Susanna Larsen, Wake Forest School of Law, JD ’27 [1]
Parent who sends their children off to elementary school know their child will come home with new knowledge but also new germs.[2] The children’s close contact, their developing immune systems, and their not-yet-cemented hygiene practices have earned children the title of “germ vectors.”[3] For the most part, children get sick with routine illnesses that they recover from, but this was not always the case.[4] Around the 1900’s, before vaccines became commonplace, about 20% of children died before reaching the age of five.[5] By boosting children’s immune systems, the standard childhood vaccines have nearly or entirely eradicated some of the more serious diseases such as polio, measles, mumps, rubella, and tetanus.[6] However, the enormous benefits from vaccines are taken for granted since the tragedy of life-ending childhood diseases seems to be a thing of the past.[7]
Vaccines are a hot topic in today’s climate.[8] Disagreements rage on regarding the science behind vaccines, risks of their use, and overall efficacy.[9] For better or worse, vaccines are undoubtedly political; multiple government agencies are involved in promulgating vaccines.[10] However, what many Americans do not realize is that the federal government’s involvement goes further.[11] Not only is the government involved in vaccine production and distribution, but it also plays a role in redressing injuries caused by vaccines.[12]
In 1986, Congress passed the National Childhood Vaccine Injury Act of 1986 (NCVIA), which created the National Vaccine Injury Compensation Program.[13] The program is funded by a seventy-five-cent excise tax on every dose of a vaccine.[14] Congress provided the United States Court of Federal Claims authority over vaccine cases and created the Office of Special Masters to handle these cases.[15] Thus, the Office of Special Masters became colloquially known as Vaccine Court.[16]
Vaccine Court currently faces unprecedented political pressures and growing scrutiny.[17] While it has previously braved storms of public outcry, it has reached a critical tipping point.[18] Most of the drastic structural changes that politicians have been calling for would exacerbate Vaccine Court’s existing flaws. This essay examines the two most criticized scheduling issues, the case backlog and restrictive statute of limitations, while offering potential solutions, and discusses Vaccine Court’s future uncertainty.
Vaccine Court’s History and Purpose
In 1976, the Centers for Disease Control and Prevention (CDC) identified a unique influenza strain.[19] Due to political influence, President Gerald Ford started a national influenza vaccination program.[20] The vaccine manufacturers, worried about potential lawsuits, asked Congress to indemnify them for potential claims.[21] The vaccine manufacturers’ concern for potential claims created the public perception that “‘There’s something wrong with [the] vaccine.’ This public misperception, warranted or not, ensured that every coincidental health event that occurred in the wake of the swine flu shot [was] scrutinized and attributed to the vaccine.”[22] Furthermore, reports of an immune system disorder linked to the influenza vaccine highlighted the need for “effective public messaging” and “liability protections for manufacturers.”[23] This created the backdrop of public hesitancy and demand for manufacturer indemnification that would later motivate the creation of Vaccine Court.
The government recognized that the vaccine manufacturers would stop creating vaccines if there was a rise in lawsuits.[24] Contrary to popular belief, vaccine manufacturers do not greatly profit from vaccines.[25] In fact, they would make much more money sticking solely to pharmaceuticals and ignoring vaccine production.[26] To create a vaccine, the manufacturers complete years of vaccine testing, submit documentation to the U.S. Food and Drug Administration (FDA), and follow further documentary and procedural requirements for the CDC.[27] This process costs the manufacturers millions, or perhaps billions, of dollars and can take years.[28] Moreover, around 66% of all vaccines do not even make it through the process, meaning that manufacturer expenses associated with those vaccines may never be recouped.[29]
Vaccine manufacturers, though imperfect, overwhelmingly create a public good.[30] Historically common life-ending diseases have been significantly prevented or their symptoms lessened.[31] Studies estimate that in every U.S. cohort which receives childhood vaccines 20 million illnesses and over 40,000 deaths are avoided.[32] Beyond the individual advantages, once a large population is vaccinated, the group benefits from “herd immunity” where diseases may be entirely eradicated.[33]
In 1986, Congress was motivated to create Vaccine Court in order to provide an alternative remedy and forum after an onslaught of vaccine suits threatened to push pharmaceutical manufacturers out of the vaccine business.[34] Vaccine Court was initially meant to help children and pregnant women injured from required vaccines but has since been extended to certain vaccinations for adults.[35] Its goals are to provide “individuals a swift, flexible, and less adversarial alternative to the often costly and lengthy civil arena of traditional tort litigation.”[36] Vaccine Court certainly has provided a remedy, having paid an estimated $5.4 billion in claims since its inception with compensation awards in about 42% of the nearly 30,000 claims filed.[37]
Vaccine Court is wholly unique in several ways. It is a “no-fault” alternative to civil courts, meaning there is no negligence attributed to any parties, just a question of whether the vaccine “more likely than not” caused the injury.[38] However, not every vaccine injury can be brought to Vaccine Court.[39] A claim must be based on the petitioner’s injury after receiving a covered vaccine, i.e., one of the vaccines the Department of Health and Human Services (HHS) flags as routinely administered.[40] Currently, there are thirteen vaccines for which compensation is available.[41] The vaccine injury table lists the compensable vaccines, eligible injuries, and expected time frame for symptoms.[42] If a petitioner’s claim fits within the injury table’s specifications, there is a presumption of causation.[43] For some Vaccine Court cases, the vaccine is listed on the table, but off-table injuries can be compensated for with more proof of causation than table injuries.[44] Overall, if the petitioner claims that a covered vaccine caused any injury, the claim must come to Vaccine Court.[45]
A Vaccine Court case starts with a petitioner filing a claim with the Court of Federal Claims, which HHS uses to make a recommendation.[46] Following that, the U.S. Department of Justice (DOJ) creates a report based on medical recommendations and legal analysis, which it submits to the Court of Federal Claims.[47] The Special Master receives the report and makes the decision on whether the petitioner should be compensated.[48] The Special Master makes decisions in two stages: whether the petitioner has a successful claim and if so, what amount should be awarded.[49] Their decision can be based on the filings but may also include hearings where both the petitioner and DOJ bring evidence and expert witnesses.[50]
