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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
Comment: Some commenters stated that removing coverage for SIRVA and syncope is inconsistent with the Programs twin purposes of creating a simplified means of recovery for those injured by the administration of vaccines and providing liability protection to vaccine administrators and manufacturers. Commenters state that the policy objective is triggered by the immunization and does not vary with whether the claimed injury is a consequence of the contents versus the administration process.
Response: The Department agrees that the VICP seeks to create a simplified means of recovery and provide certain liability protection to vaccine administrators and manufacturers. But it only seeks to do so for injuries encompassed by the Vaccine Act. The Act creates a compensation program for a vaccine-related injury or death.
42 U.S.C. 300aa11a1. Under the Act, only . . . a person who has sustained a vaccine-related injury or death can recover. 42 U.S.C. 300aa11a9. The Act defines vaccine-related injury or death as an illness, injury, condition, or death associated with one or more of the vaccines set forth in the Vaccine Injury Table, except that the term does not include an illness, injury, condition, or death associated with an adulterant or contaminant intentionally added to such a vaccine. 42 U.S.C. 300aa335
emphasis added; see also Dean v.
HHS, No. 161245V, 2018 WL 3104388, at 9 Fed. Cl. Spec. Mstr. May 29, 2018 defining vaccine as any substance designed to be administered to a human being for the prevention of 1 or more diseases quoting 26 U.S.C.
4132a2. Thus, the compensation program covers injuries associated with the vaccine itself.
SIRVA is not a vaccine, and it is not an injury caused by a vaccine antigen, but by administration of the vaccine by the health care provider. The Department does not think the term associated with was meant to sweep in injuries caused by negligent administration of the vaccine. Although the Act permits petitioners to recover for Vaccine Table injuries without demonstrating causation in individual cases, the term associated with nevertheless requires that the injury, in general, be causally related to the vaccine itself. This is clear both from dictionary definitions of associated, which means related, connected, or combined together MerriamWebster.com Dictionary, MerriamWebster, https www.merriamwebster.com/dictionary/associated.
Accessed 10 Jul. 2020, and from the text of the Act itself, see, e.g., 42 U.S.C.

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300aa22b1 focusing on injuries that resulted from vaccine side effects; 42
U.S.C. 300aa13a1B & 2B
excluding trauma that has no known relation to the vaccine involved.
Importantly, in the key operative provisions discussed above, the phrase associated with is linked to the vaccine itself, not to the technique in administering the vaccine. See Decker v.
Nw. Envtl. Def. Ctr., 568 U.S. 597, 611
2013 in interpreting phrase associated with industrial activity, the key consideration is the scope of industrial activity; the statute does not foreclose a more specific definition by the agency and a reasonable interpretation . . . could . . . require the discharges to be related in a direct way to operations at an industrial plant ; Chevron, U.S.A., Inc. v. Nat.
Resources Def. Council, Inc., 467 U.S.
837, 861 1984 The meaning of a word must be ascertained in the context of achieving particular objectives, and the words associated with it may indicate that the true meaning of the series is to convey a common idea..
That basic requirement is not met with SIRVA and vasovagal syncope.
While the act of being vaccinated may be a but-for cause of those injuries, the injury is not associated with the vaccine itself because, with proper administration technique, those injuries will not result from the vaccine. Rather, SIRVA and vasovagal syncope result from the use of improperthat is, negligentadministration technique.
There are several indicators in the language and structure of the Vaccine Act that show it was not meant to cover negligent administration of the vaccine.43
Comment: Many commenters stated that the proposed rule is not supported by the cited financial concerns; that SIRVA payouts in the last three years only account for 1% of the $4 billion life-to-date total that the program has paid for claims for all injuries. They contend that the fund has enough money to support SIRVA claims. Other commenters pointed out that the awards paid out on an annual basis has substantially decreased, while the fund has increased in size. Some commenters contend that financial concerns is not a proper basis to remove an injury from the Table.
Response: The Department is finalizing this final rule for a combination of legal and policy reasons explained herein and in the proposed rule, not solely because any particular claims are diminishing the Trust Fund.
43 See
PO 00000

85 FR 43,796, 43,797.

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Comment: Many commenters stated that the Department should not move forward with this final rule since the ACCV voted against the rule changes.
Response: The Department is grateful to the ACCV for its time spent considering the proposed changes and for providing its comments. However, the Department found the ACCVs comments not adequately persuasive.44
For reasons stated herein and in the proposed rule, the Department believes that credible scientific and medical evidence supports this final rule.
Comment: Some commenters stated that removing SIRVA and vasovagal syncope from the Table will have the negative effective of reducing the amount of providers who are willing to administer vaccinations, thereby lowering the overall number of people vaccinated. A few commenters also stated that the legislative history of the Vaccine Act shows that Congress took steps to provide protections for healthcare providers. These commenters suggest that removing SIRVA from the Vaccine Injury Table would be contrary to Congressional intent and undercut key purposes of the Vaccine Act.
Response: The Department respectfully disagrees. The Department has been unable to locate any evidence that premiums have materially declined due to the addition of SIRVA and vasovagal syncope to the Table.
Moreover, the vaccination rate has gone down slightly since SIRVA and vasovagal syncope were added to the Table.45 In addition, certain pharmacists are already immune from suit and liability for claims for loss caused by, arising out of, relating to, or resulting from the administration of certain childhood vaccines to individuals ages three through 18 for the duration of the Secretarys Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID19.46
Comment: Some commenters disagree with the Departments statement that the present regime lessens the incentive of vaccine administrators to take appropriate precautions during administration. They state that that health care providers, including pharmacists, are highly trained, skilled professionals that seek to provide high quality care to their patients, and are not likely to be negligent in the care they provide because of their knowledge of 44 See 85 FR 43,80143,802 for a detailed discussion of why the Department did not find the ACCVs comments to be adequately persuasive.
45 See, e.g., https www.cdc.gov/flu/fluvaxview/
coverage1718estimates.htm; https www.cdc.gov/
nchs/data/hus/2018/031.pdf.
46 See 85 FR 52,136, 52140 Aug. 24, 2020.

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