By Barbara Loe Fisher
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On December 22, 2020, a non-profit limited company based in Great Britain that calls itself the Center for Countering Digital Hate (CCDH)1 2 3 published a report entitled The Anti-Vaxx Playbook.4 It contains false and misleading information about the Fifth International Public Conference on Vaccination, which was sponsored by the 39-year old U.S. non-profit educational charity the National Vaccine Information Center, and held online in October 2020. Promotion of the CCDH report resulted in the spreading of fake news and misinformation by mainline media outlets in Great Britain and the U.S.5 6 7 8 9
NVIC’s pay-for-view digital conference was transparently open to the public and featured presentations by 51 speakers from the U.S. and other countries discussing vaccine science, public health policy and law, informed consent and civil liberties. Dedicated to “Protecting Health and Autonomy in the 21st Century,” the conference was made available on Feb. 2, 2021 for free viewing online.
CCDH Misinformation Campaign Designed to Discredit, Destroy NVIC
Influence Watch, which monitors individuals and groups that influence10 public policy, describes the Center for Countering Digital Hate – CCDH - as a “London-based advocacy group that targets accused ‘hate groups’ and individuals for de-platforming campaigns to remove them from major social media outlets” and “has ties to the left-wing British Labour Party and British left-progressivism.”11 The anonymously funded CCDH also has an office in Washington, D.C. and the defamatory publicity campaign created in December 2020 was designed to not only discredit NVIC’s four decade public record of working within the US democratic system to secure vaccine safety and informed consent protections in public health policies and laws, but to destroy our small charity.
The misinformation campaign was spearheaded by the CEO of CCDH, who is a political operative12 personally affiliated with Great Britain’s socialist Labour Party.13 14 15 The report deceived readers by describing NVIC’s 2020 conference as a meeting “recently held in private over three days,” which implied secrecy,16 even though the event was transparently open to the public just like the four previous vaccination conferences NVIC hosted in 1997, 2000, 2002 and 2009.17 One British tabloid read the report and described NVIC’s public conference as a “private conference call” where “secret plans” were plotted to “launch the largest ever misinformation campaign about vaccines.”18
Last summer, CCDH published their first report alleging that Big Tech companies operating social media platforms make big profits by allowing individuals and organizations criticizing vaccine science, policy and law to message on their platforms,19 and should take stronger action to censor online public conversations about vaccination that do not conform with the “scientific consensus that vaccines are safe.”20 21 That July 2020 report was promoted by mainline media outlets in Britain22 23 24 25 and the U.S.26
However, CCDH’s report published five months later in December 2020, which created fake news and misinformation about NVIC’s conference, contained even more inflammatory rhetoric. It demonized those who criticize vaccine safety as “malignant actors,”27 and CCDH demanded that companies and governments virtually eliminate individuals or groups publishing information online that fails to align with government and industry narratives about vaccination and public health policy.
In that report, CCDH ordered Big Tech companies and governments to censor and punish dissenters, charging that, “anything less than the dismantling of these individuals’ profiles, pages and groups and permanent denial of service, now they know what is happening, is willing acquiescence.”28
On Jan. 18, 2021, the anonymously funded CCDH once again publicly attacked the National Vaccine Information Center, this time for applying for a US Paycheck Protection Program loan to secure the continued employment of NVIC’s 21 workers during massive nationwide unemployment caused by lockdowns. The British non-profit company appeared to suggest that the U.S. government should not have been viewpoint-neutral in granting relief loans, but should have applied an ideological litmus test to NVIC’s loan request that was made to retain employees during catastrophic economic hardship caused by lockdowns that have affected donations to charities.29
CCDH CEO Imran Ahmed said, “Lending money to these organizations so they can prosper is a sickening use of taxpayer money.”30 Once again, mainline media outlets in Britain and the US widely promoted CCDH’s allegations.31 32 33 34 35
Six months of orchestrated public attacks on NVIC by CCDH have generated hate mail to our small charity, which was founded and has been led by parents of vaccine injured children for four decades.36
Strong Freedom of Dissent History in U.S.
I was born into a post-War World II generation in the United States of America, a generation known for challenging the status quo and exercising the right to dissent, which is protected under the U.S. Constitution.37 Whether it was advocating for the right to listen to rock ‘n’ roll and joining anti-nuclear protests in the 1950s,38 39 or marching in support of civil rights and opposing an undeclared war in Asia in the 1960’s,40 41 or women fighting for equal opportunity and pay and consumer activists working for environmental protection and car safety laws in the 1970s,42 43 44 45 or mothers protesting against drunk drivers46 and choosing a drug free birth and breastfeeding for their babies in the 1980’s,47 48 the baby boomer generation has been known for exercising freedom of thought and speech. Contentious social, political and health issues of the 20th century sparked heated debates on college campuses,49 where students could still explore, critique and openly search for truth, and in mainline newspapers, magazines and radio and television stations, where point/counterpoint examination of controversial topics was the hallmark of good journalism because public debate is the hallmark of free speech.
