VACCINE INJURY 

COMPENSATION

Most Claims Took 

Multiple Years and 

Many Were Settled 

through Negotiation

Report to the Chairman, Committee on 

Oversight and Government Reform, 

House of Representatives

November 2014

GAO-15-142

United States Government Accountability Office
United States Government Accountability Office

Highlights of GAO-15-142, a report to the 

Chairman, Committee on Oversight and 

Government Reform, House of 

Representatives

November 2014

VACCINE INJURY COMPENSATION

Most Claims Took Multiple Years and Many Were 

Settled through Negotiation

Why GAO Did This Study

Vaccines save lives by preventing 

disease in the people who receive 

them. In some instances, however, a 

vaccine can have severe side effects, 

including death or an injury requiring 

lifetime medical care. VICP provides 

compensation to people for injuries 

and deaths associated with certain 

vaccines for medical and other costs. 

The program includes an injury table 

that lists the injuries that are presumed 

to be caused by vaccines covered by 

the program. The program may also 

compensate individuals for injuries not 

on the table; however, in those cases 

causation is not presumed. In both 

cases, medical and other records are 

required. VICP pays claims from a trust 

fund. Since the program began in 

1988, it has awarded more than 

$2.8 billion in compensation.

GAO was asked to review the 

program. GAO examined (1) how long 

it has taken to adjudicate claims and 

how claims have been adjudicated, 

(2) the changes to the vaccine injury 

table, and (3) how the balance of and 

spending from the Vaccine Injury 

Compensation Trust Fund have 

changed, among other objectives.

GAO examined data and interviewed 

officials from HHS, DOJ, and USCFC, 

including data on claims filed since 

fiscal year 1999 and their status as of 

March 31, 2014; reviewed laws and 

agency documents; and reviewed 

Treasury data and agency data on 

compensation and obligations for other 

VICP-related expenses for fiscal years 

2009 through 2013.

HHS and USCFC agreed with GAO’s 

findings, and HHS, USCFC, DOJ, and 

Treasury provided technical comments 

that were incorporated as appropriate.

What GAO Found

Most of more than 9,800 claims filed with the National Vaccine Injury 

Compensation Program (VICP) since fiscal year 1999 have taken multiple years 

to adjudicate (see fig.). More than 1,000 (11 percent) of claims filed since fiscal 

year 1999 were still in process (pending) as of March 31, 2014; most of these 

were pending for 2 years or less. A greater percentage of the claims filed since 

fiscal year 2009 were resolved within 1 or 2 years. In all but 1 year since fiscal 

year 2009, the program has met the target for the average time to adjudicate 

claims (about 3.5 years) tracked by the Department of Health and Human 

Services (HHS), which administers the program. Officials from the U.S. Court of 

Federal Claims (USCFC), where VICP claims are adjudicated, report that delays 

may occur while petitioners gather evidence for their claims. Since 2006, about

80 percent of compensated claims have been resolved through a negotiated 

settlement.

Time to Adjudicate National Vaccine Injury Compensation Program Claims Filed Fiscal Years 

1999-2014, as of March 31, 2014

Since fiscal year 1999, HHS has added six vaccines to the vaccine injury table, 

but it has not added covered injuries associated with these vaccines to the table. 

This means that while individuals may file VICP claims for these vaccines, each 

petitioner must demonstrate that the vaccine that was administered caused the 

alleged injury. HHS is considering adding covered injuries associated with these 

vaccines; but as of September 2014, it had not published any final rules to do so.

The balance of the Vaccine Injury Compensation Trust Fund, managed by the 

Department of the Treasury (Treasury) increased from $2.9 billion in fiscal year 

2009 to nearly $3.3 billion at the end of fiscal year 2013 as the trust fund’s 

income (from net revenues from vaccine excise taxes and interest on 

investments) outpaced its disbursements to HHS, USCFC, and the Department 

of Justice (DOJ), which represents HHS in VICP proceedings. VICP 

compensation, funded by the trust fund, increased from less than $126 million in 

each of fiscal years 1999 to 2009 to over $254 million in fiscal year 2013.

View GAO-15-142. For more information, 

contact Marcia Crosse at (202) 512-7114 or 

crossem@gao.gov.
Page i GAO-15-142 National Vaccine Injury Compensation Program

Letter 1 

Background 4

Most Claims Took Multiple Years to Adjudicate and Many Were 

Adjudicated by Settlement or Addressed by an Omnibus 

Proceeding 9

Vaccines Have Been Added to the Vaccine Injury Table since 

Fiscal Year 1999 without Covered Injuries, Resulting in More 

Off-Table Claims 16

Trust Fund Balance Has Increased since 2009, As Has Petitioner 

and Attorney Compensation and Other VICP-Related Spending 21

Information on VICP Petitioner Experience Is Limited; HHS Is 

Taking Steps to Address Criticism of Its Outreach Efforts 29

Concluding Observations 33

Agency Comments 34

Appendix I Vaccine Injury Table, September 2014 36

Appendix II Covered Vaccines and Injuries on the Vaccine Injury Table, 

Fiscal Years 1999-2014 38

Appendix III Compensation to Petitioners and Attorneys’ Fees and Costs, 

Fiscal Years 1999-2013 40

Appendix IV Comments from the Department of Health and Human Services 42

Appendix V Comments from the United States Court of Federal Claims 44

Appendix VI GAO Contact and Staff Acknowledgments 46

Contents
Page ii GAO-15-142 National Vaccine Injury Compensation Program

Tables

Table 1: Amounts Obligated by HRSA, DOJ, and USCFC for the 

National Vaccine Injury Compensation Program 

Administrative Expenses 28

Table 2: Compensation to Petitioners under the National Vaccine 

Injury Compensation Program, Fiscal Years 1999-2013 40

Table 3: Payments to Attorneys under the National Vaccine Injury 

Compensation Program, Fiscal Years 1999-2013 41

Figures

Figure 1: Time Taken to Adjudicate National Vaccine Injury 

Compensation Program Claims Filed Fiscal Years 1999-

2014, as of March 31, 2014 10

Figure 2: Status of National Vaccine Injury Compensation 

Program Claims Filed Fiscal Years 2009-2014, as of 

March 31, 2014 11

Figure 3: Number of National Vaccine Injury Compensation 

Program Claims Filed Alleging Autism, Fiscal Years 

1999-2014, as of March 31, 2014 16

Figure 4: Vaccine Injury Compensation Trust Fund Income, 

Disbursements, and Balance for Fiscal Years 2009–2013 23

Figure 5: Compensation to Petitioners under the National Vaccine 

Injury Compensation Program 25

Figure 6: Payments to Attorneys under the National Vaccine Injury 

Compensation Program 27
Page iii GAO-15-142 National Vaccine Injury Compensation Program

Abbreviations

DOJ Department of Justice

FTE full-time equivalent

HHS Department of Health and Human Services

HRSA Health Resources and Services Administration

Treasury Department of the Treasury

USCFC U.S. Court of Federal Claims

VICP National Vaccine Injury Compensation Program

This is a work of the U.S. government and is not subject to copyright protection in the 

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without further permission from GAO. However, because this work may contain 

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necessary if you wish to reproduce this material separately.
Page 1 GAO-15-142 National Vaccine Injury Compensation Program

441 G St. N.W.

Washington, DC 20548

November 21, 2014

The Honorable Darrell E. Issa

Chairman

Committee on Oversight and Government Reform

House of Representatives

Dear Mr. Chairman:

Vaccines save lives by preventing disease in the people who receive 

them. In some instances, however, a vaccine can have severe side 

effects, including death or an injury requiring lifetime medical care.1

To address this issue, Congress established the National Vaccine Injury 

Compensation Program (VICP), which is administered by the Department 

of Health and Human Services (HHS).

In the 

1980s, lawsuits stemming from such incidents threatened to affect the 

availability and cost of vaccines as well as the development of new ones.

2

 People who believe they or their 

child have been injured by vaccines covered by the program may file a 

petition making a claim with VICP for compensation for medical and other 

costs and for pain and suffering, as an alternative to civil court.3

 

1

In this report, we use the term injury to refer to an illness, disability, or similar condition.

The 

program uses a vaccine injury table that lists the injuries and conditions 

that are presumed to be caused by vaccines covered by the program and 

thus may entitle a petitioner to compensation. The program may also 

compensate petitioners for injuries or conditions that are not on the 

vaccine injury table; however, in those cases causation is not presumed 

and the petitioner must demonstrate that the vaccine caused the injury or 

condition. The program pays claims from the Vaccine Injury 

Compensation Trust Fund, a trust fund supported by an excise tax on 

each dose of a vaccine covered by the program; since the program 

2

VICP was established by the National Childhood Vaccine Injury Act of 1986. Pub. L. 

No. 99-660, title III, §§ 301 et seq., 100 Stat. 3743, 3755 (amending the Public Health 

Service Act by inserting a new title XXI; codified, as amended, at 42 U.S.C. 300aa-1 et 

seq.).

3

Petitions may also be filed for compensation for deaths from vaccines covered by the 

program.
 

Page 2 GAO-15-142 National Vaccine Injury Compensation Program

began in 1988, more than 15,000 claims had been filed and more than 

$2.8 billion has been awarded to petitioners.

In 1999, we reported that while the program appears to provide an easier 

process for obtaining compensation than through the civil court system, 

the claims process was not as quick or easy as expected.4

To address these questions, we used data and information from the 

federal agencies involved in administering the program and managing the 

Vaccine Injury Compensation Trust Fund, and from stakeholders. 

Specifically, to examine how long it has taken to adjudicate VICP claims 

we examined VICP data and interviewed officials from HHS’s Health 

Resources and Services Administration (HRSA), which administers VICP; 

the Department of Justice (DOJ), which represents HHS in VICP 

proceedings; and the U.S. Court of Federal Claims (USCFC) and the 

Office of Special Masters within USCFC that adjudicates, or decides, 

VICP claims.

Recently, 

concerns have been raised about the timeliness for adjudicating VICP 

claims and making changes to the vaccine injury table, how the funds in 

the Vaccine Injury Compensation Trust Fund have been spent, and 

petitioner experiences and awareness of the program. You asked that we 

examine these issues. Specifically, this report examines (1) how long it 

has taken to adjudicate VICP claims and how claims have been 

adjudicated, (2) the changes to the vaccine injury table and in the types of 

claims filed, (3) how the balance of and spending from the trust fund have 

changed, and (4) available information on petitioner experience with VICP 

and how HHS has informed the public of the availability of VICP.

