by Barbara Loe Fisher
I remember when I took my first-born baby to the pediatrician for his first checkup 40 years ago. Like most young Moms, I looked up to my pediatrician and completely trusted him. I did everything he told me to do, never questioning his expertise or doubting him, believing that he would never recommend or do anything that would put my baby in harm’s way.
Much has changed since 1978. Back then infants and children were getting half as many vaccines as they do today.1 Parents had no information at all about vaccine risks and failures. We just followed the doctor’s orders.
Today, the subject of vaccination is the most often discussed health topic in America. Not a day goes by without mothers and fathers being reminded that the health of the nation depends upon making sure their children get every one of the 69 doses of 16 CDC recommended vaccines exactly on schedule. 2 3 4
CDC Vaccine Schedule: A Commandment
These days, that CDC vaccine schedule is no longer being viewed simply as a recommendation, it is being treated as a commandment. We are told it is our patriotic civic duty to get our children vaccinated and ourselves, too. The implication is that we are committing treason if we don’t.5
These days, a well baby checkup can be a frightening and gut-wrenching experience for a new Mom bringing her baby to the pediatrician’s office. That is because, with the approval of the American Academy of Pediatrics (AAP), many pediatricians have taken the hardline position that they do not have to discuss vaccination with parents or, if they do, they can threaten them with dismissal from the practice for not obeying a direct order.6 7 8
Almost No Medical Contraindications to Vaccination
The National Vaccine Information Center is regularly contacted by mothers reporting that pediatricians are refusing to provide medical care to their babies if they decline or ask to delay even one of the two dozen doses of nine vaccines that CDC officials order pediatricians to give infants in the first year of life.9 10 This schedule includes a hepatitis B vaccination on the day of birth and eight more doses of vaccines given at the two-month well baby checkup.11 12 It is an early childhood vaccine schedule that, in 2013, the Institute of Medicine concluded has not been adequately studied for safety.13 14
Because public health officials have eliminated almost all medical contraindications to vaccination, pediatricians are insisting on re-vaccinating children who have had serious vaccine reactions, including convulsions.15 16 They are writing off vaccine reactions as unimportant, even after children regress further and further into chronic poor health following each series of vaccinations.17 18
Sacred Trust Between Pediatricians and Mothers Broken
Pediatricians’ offices have become ugly battlegrounds. Intelligent, well-informed and loving parents asking legitimate questions about vaccination are being belittled and treated with disrespect and contempt by too many pediatricians robotically implementing the CDC’s inflexible vaccine schedule in clear violation of the informed consent principle.
Don’t take my word for it, go to NVIC’s Cry for Vaccine Freedom Wall and read report after report of just how terrifying pediatric check-ups have become. The sacred trust between mothers and pediatricians fostered by mutual respect and shared decision-making has been broken. Sadly, the admiration and trust that mothers used to have for family pediatricians is melting away and being replaced by fear.
Doctors are not our masters. We pay them well to do a job, not to exploit and terrify us. Discrimination, coercion and force have no place in modern medicine or in public health policy.19 20 21 22 23 24
Injustice, Suffering and Social Reform
Every social reform movement in history has been shaped by injustice and suffering. Suffering is often the greatest catalyst for change, and change will come if we believe it is possible. Working to successfully reform vaccine policies and laws that cause suffering is not an impossible dream.25 It will be done if we believe it can be done.
It is time to let our elected representatives know that we want them to put legal boundaries on the authority that doctors and public health officials wield in our society.
Learn more about what you can do to protect your human right to informed consent to vaccination on NVIC.org and NVICAdvocacy.org 26 27
It’s your health. Your family. Your choice.
Click the plus sign at the bottom of this page to view and/or post comments on our commentary.
1 CDC. Recommended schedule for active immunization of normal infants and children 1983.
2 U.S. Centers for Disease Control and Prevention (CDC). Recommended Immunization Schedules for Persons Aged 0 Through 18 Years, United States, 2018.
3 Kempe A, O’Leary S et al. Physician Response to Parental Requests to Spread Out the Recommended Vaccine Schedule. Pediatrics 2015; 135(4).
4 Radcliffe S. Not in My Office: Pediatricians Debate Treating Unvaccinated Kids. Healthline Feb. 5, 2015.
5 Thompson D. More parents believe vaccines are unnecessary. Health Day Aug. 29, 2016.
6 American Academy of Pediatrics. Medical Versus Nonmedical Exemptions for Child Care and School Attendance. Pediatrics August 2016.
7 Edwards K, Hackell JM. Countering Vaccine Hesitancy. Pediatrics 2016; 138(3).
8 Nelson R. New AAP Policy on Patient Dismissal for Vaccine Refusal May "Erode Solidarity" Among Pediatricians. Infectious Disease Advisor May 24, 2018.
9 Radcliffe S. Not in My Office: Pediatricians Debate Treating Unvaccinated Kids. Healthline Feb. 5, 2015.
10 ABC-TV (Denver). More Doctors Refusing to Treat Unvaccinated Children. Nov. 2, 2015
11 National Vaccine Information Center. 50 Doses of 14 Vaccines Before Age Six?
12 Fisher BL. Is the Childhood Vaccine Schedule Safe? National Vaccine Information Center Oct. 1, 2017.
13 Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. Summary: Health Outcomes (p. 5-6) and Conclusions About Scientific Findings (p. 11) and Review of Scientific Findings (p. 75-98). The Childhood Immunization Schedule and Safety Stakeholder Concerns, Scientific Evidence and Future Studies; Washington, D.C. The National Academies Press 2013.
14 NVIC. National Vaccine Information Center Supports Three of Five Recommendations of New IOM Report on U.S. Childhood Immunization Schedule Safety and Calls for Transparency. Business Wire Jan. 16, 2013.
15 CDC. Recommendations and Guidelines of the Advisory Committee on Immunization Practices (ACIP): Contraindications and Precautions. Table 4-2. Conditions incorrectly perceived as contraindications or precautions to vaccination (i.e., vaccines may be given under these conditions). Sept. 14, 2018.
16 CDC. Febrile Seizures Following Childhood Vaccinations, Including Influenza Vaccination. Nov. 2, 2017.
17 Fisher BL. Blackmail and the Medical Vaccine Exemption. National Vaccine Information Center May 18, 2018.
18 Fisher BL. Do You Know How to Recognize a Vaccine Reaction? National Vaccine Information Center Aug. 27, 2018.
19 Berezow A. Jail 'anti-vax" parents . USA Today Jan. 28, 2015.
20 Mathews J. Unvaccinated Families Addresses Should Be Made Public. Time Magazine Feb. 13, 2015.
21 Danziger PD, Diamond R. The Vaccination Double Standard. Slate July 25, 2016.
22 Fentiman LC. When it comes to vaccines, rich parents get away with child neglect. Washington Post May 10, 2017.
23 Fisher BL. Class and Race Profiling in the Vaccine Culture War. National Vaccine Information Center July 17, 2017.
24 Caceres M. Professor Says Parents Have No Right to Refuse Vaccines for Their Children. The Vaccine Reaction Oct. 31, 2018.
25 Fisher BL. Guide to Reforming Vaccine Policy and Law. National Vaccine Information Center 2017.
26 Fisher BL. The Moral Right to Conscientious, Philosophical and Personal Belief Exemption to Vaccination. National Vaccine Advisory Committee May 2, 1997.
27 Fisher BL. Why is Informed Consent to Vaccination a Human Right? National Vaccine Information Center June 28, 2018.
By Theresa Wrangham
As Vaccine Awareness Week 2018 approaches, I am reminded how precious freedom of speech is in our country and how important it is to defend it.
Late last week, NVIC was informed that Pinterest removed our account. The Pinterest Team stated, “many of your pins violate our Community Guidelines on misinformation” and explained that “we take actions against accounts that repeatedly save content that includes harmful advice, misinformation that targets individuals or protected groups, or content that originates from disinformation campaigns.”
Earlier this week I sent a letter to Pinterest appealing the take down of NVIC’s Pinterest account. While we wait for a response, I hope you will take a moment to think about what value you place on freedom of thought, speech and autonomy. What value do you place on the free press and Internet? Should opposing facts and opinions be censored when they do not agree with the majority? Will rational dissenting viewpoints be conveniently painted as “fake news” or “misinformation?”
Amid well-publicized vaccine failures for mumps,1 2 3 pertussis,4 5 6 7 and influenza,8 9 10 we cannot talk about vaccines…unless it is to praise them. To do other than praise vaccines is to be labeled anti-vaccine. It shouldn’t matter if you do not vaccinate, selectively vaccinate, or vaccinate according to government recommendations because we live in a country with a Constitution that basically says we don’t have to agree with each other and may voice our viewpoints without being sanctioned. I was taught that, while we may not always agree with each other, we can respectfully speak and listen to each other.
A lot has changed culturally in that respect since I made vaccine decisions for my two daughters. They are grown and gone. But I didn’t have to hide our decision from our neighbors; it was something we could actually talk about, without fear or judging each other. That’s not really true today.11
I chose to work at NVIC because of this organization’s long-established track record of neutrality, education and defense of the informed consent ethic.12 13 I have long-admired our co-founders who gave voice to the fact that vaccines can cause injury and death, and who fought like hell to get that fact publicly acknowledged. How did they do that? Well, it wasn’t their opinion that convinced Congress to include vaccine safety and research provisions in the National Childhood Vaccine Injury Act of 1986. NVIC’s co-founders efforts were grounded in the medical literature, which had recorded for decades that DPT vaccine is a highly reactive vaccine that could cause brain damage in children.14 15 16 17 They were, in turn, supported by many parents of children who were also vaccine-injured and wanted safety reforms instituted in the vaccination system. Ironically, it was a journalist who blew the whistle on the whole cell pertussis vaccine,18 19 and the rest as they say is history. Or is it?
I am not sure if what passes for news today really is news. I do know that respect for autonomy, freedom of speech and the exercising of informed consent to vaccination is eroding.20
I will never forget the mom who walked up to me in Colorado as we were opposing a bill proposing to restrict the personal belief exemption to vaccination. That mom said – “I vaccinate my child with all CDC recommended vaccines” – and she paused, while I took a deep breath and got ready to defend my ground. Then she added - “And I am appalled that someone wants to take away my right to decide which vaccines to use.”