If either party is unsatisfied with the Special Master’s decision, the decision can be appealed to the Court of Federal Claims within thirty days.[51] The Court of Federal Claims reviews the Special Masters’ factual findings under an arbitrary and capricious standard, while damage decisions are reviewed de novo.[52] Alternatively, petitioners can reject the Special Master’s decision and bring their claim against vaccine manufacturers in civil court.[53] Moving a vaccine case to civil court is only available after the final judgment or if a claim has no decision after 240 days pending or no judgment after 420 days pending in Vaccine Court.[54] Nonetheless, most petitioners stay in Vaccine Court since “it is widely considered harder for a petitioner to win in civil court.”[55]
Vaccine Court comes with benefits such as relaxed discovery and evidentiary procedures, creating “a less-adversarial, expeditious, and informal proceeding” and allowing Special Masters to utilize “flexible and informal standards of admissibility of evidence.”[56] Attorney’s costs and fees are also compensated regardless of case outcome so long as the costs are reasonable and the claim was brought in good faith on a reasonable basis.[57] Perhaps most compelling for a petitioner is Vaccine Court’s lower burden of proof in comparison to that of civil court.[58] In Vaccine Court, petitioners merely need to qualify for a causation presumption with an on-table injury or prove more likely than not that the vaccine caused their injury, while in civil court that same party would need evidence of fault to prove some degree of negligence, defective design, or some other tort action.[59]
However, Vaccine Court has its drawbacks. Vaccine Court is perhaps most heavily criticized for schedule-related issues.[60] Two areas require the most improvement: the insufficient time available to the Special Masters given their workload and the repressive statute of limitations for injured petitioners. Nonetheless, Vaccine Court is a valuable forum capable of administering much-needed justice and ought to be reformed rather than abolished.
Case Backlog
One area requiring improvement is Vaccine Court’s overwhelming workload. From October 2024 to September 2025, the Vaccine Court reached a final decision on 1331 cases.[61] However, at any given time, there were about 3400 pending cases.[62] These numbers are an uptick from prior years.[63] Before the twenty-first century, Vaccine Court received approximately 120 claims yearly, which spiked to an average of 787 claims yearly between 2000 and 2013. Numbers rose even further with over 1,000 claims every year since 2016.[64] As the Chief Special Master explained, “it becomes more difficult each year to resolve the huge number of case filings in the expedient fashion they deserve.”[65] Vaccine Court needs additional Special Masters and dedicated settlement staff, alongside more detailed tables reducing time-consuming discretion.
Congress could authorize increased resources for the Special Masters but has yet to do so.[66] In fact, the number of authorized Special Masters has never risen. The Office of Special Masters’ mandate authorizes up to eight Special Masters who act as judges.[67] While there have been proposals to raise that number, none have passed.[68] Additionally, each Special Master reapplies every four years.[69] The terms should be extended to allow Special Masters to focus more on their work rather than securing their jobs. The hiring process involves standard legal documentation such as a cover letter, two writing samples, and a list of references, in addition to interviews and background checks, which take valuable time away from Vaccine Court cases since parts of this process is repeated every four years.[70] Although Congress continues to avoid passing bills to increase the number of Special Masters, it may be more open to funding additional staff to address the backlog. In its 2026 judiciary budget summary, Congress stated that increased funding should add “court support staff due to caseload and workload estimates.”[71] Staff members could be hired to handle at least part of the Special Masters’ responsibilities, namely the “case management, which involves overseeing the collection of information and setting time frames for its submission,” which would not require the same qualifications as the Special Masters’ other functions.[72]
Furthermore, Vaccine Court’s backlog would decrease if settlement specialists were hired to facilitate negotiation, recommend settlement terms, and mediate areas of disagreement. Approximately 60% of compensated cases end in a settlement.[73] Parties “are encouraged to contact” the Special Master throughout the settlement process and especially so “whenever they enter into good faith settlement discussions or desire the guidance or assistance” of the Special Master.[74] A mediator can be assigned, but the Special Master is still involved throughout the process, which uses their time less efficiently.[75] In 2026, Congress provided $15.2 million for administrative expenses, including “funding for medical review staff, contractors to conduct timely medical reviews, medical experts for reviews, and expert testimony given during [Vaccine] Court proceedings.”[76] With more cases settling due to experienced settlement staff facilitating the process, there would be less need for expert testimony in later proceedings. Rather, those funds, along with any other costs avoided by settling before litigation, can be diverted to hiring settlement staff. These specialists could fully replace the Special Master in the settlement processes.[77]
Moreover, the vaccine injury table should include more variety or levels to avoid lengthy deliberations.[78] Currently, cases are expected to take two years from the date of filing if they go directly to settlement.[79] If the case requires further deliberations, it can easily take five years.[80] Even after determining a petitioner’s eligibility, the compensation determinations take more time as the Special Master has to look closely at the individualized facts.[81]
Variety in degrees of injury and time frames in the vaccine injury table would help facilitate causation and damage award determinations. Different levels could specify damage awards according to the level of severity, accounting for the degree of medical certainty of causation.[82] The table already defines medical symptoms but should further describe each symptom by various levels of severity to aid in damage award calculations.[83] Additionally, rather than one estimated time frame for each symptom onset, there should be a multiple windows of time with different damage amounts according to when the symptom manifested.[84] A petitioner would have more leeway to qualify as an on-table injury, leading to a speedier resolution with a lower but guaranteed compensation award as compared to arguing an off-table injury case. If more cases could fit within an expanded vaccine injury table, cases could move more quickly through Vaccine Court and Special Masters would have more baselines to set monetary awards.