5 We analyzed USCFC data to examine time frames for the 

adjudication of claims filed in fiscal years 1999-2014.6

 

4

GAO, Vaccine Injury Compensation Program Challenged to Settle Claims Quickly and 

Easily, 

To examine 

changes to the vaccine injury table and in the types of claims filed, we 

reviewed relevant laws, and other documents, including Federal Register 

notices, studies conducted for HHS by the Institute of Medicine, and 

HRSA’s proposals for revising the vaccine injury table since fiscal year 

GAO/HEHS-00-8 (Washington, D.C.: Dec. 22, 1999).

5

For the purposes of this report, we use the term claim to refer to the petition and case 

filed under VICP. We refer to the individuals filing the claims as petitioners. HRSA 

administers the program in conjunction with DOJ and USCFC.

6

We examined USCFC data showing when VICP petitions were filed and when each claim 

was adjudicated for petitions filed from fiscal year 1999 through March 31, 2014.
 

Page 3 GAO-15-142 National Vaccine Injury Compensation Program

1999, and interviewed officials from HRSA and members of its Advisory 

Commission on Childhood Vaccines.7 We also examined HRSA data on 

the numbers of claims filed, by vaccine, and USCFC data on the number 

of claims alleging injuries on the vaccine injury table. To examine the 

balance of and spending from the Vaccine Injury Compensation Trust 

Fund, we reviewed reports from the Department of the Treasury 

(Treasury), which manages the trust fund, to determine the income into 

and disbursements from the trust fund for fiscal years 2009-2013. We 

also analyzed HRSA data on the amounts the agency reported for

petitioner compensation and attorneys’ fees and costs, and data from 

HRSA, DOJ, and USCFC on the amounts they obligated for 

administrative and other expenses related to processing VICP claims for 

those fiscal years using appropriations from the trust fund.8 Finally, to 

examine available information on petitioner experience with VICP and 

how HHS has informed the public of the availability of VICP, we reviewed 

documents, including the Public Health Service Act, agencies’ 

congressional budget justifications, agency strategic plans, and studies 

prepared for HHS. We also reviewed statements and interviewed officials 

from HRSA, DOJ, and USCFC and stakeholders (from organizations 

representing providers, petitioners’ attorneys, and parents) regarding 

available information on petitioner experiences with VICP and steps HHS 

has taken to inform the public about the availability of the program.9

 

7

The Advisory Commission on Childhood Vaccines (ACCV) consists of nine members 

appointed by the Secretary of Health and Human Services and advises the Secretary on 

certain issues relating to VICP. See 42 U.S.C. § 300aa-19. Some individual members of 

the ACCV provided GAO with their personal views that do not necessarily reflect the 

official position of the ACCV, which is reflected in consensus recommendations made by 

the ACCV to the Secretary of HHS.

We 

determined that the data we used from HRSA, DOJ, and USCFC and 

from Treasury reports on the trust fund were sufficiently reliable for our 

purposes by discussing data collection processes and limitations of the 

data with agency officials, conducting electronic data checks, and 

comparing the data against other published sources.

8

The term obligation refers to a definite commitment by a federal agency that creates a 

legal liability to make payments immediately or in the future. We examined agency data on 

obligations for full-time equivalent (FTE) staff, and for other expenses.

9

The stakeholders we contacted included the National Vaccine Information Center, 

Vaccine Injured Petitioners’ Bar Association, American Academy of Family Physicians, 

and American Academy of Pediatrics. In addition, other individuals and organizations 

contacted GAO and provided comments, which we considered as we conducted our 

review.
 

Page 4 GAO-15-142 National Vaccine Injury Compensation Program

We conducted this performance audit from February 2014 to November 

2014 in accordance with generally accepted government auditing 

standards. Those standards require that we plan and perform the audit to 

obtain sufficient, appropriate evidence to provide a reasonable basis for 

our findings and conclusions based on our audit objectives. We believe 

that the evidence obtained provides a reasonable basis for our findings 

and conclusions based on our audit objectives.

In general, individuals seeking compensation for a vaccine-related injury 

or death must first file a petition making a claim for compensation under 

VICP before suing in civil court.10 Several federal agencies—HHS, DOJ, 

and USCFC, are involved in administering VICP, and Treasury manages 

the trust fund which funds compensation for successful claims.

VICP includes a vaccine injury table that lists the vaccines covered by the 

program and the injuries associated with each those vaccines. (See app. I 

for the table.) Vaccines are added to the list covered by the program after 

the Centers for Disease Control and Prevention recommends them for 

routine administration to children and they are made subject to an excise 

tax that funds the Vaccine Injury Compensation Trust Fund.11 When 

individuals submit a claim for an injury listed on the table (called an ontable injury), they do not need to prove that the injury was caused by the 

vaccine. Instead, if they submit documentation showing that they received 

a particular vaccine and that they sustained the associated covered injury 

within the time interval specified on the table, they may receive 

compensation based on a presumption of causation (unless there is 

evidence that the injury is due to other factors).12

 

10Petitioners must first file a VICP claim before suing in civil court unless the civil suit is for 

$1,000 or less. 42 U.S.C. § 300aa-11(a)(2)(A). 

Individuals seeking 

compensation may submit claims for injuries not listed on the table (called 

11The program may provide compensation for individuals who were injured or died after 

receiving the covered vaccines regardless of their age at the time of vaccination—that is, 

even though the vaccines are recommended for routine administration for children, adults 

who are vaccinated with a covered vaccine are also eligible for the program.

1242 U.S.C §§ 300aa-11(c)(1), 300aa-13(a)(1). A petitioner’s claim of an on-table injury 

must also meet the Qualifications and Aids for Interpretation that define the injuries listed 

on the vaccine injury table.

Background

Vaccines Covered by the 

Program and on the 

Vaccine Injury Table
 

Page 5 GAO-15-142 National Vaccine Injury Compensation Program

off-table injuries) but they need to demonstrate by the preponderance of 

the evidence that the vaccine caused the alleged injury.13

HHS has authority to promulgate rules to modify the vaccine injury table 

when certain criteria are met.14 HHS is also required to amend the table 

to include a vaccine within 2 years of the Centers for Disease Control and 

Prevention’s recommending it for routine administration to children.15 The 

Advisory Commission on Childhood Vaccines, which was established by 

the act creating the program, is required to make recommendations 

concerning changes to the table.

16 In 1999, GAO reported that HHS 

added seven injuries and removed three others from the table in 1995 

and 1997, respectively, using findings from Institute of Medicine reviews 

conducted in 1991 and 1994—in conjunction with public policy 

considerations provided by the Advisory Commission on Childhood 

Vaccines, scientific issues raised by HHS’s National Vaccine Advisory 

Committee, and input from the public.17

Individuals who believe they or their child have been injured by or a death 

resulted from a vaccine covered by the program may file a petition 

 

13The preponderance of evidence standard is generally interpreted to require that the 

party with the burden of persuasion—here, that party is the petitioner—must establish that 

a fact in question is more likely true than not. See 29 Am. Jur. 2d Evid. § 173. This 

standard is used for VICP claims in a manner similar to its use in civil court but without 

regard to fault.

14The agency must provide for notice and opportunity for a public hearing and at least 

180 days of public comment, as well as provide the Advisory Commission on Childhood 

Vaccines at least 90 days to provide recommendations and comment on proposed rules to 

modify the table.

1542 U.S.C. § 300aa-14(e). The effective date for a vaccine added to the vaccine injury 

table is the effective date of an excise tax on the vaccine. The Omnibus Budget 

Reconciliation Act of 1993. Pub. L. No. 103-66 § 13632 (a)(3), 107 Stat. 312, 646 (codified 

at 42 U.S.C. § 300aa-14 note). When a new vaccine or a new injury is added to the 

vaccine injury table, claims that do not meet the general filing deadlines must be filed 

within 2 years from the date the vaccine or injury is added to the table for injuries or 

deaths that occurred up to 8 years before the table change.

16Pub. L. No. 99-660, § 311(a), 100 Stat. 3771 (codified as amended at 42 U.S.C. 

§ 300aa-19).

17GAO/HEHS-00-8. 

VICP Claims Process
 

Page 6 GAO-15-142 National Vaccine Injury Compensation Program

making a claim with the USCFC.18 In general, to be eligible for 

compensation, a petition must be filed (1) for a vaccine-related injury 

within 3 years of the first symptom of the injury (or significant aggravation 

of an injury), or (2) for a death within 2 years of the death and within 

4 years after the first symptom of the vaccine-related injury (or 

signification aggravation of an injury) from which the death resulted.19

HHS, as the respondent in the process, receives a copy of the petition, 

including medical records, and other documentation filed with the 

USCFC. HRSA sends a report of its medical review including HHS’s 

recommendation regarding the claim to DOJ. DOJ lawyers, representing 

HHS in the proceedings, review the HRSA report and the legal aspects of 

the claim and produce a report that outlines the government’s position as 

to why compensation should or should not be awarded, provides a 

summary and medical analysis of the petitioner’s claims, and asserts 

applicable legal arguments.

After the claim is filed in USCFC, it is assigned to a special master, a 

judicial officer who examines the evidence and adjudicates the claim.20

The special master reviews the petition and may order the petitioner to 

provide additional records if they are missing or if they are insufficient.21

 

18Individuals eligible to file a VICP claim include the person who sustained the vaccinerelated injury or that person’s legal representative if that person is a child, disabled, or 

deceased. 42 U.S.C. § 300aa-11(b)(1)(A). 

Additionally, petitioners and DOJ may file expert reports including 

additional medical evidence from scientific literature or studies. The 

19See 42 U.S.C. § 300aa-16.

20The Office of Special Masters is an office within the USCFC, part of the judiciary, 

comprising up to eight court-appointed special masters who develop expertise in vaccineinjury claims. According to the Office of Special Masters, most claims are assigned to 

special masters on a random basis, but to the extent that a special master has acquired 

expertise in a specific injury or vaccine, claims may be directed to a particular special 

master.