The America where I grew up in the mid-20th century was a beacon of hope for people living behind the Iron Curtain50 and in other totalitarian or authoritarian societies,51 where exercise of freedom of thought, speech and conscience and the right to dissent and peacefully assemble and petition the government for redress of grievances had been eliminated, where people had been turned into silent indentured servants working to serve a small ruling class in control of the state.52 Statists, who believe that economic control and planning must be in the hands of a highly centralized government,53 are always afraid of the truth, afraid that people armed with knowledge will act together to challenge control of the state by a powerful and privileged few.
Without Debate, Without Criticism “No Republic Can Survive”
I was in junior high school when President John F. Kennedy addressed the American Newspaper Publishers Association in 1961. He said:54
“Without debate, without criticism no administration and no country can succeed and no republic can survive. That is why the Athenian lawmaker Solon decreed it a crime for any citizen to shrink from controversy. And that is why our press was protected by the First Amendment-- the only business in America specifically protected by the Constitution - not primarily to amuse and entertain, not to emphasize the trivial and the sentimental, not to simply "give the public what it wants"--but to inform, to arouse, to reflect, to state our dangers and our opportunities, to indicate our crises and our choices, to lead, mold, educate and sometimes even anger public opinion.”
He closed with these words:
“So it is to the printing press - to the recorder of man's deeds, the keeper of his conscience, the courier of his news - that we look for strength and assistance, confident that with your help, man will be what he was born to be: free and independent.”
That speech given 60 years ago was a ringing endorsement for freedom of the press. Yet, in the 21st century, it is becoming clear that there are political operatives and corporations seeking to censor freedom of thought and speech by citizen journalists publishing analysis and perspective on the world wide web, an electronic communications network that has been the world’s biggest forum for free speech over the past quarter century.55 56
Right to Dissent, Freedom of Speech Under Assault in America
The right to dissent57 and exercise freedom of thought, speech and conscience58 is under assault in America,59 even though these cherished civil liberties are codified into the Bill of Rights of the U.S. Constitution. And civil liberties are under assault internationally in other nations with representative democracies, as well.60
Today, political operatives are pressuring government, media corporations and other institutions to eliminate freedom of speech, especially public conversations about vaccine science, policy and law.61 62 63 Spirited public debate about vaccine safety and mandatory vaccination laws has been going on for more than two centuries.64 65 What is the justification for censoring that public conversation now and punishing those who engage in it with economic and social sanctions?66 67 And if the public conversation about vaccination and health can be censored, what topic will be the next one put on the “no fly” list?68 69
NVIC: Working to Reform Vaccine Policy and Law for Four Decades
I am a co-founder and president of the highly rated non-profit educational charity established in 1982 and known today as the National Vaccine Information Center.70 71 Our mission is to prevent vaccine injuries and deaths through public education. NVIC does not make vaccine use recommendations. We advocate for the human and legal right to make informed and voluntary decisions about vaccination without being coerced or punished for the decision made.72
Our not-for-profit charitable organization was established for one reason: we were mothers and fathers of children brain injured by the highly reactive pertussis vaccine in the DPT shot and we wanted a safer pertussis vaccine to replace the one that had hurt our children. That goal was accomplished after 14 years of consumer advocacy when a less reactive acellular pertussis (DTaP) vaccine was licensed for babies in the U.S. in 1996.73
We also wanted parents to have access to accurate and full information about the risks and complications of both diseases and vaccines before children are vaccinated, so parents and pediatricians could work together to identify those children who are more susceptible to vaccine reactions and protect their health. That is why we worked with Congress to secure vaccine safety informing, recording, reporting and research provisions in the 1986 National Childhood Vaccine Injury Act, a law in which the U.S. government officially acknowledged for the first time that vaccine safety should be made a national priority because federally licensed and recommended and state mandated childhood vaccines can and do cause permanent injuries and even death for some children.74 75 76
We are not all the same. We do not all react the same way to pharmaceutical products,77 78 79 which is why our organization has strongly supported research into genetic, epigenetic, environmental and other risk factors that make some individuals more susceptible to adverse responses to vaccination.80 81
We believe every life is important, and that the lives of those harmed by vaccines and infectious diseases should be equally valued and protected. We believe that consumer advocacy has and should continue to play an active role in holding pharmaceutical companies and government agencies accountable for vaccine product safety, and we are dedicated to working responsibly within the democratic system of this Constitutional Republic to make health policy and law safer and more effective for everyone.82 83 84
Since 1988, I and other NVIC representatives have served as consumer members of the National Vaccine Advisory Committee, FDA Vaccines & Related Biological Products Advisory Committee, Advisory Commission on Childhood Vaccines, Vaccine Policy Analysis Collaborative and other federal and state public engagement projects discussing vaccine science, policy and law issues with vaccine developers, federal and state health officials, medical trade and pharmaceutical industry representatives, and members of other non-profit organizations.85 86 87 My 22 years of service as a consumer member on federal advisory committees and public engagement projects includes four years as a member of the Institute of Medicine Vaccine Safety Forum at the National Academy of Science, where I helped to coordinate public workshops on vaccine science, policy and law issues88 and was an editor for the 1998 report on Risk Communication and Vaccination published by the National Academy Press. That report importantly stated that:89
“The goal that all parties share regarding vaccine risk communication should be informed decision making. Consent for vaccination is truly “informed” when the members of the public know the risks and benefits and make voluntary decisions. The discussion of mandatory vaccination at the workshop suggested that it may interfere with informed consent and may damage trust and deter effective communication, and thus needs to be carefully weighed against its benefits.”
