Public Comments and Statements to Federal Agencies
Updated June 10, 2022
Department of Health and Human Services
- April 2021: Written, referenced public comment by NVIC Co-founder and President Barbara Loe Fisher and Executive Director Theresa Wrangham on behalf of NVIC supporting the withdrawal of the final DHHS rule romoving recognized vaccine injuries for syncope and shoulder injury related to vaccine administration (SIRVA) from the federal Vaccine Injury Table (VIT).
- February 2021: Written, referenced public comment by NVIC Co-founder and President Barbara Loe Fisher and Executive Director Theresa Wrangham regarding the review of the final rule and delay of effective date for DHHS to remove recognized vaccine injuries for syncope and shoulder injury related to vaccine administration (SIRVA) from the federal Vaccine Injury Table (VIT). NVIC's continues to oppose the removal of these injuries and requested that the rule be reversed.
- January 2021: Written, referenced public comment by NVIC Co-founder and President Barbara Loe Fisher and Executive Director Theresa Wrangham regarding the Notice of Proposed Rule-Making (NPRM) by DHHS to remove recognized vaccine injuries for syncope and shoulder injury related to vaccine administration (SIRVA) from the federal Vaccine Injury Table (VIT). NVIC's response opposed this NPRM and documents evidence base reviewed by the National Academies of Science and previous support of DHHS to include these injuries within the VIT to expedite vaccine injury compensation and to uphold the spirit and intent of the National Childhood Vaccine Injury Compensation Act of 1986.
- May 2020: Written referenced public comment by NVIC Co-founder and President Barbara Loe Fisher and Executive Director Theresa Wrangham regarding requests for comments by the Agency for Healthcare Research and Quality (AHRQ) on Supplemental Evidence and Data Request on Safety of Vaccines Used for Routine Immunization in the United States. NVIC's response included a statement opposing a review of vaccine safety evidence conducted by the AHRQ, due to inherent conflicts of interest and lack of independence.
- October 2019: Written referenced public comment by NVIC's Co-founder and President Barbara Loe Fisher regarding the developing of the 2020-2025 National Vaccine Plan and detailed past failures by DHHS to appropriately implement the 1986 National Childhood Vaccine Injury Act.
- January 2019: Written referenced public comment by NVIC's Executive Director Theresa Wrangham regarding the Healthy People 2030 Core, Developmental and Research Objectives relating to vaccination goals. The referenced comment noted that increased vaccine uptake does not necessarily equate to increased infectious disease prevention, citing overall ineffectiveness of the influenza vaccine as an example. The comment further noted the lack of reporting goals to improve the reporting of vaccine adverse events and informed vaccination decision-making and requested corrections of these oversights.
- September 2018: Oral and written referenced public comment by NVIC Co-founder and President Barbara Loe Fisher presented at the Notice for Proposed Rule Making (NPRM) public hearing of the Health Resources and Services Administration (HRSA) on the addition of CDC recommended vaccines for pregnant women to the VICP’s Vaccine Injury Table (VIT) of the federal Vaccine Injury Compensation Program (VICP).. She stated, “Although this NPRM requests public comment on how the addition of this new maternal vaccination category should be formatted on the Vaccine Injury Table, the public is hampered from making informed comment because of knowledge gaps, not only about the complexity of immune function during pregnancy, but about the safety and effectiveness of administering vaccines to pregnant women and potential negative health outcomes for the unborn child developing in the womb, including impaired immune responses to vaccination after birth.”
- June 2018: Written referenced public comment by NVIC Co-founder and President Barbara Loe Fisher and NVIC Executive Director Theresa Wrangham submitted to the Food and Drug Administration on “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials; Draft Guidance; Availability.” NVIC stated, “Pregnant women, developing fetuses and newborns are among the vulnerable populations for which high standards for proof of necessity; safety and effectiveness of vaccines should first be established in non-vulnerable populations…Given the acknowledged scientific research deficits, and lack of evidence to support the current off label use of vaccines during pregnancy, the draft document for industry would greatly benefit from inclusion of metrics specific to vaccines. There is urgent need to better understand the biological mechanisms of adverse responses to vaccination, high risk factors that make some individuals more susceptible to vaccine injury and death, and whether inducing inflammatory responses to acquire artificial active immunity by atypically manipulating the immune systems of pregnant women contributes to poor health outcomes in pregnant women and in their fetuses or infants born live.”