S H E G O T I T.
While NVIC’s supporters make many different vaccination decisions, we have one thing in common - CHOICE! NVIC has never been about telling the public to vaccinate or not to vaccinate. Are we critical of vaccine laws and policies? You bet! Do we focus on vaccine risks? Of course! Do we support voluntary vaccine decision-making? Absolutely! Why?
OUR MISSION - The National Vaccine Information Center (NVIC) is dedicated to preventing vaccine injuries and deaths through public education and advocating for informed consent protections in medical policies and public health laws. NVIC defends the human right to freedom of thought and conscience and supports the inclusion of flexible medical, religious and conscientious belief exemptions in vaccine policies and laws.
NVIC was founded by parents of vaccine-injured children. Everything we do is through that lens. Our co-founders, who faithfully vaccinated their children without asking any questions, were never told vaccines come with a risk of injury and death. After their children were injured, NVIC’s co-founders felt strongly that parents should know prior to vaccination more about the risks and complications of diseases and vaccines prior to vaccination so that parents could make voluntary, educated vaccination decisions for their children.
Throughout NVIC’s existence over the past 36 years, government has continued to minimize vaccine risks and the numbers of people who are being harmed by vaccines.21 Today, the media often tells only one side of the vaccine story and the proponents of mandatory vaccination policies proclaim, “the science is done.”
Science is never done; it evolves. Look no further than the reports on vaccines published by the Institute of Medicine to understand the science is far from done.22 23 24 25 26 27 And even if such a concept were possible, it should not override one’s ability to say, “no thanks, that’s not for me,” to a medical procedure. Vaccines are pharmaceutical products that can cause injury or death. That is not opinion, it is fact.28 29 30 31 32 NVIC provides information on diseases and vaccines to empower consumers to research, be curious, ask questions and make educated decisions.
It likely took only a moment and a few keystrokes to suspend NVIC’s Pinterest account, but no matter what happens with our appeal, NVIC is not going away. We were an organized public resource long before the advent of personal computers, mobile devices, and web-based social media platforms. You can always find us at NVIC.org, NVICAdvocacy.org and TheVaccineReaction.org.
It only takes a few keystrokes by you to directly connect with NVIC. You can sign up to be a subscriber of our monthly NVIC Newsletter or The Vaccine Reaction weekly journal and become a registered user of the NVIC Advocacy Portal today. That is how you can stay connected to NVIC so we do not lose touch with each other.
You are why NVIC has been able to make a difference in raising awareness about vaccination, health and autonomy. Be strong and continue to have the courage to share your concerns with others so we can work together to preserve freedom of thought, speech, conscience and vaccine choice in America.
Many thanks for your continued support!
NVIC Executive Director
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1 Barclay, L. Lie, D. Large Mumps Outbreak Characterized by 2-Dose Vaccine Failure. Medscape. Apr. 9, 2008.
2 CNN. More than 1,000 get mumps in New York, New Jersey since August. Feb. 8, 2010.
3 Klass, P. Mumps Makes a Comeback, Even Among the Vaccinated. New York Times. Nov. 6, 2017.
4 CDC. Pertussis Frequently Asked Questions: Do pertussis vaccines protect for a lifetime? Doesn’t herd immunity protect most people? Dec. 19, 2013.
5 Wendelboe AM, Annelies VR et al. Duration of Immunity Against Pertussis After Natural Infection or Vaccination. Pediatr Infect Dis J 2005; 24(5): S58-S61.
6 Witt MA, Katz PH, Witt DJ. Unexpectedly Limited Durability of Immunity Following Acellular Pertussis Vaccination in Pre-Adolescents in A North American Outbreak. Clin Infect Dis 2012; 54(12): 1730-1735.
7 CDC. Pertussis Epidemic – Washington, 2012. MMWR July 20, 2012; 6(28): 517-522.
8 CDC. Adjusted effectiveness estimates for influenza seasons from 2004-2018. Sep. 6, 2018.
9 Fisher, B. CDC Admits Flu Shots Fail Half the Time. NVIC Newsletter. Apr. 26, 2016.
10 NVIC. How Effective is Influenza Vaccine?
11 Cáceres, M. Harvard Medical School Doctor: Vaccine Science is Not Settled. The Vaccine Reaction. Aug. 18, 2018.
12 NVIC. NVIC’s History.
13 NVIC. Informed Consent.
14 Madsen, T. Vaccination against whooping cough. JAMA. 1933 101(3):187-88.
15 Byers RK, Moll FC Encephalopathies following prophylactic pertussis vaccine. Pediatrics.1948 Apr;1(4):437-57.
16 Kulenkampff M, Schwartzman JS, Wilson J Neurological complications of pertussis inoculation. Arch. Dis. Child. 1974, 49, 46
17 Miller DL, Ross EM et al. Pertussis immunization and serious acute neurological illness in children. British Medical Journal 1981; 282:1595-9.
18 YouTube. DPT:Vaccine Roulette.
19 Trebbe AL. Local TV Honors Its Own: Channels 4 and 7 Sweep the Emmys. Washington Post June 27,1983.
20 Fisher BL. A Guide to Reforming Vaccine Policy & Law. National Vaccine Information Center 2014; 2017.
21 Fisher, BL. Williams, K. Wrangham T. NVIC Response to the Government Accounting Office request for NVIC’s perspective on the federal vaccine injury compensation program (VICP). Jul. 11, 2014.
22 Institute of Medicine Vaccine Safety Committee. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC. The National Academies Press. 1991
23 Institute of Medicine Vaccine Safety Committee. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, D.C. The National Academies Press 1994.
24 Institute of Medicine Vaccine Safety Forum. Howe CJ, Johnston RB, Fenichel GM, Editors. Summaries of Two Workshops. Washington, D.C. The National Academy Press 1997.
25 Institute of Medicine. Adverse Effects of Vaccines: Evidence and Causality. Appendix D. Causality Conclusion Tables. Washington (DC): National Academies Press. 2012.
26 Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. The Childhood Immunization Schedule and Safety Stakeholder Concerns, Scientific Evidence and Future Studies. Summary (p. 5-6). Washington, D.C. The National Academies Press 2013. Summary of Scientific Findings. (pp. 129-130).
27 National Vaccine Information Center. NVIC Supports Three of Five Recommendations of New IOM Report on U.S. Childhood Immunization Schedule Safety and Calls for Transparency. BusinessWire Jan. 16, 2013.
28 U.S. Health Resources and Administrative Services (HRSA). Vaccine Injury Table. Sep. 2018.
29U.S. 42 U.S.C. §§ 300aa-10. Establishment of Program. U.S. Government Publishing Office. 2016.
30 Institute of Medicine Vaccine Safety Committee. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC. The National Academies Press. 1991
31 Institute of Medicine Vaccine Safety Committee. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, D.C. The National Academies Press 1994.
32 Institute of Medicine. Adverse Effects of Vaccines: Evidence and Causality - Appendix D. Causality Conclusion Tables. Washington (DC): National Academies Press. 2012.
Barbara Loe Fisher
Co-founder & President
National Vaccine Information Center (NVIC)
Public Comment - NPRM Hearing
Health Resources and Services Administration (HRSA)
U.S. Department of Health and Human Services (DHHS)
Sept. 17, 2018
To activate and view hyperlinked references, please click once and then click any superscripted number below to access a hyperlinked reference, or scroll down to the bottom of the article to view all hyperlinked references.
National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table
This public comment is being submitted on behalf of more than 200,000 supporters of the nonprofit National Vaccine Information Center, a charity founded in 1982 by parents of DPT vaccine injured children to prevent vaccine injuries and deaths through public education. 1 I was among the parent co-founders who worked with Congress in the early 1980s to secure informing, recording, reporting and research provisions in the National Childhood Vaccine Injury Act of 1986, and to develop a Vaccine Injury Table for the Vaccine Injury Compensation Program (VICP) created by Congress under that historic law. 2 3 4 Information about the law can be found at NVIC.org.
We are here today because in 2016, Congress amended the 1986 Act to add vaccines recommended by the CDC for routine administration to pregnant women to the Vaccine Injury Table. That amendment would not have been included in the 21st Century Cures Act 5 without the strong support of the Department of Health and Human Services, which has been advocating since 2013 for this addition. 6 7 Congressional action was required to do it because the 1986 Act was not about vaccines recommended for adults or unborn babies developing in the womb.
As stated in multiple congressional hearings between 1982 and 1986, the National Childhood Vaccine Injury Act was created by Congress for one purpose: to protect the availability and lower the costs of federally recommended vaccines for children that are state mandated for school attendance. 8 9 DHHS and the Department of Justice opposed the 1986 Act because it preserved product liability for the four pharmaceutical companies producing DPT, polio and MMR vaccines, the seven vaccines that were recommended and mandated for children at that time (Wyeth, Lederle, Connaught and Merck). 10 11 Today, there are 10 companies marketing 16 vaccines that the CDC now recommends and states mandate for children to attend daycare and school (Pfizer, GlaxoSmithKline, Merck, Wyeth, Sanofi, Seqiris, Protein Sciences, MedImmune, Dynavax, Novartis). 12 13
In 1993, DHHS lobbied for amendments to the Act that transferred almost all authority from Congress to DHHS to add new vaccines to the Vaccine Injury Table and revise guidelines for awarding federal compensation. 14 15 16 In 2011, both DHHS and DOJ joined with vaccine manufacturers and asked the U.S. Supreme Court to do what Congress did not do in 1986 and finally cut off all product liability for companies marketing federally recommended and state mandated vaccines for children in the U.S. 17 18 19 20
Although this NPRM requests public comment on how the addition of this new maternal vaccination category should be formatted on the Vaccine Injury Table, 21 the public is hampered from making informed comment because of knowledge gaps, not only about the complexity of immune function during pregnancy, 22 23 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. 24 25 26 27 28 29 30 31 Although DHHS partially complied with vaccine safety research provisions included in the 1986 Act by commissioning the National Academy of Sciences to appoint committees to evaluate and publish reports on the adverse effects of childhood vaccines, it is important to note that reports published by the Institute of Medicine between 1991 and 2013 repeatedly stated that there have been long standing gaps in basic science knowledge about the biological mechanisms of vaccine injury and death and which individuals are more susceptible to harm from vaccination. 32 33 34 35 36 37
DHHS has not taken action to fill in basic vaccine science knowledge gaps outlined in IOM reports spanning more than two decades. The continuing lack of scientific understanding about how and why vaccines fail to protect 38 39 or injure and kill without warning, and why some individuals are biologically and environmentally at higher risk for suffering harm, 40 is also true for pertussis containing Tdap vaccine and influenza vaccines recommended for all women during every pregnancy. Tdap and influenza vaccines were never tested or licensed for use in pregnant women and are labeled as either Pregnancy Category B or C products. 41 42 Various package inserts for these vaccines contain warnings such as “animal reproduction studies have not been conducted;” and “it is not known whether the vaccine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity;” and “there are no adequate and well controlled studies in pregnant women;” and “the vaccine’ has not been evaluated for carcinogenic or mutagenic potential;“ and “available data on the vaccine administered to pregnant women are insufficient to inform vaccine associated risks in pregnant women;” and “the vaccine should be given to pregnant women only if clearly needed.” 43
Maternal vaccination policy has preceded the science.
