Vaccine Advisory Committee Statements
Since 1982, NVIC has advocated for well-designed, independent, on-going scientific studies to: (1) define the various biological mechanisms involved in vaccine injury and death: (2) identify genetic and other biological high risk factors for suffering chronic brain and immune system dysfunction after vaccination; and (3) evaluate short and long-term health outcomes of individuals, who use many vaccines, and those, who use fewer or no vaccines, to determine the health effects of vaccine policies and laws on individuals and the public health.
NVIC's co-founders worked with Congress on the National Childhood Vaccine Injury Act of 1986, which acknowledged that vaccine injuries and deaths are real and that the vaccine injured and their families should have access to both a federal vaccine injury compensation program (VICP) administrative alternative to a vaccine injury lawsuit, while protecting access to the civil justice system to seek compensation for harm caused by federal recommended childhood vaccines. Congress recognized the need to make the mass vaccination system safer and NVIC co-founders were responsible for securing vaccine safety informing, recording, reporting and research provisions in the 1986 Act.
Congress established a National Vaccine Program Office (NVPO) in the Department of Health and Human Services (HHS) as part of the 1986 Act and also created several new federal vaccine advisory committees: Advisory Commission on Childhood Vaccines (ACCV) and National Vaccine Advisory Committee (NVAC). Together with the long standing Vaccines and Related Biological Products Advisory Committee (VRBPAC) in the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP), these vaccine advisory committees play pivotal roles in HHS in the licensing and regulating of vaccines, the processing of claims in the federal vaccine injury compensation program (VICP) and in the shaping of vaccine policy and law in the U.S.
The public may attend and make public comment in person or view federal vaccine advisory committee meetings online. However, it should be understood that these committees are advisory in nature, as noted in the Federal Advisory Committee Act (FACA). Since 1988, NVIC has participated in, monitored and reported on the activities and recommendations made by these committees. Committee minutes and updates of votes and actions taken are posted on their respective websites.
For more information on federal vaccine advisory committees, click the links below. Scroll down to read a selection of written and oral public comments NVIC has provided to these committees and to federal agencies on vaccine-related issues.
Selected NVIC Public Comments and Statements to Federal Vaccine Advisory Committees and Federal Agencies
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.”
Advisory Commission on Childhood Vaccines (ACCV)
- December 2020: NVIC Presentation to the ACCV - Consumer Perspective on DHHS Proposed Removal of Syncope and SIRVA from the Vaccine Injury Table. NVIC's Executive Director made this presentation to the ACCV by invitation and as an organization of standing.
- December 2020: Oral Public Comment by NVIC's Executive Director opposing DHHS removal of SIRVA and syncope from the Vaccine Injury Table and noting federal requirements to add vaccines to the vaccine injury table within two years of their routine recommended use in children.
- May 2020: Oral Public Comment by NVIC's Executive Director by invitation of the ACCV. Ms. Wrangham's comment focused on the lack of transparency and compliance with the National Childhood Vaccine Injury Act of 1986 relating to HHS' plan to remove SIRVA and syncope from the Vaccine Injury Table without a presentation of evidence to the ACCV. She noted that historically a presentation of evidence to the ACCV was made prior to any changes to the Table to allow ACCV to comply with their duties under the 1986 Act. Lastly, she noted the long history of amendments to the 1986 Act that has essentially gutted consumer protections and the abuse of agencies in making vaccine injury compensation highly adversarial and a serious departure from the spirit and intent of the 1986 Act.
- April 2020: Referenced Written Response & Request Relating to Proposal to Remove SIRVA and syncope from the Federal Vaccine Injury Table (VIT) - NVIC submitted a formal written request for the ACCV to hold public discussions regarding potential federal rule-making to remove SIRVA and syncope from the federal vaccine injury table (VIT), as required by federal law. NVIC also requested copies of "confidential" correspondence sent to the ACCV on these proposed changes, as they are required to be public. Additionally, NVIC requested a review of evidence prior to recommendations by the commission for change the VIT. SIRVA and syncope were added to the VIT based on recommendations and review of evidence by a past ACCV. NVIC supports retaining these injuries on the VIT.
- September 2019: Oral Public Comment by NVIC's Executive Director, Theresa Wrangham noted that the CDC's presentation of vaccine information statement drafts would benefit from the inclusion of clearer language on the statute of limitations relating to the vaccine injury compensation program, integrating outcomes listed on the vaccine injury table within the vaccine information statement and information on how to access the vaccine manufacturers product insert for additional details on vaccine risks. Ms. Wrangham also renewed requests for the process workgroup to explore the adequacy of awards and satisfaction of petitioners submitting vaccine injury compensation program, as recommended by a previously commissioned federal report as well as issue a recommendation for the closure of acknowledged vaccine safety research deficits to better inform mechanisms of injury and expedite injury compensation.