Expanding the vaccine injury table would compensate some undeserving petitioners by giving greater leeway in causation timelines and qualifications. Nonetheless, Vaccine Court’s purpose is to act “with certainty and generosity” in compensating those injured.[85] An improved vaccine injury table would create clearer, more certain outcomes, ultimately reducing the likelihood of time-consuming and costly judicial reviews.[86] By creating more leeway to qualify as on-table, some of the difficult questions that Special Masters must answer in a more pro-petitioner way aligned with Congress’ purpose in creating Vaccine Court could be resolved. Thus, with more Special Masters and other staff alongside amendments to the vaccine injury table, Vaccine Court will be in a better position to efficiently resolve petitioners’ claims.
Racing the Statute of Limitations
Petitioners face their own timing issues with an overly restrictive statute of limitations. This is worsened by misunderstandings about what triggers the statute of limitations and petitioners’ lack of awareness about Vaccine Court. Luckily, aspects of both issues can be resolved with a single solution.
To start, petitioners must bring their claim to the Court of Federal Claims within three years of their first symptom or two years after the time of death.[87] This length of time may seem reasonable on its face, especially since it resembles the statute of limitations for most misdemeanors and personal injury claims.[88] However, the citizens that Vaccine Court was designed to protect are often ignorant that Vaccine Court is an option for them since its existence is not common knowledge.[89] When a parent is caring for an ill child or an adult is themselves going through periods of hospitalization, they are occupied with that task and likely never consider contacting lawyers or researching potential legal claims. In addition, many petitioners misunderstand when the statute of limitations begins to run.[90] The statute of limitations starts at the initial symptom, not once the petitioner realizes they have a cause of action.[91] These two misconceptions about Vaccine Court, in conjunction with its unique purpose, ought to convince Congress to remedy these issues.[92]
The government has tried to address the lack of awareness of Vaccine Court and of compensable claims. In the early 2000’s, the government considered launching an advertisement campaign for Vaccine Court.[93] However, that plan never came to fruition, and commentators note that the publicity plan for the Vaccine Court is a double-edged sword; injured patients can be more compensated, but the public loses confidence in vaccines with having more awareness of negative side effects.[94]
There is a better solution to fix both the statute of limitations and Vaccine Court awareness issues: Congress should change the event triggering the statute of limitations to be a medical report mandated under the NCVIA. Instead of a general public-focused education initiative, healthcare providers should be the focus. Healthcare providers should already be familiar with basic patient disclosure and reporting requirements, especially since they are legally required to convey vaccine information statements to vaccine recipients.[95] Under the NCVIA, healthcare providers must report “adverse experiences” on the Vaccine Adverse Event Reporting System (VAERS).[96] These reports do not need to allege causation but merely flag a negative patient outcome that is suspected to be associated with a vaccine.[97] VAERS also requires vaccine providers to submit records on case reports and clinical trials with instances of adverse effects.[98] Healthcare providers should be entrusted with documenting and uploading all occurrences of unexpected medical symptoms for three years after a minor or pregnant patient receives a vaccine. This three-year watch period should apply to vaccines given to children and pregnant women since those demographics cover shorter periods of time and receive more medical oversight.[99] For the few compensable vaccines given to adults, such as the flu vaccine, a much shorter watch period should apply since those vaccines are often continually administered over one’s entire life.[100] Instead, a heightened reporting period of about one month should suffice for ordinary adults since they can be held responsible for informing their medical providers about any adverse side effects.
Consequently, the VAERS database should be made further accessible to patients and include information about Vaccine Court.[101] Patients may acquire their VAERS information either by filing a Freedom of Information Act request or by accessing the expanded VAERS website, Wonder.[102] A petitioner should have access to objective information from a VAERS report indicating when a healthcare provider first suspects the petitioner might have a vaccine-caused injury, putting the petitioner on notice of the potential for a claim. This allows for a less subjective query than petitioners’ subjective knowledge of a claim but a more lenient time frame than the statute of limitations which triggers at the first innocuous symptom. Accordingly, Congress should change the initiating action for the statute of limitations to when a health provider first submits a VAERS report suspecting an injury could be vaccine related.[103]
The Future for Vaccine Court
While the Vaccine Court has its critics, none are as loud as Secretary of Health and Human Services Robert F. Kennedy Jr.[104] According to Kennedy, Vaccine Court has “devolved into a morass of inefficiency, favoritism and outright corruption.”[105] Kennedy proposes changes which would, in effect, add a new vaccination and new injury: Covid-19 and autism, respectively.[106] His preliminary plans include moving Covid-19 vaccine claims to Vaccine Court and adding additional injuries recognizing autism as a side effect of certain vaccines.[107] He speaks of a total overhaul of Vaccine Court, but commentators worry that Kennedy’s changes would effectively destroy Vaccine Court.[108]
Though moving Covid-19 vaccine injury claims to Vaccine Court seems logical, merging that many claims into Vaccine Court right now is an unsustainable plan.[109] There are an estimated 9,000 pending Covid-19 vaccine injury cases, and adding those onto the Special Masters’ workload would worsen the already concerning backlog in Vaccine Court and delay the process for all claims.[110] Rather, the Covid-19 claims should stay with the separate program, the Countermeasures Injury Compensation Program (CICP), and adjudicate claims there until Vaccine Court addresses its backlog.[111]