Now, with the addition of vaccines recommended for pregnant women to the Vaccine Injury Table, the 12 other vaccines the CDC currently recommends for children become candidates for a future maternal use recommendation by CDC 44 because the manufacturers of those vaccines are now protected from liability when a pregnant woman and/or her unborn baby born alive is harmed in the womb by vaccination, although there is less clarity about whether DHHS will offer compensation when maternal vaccinations cause a miscarriage or stillbirth. In addition, the manufacturers of two new experimental vaccines specifically targeting pregnant women – RSV 45 and strep B 46 – will be shielded from liability, as will manufacturers of other new vaccines the CDC recommends for use by all pregnant women. 47 This is a stunning expansion of vaccine product liability protection for the pharmaceutical industry in a 1986 tort reform Act that created a federal compensation program option for children injured by government recommended and mandated vaccines that was never intended to cover adults or be an exclusive remedy. 48
Currently, pertussis containing and influenza vaccines account for the majority of federal compensation awards, although two out of three vaccine injury claims are denied. 49 These vaccines contain adjuvants and other ingredients known to be neurotoxic 50 51 52 53 54 but have not been evaluated for neurotoxic, genotoxic, 55 or adventitious agent 56 effects or stimulation of intrauterine inflammation in the pregnant woman or her fetus that may cause miscarriage or brain injury or otherwise damage the health of the baby after birth. In this regard, there have been two signals, one for miscarriage and one for clinical chorioamnionitis associated with vaccines given to pregnant women. 57 58 59 These two adverse outcomes should be added to the Vaccine Injury Table for maternal vaccines, in addition to the serious complications of encephalitis/encephalopathy and Guillain Barre syndrome already listed for these vaccines on the Table.
Of particular concern is evidence published in the medical literature indicating that chronic inflammation in a pregnant women or developing fetus frequently leads to poor health outcomes in children, including neurodevelopmental delays. 60 61 62 The fact that vaccination provokes an inflammatory response in the body to stimulate the production of artificial immunity, an inflammatory response that can become chronic in some individuals, should not be ignored. Evidence of intrauterine inflammation and elevated concentrations of cytokines in the umbilical cord or plasma of newborns, whose mothers were vaccinated during pregnancy, should be considered when those children later develop neurodevelopmental delays and neurodevelopmental delays should be added to the Vaccine Injury Table. 63 64
Emerging scientific evidence confirms that not only is there a fundamental lack of scientific understanding about how infectious diseases and vaccines stimulate natural or artificial immunity in the body at the cellular and molecular level, but there are basic science knowledge gaps about how infections and vaccines cause complications leading to injury and death. 65 Future genetically engineered vaccines recommended for pregnant women will contain new ingredients to which pregnant women and unborn babies have never been exposed. 66 It is urgent that this federal agency responsible for protecting the public health fully comply with the vaccine safety research provisions in the 1986 law 67 by funding independent research to develop pathological profiles based on cellular, molecular and other biological evidence for the purpose of creating vaccine contraindications that will prevent harm, and to facilitate the awarding of vaccine injury compensation when there is evidence of harm.
Finally, between 2014 and 2016 and recently in a public comment to the FDA concerning including pregnant women in clinical trials, the National Vaccine Information Center has asked for DHHS officials to affirm the ethical principle of informed consent to medical risk taking, which includes vaccine risk taking. 68697071 There is no single vaccine-related issue of more concern to Americans than protection of this internationally recognized human right for pregnant women, parents of minor children and adults of all ages, who are too often being threatened and sanctioned if they do not agree to receive all government recommended and mandated vaccines for which the pharmaceutical industry has had no product liability since 2011. 7273
Thank you for your consideration of this public comment.
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1 National Vaccine Information Center. NVIC: About Us. 2018.
2 Public Law 99-660. Title III – National Childhood Vaccine Injury Act of 1986. 42 USC 300aa. Nov. 14, 1986.
3 Fisher BL. Statement of National Vaccine Information Center: Compensating Vaccine Injuries: Are Reforms Needed? U.S. House Subcommittee on Criminal Justice, Drug Policy and Human Resources Hearing Sept. 28, 1999.
4 Fisher BL. The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform. Advisory Commission on Childhood Vaccines Nov. 18, 2008.
5 Nair N. The 21st Century Cures Act and the National Vaccine Injury Compensation Program (VICP). National Vaccine Advisory Committee Feb. 7, 2017.
6 National Vaccine Advisory Committee. Maternal Immunization Working Group: Proposed Recommendations. June 2013.
7 Orenstein WA, Gellin BG et al. The National Vaccine Advisory Committee: Reducing Patient and Provider Barriers to Maternal Immunizations. Public Health Rep 2015; 130(1): 10-42.
8 Institute of Medicine and National Research Council. The Rationale for Providing Compensation for Vaccine-Related Injury. Chapter 9: Vaccine Injury Compensation and Liability Remedies. Vaccine Supply and Innovation 1985. Washington, DC: The National Academy Press. (pp. 148-151).
9 Myers PH. Fixing the Flaws in the Federal Vaccine Injury Compensation Program. Administrative Law Review 2011; 65(4): 785-851.
10 Mariner WK. Innovation and Challenge: The First Year of the National Vaccine Injury Compensation Program. Report prepared for Administrative Conference of the United States 1991.
11 CDC. Recommended schedule for active immunization of normal infants and children - 1983.
12 FDA. Vaccines Licensed for Use in the U.S. Mar. 29, 2018.
13 CDC. Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, United States, 2018. Jan. 1, 2018.
14 42 USC Chapter 6A, Subchapter XIX: Vaccines. Public Health Service. National Childhood Vaccine Injury Compensation Act of 1986 with amendments.
15 DHHS. National Vaccine Injury Compensation Program Revision of the Vaccine Injury Table Final Rule. Federal Register Feb. 8, 1995; 60(26): 7678-7696.
16 Allen A. Shots in the Dark. Washington Post Aug. 30, 1998.
17 U.S. Supreme Court. Brief for the United States as Amicus Curiae Supporting Respondent in Bruesewitz v Wyeth. July 30, 2010.
18 U.S. Supreme Court. Brief of GlaxoSmithKline, Merck Sharp & Dohme Corp. and Sanofi Pasteur, Inc. as Amici Curiae in support of respondent in Bruesewitz v Wyeth. July 30, 2010.
19 Supreme Court of the United States. Bruesewitz v. Wyeth No. 09-152. Justice Sotomayor with whom Justice Ginsberg joins, dissenting Feb. 22, 2011.
20 National Vaccine Information Center. National Vaccine Information Center Cites “Betrayal” of Consumers by U.S. Supreme Court Giving Total Liability Shield to Big Pharma. NVIC Press Release Feb. 23, 2011.
21 HRSA. Seeking Public Comments on the Notice of Proposed Rulemaking: National Vaccine Injury Compensation Program: Adding the Category of Vaccines Recommended for Pregnant Women to the Vaccine Injury Table. National Vaccine Injury Compensation Program News: September 2018.
22 Mor G, Cardenas I. The Immune System in Pregnancy: A Unique Complexity. Am J Reprod Immunol. Jun. 2010. 63(6): 425–433.
23 Zouikr I, Tadros MA et al. Altered nociceptive, endocrine, and dorsal horn neuron responses in rats following a neonatal immune challenge. Psychoneuroendocrinology 2014; 41: 1-12.
24 Regan AK. The Safety of Maternal Vaccination. Hum Vaccin Immunother 2016; 12(12): 3132-3136.
25 Food and Drug Administration. FDA Update: Vaccines for Use in Pregnancy to Protect Young Infants from Disease. Vaccines & Related Biological Products Advisory Committee Nov. 13, 2015.
26 Ladhani SN, Andrews NJ, Southern J, Jones CE, Amirthalingam G, Waight PA, et al. Antibody responses after primary immunization in infants born to women receiving a pertussis-containing vaccine during pregnancy: single arm observational study with a historical comparator. Clin Infect Dis 2015; 61:1637–44.
27 Feunou PF, Mielcarek N, Locht C. Reciprocal interference of maternal and infant immunization in protection against pertussis. Vaccine 2016; 34(8): 1062-1069.
28 Maertens K, Burbidge P et al. Pneumococcal Immune Response in Infants Whose Mothers Received Tetanus, Diphtheria and Acellular Pertussis Vaccination During Pregnancy. Ped Infect Dis J 2017; 36(12): 1186-1192.
29 Schlaudecker EP, Ambroggio L et al. Declining responsiveness to influenza vaccination with progression of human pregnancy. Vaccine 2018; 36(31): 4734-4741.
30 Halperin SA, Langley JM et al. A Randomized Controlled Trial of the Safety and Immunogenicity of Tetanus, Diphtheria, and Acellular Pertussis Vaccine Immunization During Pregnancy and Subsequent Infant Immune Response. Clin Infect Dis July 13, 2018.
31 Wilcox CR, Jones CE. Beyond Passive Immunity: Is There Priming of the Fetal Immune System Following Vaccination in Pregnancy and What Are the Potential Clinical Implications? Front Immunol 2018; 9(1548).
32 Institute of Medicine Vaccine Safety Committee. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC. The National Academies Press. 1991. Afterword on Research Needs. (p. 206).