21A special master may suspend activity on a claim while waiting for additional 

documentation.
 

Page 7 GAO-15-142 National Vaccine Injury Compensation Program

special master then determines whether a claim should be 

compensated.22

For claims that are compensated, there are three adjudication categories:

• Concession. In a concession, HHS’s review of medical records, 

scientific literature, and other documents finds that the petitioner is 

entitled to compensation, because the evidence meets the criteria of 

the vaccine injury table or because it is more likely than not that the 

vaccine caused the injury.

• Negotiated settlement. In a negotiated settlement, the petition is 

resolved via negotiation between HHS (represented by DOJ) and the 

petitioner.23

• Contested decision in favor of the petitioner. If HHS does not 

concede that a petition should be compensated or if both parties do 

not agree to settle, the special master issues a decision after weighing 

the evidence presented by both sides, which may involve conducting 

a hearing.24

If the petitioner is entitled to compensation as a result of a concession or 

contested decision in favor of the petitioner, the proceeding then moves 

to the damages phase, in which the amount of compensation is 

determined.25

 

22Even when HHS concedes a case or a case is settled, the USCFC issues a decision 

and judgment awarding compensation. A claim is not compensated if the court determines 

the petitioner is not entitled to compensation or in certain other circumstances, such as

where the petitioner elects not to receive compensation or withdraws the petition.

In a negotiated settlement, the amount of compensation is 

23According to HRSA, such a settlement is not an admission by HHS that the vaccine 

caused the petitioner’s alleged injuries, and in settlements, the court does not determine 

that the vaccine caused the injury. See Health Resources and Services Administration, 

Statistics Report-August 1, 2014, 

http://www.hrsa.gov/vaccinecompensation/statisticsreport.pdf, p. 9, accessed Sept. 8, 

2014. Once a settlement is reached, it must be formally approved by the decision of the 

special master, provided the special master determines it is reasonable.

24If the special master rules that a petitioner is not entitled to compensation, the petitioner 

may request to have the decision reviewed by a judge of the USCFC who may issue a 

decision in favor of the petitioner. HHS may appeal the decision of the special master if 

the petitioner is awarded compensation.

25Damages may be agreed to by the parties, or the special master may hold another 

hearing or rule upon the record without conducting a hearing.
 

Page 8 GAO-15-142 National Vaccine Injury Compensation Program

included in the settlement presented to the special master. VICP may 

also pay for attorneys’ fees and costs deemed reasonable even for 

unsuccessful petitioners, and the amounts of these fees and costs may 

be part of a settlement between the parties or determined by the special 

masters.26 After the claim has been adjudicated within VICP, the 

petitioner may choose to file a suit in civil court. Even if found to be 

entitled to compensation, the petitioner may elect to reject the 

compensation awarded and file a suit in civil court.27

The Vaccine Injury Compensation Trust Fund, managed by Treasury, is 

funded by an excise tax imposed on each dose of vaccine sold in the 

United States that is routinely recommended for administration to 

children.28 Appropriations from the trust fund to HRSA pay compensation 

awarded under VICP for vaccine-related injury or death to the petitioner 

and may also pay for petitioner attorneys’ fees and costs. Appropriations 

from the trust fund to HRSA, DOJ, and USCFC (for the Office of Special 

Masters) also pay for administrative and other expenses associated with 

processing VICP claims.29

USCFC has managed large influxes of similar vaccine injury claims 

through omnibus proceedings or groupings of claims. According to the 

Office of Special Masters, many of the claims alleging that a particular 

vaccine caused the same injury will rely on similar evidence, so by using 

omnibus proceedings or groupings to examine evidence for similar 

claims, the courts can more efficiently review the evidence.30

 

26Attorney fees and costs may be paid if the court determines there is a reasonable basis 

for the petition and the petition was filed in good faith. These payments generally reflect 

the actual time and expense devoted to the case.

In omnibus 

27See 42 U.S.C. § 300aa-21(a). 

28The Vaccine Injury Compensation Trust Fund is funded by a $0.75 excise tax on each 

dose of vaccine recommended by HHS’s Centers for Disease Control and Prevention for 

routine administration to children. The excise tax is imposed on each disease that is 

prevented in a vaccine. Influenza vaccine, for example, is taxed $0.75 because it prevents 

one disease; measles-mumps-rubella vaccine, which prevents three diseases, is taxed 

$2.25. The trust fund receives net revenues from the excise tax, plus interest on 

investments in government securities.

29Within USCFC, only the Office of Special Masters receives appropriations from the trust 

fund.

30The Chief Special Master is responsible to provide for the efficient, expeditious, and 

effective handling of petitions under VICP. 41 U.S.C. § 300aa-12(c)(6). 
 

Page 9 GAO-15-142 National Vaccine Injury Compensation Program

proceedings, petitioners select a lead claim in each category of injury, 

and develop these lead claims while the remaining petitioners choosing to 

participate in the omnibus elect for their remaining claims to be stayed, or 

put on hold, until the lead claim reaches a final disposition.

HHS is required to include a statement of the availability of VICP in the 

vaccine information materials that health care providers are to distribute 

to the parent or legal representatives of a child or to any other individual 

to whom the provider intends to administer a covered vaccine.31 These 

materials—referred to as vaccine information statements by HHS—are 

intended to explain both the benefits and risks of a vaccine covered by 

VICP. HHS is also required to undertake reasonable efforts to inform the 

public of the availability of the program.32

Most of the VICP claims filed since fiscal year 1999 have taken multiple 

years to adjudicate, but those filed since fiscal year 2009 have taken less 

time. For many claims, the parties have concluded the proceeding 

through a negotiated settlement, rather than a contested decision 

adjudicated by a special master or the courts. Additionally, certain claims 

were addressed along with similar claims as part of an omnibus 

proceeding or informal grouping.

VICP claims filed since fiscal year 1999 took an average of about 5 and a 

half years to adjudicate, according to USCFC data for the nearly 8,800 

claims filed since fiscal year 1999 that were adjudicated as of March 31, 

2014.33

 

31See 42 U.S.C. § 300aa-26.

There was wide variation in the amount of time to adjudicate 

these claims. The claim that took the shortest time to adjudicate was filed 

in fiscal year 1999 and took 2 days, and the claim that took the longest 

time to adjudicate was filed in fiscal year 1999 and took 5,276 days (more 

3242 U.S.C. § 300aa-10(c). 

33USCFC data on processing times for claims runs from the time the petition was filed 

until judgment was entered.

Requirements for 

Disseminating Information 

on the Program

Most Claims Took 

Multiple Years to 

Adjudicate and Many 

Were Adjudicated by 

Settlement or 

Addressed by an 

Omnibus Proceeding

Most Claims Filed Since 

Fiscal Year 1999 Have 

Taken Multiple Years to 

Adjudicate
 

Page 10 GAO-15-142 National Vaccine Injury Compensation Program

than 14 years). More than 1,000 (11 percent) of the claims filed since 

fiscal year 1999 were still in process (pending) as of March 31, 2014; 

most of these had been pending for 2 years or less (see fig. 1.)

Figure 1: Time Taken to Adjudicate National Vaccine Injury Compensation Program 

Claims Filed Fiscal Years 1999-2014, as of March 31, 2014

Note: This figure shows the time (as of March 31, 2014) to adjudicate claims for which petitions were 

filed in fiscal year 1999 through March 31, 2014, based on data from the U.S. Court of Federal 

Claims. Figures do not sum to 100 due to rounding.

For claims filed since fiscal year 2009, a greater percentage of claims 

were resolved within 1 or 2 years. One possible reason is that the vast 

majority of claims alleging autism as the injury were filed prior to fiscal 

year 2009. Autism claims may have taken longer because they were part 

of an omnibus proceeding, which suspended activity on most autism 

claims for a period of time. According to USCFC data, for the more than 

1,400 claims filed since fiscal year 2009 that were adjudicated as of 

March 31, 2014, the average amount of time to adjudicate a claim was 

587 days (about 1.6 years). More than 900 (40 percent) of the claims filed 
 

Page 11 GAO-15-142 National Vaccine Injury Compensation Program

since fiscal year 1999 were still pending, which could cause this average 

to increase over time as these pending claims are resolved (see fig. 2).34

Figure 2: Status of National Vaccine Injury Compensation Program Claims Filed 

Fiscal Years 2009-2014, as of March 31, 2014

Of the pending claims, nearly half had been pending for 1 year or less as 

of March 31, 2014.

Note: This figure shows the status (as of March 31, 2014) of nearly 2,400 claims for which petitions 

were filed in fiscal year 2009 through March 31, 2014, based on data from the U.S. Court of Federal 

Claims.

HHS has reported the program has met its annual target of 1,300 days 

(about 3.5 years) for the average time to adjudicate non-autism claims in 

all but 1 year since fiscal year 2009. This target (1,300 days) has been in 

 

34Of the claims filed since fiscal year 2009 that were adjudicated as of March 31, 2014, 

the claim that took the shortest time to adjudicate took 3 days, and the claim that took the 

longest time to adjudicate took 1,981 days (nearly 5 and a half years).
 

Page 12 GAO-15-142 National Vaccine Injury Compensation Program

place since fiscal year 2009, and applies to claims concluded in a given 

fiscal year, regardless of the year they were filed, excluding claims that 

alleged autism as the vaccine-related injury.35

Organizations representing petitioners have criticized the program for 

taking a long time to resolve claims. Petitioners report that long 

processing times delay receiving compensation to pay medical bills and 

other expenses related to the alleged injury. A HRSA-contracted survey 

of petitioners whose claims were adjudicated (regardless of whether or 

not they received compensation under VICP), found that nearly two-thirds 

of the 103 respondents indicated they were somewhat or very dissatisfied 

with the length of the process.

HRSA has reported 

meeting this goal since fiscal year 2009, except in fiscal year 2012, when 

VICP claims concluded that year took an average of 1,309 days to 

complete.

36 Petitioners may withdraw if a VICP 

decision is not made on their claim within specific time periods but 

according to the Office of Special Masters, petitioners rarely exercise this 

option.37

Officials cite certain delays within the process as factors that can increase 

average claims processing times. Officials at USCFC and DOJ told us 

 

35Performance measures, including a measure for average claims processing time, were 

developed for VICP during the Program Assessment Rating Tool review conducted by the 

Office of Management and Budget for the fiscal year 2007 budget. HHS reports the 

targets and tracks the program’s performance for average claims processing time in 

HRSA’s annual congressional budget justifications.

