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AFM Compared to Guillain-Barre Syndrome

Posted: 12/10/2018 7:23:52 PM | with 0 comments
cells

Although there is no conclusive evidence that recently reported cases of acute flaccid myelitis (AFM) is caused by a virus, officials at the CDC suggest that a virus is to blame.  This viral association appears to be based on the observation that during the four weeks preceding the onset of limb weakness, signs and symptoms consistent with a viral illness were reported for 99 percent of the confirmed AFM patients.  

Officials seem to be assuming that only a viral infection can cause these types of symptoms, although adverse effects from medications, environmental toxins and vaccines can also cause these symptoms. 

However, Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases recently said that AFM “seems to be more of an autoimmune syndrome, as opposed to a direct result of a virus.” If AFM is indeed a type of autoimmune disorder, then what is causing the development of weakness and loss of muscle tone and reflexes in the arms or legs, facial droop or weakness, difficulty moving the eyes, drooping eyelids, difficulty swallowing and slurred speech in previously healthy children?

Messonnier has compared AFM to what happens with the autoimmune neurological disorder known as Guillain-Barré Syndrome.  Unfortunately, there are outstanding questions about what exactly causes Guillain-Barré Syndrome, but according to the Mayo Clinic, “The disorder usually appears days or weeks after a respiratory or digestive tract infection. Rarely, recent surgery or immunization can trigger Guillain-Barre Syndrome.”

Vaccines can trigger Guillain-Barre? Yes. Guillain-Barre has been reported following the inactivated flu, MMR II (mumps, measles, rubella), hepatitis B, meningococcal polysaccharide, tetanus and polio vaccines.

Based on Messonnier’s view that AFM might be an autoimmune disorder similar to Guillain-Barré Syndrome, and based on the fact that Guillain-Barré Syndrome can reportedly be triggered by a number of vaccines, it would be reasonable to at least consider the possibility of an association between AFM and vaccination.  CDC officials have not released information about how many of the AFM cases were recently vaccinated or if there have been any cases of AFM diagnosed in children who are completely unvaccinated or who have received only a few vaccinations.

Officially, AFM is still a “mystery illness,” so it makes no sense to close any door to inquiries that could yield important clues about why healthy children are suddenly being paralyzed without warning.

Read the full article AFM Compared to Guillain-Barre Syndrome in NVIC’s online newspaper The Vaccine Reaction.  Read more about AFM in Acute Flaccid Myelitis and Routine Childhood Vaccinations:  This is Nothing New, and autoimmunity in Why are Americans So Sick?  Learn more about vaccine side effects in Vaccine’s “Side Effects” are Real and Plenty.


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The New Internet Police Protecting You From Freedom of Thought and Speech

Posted: 12/3/2018 6:39:18 AM | with 19 comments

by Barbara Loe Fisher

Before the Internet was launched in 1992, our thoughts, values and beliefs were informed by our family and friends and by the books, magazines and newspapers we read and by what we heard on radio and saw on television. If we wanted to communicate with each other we would pick up the telephone, write a letter or meet face to face.

The Internet changed everything.

The World Wide Web gave us electronic access to free, uncensored information on our computers, tablets and cell phones and the ability to instantly share that information with each other. It connected us together in a virtual public square, where we could do our own research and talk about our personal experiences, and express what we think and believe and how we feel about important issues that affect our lives.

There are three billion people on the Internet communicating with each other. 1 Except for the printing press created in the 15th century, there is no other single means of communication that has had as profound an impact on freedom of thought and speech as the World Wide Web.

Yes, the Internet has changed everything. And, now, everyone needs to know how the Internet is changing.

internet

In the very near future you may not be able to find information about vaccine science, policy and law published on websites like NVIC.org and

TheVaccineReaction.org or be able to connect with us on social media platforms to have an open conversation about it. With the cancellation of net neutrality in the U.S. in 2017,3 the two decade forging of public-private business partnerships between governments and politically powerful corporations and institutions has cleared the way for factual information about health to be censored as “fake news” and quietly removed from the Internet if it does not conform with public health policy and government recommendations for use of pharmaceutical and food products.

Has the Internet been hijacked by Wall Street? It sure looks that way.

An electronic wall is being built to block you from getting information you want so you only get information someone else decides you need. An electronic burning of the books has begun, and the people are being silently herded into a virtual Dark Age. While this censorship is starting with conversations about health and vaccination, it will not end there.

Those who have bought and control the Internet now have the power to restrict or block any kind of information they do not want you to see or talk about with your family, friends and others you connect with online.5

So who is doing the judging of what is truth and what is “fake news” online?

