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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
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the Table,38 so it seems unlikely that this final rule will chill vaccine production.
Comment: Many commenters stated that there is no data supporting the Departments position that the trust fund is running out of money. These commenters state that without this data, HHS should not change the Vaccine Injury Table.
Response: SIRVA claims are diminishing the Trust Fund.39 The Department did not state that the Trust Fund is running out of money. 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: Many commenters do not believe that reducing the caseload of the VICP is a plausible justification to change the Injury Table. Others believe that the VICP should just hire more people to help process the caseload.
Response: 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 of caseload concerns.
Comment: Some commenters stated that limiting VICP claims would be harmful to families because if individuals and their families are inadequately compensated for injuries or death, they can be economically harmed. These costs could also be passed on to taxpayers when injured individuals and their families are forced to resort to extreme measures such as filing for bankruptcy.
Response: If SIRVA and vasovagal syncope were removed from the Table, individuals could still file SIRVA and vasovagal syncope claims in state court.40
Comment: Some commenters stated that HHSs interpretation of Section 300aa11a2A of the Vaccine Act is flawed because it interprets associated with the vaccine to mean that the injury must come from the vaccine itself instead of from the administration of the vaccine. The Department relies on a dictionary definition of associated with to conclude that it means related, connected, or combined together, but does not explain why this definition forecloses cases in which the vaccine combines together with its administration to bring about the 38 See, e.g., https www.cdc.gov/flu/fluvaxview/
coverage-1718estimates.htm; https www.cdc.gov/
nchs/data/hus/2018/031.pdf.
39 85 FR 43,798.
40 Or Federal district court if they satisfy the requirements of 28 U.S.C. 1332 or 28 U.S.C. 1367.

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illness. Furthermore, the phrase associated with the administration of the vaccine is not qualified. Congress could have said associated with the non-negligent administration of the vaccine or associated with the proper administration of the vaccine.
Commenters suggested that if as HHS
states in the proposed rule Congress intended to cover only those injuries associated with some antigen, then lawmakers would have used that word somewhere in the Act.
Commenters stated that according to the tort law principles in which the Vaccine Act is grounded, legal cause often implicates the combined effects of two or more forces, each constituting a substantial factor in bringing about the harm, and imposes liability upon each person or thing responsible for those forces. Therefore, consistent with tort law principles, a SIRVA claimant can be found to have sustained a vaccinerelated injury when a third partys negligent administration of the vaccine acts concurrently with the contents of needle, i.e., the vaccine, which combined effect is in turn a substantial factor in bringing about the petitioners harm. The commenter stated that this is consistent with the definition of associated with.
Response: Cases where the vaccine combines together with its administration to bring about the illness are fairly characterized as resulting from the administration technique, since they would not have occurred if the administration were proper. The fact that Congress could have said nonnegligent administration of the vaccine or associated with the proper administration of the vaccine does not call into question the Departments careful examination of, and analysis of, the relevant statutory terms, which is informed by the Departments expertise in this subject matter.
Comment: Some commenters disagree with the Departments reasoning that associated with does not include injuries caused by negligent administration of the vaccine. They point to 42 U.S.C. 30aa11 which they contend specifically provides for administration of the vaccine. They state that the Act refers to administration of the vaccine 17
times. Other commenters list prior interpretation of the act to be inconsistent with the Departments new interpretation.
Response: The Vaccine Act does in certain places refer to administration of or the administrator of the vaccine. But the Department thinks that those usages were not meant to suggest the Program covers negligence in the
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administration of the vaccine, but served other purposes. At most, these usages render the statute ambiguous with respect to needle injuries. In Section 300aa11a2A, the statute precludes suits against a vaccine administrator, but this reference does not define the scope of the compensation programinstead, it protects administrators from suits arising from a vaccine-related injury or death associated with the administration of a vaccine. This language is not entirely clear, as it appears to impose two distinct qualifications that both must be met but are worded slightly differently. It may be a belt and suspenders approach to ensure that vaccine administrators are protected from tort claims like in Amendola, where the vaccine itself was properly administered and caused the injury, but the petitioner alleged the administrator was negligent in deciding to give the vaccine. See 989 F.2d at 1186
holding Vaccine Program does not exclude cases of negligence in deciding, for example, whether to administer an otherwise satisfactory vaccine. The important point is that the first qualificationarising from a vaccine-related injuryis also included here and, Congress defined this requirement to include only injuries associated with the vaccine itself. See also 42 U.S.C. 300aa11b1A
referencing individuals who died as the result of the administration of a vaccine but only if the individual sustained a vaccine-related injury. In setting up the original Vaccine Injury Table, Congress referenced conditions resulting from the administration of such vaccines. 42 U.S.C. 300a14a.
But this phrase was not designed to define the scope of the program or the Table; instead, Congress directed the Secretary to add conditions to the Table if they were associated with such vaccines. 42 U.S.C. 300aa14e1B &
2B. And it is telling that Congress included nothing similar to SIRVA or other injuries caused by negligent vaccine administration in the original Table, rather than injuries associated with the vaccine components themselves. Finally, that Congress asked the Secretary to make or assure improvements in the administration of vaccines, 42 U.S.C. 300aa27a2, among many areas of improvement in the vaccination process, does not imply that the compensation program covers negligent administration.
Furthermore, state courts have found that injuries arising from negligent administration of a vaccine are not vaccine-related injuries under 42

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