33 Institute of Medicine Vaccine Safety Committee. Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality. Washington, D.C. The National Academies Press 1994. Need for Research and Surveillance. (pp. 305 & 307).
34 Institute of Medicine Vaccine Safety Forum. Howe CJ, Johnston RB, Fenichel GM, Editors. Summaries of Two Workshops. Washington, D.C. The National Academy Press 1997.
35 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Evaluation of Biologic Mechanisms of Adverse Effects: Increased Susceptibility. (p. 82). Washington, D.C. The National Academies Press 2012.
36 Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. The Childhood Immunization Schedule and Safety Stakeholder Concerns, Scientific Evidence and Future Studies. Summary (p. 5-6). Washington, D.C. The National Academies Press 2013. Summary of Scientific Findings. (pp. 129-130).
37 National Vaccine Information Center. NVIC Supports Three of Five Recommendations of New IOM Report on U.S. Childhood Immunization Schedule Safety and Calls for Transparency. BusinessWire Jan. 16, 2013.
38 Pulendran B, Ahmed R. Immunological mechanisms of vaccination. Nat Immunol 2011; 12(6): 509-517.
39 Saul N, Wang K et al. Effectiveness of maternal pertussis vaccination in preventing infection and disease in infants: The NSW Public Health Network case-controlled study. Vaccine 2018; 36: 1887-1892.
40 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Evaluation of Biologic Mechanisms of Adverse Effects: Increased Susceptibility. (p. 82). Washington, D.C. The National Academies Press 2012.
41 Roberts JN, Gruber MF. Regulatory considerations in the clinical development of vaccines indicated for use during pregnancy. Vaccine 2015; 33(8): 966-972.
42 Drugs.com. FDA Pregnancy Categories.
43 FDA. Vaccines Licensed for Use in the U.S. Mar. 29, 2018.
44 Groom HC, Irving SA et al. Uptake and safety of Hepatitis B vaccination during pregnancy: A Vaccine Safety Datalink study. Vaccine Sept. 4, 2018.
45 Blanco JCG, Pietneva LM et al. Efficacy of a respiratory syncytial virus vaccine candidate in a maternal immunization model. Nat Commun 2018; 9: 1904.
46 Dzanibe S, Mahni SA. Systematic review of the clinical development of group B streptococcus serotype-specific capsular polysaccharide-based vaccines. Exp Rev Vaccines 2018; 17(7).
47 Munoz FM. Current challenges and achievements in maternal immunization research. Front Immunol 2018; 9(436).
48 Supreme Court of the United States. Bruesewitz v. Wyeth No. 09-152. Justice Sotomayor with whom Justice Ginsberg joins, dissenting Feb. 22, 2011.
49 HRSA. Vaccine Injury Compensation Program (VICP) Data & Statistics. Aug. 31, 2018.
50 Burbacher TM, Shen DD et al. Comparison of Blood and Brain Mercury Levels in Infant Monkeys Exposed to Methylmercury or Vaccines Containing Thimerosal. National Center for Biotechnology Information, U.S. National Library of Medicine Apr. 21, 2005.
51 Shaw CA, Tomlejenovic L. Aluminum in the central nervous system (CNS): toxicity in humans and animals, vaccine adjuvants, and autoimmunity. Immunol Res. 2013; 56;(2-3):304-16.
52 Herberts C, Melger B et al. New adjuvanted vaccines in pregnancy: what is known about their safety? Exp Rev Vaccines 2010; 9(12).
53 Kataoka M, Ochiai M et al. A need for careful evaluation of endotoxin contents in acellular pertussis-based combination vaccines. Biologicals 2012; 40(1): 49-54.
54 Fisher BL. Are Vaccine Ingredients Safe? National Vaccine Information Center Jan 26, 2018.
55 FDA. Guidance for Industry: S2(R1) Genotoxicty Testing and Data Interpretation for Pharmaceuticals Intended for Human Use. CDER and CBER June 2012.
56 FDA. Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications. CBER February 2010.
57 Donahue JG, Kieke BA et al. Association of spontaneous abortion with receipt of inactivated influenza vaccine containing H1N1pdm09 in 2010-11 and 2011-12. Vaccine 2017; 35(40): 5314-5322.
58 Kharbanda EO, Vasquex-Benitez G et al. Evaluation of the association of maternal pertussis vaccination with obstetric events and birth outcomes. JAMA 2014; 312(18): 1897-1904.
59 Romero R, Chaemsaithong P et al. Clinical chorioamnionitis at term V: umbilical cord plastma cytokine profile in the context of a systemic maternal inflammation response. J Perinat Med 2016; 44(1): 53-76.
60 Harvey L, Boksa P. Prenatal and postnatal animal models of immune activation: Relevance to a range of neurodevelopmental disorders. Dev Neurobiol 2012; 72(1): 1335-1348.
61 Brown AG, Tulina NM et al. Exposure to intrauterine inflammation alters metabolomics profiles in the amniotic fluid, fetal and neonatal brain in the mouse. PLOS One Oct. 19, 2017.
62 Ghassabian A, Albert PS et al. Gestational cytokine concentrations and neurocognitive development at 7 years. Transl Psychiatry 2018; 8:64.
63 Tilley SK, Joseph RM et al. Genomic markets of prenatal intrauterine inflammation in umbilical cord tissue predict later life neurological outcomes. PLOS One 2017; 12(5).
64 Donowitz JR, Cook H et al. Role of maternal health and infant inflammation in nutritional neurodevelopmental outcomes of two-year-old Bangladeshi children. PLOS Negl Trop Dis 2018; 12(5).
65 Flaxman A, Ewer KJ. Methods for Measuring T-Cell Memory to Vaccination: From Mouse to Man. Vaccines 2018; 6(43).
66 Liao W, Zhang TT et al. Integration of Novel Materials and Advanced Genomic Technologies into New Vaccine Design. Curr Top Med Chem 2017; 17(20): 2286-2301.
67 42. U.S.C. 300aa-1. Establishment – Related Studies and Study of Other Vaccine Risks.
68 Fisher BL, Wrangham TK. Public Comment of National Vaccine Information Center for NVPO on Draft NVAC Maternal Immunization Working Group Recommendations on Maternal Immunizations. Apr. 25, 2014.
69 Fisher BL. Public Comment on Proposed Changes to FDA Requirements for Licensure of Vaccines Intended for Use During Pregnancy. FDA Vaccines & Related Biological Products Advisory Committee Meeting Nov. 13, 2015. https://www.nvic.org/nvic-vaccine-news/november-2015/fda-to-fasttrack-
70 Fisher BL, Wrangham TK. Public Comment on the Maternal Immunization Working Group Phase II’s Draft Report and Draft Recommendations for Overcoming Barriers and Identifying Opportunities for Developing Maternal Immunizations for Consideration by the National Vaccine Advisory Committee. Sept. 9, 2016.
71 Fisher BL, Wrangham TK. Public Comment of National Vaccine Information Center for FDA NPRM on “Pregnant Women: Scientific and Ethical Considerations for Inclusions in Clinical Trials: Draft Guidance; Availability. June 9, 2018.
72 Fisher BL. Forced Vaccination: The Tragic Legacy of Jacobson v. Massachusetts. National Vaccine Information Center Nov 2, 2016.
73 National Vaccine Information Center. Cry for Vaccine Freedom Wall.
By Barbara Loe Fisher
To activate and view hyperlinked references, please click once and then click any superscripted number below to access a hyperlinked reference, or scroll down to the bottom of the article to view all hyperlinked references.
It is a primitive bacterial vaccine licensed in 1914. 1 It has not been given to babies in America for 20 years. It is the vaccine that had brain damaged so many children and caused so many vaccine injury lawsuits 2 that Big Pharma used it to blackmail Congress into giving vaccine manufacturers a partial product liability shield in 1986, which the U.S. Supreme Court made even bigger in 2011. 3
I’m talking about whole cell pertussis vaccine in DPT, a crude brew of whole B. pertussis bacteria heated and washed with formaldehyde 4 but still full of neurotoxic aluminum 5 and mercury 6 along with shock-inducing endotoxin, 7 8 as well as brain damaging bioactive pertussis toxin, 9 10 11 a toxin so lethal that researchers use it to deliberately induce acute experimental autoimmune encephalomyelitis (EAE) in lab animals. 12 13 14 Whole cell pertussis vaccine: the most reactive vaccine still given to infants and children in developing countries because it costs drug companies just pennies to make a dose of it. 15 Whole cell pertussis vaccine, the one that put pressure on the B. pertussis bacterium to mutate into vaccine resistant strains beginning in the 1950s. 16 17
Vaccinologists Beating the Drum to Bring Back Toxic DPT Vaccine
Now some vaccinologists are beating the drum to bring back that nasty old vaccine and give it to newborn babies in America. 18 19 They say they think the toxin-filled whole cell pertussis vaccine in DPT works a little better at preventing whooping cough a little longer than the purified acellular pertussis vaccine in DTaP. They want to “prime” little six to eight-week old babies with ALL the bioactive toxins in the whole cell pertussis vaccine’s crude brew. Apparently they think it is worth the risk to pretend like they have fixed the problem.
In the 1980s, parents of DPT vaccine injured children worked for more than a decade to get the less reactive DTaP vaccine licensed in America because we knew Japan had been using it since 1981 with no reported whooping cough outbreaks and far fewer serious reactions. 20 As public outrage about the reactivity of whole cell pertussis vaccine grew and DPT vaccine injury lawsuits piled up, in 1996 U.S. public health officials finally licensed a purified acellular pertussis vaccine for infants. 21 22 23
Liability Free Vaccine Industry Wants to Re-write History
But they never forgave parents of vaccine injured children for making it happen and, by 1998, they had branded vaccine safety advocates as “anti-vaccine.” 24 25 Now that the U.S. Supreme Court has declared FDA licensed vaccines to be “unavoidably unsafe” and handed drug companies a free “get out of jail” pass for vaccine injuries and deaths, 26 it is starting to look like the goal all along was to eventually bring back the old pertussis vaccine so the vaccine industry never again will have to spend another dime to improve a vaccine the FDA has licensed as “safe.”
The attempt to rewrite history has begun, and the strategy is to rehabilitate the bad reputation of whole cell DPT vaccine so the clock can be turned back.