36Altarum Institute, Determining the Feasibility of Evaluating the National Vaccine Injury 

Compensation Program, Final Report, a report prepared for the Health Resources and 

Services Administration, June 15, 2009. Of 716 petitioners the researchers identified as 

meeting their inclusion criteria,107 responded to their survey and 103 responded to this 

question on the length of the process. The results of this study cannot be generalized to 

the population of all petitioners who completed the VICP process; instead, they reflect only 

the VICP petitioners who responded to the survey. According to HRSA, petitioners were 

included in the sample if they (1) had filed a claim that had been compensated or 

dismissed in fiscal years 2004-2008 and (2) were represented by an attorney.

37If a special master fails to make a decision on a petition within 240 days (excluding any 

period of suspension), or if USCFC fails to enter a judgment on a petition within 420 days 

after the date on which the petition was filed (excluding any period of suspension), 

petitioners can withdraw their claim from VICP. 42 U.S.C. § 300aa-12(g). While USCFC 

officials report that most claims exceed both the 240-day and the 420-day limits when 

periods of suspension are not excluded, USCFC does not track suspensions so available 

data do not show how much time a case was suspended and how many cases met the 

statutory time frames.
 

Page 13 GAO-15-142 National Vaccine Injury Compensation Program

that the time petitioners spend gathering supporting documentation or 

evidence can add significantly to the amount of time required to process a 

claim. These delays may occur at multiple points in the claims process, 

from petitioners needing to gather sufficient documentation for the court 

to begin an initial review, to the court needing documentation to 

determine the amount of compensation that a successful petitioner will 

receive.38 According to HRSA, for claims adjudicated as of March 31, 

2014, its medical review process averaged over 700 days for claims filed 

in fiscal year 2010. HRSA attributes the length of time for medical review 

primarily to time spent waiting for petitioners to submit requested 

documentation. During the medical review, HRSA may also consult with 

external experts, who require additional time to review the details of the 

case; HRSA’s data indicate that over 1,200 outside reviews were 

conducted from fiscal years 2009 to 2014. Additionally, when special 

masters are reviewing the claim, a party may request that the special 

master delay a decision until additional documentation is available.39

Special masters may also request additional information from 

petitioners—such as a specialist physician’s opinion.

According to HRSA data for claims filed since 2006, most compensated 

claims were adjudicated through negotiated settlement rather than a 

concession or a contested decision. HRSA’s data indicated that about 

80 percent of the more than 1,500 non-autism VICP claims filed since 

2006 for which compensation was awarded were adjudicated through a 

negotiated settlement between the parties, compared to about 10 percent 

involving a contested decision in favor of the petitioner and about 

10 percent conceded by HHS.40

 

38Petitioners are required by statute to submit their supporting documentation or evidence 

at the time they file their petition. See 42 U.S.C. § 300aa-11(c)(2). According to DOJ, 

petitions are frequently filed without documentation, which delays adjudication.

According to HRSA, claims which HHS 

does not concede may be resolved via a negotiated settlement for several 

reasons, including a desire by both parties to resolve a case quickly and 

efficiently. According to the Office of Special Masters, a special master 

39Special masters report allowing these delays in order to accumulate sufficient evidence 

to adjudicate a claim, but they could not provide a precise number.

40See Health Resources and Services Administration, Statistics Report-October 2, 2014, 

http://www.hrsa.gov/vaccinecompensation/statisticsreport.pdf, accessed October 8, 2014.

Many Claims Were 

Adjudicated through 

Settlement or Grouped in 

an Omnibus Autism 

Proceeding
 

Page 14 GAO-15-142 National Vaccine Injury Compensation Program

may recommend parties settle as an expeditious and efficient method of 

resolving certain claims.

The Office of Special Masters created an omnibus proceeding in order to 

address thousands of autism cases systematically and efficiently.41

Beginning in 1999, parents began filing petitions for compensation under 

VICP alleging that autism or neurodevelopmental disorders similar to 

autism were caused by the measles-mumps-rubella vaccine or vaccines 

containing thimerosal, a mercury-containing preservative used in some 

vaccines, covered by the program, or both. In 2002, the Office of Special 

Masters held a series of meetings with an informal advisory committee, 

including attorneys who represented many potential petitioners and legal 

and medical representatives of HHS, to address the task of dealing with 

these claims. The Office of Special Masters decided to utilize a two-step 

procedure: first, looking into whether the vaccinations in question can 

cause autism and, if so, the circumstances under which this occurs, and 

second, applying the conclusions from the first step to the individual 

claims. The omnibus autism proceeding included test cases for two 

different theories by which vaccines were alleged to cause autism.42

Some petitioners withdrew from the omnibus proceeding and elected to 

proceed within the vaccine program on other theories of causation. Some 

petitioners withdrew from the program entirely, as was their statutory 

right, which enabled them to pursue claims against vaccine 

manufacturers in civil court.43

 

41The omnibus autism proceeding was the largest of several instances in which the courts 

addressed groupings of similar claims. Since 1999, the USCFC has grouped similar 

claims to manage hepatitis B vaccine injury claims, claims alleging an injury of type 1 

diabetes, and claims that certain childhood vaccinations have caused or contributed to 

autism. According to the Office of Special Masters, the omnibus autism proceeding was 

the largest of these groupings, involving over 5,000 claims, with the hepatitis B grouping 

involving several hundred and the type 1 diabetes grouping involving fewer than 50 

claims.

42According to the Office of Special Masters, petitioners withdrew a third theory of 

causation.

43See 42 U.S.C. § 300aa-21(b). By filing a “Short-Form Autism Petition for Vaccine 

Compensation,” a petitioner could elect to be part of the Omnibus Autism Proceeding and 

simultaneously choose to stay his or her case-specific proceeding on his own petition until 

the conclusion of the Omnibus Autism Proceeding. See Office of Special Masters, Autism 

General Order #1, July 3, 2002 

(http://www.uscfc.uscourts.gov/sites/default/files/autism/Autism+General+Order1.pdf), 

accessed October 14, 2014.
 

Page 15 GAO-15-142 National Vaccine Injury Compensation Program

The influx of new VICP claims for autism continued in fiscal years 2002-

2005, while the number of new non-autism claims remained relatively 

stable (see fig. 3). HRSA data show that during this period, nearly 

90 percent of VICP claims filed alleged autism as the vaccine-related 

injury. Ultimately, the special masters did not award compensation in any 

of the test cases,44 and most remaining omnibus autism proceeding 

claims were dismissed. However, according to the Office of Special 

Masters, some petitioners who had been part of the omnibus autism 

proceeding continued with claims separate from the omnibus 

proceeding.45

 

44See In Re: Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a 

Similar Neurodevelopmental Disorder, Fed. Cl. Spec. Mstr. Update, p. 3, Jan. 12, 2011 

(indicating that proceedings in all test cases had concluded and that decisions in all such 

cases rejected petitioners’ theories of causation).

45According to the Office of Special Masters, these petitioners proceeded on other 

theories of causation.
 

Page 16 GAO-15-142 National Vaccine Injury Compensation Program

Figure 3: Number of National Vaccine Injury Compensation Program Claims Filed Alleging Autism, Fiscal Years 1999-2014, as 

of March 31, 2014

Note: Data for fiscal year 2014 are as of March 31, 2014.

HHS has added vaccines to the vaccine injury table without adding 

covered injuries associated with those vaccines. Following their addition 

to the table, more claims were filed for off-table injuries.

Vaccines Have Been 

Added to the Vaccine 

Injury Table since 

Fiscal Year 1999 

without Covered 

Injuries, Resulting in 

More Off-Table 

Claims
 

Page 17 GAO-15-142 National Vaccine Injury Compensation Program

Since fiscal year 1999, HHS has added six vaccines to the vaccine injury 

table (but has not added covered injuries associated with these vaccines 

to the table).46 This means that while individuals may file VICP claims for 

those vaccines, each petitioner must demonstrate that the vaccine that 

was administered caused the alleged injury. In general, each of the six 

vaccines was added within 2 years of the Centers for Disease Control 

and Prevention’s recommending it for routine administration to children 

and having an excise tax imposed.47 Since 1999, two vaccines, both of 

which had covered injuries associated with them, were removed from the 

vaccine injury table.48 See appendix II for the vaccines and injuries added 

and removed from the vaccine injury table since 1999. At the end of the 

fiscal year 2014, 16 vaccines were covered by the program, 8 of which 

did not have associated covered injuries on the table.49

HHS has been considering adding injuries to the table in association with

the eight vaccines that are listed without covered injuries.50

• In July 2013, HRSA published a proposed rule to add intussusception 

(obstruction of the bowels) as an injury associated with the rotavirus 

Specifically, 

HRSA officials said they are working on a final rule to add an injury 

associated with one vaccine and a proposed rule that would add injuries 

associated with several other vaccines. 

 

46Although the rhesus-based rotavirus vaccine was added to the table with an associated 

injury in 2002, it was removed in 2008. See 67 Fed. Reg. 48558 (Jul. 25, 2002) (addition 

to table); 73 Fed. Reg. 59528 (Oct. 9, 2008) (removal from table). 

47In October 1999, the Centers for Disease Control and Prevention recommended the 

hepatitis A vaccine be administered to children in states, counties, and communities with 

rates of hepatitis A that were twice the 1987-1997 national average or greater. However, 

the hepatitis A vaccine was not covered by VICP until 2004, when the American Jobs 

Creation Act of 2004 imposed an excise tax for all hepatitis A vaccines. Pub. L. No. 108-

357, § 889(a), 118 Stat. 1418, 1643 (codified at 26 U.S.C. § 4132(a)(I)).

48In addition to the rhesus-based rotavirus vaccine, which was removed in 2008, 

unconjugated Hemophilus influenza type b (Hib) polysaccharide vaccine was removed 

from the vaccine injury table in 2002. See 67 Fed. Reg. 48558 (Jul. 25, 2002).

49There were two vaccines on the table prior to fiscal year 1999 that had no covered 

injuries listed: Hemophilus influenza type b (Hib) vaccine (which prevents meningitis and 

other serious infections) and varicella vaccine (which prevents chicken pox).

