vaccine Injuries
Federal law has two distinct compensation regimes that may compensatejama/fullarticle/2776557 (reporting rates of 2.5 to 4.7 cases of anaphylaxis per million doses administered).
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Compensation Programs for COVID-19 Vaccine Injuries
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 individuals harmed by
adverse reactions to vaccines. In general, the National Vaccine Injury Compensation Program 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 (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).administered in the United States (such as pediatric and seasonal influenza vaccines).
1214 During During
certain public health emergencies, the Countermeasures Injury Compensation Program (CICP) certain public health emergencies, the Countermeasures Injury Compensation Program (CICP)
may provide compensation for injuries and deaths resulting from the administration of “covered may provide compensation for injuries and deaths resulting from the administration of “covered
countermeasures,” which may include vaccines, under the Public Readiness and Emergency countermeasures,” which may include vaccines, under the Public Readiness and Emergency
Preparedness Act (PREP Act).Preparedness Act (PREP Act).
1315
Under the Secretary of Health and Human Services’ (HHS’s) PREP Act Declaration for COVID-
Under the Secretary of Health and Human Services’ (HHS’s) PREP Act Declaration for COVID-
19 (and its amendments), COVID-19 vaccines are 19 (and its amendments), COVID-19 vaccines are
considered covered countermeasures within the PREP covered countermeasures within the PREP
Act’s scope.Act’s scope.
1416 As a result, CICP—and not VICP— As a result, CICP—and not VICP—
will applycurrently applies to injuries resulting from COVID-19 to injuries resulting from COVID-19
vaccinations while the public health emergency persists and the Declaration remains in force.15 Compensation through CICP is generally somewhat more limited than through VICP.16
This CRS 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, which 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
ncov/vaccines/safety/myocarditis.html (last updated Nov. 12, 2021); Selected Adverse Events Reported After COVID-
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/, CDC, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/
adverse-eventsmyocarditis.html (last updated .html (last updated
Nov. 16, 2021); Sept. 27, 2022); see also Hannah G. Rosenblum et al., 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 , 70 MMWR 1094–99
(Aug. 13, 2021), https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e4.htm (estimating rates of (Aug. 13, 2021), https://www.cdc.gov/mmwr/volumes/70/wr/mm7032e4.htm (estimating rates of
GBSGuillain-Barré Syndrome, myocarditis, , myocarditis,
and other serious adverse events per million vaccine doses administered)and other serious adverse events per million vaccine doses administered)
.
12; 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/, HEALTH RES. & SERVS. ADMIN. (HRSA), https://www.hrsa.gov/
vaccine-compensation/index.html (last updated vaccine-compensation/index.html (last updated
Nov. 2021Jan. 2023); );
Covered Vaccines, HRSA, https://www.hrsa.gov/vaccine-, HRSA, https://www.hrsa.gov/vaccine-
compensation/covered-vaccines/index.html (last updated compensation/covered-vaccines/index.html (last updated
Nov. 2021Jan. 2023) (“The National Vaccine Injury Compensation ) (“The National Vaccine Injury Compensation
Program (VICP) covers most vaccines routinely given in the U.S.”). Program (VICP) covers most vaccines routinely given in the U.S.”).
1315 See Countermeasures Injury Compensation Program (CICP), HRSA,, HRSA,
https://www.hrsa.gov/cicp/ (last updated https://www.hrsa.gov/cicp/ (last updated
Nov. 2020Jan. 2023); Public Readiness and Emergency Preparedness Act, ); Public Readiness and Emergency Preparedness Act,
Pub. L. NoP.L. 109-148, div. C, 119 Stat. 2818 (2005). . 109-148, div. C, 119 Stat. 2818 (2005).
1416 Fourth Amendment to the Declaration under the Public Readiness and Emergency Preparedness Act for Medical 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) 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.”); (“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 , 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 PREPAREDNESS & RESPONSE (HHS ASPR), https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx (last
updated Oct. 8, 2021visited Jan. 25, 2023) (links to the ) (links to the
COVID-19 PREP Act Declaration and 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.19amendments).
15 Frequently Asked Questions, HRSA, https://www.hrsa.gov/cicp/faq (last updated Jan. 2021) (“COVID-19 vaccines are covered countermeasures under the Countermeasures Injury Compensation Program (CICP), not the National Vaccine Injury Compensation Program (VICP).”).
16 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.
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diagnostics, treatments, and vaccines.17 In a declaration effective February 4, 2020 (the PREP Act In a declaration effective February 4, 2020 (the PREP Act
Declaration), the Secretary invoked the PREP Act and declared Declaration), the Secretary invoked the PREP Act and declared
the spread of COVID-19 to be a public health COVID-19 to be a public health
emergency warranting liability protections for covered countermeasuresemergency warranting liability protections for covered countermeasures
.18 (e.g., drugs, biologics, and medical devices used to diagnose, treat, or prevent COVID-19).20 Pursuant to the PREP Pursuant to the PREP
Act Declaration and its subsequent amendments,Act Declaration and its subsequent amendments,
1921 manufacturers, distributors, and health care manufacturers, distributors, and health care
providers are generally immune from legal liability (i.e., they cannot be sued for money damages 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 in court) for losses related to the administration or use of covered countermeasures against
COVID-19.COVID-19.
2022
In addition to providing immunity from liability, the PREP Act established CICP, a compensation
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 program for individuals seriously injured or killed as a direct result of the administration or use of
a covered countermeasure.a covered countermeasure.
