Photo Credit: https://www.sciencenews.org/article/covid-coronavirus-vaccine-development-speed (last visited Jan. 13, 2022).
Authored By: Anna Alyce Eastburn
Research and Writing Editor, American Journal of Trial Advocacy
Vaccines are one of the most successful public health tools in preventing and protecting against vaccine-preventable diseases.[i] According to the U.S. Centers for Disease Control and Prevention, the immunization of each U.S. child with the current childhood immunization schedule prevents approximately 42,000 deaths and 20 million cases of disease, with a net savings of nearly $14 billion in direct costs and $69 billion in total societal costs.[ii] Despite vaccines being the best defense against vaccine-preventable diseases, no vaccine is 100% safe or effective.[iii]
To compensate vaccine-injured individuals, Congress adopted the National Childhood Vaccine Injury Act of 1986 (Injury Act), which created the National Vaccine Injury Compensation Program (NVCIP).[iv] The purpose of the program was to ensure a stable market supply of vaccines, stabilize vaccine costs, and provide cost-effective arbitration for injury claims.[v] Accordingly, a petitioner has two methods of recourse under the NVICP.[vi] Under the first method, the petitioner can establish that they received a vaccine listed on the vaccine-injury table and suffered one of the listed injuries within the prescribed period.[vii] Or, a petitioner can claim an “off-table” injury, where they must establish actual causation by a preponderance of the evidence.[viii] For successful petitioners’ claims cost and attorney’s fees are awarded out of the Vaccine Injury Compensation Trust Fund.[ix] The government funds the program by a $.75 excise tax on vaccines recommended by the CDC for routine administration to children; the CDC imposes the excise tax on each dose of a vaccine.[x] As of August 2021, the fund’s balance with treasury reflects $15,963,488,212.57 billion.[xi] On average, the fund pays $216 million a year to an average of 615 claimants.[xii]
At present, the National Vaccine Injury Compensation Program does not cover any of the three COVID-19 vaccines currently available for immunization.[xiii] The exclusion of the COVID-19 vaccines from the program is partly due to the Department of Health and Human Services(DHS) classifying COVID-19 as a global health emergency.[xiv] When DHS declared COVID-19 a public health emergency, the declaration triggered the Public Readiness and Emergency Preparedness Act (PREP).[xv] PREP Act is a federal law requiring all individuals injured by vaccines given as countermeasures during a declared global health crisis to claims under the Countermeasure Injury Compensation Program (CICP).[xvi] A vaccination, medication, device, or other recommended item used to combat and protect people during a declared pandemic, epidemic, or security threat constitutes a countermeasure.[xvii] CICP differs significantly from VICP in that CICP requires a higher burden of proof than VICP and only compensates individuals with severe injuries and death.[xviii] For example, CICP only covered injuries such as anaphylaxis and Guillian-Barré Syndrom[xix] for individuals who received the 2009 H1NI pandemic influenza virus vaccine.[xx] The programs are also distinct from each other in that they are authorized by two distinct programs, have different filing deadlines, cover different products, cover different types of injuries, benefits, and compensation are different, and payment of legal fees and costs are different.[xxi] If eligible for benefits under CICP, an individual may be compensated by DHS for medical expenses, lost employment income, benefits to the estate, survivor death benefits.[xxii] Unlike VICP, individuals injured by countermeasure vaccines are not eligible to receive attorney’s fees, and the cost for filing a claim makes the process for filing a claim more complex and costly.[xxiii] Additionally, the CICP limits lost-income recovery to $50,000 for each year the individual is unable to work.[xxiv] The program also does not compensate for pain, suffering, or emotional distress.[xxv] Even after the declaration has been lifted, individuals injured from COVID-19 vaccines will be ineligible to pursue claims under the VICP.[xxvi]
[i] See the Centers for Disease Control and Prevention, Vaccine Safety: Overview, History, and How it Works, (September 9, 2020), https://www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html.
