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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations that cannot be predicted in advance and can occur without fault. Vasovagal syncope is generally not that type of injury or illness. Scientific and medical literature support the conclusion that syncope may be caused by the act of vaccination, but not its contents.25
Texas state malpractice laws are beyond the scope of this final rule.
Comment: Some commenters stated that contrary to the Departments position that vasovagal syncope is not a vaccine-related injury, the IOM found sufficient mechanistic evidence supporting the conclusion that syncope is directly related to vaccine administration, and that the CDC has reported people fainting after receiving nearly all vaccines. While the commenters agree that steps can be taken to reduce the risk of syncope, they state that it should remain on the Injury Table.
Response: The IOM found insufficient epidemiologic evidence of an association between the injection of a vaccine and syncope, but it found sufficient mechanistic evidence supporting the conclusion that syncope is directly related to vaccine administration. 26 The IOM explained that evidence it examined as part of its review suggested that the injection, and not the contents of the vaccine, contributed to the development of syncope. 27 In addition, because syncope is an injury related solely to the injection of a vaccine, the Department did not add syncope to the 2017
revisions to the Table as an injury for vaccines that are not administered by injection, such as oral polio and rotavirus vaccine.
Comment: One commenter stated that removing syncope from the table would go against three decades of precedent and the weight of the medical evidence.
Response: The Department respectfully disagrees. Vasovagal syncope was not added to the Table until 2017. From the inception of the Table until 2017, vasovagal syncope is not included.
Section VII: Comments Regarding Item VII

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Comment: Some commenters are concerned that removing Item XVII from 25 80 FR 45,137 The IOM found that one case report suggested that the injection, and not the contents of the vaccine, contributed to the development of syncope. See also IOM Report at 18 injection of vaccine, independent of the antigen involved, can lead to syncope; Miller, E.
and Woo, E.J. Time to prevent injuries from postimmunization syncope, Nursing, 2006 36 12:
20.
26 80 FR 45137.
27 80 FR 45137. See also IOM Report.

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the Table will remove an avenue to add new vaccines to the Table.
Response: The Department is removing Item XVII from the table because it has serious concerns that Item XVII is contrary to law, including the procedures described in the Vaccine Act for amending the Table.
Specifically, to the extent that Item XVII
provides a unilateral mechanism for adding injuries and vaccines to the Table, it may be inconsistent with the Vaccine Act. The Vaccine Act provides a method for adding new vaccines to the Table, and it is far from clear that the approach in Item XVII complies with that method. The Vaccine Act provides that the Secretary may promulgate regulations to modify the Table, but in doing so, he shall provide for notice and opportunity for a public hearing and at least 180 days of public comment. 28 Moreover, the Table cannot be revised unless the Secretary has first provided to the ACCV a copy of the proposed regulation or revision, requested recommendations and comments by the ACCV, and afforded the ACCV at least 90 days to make such recommendations. 29 Item XVII, by contrast, suggests that vaccines are added to the Table once the CDC
recommends them for routine administration to children and an excise tax is imposed, even prior to notice and public comment or comments from the ACCV.30 This may be inconsistent with the rulemaking requirements of the Administrative Procedure Act 5 U.S.C.
553, the Regulatory Flexibility Act, 5
U.S.C. 601 et seq., various Executive Orders that cabin rulemaking see, e.g., Executive Order 12866, and the Vaccine Act.
Moreover, even with the removal of Item XVII, new vaccines may be added to the Table under 42 U.S.C. 300aa 14d, when appropriate.
Comment: One commenter stated that HHSs argument that Item XVII is unlawful is without merit. Article I of the Constitution provides Congress the authority to delegate responsibilities to 28 42

U.S.C. 300aa14c1.
U.S.C. 300aa14d.
30 The language in Item XVII also raises Constitutional concerns. Item XVII in effect allows CDC to add vaccines to the Table so long as the Secretary publishes notice of coverage. The Office of Legal Counsel has previously opined that a statute that sought to authorize the CDC director to take certain action unilaterally was inconsistent with the Executive Powers Clause. Statute Limiting The Presidents Authority To Supervise The Director Of The Centers For Disease Control In The Distribution Of An AIDS Pamphlet, 12 U.S. Op. Off.
Legal Counsel 47, 48, 1988 WL 390999, at 1. For the same reasons, it is not clear that the CDC
director, as an inferior officer, has the authority to unilaterally add vaccines to the Table without the approval of the Secretary.
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independent agencies, and the Vaccine Act expressly provides that HHS shall amend the Vaccine Injury Table to include any CDC vaccine recommended for routine childhood use within two years. According to this commenter, Congress provided the CDC with an autonomous role in the VICP process, and its recommendations are separate from administrative action by HHS.
Therefore, commenters stated that Item XVII is lawful.
Response: The Vaccine Act provides that the Secretary may promulgate regulations to modify the Table, but in doing so, he shall provide for notice and opportunity for a public hearing and at least 180 days of public comment. 31 Moreover, the Table cannot be revised unless the Secretary has first provided to the ACCV a copy of the proposed regulation or revision, requested recommendations and comments by the ACCV, and afforded the ACCV at least 90 days to make such recommendations. 32 Item XVII, by contrast, suggests that vaccines are added to the Table once the CDC
recommends them for routine administration to children and an excise tax is imposed, even prior to notice and public comment or comments from the ACCV.
Comment: One commenter stated that Item XVII does have merit, especially because it streamlines the process to allow for quicker inclusions of important vaccines. This commenter stated that this is especially important and timely due to the impact of the COVID19 pandemic and the need to provide quick compensation for COVID19 vaccine-related injuries or deaths. Removing Item XVII would just frustrate the stated purpose of the Vaccine Act.
Response: The Department appreciates the desire to quickly add vaccines to the Table. However Congress in 42 U.S.C. 300aa14
specified the procedures that must be followed to amend the Table. In addition, an excise tax would have to be imposed.
Comment: A few commenters opposed the removal of the mechanism to add vaccines to the Table under item XVII. According to the commenters, the proposed rule would stop the automatic addition of COVID19 and other new vaccines to the VICP, which could potentially delay or permanently prevent the COVID19 vaccine from being covered under the VICP, and subjecting administrators to lawsuits in the future. Commenters suggested that 31 42
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U.S.C. 300aa14c1.
U.S.C. 300aa14d.

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