FDA Prepares to Fast Track New Vaccines Targeting Pregnant Women

Posted: 11/17/2015 5:30:38 PM | with 21 comments

Following is a public comment made by Barbara Loe Fisher, NVIC Co-founder & President, at the Nov. 13, 2015 meeting of the FDA Vaccines & Related Biological Products Advisory Committee (VRBPAC) on proposed changes to FDA requirements for licensure of vaccines intended for use during pregnancy

Pregnancy Health ConcernsBirth defects, chromosomal damage, premature birth, low birth weight, pregnancy complications and sudden infant death syndrome, not infectious diseases, are the leading causes of death for about 23,000 infants dying before their first birthday in the US every year, with half of those deaths occurring on the first day of life. 1   2  Women getting pregnant and delivering babies in America today have more than twice the risk of dying during pregnancy, childbirth or within one year of giving birth than they did three decades ago, with heart failure, high blood pressure and stroke, diabetes, and blood clots being among the leading causes of death. 3   4

In 2006, CDC officials directed doctors to give all pregnant women a flu shot 5  and, in 2011, a Tdap shot during every pregnancy, no matter how little time has elapsed between pregnancies. 6   Prior to FDA licensure, influenza, diphtheria, tetanus and pertussis vaccines were not tested in or proven safe and effective for pregnant women in large clinical trials when given during every pregnancy either singly or simultaneously. 7   8

Categorized by FDA as Pregnancy Category B and C biologicals 9   because it is not known whether the vaccines are genotoxic and can cause fetal harm or can affect maternal fertility and reproduction, administering influenza and Tdap vaccines to pregnant women is an off-label use of these vaccines. 10   11   12   It is a policy that assumes maternal vaccination is necessary, safe and effective without proving it. 13

Tdap vaccine was licensed by FDA as a single dose pertussis booster shot in individuals over 10 or 11 years old, and pertussis containing vaccine injuries and deaths are the most compensated claim in the federal vaccine injury compensation program (VICP) for infants and children, while influenza vaccine-related injuries and deaths are the most compensated claim for adults. 14   And yet, in the absence of credible biological mechanism and epidemiologic evidence pre-licensure proving these vaccines are safe for all pregnant women, their fetuses and newborns, female health care workers are being fired for refusing to be injected with them while they are pregnant. 15

Epidemiology and Public HealthThis maternal vaccination policy is a violation of the precautionary principle to “first, do no harm,” 16   and it is of grave concern to women having babies in America, especially pregnant health care workers. When federal vaccine use recommendations are being turned into laws that punish Americans refusing to obey them with denial of a school education, medical care and employment, 17   18  maintaining high FDA vaccine licensing standards is absolutely essential.

There have been no well designed prospective, long term case controlled studies enrolling large groups of American women who get influenza and Tdap vaccines during pregnancy and comparing their health and the viability of their fetuses and newborns to women who do not get vaccinated. There are no published studies to identify unresolved vaccine-induced inflammation in the brains and bodies of the fetus, mother and newborn; or to measure atypical changes in brain and immune function and chromosomal integrity, including evaluating the numbers of de novo mutations present before and occurring after vaccination.

Maternal vaccination policy has preceded vaccine safety science. Now, there are proposals on the table here in this Committee and in the 21st Century Cures Act backed by FDA and industry to lower FDA licensing standards to ensure that vaccine Vaccine safety science is necessarypolicy can continue to precede vaccine safety science in the future. 19   Considerable discussion today about making a priori assumptions that complications and fetal death following maternal vaccination are only coincidentally and not causally related to vaccination 20   is a big red flag for vaccine consumers in the absence of credible pathological evidence to conclusively determine what is and is not vaccine induced.

The National Vaccine Information Center is opposed to FDA retroactively licensing influenza and Tdap vaccines for use in pregnant women and fast tracking RSV 21   and group strep B 22   vaccines to licensure by using small clinical trials; adaptive trial designs; Baysian methods of data analysis; biomarkers and surrogate endpoint measures rather than actual clinical endpoints; or using clinical experience instead of good bench science and randomized controlled clinical trials with long term follow-up to prove effectiveness and safety.

