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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations death, unless the person has first filed a petition in the Court. This is mandated by statute, and the Department does not have the authority to change this.
Comment: Some commenters believe that removing SIRVA and Vasovagal syncope will result in burdensome and time consuming litigation that is unfair to those injured since they would have to provide evidentiary support in state court. They also believe that the claims will clog up federal, state, and local courts. Other commenters suggested that removing these injuries from the VICP
will lead to claim suppression because many individuals will not have the resources to pursue their claims in court.
Response: It is the Departments position that if SIRVA and vasovagal syncope were removed from the Table, individuals could still file SIRVA and vasovagal syncope claims in state court, or Federal district court if they satisfy the requirements of 28 U.S.C. 1332 or 28
U.S.C. 1367. Once in those court, petitioners would be required to prove causation between the manner of administration and the claimed injury.
Further, this final rule is unlikely to unduly burden the civil tort system. The Department conducted a search in the WestLaw legal database for cases in state court that contained both the terms SIRVA and vaccine, and found only 20 hits, at least two of which were cases involving an entity named SIRVA
and not the injury. It is possible that some additional cases were filed in federal district court. Nonetheless, the Department believes based on this data that any additional burden on the civil tort system, which would be dispersed across States and not concentrated in any one or few States, from removing SIRVA and vasovagal syncope from the Table and reverting to the status quo as of January 2017 will be minimal.
Comment: Some commenters worry that removing SIRVA and vasovagal syncope from the Table will result in doctors and pharmacists being unwilling to administer vaccines because they fear personal liability.
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, but the Department also wants to incentivize those who administer vaccines to do so properly.34
34 See Frakes, M., & Jena, A.B. 2016. Does Medical Malpractice Law Improve Health Care Quality?. Journal of public economics, 143, 142
158. https doi.org/10.1016/j.jpubeco.2016.09.002
Finding evidence suggesting that treatment quality may improve upon reforms that expect
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Doing so will improve public confidence in vaccinations. Many physicians and pharmacists were willing to administer vaccines prior to SIRVA and vasovagal syncopes addition to the Table in 2017. 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 COVID19.35
Comment: Commenters suggest that the tax on flu vaccines that sustain the VICP fund should be returned to the doctors, pharmacists, and other vaccine administrators so that individuals injured by administration can sue the provider directly.
Response: The source of funding for the VICP is the Trust Fund. The Trust Fund is funded by an excise tax on each dose of vaccines recommended by the CDC for routine administration to children. To the extent that the commenter is proposing a change to the funding mechanism for the VICP, effectuating such a change is beyond the scope of this final rule.
Comment: Some commenters asked that all time limits for injuries be removed from the VICP.
Response: Revision of the statute of limitations would require a statutory amendment and thus is not within the scope of this final rule.
Comment: Many commenters wrote about their personal negative reactions to vaccine components.
Response: These comments are outside the scope of this rulemaking, since the scientific literature indicates that SIRVA and vasovagal syncope results from poor vaccination technique and the act of injection, rather than the vaccine components.
Comment: Some commenters asked that vaccine injury reporting be significantly improved to reflect all injuries caused by vaccine components.
Some asked that reporting to the Vaccine Adverse Event Reporting System VAERS be mandatory. A
commenter referenced the Harvard Pilgrim Health Care report which found that less than 1 percent of vaccine adverse events are reported.
Response: This final rule concerns the VICP, which is distinct from the Vaccine Adverse Event Reporting physicians to adhere to higher quality clinical standard.
35 See 85 FR 52,136, 52140 Aug. 24, 2020.

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System. As such, these comments are outside the scope of this final rule.
Comment: Two commenters opposed removing SIRVA from the Table because they stated that they have seen compensation greatly help those injured by providing resources for rehab treatment.
Response: The Department sympathizes with those who suffered an injury, but it is the Departments belief that Congress intended for the Vaccine Acts compensation system to be used for unavoidable injuries and illnesses that cannot be predicted in advance and can occur without fault. SIRVA is generally not that type of injury or illness. Moreover, under this final rule, those with SIRVA injuries are not barred from suing those who injured them in state court. Those injured still have an opportunity to be compensated.
Comment: Many commenters believe that the proposed rule changes are contrary to the legislative intent behind the creation of the vaccine injury compensation program, namely providing fair and prompt compensation to those individuals that have suffered well recognized injuries related to certain vaccines whilst shielding the pharmaceutical and medical industries from significant exposure.
Response: The Department explained in the proposed rule 36 and elsewhere herein why this final rule is consistent with Congressional intent.
Comment: Some commenters stated that it was the intention of Congress to centralize claims for compensation out of hundreds of tort venues to a centralized administrative compensation system, and removing SIRVA and vasovagal syncope is contrary to that congressional intent.
Response: The Department explained in the proposed rule 37 and elsewhere herein why this final rule is consistent with Congressional intent. SIRVA and vasovagal syncope are not the sorts of injuries that Congress intended for inclusion in the Table.
Comment: Many commenters believe that the proposed rule change will result in exposing pharmaceutical companies to liability and will inadvertently chill vaccine production.
Response: For the most part, this final rule merely reverts to the status quo as of January 2017. In fact, the vaccination rate has gone down slightly since SIRVA
and vasovagal syncope were added to 36 See 37 See
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