- June 2019: Oral Public Comment by NVIC's Executive Director, Theresa Wrangham expressing concern over the fact that ACCV rarely meets face to face while other similar vaccine advisory committees are given budgets to do so for every meeting. Ms. Wrangham also noted that NVIC shares the Commission's concerns about how few children are in the VICP system and subsequently compensated, given that at inception of the VICP that vaccine injuries sustained by children were the primary focus of the program and encouraged the ACCV to explore the shift in awards from children to adults. Ms. Wrangham also renewed NVIC's request that the ACCV support the need for informed consent protections in vaccine laws and policies and counter recommendations from the NVAC, given that the evidence base used by the ACCV to make recommendations for additions to the federal vaccine injury table also notes long-standing vaccine safety research deficits and acknowledges unknowable risks for injury that cannot be screened for ahead of vaccination, which underscore the need for flexible exemptions within vaccine mandates.
- March 2019: Oral public comment by NVIC's Executive Director Theresa Wrangham in which she reviewed the lack of balance in recent Congressional hearings on exemptions and measles and the refusal to allow NVIC's participation as an organization of standing to represent vaccine safety and informed consent concerns. She emphazised the critical role of balance in such proceedings and that the lack of balance serves only to demonize, discriminate and treat those injured by vaccines as acceptable collateral damage in the forwarding of an unrealistic one-size-fits-all policy, regardless of who is harmed. Additionally, such policy and law discriminates against a minority that is often invisible until harmed and prevents the exercise of the basic human right of autonomy in medical risk-taking procedures. She reminded the Commission that perspectives critical of vaccine law and policy are not necessarily anti-vaccine and that descent is part of a healthy government and the discharge constitutional rights. In closing, Theresa encouraged the ACCV consider creating a questionnaire for award recipients ibased on previous federally commissioned reports to examine VICP award adequacy. Such an effort would better inform awards going forward.
- December 2018: Oral public comment by NVIC's Executive Director Theresa Wrangham in which she reviewed ACCV consumer positions as defined in the National Childhood Vaccine Injury Act of 1986. She said that any statutory recommendations from the ACCV to the Secretary of Health should add a fourth consumer position for a vaccine injured adult, rather than redefine one of the three consumer positions currently authorized by the Act.
- September 2018: Oral public comment by NVIC's Executive Director noted that the Vaccine Information Statements (VIS) reviewed by ACCV and published by the Centers for Disease Control (CDC) do not provide adequate vaccine and disease information to parents of minor children or adults receiving vaccines. She asked ACCV to request that additional information be added to the VIS as allowed under the 1986 Act. She summarized NVIC’s role in previous federal stakeholder public engagement projects and FACA workgroups and requested that NVIC be included in future stakeholder initiatives. She renewed NVIC’s long standing request that the ACCV review federally commissioned reports on operation of the VICP, which recommended the government do more to promote public awareness about the VICP and determine whether VICP awards are adequate and whether improvements are needed to make the compensation petition process a more positive experience for those filing vaccine injury claims.
- March 2018: Oral public comment by NVIC's Executive Director expressing concerns that also have been voiced by ACCV commissioners about transparency in federal presentations on additions of injuries to the Vaccine Injury Table (VIT) that lack information on the identity of funders of research presented to the committee. She also questioned the quality of research used to make VIT changes. She renewed NVIC’s request that federal presentations to the ACCV also include VICP expert testimony or injury award data when changes to the VIT are considered, similar to what occurred when there was a federal petition for the addition of GBS following influenza vaccination to the VIT.
- December 2017: Oral public comment by NVIC's Executive Director noted the significant increase in the number of public petitions to add new injuries to the Vaccine Injury Table (VIT) She renewed NVIC’s request that members of the public requesting that more injuries be added to the VIT be given an equal opportunity to make presentations to ACCV, similar to federal officials responding to these petitions. She noted that there is nothing preventing ACCV from including public presentations in the VIT petition process.
- September 2016: Oral public comment by NVIC’s Executive Director Theresa Wrangham asking the ACCV consider recommending the funding of independent research to close vaccine safety science deficits because knowledge gaps have resulted in increased caseloads and significant delays in making vaccine injury awards in the VICP.
- September 2017: Oral Public Comment by NVIC's Executive Director, Theresa Wrangham requesting that the ACCV explore VICP petition satisfaction on adequacy of awards. Ms. Wrangham also noted that CDC's Immunization Safety Office data demonstrates vaccine adverse event reports are largely submitted by means other than the internet and suggested that ACCV request information on the negative impacts of a paperless vaccine adverse event reporting system, given that not everyone has access to the internet and that reactions are already underreported.