We believe the human right to freedom of thought, speech and conscience should be respected, not devalued. As public health regulations and laws are being created during the coronavirus pandemic to restrict or eliminate civil liberties,90 we should be encouraging people to have civil conversations about vaccination, health and autonomy. Americans should be welcomed by legislators to participate in - not be shut out of - the democratic law making process.91
When people feel disenfranchised and believe that those in power do not care about their lives or the lives of their children, that is when trust in government is lost and people let fear, anger, and despair control their actions. Empowering people with knowledge and the hope they can help effect meaningful change if they do it in a rational and constructive way has always been one of NVIC’s guiding principles.92
Fifth International Public Conference on Vaccination Features Principled, Courageous Speakers
I want to thank the generous sponsors and attendees of the Fifth International Public Conference on Vaccination: Protecting Health and Autonomy in the 21st Century, who helped to make it financially possible for NVIC to host a virtual conference last fall.93 The conference had been scheduled for two years to be held in October 2020 in a hotel in the Washington, DC area. When travel and social distancing restrictions were enacted in the spring of 2020, we had to make a choice between cancelling the conference or pivoting to a pay-for-view online public conference.
We chose to hold the conference online because we knew that the controversial issues being debated in the public square this year needed a public forum where well anchored information and perspective could be presented. We owe a debt of gratitude to the more than two dozen principled and courageous scientists, physicians, holistic health professionals, authors, attorneys, faith leaders, parents of vaccine injured children and civil and human rights activists, who represent diverse areas of expertise and participated in our conference.94
NVIC Will Not Abandon Our Mission
No matter how many political operatives, corporations and institutions threaten and try to discredit NVIC and our work in order to silence us, we will not abandon our 40 year mission dedicated to preventing vaccine injuries and deaths through public education and defending the ethical principle of informed consent. We are moving forward with faith and resolve that we can secure a future for America that protects health and autonomy in the 21st century.
Because we know that if the state can tag, track down and force individuals against their will to be injected with biologicals of known and unknown toxicity today, then there will be no limit on which individuals freedoms the state can take away in the name of the greater good tomorrow.
Be the one who never has to say you did not do today what you could have done to change tomorrow.
It’s your health. Your family. Your choice.
And our mission continues. No forced vaccination. Not in America.
Click the plus sign at the bottom of this page to view and/or post comments on our commentary.
1 Center for Countering Digital Hate. About.
2 Ross C. British Group Tied to Labour Party is Trying to Take Down American Conservative Websites. Daily Caller June 17, 2020.
3 Tomlinson C. Foreign Interference: UK Govt-Linked Group Attempts to Ban Conservative Websites from Google Ads. Breitbart June 17, 2020.
4 CCDH. The Anti-Vaxx Playbook. December 2020.
5 Sun Reporter. VAXX LIE THREATS: Secret plans reveal top anti-vaxxers plotting to exploit Covid to launch huge misinformation campaign about vaccines. Dec. 22, 2020.
6 Williams R. Anti-vaxxers ‘aim to indoctrinate vaccine-hesitant ethnic minorities and parents’ on private Facebook groups. Inews Dec. 22, 2020.
7 Srikanth A. Anti-vaccination movement sees COVID-19 as an opportunity, taking efforts online. The Hill Dec. 22, 2020.
8 Dwoskin E. Vaccine opponents outline online campaigns to sow distrust in coronavirus vaccine. Washington Post Dec. 23, 2020.