The Internet Police Thinking and Speaking for You

Web of Trust6 and Snopes,7 both for-profit enterprises, have attempted to police the Internet for the past decade by rating websites for “trustworthiness” or branding articles published online as “true” or “false,” even as they themselves became embroiled in controversy about trustworthiness.10 But Snopes and Web of Trust are rookies compared to the professional SWAT team hired this year by a new corporation, NewsGuard Technologies, Inc., to rate websites and online publications so, in their own words, they can quote “fight false news, misinformation and disinformation.”11 12 13 14 15 16 17 NewsGuard is collaborating with The Paley Center for Media,18 Google,19 Microsoft,20 21 Publicis,22 23 24 25 26 27 28 29 30 31 schools, libraries32 and other institutions to protect you and your children from news and perspective they think will harm you and society.

There is no question that “fake news” is a real problem in both mainstream and alternative media when demonstrably false information is deliberately disguised as fact. However, it is also a real problem when demonstrably factual information or perspective is mislabeled as “fake news,” simply because it criticizes government policy or threatens the bottom line of corporations selling government recommended commercial products like liability free vaccines.

dollars handshake

One of the most politically powerful public-private partnerships today is the lucrative one that has been forged by the pharmaceutical industry with government,33 34 35 36 37 38 mainstream media39 and wealthy philanthropic foundations with political agendas.40 41 42 43 44 45

NVIC Giving a Voice for the Vaccine Injured, Defending Human Rights

It has been 25 years since the nonprofit charity founded in 1982 by parents of vaccine injured children, the National Vaccine Information Center (NVIC), began posting vaccine information on the Internet. Our mission is to prevent vaccine injuries and deaths through public education and to protect the ethical principle of informed consent to medical risk taking, which serves as the foundation for the ethical practice of medicine.46 The co-founders and parent representatives of NVIC have a long, transparent public record of consumer advocacy, including working with Congress to secure vaccine safety informing, recording, reporting and research provisions in the National Childhood Vaccine Injury Act of 1986 and serving on federal vaccine advisory committees and testifying in congressional and state legislative hearings.47 48

We represent and give a voice to a vulnerable minority, the ones for whom the risks of vaccination turn out to be 100 percent. But we also represent and give a voice to people who believe that the human right to freedom of thought, speech, conscience and informed consent must be protected.49

Verifiable Facts About Vaccination Not “Fake News”

Ten years before the birth of the Internet, one of the best-kept secrets in America was that vaccines can and do cause injury and death and that some individuals are more vulnerable to being harmed by vaccination. In 1982, an Emmy award winning television documentary DPT: Vaccine Roulette produced by consumer reporter Lea Thompson alerted parents and pediatricians that the whole cell pertussis vaccine in DPT shots could brain damage children.50 51 It was a mainstream media outlet – NBC – that blew the whistle on the pharmaceutical industry’s neglect, and the medical establishment’s denial of DPT vaccine reactions, and the 50-year failure of industry and government to improve the safety of a vaccine mandated for all children to attend school.

These are verifiable facts: the truth, not “fake news.”

Three years later in 1985, Harcourt Brace Jovanovich published DPT: A Shot in the Dark, a book that further documented the risks and failures of the old crude whole cell pertussis vaccine.52 A year later, Congress passed the National Childhood Vaccine Injury Act. In that legislation, for the first time the US government acknowledged that FDA licensed and CDC recommended vaccines can and do injure children.53 54

Since the 1986 Act was passed, the government has awarded four billion dollars in compensation to thousands of children and adults who have suffered permanent injuries, or whose loved ones have died after being given federally licensed and recommended vaccines.55

These are verifiable facts: the truth, not “fake news.”

Between 1991 and 2013, the National Academy of Sciences published a series of reports on vaccine adverse effects.56 These reports confirmed that vaccines can cause brain and immune system disorders, and that genetic, biological and environmental risk factors make some individuals more vulnerable to being harmed but doctors don’t know how to identify them because of gaps in vaccine science.57

boy being vaccinated

These are verifiable facts: the truth, not “fake news.”

More than 684,000 adverse events following vaccination, including hospitalizations, injuries and deaths, have been reported to the federal government since 1990.58 This number is estimated to represent less than one percent of all vaccine adverse events that have actually occurred.59

These are verifiable facts; the truth, not “fake news.”

The U.S. government now recommends that children receive 69 doses of 16 vaccines between the day of birth and age 18, with 50 doses given before the age of six,60 which is triple the number of vaccinations given to children in 1983.61 Almost all of these vaccinations are mandated by states for children to attend school62 and some children are being refused medical care and adults are being fired from their jobs if they don’t get every one of them, even after suffering vaccine reactions and deterioration in health.63 64 65 66 67

Vaccine policy and mandates have helped to create a global vaccine market now projected to bring in a staggering $57 billion dollars for drug companies by 2025.68 69

These are verifiable facts, not “fake news.” But very soon you may not be able to get this information or talk about it online.