- June 2016: Oral public comment by NVIC's Executive Director requesting that ACCV consider a more transparent process for filing vaccine injury petitions in the VICP and also conduct a review and publish a report on the adequacy of VICP awards and petitioner satisfaction.
- March 2016 Oral public comment by NVIC's Executive Director criticizing the lack of harmonization between NVAC and ACCV on maternal vaccination, with a request that ACCV issue a statement reaffirming that vaccines carry a risk for injury and death and supporting the human right of individuals to exercise voluntary, informed consent to vaccination without penalty.
- January 2016: NVIC's referenced written public comment by Barbara Loe Fisher, NVIC Co-founder and President, and Executive Director Theresa Wrangham to the Health Resources Services Administration (HRSA) on proposed changes by HHS to the VICP’s Vaccine Injury Table (VIT). NVIC urged HHS to reject proposed revisions to the definition of encephalopathy to maintain the spirit and intent of the 1986 National Childhood Vaccine Injury Act, to facilitate the awarding of vaccine injury compensation, and to prevent penalizing and unfair discrimination against those born with certain genes or pre-existing health conditions that may be triggered or significantly aggravated by federally recommended and state mandated vaccines. The Executive Director additionally submitted an oral public comment at the Jan. 14 ACCV meeting.
- December 2015: Oral public comment by NVIC’s Executive Director on the need for public access to ACCV meeting presentations, with a request for the ACCV to review reports and progress on raising public awareness about the VICP, as well as a request for ACCV to issue a statement that supports the informed consent ethic and voluntary health care decisionmaking.
- September 2015: Oral public comment by NVIC’s Executive Director on vaccine reactions and injuries and roadblocks in the VICP that delay and prevent the awarding of vaccine injury compensation.
- June 2015. Oral public comment by NVIC’s Executive Director criticizing the lack of transparency in data contained in the VICP’s Data & Statistic’s Report, which had disappeared from the VICP’s website. NVIC also supported a separate certification program for health care providers to prevent shoulder injuries from injected vaccines, now that SIRVA has been added to the Vaccine Injury Table.
- December 2014: Oral public comment by NVIC’s Executive Director about the need to educate the public about the VICP and the need for make vaccine reaction reporting a priority to humanize vaccine injuries and deaths and to prevent demonization of families who have experienced vaccine reactions and subsequently decline one or more federally recommended vaccines. She called on the ACCV to issue a recommendation supporting the informed consent ethic.
- August 2014. Referenced written public comment submitted by Barbara Loe Fisher, NVIC Co-founder and President, and Executive Director Theresa Wrangham to the ACCV asking the committee to reconsider agreeing to an HHS recommendation to change the definition of encephalopathy in the VICP’s Vaccine Injury Table for the purpose of limiting the number of vaccine injury compensation awards. NVIC criticized the agency’s deviation from the Institute of Medicine’s definition of encephalopathy and urged ACCV to withdraw support for the definition change because it violates the spirit and intent of the 1986 National Childhood Vaccine Injury Act.
- June 2014: Oral public comment by NVIC’s Executive Director for ACCV to reconsider HHS’s recommendation to change the definition of encephalopathy in the VICP’s Vaccine Injury Table. She also requested that an adjustment be made to the process for revising Vaccine Information Statements (VIS) published by the Centers for Disease Control (CDC), which Congress mandated in the 1986 Act be given to parents of minor children by vaccine providers before vaccination.
- March 2014: Oral Public comment by NVIC’s Executive Director requesting that ACCV consider adding language to the Vaccine Information Statements being revised by the CDC. She stated that, while NVIC supports extending the statute of limitations to allow more vaccine injured petitioners to qualify for federal compensation awards, NVIC is opposed to taking any action that makes the VICP the sole legal remedy because it would violate the spirit and intent of the 1986 Act.
- December 2013: Oral public comment by NVIC’s Executive Director voicing NVIC’s opposition to HHS taking money from the VICP Trust Fund to fund vaccine safety research or for any purpose other than providing financial compensation for the vaccine injured. She also urged that HHS do more to promote public awareness about the VICP through media advisories and press releases to reduce the numbers of vaccine injured claimants being excluded from qualifying for federal compensation because they were unaware of the VICP and missed the statute of limitations.
- September 2013: Oral public comment by NVIC’s Executive Director Theresa Wrangham stating that NVIC supports the addition of Guillain Barre Syndrome (GBS) to the Vaccine Injury Table of the VICP, as well as calling for greater transparency by HHS when reporting information about vaccine injury awards and operation of the VICP.
- June 2013: Oral public comment by NVIC’s Executive Director requesting that HHS provide more transparency with regard to the data and statistics tables on the VICP website that includes more specific de-identified information on compensation awards, including amounts of settlements and types of injuries that were compensated.