50HHS has also been considering adding injuries in association to covered vaccines that 

already have associated injuries on the vaccine injury table.

Six Vaccines Have Been 

Added to the Vaccine 

Injury Table since Fiscal 

Year 1999 without 

Covered Injuries; HHS Is 

Considering Additional 

Changes
 

Page 18 GAO-15-142 National Vaccine Injury Compensation Program

vaccine.51

• HRSA officials said they are developing a proposed rule to add 

covered injuries for all seven of the remaining vaccines on the table 

without covered injuries. For example, HRSA is considering proposing 

to add Guillain-Barré Syndrome (a disorder in which the body’s 

immune system attacks part of the nervous system and is 

characterized by muscle weakness and paralysis), as an injury 

associated with the influenza vaccine. The agency is also considering 

proposing to add other injuries associated with the influenza, 

hemophilus influenza type b conjugate, varicella, pneumococcal 

conjugate, hepatitis A, meningococcal, and human papillomavirus 

vaccines.

In proposing the addition, HRSA considered reviews and 

injury claims attributed to another vaccine that protected against 

rotavirus but had been removed from the table in fiscal year 2009. 

According to HRSA, the agency is working on a final rule to add this 

injury.

 

5178 Fed. Reg. 44512 (Jul. 24, 2013) (to be codified at 42 U.S.C. § 100.3).
 

Page 19 GAO-15-142 National Vaccine Injury Compensation Program

According to HRSA officials, the factors informing the table changes that 

they are considering proposing include (1) an Institute of Medicine study 

of certain vaccines;52 (2) HHS’s independent review of vaccine causation 

and medical and scientific evidence; (3) the need to clarify injury 

definitions on the table53

As of September 30, 2014, HRSA had not promulgated regulations to 

make these changes to the vaccine injury table. According to HRSA 

officials, the agency plans

; and (4) recent studies related to injuries 

associated with the influenza vaccine.

• to publish the final rule to add the injury associated with the rotavirus 

vaccine to the table by July 2015,54

• to publish a proposed rule for the other injuries it is considering adding 

to the table by August 2015.

and

According to HRSA officials, the process to publish such a proposed rule 

can take about 9 months to 1.5 years. The officials also said that the 

process for publishing such a final rule can take about 1.5 years to 

2.5 years after the proposed rule is published. In its justification 

accompanying its fiscal year 2013 budget request, HRSA acknowledged 

that many stakeholders, including Congress, have voiced interest and 

concern over keeping the injury table in line with current science. At that 

time, HRSA reported that other VICP activities, including medical reviews 

and court deadlines, have taken priority over updating the table.55

 

52In 2009, HHS commissioned the Institute of Medicine to review specific injuries in 

association with vaccines that are currently on the table. These vaccines include varicella; 

influenza, hepatitis B; human papillomavirus; measles, mumps, and rubella; hepatitis A; 

meningococcal; and vaccines containing tetanus. See Institute of Medicine, Adverse 

Effects of Vaccines: Evidence and Causality (Washington, D.C.: The National Academies 

Press: 2012). 

53HRSA officials said they are also considering changes in the language defining injuries 

on the table.

54Public hearings on the proposed rule for adding intussusception as a covered injury 

associated with the rotavirus vaccine took place on January 13, 2014, and April 28, 2014.

55Health Resources and Services Administration, Justification of Estimates to 

Appropriations Committees, Fiscal Year 2013, accessed November 4, 2014

http://www.hrsa.gov/about/budget/budgetjustification2013.pdf. 
 

Page 20 GAO-15-142 National Vaccine Injury Compensation Program

While the injuries HRSA is considering have not yet been added to the 

table, HRSA and DOJ officials report that many claims alleging these 

injuries that HRSA is considering adding to the table have been conceded 

or settled. For example, according to DOJ officials, there have been 

numerous settlements for cases alleging Guillain-Barré Syndrome as an 

injury associated with the influenza vaccine.

The addition of the six vaccines to the vaccine injury table without 

associated injuries has contributed to an increase in off-table claims. 

When we reported on this program in 1999, 2 of the 12 vaccines on the 

injury table were without associated injuries listed on the table. We 

reported that about one-quarter (28 percent) of claims filed as of February 

1999 were for off-table injuries.56 In contrast, of the 3,007 claims filed 

since fiscal year 2005 (the year that trivalent influenza vaccine was added 

to the table) for which the covered vaccine associated with the alleged 

injury was specified, at least 59 percent were associated with one of five 

vaccines added to the table without associated table injuries, according to 

HRSA data.57

Claims alleging injuries to adults also increased as a result of the addition 

of vaccines that are recommended for administration in adults (as well as 

children) to the vaccine injury table. Several of the vaccines added to the 

injury table—in particular, the vaccine to prevent influenza—are 

To receive compensation, the petitioners in these claims 

would not have the presumption of causation associated with an on-table 

claim. Overall, since 2009, more than 98 percent of the new claims filed 

alleged off-table injuries that required the petitioner to prove their injury 

was caused by the vaccine they received, according to the Office of 

Special Masters.

 

56GAO/HEHS-00-8. 

57The five vaccines included hepatitis A, human pappilomavirus, influenza, 

meningococcal, and pneumococcal conjugate vaccines. According to HRSA data, 1,245 

claims filed since fiscal year 2005, including claims filed as part of the Omnibus Autism 

Proceeding, did not specify a vaccine and 30 claims specified a nonqualified vaccine—

that is, a vaccine not covered under VICP.

Changes in the Vaccine 

Injury Table Contributed to 

More Claims for Off-Table 

Injuries and for Injuries in 

Adults
 

Page 21 GAO-15-142 National Vaccine Injury Compensation Program

recommended for routine administration to adults as well as children.58 As 

a result, although the vaccines were added to the table because they 

were recommended for children, adults who are vaccinated with them are 

also eligible for compensation under VICP. More than half (51 percent) of 

the 4,402 VICP claims filed since fiscal year 1999 (for which the covered 

vaccine associated with the alleged injury was specified) were for injuries 

to adults and 1,287 (29 percent) were for adults alleging injuries in 

association with influenza vaccine, according to HRSA data.59

The Vaccine Injury Compensation Trust Fund balance increased to more 

than $3 billion in fiscal year 2013 despite increased spending by HRSA, 

DOJ, and USCFC on petitioner compensation, attorneys’ fees and costs, 

and other VICP-related expenses.

 

58Vaccines generally recommended for adults (as well as children) and currently covered 

by VICP include vaccines to protect against influenza, tetanus, diphtheria, pertussis, 

varicella, human papillomavirus, pneumococcal disease (pneumococcal conjugate 

vaccine), measles, mumps, and rubella. See 

http://www.cdc.gov/vaccines/schedules/downloads/adult/adult-schedule-easy-read-bw.pdf, 

accessed Oct. 9, 2014.

59According to HRSA data, 5,377 claims filed since fiscal year 1999 (as of March 31, 

2014) did not specify which covered vaccine caused an alleged injury and 57 claims 

specified a vaccine not covered by the program. 

Trust Fund Balance 

Has Increased since 

2009, As Has 

Petitioner and 

Attorney 

Compensation and 

Other VICP-Related 

Spending
 

Page 22 GAO-15-142 National Vaccine Injury Compensation Program

The balance in the trust fund increased from $2.9 billion at the end of 

fiscal year 2009 to nearly $3.3 billion at the end of fiscal year 2013.60 The 

balance increased because the trust fund’s income outpaced its 

disbursements to HRSA, DOJ, and USCFC, although disbursements 

also increased during this period (see fig. 4).61 Treasury reported over 

$200 million in net revenues from the vaccine excise tax in each of fiscal 

years 2009-2013. As required by applicable law pertaining to the 

management of trust funds, Treasury oversees the investment of part of 

the net revenue from vaccine excise taxes.62

 

60In this report, investments in U.S. securities issued by the Bureau of Fiscal Service and 

the fund balance with Treasury comprise the balance of the trust fund at the end of the 

fiscal year.

Interest from these 

investments ranged from about $49 million in fiscal year 2012 to about 

$126 million in fiscal year 2011.

61Net revenue from vaccine excise taxes and interest on investments comprise income for 

the trust fund. Disbursements to HRSA—for compensation to petitioners, attorneys’ fees 

and costs, and administrative expenses, and to DOJ and the USCFC for the Office of 

Special Masters—for expenses associated with processing National Vaccine Injury 

Compensation Program (VICP) claims, comprise disbursements from the trust fund.

62See 26 U.S.C. § 9602.

From Fiscal Year 2009 to 

2013 the Trust Fund 

Balance Gradually 

Increased to More than 

$3 Billion
 

Page 23 GAO-15-142 National Vaccine Injury Compensation Program

Figure 4: Vaccine Injury Compensation Trust Fund Income, Disbursements, and 

Balance for Fiscal Years 2009–2013

Note: This figure presents the Vaccine Injury Compensation Trust Fund balance (in terms of 

investment in U.S. securities issued by the Bureau of Fiscal Service and the fund balance with 

Treasury) at the end of the fiscal year. It also presents the income to trust fund (in terms of net 

revenue from excise taxes on vaccines and interest on investments) as well as disbursements to the 
 

Page 24 GAO-15-142 National Vaccine Injury Compensation Program

Health Resources and Services Administration (HRSA)—for compensation to petitioners, attorneys’ 

fees and costs, and administrative expenses, and to the Department of Justice (DOJ) and the U.S. 

Court of Federal Claims (USCFC) for the Office of Special Masters—for expenses associated with 

processing National Vaccine Injury Compensation Program (VICP) claims, as reported in the 

Treasury reports.

Total compensation to petitioners and the number of claims compensated 

have both increased since fiscal year 1999. Petitioners’ compensation 

paid by HRSA using appropriations from the trust fund increased to over 

$254 million in fiscal year 2013. With the exception of fiscal year 2000, 

the total amount spent on compensation awarded to petitioners remained 

under $125 million between fiscal years 1999 and 2009. The total amount 

spent on compensation to petitioners increased to nearly $180 million in 

fiscal year 2010 and to more than $250 million in fiscal year 2013 (see 

fig. 5 and app. III).63

 

63There is no cap on the amount of an award in a vaccine injury case, but the law does 

provide certain restrictions, such as a prohibition on punitive damages and limits on pain 

and suffering and emotional distress. Awards may include compensation for actual and 

anticipated loss of earnings. In some cases, compensation may be provided in the form of 

an annuity. In the event of a vaccine-related death, VICP will award $250,000 to the estate 

of the deceased. See 42 U.S.C.§ 300aa–15. Injury-related damages in addition to the 

statutory death benefit may be awarded.

