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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
being removed from the Table secretly. The ACCV publicly discussed the proposal on March 6, 2020 and May 18, 2020. Recordings of both discussions are publicly available at https www.hrsa.gov/advisorycommittees/vaccines/meetings.html.
The Department subsequently published the Notice of Proposed Rulemaking in the Federal Register and provided a 180-day public comment period. It also held a public hearing on the proposed rule on November 9, 2020. The fact that the commenters were able to comment on the proposed rule indicates that SIRVA and vasovagal syncope are not being removed secretly. This final rule has zero impact on the COVID19
vaccine, which is not currently on the Table. Those injured by the COVID19
vaccine can recover from the CICP if they satisfy the statutory and regulatory prerequisites.
Comment: A commenter expressed anger about the COVID19 vaccine altering the very DNA of its recipient.
Response: This comment is outside the scope of this rulemaking. The Department notes, though, that COVID
19 mRNA vaccines do not affect or interact with DNA in any way.15
Comment: Some commenters asked the Department to consider giving people stimulus checks in exchange for receiving the COVID19 vaccine.
Response: Whether to provide stimulus checks for receiving the COVID19 vaccine is outside the scope of this final rule.
Comment: One commenter asked the Department to reconsider removing SIVRA and vasovagal syncope from the Table because nurses, and those on the medical front line, need protection from liability, especially considering the overwhelming year they have had due to the COVID19 pandemic.
Response: The Department thanks front-line workers for the tremendous work they have done over the past year.
This final rule does not impact PREP
Act immunity for Covered Persons as defined in the PREP Act who manufacture, distribute, order, or administer COVID19 vaccines. Under the PREP Act and the Secretarys March 10, 2020 PREP Act declaration, as amended, during the effective period of the declaration, Covered Persons are immune from suit and liability absent willful misconduct under Federal and State law with respect to all claims for loss caused by, arising out of, relating to, or resulting from the administration 15 More information about how COVID19 mRNA
vaccines work can be found at https www.cdc.gov/
coronavirus/2019-ncov/vaccines/different-vaccines/
mrna.html.

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to or the use by an individual of a covered countermeasure.16
Section III: General Support for the Proposed Rule Comment: Some commenters believe that there is no good rationale to include adverse events that are due to the physical administration of the vaccine rather than the effects of the contents.
Commenters believe keeping those events covered by the program actually waters down the intent of the program and pulls away resources from the people who were actually affected by the vaccines themselves.
Response: The Department agrees.
Comment: Some commenters believe that the high number of SIRVA and vasovagal syncope cases submitted to the VICP has led to a falsely elevated number of reported side effects and reinforcing the fear of receiving vaccines by those who may be uninformed.
Response: The Department agrees.
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, removing SIRVA
and vasovagal syncope from the Table would more accurately reflect the number of reported side effects actually caused by vaccine components. Such claims, which are not associated with vaccines or their components, therefore erroneously suggest that vaccines are less safe than they in fact are.
Comment: Some commenters believe that SIRVA and vasovagal syncope cases submitted to the VICP has also has contributed to a delayed process in awarding monies to those with valid claims related to the vaccine itself.
Response: The Department agrees.
Comment: Some commenters believe the federal government is not the place to lodge a complaint related to the administration of a vaccine. The appropriate place to do this is through the traditional court system or through practitioner licensing boards. They believe that current use and the number of claims for shoulder injury in adults are against the intent and spirit of the original law.
Response: The Department thanks the commenters for these comments. 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 and 16 42 U.S.C. 247d6d; see also Fourth Amendment to the Secretarys PREP Act Declaration, 85 FR79,190, 79,195 Dec. 9, 2020.

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vasovagal syncope are generally not those types of injuries or illnesses. With proper injection technique, SIRVA is likely preventable. The scientific literature also suggests that those administering vaccines can take steps to significantly reduce the likelihood of vasovagal syncope.
Section IV: General Concerns Comment: Many commenters believed that vaccine or pharmaceutical companies should be solely liable for all negative side effects caused by their vaccines. They called for the repeal of the laws which grant vaccine manufactures immunity.
Response: The National Childhood Vaccine Injury Act of 1986 was passed by Congress. To repeal the Act would require a statutory amendment and thus is not within the scope of this final rule.
Comment: Some commenters fear that the proposed rule will disband the entire VICP.
Response: This final rule is not disbanding the VICP. For the most part, this final rule reverts to the status quo as of January 2017. The one additional change, removing Item XVII, is being done because the Secretary has serious concerns that Item XVII does not comport with applicable law. All vaccines currently on the Table, and the vast majority of injuries currently on the Table, will remain on the Table after this final rule becomes effective.
Comment: Many commenters stated that the National Vaccine Injury Compensation Program covers injuries caused not only by the contents of the vaccine, but also the administration of the vaccine. They stated that but for the vaccine, there would not be a faulty administration, and there would not be a SIRVA injury. Many other commenters stated that all injuries, whether caused by the contents of the vaccine or by faulty administration of the vaccine, should be covered by the VICP.
Commenters stated that HHS incorrectly interpreted the Vaccine Act to preclude claims involving negligence by the vaccine administrator. This commenter stated that contrary to the HHS
interpretation of the Act, legislative history shows that Congress expressly indicated that it sought to broadly cover all injuries or death associated with vaccine administrations.
Response: The Secretary respectfully disagrees with the comment that whether or not SIRVA is caused by faulty administration the VICP should cover the injuries. The Department has concluded that the Vaccine Act should be read as not applying to cover injuries, like SIRVA and vasovagal syncope, which involve negligence by the vaccine
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