- March 2013: Oral public comment by NVIC’s Executive Director stating that NVIC supports extending the statute of limitations on vaccine injury claims, greater transparency in reporting of details of vaccine injury compensation award and meaningful public participation in the revision of Vaccine Information Statements (VIS) published by the CDC.
- June 2012. Oral public comment by NVIC’s Executive Director stating that NVIC supports more and higher quality vaccine safety science to close vaccine safety knowledge gaps but opposes taking money out of the VICP Trust Fund to fund that research because Trust Fund money is supposed to be used to compensate the vaccine injured.
- November 2008: Invited oral and written referenced presentation by NVIC Co-founder and President Barbara Loe Fisher entitled The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform? She said, “I sincerely regret having to come here today to reiterate much of what I told Congress in 1999, as well as provide further evidence that this program is not operating in a way that lives up to the spirit and intent of what legislators intended when parents with vaccine injured children agreed to work on this Act 25 years ago, believing the vaccine injured and their attorneys would be treated with fairness, compassion, and good will in this program.
National Vaccine Advisory Committee (NVAC)
- February 2020: Oral Public Comment by NVIC's Executive Director, Theresa Wrangham addressing options to rebuilding trust in vaccination via addressing issues, rather than referring to those with legitimate vaccine safety and informed consent concerns as anti-vaccine and marginalizing vaccine injury. Ms. Wrangham also questioned the stories shared with the NVAC from consumers, in that they are largely about vaccine success, or injury from disease, while there are no stories from the vaccine injured and few discussions relating to vaccine failures.
- September 2019: Oral Public Comment by NVIC's Executive Director, Theresa Wrangham noted a continual lack of goals by the National Vaccine Program relating to informed consent protections in vaccine policy recommendations made by the NVAC and reminded the NVAC that part of their charge was “to achieve optimal prevention of human infectious diseases through immunization and to achieve optimal prevention against adverse reactions to vaccines.”
- June 2019: Oral Public Comment by NVIC's Executive Director, Theresa Wrangham noted that comments by Dr. Salmon regarding the mischaracterization of individuals with legitimate vaccine safety concerns as anti-vaccine was timely, but that it was unfortunate that there was little discussion of closing vaccine safety research deficits. Instead discussion continues on how to "convince" people who are hesitant to vaccinate without addressing safety concerns.
- September 2018: Oral public comment by NVIC’s Executive Director Theresa Wrangham noting that equal attention is not given to funding independent research to close acknowledged vaccine safety research gaps during NVAC meetings, while funding for new vaccine development is aggressively pursued by the NVAC. She pointed out that there is also a lack of acknowledgment of the importance of informed consent protections in vaccine policy discussions as a whole. She questioned if, given the discussion of advances in technology, such as self administered microneedle vaccine patches, there were discussions underway at HHS to ensure that that consumers would receive vaccine risk information prior to vaccination in compliance with the 1986 National Childhood Vaccine Injury Act safety provisions.
- June 2018: Oral public comment by NVIC’s Executive Director noted that NVAC rushed to obtain federally required public comments via the Federal Register on their draft HPV vaccine recommendations in order to fast track a vote on the document during the June 2018 meeting. She expressed concern that the public was unable to see edits made to the document during meeting discussions. She noted the recommendations did not contain informed consent protections and did not include recent data presented by the CDC to the ACIP in February 2018 demonstrating that it is likely that the effectiveness of HPV vaccine in preventing cancer will not be known for decades.
- June 2018: Written referenced public comment submitted to the National Vaccine Program Office by NVIC Co-founder and President Barbara Loe Fisher and Executive Director Theresa Wrangham on draft recommendations of the Human Papillomavirus Vaccination Implementation Work Group Draft Report for Consideration by NVAC. NVIC stated, “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.”
- May 2018: Oral public comment by NVIC’s Executive Director criticizing lack of transparency and public participation in NVAC’s working group draft recommendations focusing on developing strategies to increase HPV vaccine coverage in the U.S. She noted that HPV is a sexually transmitted disease the CDC has acknowledged resolves without complications in the vast majority of people (over 90 percent) and that this information is important to consumers as they make a benefit-risk an analysis about whether or not to get HPV vaccinations. She requested that NVAC include this information in their recommendations
- February 2017: Oral public comment by NVIC’s Executive Director correcting the record relating to the history of the 1986 National Childhood Vaccine Injury Act NVIC’s role in securing vaccine safety informing, recording and reporting provisions in the law to help prevent vaccine injuries and deaths. She noted that NVIC was incorrectly referred to by members of the committee as “anti-vaccine,”when NVIC transparently has taken a pro-education, pro-informed consent position since it was founded in 1982. She also stated that, despite NVIC’s many years of stakeholder participation in federal vaccine advisory committees, NVIC was not included in recent NVAC stakeholder engagements and she requested NVIC’s inclusion in future stakeholder activities conducted by the committee.