2123 CICP is a regulatory process administered by CICP is a regulatory process administered by
HHS’sthe Health Health
Resources and Services Administration (HRSA).Resources and Services Administration (HRSA).
2224 HRSA regulations govern CICP’s procedures HRSA regulations govern CICP’s procedures
and eligibility determinations.and eligibility determinations.
23
Covered Vaccines and Injuries
Under the PREP Act and the amended 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.”24 For example, personal protective equipment (PPE) (e.g., respirators), ventilators, therapeutic drugs (e.g., remdesivir), and monoclonal antibody treatments approved or authorized by FDA to treat or prevent COVID-19 are covered countermeasures under the PREP Act.25 Notably, FDA-authorized or -approved COVID-19 vaccines—such as those produced by Pfizer, Moderna, and Johnson & Johnson—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.26 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
17 42 U.S.C. § 247-6d(a)–(b). 1825
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 Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against
COVID-19, 85 Fed. Reg. 15,198 (Mar. 17, 2020). COVID-19, 85 Fed. Reg. 15,198 (Mar. 17, 2020).
1921 See Public Readiness and Emergency Preparedness Act, HHS ASPR, https://www.phe.gov/Preparedness/legal/, HHS ASPR, https://www.phe.gov/Preparedness/legal/
prepact/Pages/default.aspx (last prepact/Pages/default.aspx (last
updated Oct. 8, 2021visited Jan. 25, 2023) (linking to the ) (linking to the
COVID-19 PREP Act Declaration amendments). PREP Act Declaration amendments).
2022 See 42 U.S.C. § 247d-6d(a); 42 U.S.C. § 247d-6d(a);
see generally PREP Act Q&As, HHS ASPR, https://www.phe.gov/Preparedness/legal/, 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 prepact/Pages/prepqa.aspx. For a detailed discussion of the scope of liability immunity under the PREP Act, see CRS
Legal Sidebar LSB10443, Legal Sidebar LSB10443,
The PREP Act and COVID-19: Limiting, Part 1: Statutory Authority to Limit Liability for Medical Countermeasures, by Kevin J. Hickey.
21 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; 42 U.S.C. § 247d-6e;
Countermeasures Injury Compensation Program (CICP), HRSA,, HRSA,
https://www.hrsa.gov/cicp/ https://www.hrsa.gov/cicp/
(last updated (last updated
Nov. 2020).
22Jan. 2023).
24 See CICP Frequently Asked Questions, HRSA,, HRSA,
https://www.hrsa.gov/cicp/faq/index.html (last https://www.hrsa.gov/cicp/faq/index.html (last
updatedvisited Jan. Jan.
2021). 2325, 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, See 42 C.F.R. pt. 110. 24 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).
25 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 Nov. 18, 2021) (listing FDA emergency use authorizations for vaccines, drugs, biologics, and medical devices used against COVID-19).
26 42 U.S.C. § 247d-6e(d)(4).
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from COVID-19 vaccinations.27 (As discussed in detail below, VICP may eventually apply to COVID-19-vaccine injuries after the public health emergency terminates, contingent on certain contingent on certain
statutory and regulatory changes.statutory and regulatory changes.
)
CICP compensation is limited to eligible individuals, such as persons injured by countermeasures
CICP compensation is limited to eligible individuals, such as persons injured by countermeasures
or their survivors.or their survivors.
2830 CICP provides compensation only for death or “serious physical injuries”— 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.that is, injuries that warrant hospitalization or lead to a significant loss of function or disability.
29 Thus, individuals31 Individuals who experience only minor, short-term side effects from a COVID-19 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 vaccine—such as mild soreness, headache, or fatigue—would not be eligible for CICP
compensation.compensation.
3032
Procedure for Obtaining Compensation
To apply for CICP compensation, a claimant To apply for CICP compensation, a claimant
generally must file a request for benefits within one year of the must file a request for benefits within one year of the
date the countermeasure was administered.date the countermeasure was administered.
3133 (If the Secretary publishes a new Countermeasure (If the Secretary publishes a new Countermeasure
Injury Table, a newly eligible claimant may file within one year after the new table is established.32) In addition to the request form, claimants may need to submit medical records and other evidence to establish eligibility.33 If determined to be eligible, claimants may submit additional documentation to demonstrate the compensation amount.34 Eligibility and compensation determinations are made by CICP as the Secretary’s delegate.35 Claimants may seek reconsideration of an adverse eligibility decision by CICP, but the ultimate decisionmaking authority lies with the Secretary.36 The PREP Act precludes judicial review of the Secretary’s eligibility and compensation decisions.37
CICP claimants can prove eligibility for compensation in one of two ways.38 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
27Injury 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,, HRSA,
https://www.hrsa.gov/cicp/faq/index.html (last https://www.hrsa.gov/cicp/faq/index.html (last
updatedvisited Jan. Jan.
202125, 2023) (“COVID-19 vaccines are covered countermeasures under the Countermeasures Injury Compensation ) (“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 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). for willful misconduct. 42 U.S.C. §§ 247d-6d(d)(1), 247d-6e(d)(4).
2830 See 42 C.F.R. § 110.10. 42 C.F.R. § 110.10.
2931 See id. § 110.3(z); 42 U.S.C. § 247d-6e(e)(3). § 110.3(z); 42 U.S.C. § 247d-6e(e)(3).
3032 Possible Side Effects After Getting a COVID-19 Vaccine,, CDC, https://www.cdc.gov/coronavirus/2019-ncov/ CDC, https://www.cdc.gov/coronavirus/2019-ncov/
vaccines/expect/after.html (last vaccines/expect/after.html (last
visited Nov. 17, 2021updated Sept. 14, 2022) (describing temporary arm pain, tiredness, muscle pain, fever, ) (describing temporary arm pain, tiredness, muscle pain, fever,
and other “common side effects” of COVID-19 vaccines). and other “common side effects” of COVID-19 vaccines).