Spending on 

Compensation to 

Petitioners and Attorneys 

Has Increased since 

Fiscal Year 1999
 

Page 25 GAO-15-142 National Vaccine Injury Compensation Program

Figure 5: Compensation to Petitioners under the National Vaccine Injury Compensation Program

Note: This figure presents the total amounts and numbers of claims paid by the Health Resources 

and Services Administration to petitioners under the National Vaccine Injury Compensation Program 

for each of fiscal years 1999-2013. Data are presented by the fiscal year in which the compensation 

was paid.

According to the Office of Special Masters, the increase in the total 

amount paid to petitioners in compensation and number of compensated 

claims is related to the addition of the influenza vaccine to the vaccine 

injury table. The influenza vaccine, which is administered to millions of 

people each year, was added to the injury table in fiscal year 2005.

The annual amount the VICP program paid for attorneys’ fees and costs 

remained relatively steady from fiscal year 1999 to fiscal year 2007, but 

started to increase in fiscal year 2008, consistent with an increase in the 

total number of payments to attorneys (see fig. 6 and app. III). In order to 

help ensure access to the program, VICP may pay for reasonable 

attorney fees and costs upon a determination that the petition was 

brought in good faith and there was a reasonable basis for the claim for 
 

Page 26 GAO-15-142 National Vaccine Injury Compensation Program

which the petition was brought, regardless of whether the petitioner’s 

claim is compensated or dismissed.64 The majority of VICP payments for 

attorneys’ fees and costs have been for compensated or dismissed 

claims; however, since fiscal year 2008, VICP has also paid some interim 

attorneys’ fees and costs for selected ongoing claims at the special 

master’s discretion.65

 

64Attorneys are prohibited from taking a contingent fee on compensation awarded to a 

petitioner. 42 U.S.C. § 300aa-15(e).

Compensation for attorneys’ fees and costs must be 

reasonable such that it generally reflects the actual time and expense 

devoted to the case.

65According to the Office of Special Masters, interim awards are made at the special 

master’s discretion, depending on a variety of factors, including but not limited to the 

duration of the litigation (e.g., lengthy proceedings), the stage of the proceedings, the 

amounts sought (e.g., demonstrating that substantial costs have been incurred), and the 

documented need for an interim award (e.g., demonstrating undue hardship).
 

Page 27 GAO-15-142 National Vaccine Injury Compensation Program

Figure 6: Payments to Attorneys under the National Vaccine Injury Compensation Program

Note: This figure presents the total amounts paid in attorneys’ fees and costs for each fiscal year 

(based on the fiscal year in which the payment was made). Attorneys’ fees and costs reflect the 

actual time and expense devoted to the case as opposed to a percentage of the compensation.

The total amount obligated by HRSA, DOJ, and USCFC (for the Office of 

Special Masters) to pay for staff and other expenses related to processing 

VICP claims increased from $17 million in fiscal year 2009 to about 

$19 million in fiscal year 2013.66

 

66The total obligation to each agency may not match the amount that Treasury reported it 

disbursed from the trust fund during a given fiscal year because the agencies’ obligations 

for petitioners’ compensation, attorneys’ fees, and other expenses associated with the 

program do not always occur in the same fiscal year that Treasury disburses funding to 

the agencies.

The three departments obligated a total 

of about $91 million for expenses associated with processing VICP claims 

during those 5 fiscal years. About two-thirds of VICP-related expenses 

Spending on Agency Staff 

and Other VICP-Related 

Expenses Has Increased
 

Page 28 GAO-15-142 National Vaccine Injury Compensation Program

($61 million) was obligated to pay the salaries and benefits of full-time 

equivalent (FTE) agency staff and about one-third ($30 million) was 

obligated for other VICP-related expenses (see table 1).

Table 1: Amounts Obligated by HRSA, DOJ, and USCFC for the National Vaccine Injury Compensation Program 

Administrative Expenses

Dollars in millions

HRSAa DOJ USCFCb

Fiscal year

FTE staff 

(number)

Other 

expenses

FTE staff 

(number)

Other 

expenses

FTE staff

(number)

Other 

expenses

Total

obligations

2009 $2.8 (18) $2.6 $4.5 (34) $3.2 $3.2 (24) $0.8 $17.0

2010 3.4 (22) 3.1 5.0 (34) 2.5 3.3 (25) 1.7 19.0

2011 3.8 (22) 2.7 5.4 (33) 2.4 3.4 (26) 0.8 18.5

2012 4.2 (22) 2.3 5.4 (34) 1.6 3.7 (29) 1.0 18.1

2013 3.8 (20) 2.5 5.5 (34) 2.1 3.7 (29) 1.1 18.7

Total $17.9 $13.2 $25.8 $11.9 $17.3 $5.4 $91.4

Source: GAO summary of HHS, DOJ, and USCFC data. | GAO-15-142

Legend: HRSA = Health Resources and Services Administration; DOJ = Department of Justice;

USCFC = U.S. Court of Federal Claims; FTE = Full-time equivalent.

Notes: Figures do not sum to totals due to rounding.

a

Amounts obligated by HRSA do not include compensation to petitioners or attorney costs.

b

Amounts obligated by USCFC were for the Office of Special Masters.

The amounts obligated for FTE salaries and benefits were for staff of 

HRSA, DOJ, and USCFC’s Office of Special Masters who process the 

claims and represent the government’s interest in legal proceedings. For 

example, USCFC’s Office of Special Masters paid the salaries and 

benefits for special masters and clerks. The average number of full-time 

equivalent (FTE) staff supported across the three agencies was 81 per 

fiscal year.

Each agency also had other VICP-related spending reimbursed by the 

trust fund. For example, HRSA reported obligating about $9.6 million for 

medical experts to review petitioner claims and provide expert testimony 

during adjudication proceedings for fiscal years 2009 through 2013. 

HRSA also obligated funds to support the Advisory Commission on 

Childhood Vaccines, including compensation and travel expenses for 

commission members. The departments reported obligating funds for 

costs for travel, processing documents, maintaining records, rent, 

supplies, and equipment. For example, obligations include rental 
 

Page 29 GAO-15-142 National Vaccine Injury Compensation Program

payments to the General Services Administration by DOJ and the cost of 

court reporters funded by USCFC’s Office of Special Masters.

Information on petitioners’ experience with VICP is limited. HRSA has 

taken some steps to undertake outreach activities, but the agency has not 

yet assessed the effect of these efforts.

Other than a study for HRSA on petitioners’ satisfaction with VICP, the 

agency officials and stakeholders we interviewed and the documents we 

reviewed did not identify any data or studies regarding the experience of 

individuals who have filed VICP claims. The study prepared for HRSA, 

dated 2009, reported the responses from 107 petitioners whose claims 

were compensated or dismissed in fiscal years 2004-2008. Because this 

was a voluntary survey with a low response rate, its results cannot be 

generalized to all petitioners who completed the VICP process; instead, it 

reflects only the experience of the VICP petitioners who responded to the 

survey.67

 

67Altarum Institute, Determining the Feasibility of Evaluating the National Vaccine Injury 

Compensation Program. HRSA contracted for this study in 2005, which surveyed 

petitioners regarding their perceptions of access to VICP information, program 

implementation and processes, financial award decision, and overall satisfaction. 

According to HRSA, petitioners were included in the sample if they (1) had filed a claim 

that had been compensated or dismissed in fiscal years 2004-2008 and (2) were 

represented by an attorney. Of 716 petitioners the researchers identified as meeting their 

inclusion criteria, 107 responded to their survey.

We also obtained comments from stakeholders, including 

officials from organizations representing providers, petitioners’ attorneys, 

and parents. These stakeholder comments, while providing insight into 

petitioner experiences, are anecdotal and do not represent the 

experience of all petitioners who have filed VICP claims. Members of the 

Advisory Commission on Childhood Vaccines we interviewed expressed 

interest in obtaining additional information on petitioner’s experience with 

VICP; however, they told us they had not done so, citing concerns about 

confidentiality and other issues.

Information on VICP 

Petitioner Experience 

Is Limited; HHS Is 

Taking Steps to 

Address Criticism of 

Its Outreach Efforts

Information on Petitioners’ 

Experiences with VICP Is 

Limited
 

Page 30 GAO-15-142 National Vaccine Injury Compensation Program

The limited comments on petitioners’ experience from those who 

responded to the survey prepared for HRSA and from stakeholders 

included the following:

• Some petitioners responding to the HRSA survey reported being 

dissatisfied with the claims process and some commented that the 

process places too great a burden on petitioners and family members, 

with requests for additional information after the claims were filed. 

Similarly, one stakeholder said that petitioners view the vaccine injury 

claims process as confusing, time-consuming, too lengthy, and 

traumatic. Another stakeholder, on the other hand, commented that 

while vaccine-related injuries do not happen often, the program 

handles them efficiently and fairly when they do happen.

• Other comments from petitioners responding to the HRSA survey and 

stakeholders were related to the payment process and amount of 

compensation. More than half of the 61 petitioners who responded to 

a question on the method of payment in the HRSA survey reported 

being somewhat or very satisfied with the method of award payment; 

however, 14 respondents suggested more timely and flexible payment 

mechanisms. About half of the 63 respondents to the question on the 

amount of compensation reported the award amount was inadequate 

to cover past and future medical care. Similarly, stakeholders we 

interviewed reported concerns with the amounts petitioners receive, 

the method of payment, and a perceived lack of transparency 

regarding how the money from the Vaccine Injury Compensation Trust 

Fund has been spent. For example, one stakeholder told us that 

petitioners felt forced to settle for less than what it will cost them to 

care for their children or themselves for their lifetimes, and another 

stakeholder raised concerns about the choice of annuities for 

petitioners.

