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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations liability protection. Further they list several instances where civil action can be filed under the Act under 42 U.S.C.
300aa21a, the patient/petitioner may reject the Federal Claims judgment and pursue a civil action; the vaccine administered is not listed in the Table;
the injury sustained is not listed in the Table; the injury/illness did not last 6
months. Commenters argue that health care providers are bound by their ethical, moral, and legal duties to protect public health and no other consideration eliminates or lessens that commitment.
Response: The Department is grateful for the many health care professionals and pharmacists who improve public health by vaccinating the American public, and does not believe they would intentionally administer a vaccine in an improper manner. The Department has taken many steps during the COVID19
pandemic to increase the universe of individuals who can safely vaccinate.
Ensuring vaccines are administered safely will increase public confidence in vaccinations. Since Vaccine Act proceedings are generally sealed and not made available to the public, vaccine administrators may be left unaware that they used an improper technique.47 42
U.S.C. 300aa21a does not materially change the analysis, because there are not many instances where an individual would go through the VICP process, fail to recover, and then be able to recover in state court. There are also not many instances where a petitioner would elect to forgo his or her recovery from the VICP to sue in state court, since it is not often that an individual could recover more in state court, and there are risks inherent in state court litigation.
Comment: One commenter who serves on the Advisory Commission on Childhood Vaccines stated that a representative from HHS should have come to talk to the Commission about the proposed rule. This commenter stated that additional evidence should have been provided by HHS at the May 2020 meeting of the Commission, but HHS was not involved in the meeting.
The commenter stated that it was the responsibility of HHS to provide sufficient evidence to justify its recommendation, not the job of the Commission to provide sufficient evidence to support its rejection.
Another commenter stated that by not adopting the recommendation of the Commission, HHS risks undermining the integrity of the Federal Advisory Committee Act FACA process and the willingness of qualified experts to serve on such committees.
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Response: The proposal provided to the ACCV before the May 2020 meeting, which synthesized the views of many within the Department, was the Departments best explanation for why it was proposing the changes to the Table. The Departments proposed regulation provided to the ACCV
provided ample scientific and legal justification. The Department is grateful to the ACCV for its time spent considering the proposed changes and for providing its comments, but it would raise constitutional concerns if a federal Agency had to accept the recommendations of a FACA.
Comment: A few commenters stated that there is no evidence to support that the Departments position that SIRVA
petitions are likely to unnecessarily risk reductions in the funding available for children and others who sustain unavoidable vaccine-related injury or death because the taxes collected by vaccine manufacturers and paid into the Trust Fund have exceeded outflows for every year except Fiscal Year 2013.
Commenters also stated that this reasoning ignores the fact that some SIRVA claims involve children.
Response: It stands to reason that if large sums are paid to SIRVA
petitioners, that risks reducing funding available for others who sustain unavoidable vaccine-related injuries or deaths. At the time of the proposed rule, over 99.2% of SIRVA cases 3,034 out of 3,057 filed since FY 2010 were filed by adults.48
Comment: Some commenters urge the VICP and the CICP to merge together to promote unity and clarity.
Response: Revision of the formation and organization of the VICP and the CICP would require a statutory amendment and thus is not within the scope of this final rule.
Comment: Many commenters stated that patients, healthcare providers, vaccine administrators, and vaccine manufactures do not support the Notice of Proposed Rulemaking.
Response: For the legal and policy reasons stated herein and in the proposed rule, the Department is finalizing this final rule. The Department notes, in addition, that nonSIRVA cases, including those filed on behalf of children, are adversely affected as resources are stretched or diverted to litigate SIRVA cases.
Comment: Many commenters state that even before SIRVA was added to the Table in 2017, individuals were able to receive compensation from the VICP
for their SIRVA related injuries.
Commenters point to VICP cases in 48 85

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which the Vaccine Court held that a causal connection between the administration of the vaccine and the consequential injury is sufficient proof for an award under the Vaccine Act.
Comments stated that the Departments change in policy is contrary to the Congressional Intent of the Act and would have a devastating effect upon parties ability to recover for their injuries.
Response: Prior to SIRVAs addition to the Table, SIRVA claims were sometimes awarded due to a combination of the government resolving the claims without litigating them to conclusion, and public statements by the Department suggesting SIRVA was a cognizable injury. The proposal to add SIRVA to the Table was in the works for several years before the 2015 notice of proposed rulemaking was published, and there was a great deal of public discussion about it at the ACCV and at the Court of Federal Claims annual judicial conference. The Department has in the past not always contested cases alleging injuries that have been proposed for addition to the Table if the case as pleaded fulfilled the criteria for entitlement to compensation. However, for the reasons discussed in the proposed rule and this final rule, including the Departments review of the statute and more recent scientific literature, the Department no longer believes such claims should be included on the Table or can be based on causation in fact, because they are not injuries associated with vaccines or their components, nor are they unavoidable injuries or illnesses that cannot be predicted in advance, or that can occur without fault.
Comment: Several commenters stated that HHS switched its position in this rulemaking without adequately considering the input of the Advisory Commission on Childhood Vaccines which unanimously rejected the rule change, and without discussing the change with the CDCs Advisory Committee for Immunization Practices ACIP, HHSs own National Vaccine Advisory Committee NVAC, the National Foundation for Infectious Disease NFID, and the Institute of Vaccine Safety at Johns Hopkins whose epidemiologists have consulted closely with the Program since its inception.
Response: The Department is grateful to the ACCV for its time spent considering the proposed changes and for providing its comments. The Department considered the ACCVs
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