3133 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 42 C.F.R. § 110.42(a). 32 Id. § 110.42(f). 33 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 Nov. 2020).
34 See 42 C.F.R. § 110.60–110.63; see also Filing for Benefits, HRSA, https://www.hrsa.gov/cicp/filing-benefits (last updated Oct. 2021) (“If the requester is determined to be eligible for program benefits, the requester is asked to submit additional documentation to determine the type and amount of compensation the requester may be entitled to receive.”).
35 See 42 C.F.R. § 110.72–110.74. 36 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.”).
37 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.”). 38 See 42 C.F.R. § 110.20(b)–(c).
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covered countermeasure directly causes particular injuries.39 (The table established for the H1N1 pandemic influenza vaccine is one example;40 no such table has yet been promulgated for COVID-19 countermeasures, including vaccines.) For injuries listed on a Countermeasure Injury , 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, if the claimant can show that the countermeasure recipient’s injury is listed on the
tableTable and was sustained within the relevant time interval (and meets any other requirements set forth in and was sustained within the relevant time interval (and meets any other requirements set forth in
the the
tableTable), CICP will presume the injury was a direct result of the covered countermeasure.), CICP will presume the injury was a direct result of the covered countermeasure.
4143 For For
injuries injuries
not on a Countermeasure Injury Table (or outside its scope), the claimant must prove the on a Countermeasure Injury Table (or outside its scope), the claimant must prove the
non-non-
tableTable injury was the “direct result” of the countermeasure’s administration based on injury was the “direct result” of the countermeasure’s administration based on
“compelling, reliable, valid, medical and scientific evidence” beyond mere temporal “compelling, reliable, valid, medical and scientific evidence” beyond mere temporal
association.association.
4244
Available Compensation
Compensation under CICP is limited to (1) reasonable medical expenses (e.g., unreimbursed 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 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 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.administration or use of a covered countermeasure.
4345 Attorneys’ fees and pain-and-suffering Attorneys’ fees and pain-and-suffering
damages are not available under CICP.damages are not available under CICP.
4446 CICP awards are also subject to various annual and CICP awards are also subject to various annual and
lifetime limits. For example, annual lost employment income awards are capped at $50,000 per year,45 and the standard maximum death benefit is the same as that under the Public Safety Officers’ Benefits program (currently $389,825.45).46
Given the limited number and scope of past PREP Act declarations, CICP has been used relatively infrequently since the PREP Act’s 2005 enactment.47 The majority of these non-COVID-19 claims were related to the H1N1 pandemic influenza vaccine.48 According to HRSA, for FY2010 through FY2021, CICP received 491 claims unrelated to COVID-19, of which at least 408 (83%) appear to relate to the H1N1 vaccine. Of these, 39 (8%) were determined to be eligible for compensation and 29 (6%) have been paid out by CICP, amounting to $6 million in
39 42 U.S.C. § 247d-6e(5)(A). 40 42 C.F.R. § 110.100. 41 See id. § 110.20(b). 42 See id. § 110.20(c). 43 Id. § 110.2(a). 44
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,, HRSA,
https://www.hrsa.gov/cicp/cicp-vicp (last updated Apr. 2021) (“Attorneys’ https://www.hrsa.gov/cicp/cicp-vicp (last updated Apr. 2021) (“Attorneys’
fees and costs are not paid by [CICP].”); Nicholas M. Pace, Lloyd Dixonfees 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.
Bethany Saunders-Medina, The
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-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 effects.html (“The CICP does not provide any compensation for pain, suffering, emotional distress, or similar damages
. . . .”). . . . .”).
45
47 42 C.F.R. § 110.81(c)(2). 42 C.F.R. § 110.81(c)(2).
4648 Id. § 110.82(b)(1); § 110.82(b)(1);
Benefits by Year: Public Safety Officers’ Benefits Program, U.S. DEP’T OF JUSTICE BUR. OF JUST. , U.S. DEP’T OF JUSTICE BUR. OF JUST.
ASSISTANCE, https://psob.bja.ojp.gov/knowledge-base/benefits-by-year/ (last visited ASSISTANCE, https://psob.bja.ojp.gov/knowledge-base/benefits-by-year/ (last visited
Nov. 18, 2021).
47Mar. 23, 2023).
49 See Pace et al., Pace et al.,
supra no no
te 4446 (“The NVICP has handled more than 20,000 vaccine injury claims since its inception, (“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 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].”). enacted in 2005 [and prior to COVID-19].”).
4850 See Bernard Condon & Matt Sedensky, 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) , INS. J., https://www.insurancejournal.com/news/national/2020/12/29/595414.htm (Dec. 29, 2020)
(“[Prior to COVID-19(“[Prior to COVID-19
], the, t]he vast majority of the claims under [CICP] have stemmed from the H1N1 swine flu vaccine a vast majority of the claims under [CICP] have stemmed from the H1N1 swine flu vaccine a
decade ago.”). decade ago.”).
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awards.49 (Ten of the claims determined to be eligible for compensation had no eligible reported medical expenses or lost employment income.)