• Other comments on the program from stakeholders were related to 

the perception of an adversarial or unfriendly environment throughout 

the process, the use of settlements and perceived pressure to settle 

claims, the use of omnibus proceedings to group claims together, and 

concerns about confidentiality of the medical information filed by the 

petitioner. Some petitioners responding to the HRSA survey and 

some stakeholders also reported difficulties finding an attorney to 

represent petitioners in the process; however, petitioners responding 

to the survey were split on this issue—about the same number 

reported that finding an attorney was difficult as reported that finding 

an attorney was easy.
 

Page 31 GAO-15-142 National Vaccine Injury Compensation Program

HRSA has acknowledged being criticized for years for not adequately 

promoting public awareness of VICP, and has recently taken some steps, 

such as developing and starting to implement an outreach plan for fiscal 

year 2014 and developing an outreach plan for fiscal year 2015, to 

improve its efforts to reach out to providers and the public.68 In its 2006 

VICP strategic plan, HRSA noted that one of the critical issues facing the 

program from 2005 to 2010 was that many parents, the general public, 

attorneys, and health care professionals were not aware VICP existed.69

In 2009, HRSA contracted for the development of a comprehensive 

national marketing and outreach communication plan; the contactor 

presented the plan to HRSA in November 2010.

70 According to HRSA, 

the agency used this plan to guide outreach efforts.71 Prior to the fiscal 

year 2014 plan, HRSA also reported exhibiting at professional 

conferences; updating the VICP website and the VICP booklet that is 

available from the website (including translating the booklet into Spanish); 

facilitating the review of vaccine information statements (which include a 

statement on VICP) by the Advisory Commission on Childhood Vaccines; 

and responding to media inquiries and inquiries received via e-mail, 

letters, and the program’s toll-free number.72

 

68In each of HRSA’s annual justification of estimates for appropriations committees for 

fiscal years 2011-2014, HRSA noted that the agency has been criticized for not 

adequately promoting public awareness of the VICP.

HRSA officials also noted 

the need to carefully balance messages that increase awareness of VICP 

with public health messages that encourage and promote immunizations.

69Division of Vaccine Injury Compensation, National Vaccine Injury Compensation 

Program Strategic Plan (April 2006).

70Banyan Communications, Inc., The Comprehensive National Vaccine Injury 

Compensation Program Marketing and Outreach Communication Plan, a report prepared 

for the Health Resources and Services Administration, (Nov. 2010).

71According to HRSA officials, the agency has been implementing some of the activities 

recommended in the November 2010 plans since that plan was issued, but the agency did 

not formally document its outreach efforts until the fiscal year 2014 VICP outreach plan. 

Agency officials report that the 2014 plan was developed because HRSA is taking a more 

strategic approach to its outreach and wanted to formally document these efforts.

72As part of its fiscal year 2011 budget justification, HRSA reported that exhibiting at 

conferences had proven beneficial in increasing knowledge of the availability of the 

program and that it planned exhibiting at medical and legal conferences in fiscal year 

2011.

HHS Is Taking Steps to 

Address Criticism of Its 

Efforts to Inform the Public 

of the Program
 

Page 32 GAO-15-142 National Vaccine Injury Compensation Program

HRSA shared an overview of its outreach plans with its Advisory 

Commission on Childhood Vaccines in September 2014. HRSA reported 

that many of the activities in the agency’s 2014 outreach plan were in 

process at the end of the fiscal year. These activities included reviewing 

the VICP booklets to use plain language and make them more userfriendly, reviewing and upgrading the VICP website to improve navigation, 

developing VICP message points for target audiences and slides about 

the program to be used in speeches and other presentations by HRSA 

staff, and requesting federal websites to provide information on the 

program and to link to the VICP website. In its outreach plan for fiscal 

year 2015, the agency is targeting health care providers, parents and 

expectant parents, adults aged 50 years and older (including Spanishspeaking older adults), and civil litigation and health attorneys, with the 

goal of informing target audiences of the availability of the program. 

According to HRSA, these target audiences were selected because they 

include individuals who administer vaccines and individuals (or their 

caregivers) who receive vaccinations. HRSA has identified a number of 

measures to assist in tracking performance of its fiscal year 2015 plan, 

including website metrics, the number of “retweets” and “shares” from 

social media initiatives, the number of media inquiries, and the number of 

attendees or participants at outreach events. Because the agency has not 

completed many of its planned efforts to improve how it informs the public 

of the availability of the program, it is too early to determine the effect of 

HRSA’s current and planned outreach efforts.

Without awareness of the program, individuals who might otherwise 

receive compensation for a vaccine-related injury or death could be 

denied compensation because of a failure to file their claim within the 

statutory deadlines. One stakeholder commented that the public is largely 

unaware of the program, and this lack of awareness contributes to 

missing filing deadlines and individuals being denied the opportunity for 

compensation. Members of the Advisory Commission on Childhood 

Vaccines also told us that many individuals may not know there is a 

statute of limitations on filing a claim and many miss the opportunity to file 
 

Page 33 GAO-15-142 National Vaccine Injury Compensation Program

a claim because of the statute of limitations.73 In December 2013, the 

commission recommended extending the statute of limitations for 

vaccine-related injuries and deaths. Extending the statute of limitations 

would require amending the applicable statutory provision.74

It has been more than 25 years since VICP went into effect in 1988. In 

that time, the program has awarded more than $2.8 billion to thousands 

of petitioners. Several aspects of the program have changed over the 

years. First, while claims alleging injuries on the vaccine injury table made 

up the majority of claims filed in the first decade of the program, today—

after the addition of new vaccines, particularly influenza vaccine, to the 

table without associated injuries—the majority of the claims filed involve 

off-table injuries. Stakeholders report that the program has an adversarial 

environment, as petitioners are required to demonstrate a covered 

vaccine caused the injury on their VICP claim when there are no 

associated injuries on the table. The extent to which this will change if 

HHS updates the vaccine injury table to include more injuries, as 

expected, is yet to be seen. Second, most of the compensated cases are 

now adjudicated through negotiated settlement, rather than contested 

decisions before the special master. And while the vaccines covered by 

the program are included because they are recommended for children, 

many of the program’s petitioners in recent years are adults who received 

covered vaccines.

Addressing one criticism of the program by stakeholders—specifically the 

need to increase the statute of limitations—would require a statutory 

change in the program. Regardless of whether the statute of limitations is 

 

73The current statute of limitations, in general, requires that claims be filed within 3 years 

of the date of the first symptom or manifestation of the onset or significant aggravation of 

an injury and within 2 years of a death (and within 4 years of the date of the first symptom 

or manifestation of the onset or significant aggravation of the injury from which a death 

resulted). Generally, when a vaccine or injury is added to the vaccine injury table, 

petitioners are required to file claims within 2 years from the date the vaccine or injury is 

added to the table for injuries or deaths that occurred up to 8 years before the table 

change. See 42 U.S.C. § 300aa-16.

74HHS has proposed extending the statutory time limits for filing a VICP claim in the past. 

For example, in commenting on a draft of our 1999 report, the department stated that the 

legislative proposals it had sent to the Congress included doubling the statutory time limit 

for filing a claim. GAO/HEHS-00-8, 39. DOJ officials also reported they believed their 

department had supported previous proposals to extend the program’s statute of 

limitations.

Concluding 

Observations
 

Page 34 GAO-15-142 National Vaccine Injury Compensation Program

increased, HHS’s efforts to increase awareness of the availability of the 

program will be important to help ensure that potential petitioners are 

aware of the program and can file claims in time. While HHS has recently 

taken or planned steps to improve its outreach activities, what effect, if 

any, these efforts will have remains to be seen. As the agency moves 

forward, it will be important for HRSA to identify which activities are 

reaching its target audiences.

We provided a draft of this report to HHS, DOJ, USCFC, and Treasury.

HHS and USCFC agreed with our findings and provided written 

comments, which are reprinted in appendixes IV and V, respectively. In 

its comments, HHS emphasized that it administers VICP jointly with DOJ 

and USCFC, with HHS responsible for reviewing petitioners’ claims, 

providing recommendations for entitlement to compensation, and making 

payments to petitioners and attorneys. In commenting on our 

identification of its efforts on VICP outreach, HHS noted that it is 

strengthening its outreach efforts by implementing its fiscal year 2015 

VICP outreach plan, which increases outreach to target populations and 

includes performance measures. In its written comments, USCFC noted 

that the Administrative Office of the United States Courts and USCFC 

both supply administrative support to the Office of Special Masters and 

VICP without reimbursement from the trust fund. The court also 

commented that, while considerable strides have been made in reducing 

the average processing time for claims in recent years, the climbing and 

changing nature of the caseload, coupled with the statutory cap on the 

number of special masters, present a continuing challenge to the Office of 

Special Masters’ ability to continue to reduce average processing times. 

USCFC also commented that following omnibus proceedings, claims 

have been resolved more expeditiously in recent years, and often through 

settlements. USCFC also commented that the Office of Special Masters 

strives to resolve all cases fairly and expeditiously. HHS, USCFC, DOJ, 

and Treasury also provided technical comments that were incorporated, 

as appropriate.

We are sending copies of this report to the Secretary of Health and 

Human Services, the Attorney General of the United States, the Chief 

Judge of the United States Court of Federal Claims, and the Secretary of 

the Treasury. In addition, the report is available at no charge on the GAO 

website at http://www.gao.gov. 

Agency Comments
 

Page 35 GAO-15-142 National Vaccine Injury Compensation Program

If you or your staff have any questions about this report, please contact 

me at (202) 512-7114 or crossem@gao.gov. Contact points for our 

Offices of Congressional Relations and Public Affairs may be found on 

the last page of this report. GAO staff who made key contributions to this

report are listed in appendix VI. 