- September 2016: Written referenced public comment submitted by Barbara Loe Fisher, NVIC Co-founder and President, and Executive Director Theresa Wrangham to the National Vaccine Program Office on the NVAC's Maternal Immunizations Working Group Phase II's Draft Report for Overcoming Barriers and Identifying Opportunities for Developing Maternal Immunizations. NVIC stated, “NVIC strongly opposes adoption of any government performance measure gauging vaccine distribution by obstetricians or other vaccine providers as an incentive to pressure providers and pregnant women to conform to ACIP recommendations to meet federal health agency goals of achieving higher vaccine uptake among pregnant women.”
- June 2016: Oral public comment by NVIC's Executive Director expressing concern about the importance of maintaining privacy and ensuring safety when involving pregnant women in clinical trials.
- June 2016: Oral public comments by NVIC's Executive Director Theresa Wrangham during the two-day meeting reflected in NVAC Meeting Minutes (pages 19 and 39). She expressed concern about NVAC's recommendations supporting minors giving consent to receiving vaccines without parental knowledge or consent; the redefining of pregnant women as a “scientifically complex population” rather than a “vulnerable population;” and the need for transparency, privacy and informed consent protections in vaccine registries; and a greater respect for and discussion about why some families have vaccine hesitancy..
- February 2016. Oral public comments by NVIC's Executive Director during the two-day meeting focused on the need for HHS to fill in vaccine safety science gaps; protection of informed consent rights in vaccination campaigns in developing countries; and protection of privacy and informed consent rights in Immunization Information Systems (IIS) and Electronic Medical Records (EMR).
- June 2015: Oral public comment by NVIC's Executive Director Theresa Wrangham requesting that NVAC give equal time to oral public comments and stated that NVIC has concerns about NVAC's Vaccine Confidence report. She said, “It is both unreasonable and unethical to expect Americans to vaccinate with confidence in a public health environment that lacks the political will to address the core issues that surround vaccine confidence. Investments in new and improved “communications packages” will not change minds. The public deserves from you an equal commitment in characterizing vaccine injury risks and preventing vaccine injury and death because the parent who’s child is injured or dies as a result a vaccine adverse event is just as aggrieved as the parent who loses their child to a vaccine-targeted disease. They are equal tragedies. The goal of public confidence in vaccines will never reached until legitimate safety concerns and conflicts of interest are resolved and informed consent and the human right to delay or decline vaccines is respected.”
- March 2015: Written referenced public comment by Barbara Loe Fisher, NVIC Co-founder and President, and Executive Director Theresa Wrangham submitted to the National Vaccine Program Office on the NVAC Draft National Adult Immunization Plan. NVIC stated, “NVIC opposes the overall use of Healthy People 2020 Goals as the cornerstone for implementing the National Adult Immunization Plan (NAIP). Our opposition is based on the fact that these goals have no “statutory authority to direct the activities of or hold accountable components of the US health system” and many of the goals are created arbitrarily. Not only does the NAIP not reflect that Healthy People 2020 Goals are aspirational, the implementation of these goals appears to seriously undermine the informed consent ethic.”
“Adult vaccination policies must incorporate measures that allow adults to make informed and voluntary vaccination decisions without sanction, as is allowed with all other medical procedures and use of pharmaceutical products that carry risks that can be greater for some people than other people. The public health agenda outlined in the NAIP cannot be allowed to supersede the informed consent rights of adults to achieve a numerical adult vaccine uptake goal set by government health officials. Each adult American should be allowed to determine what risk they are willing to accept when considering vaccination and should not be sanctioned for the decision they make.”
- September 2014: Oral public comment by NVIC's Executive Director requested that the public be allowed to give oral public comment for at least three minutes and that NVAC be more transparent and provide NVAC’s meeting notebook, presentations and meeting minutes online as provided by the Federal Advisory Committee Act. She commented that it is inappropriate to use Ebola outbreaks as an opportunity for marketing vaccines and encouraged transparency in vaccine risk communications. She said vaccine science research gaps fuel legitimate concerns about vaccine safety.
- June 2014: Oral public comment by NVIC's Executive Director stating that NVIC is opposed to vaccine policies and laws that lack flexible vaccine exemptions in contrast to NVAC presentations encouraging restriction or removal of vaccine exemptions. She criticized the emphasis of NVAC discussions on vaccine innovation and development, noting that NVAC’s charge includes the prevention of vaccine adverse events and that discussions should also address acknowledged gaps in vaccine safety research and the urgent need for independent research to close those gaps.