The fact that vaccine manufacturers, regulators, policymakers and providers are completely shielded from civil liability for vaccine injuries and deaths 23   makes it even more important for FDA standards for proof of vaccine safety and effectiveness to be very high, especially when licensing vaccines targeting pregnant women and their unborn babies.



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Vaccine Injury Compensation: Government’s Broken Social Contract with Parents

Posted: 11/2/2015 10:02:12 AM | with 11 comments

By Barbara Loe Fisher

To activate and view hyperlinked references, please click here 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.

Three decades ago, Congress created a federal vaccine injury compensation program (VICP) and gave the pharmaceutical and medical trade industries a partial product liability shield under the National Childhood Vaccine Injury Act of 1986. The goal was simple: to restrict civil lawsuits against vaccine manufacturers and negligent doctors whenever government mandated vaccines injure and kill Americans. 1

In the 21st century, Congress went further and directed federal agencies to develop a public-private business partnership with the pharmaceutical industry. 2 3 Today, multi-national corporations marketing vaccines enjoy a $15 billion dollar U.S. and $30 billion dollar global vaccine market that will reach $100 billion in 10 years. 4 5

At the same time, Congress appropriates billions of U.S. taxpayer dollars to federal agencies working with Big Pharma to develop hundreds of new vaccines, 6 7 while vaccine licensing standards have been lowered so companies can fast-track experimental vaccines to market. 8 9 Meaningful congressional oversight on vaccine regulation and policymaking is non-existent today, in part because the pharmaceutical industry is the number one wealthiest and most powerful lobby on Capitol Hill. 10 11 12 13

Obtaining Vaccine Injury Compensation: Do You Feel Lucky?

feel-lucky.jpgParents, who file a claim today on behalf of a brain damaged vaccine injured child in the federal vaccine injury compensation program (VICP) under the 1986 Act, know that the odds of obtaining financial assistance from the government are not much better than the odds of winning a lottery. 14 Department of Health and Justice officials fight almost every award in the U.S. Court of Claims so two out of three vaccine injury claims are denied. 15

Parents already traumatized because their healthy child was permanently disabled or died after receiving a government licensed pharmaceutical product they were promised would keep their child well, are traumatized again in what has become a highly adversarial and lengthy process that too often ends in disbelief, anger and heartbreak.

Government Officials Gut 1986 NCVIA and Betray Public Trust

Congress created the National Childhood Vaccine Injury Act (NCVIA) in 1986 as a social contract between government and parents, who are required under state vaccine laws to give their children federally recommended vaccines in order to attend school. Since 1995, the vaccine injury compensation program set up under the National Childhood Vaccine Injury Act has been systematically gutted by government officials, who vigorously opposed passage of the law in 1986 16 and have been determined to destroy it ever since.

After the U.S. Supreme Court in 2011 effectively completely shielded the pharmaceutical industry from all civil liability for injuries and deaths caused by FDA licensed vaccines, 17 there has been no legal accountability for any corporation or individual who develops, licenses, recommends, promotes, administers or mandates vaccines that injure and kill Americans.

The history of the National Childhood Vaccine Injury Act is one that has been marked by a profound betrayal of the public trust by government. At the center of that betrayal are doctors and scientists working for government and with industry, who are so determined to deny vaccine risks and cover up the casualties of one-size-fits-all vaccine policies, that they will throw innocent children under the bus to do it.