- June 2018. Written referenced public comment by NVIC’s Co-founder and President/CEO and Executive Director submitted to the National Vaccine Program Office (NVPO) on the Human Papillomavirus Vaccination Implementation Work Group Draft Report and Draft Recommendations for Consideration by the National Vaccine Advisory Committee. NVIC stated:
“We submit this public comment to respectfully express our on-going deep concern regarding the lack of attention to vaccine safety and informed consent protections in recommendations made by the National Vaccine Advisory Committee (NVAC), in this case, the HPV Working Group. The HPV Vaccination Work Group Draft Report and Recommendations appears to have been rushed to public comment. The public was given only 15 days to respond and public comments were limited to three pages. This very short notice has hampered the public’s ability to comment and there has been a lack transparency in that comments received on the Federal Register have been blocked from public view. Stakeholder engagement on the draft report and recommendations also appears to have been limited to those in agreement with the federal HPV vaccination schedule with no representation of parent organization stakeholders concerned about vaccine safety and informed consent issues”
We note that nowhere in the draft document is any attention paid to vaccine safety, no mention of the legal duty under the 1986 Vaccine Injury Act for vaccine administrators to inform or record and report vaccine adverse events. The national HPV vaccine promotion strategy recommended in this document fails to acknowledge the personal and family medical histories of individuals or respect for their values and conscientiously held beliefs, including religious beliefs.21 This approach is a prescription for causing mistrust of doctors aggressively implementing one-size-fits-all federal vaccine policies that place a greater emphasis on meeting vaccine uptake goals than protecting the health of individuals susceptible to vaccine adverse responses or respecting freedom of conscience and personal values and beliefs.”
Given that it may take decades to fully evaluate and answer outstanding questions about HPV vaccine effectiveness and safety, NVIC recommends a more restrained NVAC recommendation prioritizing safety, affirming respect for the precautionary principle and the informed consent ethic, and encouraging shared decision making by vaccine providers and the people to foster relationships based on transparency, patient empowerment and trust.”
- October 2016: Written referenced public comment submitted by NVIC on the Notice of Proposed Rule Making: Control of Communicable Diseases published by Centers for Disease Control and Prevention (CDC) to amend the Public Health Service Act to codify into law when and how the federal government can “more quickly and efficiently” exercise police power to apprehend individuals or their minor children, who are entering the U.S. or traveling across state borders by airplane, ship, bus or train, and isolate or involuntarily quarantine them if they have minor symptoms of illness that could indicate “they are or may become infected with quarantinable infectious diseases. NVIC stated:
“It is un-American to detain citizens for minor illness symptoms or to involuntarily quarantine and force them to choose between losing their freedom and signing a contract with the government consenting to vaccination and other “public health measures,” including electronic tracking, that could result in harm, especially when federal government employees are not legally liable in civil courts for any harm that is done… This NPRM exemplifies the kind of federal government overreach that increases fear and distrust of government officials and public health policies. It places travelers at risk for physical, mental, emotional and psychological harm and financial hardship when federal health officials invoke police power in the name of disease control, violating the long-standing rule that government should respect individual autonomy and use the least restrictive means to achieve public health goals. The National Vaccine Information Center (NVIC) opposes the NPRM and calls on the Secretary of the Department of Health and Human Services to withdraw it and for Congress to ensure that it does not become law.”
- July 2014: Written referenced public response by NVIC Co-founder and President Barbara Loe Fisher, Co-founder and Vice President Kathi Williams and Executive Director Theresa Wrangham to an inquiry from the Government Accountability Office about the operation of the federal vaccine injury compensation program (VICP) created by Congress in the National Childhood Vaccine Injury Act of 1986. In this 40-page statement by NVIC reviewing the history of the 1986 Act and implementation of the VICP by HHS, the Department of Justice and U.S. Court of Claims, NVIC provides a comprehensive critique of the misadministration the VCIP and the failure by HHS to appropriately implement the vaccine safety informing, recording, reporting and research provisions in the law. NVIC stated:
“Steps taken over the past three decades by the Department of Health and Human Services, Department of Justice and special masters in the U.S. Court of Claims have resulted in unjust limitation of the numbers of children receiving vaccine injury compensation after receipt of federally recommended or state mandated vaccines. Three out of four VICP petitioners are denied awards. Since 1988, there have been 15, 269 claims filed; 9,786 claims dismissed, and 3,645 compensated as of July 1, 2014. It is both shocking and telling that in a federal program created by Congress to provide financial assistance to children injured by government recommended and mandated vaccines, today only 20% of the total number of compensation awards are made to children while 80% are for adults. Currently, there are twice as many adult plaintiffs filing petitions for federal vaccine injury compensation than child plaintiffs.”
“Having worked hard to protect the legal rights of vaccine injured children and their parents when Congress took action in the early 1980’s to “protect the vaccine supply” after drug companies threatened to stop making childhood vaccines if they were not given liability protection, we are extremely disappointed by the failure of the 1986 law to fulfill the promises made to parents during the legislative process. We are deeply troubled by what has happened to a program that was sold to the American people as a no-fault, non-adversarial alternative to a civil product liability or malpractice lawsuit involving drug companies marketing federally recommended and state mandated childhood vaccines and pediatricians administering those vaccines to children in the U.S.”