Vaccinologists may want to rewrite history, but it is harder to do when the facts are so well documented in the medical literature. 27 For those who want to get educated about the history of pertussis and pertussis vaccination, the online Library of Medicine is a great place to start. 28
Pertussis Fact Number One: Described as the “100 day cough,” B. pertussis disease has been around since at least the 16th century, and it can be especially serious for babies who cannot breathe when the sticky mucous produced by the gram negative bacteria clogs their tiny airways. The World Health Organization estimates that globally 85% of children have gotten three pertussis shots, but every year there are about 160,000 children under age five who die from pertussis complications like pneumonia, and over 60 percent of these children live in Africa. 29 30 Mortality from infectious diseases is always higher where people live in poverty, with crowding and poor sanitation, industrial pollution, substandard nutrition, and lack of access to health care facilities. 31
In 2017, there were 15,808 cases of pertussis reported in America with 13 deaths, 32 although most cases of whooping cough are never identified and reported to the government. That’s because you can be infected with pertussis and show few or no symptoms, whether you have been vaccinated or not. 33 34
Pertussis Fact Number Two: After recovering from a pertussis infection, natural immunity is thought to last between seven and 20 years and artificial immunity has been estimated to wane as early as two years after getting vaccinated with either whole cell or acellular pertussis vaccines. 35 36 37 Vaccinated and unvaccinated people can get two or three pertussis infections during their lifetime, and immunity can be asymptomatically boosted after the first infection.
Pertussis Fact Number Three: As early as 1965 and all through the 1980s and 1990s, public health officials in the U.S. and Europe knew that whole cell pertussis vaccine in DPT was not preventing infections in many vaccinated children and previously vaccinated adults. 38 39 40 41 42 43 Just like before DPT vaccination programs, pertussis increases continued to be reported in cycles of three to five years, 44 45 46 47 48 49 including in the U.S. where 95 percent of children had gotten three to five DPT shots. 50 51
It was obvious more than 30 years ago that whole cell pertussis vaccine in DPT was not only highly reactive, but was marginally effective.
Pertussis Fact Number Four: Between 1986 and 1996, multiple clinical trials confirmed that the less reactive acellular DTaP vaccine demonstrated superior efficacy and effectiveness compared to the old and more reactive DPT vaccine. 52 53 54 55 Even so, whooping cough outbreaks continued in the 21st century both in countries that had made the switch to the improved one and in countries that stayed with the more reactive old one.56 57 58 59 60 By 2006, U.S. health officials recommended booster doses of acellular Tdap vaccine for teenagers. 61 Then, in 2010, the Tdap booster shot was found to be only about 66 percent effective. 62
Frustrated by continuing reports of whooping cough cases in vaccinated children, by 2012 the false narrative being forwarded in the U.S. media was to blame whooping cough outbreaks on acellular DTaP vaccine, 63 while also pointing a finger at a tiny minority of unvaccinated children and the availability of personal belief exemptions in state vaccine laws. 64 65
Vaccinologists in the U.S. piled on the acellular vaccine 66 67 68 69 70 and, when FDA researchers reported in 2014 that infant baboons given whole cell pertussis vaccine cleared pertussis infection more rapidly than those given acellular vaccine, 71 the drum beat to resurrect whole cell DPT began to get louder. 72 73 74 75 76
In July 2018, the obedient US media hyped a small study out of California promoting the idea that whole cell pertussis vaccine stimulates a broader type of immunity that lasts longer than acellular pertussis vaccine. 77 The by-now familiar refrain was that it would be better to give babies a couple of doses of the old admittedly more reactive whole cell pertussis vaccine followed up by booster doses of acellular vaccine.
The public was being softened up to accept the unacceptable.
Pertussis Fact Number Five: It is important to remember that both the old and newer pertussis vaccines only provide temporary immunity that wanes within two to five years. Vaccinated people can become “silent reservoirs” of subclinical pertussis infection and transmit whooping cough without even knowing it. 78 79 80
That is because there is a big difference between a vaccine that prevents infection and a vaccine that prevents disease and symptoms of infection. 81 This difference explains why pertussis vaccine induced herd immunity has always been a myth, an illusion created when asymptomatic boosting of pertussis immunity through natural infection occurs in highly vaccinated populations.82 83 84 85
But wait, there is more.
Everybody knows about how the indiscriminate use of antibiotics has led to virulent antibiotic-resistant strains of bacteria, which evolved to evade those miracle drugs that do save lives when doctors prescribe them properly. Well, the same thing has happened with the B. pertussis bacterium, which started evolving to become vaccine resistant soon after public health officials and pediatricians prescribed multiple doses of whole cell DPT vaccine for all children.
As I explained in my 2016 commentary, Pertussis Microbe Outsmarts the Vaccines As Experts Argue About Why, bench scientists have been publishing scientific evidence for more than 20 years that vaccine-resistant B. pertussis strains began to emerge after whole cell pertussis vaccine was licensed in the late 1940s and before acellular pertussis vaccine was licensed in the mid 1990s. 86 Public health officials at the CDC and around the world admitted in 2014 that “most mutations in genes encoding acellular vaccine components arose in the period in which the whole cell vaccine was used.” 87
Pertussis Vaccines Don’t Contain Circulating B. Pertussis Strains
The science on that point is clear: The B. pertussis bacterium adapted to whole cell pertussis vaccination programs to survive, and now that evolutionary process is accelerating. 88 89 Today, none of the whole cell or acellular pertussis vaccines doctors routinely administer to children and pregnant women contain the mutated B. pertussis strains widely circulating and causing whooping cough in human populations. 90 91
The inconvenient truth is that mutated, vaccine resistant pertussis strains are being identified more often in vaccinated persons than in unvaccinated persons. 92
So why would any rational thinking person with an ounce of moral integrity suggest that subjecting newborn babies to the more reactive pertussis vaccine is the solution to preventing whooping cough, when none of the pertussis vaccines contain the new pertussis strains causing whooping cough today?
Vaccinologists and Basic Science Knowledge Gaps
After a century of pertussis vaccination programs, vaccinologists still do not know how pertussis infections - or many other infections - stimulate long lasting cell mediated and humoral immunity in the body. 93 That lack of basic scientific knowledge is why they don’t know how to make vaccines that provide long lasting artificial immunity and why they don’t have correlates for immunity to accurately measure what kind of immunity vaccines do or do not provide. 94 95
After a century of global vaccination, vaccinologists also admit they still do not understand why and how natural infections or vaccines cause complications that can lead to brain damage and death and they don’t know how to accurately identify who is more susceptible to harm. 96 97 98 That is why they don’t know how to make vaccines that are free from serious side effects. 99 100
And after a century of laws requiring infants and children to get a growing list of old and new vaccines, there is little effort being made to find how many of those vaccines have caused or will cause microbes to evolve into more virulent, vaccine resistant forms. 101 102 103 104
Doctors and Patients Kept in the Dark
Vaccination is often hailed as the greatest achievement in the history of medicine, but doctors giving vaccines and people getting them have been kept in the dark about just how much is not known about vaccine risks and failures. So when a healthy child or pregnant women gets vaccinated and dies, or is never well again, doctors kept in the dark are conditioned to tell mothers kept in the dark that the vaccine or combination of vaccines just given had nothing to do with it.
Vaccine policy and law has preceded the science and it is especially true when it comes to pertussis vaccination. You only have to read articles in the medical literature about long standing problems with pertussis vaccine toxicity and potency tests to find out how much vaccinologists don’t know about the safety and effectiveness of pertussis vaccines. 105 106
Whole Cell DPT Vaccine: Most Reactive Vaccine on Market Today
For young parents, who may not be familiar with the bad side effects of whole cell DPT vaccine, you can learn more by accessing hyperlinked references to the medical literature at the end of this commentary. To give you an idea about what you will learn, following are a few facts about the old whole cell pertussis vaccine that stopped being given to infants in America in the late 1990s:
- In 1933, the whole cell pertussis vaccine was reported to kill infants without warning. 107
- By the 1960s, the medical community knew that whole cell pertussis vaccine could cause convulsions and brain damage in children. 108 109
- By 1981, there was little doubt that whole cell pertussis vaccine is the most reactive vaccine ever given to infants and children, second only to smallpox vaccine. 110 111 112
In 1982, the eyes of parents in America were opened by the award winning television documentary DPT: Vaccine Roulette, followed by parents founding the organization known today as the National Vaccine Information Center and the publishing of the book DPT: A Shot in the Dark in 1985. 113 The reactivity of DPT vaccine was out in the open and mothers were sharing their first hand experiences of how they watched their babies suffer terrible DPT vaccine reactions.
Between 50 and 80 percent of babies who get whole cell DPT shots run fevers, and experience pain, redness and swelling at the site of the injection, and many of them are more fussy or lose their appetite for a day or two. 114 If DPT vaccine reactions were confined to sore arms and legs or low fevers and a little extra fussiness, there would never have been a call by parents to make that old vaccine less reactive.
No, the fact is that, for nearly a century, whole cell pertussis vaccine has been notorious for causing far more serious reactions like high-pitched screaming (also known as the encephalitic cry) 115 and hypotonic/hyporesponsive episodes (also known as collapse/shock), 116 and febrile or afebrile convulsions (also known as seizures) 117 118 and brain inflammation (also known as encephalitis, encephalomyelitis and encephalopathy). 119 120 121 Between 25 and 60 percent of children who develop acute encephalitis or encephalopathy or have convulsions, including febrile convulsions - for any reason - are left with some kind of brain like personality changes, developmental delays and learning disabilities, ADHD, seizure disorders, lower IQ, speech, motor and behavior disorders and other disabilities. 122 123 124 125 126
The Science Is Clear: DPT Injures and Kills More Often Than DTaP
- A 1981 U.S. study funded by the FDA and conducted at UCLA found that 1 in 875 DPT shots was followed by a convulsion or collapse/shock reaction. 127 Some of the children in that study were left with neurological problems and low IQs.