9 Editorial Board. The anti-vaxxers are determined to sow doubt. Here’s how to build faith instead. Washington Post Jan. 10, 2021.
10 Influencer Marketing Hub. What Is An Influencer? Oct. 15, 2020.
11 Influence Watch. Center for Countering Digital Hate.
12 Attkisson S. The Smear: How Shady Political Operatives and Fake News CONTROL What You See, What You Think and How You Vote. Harper Collins Publishers 2017.
13 Influence Watch. Center for Countering Digital Hate.
14 Lucas F. 4 Things to Know About the British Group Targeting The Federalist. The Daily Signal June 21, 2020.
15 Webb PD and editors. Labour Party, political party, United Kingdom.Encyclopedia Britannica Apr. 7, 2020.
16 CCDH. The Anti-Vaxx Playbook. Pg. 4. December 2020.
17 National Vaccine Information Center. About Us. NVIC’s History: NVIC Educational Conferences.
18 Sun Reporter. VAXX LIE THREATS: Secret plans reveal top anti-vaxxers plotting to exploit Covid to launch huge misinformation campaign about vaccines. Dec. 22, 2020.
19 CCDH. The Anti-Vaxx Industry: How Big Tech powers and profits from anti-vaccine misinformation. July 2020.
20 Ibid. Pg. 3.
21 Barrio JR. Consensus Science and the Peer Review. Mol Imaging Biol 2009; 11(5): 293.
22 Ahmed I. It’s time the tech giants cracked down on the anti-vaxx infodemic. The Telegraph July 7, 2020.
23 Deardon L. Coronavirus: Social media firms make $1Bn a year from anti-vax followers, report says. The Independent July 7, 2020.
24 Elmore C. Left unchallenged, anti-vaxxers could become as contagious as coronavirus itself. Telegraph July 26, 2020.
25 Helm T. Social media firms must face sanction for ‘anti-vax’ content, demands Labour. The Guardian Nov. 15, 2020.
26 Ahmed I. Despite COVID-19 pandemic, tech giants still profit from anti-vaccination movement. USA Today July 17, 2020.
27 CCDH. The Anti-Vaxx Playbook. Pg. 4 December 2020.
28 Ibid. Pg. 5.
29 Olson W. The Problem with PPP Isn’t That Wrongheaded Groups Got Loans. CATO Jan. 19, 2021.
30 Dwoskin E, Gregg A. Five groups got more than $850,000 in PPP loans to help small businesses through the pandemic. Washington Post Jan. 18, 2021.
31 Holpuch A. Give anti-vaccine groups got loans via US government relief program – report. The Guardian Jan. 18, 2021.
32 Dwoskin E, Gregg A. Five groups got more than $850,000 in PPP loans to help small businesses through the pandemic. Washington Post Jan. 18, 2021.
33 Inman D. Trump administration bailed out anti-vaccine groups during the pandemic. Yahoo News Jan. 18, 2021.
34 Walsh J. Report: Anti-Vaccine Groups Collected Federal Covid Relief Funds. Forbes Jan. 18, 2021.
35 Cowley S. Anti-Vaccine groups received more than $1 million in small-business relief loans. New York Times Jan. 18, 2021
36 NVIC. Barbara Loe Fisher bio and About Us. January 2021.
37 ACLU. The United States Bill of Rights: First Ten Amendments to the Constitution.
38 Williams S. Rock ‘n’ roll “moral panics” – Part One: 1950s and 1960s. University of Southern Indiana Feb. 20, 2017.
39 Rothwell SL. Antinuclear movement. Encyclopedia Britannica Nov. 5, 2014.
40 U.S. Library of Congress. Civil Rights History Project: Youth in the Civil Rights Movement.
41 The White House Historical Association. The Anti-War Protests of the 1960s-70s.
42 Burkett E. Women’s rights movement. Apr. 27, 2001.
43 Pruitt S. How the First Earth Day Was Born From 1960s Counterculture. A&E Television Networks.
44 Walls S. Environmental Movement. Sonoma State University Nov. 9, 2014.
45 Advocatetanmoy Law Library. The History of Consumer Movement: United States of America. Aug. 28, 2018.
46 Mothers Against Drunk Driving. About.
47 Zwelling E. Down Memory Lane: Recollections of Lamaze International: First 50 Years. J Perinatal Educ 2010; 19(30): 11-16.
48 Wright AL, Schanter RJ. The Resurgence of Breasfeeding at the End of the Second Millennium. J Nutrition 2001; 131(2): 4215-4255.
49 Behrent MC. A Tale of Two Arguments about Free Speech on Campus. American Association of University Professors. Winter 2019.