CICP and Vaccine Court function too differently to seamlessly merge without extensive preparation. For instance, CICP receives funding through congressional allocations unlike the self-funded Vaccine Court, and each program receives, reviews, and adjudicates claims completely differently.[112] While both programs aim to streamline financial recovery for vaccine injuries and suffer from significant backlog, that is the extent of their similarities.[113] Before addressing the possibility of combining programs, Congress could consider adapting CICP to better mirror the procedures for Vaccine Court, such as creating a public injury and compensation table to improve transparency and make determinations more efficiently.[114]
Furthermore, Vaccine Court has already addressed autism claims and found them predominantly unmeritorious. Reopening those potential causes would invite another influx of cases while simultaneously casting doubt on Vaccine Court’s prior autism proceedings and scientific evidence as a whole.[115] From 2007 to 2008, Vaccine Court combined approximately 5000 autism-related cases into the Omnibus Autism Proceedings with six test cases.[116] Attorneys representing petitioners in autism claims selected the six test cases, meaning the most viable and persuasive cases were chosen.[117] The Special Masters investigated whether autism could be caused by vaccines with the two theories brought by the test cases, and applied their findings to the individual test cases.[118] The Special Masters reviewed immense amounts of scientific evidence.[119] In just one case, Special Master Hastings considered “23 separate medical expert reports, heard live testimony from 16 expert witnesses, and reviewed 658 medical journal articles”[120] By 2010, Vaccine Court ultimately determined that there was no viable theory linking vaccines with causing autism.[121] Upon review for some of the test cases, both the Court of Federal Claims and the Court of Appeals for the Federal Circuit affirmed the Special Masters’ decisions.[122] Thus, Vaccine Court, threatened with “meritorious filings,” determined that autism cases should not be encouraged nor brought to Vaccine Court.[123]
Most alarmingly, the science of vaccines has been conflated with partisan politics. Public misconception still exists about vaccines causing autism and such belief is fueled by the political climate. For instance, the executive branch currently claims that “the statement ‘Vaccines do not cause autism’ is not an evidence-based claim.”[124] However, there is still insufficient scientific research to even imply that vaccines cause autism.[125] That is not to say that it is impossible for vaccines to cause autism; science is an evolving area and a new link could be discovered. Nonetheless, science builds upon itself and prior, well-supported scientific conclusions ought to receive more deference than politicians lacking medical training.[126] Without the emergence of novel scientific research demonstrating a vaccine link, autistic individuals should be supported by improved disability programs, not Vaccine Court.[127] To hold otherwise would undermine decades of scientific backing and give too much political meaning to scientific data.[128]
Conclusion
Vaccines ought to be seen as a public good rather than a political debate. One can hope that with the attention the Vaccine Court is receiving, and the topic of vaccines overall, beneficial changes in the Vaccine Court’s structure are underway. Vaccine Court was built for the admiral goal of making harmed Americans whole and ought to be reformed rather than eradicated. To address the inordinate case backlog, Vaccine Court should receive additional Special Masters and dedicated settlement staff alongside more detailed tables simplifying proceedings. To alleviate the confusion caused by the statute of limitations, the medical report mandated under the NCVIA should be the triggering event. Accordingly, the executive branch should not greatly alter Vaccine Court until the case backlog and statute of limitations are improved and any amendments should be based on supporting evidence. Finally, the American public should give scientific evidence a healthy deference, offsetting the political pressures Vaccine Court currently faces.
[1] The views expressed in this article are mine alone and do not reflect or reveal the opinions of any chambers in the Court of Federal Claims.
[2] See Why does my child get sick after starting school or daycare?, Akron Children’s (July 25, 2026), https://www.akronchildrens.org/inside/2024/09/16/why-does-my-child-get-sick-after-starting-school-or-day-care/.
[3] See Maria Godoy, Your kids are adorable germ vectors. Here’s how often they get your household sick, NPR (Jan. 26, 2023), https://www.npr.org/sections/health-shots/2023/01/26/1151333478/your-kids-are-adorable-germ-vectors-heres-how-often-they-get-your-household-sick; What Germs Are Coming Home With Your Child?, Uhealth Collective (Aug. 28, 2023), https://news.umiamihealth.org/en/what-germs-are-coming-home-with-your-child/; Cindy Paul, Little Germ Factories, Rutgers: Rutgers Mag. (May 28, 2020), https://www.rutgers.edu/magazine/spring-2020/little-germ-factories.
[4] Godoy, supra note 3.
[5] Revolutionary Medicine: The Importance of Child Vaccines, Am. Lung Ass’n: Each Breath (Apr. 4, 2025), https://www.lung.org/blog/child-vaccine-history.
[6] See Louise Fleming, Childhood immunizations: The cornerstone of preventive pediatric care, J. Preg. Neonatal Med., Aug. 2023 at 1, 1.
[7] Steven Woolf & Jill Rosenthal, Childhood Vaccination Has Saved Millions of Lives, but Rising Hesitancy Could Reverse Decades of Progress, Ctr. Am. Progress (Jan. 8, 2025), https://www.americanprogress.org/article/childhood-vaccination-has-saved-millions-of-lives-but-rising-hesitancy-could-reverse-decades-of-progress/#:~:text=Perhaps%20partly%20owing%20to%20the,lives%2C%20and%20yield%20net%20savings.
[8] See Drew Altman, The Problem Isn’t Trust in Vaccines, It’s That People Don’t Know Who to Trust, KFF (Aug. 19, 2025), https://www.kff.org/from-drew-altman/the-problem-isnt-trust-in-vaccines-its-that-people-dont-know-who-to-trust/.
[9] See Jeffrey M. Jones, Far Fewer in U.S. Regard Childhood Vaccinations as Important, Gallup (Aug. 7, 2024), https://news.gallup.com/poll/648308/far-fewer-regard-childhood-vaccinations-important.aspx
[10] This primarily includes the Department of Health and Human Services which is over the Food and Drug Administration and Centers for Disease Control and Prevention. Jennifer Kates & Josh Michaud, How HHS, FDA, and CDC Can Influence U.S. Vaccine Policy, KFF (Nov. 20, 2024), https://www.kff.org/covid-19/how-hhs-fda-and-cdc-can-influence-u-s-vaccine-policy/. The Health Resources and Services Administration, the National Institutes of Health, and the Center for the Biomedical Advanced Research and Development Authority participate in vaccine oversight. Id.
[11] Jon Wertheim, Vaccine court: Where Americans who suffer rare injury after vaccination can take their claims, CBS News (Oct. 5, 2025), https://www.cbsnews.com/news/vaccine-court-americans-who-suffer-rare-injury-after-vaccination-take-claims-60-minutes-transcript/.