In light of the COVID-19 pandemic, HRSA has received a larger number of CICP claims than it has received historically. As of October 1, 2021, CICP has received 3,158 claims alleging injury or death relating to COVID-19 countermeasures, of which 1,357 claims (43%)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- relate to COVID-
19 vaccines.50 CICP has not yet compensated any claims relating to COVID-19 countermeasures; it has denied three claims because the standard of proof for causation was not met and/or a covered injury was not sustained, and determined one claim to be eligible for compensation, pending a review of the eligible expenses.51 The remainder of the COVID-19 countermeasure claims (99.9%) are in review or pending CICP review.52
Several COVID-19 emergency appropriations allow the Secretary to transfer funds to the Covered Countermeasure Process Fund.53 Such funds, in addition to prior-year fund balances, can be used for CICP compensation awards.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 After the Secretary terminates the PREP Act Declaration for the COVID-19 pandemic, any
injuries or death injuries or death
from COVID-19 vaccines administered after the Declaration endsrelated to COVID-19 vaccine administration would be would be
addressed in court under tort lawaddressed in court under tort law
, unless the COVID-19 vaccines are added to VICP. unless the COVID-19 vaccines are added to VICP.
5458 VICP VICP
provides compensation for injuries and deaths provides compensation for injuries and deaths
caused by certainassociated with vaccines that are listed on the Vaccine Injury Table and subject to an excise tax.59
Congress created the VICP via vaccines that are subject to an excise tax and listed on the Vaccine Injury Table.55
VICP was created by the National Childhood Vaccine Injury Act of 1986 (NCVIA) amid concerns the National Childhood Vaccine Injury Act of 1986 (NCVIA) amid concerns
that lawsuits against vaccine manufacturers and health care providers alleging vaccine injuries that lawsuits against vaccine manufacturers and health care providers alleging vaccine injuries
could could deter pharmaceutical innovation, lead to vaccine shortageslead to vaccine shortages
, and lower immunization rates. and lower immunization rates.
5660 Under a typical state tort law Under a typical state tort law
framework, an injured person must generally prove that a vaccine caused the injury and that 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 either the vaccine manufacturer is at fault (e.g., negligent, failed to warn adequately) or, under
products liability doctrines, that the vaccine was defective.products liability doctrines, that the vaccine was defective.
5761 If the person cannot prove one of If the person cannot prove one of
these elements—for example, if the manufacturer adequately warned of side effects or it is these elements—for example, if the manufacturer adequately warned of side effects or it is
unclear whether the vaccine caused the injury—the 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).
58claimant receives no compensation. If the
49 See Countermeasures Injury Compensation Program (CICP) Data, HRSA, https://www.hrsa.gov/cicp/cicp-data (last updated Oct. 1, 2021) (listing 3,649 total claims, of which 3,158 relate to COVID-19 countermeasures, 408 relate to the H1N1 vaccine, 39 were eligible for compensation, and 29 were compensated).
50 See id. at tbl. 1. 51 Id. at “Has the CICP made any decisions regarding COVID-19 Claims?”. 52 See id. at tbl. 1 (listing 3,158 COVID-19 countermeasure claims, of which 4 have an eligibility determination). 53 See, e.g., Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. No. 116-136, div. B, tit. VIII, 134 Stat. 281, 560–61 (Mar. 27, 2020).
54 42 U.S.C. §§ 300aa-10–300aa-44; 26 U.S.C. §§ 4131, 4132, 9510. 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 , HRSA, https://www.hrsa.gov/vaccine-compensation/index.html (last updated
NovemberNov. 2021). 2021).
5559 42 U.S.C. §§ 300aaa-11–300aa-15; 26 U.S.C. §§ 4131, 4132, 9510; 42 C.F.R. § 100.3; 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, , HRSA,
https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/vaccine-injury-table.pdf. https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/vaccine-injury-table.pdf.
56 Pub. L. No60 P.L. 99-660, § 311, 100 Stat. 3758 (1986); . 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 , S. REP. NO. 99-483, at 2–6 (1986); H. REP. NO. 99-908, at
4–7 (1986). 4–7 (1986).
5761 RESTATEMENT (SECOND) OF TORTS § 281; RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY §§ 1, 10. RESTATEMENT (SECOND) OF TORTS § 281; RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY §§ 1, 10.
See also CRS In Focus IF11291, CRS In Focus IF11291,
Introduction to Tort Law, by Kevin M. Lewis. , by Kevin M. Lewis.
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vaccine manufacturer is found liable, however, it may be responsible for compensatory damages and potentially punitive damages as determined by a jury.58 Regardless of the outcome, both sides generally would be responsible for litigation costs.59
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.60 The program shields manufacturers of certain vaccines from most liability for vaccine-related injuries and deaths, while providing compensation to those injured by vaccines from a trust fund funded by excise taxes paid by the vaccine manufacturers.61 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 November 1, 2021, more than 24,538 petitions for compensation have been filed, of which 20,400 have been adjudicated, and 8,439 determined to merit compensation.62 The program has paid out more than $4.6 billion in compensation since its inception.63
Covered Vaccines and Injuries
To receive compensation, an injured party must show he or she received62 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.” a “covered vaccine.”
64 70 Not every FDA-approved vaccine is covered by VICP. The NCVIA included an initial Vaccine Not every FDA-approved vaccine is covered by VICP. The NCVIA included an initial Vaccine
Injury Table listing vaccines covered by the Injury Table listing vaccines covered by the
program.65Program.71 Under the Act, the Secretary Under the Act, the Secretary
can add vaccines to the program by amendingmay promulgate regulations to amend the Vaccine Injury Table to the Vaccine Injury Table to
addinclude additional vaccines recommended by vaccines recommended by
the CDC for routine administration to children or pregnant women within two years of such a the CDC for routine administration to children or pregnant women within two years of such a
recommendation.recommendation.