[ii] Nili Karako-Eyal, Increasing Vaccination Rates Through Tort Law: Theoretical and Empirical Insights, 86 Umkc L. Rev. 1, 6 (2017).
[iii] Centers for Disease Control and Prevention, supra note 1.
[vi] HRSA, About the National Vaccine Injury Compensation Program, (date last reviewed: December 2021), https://www.hrsa.gov/vaccine-compensation/about/index.html.
[vii] 42 U.S.C.A. §§ 300aa-14(a).
[viii] Public Health Service Act §§ 2111, 2113; 42 U.S.C.A. §§ 300aa-11(c)(1)(C), 300aa-13(a)(1).
[ix] HRSA, Vaccine Injury Compensation Data, (Date Last Reviewed: December 2021), https://www.hrsa.gov/vaccine-compensation/data/index.html.
[x] HRSA, About the National Vaccine Injury Compensation Program, (Date Last Reviewed: December 2021), https://www.hrsa.gov/vaccine-compensation/about/index.html (“Funded by a $.75 excise tax on vaccines recommended by the Centers for Disease Control and Prevention for routine administration to children, the excise tax is imposed on each dose of a vaccine.”).
[xi] Vaccine Injury Trust Fund (August 2021), https://www.treasurydirect.gov/ftp/dfi/tfmb/dfivi0821.pdf.
[xii] Katharine Van Tassel et al., Covid-19 Vaccine Injuries –– Preventing Inequities in Compensation, N Engl Med 2020 (March 11, 2021), https://www.nejm.org/doi/full/10.1056/NEJMp2034438
[xiii] HRSA, Covered Vaccines, (Date Last Reviewed: December 2021), https://www.hrsa.gov/vaccine-compensation/covered-vaccines/index.html.
[xiv] Tassel, supra note 12.
[xv] 42 U.S.C. §§ 247-6d, 247d-6e.
[xvi] Public Health Emergency, Expanding Access to Covid 19 Therapeutics, (Last Reviewed: September 21, 2021), https://www.phe.gov/Preparedness/legal/prepact/Pages/PREPact-NinethAmendment.aspx.
[xix] Code of Federal Regulations, Title 42 – Public Health, (October 1, 2016), https://www.govinfo.gov/content/pkg/CFR-2016-title42-vol1/xml/CFR-2016-title42-vol1-part110-subpartK.xml. (“Guillain-Barré Syndrome (GBS) is an acute monophasic peripheral neuropathy that currently is known to encompass a spectrum of four clinicopathological subtypes described below. For each subtype of GBS, the interval between the first appearance of symptoms and the nadir of weakness is between 12 hours and 28 days. This is followed in all subtypes by a clinical plateau with stabilization at the nadir of symptoms, or subsequent improvement without significant relapse. Death may occur without a clinical plateau. Treatment related fluctuations in all subtypes of GBS can occur within 9 weeks of GBS symptom onset and recurrence of symptoms after this time frame would not be consistent with GBS.”)
[xx] Code of Federal Regulations, Title 42 – Public Health, (October 10, 2016), https://www.govinfo.gov/content/pkg/CFR-2016-title42-vol1/xml/CFR-2016-title42-vol1-part110-subpartK.xml.
[xxi] HRSA, Comparisons of Countermeasures Injury Compensation Program (CICP) to the National Vaccine Injury. Compensation Program (VICP), (Date Last Reviewed: April. 2021), https://www.hrsa.gov/cicp/cicp-vicp
[xxiii] Katharine Van Tassel et al., Covid-19 Vaccine Injuries –– Preventing Inequities in Compensation, N Engl Med 2020 (March 11, 2021), https://www.nejm.org/doi/full/10.1056/NEJMp2034438.
[xxiv] HRSA, Countermeasures Injury Compensation Program, (Last. Revised: December 2020: December 2020), https://www.hrsa.gov/sites/default/files/hrsa/cicp/cicpfactsheet.pdf.