[12] See id.
[13] Maia Rosenfeld, This Teen Never Got His Day in Vaccine Court. His Former Lawyer Now Advises RFK on Its Overhaul., KFF Health News (Jan. 29, 2026), https://kffhealthnews.org/news/article/vicp-vaccine-court-cases-moved-lawsuits-lawyers-merck-hpv-rfk-allies-hhs/.
[14] About the National Vaccine Injury Compensation Program, Health Res. & Servs. Admin., https://www.hrsa.gov/vaccine-compensation/about (last visited July 28, 2026).
[15] Jeffrey Kluger, Here’s How the Anti-Vaxxers’ Strongest Argument Falls Apart, Time (Aug. 19, 2015), https://time.com/3995062/vaccine-injury-court-truth/.
[16] See David Carney, What is Vaccine Court?, Vaccine Injured Petitioners Bar Ass’n (Jan. 19, 2026), https://www.vipbar.org/blog/what-is-vaccine-court/.
[17] See Christina Jewett & Apoorva Mandavilli, Kennedy’s Next Target: the Federal Vaccine Court, N.Y. Times (Oct. 20, 2025), https://www.nytimes.com/2025/08/11/health/kennedy-vaccine-court.html.
[18] See id.
[19] Christine Coughlin, FDA’s Accelerated Approval, Emergency Use Authorization, and Pre-Approval Access: Considerations for Use in Public Health Emergencies and Beyond, 23 N.C. J. L. & Tech. 741, 759 (2022).
[20] Id.
[21] Id.
[22] Id.
[23] Id. at 759–60.
[24] See Paul D. Rheingold & Clifford J. Shoemaker, The Swine Flu Litigation, ABA: Litig. Section (Dec. 7, 2020), https://www.americanbar.org/groups/litigation/resources/newsletters/mass-torts/the-swine-flu-litigation/?login.
[25] Fact or Fiction? Big Pharma, Immunize for Good, https://immunizeforgood.com/fact-or-fiction/big-pharma/ (last visited July 29, 2026).
[26] Inst. of Med of Nat’l Acad. of Sci., Financing Vaccines in the 21st Century: Assuring Access and Availability 116 (National Academies Press 2004), https://www.ncbi.nlm.nih.gov/books/NBK221811/.
[27] Coughlin, supra note 19, at 748–49.
[28] Id. at 750.
[29] Id.
[30] Debates continue over whether vaccine manufacturers should profit at all. However, seat belt manufacturers profit and they provide a similar public protection. See Immunize for Good, supra note 25. Regardless of whether vaccine manufacturers have some profit incentive, the service they provide is invaluable to the overall public.
[31] See Andrew J. Shattock et al., Contribution of Vaccination to Improved Survival and Health: Modelling 50 Years of the Expanded Programme on Immunization, 403 Lancet 2307, 2307 (2024).
[32] C. Lee Ventola, Immunization in the United States: Recommendations, Barriers, and Measures to Improve Compliance, Part 1: Childhood Vaccinations, 41 Pharm. & Therapeutics 426, 426 (2016)
[33] Id.
[34] Beverly Jones Sill, Toussaint v. Merck & Co.: Opening the Door to Thimerosal Vaccine Litigation in Civil Court?, 21 Ga. St. U. L. Rev. 773, 773 (2005).
[35] Vaccine Injury Compensation Programs: An Effective Balance of Public Health and Personal Remedy, Immunize 1 (Nov. 2022), https://www.immunize.org/wp-content/uploads/catg.d/p2075.pdf.
[36] Vaccine Claims / Office of Special Masters, U.S. Ct. of Fed. Claims, https://www.uscfc.uscourts.gov/vaccine-claims-office-special-masters (last visited July 29, 2026).
[37] Health Res. & Servs. Admin., Data & Statistics 1 (June 2025), https://www.hrsa.gov/sites/default/files/hrsa/vicp/vicp-stats-06-01-25.pdf.
[38] Wertheim, supra note 11.
[39] See National Vaccine Injury Compensation Program, Health Res. & Servs. Admin. (July 2026), https://www.hrsa.gov/vaccine-compensation.
[40] See Covered Vaccines, Health Res. & Servs. Admin. (July 2026), https://www.hrsa.gov/vaccine-compensation/covered-vaccines. The injury must also reach a minimum level of severity. See Who Can File a Petition, Health Res. & Servs. Admin. (July 2026), https://www.hrsa.gov/vaccine-compensation/eligible#:~:text=Severity%20requirements,Resulted%20in%20death.
[41] National Vaccine Injury Compensation Program, Health Res. & Servs. Admin. (March 2019), https://www.hrsa.gov/sites/default/files/hrsa/vicp/vicp-fact-sheet.pdf. As of July 2026, the table vaccines are those for diphtheria, haemophilus influenza, hepatitis A, hepatitis B, human papillomavirus, seasonal influenza, measles, mumps, meningococcal, pertussis, pneumococcal conjugate, polio, rotavirus, rubella, tetanus, and varicella. Covered Vaccines, Health Res. & Servs. Admin. (July 2026), https://www.hrsa.gov/vaccine-compensation/covered-vaccines.
[42] See Vaccine Injury Table, Health Res. & Servs. Admin. (Jan. 2022), https://www.hrsa.gov/sites/default/files/hrsa/vicp/vaccine-injury-table-01-03-2022.pdf.
[43] Covered Vaccines, supra note 41.
[44] See Vaccine Injury Table, supra note 42. Table injury cases are easier to prove with an assumption of causation, while off-table cases require extra proof of causation. See Miles E. Coleman, An Overview of the National Childhood Vaccine Injury Act, 21 S.C. L. 40, 45 (2010). More specifically, for off-table injuries, the petitioner must demonstrate “a medical theory causally” linking the vaccine and injury, a “logical sequence of cause and effect” demonstrating that the vaccine caused the injury, and “a showing of a proximate temporal relationship” between the vaccine and injury. Althen v. v. Sec’y of Health & Hum. Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005).