- The 1981 British National Childhood Encephalopathy Study (NCES) estimated that the risk for a previously healthy child developing a serious neurological problem within seven days of DPT vaccination was 1 in 110,000 DPT shots and the risk of chronic brain dysfunction was 1 in 310,000 DPT shots. 128 Some of the children in that study were left with brain damage manifested by “neurologic, motor, sensory, educational behavioral and self-care dysfunctions.” 129
- In 1985, CDC officials reported that children who experienced a neurological problem after DPT vaccination had a 7 times greater risk if they had a personal history of convulsions and a 4.5 times greater risk if they had a family history of convulsions. 130
- In 1991 and 1994, two Institute of Medicine committees analyzed the scientific evidence and confirmed that DPT vaccine can cause acute encephalopathy and brain damage in previously healthy children. 131 132
- Most developing countries still use whole cell DPT and, in 2018, Brazil reported that adverse events following DPT and DPT-Hib shots account for more than 75 percent of reported childhood vaccine reactions; 133
- In the U.S. vaccine injury compensation program (VICP), DPT vaccine is the vaccine with the most injury claims filed, including for death, and it is the second most compensated vaccine injury claim, with influenza vaccine now in first place. 134
- DTaP vaccine still generates a significant number of adverse reaction reports 135 136 but, with few exceptions, multiple studies confirm that DTaP vaccine is up to two-thirds less reactive than DPT vaccine. 137 138 139 140 141
To all those doctors out there who think you have a problem with public trust in vaccine safety today, 142 143 just wait until you try to strong arm mothers and fathers in America to give their newborn babies that nasty old whole cell pertussis vaccine.
But wait, there is more.
In 2015, the World Health Organization issued a new pertussis vaccine position paper to give doctors in every nation their marching orders. 144 In that paper, global public health officials rejected nearly a century of scientific evidence documenting the toxicity and risks of whole cell pertussis vaccine. They said that, except for anaphylaxis, there are no contraindications to giving children any type of pertussis-containing vaccine.
No contraindications. No medical exemptions. Not for children who are sick at the time of vaccination or have suffered high pitched screaming, collapse, convulsions and brain injury within hours, not for children who almost died after vaccination.
Who paid for this scientifically illiterate position paper that cruelly devalues the lives of individual children? The four top funders of the World Health Organization are the U.S. government, the Bill and Melinda Gates Foundation, the British government and GAVI, the Vaccine Alliance, which includes the largest vaccine manufacturers in the world. 145
If this can be done with pertussis vaccine, it can be done with every future vaccine that Pharma is creating and governments will recommend and mandate, from cytomegalovirus and strep B to syphilis and HIV. 146 147 148 149
The End Game: Forced Vaccination, No Exceptions
This is the End Game being played out on the world stage that I have been warning since 1993 was coming, the day when every vaccine that the pharmaceutical industry creates and government health officials recommend will be forced on you and your children. 150 151 No questions, no mercy, no exceptions.
We, the people, are the barrier that stands between our children and grandchildren and the toxic whole cell pertussis vaccine the vaccine industry wants to bring back to America so they can rewrite history and turn the clock back.
Before the drum beat gets any louder, 152 it is up to each one of us to stand up and defend freedom of thought and speech and conscience in America so we can protect our right to know and freedom to make voluntary vaccine decisions for ourselves and our children.
Nobody Will Save You But You
Nobody will save you and your family from what is coming tomorrow except the action that you, personally, take today. Please share this commentary with your family and friends and make an appointment to speak with your elected representatives. Sign up to use the free online NVIC Advocacy Portal and join with other concerned citizens in your state who want to stop the liability free vaccine industry from continuing to exploit the health of our children and our nation.
It’s your health. Your family. Your choice.
Click the plus sign at the bottom of this page to view and/or post comments on our commentary.
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111 Cody CL, Baraff LJ, Cherry JD et al. Nature and Rates of Adverse Reactions Associated with DTP and DT Immunizations in Infants and Children. Pediatrics 1981; 68(5).
112 Miller DL, Ross EM et al. Pertussis immunization and serious acute neurological illness in children. British Medical Journal 1981; 282:1595-9
113 Coulter HL, Fisher BL. DPT: A Shot in the Dark. Harcourt Brace Jovanovich, 1985; Warner Books 1986; Avery/Putnam 1991.
114 Barkin RM, Pichichero ME. Diphtheria-pertussis-tetanus vaccine: reactogenicity of commercial products. Pediatrics 1979; 63(2): 256-260.
115 Neuroimmunolgy Clinic, KK Women’s and Children’s Hospital. Encephalitis in Children: Symptoms, Complications and Treatment. Health Xchange 2016.
116 DuVernoy TS, Braun MM, the VAERS Study Group. Hypotonic-Hyporesponsive Episodes Reported to the Vaccine Adverse Event Reporting System (VAERS), 1996-1998. Pediatrics 2000; 106(4).
117 Wheless JW, Sirven JI. Seizures in Newborns. Epilepsy Foundation Aug. 27, 2013.
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120 HRSA. Encephalopathy, Encephalitis, Acute Dissemination Encephalomyelitis. Vaccine Injury Compensation Program Vaccine Injury Table. Mar. 21, 2017.
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129 Institute of Medicine Committee to Study New Research on Vaccines. DPT Vaccine and Chronic Nervous System Dysfunction: A New Analysis. Executive Summary (pp.1-2) Washington, D.C. The National Academies Press 1994.
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NVIC’s 2018 Annual Report on U.S. State Vaccine Legislation: Breakdown, Trends and Predictions
By NVIC Advocacy Team
Protection of the human right to exercise informed consent to vaccination continues to be a topic that is of great concern for many people in America. In a 2018 Annual Report on U.S. State Vaccine Legislation, the non-profit charity National Vaccine Information Center (NVIC) reports that during this year’s legislative session, no state eliminated or restricted existing medical, religious and conscientious or philosophical exemptions for daycare or school attendance.
This is the third year in a row that state legislatures have rejected the efforts of vaccine industry lobbyists to persuade more state governments to do what California did in 2015 and eliminate the legal right of citizens to exercise freedom of thought, conscience and informed consent when making vaccine decisions for themselves and their children.
Working to prevent vaccine injuries and deaths through public education since 1982, NVIC is the largest and oldest U.S. charity disseminating information about diseases, vaccines and informed consent to vaccination. NVIC provides well-referenced, accurate information to the public about vaccination and health but does not make vaccine use recommendations. In 2010, NVIC launched the NVIC Advocacy Portal (NVICAP), a free online vaccine choice advocacy network, for the purpose of securing and defending informed consent protections in state vaccine policies and laws.
NVIC works alongside and shares legislative information with many health freedom groups that support NVIC’s more than three-decade call for the protection of vaccine informed consent rights in America. The NVIC Advocacy Portal team, including key NVIC Advocacy directors in many states, works with families and enlightened health care professionals to educate legislators and protect vaccine informed consent rights.
During the 2018 legislative session, NVIC analyzed, tracked and issued positions on 143 vaccine related bills in 36 states through the NVICAP.1
If you live in one of the following 36 states, your state had one or more of the 143 vaccine bills being considered in the 2018 legislative session and tracked by NVIC: Alabama, Arizona, California, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Virginia, Vermont, Washington, Wisconsin, and West Virginia.
Bills referenced in this report are published on the NVICAP and registered users can obtain a more detailed bill analysis, including current status, NVIC’s position on the bill, and recommended action.
Highlights from 2018
There were three significant positive take away points from the outcome of the 2018 legislative session:
- No state lost or restricted existing vaccine exemptions for school, daycare, or other statewide requirements;
- Out of the 82 vaccine-related bills that NVIC opposed, only 17 bills passed. Out of the 17 bills that did pass, only four bills had elements that NVIC targeted for strong opposition; and
- The 2018 legislative session featured more proposed vaccine-related bills worthy of support (47) than any session since the launching of NVIC’s Advocacy Portal in 2010.
There were three states with 10 or more bills filed this session. Oklahoma set the record with 13 bills, but they all died. Minnesota had 10 bills filed that all died. New York also had 10 bills filed and only one bad bill passed (A 9507), which allows pharmacists to give flu shots to young children two years and older and compels pharmacists administering vaccines to children to not only report and track the shots they administer, but to track vaccine refusals as well.
The three other bills passed that NVIC strongly opposed: a meningitis vaccine mandate in Louisiana (HB 176) and Maine (LD 1664), and a bill in Alabama (HB 76), which requires religiously-affiliated private daycares and preschools to give the Department of Human Services vaccine records on request. The remaining 13 bills that NVIC opposed fall into the category of Required Vaccine Marketing and Promotion.
The vaccine-related bills that either passed or were defeated in states during the 2018 legislative session are broken out and described below by category.
2018 Bill Analysis by Category
The four main areas that NVIC focuses on when tracking proposed bills are: (1) vaccine exemptions and informed consent rights; (2) vaccine mandates; (3) vaccine tracking and reporting and (4) vaccines in general. Some bills may be included in multiple categories. For example, a proposed bill attempting to mandate a vaccine may also have a requirement for vaccine tracking so it would be counted in both categories but only counted once in the total bill count.
The breakout and analysis of bills in these different categories identifies trends across the states and serves as a guide if you want to become active by joining the NVIC Advocacy Portal (NVICAP) and educating your state legislators and community in 2019 about why it is so important to protect vaccine informed consent rights.
Vaccine Exemptions and Informed Consent (61 bills)
The majority of the 61 vaccine-related bills filed in state legislatures in 2018 had components that affected vaccine exemptions and informed consent rights. NVIC opposed 20 of the proposed bills, supported 37, and “watched” four of them. This is a huge improvement from 2017, when NVIC tracked 81 bills, opposed 42 and supported 39 bills. This shift can be directly credited to positive action taken by forward thinking state legislators, who were given fact based information about vaccination and diseases by concerned citizens who took the time to make one-on-one personal contact with their elected representatives.
The NVIC Advocacy team provides referenced, accurate vaccine information and talking points for NVICAP users to background legislators. Some of the position statements NVIC posted on the Advocacy Portal in 2018 were listed as bills to “watch” because our analysis indicated they contained sections that could be vulnerable to amendments that would conflict with NVIC’s mission.
Eliminating or Restricting Vaccine Exemptions
Vaccine choice advocates successfully held the line on protecting vaccine exemptions in 2018 and no state legislature repealed or restricted existing school, daycare or statewide vaccine exemptions.
Only three bills and one resolution spanning two states proposed to eliminate vaccine exemptions, and these attempts failed. In Minnesota, two bills that tried to eliminate conscientious vaccine exemptions (SF 3977 and HF 4406) failed to secure even a single hearing. The same thing happened in Oklahoma, where a bill (SB 1123) that would have eliminated all exemptions to vaccination except for limited medical reasons, along with a resolution (SJR 57), which would have placed the elimination of all non-medical exemptions on the next general election ballot, were both rejected.