50 Stransky O. Censorship Behind the Iroan Curtain and Its Parallels Today. Sampsonia Way Jan. 23, 2013.
51 Philosophy Basics. History of Totalitarianism.
52 Kaiser D. The Cultural Revolution and the History of Totalitarianism. Time Magazine May 16, 2021.
53 The Free Dictionary by Farlex. Definition of Statist: The practice or doctrine of giving a centralized government control over economic planning and policy.
54 Kennedy JF. The President and the Press: Address before the American Newspaper Publishers Association. JFK Library Apr. 27, 1961.
55 Ocie S. A Brief History of Internet Censorship. Influencive Apr. 20, 2019.
56 ACLU. Internet Speech.
57 Brian B. Suppression of Dissent. What It Is and What to Do About It. Social Medicine 2012; 6(4): 246-248.
58 American Civil Liberties Union (ACLU). Freedom of Expression: ACLU Briefing Paper Number 10. UpCounsel.
59 Fisher BL. The New Internet Police Protecting You From Freedom of Thought and Speech. NVIC Newsletter Dec. 3, 2018.
60 Farris M, Coleman D. First Principles on Human Rights: Freedom of Speech. Heritage Foundation July 17, 2020.
61 Fisher BL. Freedom to Dissent and the New Blacklist in America. NVIC Newsletter July 1, 2019.
62 Furedi F. Even anti-vaxxers must have freedom of speech. Spiked Nov. 11, 2020.
63 Crooke A. The Digital Iron Curtain Descends. Strategic Culture Foundation Nov. 20, 2020.
64 Weber TP. Alfred Russell Wallace and the Antivaccination Movement in Victorian England. Emerg Infect Dis 2010; 16(4).
65 Philadelphia College of Physicians and Surgeons. History of Anti-Vaccination Movements. Jan 10, 2018.
66 Fisher BL. Taking No Prisoners in the Vaccine Culture War. NVIC Newsletter Mar. 13, 2019.
67 Fisher BL. The National Plan to Vaccinate Every American. Mar. 21, 2020.
68 Lipsey S. 8 Ways You Can End Up On the No Fly List. Fox Sept. 9, 2019.
69 Markowitz G. What is a ‘vaccine passport and will you need one the next time you travel? World Economic Forum Jan. 20, 2021.
70 NVIC. Barbara Loe Fisher bio and About Us. January 2021.
71 GuideStar. Profile: National Vaccine Information Center. January 2020.
72 Fisher BL. The Moral Right to Conscientious, Philosophical and Personal Belief Exemption to Vaccination. Oral presentation to the National Vaccine Advisory Committee May 2, 1997.
73 National Vaccine Information Center. NVIC’s History: NVIC Vaccine Safety and Informed Consent Advocacy.
74 National Vaccine Information Center. NVIC’s History: National Childhood Vaccine Injury Act of 1986.
75 National Vaccine Information Center. NVIC Position Statement: National Childhood Vaccine Injury Act of 1986. May 2018.
76 7th Chakra Films. The Act. 2020.
77 Poland GA, Oysyannikova IG, Jacobson RM. Personalized vaccines: the emerging field of vaccinomics. Expert Opin Biol Ther 2010; 8(11): 1659-1667.
78 McGarvey PB, Suzek BE, Baraniuk JN et al. In ilico analysis of autoimmune diseases and genetic relationship to vaccination against infectious diseases. BMC Immunol 2014; 15: 61.
79 Soriano A, Nesher G, Shoenfeld Y. Predicting post-vaccination autoimmunity: Who might be at risk? Pharmacological Research 2015; 92: 18-22.
80 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Evaluation of Biologic Mechanisms of Adverse Effects: Increased Susceptibility Chapter 3: Page 82. In: Adverse Effects of Vaccines: Evidence and Causality. Washington, DC: The National Academies Press 2012.
81 NVIC. National Vaccine Information Center Supports Three of Five Recommendations of the New IOM Report on U.S. Childhood Immunization Schedule Safety and Calls for Transparency. Business Wire Jan. 16, 2013.
82 Fisher BL, Wrangham TK. NVIC public comment for the National Vaccine Program Office on reforming the U.S. vaccine safety system. June 6, 2011.
83 Fisher BL, Williams K, Wrangham TK. NVIC Response to Government Accountability Office (GAO) inquiry on History and Implementation of the National Childhood Vaccine Injury Act. July 11, 2014.
84 National Vaccine Information Center. NVICAdvocacy.org
85 National Vaccine Information Center. Barbara Loe Fisher Bio. Vicky Pebsworth, PhD, RN Bio.
86 National Vaccine Information Center. Vaccine Advisory Committee Statements.
87 Fisher BL. Statement of Public Perspective on Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. Institute of Medicine Feb. 9, 2012.