Sincerely yours,

Marcia Crosse

Director, Health Care
Appendix I: Vaccine Injury Table, September 

2014

Page 36 GAO-15-142 National Vaccine Injury Compensation Program

Vaccine Injurya Time periodb

Vaccines against tetanus (e.g., DTaP, DTP, DT, Td, or TT) Anaphylaxis or anaphylactic shock 4 hours

Brachial neuritis 2-28 days

Vaccines against pertussis (e.g., DTP, DTaP, P, DTP-Hib) Anaphylaxis or anaphylactic shock 4 hours

Encephalopathy (or encephalitis) 72 hours

Vaccines against measles, mumps, rubella in any combination 

(e.g., MMR, MR, M, R)

Anaphylaxis or anaphylactic shock 4 hours

Encephalopathy (or encephalitis) 5-15 days

Vaccines against measles (e.g., MMR, MR, M) Thrombocytopenic purpura 7-30 days

Vaccine-strain measles viral infection in an 

immunodeficient recipient

6 months

Vaccines against rubella (e.g., MMR, MR, R) Chronic arthritis 7-42 days

Vaccines against polio (polio live virus-containing (OPV)) Paralytic Polio

—In a nonimmunodeficient recipient 30 days

—In an immunodeficient recipient 6 months

—In a vaccine-associated community case Not applicable

Vaccine-strain polio viral infection

—In a nonimmunodeficient recipient 30 days

—In an immunodeficient recipient 6 months

—In a vaccine-associated community case Not applicable

Vaccines against polio (polio inactivated virus-containing (IPV)) Anaphylaxis or anaphylactic shock 4 hours

Vaccines against hepatitis B Anaphylaxis or anaphylactic shock 4 hours

Vaccines against hemophilus influenzae type b 

(Hib conjugate vaccine)

No condition specified Not applicable

Vaccines against varicella No condition specified Not applicable

Vaccines against rotavirusa No condition specified Not applicable

Vaccines against pneumococcal disease 

(pneumococcal conjugate vaccine)a No condition specified Not applicable

Vaccines against hepatitis Aa No condition specified Not applicable

Vaccines against influenza (trivalent vaccine)a,c No condition specified Not applicable

Vaccines against meningococcal diseasea No condition specified Not applicable

Vaccines against human papillomavirus (HPV) No condition specified Not applicable

Source: GAO summary of information from the Health Resources and Services Administration. | GAO-15-142

Notes: In addition to the specific vaccines currently listed on the table, the National Vaccine Injury 

Compensation Program (VICP) also covers new vaccines recommended by the Centers for Disease 

Control and Prevention for routine administration to children after publication by the Secretary of a 

notice of coverage, effective on the date of an applicable excise tax.

a

This column includes the illness, disability, injury, or condition covered by the program. In addition, 

covered injuries include any acute complication or sequela (including death) of the listed injuries (for 

all but the Hib, varicella, rotavirus, pneumococcal conjugate, hepatitis A, trivalent influenza, 

meningococcal, and HPV vaccines).

Appendix I: Vaccine Injury Table, September 

2014
Appendix I: Vaccine Injury Table, September 

2014

Page 37 GAO-15-142 National Vaccine Injury Compensation Program

b

For first symptom, onset, or aggravation of injury after vaccination.

c

Trivalent influenza vaccine was added to the table effective July 1, 2005. All additional seasonal 

influenza vaccines, including quadrivalent vaccine, are covered by VICP, effective November 12, 

2013.
Appendix II: Covered Vaccines and Injuries on 

the Vaccine Injury Table, Fiscal Years 1999-

2014

Page 38 GAO-15-142 National Vaccine Injury Compensation Program

Fiscal year

Vaccine 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014a

Vaccines and Injuries Added to the Table before Fiscal Year 1999

Tetanuscontaining● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Pertussiscontaining● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Measles, 

mumps, rubella 

in any 

combination

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Measlescontaining● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Rubellacontaining● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Polio live viruscontaining● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Polio inactivated 

virus-containing

● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Hepatitis B ● ● ● ● ● ● ● ● ● ● ● ● ● ● ● ●

Hemophilus 

influenza type b 

(Hib) conjugateb

○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Varicellab ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Vaccines and Injuries Added and Proposed to be Added to the Table During and After Fiscal Year 1999

Rotavirusc ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ◐c ◐c

Pneumococcal 

conjugate

— ○d ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Hepatitis A — — — — — — ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Trivalent 

influenzae — — — — — — ○ ○ ○ ○ ○ ○ ○ ○ ○ ○

Meningococcal — — — — — — — — ○ ○ ○ ○ ○ ○ ○ ○

Human 

Papillomavirus

— — — — — — — — ○ ○ ○ ○ ○ ○ ○ ○

Vaccines and Injuries Added and Removed from the Table since Fiscal Year 1999

Hib 

polysaccharide 

(unconjugated)

● ● ● ● — — — — — — — — — — — — 

Rotavirus 

rhesus-based

— — — ● ● ● ● ● ● ● ● — — — — — 

Source: GAO analysis. | GAO-15-142

Appendix II: Covered Vaccines and Injuries 

on the Vaccine Injury Table, Fiscal Years 

1999-2014
Appendix II: Covered Vaccines and Injuries on 

the Vaccine Injury Table, Fiscal Years 1999-

2014

Page 39 GAO-15-142 National Vaccine Injury Compensation Program

Legend:

● = at least one injury specified for this vaccine on the table at any point during the fiscal year

◐ = HHS issued a proposed rule to add an injury to the table during the fiscal year

○ = there are no table injuries specified for this vaccine

— = the vaccine is not on the table

Notes: When no injury is identified or specified for the vaccine, the petitioner must prove that the 

injury was caused by the vaccine. In addition to the vaccines listed on the table, the National Vaccine 

Injury Compensation Program (VICP) may also cover any new vaccines that are recommended by 

the Centers for Disease Control and Prevention’s for routine administration to children and which are 

subject to an excise tax, but are not yet specifically listed on the vaccine injury table.

a

The information in this column is up to date as of September 17, 2014.

b

Hemophilus influenza type b conjugate and varicella vaccines were added to the table effective 

August 6, 1997.

c

Rotavirus was added to the table effective October 22, 1998. HHS issued a proposed rule on 

July 24, 2013, to add an injury to the table associated with rotavirus vaccine. However, the rule was 

not finalized before the end of fiscal year 2014.

d

Pneumococcal conjugate vaccine was added to the table effective December 18, 1999.

e

Trivalent influenza vaccine was added to the table effective July 1, 2005. All additional seasonal 

influenza vaccines, including quadrivalent vaccine, are covered by VICP, effective November 12, 

2013.
Appendix III: Compensation to Petitioners and 

Attorneys’ Fees and Costs, Fiscal Years 1999-

2013

Page 40 GAO-15-142 National Vaccine Injury Compensation Program

This appendix shows the total amount paid in compensation to petitioners 

under the National Vaccine Injury Compensation Program and the 

number of compensated claims in fiscal years 1999-2013 (see table 2). It 

also shows the amounts the program paid in attorneys’ fees and costs for 

those same fiscal years (see table 3).

Table 2: Compensation to Petitioners under the National Vaccine Injury 

Compensation Program, Fiscal Years 1999-2013

Fiscal year Petitioners’ award amount Number of compensated claims

1999 $95,917,681 96

2000 $125,945,196 136

2001 $105,878,633 97

2002 $59,799,604 80

2003 $82,816,240 65

2004 $61,933,764 57

2005 $55,065,797 64

2006 $48,746,163 68

2007 $91,449,434 82

2008 $75,716,552 141

2009 $74,142,491 131

2010 $179,387,341 173

2011 $216,319,428 251

2012 $163,511,999 250

2013 $254,666,327 375

Total $1,691,296,649 2,066

Source: HRSA Data and Statistics Report, August 1, 2014. | GAO-15-142

Appendix III: Compensation to Petitioners 

and Attorneys’ Fees and Costs, Fiscal Years 

1999-2013
Appendix III: Compensation to Petitioners and 

Attorneys’ Fees and Costs, Fiscal Years 1999-

2013

Page 41 GAO-15-142 National Vaccine Injury Compensation Program

Table 3: Payments to Attorneys under the National Vaccine Injury Compensation 

Program, Fiscal Years 1999-2013

Fiscal year

Compensated 

attorneys’ 

fees/cost 

payments

Dismissed 

attorneys’ 

fees/cost 

payments

Interim 

attorneys’ 

fees/cost 

payments

Number of 

payments to 

attorneys 

1999 $2,799,911 $2,306,957 $0.00 213

2000 $4,112,369 $1,724,451 $0.00 216

2001 $3,373,866 $2,066,225 $0.00 154

2002 $2,653,599 $656,245 $0.00 130

2003 $3,147,755 $1,545,655 $0.00 134

2004 $3,079,329 $1,198,616 $0.00 126

2005 $2,694,664 $1,790,587 $0.00 135

2006 $2,441,199 $1,353,633 $0.00 122

2007 $4,034,154 $1,692,020 $0.00 143

2008 $5,191,771 $2,511,313 $117,265 216

2009 $5,404,712 $1,557,140 $4,241,363 195

2010 $5,961,744 $1,886,240 $1,978,804 251

2011 $9,572,043 $5,589,417 $2,001,771 682

2012 $9,104,489 $8,621,182 $5,420,258 1,304

2013 $13,333,180 $6,970,279 $1,454,852 1,128

Total $76,904,784 $41,469,960 $15,214,312 5,149

Source: HRSA Data and Statistics Report, August 1, 2014. | GAO-15-142
Appendix IV: Comments from the Department 

of Health and Human Services

Page 42 GAO-15-142 National Vaccine Injury Compensation Program

Appendix IV: Comments from the 

Department of Health and Human Services
Appendix IV: Comments from the Department 

of Health and Human Services

Page 43 GAO-15-142 National Vaccine Injury Compensation Program
Appendix V: Comments from the United States 

Court of Federal Claims

Page 44 GAO-15-142 National Vaccine Injury Compensation Program

Appendix V: Comments from the United 

States Court of Federal Claims
Appendix V: Comments from the United States 

Court of Federal Claims

Page 45 GAO-15-142 National Vaccine Injury Compensation Program
Appendix VI: GAO Contact and Staff 

Acknowledgments

Page 46 GAO-15-142 National Vaccine Injury Compensation Program

Marcia Crosse, (202) 512-7114 or crossem@gao.gov

In addition to the contact named above, Kim Yamane, Assistant Director; 

George Bogart; Carolyn Garvey; Cathleen Hamann; Katherine Perry; 

Fatima Sharif; and Eric Wedum made key contributions to this report.

Appendix VI: GAO Contact and Staff 

Acknowledgments

GAO Contact

Staff 

Acknowledgments

(100007)
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