Minnesota HF 96 and SF 143 would have required parents to get a physician to sign off on the conscientious belief exemption and would have replaced the language “conscientious belief” with “personal belief,” but both of these bills died. Government health officials do not like vaccine exemption language that includes the words “religious” or “conscientious” because freedom of religion and freedom of conscience are defined as human rights.
At the time this report was written (September 8, 2018), there were two bills still pending in Ohio and New Jersey that would restrict vaccine exemptions. A bill in Ohio (HB 559) proposed to mandate that parents use a state form to file a vaccine exemption for their child, which requires the signature of a health care provider, and two bills in New Jersey (A 3818 and S 2173) proposed to restrict religious belief exemptions to vaccination. New Jersey families supporting the legal right to take a religious vaccine exemption will need to watch these bills closely and be ready to immediately take action to oppose them in order to protect that right. NVICAP is watching those bills and will post new information on the status of those bills as it becomes available.
It is critical that vaccine choice advocates residing in states, which currently have philosophical or conscientious vaccine exemptions, be aware that NVIC predicts there will be renewed unjustified attacks on those exemptions by the vaccine industry and medical trade associations next year. Now is the time to educate your legislators through the end of this year and early next year so you can be ready to counter bills that will restrict or eliminate those exemptions. Recently, certain states have been heavily targeted for criticism by the mainstream media and forced vaccination proponents for allowing philosophical or conscientious vaccine exemptions, including Arkansas, Arizona, Idaho, Maine, Minnesota, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Texas and Utah.2
Exemption Disclosure and School Shaming
One way vaccine industry lobbyists place disruptive pressure on schools allowing students to enroll with vaccine exemptions is to lobby for legislation that requires individual schools to publish vaccine exemption rates and post that information online. These bills are promoted under the guise of educating parents, but they are really about government-sponsored shaming that pits school against school and parent against parent for the purpose of marginalizing and increasing peer pressure on families whose children have vaccine exemptions.
Fortunately, there were only three school shaming bills filed this session with two in New York (A 3912 and S 2955) and one in Arizona (SB 1358), and none of these passed. This is a big improvement compared to the 11 school shaming bills filed in 2017.
Children Vaccinating Themselves?
A very troubling area of proposed legislative changes are bills that allow minor children to be vaccinated without the knowledge or informed consent of their parents. A child is less likely than an adult parent to understand their personal and family medical history, including a history of vaccine reactions, allergies and autoimmune or neurological disorders. Minor children do not have the same kind of critical thinking skills or emotional maturity required to make a vaccine benefit-risk decision compared to an adult. In addition, if a child receives a vaccination without a parent’s knowledge or informed consent and experiences a vaccine reaction, a parent might not recognize the potential cause of their child’s sudden decline in health. This lack of knowledge by parents could be life threatening for the child.
The Minnesota legislature saw four bills introduced that would have allowed minor children to consent to HPV vaccinations without their parents’ knowledge or approval and none of them even garnered enough support among legislators to schedule a hearing. A child vaccine consent bill, which covered the HPV vaccine and vaccines for other sexually transmitted diseases, was introduced in Connecticut but failed to move out of committee. New Hampshire went even further with another unsuccessful child consent bill that proposed granting permission to minor teens aged 16 and older to agree to all medical procedures, including for vaccinations, without parental knowledge or consent.
Expanding Vaccine Exemptions and Informed Consent
Hard working vaccine and health freedom advocates and open minded legislators came together to introduce 16 bills filed in eight states to expand vaccine exemptions and protect informed consent rights.
Legislators in Hawaii, Mississippi, Rhode Island and West Virginia introduced bills to add philosophical or conscientious belief exemptions. Mississippi and West Virginia legislators proposed bills to add religious exemptions to vaccine laws that currently only allow a narrow medical exemption, while New York considered a bill to streamline and simplify the obtaining of a religious exemption. None of these bills passed this session.
Regarding adult employees, Illinois successfully passed a religious exemption (HB 2984) for annual flu vaccination requirements for health care workers. Minnesota, Mississippi, Oklahoma, and West Virginia had bills filed adding exemptions for other adult employees, but none of them passed.
Expanding vaccine informed consent rights is an area that 10 states took on during 2018. Although none of these bills passed (Pennsylvania is still pending), bills to obtain informed consent prior to vaccination were introduced in Hawaii, Minnesota, Oklahoma, and Rhode Island, and bills that would require disclosure of vaccine exemptions were introduced in Indiana and Pennsylvania. These are examples of bills protecting informed consent rights that more legislators have been receptive to filing in state legislatures.
Oklahoma broke important ground this session taking a stand for parental rights. A bill was filed (SB 1432) to remove the ability of the Department of Human Services to vaccinate children in protective custody and another bill (SB 1433) was filed to clarify that refusing to vaccinate or delaying vaccination is not child abuse. While these bills did not pass, reigning in state child protective services offices attempting to criminalize voluntary vaccine decision making and override parental rights is another area state legislators have expressed an interested in addressing with proactive legislation.
Since the American Academy of Pediatrics (AAP) came out squarely against conscientious and religious vaccine exemptions in 2016, 3 more families have experienced their children being “fired” from pediatric practices if parents decline to give their children every one of the 69 doses of 16 federally recommended vaccines on a vaccine schedule endorsed by the CDC and AAP. 4 In two states, legislators introduced bills that addressed this kind of physician discrimination and withholding of medical care from different perspectives, although neither of the bills passed. In Missouri, a bill (HB 1560) was proposed to prohibit discrimination against children by preventing doctors from expelling patients based on vaccination status. In Oklahoma, a bill (HB 3444) was introduced prohibiting health insurance companies from (1) requiring the administration vaccines; (2) penalizing doctors for not administering vaccines, or (3) providing financial incentives to physicians to issue a vaccination protocol.
Threats and outright denial of healthcare by physicians based on a patient’s vaccination status is a growing problem in America and a number of state legislators are justifiably concerned about it and have become more open to considering bills to prohibit such abusive practices. NVIC encourages families to educate their legislators about harassment and discriminatory practices by physicians and to share personal experiences related to threats and sanctions by physicians – or anyone else - for exercising vaccine informed consent rights by posting on NVIC’s Cry For Vaccine Freedom Wall.
Vaccine Mandates (30 bills)
In 2018, out of 19 bills that proposed to expand and add new vaccine mandates, only bills adding a meningitis vaccine mandate for 11th graders attending school in Louisiana (HB 176) and a legislative rule review bill (LD 1664) approving a health department rule requiring meningitis vaccinations in Maine for 7th and 12th grade students were passed. Bills to mandate meningitis vaccinations for school students failed in Kansas, Oregon and Virginia.
An HPV vaccine mandate in Florida (HB 1343 and SB 1558) was defeated after significant vocal opposition. Hawaii, Missouri, and West Virginia all failed to pass bills mandating more vaccines for various health care workers.
In Arizona, a bill (SB 1383) attempting to repeal the legal protection clarifying that foster parents are not required to vaccinate their natural or adoptive children as a condition of foster home licensure was defeated. This was the same as SB 1268 from 2017 that failed to move forward as well. We are grateful that Arizona legislators have consistently upheld the rights of parents to make informed vaccination decisions for their own children while they are helping to provide temporary homes for foster children.
New Jersey has bills (A 3587 and S 634) still pending that would mandate more vaccines for healthcare workers and healthcare vendors (A 2397), as well as mandate meningitis vaccinations for college students (A 1991 and S 941), and HPV vaccinations for students 6th through 12th grade (A 1847). NVIC opposes all of these bills and will continue to post information about their movement on the NVICAP.
NVIC supported seven bills in five states that would have restricted vaccine mandates. Bills were introduced in Missouri, Mississippi and New Hampshire to eliminate Hepatitis B vaccine mandates but none passed. Bills in both Michigan (HB 5162 and HB 5163) and Oklahoma (HB 2623) sought to return the power to add new vaccines to the mandated schedule back to a vote by the legislature instead of continuing to allow state health department officials to add new vaccine mandates through an administrative rule making process. The Oklahoma bill died, and Michigan HB 5162 and HB 5163 have not seen action since hearings at the end of 2017.
Vaccine Tracking and Reporting (22 bills)
Forced inclusion and OPT-OUT electronic vaccine tracking registries and enforcement systems continue to threaten the medical privacy of citizens and the legal right to delay or decline one or more federally recommended vaccines without harassment or punishment. The 2018 legislative session included 22 bills in this category that NVICAP posted and tracked. This included six bills proposed in three states to expand government operated childhood vaccine tracking databases to also require the vaccination status of adults to be tracked.
Florida, the third most populous state, saw multiple bills (CS/CS/HB 1045, CS/CS/HB 1047, and CS/CS/SB 1680) introduced proposing to legally require the vaccination status of every state resident to be stored and tracked in Florida’s government run electronic vaccine tracking registry for the purpose of reaching a 100% vaccine compliance rate by all children and adults. Requiring doctors to automatically upload the vaccine status of their patients into the state vaccine tracking system without securing their expressed OPT-IN informed consent of the person violates Section 23 of the Florida Constitution, which guarantees Florida residents the Right of Privacy: “Every natural person has the right to be let alone and free from governmental intrusion into the person’s private life except as otherwise provided herein.” 5
Medical privacy and vaccine choice advocates worked together in Florida to educate legislators about the intrusive nature of these vaccine tracking bills. Although none of these bills ultimately passed during the 2018 legislative session, Florida residents need to be ready next year during the 2019 session to continue to educate legislators about the importance of protecting medical privacy and vaccine informed consent rights in Florida.
In Kansas, a bill (HB 2121) was introduced that would have required all vaccines administered in the state to be entered into the state’s electronic vaccine tracking system. Two bills (H 7882 and S 2530A) introduced in Rhode Island would have expanded the state’s vaccine tracking registry to include all adults. NVIC opposed all of these bills because they didn’t require an adult’s OPT-IN written informed consent prior to being included in the vaccine tracking system. Fortunately, none of these bills passed.