88 National Vaccine Information Center. Institute of Medicine (IOM) Reports and NVIC Statements.
89 Evans G, Bostrom A, Johnston RB, Fisher BL, Stoto MA, Editors. Risk Communication and Vaccination: Summary of a Workshop. Institute of Medicine Vaccine Safety Forum. National Academy Press 1997.
90 Fisher BL. How Fear of a Virus Changed Our World. NVIC Newsletter June 1, 2020.
91 National Vaccine Information Center. New York Bill Removing Religious Vaccine Exemption Turned Into Law On One Day With No Public Hearings. The Vaccine Reaction June 14, 2019.
92 Fisher BL. Defending Freedom of Religion and Conscience: Oral and Referenced Written Statement in Virginia Legislature. Joint Commission on Healthcare Healthy Living Health Services Subcommittee Aug. 3, 2016.
93 National Vaccine Information Center. Fifth International Public Conference on Vaccination: Protecting Health and Autonomy in the 21st Century. Starfish Sponsors.
94 National Vaccine Information Center. Fifth International Public Conference on Vaccination: Protecting Health and Autonomy in the 21st Century. Home and About.
ACCV Federal Advisory Report
By Theresa Wrangham
During 2020, a rule-making process to modify the federal Vaccine Injury Table (VIT) by less than transparent means has unfolded over the course of meetings held by the federal Advisory Commission on Childhood Vaccines (ACCV).
An unscheduled discussion took place, during the ACCV’s March meeting, about confidential correspondence that was sent to each Commissioner by the Department of Health and Human Services (DHHS). The correspondence solicited each Commissioner’s personal comments on a draft Notice of Proposed Rule Making (NPRM) to remove syncope and shoulder injury related to vaccine administration (SIRVA) from the VIT. Dr. Cody Meissner, who was the Chair of the Commission, encouraged Commissioners to respond to the correspondence privately, because he said it would be unlikely that the Commission would reach a consensus.1
Backdoor Attempt to Remove Recognized Vaccine Injuries
The Chairman’s encouragement that committee members respond privately to DHHS about the draft NPRM is contrary to the National Childhood Vaccine Injury Act of 1986.2 This federal law requires that any changes to the VIT be discussed in open meetings conducted by the ACCV and that their recommendations be made publicly, prior to the DHHS Secretary’s publishing of an NPRM to alter the VIT. The soliciting of private comments by DHHS from Commissioners appears to have been a backdoor attempt to circumvent long standing federal law.3 4 5
Commissioners Kain and Howie, who strongly opposed Dr. Meissner’s actions, stated that discussion about changes to the VIT should be undertaken publicly as a committee. They also expressed deep concern about the removal of these injuries without a presentation of evidence that would justify their removal from the VIT.6
NVIC Requests Public Discussions of DHHS Draft NPRM
In addition to concerns expressed by ACCV Commissioners in March, NVIC issued a letter in April7 to DHHS and the ACCV noting the legal requirement of the ACCV to publicly discuss and make recommendations to the DHHS Secretary prior to publishing an NPRM. NVIC also requested that ACCV review the original evidence that was presented when these injuries were added to the VIT by unanimous vote in 2012 and weigh it against any new evidence that would justify the removal of these injuries from the VIT.8
An unscheduled ACCV meeting to discuss DHHS’ proposed removal of SIRVA and syncope from the VIT was held on May 18, 2020, due to pressure from organizations and members of the public injured by vaccines, their attorneys and medical professionals.9
Evidence Base for SIRVA and Syncope
In 2009, DHHS engaged the Institute of Medicine (IOM) to review the epidemiologic, clinical, and biological evidence of adverse health outcomes associated with nine vaccines routinely recommended for children in the CDC’s childhood vaccination schedule.
The subsequent IOM physician committee report published in 2012 included a review of the evidence relating to reports of vaccine adverse events for syncope and SIRVA. Using their standard assessment, the IOM10 found strong mechanistic evidence11 to support a causal relationship between the injection of vaccines for the injuries of syncope and SIRVA, and did not rule out vaccines themselves as a possible mechanism for these injuries.
