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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
XVII, includes any new vaccine recommended by the Centers for Disease Control and Prevention for routine administration to children, after publication by the Secretary of a notice of coverage. 5 Two injuriesShoulder Injury Related to Vaccine Administration SIRVA and vasovagal syncopeare listed as associated injuries for this category. Through this general category, new vaccines recommended by the CDC for routine administration to children and subject to an excise tax are deemed covered under the VICP prior to being added to the Table as a separate vaccine category through Federal rulemaking.
The Department previously issued a notice of proposed rulemaking that proposed to remove SIRVA, vasovagal syncope, and Item XVII from the Vaccine Injury Table found at 42 CFR
100.3. The Department did so for the reasons set forth in the proposed rule.6
Pursuant to the Vaccine Act, HHS
provided the proposed revisions to the Vaccine Table to the ACCV.7 The ACCV
considered the proposed changes set forth in the proposed rule on March 6, 2020 and May 18, 2020. Four members of the ACCV also held a workgroup meeting on April 3, 2020 to discuss the proposed changes. On July 16, 2020, the proposed rule went on public display, with a comment period that ended on January 12, 2021.8 On November 9, 2020, the Department held a public hearing pursuant to 42 U.S.C. 300aa 14c1 via teleconference to discuss the proposed rule.9
The Department now finalizes the proposed rule to remove SIRVA and vasovagal syncope from the Table found at 42 CFR 100.3a and to remove the corresponding descriptions of those injuriesQualifications and Aids to Interpretation QAIfrom 42 CFR
100.3c. This decision is based upon a review of the relevant statutory provisions and the scientific literature, as well as the Departments experience since SIRVA and vasovagal syncope were added to the Table. The Department also finalizes its proposal to remove Item XVII from the Table found at 42 CFR 100.3a, because the Department has serious concerns that Item XVII is contrary to applicable law, 5 42

CFR 100.3a.
85 FR 43794 July 20, 2020 proposed rule.
7 The Department first provided the proposed revisions to the Table and requested recommendations and comments by the ACCV on or about February 15, 2020.
8 National Vaccine Injury Compensation Program:
Revisions to the Vaccine Injury Table, 85 FR 43794
July 20, 2020.
9 https www.regulations.gov/
document?D=HRSA-2020-0002-0373.

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for the reasons set forth below. The Department finalizes this final rule for the reasons set forth in the proposed rule. This final rule does not impact COVID19 vaccines or PREP Act immunity for Covered Persons as defined in the PREP Act who manufacture, distribute, order, or administer COVID19 vaccines.
II. Discussion of, and Response to, Public Comments What follows is a summary of the public comments the Department received on the notice of proposed rulemaking for this rule, which had a comment period that ended on January 12, 2021, and the comments received at the public hearing on the proposed rule.
The Department received 763 comments on the proposed rule. Commenters included patients, family and friends of patients, vaccine lawyers, rehabilitation counselors, nurses, doctors, legal clinics, law firms, law schools, biotech trade associations, pharmacist acclimations, drug store associations, and non-profits. The majority of commenters made statements in opposition to the proposed rule, although some commenters supported the proposed rule.
The public hearing was conducted on November 9, 2020 from 10:00 a.m. till 3 p.m. via Adobe connect teleconference. 34 comments were provided during the public hearing on the proposed rule. Commenters included those who experienced SIRVA
injuries, doctors, vaccine lawyers, representatives from vaccine legal clinics, law professors, representatives from biotechnical associations, and representatives from vaccine information associations. All commenters who spoke at the public hearing were in opposition to the proposed rule. Below are summaries of the comments and the Departments responses.
Section I: Comments Regarding Vaccines in General Comment: Many commenters expressed concerns over the safety of vaccines in general. Some believe that all chemicals in vaccines are harmful to the body and cause bone and organ deterioration. Some believe that all vaccines should be stopped entirely.
Others called for a complete moratorium on vaccines until all negative side effects are gone. Some commenters believe that vaccine and pharmaceutical companies are evil and have bought the government to push unsafe vaccines.
They stress that vaccines are useless and unsafe and the very fact that the VICP

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is in existence proves that vaccines are unsafe.
Response: Vaccines are one of the greatest success stories in public health.
Through use of vaccines, we have eradicated smallpox and nearly eliminated wild polio virus. The number of people who experience the devastating effects of preventable infectious diseases like measles, diphtheria, and whooping cough is at an all-time low. The United States has a long-standing vaccine safety program that closely and constantly monitors the safety of vaccines. Before vaccines are approved by the Food and Drug Administration FDA, they are tested and studied extensively by scientists to help ensure they are safe and effective.
After vaccines are approved, a critical part of the vaccine safety program is that the Centers for Disease Control and Prevention CDCs Immunization Safety Office ISO and FDA monitor for possible vaccine side effects and conduct studies to determine whether health problems are caused by vaccines.
CDCs ISO data show that the current U.S. vaccine supply is the safest in history.10 Also, regulating clinical research and reviewing the safety of vaccines are responsibilities of the FDA, not the VICP, and changes in vaccine research and how vaccines are studied and tested are beyond the scope of this final rule.
Comment: Some commenters described bad reactions they, or their children, personally experienced from a range of vaccines to argue that there should be an end to mandated vaccines for children.
Response: The Department sympathizes with all those who have experienced negative reactions to vaccines. Vaccination is one of the best ways to protect against potentially harmful diseases that can be very serious, may require hospitalization, or even be deadly. Almost all individuals who are vaccinated have no serious reactions.11 Nonetheless, in the 1980s, Congress became concerned that a small number of children who received immunizations had serious reactions to them, and it was not always possible to predict which children would have reactions, or what reactions they would have.12 Therefore, Congress enacted the 10 http www.cdc.gov/vaccinesafety/
ensuringsafety/history/index.html.
11 National Vaccine Injury Compensation Program, Health Resources & Servs. Admin., https www.hrsa.gov/vaccine-compensation/
index.html last reviewed Jan. 2021.
12 H.R. Rep. No. 99908, pt. 1, at 6 1986. Even though in rare instances individuals may have adverse reactions to vaccines, the Centers for Disease Control and Prevention CDC recommends
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