Medical privacy and informed consent rights of Nebraska residents were protected when a resolution, which proposed to conduct an interim study on mandating the reporting of the vaccination status of all children and adults to the state’s electronic vaccine tracking registry, failed to pass. Pharmacists in Hawaii, who are already administering vaccines, were unsuccessfully targeted by a bill (HB 1950) that would have required them to report all vaccines given to the Hawaii Immunization Registry.
In Massachusetts, unsuccessful bills (H 3224 and S 1219) were introduced to expand the scope of the state’s vaccine tracking system to include vision screening and, in New York, bills (A3899A and S3941) proposed to make the blood lead levels of children already inappropriately stored in the vaccine registry available to schools. The stated purpose of the New York bills, which was to provide children with “appropriate educational services,” is a fallacy. There is no blood test that can accurately determine a child’s educational needs.
The New York legislature did, however, pass a bill (A 9507) that not only authorizes pharmacists to give children as young as two years old annual flu shots, it mandates the reporting and recording of the administration of the vaccine as well as vaccine refusals to the state’s electronic vaccine tracking registry. The passage of this bill will make it very difficult for families in New York City to enroll their children in daycare and preschool without annual influenza vaccinations. Just two months after the passage of A 9507, a 2013 rule invoked by the New York City Department of Health and Mental Hygiene requiring annual flu shots for preschoolers was upheld by the New York Court of Appeals. 6
In Vermont, a bill (H 247) was introduced and supported by NVIC that would have required the Department of Health to submit vaccine adverse reaction reports to the General Assembly. The bill did not pass.
Vaccines (37 bills)
Authorizing Pharmacists to Administer More Vaccines
More states continue to authorize pharmacists to expand services to include the administration of vaccines to younger and younger children. In 2018, Missouri passed bills (SB 776 and SB 826) that now allow pharmacists to give all CDC recommended vaccines to children seven years and older, and New York passed a bill (A 9507) that now allows pharmacists to give influenza vaccinations to children as young as two years old.
Requiring Vaccine Promotion/Marketing
The overall single most active category in expansion of vaccine-related state legislation so far this year has been bills proposing to legally require the marketing and promotion of specific vaccines. Unlike legal requirements to be vaccinated, these mandates require either public or private businesses to advertise and promote vaccine use.
During this year’s legislative session, the vaccine to receive the most state-backed legislative support for active marketing and promotion by schools and medical and residential facilities has been influenza vaccine. This is the same under-performing vaccine that CDC officials themselves admit has one of the worst vaccine effectiveness outcomes on record: 36% effectiveness for the 2016/2017 flu season and ranging between a dismal 10% and 60% effectiveness over the last 14 years.7
Perhaps the vaccine industry is trying to combat the well earned negative impression of the flu vaccine’s poor performance by lobbying for bills aimed at marketing and promoting use of the vaccine by children and adults. In 2018, bills were passed that now require daycare facilities in Alabama, schools in Illinois and Louisiana, and hospitals in Rhode Island, and long term and residential care facilities in Delaware and Indiana to promote annual influenza vaccinations. Similar bills to push flu vaccines in Florida, Massachusetts, Missouri, and Oklahoma all failed.
Fortunately Florida and Maryland legislators were smart enough to reject bills requiring schools to promote student use of the highly reactive HPV vaccine, 8 but a bill passed in Illinois that targets boys for HPV vaccine promotion programs.
One of the more controversial attempts to market vaccines at taxpayer expense occurred in New York this year, when a bill proposing to grant a tax exemption for dependents fully vaccinated according to state health department recommendations was defeated.
A new legislative twist to save vaccine manufacturers from having to spend as much of their own money on advertising came up this legislative session when multiple resolutions targeting adults for shingles vaccination were passed in a number of states. The CDC admits that shingles (herpes zoster) is increasing among adults in the United States.9 Some research suggests that the chickenpox (varicella zoster) vaccine licensed in 1995 and mandated in most states for children to attend school may have contributed to the increase in reported cases of shingles in older children and adults.10 This raises the question of whether the vaccine industry has been behind an orchestrated effort to get states to market shingles vaccine since so many resolutions were filed and passed in state legislatures in 2018.
The following 13 states filed resolutions to “encourage” shingles vaccinations or to declare certain months as shingles “awareness” or “improvement” months: Georgia, Illinois, Indiana, Louisiana, Michigan, Missouri, Nebraska, New Jersey, New Mexico, Pennsylvania, Rhode Island, Tennessee, and Wisconsin. The only two states that did not pass a filed shingles vaccine resolution were Wisconsin and New Jersey (still in session at the time this report was prepared).
Even Congress has jumped into the vaccine promotion resolution game to increase shingles vaccination uptake by adults. A federal bill (HR 4297) known as the Protecting Seniors Through Immunization Act of 2017, was filed in November last year, but it hasn’t moved yet.
Three more vaccine promotion resolutions were filed and passed in California (SR 120), Kentucky (HR 278) and New York (AR 1403) aimed at increasing adult vaccination rates with all vaccines the CDC recommends for adults (seasonal influenza, Tdap, Td, shingles, HPV, pneumococcal).
While resolutions passed by state legislatures are different from bills that are passed because they don’t carry the force of law, these vaccine promotion resolutions still cost taxpayers money in terms of state resources devoted to the legislative process and for employees in state agencies to implement the resolution by creating ways to promote the message contained in the resolution. These vaccine promotion messages tend to adopt a one-size-fits all approach and rarely do vaccine marketing materials contain information about vaccine risks or how to prevent vaccine injuries.
Comparing Recent Sessions to 2018
143 bills filed in state legislatures in 2018 represents a sharp decline in vaccine related legislation compared to the 184 bills filed in 2017; however it is still above the average of 135 bills filed per year when looking at the total number of state bills filed between 2014 and 2017 as reported in NVIC’s in depth analysis State Vaccine Legislation in America 2015-2017. The number of states proposing bills that affected NVIC’s mission has declined as well since last year, from 42 to 36 states.
Some of the decline in numbers of vaccine-related bills filed can be attributed to four states: Montana, Nevada, North Dakota and Texas. These state legislatures meet biannually to consider new bills and do not hold a legislative session in even years. 11 In 2017, 26 of the 184 bills filed were in Montana (2), Nevada (1) and Texas (23). If this trend continues, we should expect to see more vaccine-related bills introduced in 2019 than we have ever seen since the NVICAP was launched in 2010.
There were more positive bills filed in 2018 to expand vaccine informed consent rights, to restrict addition of new vaccine mandates and to restrict automatic inclusion of children and adults in electronic vaccine tracking systems than were introduced in 2017. There were also fewer bills that NVIC opposed this legislative session compared to 2017, such as bills proposing to eliminate or restrict vaccine exemptions, to increase vaccine tracking or to add new vaccines to school mandates, all of which had been steadily increasing before this year.
Enlightened legislators are not only listening to concerned constituents in greater numbers, they are resisting aggressive lobbying efforts by the vaccine industry to force the purchase and use of every vaccine produced by pharmaceutical companies and recommended by public health officials.
Slowly but surely as a result of many years of hard work, grassroots vaccine education and informed consent advocacy in the U.S. is achieving tangible results. It is a trend that the vaccine industry pushing for more oppressive forced vaccination legislation does not want to continue. It may help explain why there has been a recent increase in biased media articles 12 and newspaper OpEds 13 that minimize or deny very real vaccine risks 14 and attack vaccine exemptions, while marginalizing families and trying to delegitimize vaccine exemptions. 15
WHAT CAN YOU DO?
NVIC expects that the vaccine industry will step up lobbying efforts and that there will be many more vaccine-related bills filed in the states in 2019. Please become a registered user of the NVIC Advocacy Portal and check in often to learn about ways to personally educate your legislators when vaccine bills that affect your rights are moving in your state. Please encourage your family and all of your friends to do the same.
Clearly your efforts are making a much more significant difference than the media and those pushing “no exceptions” forced vaccination policies and laws are willing to admit, and your active participation is vital to protecting informed consent rights and vaccine choices in America. If you see inaccurate information in the media, please take the time to respond by making a constructive comment online. You can also email the journalist or call the media outlet and provide accurate, well referenced Diseases and Vaccines information and accurate state vaccine law information, which you can find on our website NVIC.org. NVIC’s updated, illustrated and fully referenced Guide to Reforming Vaccine Policy and Law is another good vaccine education tool for legislators and friends and family, too.
Yes, the challenges are great but so are the opportunities to educate and empower legislators and residents of every state to defend vaccine freedom of choice. NVIC is committed to continuing to make that happen and we look forward to working with you through the NVIC Advocacy Portal to help you protect vaccine informed consent rights in your state in 2019.
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1 This analysis covers Some states still have legislative action pending at the time this report is issued, so final 2018 results may change
2 Scutti S. Opting out of vaccines leaves these US 'hot spots' most vulnerable for outbreaks. CNN June 15, 2018.
3 Wyckoff AS. Eliminate nonmedical immunization exemptions for school entry, says AAP. AAP News August 29, 2016.
4 Haelle T. As More Parents Refuse Vaccines, More Doctors Dismiss Them -- With AAP's Blessing. Forbes August 29, 2016.
5 Florida Legislature. Constitution of the State of Florida. 2018.
6 Clark D. Court of Appeals Holds Flu Vaccine Mandate in NYC Child Care Programs Lawful. New York Law Journal June 28, 2018.
7 CDC. Seasonal Influenza Vaccine Effectiveness, 2005-2018. February 15, 2018.
8 National Vaccine Information Center. Human Papillomavirus (HPV) Disease and Vaccine. 2018.
9 CDC. Shingles Surveillance. 2018.
10 Raines K. Chickenpox Vaccine May Increase Shingles Risk. The Vaccine Reaction April 26, 2016.
11 NCSL. Annual versus Biennial Legislative Sessions. 2018
12 Price B. 57K Un-Vaccinated Kids Could Cause Texas Measles Outbreak, Says Physician. Breitbart August 13, 2018.
13 Editorial Board. Fort Worth is a “hot spot” for children without vaccinations, and that’s dangerous. Star-Telegram July 23, 1018.
14 Norton A. Study: Tdap Vaccine Doesn't Boost Autism Risk. WebMD August 13, 2018.
15 Editorial Board. Fringe anti-vaccine groups peddle misinformation to Minnesota legislators. Star Tribune February 2, 2018.