- April 2014: Written referenced public comment submitted by NVIC Co-founder and President Barbara Loe Fisher and NVIC’s Executive Director Theresa Wrangham to the National Vaccine Program Office (NVPO) on NVAC's Maternal Working Group's Draft Recommendations on Maternal Vaccinations. NVIC opposed many of the draft recommendations because they lacked credible scientific evidence demonstrating safety and effectiveness and raised risks for adverse health outcomes for pregnant women and their unborn babies.
- February 2014: Oral public comment by NVIC's Executive Director noted that it cost $1700 for a child to receive all federally recommended vaccines and that ever increasing vaccine costs, as well as vaccine science research deficits contribute to vaccine hesitancy. She commented that NVAC has acknowledged these deficits in their 2011 White Paper on the US Vaccine Safety System, admitting that 60% of causality assessment reviews done by the IOM since 1986 found "inadequate evidence to make a determination" on causality because the research had not been done, including vaccine safety assessments for women vaccinated during pregnancy.
- September 2013. Oral public comment by NVIC’s Executive Director on behalf of NVIC Co-founders Barbara Loe Fisher and Kathi Williams on the history of the creation of the federal Vaccine Injury Compensation Program in the National Childhood Vaccine Injury Act of 1986.
- September 2013. Oral public comment by NVIC’s Executive Director Theresa Wrangham focused on NVAC’s discussions about “vaccine hesitancy.” She said there is an urgent need for bench science to close acknowledged vaccine safety research deficits and pointed out that, “The IOM report published in August of 2011 found that for 135 (85%) of 158 of the most commonly reported vaccine adverse events for 8 childhood vaccines there was an absence of science, or lack of quality science to determine causality. Additionally, the IOM’s 2013 report on the safety of the childhood schedule found that “key elements of the entire [child vaccine] schedule – the number, frequency, timing, order and age or administration of vaccine – have not been systematically examined in research studies.”
- June 2013: Oral public comment by NVIC’s Executive Director stating NVIC’s support for the call by the Institute of Medicine in the report on the safety of the childhood vaccine schedule (0-6 years old) that HHS assess evidence regarding public confidence in the childhood vaccine schedule, develop ways to improve communication with parents, and to assess vaccine adverse events in special populations at potential increased risk for vaccine injury and deaths. She stated that NVIC strongly opposed the IOM’s two recommendations that there is no value in prospective clinical trials examining the safety of the child vaccine schedule and that future vaccine safety research could be conducted by HHS and corporate partners using existing closed database systems like the VSD. She said that public-private business partnerships between HHS and the vaccine industry pose conflicts of interest, which undermines public trust in the safety of vaccines and vaccine policies.
- February 2013: Oral public comment by NVIC’s Executive Director commenting that the 2012 Institute of Medicine report on Adverse Effects of Vaccines: Evidence and Causality found that for 85% of the most commonly reported vaccine adverse events the IOM committee reviewed, research was absent or was lacking in quality and prevented a determination of causality and that for the 15% that had adequate research, over half of those vaccine adverse events supported or favored a causal link to vaccines. She said that parents do not want another communications plan that one-sidedly touts the safety of vaccines, while omitting what is known and unknown in terms of risk, and that the public will not be convinced or coerced into trusting when communications omit valid concerns and demonize those who are raising those concerns and asking for remedy. She added that NVIC was opposed to NVAC’s recommendation that health care workers be mandated to get annual flu shots that lack exemptions and said NVIC has received an increase in harassment reports from health care workers that employers are coercing them and some are being forced to quit their jobs or being fired.
- June 2012. Oral public comment by NVIC’s Executive Director criticizing transparency of HHS and NVAC with regard to public comments made on draft Recommendations on Strategies to Achieve the Healthy People 2020 Annual Influenza Vaccine Coverage Goal for Health Care Personnel. She re-stated NVIC’s opposition to influenza vaccine mandates for health care workers that lack informed consent protections. She requested that the public be able to purchase recordings of past NVAC meetings and that NVAC post meeting presentations prior to the meeting or as soon as possible after meetings.
- February 2012: Oral public comment by NVIC’s Executive Director pointing out that systematic reviews of influenza vaccine studies report lack of evidence for effectiveness and safety and that influenza vaccine injury claims, including for GBS, are the leading claims in the vaccine injury compensation program. She stated that healthcare workers are reporting to NVIC that they are being harassed for exercising informed consent rights with regard to annual flu shots and that, “Recommendations that do not include flexible exemption provisions and access to accurate information on influenza and influenza vaccine unfairly punish health care workers who may be at greater risk for suffering harm from vaccines with the threat of losing their job for non-compliance. We respectfully request that the draft recommendations on influenza vaccine for health care workers include medical, religious and conscientious belief exemption requirements and recognition of the scientific deficits most recently acknowledged by the IOM and systematic reviews noted in our written comment.”