Toxic DPT Vaccine Brain Injures Children

PertussisI remember walking the halls of Congress in 1982 with other young parents of DPT vaccine injured children asking for a congressional investigation into the safety of the old whole cell pertussis vaccine. We did not understand why federal health agencies had not required drug companies to make that crude vaccine less toxic. We wanted to know why our babies did not have access to the less reactive new split cell pertussis vaccine in the DTaP shot that Japan was giving their children using technology developed in the 1970’s. 18

We knew that the 1981 British National Childhood Encephalopathy Study revealed that 1 in 110,000 DPT shots was followed by brain inflammation and 1 in 310,000 DPT shots by permanent brain damage. 19 We knew another prospective, case controlled study published in the U.S. the same year revealed convulsions occurred after 1 in 875 DPT shots and a collapse shock reaction occurred after 1 in 875 DPT shots, meaning that at least 18,000 children in America were either having convulsions or collapsing after DPT shots. 20 21

But Centers for Disease Control (CDC) officials did not know who those children were because pediatricians were not required to report vaccine reactions, or inform parents about how to monitor children for signs and symptoms of vaccine reactions, or keep permanent records of vaccines given, or write down serious health problems following vaccination in medical records.

Big Pharma Demands Liability Protection from Vaccine Injury Lawsuits

pointing-fingers.jpgBack in the 1970’s and 80’s, parents were filing product liability lawsuits against the three drug companies selling DPT vaccine and also against one selling live oral polio vaccine after children were paralyzed by vaccine strain polio. Parents were also filing malpractice lawsuits against pediatricians when their babies were re-vaccinated after reacting to previous DPT shots with convulsions, shock, high pitched screaming and unconsciousness, which can be signs of brain inflammation or encephalopathy, 22 a well known complication of vaccination since the first vaccines for smallpox and rabies were used in the 19th century. 23

Thirty years ago, high-powered attorneys for pharmaceutical corporations and pediatricians were blackmailing parents on the courthouse steps before jury trials began to settle vaccine injury lawsuits without going to trial. Few parents had the financial resources to battle big drug companies in court for long periods of time and so many would settle for low sums of money just before the trial began. As part of the settlement, parents had to agree that all court documents about their child’s vaccine injury would be sealed and blocked from public view.

I was among the parents of DPT vaccine injured children, who organized after watching the Emmy award winning TV documentary DPT: Vaccine Roulette in the spring of 1982. We accepted the invitation by congressional leaders taking action after the four drug companies marketing childhood vaccines in the U.S. (Wyeth, Lederle, Merck and Connaught) told Congress they would stop distributing the federally recommended and state mandated DPT, polio and MMR vaccines if Congress refused to give them a liability shield from vaccine injury lawsuits. 24

Vaccine Injury Compensation: “Simple Justice for Children?”

In an era when people communicated with each other on land lines and through the mail because there was no internet, email, personal computers or cell phones, parents of vaccine injured children fought as hard as we could to protect the legal right to sue pharmaceutical corporations for vaccine injuries and deaths under the National Childhood Vaccine Injury Act, which was the solution Congress came up with in response to threats by the pharmaceutical industry. The American Academy of Pediatrics (AAP) called the federal vaccine injury compensation program “simple justice for children.” Politicians said it would be a safety net for every child when vaccine risks turn out to be 100 percent. 25

Broken social contractWe were promised that the program would be a non-adversarial, expedited, less traumatic and less expensive administrative alternative to a lawsuit – not an exclusive legal remedy that prohibited all product liability lawsuits against vaccine manufacturers.

We believed that Congress would keep the promises made to parents when it gave partial liability protection to the pharmaceutical industry producing vaccines and the medical trade industry representing pediatricians. We believed that the informing, reporting and recording vaccine safety provisions, which the co-founders of the National Vaccine Information Center (NVIC) were specifically responsible for securing into that law, would be enforced. 26

Parents Trusted Congress Would Enforce 1986 Vaccine Injury Act

We trusted that Congress would make sure drug companies and federal health agencies would conduct biological mechanism research to identify high risk children and improve vaccine safety, and that all pediatricians and vaccine providers would be required to obey vaccine safety provisions to:

  • give parents written information about infectious diseases, vaccines and how to identify vaccine reactions before their children were vaccinated; and
  • enter reactions and serious health problems developing after vaccination into the child’s permanent medical record; and
  • keep a record of all vaccines given, including the manufacturer’s name and lot number; and
  • file a report with the federal vaccine adverse event reporting system (VAERS) when a child suffered vaccine reaction symptoms and serious health problems, was hospitalized or died after vaccination.