It is already happening.

Discrimination and Censorship: NVIC’s Information Targeted Online

Traffic to NVIC’s websites has fallen more than 50 percent since net neutrality was cancelled last year and access to our online information was restricted by suppressive algorithms and rating systems.70

Although NVIC takes a pro-education, pro-informed consent position and does not make vaccine use recommendations, NVIC’s Pinterest account was recently suspended.71 The reason given was that Pinterest takes action “against accounts that repeatedly save content that includes harmful advice, misinformation that targets individuals or protected groups or content that originates from disinformation campaigns” and that Pinterest operators “don’t allow advice when it has immediate or detrimental effects on a Pinner’s health or on public safety. This includes promotion of false cures for terminal or chronic illnesses and anti-vaccination advice,” adding that they rely on “information from national and internationally recognized institutions like the CDC and WHO World Health Organization” to guide their judgments.

NVIC is awaiting the judgment of NewsGuard Technologies about whether our weekly online journal newspaper The Vaccine Reaction will be given a green or red rating, which will send a signal to major search engines and social media platforms with the power to preserve or censor and make information disappear from the Internet.

Censoring Information for The Greater Good?

The new Internet Police scrubbing the World Wide Web of information they do not want you to see or talk about is part of the larger culture war going on today in our country and in many countries.72  73 When it comes to vaccination, discrimination and censorship is justified in the name of public safety and The Greater Good.74 75

Who’s greater good? Who among us in society should be given the power to take away our freedom to seek and obtain knowledge, to engage in rational thinking, to speak in the public square and follow the judgment of our conscience when making decisions about what we are willing to risk our lives and our children’s lives for?

In America, where the Bill of Rights in the U.S. Constitution guarantees civil liberties to protect minorities from the tyranny of the majority, we cannot wait any longer to publicly discuss and answer that question. It is a question that needs open public discussion, not censorship, because what is at stake affects not only freedom of thought and speech, but the loss of autonomy, the first and most sacred of all natural rights that protects every one of us from exploitation by wealthy corporations and politically powerful institutions.

Taking Positive Action with Eyes Wide Open and No Fear

In this time of oppression, we cannot know what needs to be done unless we go forward with our eyes wide open, understanding the new reality without fearing it. It is time to collect, preserve and cherish the good books, articles, films, videos and podcasts that have been published about vaccination and share them with our family and friends; time to save and download to our computers and external hard drives the written and video information still online that we want to keep and share with our children and our grandchildren. Time to expand the open public record by attending, testifying at and recording every legislative hearing, every town hall gathering, and every federal vaccine advisory committee meeting where people discuss vaccination or attempt to eliminate the human right to autonomy and censor freedom of thought and speech.

If the doors to the Internet are closing, we can still stand up and speak in the smaller public squares that have always been there. We can come together and talk the old fashioned way, meeting in cafes, hotels, churches and in the privacy of our own homes. We can set up telephone trees and stay in touch by mail the way we did before the Internet. We can still use the World Wide Web to create private messaging and host webinars. We can create new ways of communicating with each other using more secure channels for uncensored conversations about vaccination and health.

No matter what happens to the Internet, the best way to not lose touch with us is to register today for the free online NVIC Advocacy Portal, which is a secure communications network that puts you in electronic contact with your own legislators and provides you with real time information about vaccine-related legislation moving in your state. Taking that action provides us with an address to send you information in the mail, which also happens if you make a charitable donation to NVIC in any amount.

Today, everybody knows somebody who was healthy, got vaccinated and was never healthy again. NVIC has been here for 36 years telling the truth about vaccination and advocating for better quality vaccine science, higher government vaccine safety licensing standards, more humane public health policies and protection of informed consent rights. The truth about vaccination is out there now and the truth will shine bright and clear in the end, no matter who tries to stop it from being known.

It’s your health, your family, your choice and our mission continues: No forced vaccination. Not in America.

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Pediatricians Turn Well Baby Checkups Into Vaccine Battlegrounds

Posted: 11/5/2018 6:31:32 PM | with 8 comments

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.

parent and baby with doctor

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

dominate

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

believe

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.

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Eroding Freedoms: Pinterest Removes NVIC’s Boards

Posted: 9/18/2018 7:19:27 PM | with 6 comments

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.

pinterest

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!

Theresa Wrangham

NVIC Executive Director

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If Vaccines Injure Pregnant Women or Their Unborn Babies, What Will the Vaccine Court Do?

Posted: 9/18/2018 6:53:25 PM | with 7 comments

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)
Rockville, Maryland

Sept. 17, 2018

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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.

mom-child

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

unavoidable-unsafe

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

pregnant-lady

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

four-vaccinations

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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