66
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.67 The types of vaccines subject to the excise tax are specified in statute and therefore can be amended only by an act of Congress.68
In addition to having received a covered vaccine, the injured party must show either that (1) he or she 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 time frame specified in the table, or (2) the vaccine caused the injury.69 The Vaccine Injury Table accordingly allows
58 RESTATEMENT (SECOND) OF TORTS §§ 901–917. 59 Alyeska Pipeline Serv. Co. v. Wilderness Soc’y, 421 U.S. 240, 247 (1975). 60 42 U.S.C. §§ 300aa-13–300aa-15. 61 Id. §§ 300aa-13–300aa-15, 300aa-21–300aa-22; 26 U.S.C. §§ 4131, 4132, 9510. 62 Data & Statistics, HRSA, https://www.hrsa.gov/sites/default/files/hrsa/vaccine-compensation/data/vicpmonthlyreporttemplate%2011-01-21.pdf (last updated Nov. 1, 2021).
63 Id. 64 42 U.S.C. §§ 300aa-11(c), 300aa-33(5). 65 Id. § 300aa-14(a). 66 Id. § 300aa-14(e). 67 Id. § 300aa-14; 26 U.S.C. §§ 4132, 9510. 68 26 U.S.C. § 4132. 69 42 U.S.C. § 300aa-11(c).
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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 associated with the vaccine soon after receiving the vaccine.70 Nonetheless, injured persons still have the option of directly proving that a vaccine caused their injuries if they experience an injury not listed in the Vaccine Injury Table or the onset or aggravation of the injury is delayed.71
Procedure for Obtaining Compensation
To receive compensation through VICP for a vaccine-related injury or death, 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).72 The petition must generally contain an affidavit and supporting documentation, including relevant medical records, showing the person
received a vaccine listed in the Vaccine Injury Table; sustained 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,
an illness, disability, injury, or condition eitheror condition either
:
set forth in the Vaccine Injury Table for the particular vaccine, and the
set forth in the Vaccine Injury Table for the particular vaccine, and the
first symptom or manifestation occurred within the required time period;
first symptom or manifestation occurred within the required time period;
or or
caused by the vaccine;
caused by the vaccine;
suffered residual effects or complications that lasted for more than six months or
suffered residual effects or complications that lasted for more than six months or
required inpatient hospitalization and surgery, or died; and
required inpatient hospitalization and surgery, or died; and
has not collected another award or settlement for the injury or death.
has not collected another award or settlement for the injury or death.
7377
Petitions for vaccine-related
Petitions for vaccine-related
injuriesinjuries must generally be filed within three years of the first must generally be filed within three years of the first
symptom symptom
or significant aggravation of the injury.74of the injury or significant aggravation.78 Petitions for vaccine-related Petitions for vaccine-related
deathsdeaths must be must be
filed within two years of the death and within four years of the first symptom or significant 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.aggravation of the injury from which the death resulted.
7579 If the Vaccine Injury Table is amended If the Vaccine Injury Table is amended
such that a person qualifies for compensation who previously did not, that person has two years such that a person qualifies for compensation who previously did not, that person has two years
from when the from when the
tableTable is revised to seek compensation for injuries or deaths that occurred up to is revised to seek compensation for injuries or deaths that occurred up to
eight years before the eight years before the
tableTable was revised. was revised.
7680
When a person files a petition with the Claims Court, the clerk of the court forwards the petition
When a person files a petition with the Claims Court, the clerk of the court forwards the petition
to the to the
Office of Special Masters (OSM), and the chief special master chief special master
to assignassigns the petition to one of the petition to one of
the eight special masters.eight special masters.
77 The assigned special master conducts a proceeding to evaluate whether the petition merits compensation under VICP and, if so, how much.78 The proceedings resemble trials in allowing the presentation of evidence and submission of testimony, but they operate under more flexible, informal procedures to allow for expeditious resolution.79 Once a petition is filed, the special master has 240 days to
70 Id. §§ 300a-11, 300aa-14. 71 Id. § 300a-11(c)(1)(C)(ii). 72 Id. § 300aa-11. 73 Id. § 300aa-11(c). 74 Id. § 300aa-16(a). 75 Id. 76 Id. § 300aa-16(b). 7781 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); §§ 300aa-12(c)(1), 300aa-12(d);
see also Vaccine Claims/Office of Special Masters, U.S. COURT OF FEDERAL , U.S. COURT OF FEDERAL
CLAIMS, https://www.uscfc.uscourts.gov/vaccine-programoffice-special-masters (last visited Nov. 24, 2021). CLAIMS, https://www.uscfc.uscourts.gov/vaccine-programoffice-special-masters (last visited Nov. 24, 2021).
78 42 U.S.C. § 300aa-12. 79 Id. § 300aa-12(d)(3)(B); Vaccine Rules, Appendix B, Rules of the United States Court of Federal Claims, U.S. COURT
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issue a82 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 decision that includes factual findings and legal conclusions, though the parties may
suspend the proceedings by motion for up to 150 days if necessary.suspend the proceedings by motion for up to 150 days if necessary.
80
Following the decision, the89
The petitioner has 30 days petitioner has 30 days
to appeal a special master’s decision to the Claims Court for review.81after 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 The court then has 120 days to uphold the decision, issue its own
decision, or remand to the special master for further proceedings.decision, or remand to the special master for further proceedings.
