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Federal Register / Vol. 86, No. 12 / Thursday, January 21, 2021 / Rules and Regulations
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National Childhood Vaccine Injury Act of 1986, title III of Public Law 99660
42 U.S.C. 300aa1 et seq. Vaccine Act, which established the National Vaccine Injury Compensation Program VICP. The objectives of the VICP are to ensure an adequate supply of vaccines, stabilize vaccine costs, and establish and maintain an accessible and efficient forum for individuals found to be injured by certain vaccines to be federally compensated.
While the federal government recommends that individuals be vaccinated against a wide range of illnesses and diseases, it does not mandate them. Each state decides which vaccines are required for childs enrollment and attendance at a childcare facility or school in that state.
Vaccination requirements and allowable exemptions vary by state.13
Comment: Commenters believe that there should be no vaccines that contain metals, formaldehyde, preservatives, fetal tissue, and other potentially harmful ingredients to humans.
Response: That is beyond the scope of this final rule. For more information on the contents of vaccines and their safety, please see https www.fda.gov/
vaccines-blood-biologics/safetyavailability-biologics/commoningredients-us-licensed-vaccines.
Comment: Some commenters believe that vaccines are an attempt to supersede their rights as parents, and this regulation should be abandoned.
Response: The federal government is not trying to supersede parents rights.
The purpose of vaccines are to eradicate diseases and to reduce the number of people who experience the devastating effects of preventable infectious diseases like measles, diphtheria, and whooping cough. This regulation does not address parents rights with respect to their children.
Comment: A commenter expressed anger about the Gardasil HPV vaccine causing injury and death.
Response: There is a safe and effective HPV vaccine that can prevent the infections that most commonly cause cancer. Gardasil 9 human papillomavirus 9-valent vaccine, recombinant; 9vHPV was approved by the FDA for use in 2014. The safety of Gardasil 9 was studied in clinical trials that individuals be vaccinated against a wide range of illnesses and diseases. See Recommended Vaccines by Age. Ctrs. for Disease Control &
Prevention, https www.cdc.gov/vaccines/vpd/
vaccines-age.html last reviewed Jan. 2021.
13 More information about state vaccination requirements for daycare and school entry can be found at https www.cdc.gov/vaccines/imzmanagers/laws/state-reqs.html last reviewed Jan.
2021.

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with more than 15,000 participants before it was licensed and continues to be monitored. Gardasil 9 protects against 9 types of cancer-causing HPV
types 6, 11, 16, 18, 31, 33, 45, 52, and 58. For more information on the HPV
vaccine, side effects, and who should and should not receive this vaccine, see https www.cdc.gov/vaccinesafety/
vaccines/hpv-vaccine.html.
Comment: Some commenters asked to make vaccines optional. They believe that vaccines should not be mandated.
Commenters believe that all vaccines should be voluntary. Many commenters contended that they are not. Many expressed a strong desire against being forced to get any vaccine, specifically the COVID19 vaccine.
Response: State laws establish vaccination requirements for school children and some state healthcare workers. Revision of state laws and requirements are not within the scope of this final rule.
Comment: Some commenters expressed concern that their jobs made it mandatory to have vaccines. They believe that since their jobs make it mandatory, all related injuries should be compensated by the government.
Response: Employment requirements are beyond the scope of this final rule.
Comment: Some commenters believe that all of the studies supporting vaccines are biased and created out of fear of the vaccine lobby.
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.14 Also, regulating clinical research and reviewing the safety of 14 http www.cdc.gov/vaccin19esafety/
ensuringsafety/history/index.html.

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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.
Section II: COVID19 Vaccine Comments Comment: Some commenters expressed concern that the proposed rule did not add the COVID19 vaccine to the Table. Some commenters believe that the Notice of Proposed Rulemaking would stop the automatic addition of the COVID19 vaccine to the Vaccine Injury Table. Some believe the COVID
19 vaccine should be added to the Table to make the general public feel better about taking the vaccine; they believe that the change in the Table will increase fear of vaccination. Some commenters believe that since the COVID19 vaccine is not included on the Table, it is unsafe. Others are concerned that the Government will mandate the COVID19 vaccine, and that the changes to the Table are an attempt by the government to shield itself from any responsibility to compensate for COVID19 vaccine related injuries. Other commenters asked if someone was injured by the COVID19 vaccine, how would they be compensated.
Response: This final rule has zero impact on inclusion of the COVID19
vaccine on the Table. The COVID19
vaccine can separately be added to the Table, but the Department needs to follow the process specified in 42 U.S.C.
300aa14cd to do so. This includes that the ACCV recommend that the COVID19 vaccine be added, or opine on the Departments recommendation to add the COVID19 vaccine to the Table.
Prior to COVID19 vaccines being added to the Table, injuries resulting from these vaccines can be compensated under the Countermeasures Injury Compensation Program CICP.
The CICP is administered by the Health Resources and Services Administration, within the Department of Health and Human Services.
Information about the CICP and filing a claim are available at the toll-free number 18552662427 or the CICPs website, https www.hrsa.gov/cicp/.
Comment: Commenters believe that it is suspicious that the Administration is trying to remove injuries from the Table secretly during the COVID19
pandemic. Other commenters suggested that the Department should not remove SIRVA from the Table at a time when millions more vaccines are being administered against COVID19.
Response: The Department respectfully disagrees that injuries are
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