[45] Coleman, supra note 44, at 42.
[46] National Vaccine Injury Compensation Program, supra note 41.
[47] Id.
[48] Id.
[49] Peter H. Meyers, Fixing the Flaws in the Federal Vaccine Injury Compensation Program, 63 Admin. L. Rev. 785, 809 (2011).
[50] National Vaccine Injury Compensation Program, supra note 41.
[51] Coleman, supra note 44, at 44; see also 42 U.S.C. § 300aa-12(e).
[52] Natalie Crow, Pain and Suffering Award Determinations in Vaccine Injury Claims, 33 Fed. Cir. B.J. 121, 126 (2024).
[53] 42 U.S.C. § 300aa-21.
[54] § 300aa-21(a)–(b). The time periods do not include suspensions. Id.
[55] Vaccine Injury Compensation Programs: An Effective Balance of Public Health and Personal Remedy, supra note 35.
[56] § 300aa-12(d)(2)
[57] 42 U.S.C. § 300aa-15.
[58] See Rosenfeld, supra note 13.
[59] See Dorit Reiss, Liability for COVID-19 Vaccine Harms: We Need to Do Better, Harvard Petrie-Flom Ctr.: Bill of Health (Oct. 21, 2022), https://petrieflom.law.harvard.edu/2022/10/21/liability-for-covid-19-vaccine-harms-we-need-to-do-better/.
[60] See e.g., National Vaccine Injury Compensation Program Needs Modernizing, Hearing Before the H. Select Subcomm. on the Coronavirus Pandemic, 118th Cong. (2024) (statement of Renée J. Gentry, Director, George Washington University Law School Vaccine Injury Litigation Clinic), https://oversight.house.gov/wp-content/uploads/2024/03/Gentry-Testimony.pdf; Peter H. Meyers, supra note 49, at 801–802.
[61] U.S. Ct. of Fed. Claims, Statistical Report for the Fiscal Year October 1, 2024 – September 20, 2025 1 (2025), https://www.uscfc.uscourts.gov/sites/cfc/files/AOstats-2025%20FINAL.pdf.
[62] See id.
[63] See Health Res. & Servs. Admin., supra note 37.
[64] Id.
[65] Jon Wertheim et al., Families grappling with rare vaccine injuries turn to government program for compensation, CBS News: 60 Minutes Overtime (Oct. 5, 2025), https://www.cbsnews.com/news/vaccine-court-compensation-60-minutes/.
[66] Id.
[67] 42 U.S.C. § 300aa-12(c).
[68] See e.g., Vaccine Injury Compensation Modernization Act of 2023, H.R. 5142, 118th Cong. § 2 (2023); National Vaccine Injury Compensation Program Improvement Act of 2019, S. 1638 116th Cong. § 2 (2019).
[69] § 300aa–12(c)(4).
[70] See Position Vacancy, U.S. Ct. of Fed. Claims (2026), https://www.uscfc.uscourts.gov/sites/cfc/files/2026%20OSM%20Special%20Master%20Vacancy%20Announcment.pdf.
[71] Admin. Off. of the U.S. Cts., The Judiciary Fiscal Year 2026 Congressional Budget Summary 29 (2025), https://www.uscourts.gov/sites/default/files/document/fy-2026-congressional-budget-summary.pdf.
[72] Vaccine Claims / Office of Special Masters, supra note 36.
[73] Céline Gounder, Inside the High-Stakes Battle Over Vaccine Injury Compensation, Autism, and Public Trust, KFF Health News (Oct. 6, 2025), https://kffhealthnews.org/news/article/autism-vaccine-injury-compensation-program-public-health-trust/.
[74] Off. of Special Masters, U.S. Ct. of Fed. Claims, Guidelines for Practice Under the National Vaccine Injury Compensation Program 37 (March 11, 2024), https://www.uscfc.uscourts.gov/sites/cfc/files/vaccine_guidelines.pdf.
[75] See id.
[76] U.S. Dep’t of Health & Human Servs., Justification of Estimates for Appropriations Committees: Fiscal Year 2026 347 (2025), https://www.hhs.gov/sites/default/files/fy-2026-aha-cj.pdf https://www.hhs.gov/sites/default/files/fy-2026-aha-cj.pdf.
[77] This already mirrors the Special Processing Unit, but should be further refined and strengthened to increase Vaccine Court’s efficiency. Off. of Special Masters, U.S. Ct. of Fed. Claims, supra note 74, at 37.
[78] This would require notice and comment rulemaking from HHS. See e.g., National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table, 86 Fed. Reg. 14,567 (proposed Mar. 17, 2021) (to be codified at 42 C.F.R. pt. 100). https://www.regulations.gov/document/HRSA-2021-0001-0032.
[79] Nora Freeman Engstrom, A Dose of Reality for Specialized Courts: Lessons from the Vicp, 163 U. Pa. L. Rev. 1631, 1685 (2015); Vaccine Injury FAQ, Green & Schafle Trial Laws. https://www.greenlegalteam.com/vaccine-injury-faq/#:~:text=about%20the%20VICP.-,Do%20I%20Have%20to%20File%20My%20Case%20in%20the%20VICP,by%20proper%20directions%20and%20warnings (last visited July 29, 2026).
[80] See e.g., Vaccine Injury Claim Timelines: Stages and Deadlines You Need to Know, Siri & Glimstad (Oct. 26, 2025), https://www.sirillp.com/legal-blog/vaccine-injury/vaccine-injury-claim-timeline-deadlines/; Jeffrey S. Pop & Associates, How Long Do Vaccine Injury Cases Take? Setting Realistic Expectations, Vaccine Injury Team (Aug. 3, 2025), https://www.vaccineinjuryteam.com/blog/2025/august/how-long-do-vaccine-injury-cases-take-setting-re/.
[81] See Engstrom, supra note 79, at 1691–93.