82 Once the court issues its judgment, either because the petitioner does91 If the parties do not appeal the special master’s decision within 30 not appeal the special master’s decision within 30
daysdays
, or when the Claims Court or the court issues a decision after review, issues a decision after review,
judgment is entered and the petitioner has 60 days to appeal the judgment the petitioner has 60 days to appeal the judgment
to the U.S. Court of Appeals for the Federal Circuit (Federal Circuit).to the U.S. Court of Appeals for the Federal Circuit (Federal Circuit).
83 If the petitioner chooses 92 If the parties choose not to appeal the decision, the judgment becomes final.not to appeal the decision, the judgment becomes final.
8493
After a final judgment, the petitioner has 90 days to
After a final judgment, the petitioner has 90 days to
inform the Claims Court whether the petitioner accepts the judgment or will file a separate civil action for damages.85accept 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 A petitioner may
also withdraw also withdraw
itsthe petition and file a civil action if the special master fails to act within 240 days or 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 the Claims Court fails to enter the judgment within 420 days, both time frames excluding any
suspended time.suspended time.
8697 (Petitioners may opt not to withdraw their petitions if they do not want to risk (Petitioners may opt not to withdraw their petitions if they do not want to risk
proceeding in civil court.87) Petitioners who neither rejected a judgment nor withdrew their petition due to the court’s failure to act in time are barred from filing civil claims.88proceeding in civil court.98)
In addition to limiting the availability of civil actions
In addition to limiting the availability of civil actions
against manufacturers to parties who have gone through the to parties who have gone through the
petitionVICP’s process, process,
VICPthe 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 imposes certain limitations on vaccine manufacturers’ liability.89 For example, vaccine manufacturers are not liable for injuries or deaths due to unavoidable side effects from properly prepared vaccines accompanied by proper directions and warnings.90 Any action that proceeds against a vaccine manufacturer is tried in three stages: (1) liability, (2) general damages, and (3) punitive damages.91 Trifurcating the trial in this manner limits the evidence presented to the jury in the first and second stages to the evidence relevant to each stage of the trial.
Available Compensation
VICP allows individuals to receive compensation for
actual and reasonably projectable unreimbursable expenses directly related to the
vaccine-related injury, including the cost of diagnosis, medical care, rehabilitation, counseling, and vocational training, among others;
OF FEDERAL CLAIMS, https://www.uscfc.uscourts.gov/sites/default/files/20.08.03%20FINAL%20Vaccine%20Rules.pdf OF FEDERAL CLAIMS, https://www.uscfc.uscourts.gov/sites/default/files/20.08.03%20FINAL%20Vaccine%20Rules.pdf
(last updated Aug. 3, 2020).(last updated Aug. 3, 2020).
80
89 42 U.S.C. § 300aa-12(d)(3). 42 U.S.C. § 300aa-12(d)(3).
81 Id. § 300aa-12(e)(1). 82 Id. § 300aa-12(e)(2). 83 Id. § 300aa-12(e)–(f). 84 Id. § 300aa-12(e)(3). 85 Id. § 300aa-21(a). 86 Id. § 300aa-21(b). 87 Id. 88 Id. § 300aa-11(a)(2)(A). 89 Id. § 300aa-22. 90 Id. § 300aa-22(b). 91 Id. § 300aa-23.
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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 anticipated loss of earnings;
actual and projected pain and suffering and emotional distress, capped at actual and projected pain and suffering and emotional distress, capped at
$250,000;
$250,000;
vaccine-related death, in the amount of $250,000the amount of $250,000
, in the case of a vaccine-related death; and ; and
reasonable attorneys’ fees and other costs associated with proceeding on the reasonable attorneys’ fees and other costs associated with proceeding on the
petition.
petition.
92102
The NCVIA authorized appropriations to compensate individuals injured by vaccines
The NCVIA authorized appropriations to compensate individuals injured by vaccines
administered before October 1, 1988.administered before October 1, 1988.
93103 Compensation for injuries Compensation for injuries
forrelated to vaccines administered after vaccines administered after
October 1, 1988, is paid out of the Vaccine Injury Compensation Trust Fund (Trust Fund).October 1, 1988, is paid out of the Vaccine Injury Compensation Trust Fund (Trust Fund).
94 104 Vaccine manufacturers pay into the Trust Fund through excise taxes imposed on covered Vaccine manufacturers pay into the Trust Fund through excise taxes imposed on covered
vaccines.vaccines.
95105 The Trust Fund may The Trust Fund may
only be used to pay be used to pay
only for vaccine-related injuries from vaccines for vaccine-related injuries from vaccines
subject to the excise tax at the time of payment, and for certain government administrative subject to the excise tax at the time of payment, and for certain government administrative
expenses incurred when administering the expenses incurred when administering the
program.96Program.106 Consequently, only vaccines subject to the Consequently, only vaccines subject to the
excise tax are included in VICP. excise tax are included in VICP.
Considerations for Congress
The future of the COVID-19 pandemic, the impact of SARS-CoV-2 variants (such as the Delta and Omicron variants), and the status of vaccines authorized to prevent COVID-19 remain uncertain. The Moderna and Johnson & Johnson COVID-19 vaccines are currently available only pursuant to emergency use authorizations, and certain uses of the Pfizer-BioNTech COVID-19 vaccine are also authorized only by emergency use authorization.97 The CDC has issued an interim recommendation that children aged 5 to 17 and people who are pregnant receive a COVID-19 vaccine, but it remains to be seen whether inoculations will continue to be recommended for these groups or the general population on a regular basis as the virus evolves.98 Accordingly, it is unknown whether COVID-19 vaccines will become routinely administered, and whether the CDC will recommend any such vaccine for routine administration to children or pregnant women.