DHHS presented the IOM findings and expressed their support of adding these injuries to the VIT at the March 8, 2012 ACCV meeting.12 In turn, the ACCV unanimously voted to recommend that these injuries be added to the VIT.13 As a result, syncope and SIRVA were officially added to the VIT in January of 2017.14
The ACCV’s guiding principles for recommending changes to the VIT states that any change to the table should be evidenced based “and, whenever possible, be made to the benefit of petitioners”.15
SIRVA Now Leading VICP Compensation Awards
Injury compensation updates presented by DHHS throughout 2020 found that for the past two fiscal years the majority of petitions (54 percent) filed with the VICP were for SIRVA injuries.16 17 18 It was also noted that negotiated settlements have decreased since the addition of SIRVA to the VIT.19 The decrease in the number of SIRVA settlements is evidence that the original intent of the VIT, which was the expeditious compensation of cases resulting from a table of evidenced based injuries, has been met and its removal from the VIT would reverse that accomplishment.
ACCV Unanimously Rejects Removal of Syncope and SIRVA from Federal Vaccine Injury Table
During the ACCV’s May meeting, the ACCV unanimously rejected the proposed removal of syncope and SIRVA from the VIT, largely due to the fact that no new evidence was presented by DHHS to justify their removal.20 During the May, September and December ACCV meetings, Commissioners heard from citizens suffering from SIRVA, the Vaccine Injured Petitioners Bar Association, medical professionals, industry, and non-profit organizations such as NVIC and Vaccinate Your Family (formerly Every Child by Two) who all strongly opposed the removal of syncope and SIRVA from the VIT and requested that recommendations be deferred at least until all current research could presented to the Commission.21
Mike Milmoe, a vaccine injury attorney, was critical of DHHS’s attempt to remove these injuries from the VIT without presenting supporting evidence, especially in light of the lengthy and detailed process undertaken when these injuries were added to the table. He also found that the U.S. Department of Justice’s (DOJ) letter supporting the removal of these injuries from the VIT, due to the alleged increased workload it creates for DOJ’s staff, had no merit. As a former DOJ attorney in the VICP, Mr. Milmoe noted that by removing these injuries, DOJ staff would actually face increased workloads by having to spend more time trying to negotiate settlements rather than expediting compensation by conceding cases for injuries that appear on the VIT.22
Dr. Ramon Rodriguez, JD, from the Vaccine Injured Petitioners Bar Association, stated that DHHS’ concern that compensation of these injuries would cause depletion of the compensation trust fund was unfounded, and noted that the trust fund had continued to grow and was “healthy” despite compensation awards being made for these recognized injuries.23
John Murphy, General Counsel of Biotechnology Innovation Organization which represents the largest international biotechnology trade association in the world, stated that he supports keeping these injuries on the VIT because the rationale used when they were added to the VIT in 2017 remains largely unchanged.24
Dr. Srikumaran, an Associate Professor of Orthopedic Surgery at Johns Hopkins Shoulder and Sports Medicine, gave his professional opinion based on his clinical experience, that vaccine administration alone could not be responsible for all of the cases of SIRVA and that the vaccine itself must play a role. Both Dr. Srikumaran and Dr. Naveed Natanzi pointed out that the injection of other medications or blood products into the bursa or joint do not cause SIRVA like injuries.25
NVIC’s public comments26 27 and December presentation28 to the ACCV outlined the reasons why syncope and SIRVA should not be removed from the VIT.29 NVIC drew attention to the federal reports that were critical of the lack of a consistency in how injuries were added to or removed from the VIT, and to the fact that the continued narrowing of the VIT only makes it more difficult for claimants to receive compensation for their vaccine related injuries.30 31
NVIC’s December presentation also noted that research has continued to be published on syncope and SIRVA since the IOM’s report and should be reviewed prior to any change to the VIT relating to these injuries. The presentation also showed that there was no need to quell “frivolous” claims because historically the vast majority of injury claims have not been compensated. As December 1, 2020, DHHS reported that only 34 percent (7,705 out of 22,685) of all vaccine injury petitions filed with the VICP have been compensated.32
Steamrolling of the ACCV and Vaccine Injury Table
Despite the ACCV repeatedly requesting that DHHS present evidence as to why syncope and SIRVA should be removed from the VIT, DHHS has failed to present any evidence. As Mr. Milmoe, NVIC, and others have pointed out during ACCV meetings, this lack of participation on the part of DHHS is a stark departure from their actions when changes were made to VIT previously and typically included several presentations of evidence and a vote by the ACCV recommending a change, prior to issuance of an NPRM.33 34 35 36 37
Under federal law any changes to the VIT recommended by the ACCV are non-binding, due to their standing as an advisory committee. Therefore, now that the ACCV has made a recommendation to reject DHHS’ proposed removal of SIRVA and syncope from the VIT, that action is enough to allow the NPRM to move forward.
While DHHS has continued to refuse to present evidence to the ACCV as to why syncope and SIRVA should be removed from the VIT, NVIC, the vaccine injured, attorneys representing the vaccine injured, and health care professionals have presented evidence, opinions and concerns that overwhelmingly supported retaining syncope and SIRVA on the VIT.38 39 40
What Can You Do?
