Vaccine Advisory Committee Statements
Since 1982, NVIC has advocated that well-designed, independent, on-going scientific studies must be conducted 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 vaccination 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 be financially supported and that vaccine safety protections were needed in the mass vaccination system. This law established the following federal advisory committees, that also play a role in shaping vaccination policy in the U.S. The public may make public comment and/or attend these committee meetings and minutes and updates of tasks undertaken by these committees are posted on their websites.
For more information on these committees, click the links below and scroll down to read NVIC public comments to these committees.
The U.S. Department of Health & Human Services' (HHS) Advisory Commission on Childhood Vaccines (ACCV) advises and makes recommendations to the Secretary of Health and Human Services on issues relating to the operation of the National Vaccine Injury Compensation Program (VICP). There are nine voting members who provide oversight of the VICP and recommend ways to improve the VICP.
The U.S. Department of Health & Human Services National Vaccine Program Office's (HHS NVPO) National Vaccine Advisory Committee's (NVAC) purpose is to advise and make recommendations to the Assistant Secretary for Health in his capacity as the Director of National Vaccine Program on matters related to program responsibilities. The Assistant Secretary for Health (ASH) has been designated by the Secretary of Health and Human Services as the Director of the National Vaccine Program. NVAC public meeting schedule.
U.S. Centers for Disease Control & Prevention's (CDC) Advisory Committee for Immunization Practices (ACIP) is a group of medical and public health experts that develops recommendations on how to use vaccines to control diseases in the United States. The recommendations stand as public health advice that will lead to a reduction in the incidence of vaccine preventable diseases and an increase in the safe use of vaccines and related biological products. ACIP's public meeting schedule.
U.S. Food & Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility.
The Committee shall consist of a core of 12 voting members including the Chair. Members and the chair are selected by the Commissioner or designee from among authorities knowledgeable in the fields of immunology, molecular biology, rDNA, virology, bacteriology, epidemiology or biostatistics, allergy, preventive medicine, infectious diseases, pediatrics, microbiology, and biochemistry. NVIC's Board Member Stephanie Christner currently serves on this committee. FDA VRBPAC public meeting schedule. NVIC Public Comments
NVIC Public Comments
Advisory Commission on Childhood Vaccines (ACCV)
- Sep 2016: Public comment on behalf of NVIC by executive director Theresa Wrangham recommended that the ACCV consider recommending the funding of independent research to close acknowledged vaccine safety research deficits, rather than recommending the hire of additional special masters to handle the increasing caseloads in the federal vaccine injury compensation program (VICP). This recommendation was made due to the fact that the majority of claims submitted to the VICP are “off-the-table” petitions that require more manpower to resolve because of the vaccine safety research deficits published by the Institute of Medicine which prevent addition of injuries to the Vaccine Injury Table (VIT).
- Jun 2016: NVIC's Executive Director, Theresa Wrangham provided public comment requesting the ACCV consider a more transparent process for vaccine injury table petitions, and undertaking a report on the adequacy of VICP awards and petitioner satisfaction.
- Mar 2016: NVIC's Executive Director, Theresa Wrangham provided public comment criticising the lack of harmonization between NVAC and ACCV on maternal vaccine efforts and requested the ACCV issue a statement reaffirming that vaccines carry a risk for vaccine injury and death and support the human and inidividual right of informed consent without penalty.
- Jan 2016: NVIC's written public comment on proposed changes to the Vaccine Injury Table on behalf of more than 150,000 donor supporters and followers, in addition to the oral public comment given January 14.
- Dec 2015: NVIC's Executive Director provided public comment on behalf of NVIC regarding the need for public access to ACCV meeting presentations, and made requests for the ACCV to review reports and progress on raising the public’s awareness of the VICP, as well as issue a statement that supports voluntary vaccine health care decisions and the informed consent ethic.
- Sep 2015: NVIC's Executive Director, Theresa Wrangham's public comments on vaccine injury and the VICP roadblocks preventing injury compensation.
- Jun 2015: NVIC’s Executive Director provided public comment on behalf of NVIC regarding the lack of transparency in the VICP’s Data & Statistic’s report and data that 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 to the Vaccine Injury Table.
- Dec 2014: NVIC’s Executive Director provided public comment on behalf of NVIC about efforts needed to educate the general populace on government programs addressing vaccine injury compensation and reporting to humanize vaccine injuries and deaths and to prevent minimizing these events and demonization of families as bad citizens. This public comment also calls on the ACCV to issue recommendations that support the informed consent ethic in vaccination.
- Aug 2014: NVIC written request for the ACCV to reconsider their recommendation that deviates from IOM's definition of encephalopathy as they consider changes to the Vaccine Injury Table.
- Jun 2014: Request for ACCV to reconsider recommendation to change Vaccine Injury Table wording for encephalopathy and to consider global language relating to the revision process underway for CDC's Vaccine Information Statements.
- Mar 2014: Request for ACCV to consider language additions to the CDC's Vaccine Information Statements that are undergoing revision and review by the ACCV, agreement with the ACCV Chair's request for face to face meetings for the Commission and NVIC's opposition to the ACCV's recommendation of extending the statute of limitations at the expense of making VICP the sole remedy for vaccine injury compensation.
- Dec 2013: Statement urging that the ACCV be allowed to meet in person and NVIC's request for awareness outreach efforts of the VICP to include media advisories and press release to curb VICP claim dismissals based on exceeding the statute of limitations.
- Sep 2013: Statement by Theresa Wrangham on need for greater transparency for vaccine injury awards.
- Jun 2013: Centers on expansion of the data and statistics tables on the VICP website to include more specific information on the types of compensatory awards made for vaccine injuries.