If the CDC does recommend COVID-19 vaccines for routine administration to children or pregnant women, Congress may consider whether to add COVID-19 vaccines to the excise tax list, which would include them in VICP. Alternatively, Congress might consider a broader amendment to the excise tax statute to allow any vaccine recommended for routine administration to children or pregnant women to be automatically subject to the excise tax and therefore eligible 92 Id. § 300aa-15(a)–(e). 93 Id. § 300aa-15(j). 94 Id. § 300aa-15(i)(2); 26 U.S.C. § 9510. 95 26 U.S.C. §§ 4131–4132. 96 Id. § 9510(c). 97 Letter from Dr. Jacqueline A. O’Shaughnessy, Acting Chief Scientist, FDA, to Ruta Walawalkar, Janssen Biotech Inc., Nov. 19, 2021, https://www.fda.gov/media/146303/download; Letter from Dr. Jacqueline A. O’Shaughnessy, Acting Chief Scientist, FDA, to Michelle Olsen, ModernaTX, Inc., Nov. 19, 2021, https://www.fda.gov/media/144636/download; Letter from Dr. Jacqueline A. O’Shaughnessy, Acting Chief Scientist, FDA, to Amit Patel, Pfizer Inc., Nov. 19, 2021, https://www.fda.gov/media/150386/download.
98 COVID-19 Vaccines for Children and Teens, CDC, www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/children-teens.html (updated Nov. 23, 2021); COVID-19 Vaccines While Pregnant or Breastfeeding, CDC, www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/pregnancy.html (updated Nov. 19, 2021); COVID-19 ACIP Vaccine Recommendations, CDC, https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/covid-19.html (updated Nov. 5, 2021).
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for VICP. Or, if Congress decides that COVID-19 injuries should be compensated through VICP even while the public health emergency persists, Congress could amend the PREP Act and NCVIA accordingly.
Congress could also 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 implement an entirely new program specifically addressing compensation for
COVID-19 vaccine-related injuries or deathsCOVID-19 vaccine-related injuries or deaths
, should it so choose. Alternatively, Congress could . Alternatively, Congress could
opt to leave COVID-19 vaccines out of VICP and allow the traditional tort system to address any opt to leave COVID-19 vaccines out of VICP and allow the traditional tort system to address any
vaccine-related injuries after vaccine-related injuries after
the public health emergency ends and CICP no longer applies.
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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
Scope of Coverage
“Covered countermeasures” under the
“Covered countermeasures” under the
“Covered Vaccines” are those recommended
“Covered Vaccines” are those recommended
PREP Act, such as pandemic and
PREP Act, such as pandemic and
by CDC for routine administration to children
by CDC for routine administration to children
epidemic products used to treat,
epidemic products used to treat,
or pregnant women, subject to a federal excise
or pregnant women, subject to a federal excise
mitigate, prevent, or cure COVID-19
mitigate, prevent, or cure COVID-19
tax, and added to the Vaccine Injury Table
tax, and added to the Vaccine Injury Table
(e.g., vaccines, PPE, treatments)
(e.g., vaccines, PPE, treatments)
Covered Injuries
Covered Injuries
Death, or serious physical injury that
Death, or serious physical injury that
Death or an il ness, injury, or condition that
Death or an il ness, injury, or condition that
(1) warrants hospitalization or (2) leads
(1) warrants hospitalization or (2) leads
lasted more than six months or required
lasted more than six months or required
to a significant loss of function or
to a significant loss of function or
inpatient hospitalization and surgical
inpatient hospitalization and surgical
disability
disability
intervention and was associated with one or
intervention and was associated with one or
more vaccines in the Vaccine Injury Table more vaccines in the Vaccine Injury Table
(unless the cause was an adulterant or (unless the cause was an adulterant or
contaminant that was intentionally added to contaminant that was intentionally added to
the vaccine) the vaccine)
Process for
Process for
Administrative Process: file request form Judicial Process (“vaccine court”): file a petition
Administrative Process: file request form Judicial Process (“vaccine court”): file a petition
Obtaining
Obtaining
and supporting documentation with
and supporting documentation with
in the U.S. Court of Federal Claims
in the U.S. Court of Federal Claims
Compensation
Compensation
CICP to prove eligibility and
CICP to prove eligibility and
compensation amounts compensation amounts
Available Benefits
Available Benefits
Reasonable medical expenses, lost
Reasonable medical expenses, lost
Non-reimbursed expenses related to the injury
Non-reimbursed expenses related to the injury
employment income, and death benefits
employment income, and death benefits
for the diagnosis, medical care, and various
for the diagnosis, medical care, and various
rehabilitation and recovery services; lost rehabilitation and recovery services; lost
employment income; pain, suffering, and employment income; pain, suffering, and
emotional distress damages; death benefits; emotional distress damages; death benefits;
attorney’s fees attorney’s fees
Unavailable Benefits
Unavailable Benefits
Attorneys’ fees, pain-and-suffering
Attorneys’ fees, pain-and-suffering
Punitive or exemplary damages
Punitive or exemplary damages
damages, punitive damages
damages, punitive damages
Benefit Caps
Benefit Caps
$50,000/year for lost employment
$50,000/year for lost employment
$250,000 for death; $250,000 for pain and
$250,000 for death; $250,000 for pain and
income; lifetime cap for lost income
income; lifetime cap for lost income
suffering and emotional distress
suffering and emotional distress
(except for permanent disability); and