- January 2012: Written referenced public comment by Barbara Loe Fisher, NVIC Co-founder and President and Executive Director Theresa Wrangham submitted to the National Vaccine Program Office on NVAC’s Draft Recommendations of the Health Care Personnel Influenza Vaccination Subgroup. NVIC stated, “The draft recommendations of the HCPIVS, which advocates requiring mandatory vaccination of health care personnel, violates the ethical principle of informed consent to medical risk-taking. Therefore, NVIC does not support these recommendations or any coercive government or employment policy, which condones the use of harassment and threat of denial of employment or job dismissal as a club to force health care workers with medical, religious or conscientious belief objections to get annual flu shots… We urge the committee to include recommendations for flexible medical, religious and conscientious belief exemptions in vaccination policies instituted by employers for health care personnel.”
- June 2011. Oral public comment by NVIC’s Co-founder and President at the NVAC's Vaccine Safety Working Group’s Stakeholders Meeting calling for reform of the U.S. vaccine safety monitoring system, including creation vaccine safety oversight mechanism independent of HHS. She stated, “It has long been the position of the National Vaccine Information Center that existing federal health agencies congressionally funded and charged with the responsibility for: (1) conducting scientific research into the development of new vaccines; and (2) creating and implementing federal licensing and testing regulations for vaccine manufacturers; and (3) making national recommendations for vaccine administration and use; (4) promoting universal and mandatory use of government recommended vaccines, and (5) playing a major role in determining who does and does not receive federal vaccine injury compensation, should not also be simultaneously charged with responsibility for vaccine safety oversight.”
She added that, “After many years of actively engaging with government, in 2011, I am deeply concerned about the effort by some in the public health, medical and pharmaceutical communities to marginalize and persecute a growing minority of citizens with vaccine damaged children and those defending the ethical principle of informed consent to medical risk taking. During the past decade, I have witnessed the public discourse on the subject of vaccine safety and informed consent become so poisonous that it is resulting in the persecution of families, whose only crime is trying to protect their children from further health deterioration after vaccination. It is becoming a civil and human rights issue that threatens to jeopardize public trust in the integrity of government health policy in general. Where there is fear, there can be no trust.”
- June 2011. Written referenced public comment by Barbara Loe Fisher, NVIC Co-founder and President and Executive Director Theresa Wrangham submitted to the NVAC’s Vaccine Safety Working Group (VSWG) related to the VSWG’s Draft Report and Recommendations on the Federal Vaccine Safety System. NVIC stated, “For the past quarter century, NVIC has consistently informed the CDC, FDA, NVAC, ACCV, IOM and Congress about growing public concerns involving the urgent need to fill in gaps in vaccine science, including vaccine adverse event data collection, analysis and response; the urgent need to raise standards for vaccine safety regulation of industry; the urgent need to re-examine vaccine risk communication policies; and the urgent need to re-examine vaccine mandates that do not respect informed consent principles or acknowledge biodiversity and place some at higher risk than others for suffering vaccine reactions, injuries and deaths.”
NVIC called for the creation of an independent entity charged with the sole responsibility for vaccine safety oversight that reports directly to the President and Congress because “Simply reaffirming the legitimacy of the existing structure will not stem the documented public erosion of trust in the vaccine safety system. A substantive, appropriate response from government is urgently needed.”
- August 2010. Oral public comment by NVIC’s Executive Director noting that recent national polls indicate growing public concern about vaccine safety and the desire for better quality vaccine safety research to help inform vaccine decision making. She said NVIC encourages HHS and NVAC to more broadly engage the concerned public to answer questions and added that there are safety signals with pandemic H1N1 vaccine that should be addressed.
- June 2010. Oral public comment by NVIC Executive Director Theresa Wrangham expressing concerns about the safety of the pandemic H1N1 vaccine and deficits in the vaccine safety research agenda.
- April 2008: Invited oral and written public comment by Barbara Loe Fisher, NVIC Co-founder and President to the NVAC’s Vaccine Safety Working Group on Vaccine Safety Priorities: Engaging the Public. She noted that 1 in 6 children in America are now learning disabled, 1 in 9 suffer with asthma, 1 in 150 develop autism and 1 in 450 are diabetic and stated, “The scientific, economic, political and moral imperative for addressing the new epidemic of chronic disease and disability, which has developed in the last quarter century and is compromising more children than were ever harmed by any infectious disease epidemic, including polio, makes the vaccine safety research agenda you are developing the most important federal health research funding priority today. It is a funding priority that must not take money from the vaccine injury trust fund created in 1986 to compensate vaccine injured children, but urgently requires independent appropriations by Congress to support a national research program created in collaboration with those most concerned about vaccine safety to generate evidence-based information the people will trust.”