[82] See Alessandra Fix & Kelly Cappio, Opportunities to Modernize the Vaccine Injury Compensation Program, Avalere Health (May 15, 2020), https://advisory.avalerehealth.com/insights/opportunities-to-modernize-the-vaccine-injury-compensation-program.
[83] See id.
[84] For the current table evidencing only one symptom onset time, see Vaccine Injury Table, supra note 42.
[85] H.R. Rep. No. 99-908, pt. 1, at 3 (1986).
[86] See Engstrom, supra note 81, at 1699, 1703 (describing the “difficult judgment calls” that Special Masters make as causing “a lack of consistency and predictability” and more likely to be contested).
[87] 42 U.S.C. § 300aa-16(a). Two years after the time of death must also be within four years of the first symptom manifesting. Id.
[88] See Statute of Limitations for all 50 States, Matthiesen, Wickert & Lehrer, S.C. (Sep. 5, 2024), https://www.mwl-law.com/wp-content/uploads/2018/02/SOL-CHART-2.pdf.
[89] See Anders Kelto, Vaccine Court Aims To Protect Patients And Vaccines, NPR (June 2, 2015), https://www.npr.org/sections/health-shots/2015/06/02/411243242/vaccine-court-aims-to-protect-patients-and-vaccines. Doctors are required to report vaccine side effects to the Vaccine Adverse Event Reporting System, but this system is entirely separate from any legal systems and Vaccine Court. Frequently Asked Questions (FAQs), Vaccine Adverse Event Reporting Sys., https://vaers.hhs.gov/faq.html. (last visited July 29, 2026). This implies that even doctors cannot be presumed to have knowledge of Vaccine Court or be relied upon to advise their patients about the possibility of a claim.
[90] See generally, Cloer v. Sec’y of Health & Hum. Servs., 654 F.3d 1322, 1327–28 (Fed. Cir. 2011) (affirming the dismissal of a petitioner’s claim as untimely because she mistakenly believed the statute of limitations was not triggered until her diagnosis); Krenik v. Sec’y of Health & Hum. Servs., No. 03-2755V, 2014 WL 4387219, at *7 (Fed. Cl. July 25, 2014) (rejecting petitioner’s argument that statute of limitations began only once petitioner had actual knowledge of the diagnosis); Xiangdong He v. Sec’y of Health & Hum. Servs., No. 08-207, 2012 WL 1185686, at *8–9 (Fed. Cl. Mar. 12, 2012) (holding that an early potential symptom, regardless of how innocuous and unrelated petitioners believed the symptom to be, triggers the statute of limitations); Goetz v. Sec’y of Health & Hum. Servs., 45 Fed. Cl. 340, 342 (1999), aff’d, 4 F. App’x 827 (Fed. Cir. 2001) (denying the petitioner’s appeal because ignorance of his rights was not enough to toll the statute of limitations).
[91] See e.g., Cloer, 654 F.3d at 1340 (describing petitioner’s argument for subjective knowledge triggering the statute of limitations as being “antithetical to the simple, symptom-keyed test expressly required by the Vaccine Act’s text”); Huntoon v. United States, 167 Fed. Cl. 93, 104 (2023) (confirming that “any symptom associated with the alleged injury, even if subtle, is a triggering symptom under that Vaccine Act”).
[92] Furthermore, even getting a claim filed takes time. Claims require extensive documentation, including “maternal prenatal and delivery records, newborn hospital records (including all physicians’ and nurses’ notes and test results), vaccination records associated with the vaccine allegedly causing the injury, pre- and post-injury physician or clinic records (including all relevant growth charts and test results), all post-injury inpatient and outpatient records (including all provider notes, test results, and medication records), if applicable, a death certificate, and if applicable, autopsy results” alongside any other relevant medical documents. If some documents are not included in the claim, the petitioner must explain why those documents are unavailable. 42 U.S.C. § 300aa-11(c).
[93] See Kelto, supra note 89.
[94] See id.
[95] See About VISs, Ctrs. for Disease Control & Prevention (Aug 2, 2024), https://www.cdc.gov/vaccines/hcp/vis/about/facts-vis.html.
[96] Vaccine Safety Questions and Answers, U.S. Food & Drug Admin. (March 2, 2026), https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/vaccine-safety-questions-and-answers. Currently, there are no adverse effects should a health professional fail to report. Rather, it should become a mandated step and flagged in a patient’s file. Id.
[97] See id.
[98] Id. Unlike the medical staff, the vaccine administrators are required by law to report to VAERS. See also 21 C.F.R. § 600.80 (2026).
[99] See Pregnant? Here’s How Often You’ll Likely See Your Doctor, Cleveland Clinic: Health Essentials (Jan. 14, 2022), https://health.clevelandclinic.org/prenatal-appointment-schedule; Make the Most of Your Child’s Visit to the Doctor (Ages 1 to 4 Years), U.S. Dep’t Health & Human Servs.: Off. of Disease Prevention & Health Promotion (May 29, 2026), https://odphp.health.gov/myhealthfinder/doctor-visits/regular-checkups/make-most-your-childs-visit-doctor-ages-1-4-years.
[100] Such a long watch period for nearly half of all adults would unduly burden medical providers. See Weekly Flu Vaccination Dashboard, Ctrs. for Disease Control & Prevention: FluVaxView, https://www.cdc.gov/fluvaxview/dashboard/index.html (last visited July 29, 2026).
[101] For a minor patient, the responsibility would be on the minor’s caregiver.
[102] Frequently Asked Questions (FAQs), supra note 89. The current VAERS interface is not user friendly. Since it is public information, names and identifying information is redacted. See id. Thus, patients would need a note in their medical charts of what their unique VAERS ID number is from the health provider’s report.