- Mar 2013: States general support to extend statute of limitations on vaccine injury claims, higher transparency in reporting of compensation of vaccine injuries and meaningful public participation in VIS revisions.
- Jun 2012: Comment on Need for Independent Research Recommendation to Close Vaccine Safety Science Gaps Highlighted by the Institute of Medicine and the Preservation of the Vaccine Injury Compensation Fund for the Vaccine Injured.
- Jan 2008: Barbara Loe Fisher's presentation to the ACCV - The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform?
National Vaccine Advisory Committee (NVAC)
- Feb 2017: Public comment on behalf of NVIC by executive director Theresa Wrangham correcting the record relating to the history of the 1986 law and NVIC’s role in its passage. This comment also noted that NVIC was incorrectly referred to by members of the committee as anti-vaccine and noted that NVIC was not included in recent stakeholder engagements by the NVAC, as done previously and requested participation in future efforts.
- Sep 2016: NVIC's President and co-founder, Barbara Loe Fisher, and Executive Director Theresa Wrangham, provide NVIC's written public comment on the NVAC's Maternal Immunizations Working Group Phase II's Draft Report for Overcoming Barriers and Identifying Opportunities for Developing Maternal Immunizations.
- Jun 2016: NVIC's Executive Director, Theresa Wrangham commented on privacy concerns and the importance of safety when involving pregnant women in clinical trials.
- Jun 2016: NVIC's Executive Director provided public comments on behalf of donor supporters for each day of this meeting. Concerns expressed were the NVAC's support of minors consenting to vaccines without parental knowledge, need for transparency and privacy where vaccine registries and maternal datasets are concerned, and informed consent as it relates to vaccine hesitancy. See pages 19 and 39.
- Feb 2016: NVIC's Executive Director, Theresa Wrangham commented on vaccine safety research and human rights gaps.
- Jun 2015: NVIC's Executive Director, Theresa Wrangham commented on the ethical problems with the NVAC's Vaccine Confidence report.
- Mar 2015: NVIC's written public comment opposing many of the recommendations withing the NVAC's National Adult Immunization Plan.
- Sep 2014: NVIC's Executive Director, Theresa Wrangham commented on the ill-advised use of Ebola outbreaks as an opportunity for marketing vaccines and encouraged transparency in vaccine risk communications
- Jun 2014: Comment on NVIC's opposition to policies and laws obstructing vaccine exemptions, and the lack of balance on research to close acknowledged vacccine safety research deficits in comparison to research dedicated to the development of new vaccines.
- Apr 2014: NVIC's written opposition to NVAC's Maternal Working Group's Draft Vaccine Recommendations. recommendations.
- Feb 2014: NVIC's statement noting the increasing cost of vaccines, high rates of vaccination in the U.S., off label use of vaccines in pregnant women in the face of growing vaccine safety research deficits.
- Sep 2013 Day 2: Statement on the urgent need for bench science to close acknowledge vaccine safety research deficits to address vaccine hesitancy in parents delaying or declining one or more vaccines.
- Sep 2013 Day 1: Statement on behalf of Barbara Loe Fisher and Kathi Williams regarding the impetus behind the federal Vaccine Injury Compensation Fund (VICP).
- Sep 2013 Public Comment to the NVAC: Statement by Theresa Wrangham regarding vaccine hesitancy.
- Jun 2013: Comment on significant vaccine safety research deficits exposed by the last two reports from the IOM and the conflicts of interest between federal agencies and the vaccine industry.
- Feb 2013: Highlighting acknowledged vaccine safety research deficits, vaccine hesitancy and rebuilding public trust.
- June 2012: Committee Transparency, Vaccine Mandates for Health Care Workers and Vaccine Injury Sustained by Pregnant Women
- Feb 2012: Comment on Adoption of Required Health Care Personnel Influenza Vaccination Recommendations
- Jan 2012: Written Response on Draft Recommendations of the Health Care Personnel Influenza Vaccination Subgroup on Influenza Vaccine
- Jun 2011: Comment on NVAC's Vaccine Safety Working Group’s (VSWG) Stakeholders Meeting related to Improvements needed in U.S. Vaccine Safety System
- Jun 2011: Written Comment to NVAC on the VSWG Draft Report and Recommendations on the Federal Vaccine Safety System
- Aug 2010: Comment on H1N1 Concerns, Public Engagement on Vaccine Safety System Review and NVAC Recommendations on CDC Vaccine Safety Research
- June 2010: Comment on H1N1 Concerns and CDC Vaccine Safety Research Agenda
- Apr 2008: Comment on Vaccine Safety Research Priorities
- May 1998: Comment on Immunization Registries Workgroup on Privacy and Confidentiality
FDA Vaccines and Related Biological Products Advisory Committee - Public comment is not taken unless physically present during the meeting held in Rockville, MD. NVIC is located in Virginia. Currently NVIC's Board Member Stephanie Christner serves on this committee.
- Feb 2012: NVIC Public Comment to FDA Advisory Committee on Improvements Needed in Vaccine Licensure
- Sep 2015: NVIC's President, Barbara Loe Fisher, provided NVIC's public comment during this meeting opposing the fast-tracking of the squalene based adjuvant MF59 in influenza vaccines. Dr. Vicky Debold, NVIC's Director of Research & Patient Safety, was invited by the FDA to fill the consumer postion on this committee. Dr. Debold voted against fast-tracking of MF59, citing safety concerns and elevated adverse events noted in the data presented to the committee.
CDC Advisory Committee on Immunization Practices - 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: ACIP Chair, Jonathan Temte, read NVIC's written public comment during the June ACIP meeting. NVIC supported access to Men B vaccines, and opposed a universal recommendation that would trigger vaccine mandates in some states.