- May 1998: Invited oral and written public comment by Barbara Loe Fisher, NVIC Co-founder and President to the NVAC’s Immunization Registries Workgroup on Privacy and Confidentiality stating that NVIC opposes the creation of an electronic database operated by the government for the purpose of tagging and tracking every citizen’s vaccination status. She said there can be no guarantee that an electronic database operated by the government will not be used to punish citizens for non-compliance with federal health care or other policies and presented a petition signed by 3,000 Americans opposing government vaccine tracking systems. She added that NVAC should modify the current "Immunization Registry" proposal to require a citizen's prior written consent to be enrolled in any vaccine tracking system to protect a citizen's right to make informed, voluntary health care decisions, including vaccination decisions, without being subjected to economic or other punitive sanctions by the government.
FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) Public comment is not taken unless physically present during the meeting held in Rockville, MD.
- November 2015: Oral and referenced written public comment by NVIC Co-founder and President Barbara Loe Fisher on proposed changes to FDA requirements for licensure of vaccines intended for use during pregnancy. She stated that NVIC opposes the FDA retroactively licensing influenza and Tdap vaccines for use in pregnant women and fast tracking RSV and group strep B vaccines to licensure by using small clinical trials; adaptive trial designs; Baysian methods of data analysis; biomarkers and surrogate endpoint measures rather than actual clinical endpoints; or using clinical experience instead of good bench science and randomized controlled clinical trials with long term follow-up to prove effectiveness and safety, and added that FDA standards for proof of vaccine safety and effectiveness must be very high, especially when licensing vaccines targeting pregnant women and their unborn babies.
- September 2015. Oral public comment by Barbara Loe Fisher, NVIC Co-founder and President, at the Sept.15, 2015 meeting of VRBPAC) voicing opposition to the FDA fast-tracking licensure of the MF59 adjuvanted Fluad influenza vaccine for use by seniors over age 65. She stated, “Squalene adjuvants hyper-stimulate the immune system and have been linked with development of autoimmunity, narcolepsy and other chronic disease. Based on the very limited safety and immunogenicity evidence submitted by Novartis, MF59 adjuvanted Fluad vaccine should not be fast tracked to licensure for use by seniors over age 65. She asked the committee, “Why does Fluad need to be fast tracked to licensure for seniors without additional evidence? There is public concern that fast tracking Fluad is really about fast tracking MF59 to licensure so it can be added to lots of new vaccines targeting infants, pregnant women and every American without adequate evidence for safety or effectiveness.”
- February 2012. Oral public comment by Barbara Loe Fisher, NVIC Co-founder and President at the Feb. 29, 2012 meeting of VRBPAC on Licensure Pathways for Pandemic Influenza Vaccines. She stated, “The informed public will be carefully evaluating future pandemic vaccines, including genetically engineered influenza vaccines that contain novel adjuvants, like squalene, which ramp up the immune response. The growing numbers of children and adults with biological vulnerability to suffering immune-mediated brain and immune system dysfunction because they mount atypical inflammatory responses, are particularly wary of novel adjuvants.”
“This places a special responsibility on the FDA to ensure that candidate pandemic influenza vaccines, as well as new vaccine adjuvants not yet licensed in the U.S., are separately tested pre-licensure in animal and human trials. At a minimum, pre-licensure trials should include (1) inactive placebos and participants, who remain unvaccinated or not exposed to the novel adjuvant, as controls; (2) study populations, which reflect all populations to be targeted for vaccine or new adjuvant use post-licensure; (3) at least 60 days follow-up to evaluate safety; 4) administration of the experimental influenza vaccine simultaneously with other vaccines routinely given to children and adults and (5) robust post-licensure evaluation.”
CDC Advisory Committee on Immunization Practices (ACIP) Public comment is not taken unless physically present during the meeting held in Atlanta or one is submitted in writing in advance of the meeting. NVIC is located in Virginia.
June 2015: Written public comment by NVIC’s Executive Director Theresa Wrangham read by ACIP Chair, Jonathan Temte, during the June ACIP meeting. NVIC stated that, “Because ACIP’s routine recommendations often translate into legal vaccine mandates in many states, choice and recommendations versus vaccine requirements were unifying themes noted in the CDC’s 2011 stakeholder report on meningococcal vaccines…with regard to ACIP recommending that all children get Men B vaccines, the data is clear that a universal use recommendation is not justified. It would have far reaching consequences that will be costly and unnecessarily burdensome to parents, adults and government agencies. NVIC respectfully requests the ACIP to vote against a Men B vaccine universal use recommendation. We encourage the ACIP and CDC to revisit the stakeholder report and the need for greater flexibility in ACIP recommendations.”