(except for permanent disability); and
standard death benefit of $389,825.45 standard death benefit of $389,825.45
for FY2022 for FY2022
Filing Deadlines
Filing Deadlines
Within one year of administration of
Within one year of administration of
For injuries, within three years of the
For injuries, within three years of the
firstonset of
covered countermeasure (or within one
covered countermeasure (or within one
the first symptom; for deaths, within two years symptom; for deaths, within two years
of the
year of the issuance of an amended
year of the issuance of an amended
of the death and four years of the death and four years of the
first symptomonset of the
Countermeasure Injury Table)
Countermeasure Injury Table)
first symptom
Standard of Proof Standard of Proof
Must show the injury (1) meets the
Must show the injury (1) meets the
Must show the
Must show the
injured person (1) received a person (1) received a
vaccine
requirements on a Countermeasure
requirements on a Countermeasure
vaccine on the Vaccine Injury Table; on the Vaccine Injury Table;
(2) sustained or
Injury Table; or (2) was a direct result of
Injury Table; or (2) was a direct result of
significantly aggravated an il ness, disability,(2) sustained or significantly aggravated an
the administration or use of a covered
the administration or use of a covered
il ness, disability, injury, or condition, or died; injury, or condition, or died;
countermeasure
(3) the il ness, (3) the il ness,
countermeasure
disability, injury, condition, or death is either disability, injury, condition, or death is either
listed in the Vaccine Injury Table in association listed in the Vaccine Injury Table in association
with the vaccine and occurred within a set with the vaccine and occurred within a set
time period as specified in the time period as specified in the
tableTable or was or was
caused by the vaccine; (4) suffered the effects caused by the vaccine; (4) suffered the effects
for more than six months or required inpatient for more than six months or required inpatient
hospitalization and surgery or died; and (5) has hospitalization and surgery or died; and (5) has
not previously col ected an award for the not previously col ected an award for the
injury or death 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
Initial
CICP (as delegate of the Secretary of
CICP (as delegate of the Secretary of
U.S. Court of Federal Claims special master
U.S. Court of Federal Claims special master
Decisionmaker
Decisionmaker
HHS)
HHS)
Appeals & Judicial
Appeals & Judicial
Claimant may seek reconsideration of
Claimant may seek reconsideration of
ClaimantParties may seek review of special master may seek review of special master
Review
Review
CICP decision to a qualified independent
CICP decision to a qualified independent
eligibility decision by U.S. Court of Federal decision by U.S. Court of Federal
Claims
panel within 60 days; no further judicial
panel within 60 days; no further judicial
Claims within 30 days of decision; within 30 days of decision;
claimant may seek parties may
or administrative review
or administrative review
seek review by the U.S. Court of Appeals for the review by the U.S. Court of Appeals for the
Federal Circuit within 60 days of final Federal Circuit within 60 days of final
judgment; claimant may accept the judgment judgment; claimant may accept the judgment
or reject itor reject it
and, in which case they could file a tort file a tort
claim against the manufacturer with certain limitations claim
Funding Source
Funding Source
Emergency appropriations to Covered
Emergency appropriations to Covered
Vaccine Injury Compensation Trust Fund
Vaccine Injury Compensation Trust Fund
Countermeasure Process Fund
Countermeasure Process Fund
based on excise tax of $0.75 per dose on
based on excise tax of $0.75 per dose on
“taxable vaccines” “taxable vaccines”
Number of Claims
Number of Claims
Non-COVID-19 claims (2010–
Non-COVID-19 claims (2010–
20212023): ):
24,441 petitions as of 10/1/2021, of which
24,441 petitions as of 10/1/2021, of which
Processed
Processed
491513 claims, of which claims, of which
45240 were were
20,300 have been adjudicated: 11,947 were
20,300 have been adjudicated: 11,947 were
determined
determined
ineligible and 29eligible and 30 compensated
determined ineligible and 8,353 compensated
determined ineligible and 8,353 compensated
compensated (6%) (6%)
(41%)
(41%)
COVID-19 countermeasure claims (as of
COVID-19 countermeasure claims (as of
October 1, 2021): 3,158March 1, 2023): 11,252 claims, of which claims, of which
1,357 claims (43%) relate to8,067 (72%) allege injuries from COVID-19 COVID-19
vaccines; most of these claims (99.9%) remain in or are 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 pending review
Process for Adding
Process for Adding
Scope of “covered countermeasures” is
Scope of “covered countermeasures” is
Secretary of HHS may add vaccines to the
Secretary of HHS may add vaccines to the
New Vaccines
New Vaccines
determined by Secretary of HHS’s PREP
determined by Secretary of HHS’s PREP
Vaccine Injury Table that are (1) subject to the
Vaccine Injury Table that are (1) subject to the
Act declarations (within statutory limits)
Act declarations (within statutory limits)
excise tax; and (2) recommended by the CDC
excise tax; and (2) recommended by the CDC
for routine administration to children or for routine administration to children or
pregnant women 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. 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 Kevin J. Hickey
Erin H. Ward
Erin H. Ward
Legislative Attorney
Legislative Attorney
Legislative Attorney
Legislative Attorney
Hannah-Alise Rogers
Legislative Attorney
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Compensation Programs for COVID-19 Vaccine Injuries
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