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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
to the Table if they were associated with such vaccines. 42 U.S.C. 300aa 14e1B & 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.
Perhaps for some or all of these reasons, state courts have found that injuries arising from negligent administration of a vaccine are not vaccine-related injuries under 42
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. The Department believes SIRVA and vasovagal claims should not be included on the Table and cannot be based on causation in fact, because they are not injuries associated with vaccines or their components, nor are they unavoidable injuries or illnesses that cannot be predicted in advance, or that can occur without fault.
Comment: Some commenters asked that this final rule be postponed until the new administration enters office, arguing that it is unfair to change the VICP in the final days of President Trumps administration.

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Response: Past practice has often been to finalize rules that are ready for finalization without waiting for the incoming Administration to take office.17 This is consistent with the Departments desire to as expeditiously as possible ensure the Table complies with applicable law.
Comment: Many commenters took issue with the Departments assertion in the proposed rule that retaining SIRVA
and vasovagal syncope injuries on the Table will encourage frivolous petitions for compensation and add to DOJs caseload.
Response: The proposed rule explained in detail how DOJs caseload has increased since SIRVA and vasovagal syncope were added to the Table. DOJ had informed the Department that, 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.
Section V: SIRVA-Specific Comments Comment: Many commenters stated that according to medical literature, not all SIRVA is related to improper injection technique, and some or all cases of SIRVA result from the antigen itself, not just the needle placement in the bursa. These commenters stated that this undermines the Departments justification for removing SIRVA from the Vaccine Injury Table. They also state that HHS was incorrect to suggest that there is nearly uniform agreement in the scientific community that SIRVA is caused by improper vaccine administration, rather than by the vaccine itself. Other commenters stated that since medical literature is split on the cause of SIRVA, it should be left on the table until further research can be done.
Response: There is nearly uniform agreement in the scientific community that SIRVA is caused by improper vaccine administration, rather than by the vaccine itself.18 Since the 2017 Final Rule was promulgated, additional 17 For example, fifty-six 56 new rules were finalized in the final two 2 full days of the previous Administration. See Federal Register, https www.federalregister.gov/documents/
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18 See Barnes MG, Ledford C, Hogan K. A
needling problem: shoulder injury related to vaccine administration. J Am Board Fam Med. 2012
Nov-Dec;256:91922; Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Dont aim too high:
Avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016
May;455:3036.

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scientific research concluded that subdeltoid or subacromial bursitis and other shoulder lesions are more likely to be the consequence of a poor injection technique site, angle, needle size, and failure to take into account a patients characteristics, i.e., sex, body weight, and physical constitution, rather than antigens or adjuvants contained in the vaccines that would trigger an immune or inflammatory response. 19 The Department has not seen compelling peer-reviewed publications, submitted either by the commenters or otherwise, that calls into question this conclusion. Indeed, SIRVA
stands for shoulder injury related to vaccine administration.
Comment: Many commenters wrote about their SIRVA injuries and experiences with treatment and therapy.
Many received or were in the process of receiving compensation through the VICP. They stressed the pain and suffering they went through due to a badly administered vaccine and asked for SIRVA to remain on the Table. They believe they deserve just compensation 19 Mart n Arias, K.H., Fadrique, R., Sainz Gil, M., and Salgueiro-Vazquez, M.E., Risk of bursitis and other injuries and dysfunctions of the shoulder following vaccinations, Vaccine, 2017;35:4870
4876. See also Bancsi A, Houle SKD, Grindrod KA.
Shoulder injury related to vaccine administration and other injection site events. Can. Fam.
Physician. 2019 Jan;651:4042 explaining that SIRVA is a preventable occurrence caused by the injection of a vaccine into the shoulder capsule rather than the deltoid muscle; Macomb CV, Evans MO, Dockstater JE, Montgomery JR, Beakes DE. Treating SIRVA Early With Corticosteroid Injections: A Case Series. Mil Med. 2019 Oct 17
noting that SIRVA does not occur unless the vaccine is mistakenly given in the shoulder capsule. Another recent study reviewed the Vaccine Adverse Event Reporting System VAERS
database from July 2010 to June 2017 for reports of atypical shoulder pain and dysfunction following injection of inactivated influenza vaccine IIV. See B.F. Hibbs, C.S. Ng, O. Museru et al., Reports of atypical shoulder pain and dysfunction following inactivated influenza vaccine, Vaccine Adverse Event Reporting System VAERS, 20102017, Vaccine. The review found that, of the 266 reports where contributing factors for the injury were reported, 216 81.2% described the vaccination as being given too high on the arm. Other reports described improper or poor administration technique e.g., bone strikes, administered in tendon, uneven position between vaccinator and the patient e.g., vaccinator standing while patient sitting, vaccination needle too long, and others e.g., difficulty injecting vaccine. A small minority of reports also indicated the patient had a history of thyroid dysfunction or diabetes. 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 vaccination technique, since they would not have occurred if the injection occurred in the proper part of the body.

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