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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations for their SIRVA injury through the VICP.
These commenters stressed that the compensation is needed for treatments, pain and suffering, lost wages, and to help cover expenses while they are unable to work. They stressed that their SIRVA injuries make employment or career advancement extremely difficult, and many could no longer work in their chosen fields.
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 by the faulty party.
Comment: Many commenters asked what their recourse for SIRVA injuries would be if it is removed from the Table. Many other commenters believe that removal of SIRVA from the Table will eliminate any recourse for patients of improperly administered vaccines.
Response: Under this final rule, those with SIRVA injuries are not barred from suing those who injured them in state court or in federal court if the requirements for diversity jurisdiction under 28 U.S.C. 1332 are satisfied.
Comment: Many commenters believe that vaccine administration by poorly trained and minimally qualified staff is what leads to a high number of SIRVA
cases, so the Government should provide more training, guidelines, and supervision of medical staff and companies that administer vaccines.
These commenters suggest mandating more vaccine administration training and certification. Some suggested that funds from the VICP should be set aside to train providers with the proper technique of vaccine administration.
They believe that unless there is more regulation for continuous training on injection administration, SIRVA should not be removed from the table.
Response: The Department agrees that SIRVA is caused by improper vaccine administration. 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. Doing so will improve public confidence in
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vaccinations. Removing SIRVA from the Table further incentivizes learning proper administration technique. The Department agrees that proper vaccine administration is critical to ensure that vaccination is safe and effective. CDC
provides recommendations on vaccine administration technique, many of which can be found at https
www.cdc.gov/vaccines/hcp/admin/
admin-protocols.html.
Comment: Some commenters opposed removing SIRVA from the Table, but stress that since the injury is caused by faulty administration, the person administering the vaccine and causing the injury should be held accountable.
Response: While the Department disagrees with the suggestion to keep SIRVA on the Table, the Department understands the desire to hold accountable those who cause injury by using faulty administration. If those who administer vaccines can be held liable when a patient suffers from SIRVA as a result of the administration of the vaccine, those who administer vaccines will have greater incentive to use proper injection technique. 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 awarding no-fault compensation from the VICP to those with SIRVA and vasovagal syncope claims lessens the incentive to take appropriate precautions. Since Vaccine Act proceedings are generally sealed and not made available to the public, vaccine administrators may be left unaware that they used an improper technique. If SIRVA and vasovagal syncope are included in the Table, petitioners will continue to seek to recover from the VICP, where they can recover more easily because they need not prove causation, rather than from those who failed to properly administer the vaccine.
Comment: A commenter suggested increasing the VICP tax to help cover all SIRVA injuries and support more administration training.
Response: The Department lacks the authority to increase the VICP tax, and this is beyond the scope of this final rule.
Comment: Some commenters threatened that if SIRVA is removed from the Table, they will wage a campaign to discourage the public at large from receiving flu vaccines.
Response: Flu vaccines have a good safety record. Hundreds of millions of Americans have safely received flu vaccines over the past 50 years, and
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there has been extensive research supporting the safety of flu vaccines. A
flu vaccine is the first and best way to reduce your chances of getting the flu and spreading it to others. CDC
recommends that everyone 6 months of age and older receive a flu vaccine every year. More information on the safety of flu vaccines can be found at https
www.cdc.gov/flu/prevent/general.htm.
The Department anticipates that this final rule may result in fewer individuals suffering from SIRVA or vasovagal syncope, because it will better incentivize those administering vaccines to use proper injection technique.
Comment: Commenters believe the general public should be better informed about the risk of SIRVA. Some suggestions included an ad campaign, or informational pamphlets handed out before vaccine injection. One commenter suggested that all patients should receive the entire list of ingredients of all vaccines before they consent to the vaccine.
Response: All healthcare providers as defined in the Vaccine Act are required by the Vaccine Act 42 U.S.C. 300aa26
to give the appropriate VIS or Vaccine Information Statement to the patient or parent or legal representative prior to every administration of specific vaccines. A VIS or Vaccine Information Statement is a document, produced by CDC, that informs vaccine recipients or their parents or legal representativesabout the benefits and risks of a vaccine they are receiving.
Such materials shall be revised 1 after notice to the public and 60 days of comment thereon, and 2 in consultation with the Advisory Commission on Childhood Vaccines, appropriate health care providers and parent organizations, the Centers for Disease Control and Prevention, and the Food and Drug Administration. 42
U.S.C. 300aa26b. Since the aforementioned statutory required steps were not taken prior to the proposed rule, the commenters suggestions are outside the scope of this final rule.
Further information about vaccine ingredients can be found at https
www.cdc.gov/vaccines/vac-gen/
additives.htm.
Comment: Many commenters stress that HHS has drastically changed its position since March 21, 2017 when it adopted the Final Rule adding SIRVA to the Vaccine Injury Table. Commenters point to past Departmental interpretations of SIRVA and vasovagal syncope, and the inclusion of these injuries as covered under the VICP.
They argue that the Department does not have an adequate bases for changing
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