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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations U.S.C. 300aa335, and therefore are not preempted by the Vaccine Act. See, e.g., Neddeau v. Rite Aid of Conn., 2015
WL 5133151, at 3 Super. Ct. Conn.
July 28, 2015 state court action did not allege a vaccine-related injury and therefore was not barred by the Vaccine Act, because plaintiffs allegation that the administrator struck the needle too high was an allegation that her injuries were caused by negligence in the physical process of injecting the vaccine, not by the effects of the vaccine; Nwosu ex rel. Ibrahim v.
Adler, 969 So. 2d 516, 519 Ct. App. Fla.
2007 claim arising from a physicians negligent injection of a vaccine was not a vaccine-related injury, and adding that it is true that had the child not been vaccinated, she would not have been injured. However, her injury as alleged, does not flow from the inoculant injected into her body so it is not the type of injury covered under the Act.
The Table should only include injuries caused by a vaccine or its components, not the manner in which the vaccine was administered. Thus, a petitioner must have an injury or death associated with the vaccine, not one resulting from poor injection technique or other improper administration of the vaccine.
Comment: One commenter stated that to the extent that negligence may well be a component of some SIRVA injuries, categorically excluding these as vaccinerelated injuries would make sense only if one could show that negligence alone causes SIRVA. The commenter asserts that medical literature shows that all SIRVA injuries necessarily involve an inflammatory, immune reaction in the deltoid/bursa region. See Vaccinerelated Shoulder Discomfort, M. Bordor & E. Montalvo; Shoulder injury related to vaccine administration, S. Atanasoff, et al.
Response: SIRVA stands for shoulder injury related to vaccine administration.
The Department does not necessarily agree that the scientific literature shows that all SIRVA injuries necessarily involve an inflammatory, immune reaction in the deltoid/bursa region. It is possible that certain injuries characterized as SIRVA occur when an immunologically active substance designed to trigger an inflammatory response i.e., the vaccine antigen is injected into an area where the inflammatory response can cause joint damage i.e., the bursa or tendons as opposed to an area where the inflammatory response will not cause joint damage or permanent harm i.e., the deltoid muscle. Such injuries are fairly characterized as resulting from the
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vaccination technique, since they would not have occurred if the injection occurred in the proper part of the body.
Comment: Some commenters provided critical reviews of the research cited by HHS in the proposed rule. One commenter stated that the medical and scientific literature cited by the Department is contrary to or at best inconclusive of the proposition that SIRVA is caused solely by the physical conduct attributable to the person administering the vaccine.
Response: The Department respectfully disagrees, and maintains the view espoused in the proposed rule.
The Department correctly characterized the literature in the proposed rule.
Comment: One commenter stated that HHS wrongfully stated that the standard of proof for establishing entitlement of a SIRVA claim is too low or lenient, leading to the filing of dubious or frivolous claims without providing any evidence of this in the proposed rule.
This commenter stated that the suspicion of activity is not proper justification for the Departments proposed policy change. The commenter also stated that the Departments claim that there has been a dramatic increase in SIRVA claims is meaningless without context, such as an increase in the number of flu vaccines administered from the 2016/2017 flu season to the 2018/2019 flu season. This commenter also pointed out that the there is no evidence that SIRVA claims are diminishing the Trust Fund, because according to the US Treasury Bulletin for March 2020, the balance of the Trust Fund at the end of FY 2019 was $3.95
billion, up from $3.85 billion at the end of FY 2018.
Response: DOJ informs the Department that, as of the time of the proposed rule, out of 2,214 SIRVA
claims filed since 2017, DOJ had identified 27 cases in which altered medical records have been filed, some of which involved changes to the site of vaccination. The proposed rule noted that the vaccination rate had decreased slightly since SIRVA was added to the Table,41 yet SIRVA claims have risen dramatically in recent years. 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.
Comment: Some commenters stated that if SIRVA is removed from the Vaccine Injury Table, it will have to be covered by malpractice insurance, which could unnecessarily drive up the 41 85

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costs of delivering vaccines and reduce the number of people willing to administer them.
Response: It is not clear this was problematic in the United States before SIRVA and vasovagal syncope were added to the Table in 2017, and the Department has been unable to locate any evidence that insurance has materially declined due to the addition of SIRVA and vasovagal syncope to the Table. Moreover, the vaccination rate has gone down slightly between when SIRVA and vasovagal syncope were added to the Table and the time of the proposed rule.42
Comment: A commenter asked that if SIRVA and vasovagal syncope are removed from the Table, all claims filed before the Final Rule be allowed to continue through the National Vaccine Injury Compensation Program.
Response: This final rule applies to claims filed after the effective date of this final rule.
Comment: A commenter stated that in the 34 years since the Vaccine Act was passed by Congress, HHS has only ever added to the Injury Table, and that it is deeply troubling and potentially against the intent of the Act to remove injuries from the Table.
Response: The Vaccine Act explicitly provides that the Secretary can delete from the list of injuries, disabilities, illnesses, conditions, and deaths for which compensation may be provided.
42 U.S.C. 300aa14c3. Therefore, this final rule is consistent with the statutory text and Congressional intent.
Comment: Some commenters stated that the Departments contention that SIRVA should be removed, in part, because patient records were altered in 27 out of 2,214 cases is unsupportable.
They state that the average fraudulent health care claims, according to the National Health Care Anti-Fraud Association, is 3%, which is higher than the reported fraud in the SIRVA records, which is 1.2%. One commenter points out that, as of January 1, 2020, the Court requires that all medical records be certified under the Pre-Assignment Review Order, which greatly reduces the chance of fraudulent records.
Response: DOJ had identified 27 cases in which altered medical records have been filed, some of which involved changes to the site of vaccination.
However, it is possible there were additional instances that DOJ did not uncover. The Department is finalizing this final rule because of a combination of legal and policy reasons stated herein and in the proposed rule, not solely because of fraud.
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