DHHS must respond to written public comments received on the NPRM. The deadline for written public comments on the proposed removal of syncope and SIRVA from the VIT is January 12, 2021. NVIC urges the public to oppose DHHS’ proposal to remove these injuries from the VIT for the following reasons:
- No evidence has been presented by DHHS justifying the removal of these injuries from the VIT;
- No data exists to support the DHHS position that the trust fund is running out of money. The latest data provided to the ACCV shows that there is ample money to furnish awards for these injuries as well as new injuries that may be added to the VIT;41 42
- VICP data does not support DHHS’ assertion that retaining these injuries will encourage frivolous petitions for compensation and add to DOJ’s caseload. In fact, the VICP routinely dismisses claims without merit and the removal of these injuries from the VIT will reduce the number of claims that can been resolved quickly, increase program costs, and provide no relief to caseloads;43 44
- The removal of these injuries from the VIT conflicts with the spirit and intent of the federal law governing the VICP.45
To learn more about the VICP and the proposed changes to the vaccine injury table, listen to Theresa on the Right on Point
podcast interview (Part 1
and Part 2
) by Wayne Rhode, author of The Vaccine Court.
Read NVIC's referenced, public comment on this NPRM submitted to DHHS.
Click the plus sign at the bottom of this page to view and/or post comments on our commentary.
1 HRSA. ACCV Webinar Recording – Mark 37.40 Mar. 6, 2020.
2 GPO.gov. 42 U.S.C. §§ 300aa-14. Vaccine Injury Table. 2016.
3 GPO.gov. 42 U.S.C. §300aa–19. Advisory Commission on Childhood Vaccines. 2016.
4 HRSA. Charter - Advisory Commission on Childhood Vaccines (ACCV). Jul. 20, 2018.
5 U.S. General Services Administration (GSA). Final - Federal Advisory Committee Rule 2001. Feb. 26, 2019.
6 Wadman, Meredith. United States wants to end most payouts for leading vaccination-related injury. Science Magazine. Apr. 20, 2020.
7 Fisher, BL. Williams, K. Wrangham, TK. Hendler, C. Letter to ACCV and ACCV DFO Re: Closed Door Discussions on Possible Removal of Syncope and Shoulder Injury Related to Vaccine Administration (SIRVA) from the Federal Vaccine Injury Table (VIT). Apr. 16, 2020.
8 Fisher, BL. William, K. Wrangham, TK. Hendler, C. Referenced Written Response & Request Relating to Proposal to Remove SIRVA and Syncope from the Federal Vaccine Injury Table. Apr. 16, 2020.
9 Federal Register. Advisory Commission on Childhood Vaccines - Notice. Apr. 27, 2020.
10 Institute of Medicine Committee. Adverse Events of Vaccines: Causality Assessment. Washington, DC: The National Academies Press 2012.
11 Institute of Medicine Committee. Adverse Events of Vaccines: Evidence and Causality - TABLE 12-1 Summary of Epidemiologic Assessments, Mechanistic Assessments, and Causality Conclusions for Injection-Related Adverse Events. Washington, DC: The National Academies Press 2012.
12 U.S. HRSA. ACCV Meeting Transcript. Mar. 8, 2012.
13 U.S. HRSA. ACCV Meeting Transcript. Mar. 8, 2012.
14 Federal Register. National Vaccine Injury Compensation Program: Revisions to the Vaccine Injury Table. Jan. 19, 2017.
15 U.S. HRSA. GUIDING PRINCIPLES FOR RECOMMENDING CHANGES TO THE VACCINE INJURY TABLE. Mar. 9, 2006.
16 HRSA. Division of Injury Compensation Programs Update to ACCV. Slide 11. Mar. 6, 2020.
17 HRSA. Division of Injury Compensation Programs Update to ACCV. Slide 11. Sept. 4, 2020.
18 HRSA. Division of Injury Compensation Programs Update to ACCV. Slide 11. Dec. 3, 2020.
19 HRSA. ACCV Minutes. Pg 2. Slide 11. Mar. 6, 2020.
20 HRSA. ACCV Recommendation - Implementation of the Draft National Vaccine Injury Compensation Program NPRM. May 20, 2020.
21 HRSA. ACCV Minutes. May 18, 2020.
22 HRSA. ACCV Minutes. May 18, 2020.
23 HRSA. ACCV Minutes. May 18, 2020.
24 HRSA. ACCV Minutes. May, 18,2020.
25 HRSA. ACCV Minutes. May, 18,2020.
26 Wrangham, T. NVIC Public Comment to ACCV. May 18, 2020.