[103] The Court of Federal Claims has the authority to equitably toll when a petitioner diligently pursued their rights, but “some extraordinary circumstance” stood in their way. See Cloer v. Sec’y of Health & Hum. Servs., 654 F.3d 1322, 1344 (Fed. Cir. 2011) (internal citations omitted). Nonetheless, this essay leaves the doctrine of equitable tolling unaddressed in favor of more heavily analyzing the statute of limitations. Since some petitioners’ equitable tolling requests are tied to their lack of knowledge of causation, Congress changing the triggering event for the statute of limitations should avoid some equitable tolling requests. See e.g., id. at 1334–36 (refusing to equitably toll because of petitioner’s ignorance of her potential claim); Helton v. Sec’y of Health & Hum. Servs., No. 23-1926V, 2024 WL 3509514, at *3 (Fed. Cl. June 26, 2024) (refusing to equitably toll when a plaintiff acted diligently once learning about Vaccine Court after the statute of limitations); Speights v. Sec’y of Health & Hum. Servs., No. 03-2619V, 2013 WL 5944084, at *13 (Fed. Cl. Spec. Mstr. Oct. 17, 2013) (refusing to equitably toll when petitioner argued that she lacked awareness about Vaccine Court); Goetz v. Sec’y of Health & Hum. Servs., 45 Fed. Cl. 340, 342 (1999), aff’d, 4 F. App’x 827 (Fed. Cir. 2001) (refusing to equitably toll just because a petitioner did not learn of a causal link until after the statute of limitations).
[104] See Jewett & Mandavilli, supra note 17.
[105] Id.
[106] See Gounder, supra note 73.
[107] Jewett & Mandavilli, supra note 17. Kennedy argues for broadening the definitions of two injuries, encephalopathy and encephalitis, to allow autism cases into Vaccine Court in addition to adding autism to the list of recognized injuries. See Gounder, supra note 73.
[108] See Brit McCandless Farmer, Why the COVID vaccine isn’t part of an injury compensation court, CBS News: 60 Minutes Overtime (July 26, 2026), https://www.cbsnews.com/news/why-covid-vaccine-isnt-part-of-injury-compensation-court-60-minutes/. But see Junying Zhao et al., Reforming the countermeasures injury compensation program for COVID-19 and beyond: An economic perspective, 9 J L. & Biosci, Apr. 2022, at 23–26.
[109] See Jewett & Mandavilli, supra note 17. Currently, a separate program, the Countermeasures Injury Compensation Program, adjudicates claims regarding Covid-19 vaccine injuries. Id.
[110] See id.
[111] Id.
[112] Josh Michaud & Jennifer Kates, Federal Vaccine Injury Compensation Programs: Overview and Current Issues, KFF (May 15, 2026), https://www.kff.org/other-health/federal-vaccine-injury-compensation-programs-overview-and-current-issues/. More specifically, CICP and Vaccine Court differ in terms of the petition review process, evidentiary standard, decision-maker, compensation limits, legal fees, and funding source. Id.
[113] Id.
[114] The main complaints for CICP include low compensation, lack of meaningful opportunity for petitioners to participate, and no judicial review. See Peter H. Meyers, The Trump administration’s flawed decision on coronavirus vaccine injury compensation: recommendations for changes, 7 J L. & Biosci. 1, 4–5 (Nov. 2022); Maryanne Demasi, Covid-19: Is the US compensation scheme for vaccine injuries fit for purpose?, 377 British Med. J. 1, 1–3 (2022).
[115] See Jewett & Mandavilli, supra note 17.
[116] Lauren L. Haertlein, Immunizing Against Bad Science: The Vaccine Court and the Autism Test Cases, 75 L. & Contemp. Probs. 211, 219 (2012).
[117] Id.
[118] Id.
[119] Joëlle Anne Moreno, It’s Just A Shot Away: Mmr Vaccines and Autism and the End of the Daubertista Revolution, 35 Wm. Mitchell L. Rev. 1511, 1514–15 (2009).
[120] Id.
[121] Id. The one caveat is a settlement without a determination of causation where a child had a “rare mitochondrial disorder . . . developed autism-like symptoms after vaccination.” Céline Gounder, supra note 73. However, the government has stressed that this situation was fact-specific and unique due to her condition. Id. Thus, without a scientific backing, the settlement should be attributed to Vaccine Court’s goals of generosity and repayment, not to any scientific causal relationship between autism and vaccines. There have been no similar cases since, and this case was an “extraordinarily rare” instance dependent on a “very severe and genetic” mitochondrial disorder. Dorit Rubinstein Reiss & Rachel Heap, Using and Misusing Legal Decisions: Why Antivaccine Claims About NVICP Cases Are Wrong, 20 Minn. J. L. Sci. & Tech. 191, 221 (2019).
[122] See Reiss & Heap, supra note 121, at 236–37.
[123] Anderson v. Sec’y of Health & Hum. Servs., No. 02-1314V, 2018 WL 6787880, at *3 (Fed. Cl. Nov. 16, 2018) (citing R.V. v. Sec’y of Health & Hum. Servs., No. 08-504V, 2016 WL 7575568, at *4 (Fed. Cl. Spec. Mstr. Nov. 28, 2016)).
[124] See Autism and Vaccines, CDC: Vaccine Safety (July 22, 2026), https://www.cdc.gov/vaccine-safety/about/autism.html.
[125] See Public Health On Call, Why Experts Have Concluded That Vaccines Do Not Cause Autism, John Hopkins Univ.: Bloomberg Sch. of Pub. Health (Mar 19, 2025), https://publichealth.jhu.edu/2025/vaccines-do-not-cause-autism.
[126] See Understanding Science 101, UC Berkley: Understanding Science, https://undsci.berkeley.edu/understanding-science-101/how-science-works/the-real-process-of-science/ (last visited July 31, 2026).
[127] Dr. Roger A. Mitchell, Jr., NMA Statement on CDC Reviving Debunked Link Between Autism and Vaccines, Nat’l Med. Ass’n (Nov. 20, 2025), https://nmanet.org/news/nma-statement-on-cdc-reviving-debunked-link-between-autism-and-vaccines/; Céline Gounder, supra note 73.
[128] Mitchell, supra note 127.