Government Has Broken VICP Social Contract with Parents

Every one of the promises made to parents 30 years ago in that social contract have been broken, and “simple justice for children” has turned out to be a lie. Over the past three decades, government agencies and their pharmaceutical and medical trade industry partners have turned the National Childhood Vaccine Injury Act into a drug company stockholder’s dream and a parent’s worst nightmare.

Government Targets Pertussis Vaccine Injured Children

My sister was vaccine injuredNow, in a desperate attempt to convince the public that vaccines are the only class of pharmaceutical product in the history of pharmacology completely free of serious side effects, 27 28 the genetically defective label is being slapped on children who suffer brain inflammation and permanent brain damage after vaccination. 29 Even though scientists have known for more than a century that vaccines can cause seizures 30 and brain inflammation (encephalitis/encephalomyelitis) 31 32 33 and permanent brain damage, also called encephalopathy, 34 35 doctors working for government and with industry want to pretend that vaccines containing lab altered bacteria and live viruses, toxins, chemicals, foreign DNA and other contaminants 36 do not brain damage anyone, especially healthy infants.

Children who become brain damaged after receiving pertussis-containing vaccines (like DPT and DTaP) are especially being targeted in a blatant effort to rewrite history and cover up vaccine risks and failures. 37 38 Perhaps that is because, among the $3 billion dollars in federal vaccine injury compensation awarded over the past 27 years under the National Childhood Vaccine Injury Act of 1986, the majority of awards for children have been for pertussis-containing vaccine injuries and deaths. 39

The reason for that is because there is a substantial amount of biological mechanism and epidemiological evidence in the medical literature that pertussis vaccine is, indeed, causally related to encephalitis and chronic neurological dysfunction in both animals 40 41 42 and humans 43 44 45 46 47 48 In fact, pertussis toxin, a component of pertussis vaccine, as well as pertussis vaccine itself, have been used by lab researchers for decades to reliably stimulate experimental autoimmune encephalomyelitis in mice and rats. 49 50 51

“Unavoidably Unsafe” Vaccines 100% Safe?

Even though Congress and the U.S. Supreme Court have declared that FDA licensed vaccines are “unavoidably unsafe” for the purpose of banning product liability lawsuits against drug companies, 52 53 54 government officials still want you to believe that vaccines are 100 percent safe for you, your children and everyone you know 100 percent of the time. The “It’s your fault, not the fault of our vaccines” defense is the ultimate free pass the pharmaceutical and medical trade industries are determined to get so they can keep on telling lies like it would be safe to give babies 10,000 vaccines at once 55 to justify forcing one-size-fits-all vaccine policies on all children and adults – no exceptions and no questions asked. 56

The utilitarian “greater good” argument only works if nobody is held accountable for the individuals being sacrificed in the name of the greater good.

Health Officials Blame Spontaneous Genetic Mutations for Vaccine Injuries

The newest ploy is to allege that if a child’s health suddenly deteriorates after vaccination, especially after pertussis vaccination, it is caused by unavoidable de novo – that’s a Latin word for “new ‘‘ - genetic mutations the child probably did not inherit but spontaneously developed at some point in his or her life. 57 58

It's YOUR FaultThat’s right. Government officials and the hired guns they pay with your taxpayer dollars want you to believe that if your child was developing normally before getting three or six or 10 government mandated vaccines on the same day (especially pertussis containing vaccines) and then has a seizure and develops encephalopathy within hours or days of getting those vaccines, your child was predestined to become brain injured at that moment in time, even if no vaccines had been given. 59 60

The government’s “it’s your fault” causation theory goes like this: since public health officials believe it was your child’s destiny to develop random new mutations that cause chronic brain dysfunction, no vaccine injury compensation is to be awarded because the vaccines didn’t do it; the vaccine manufacturer selling the vaccines didn’t do it; the federal health officials who licensed and recommended the vaccines didn’t do it; the state health officials and legislators who voted to mandate the vaccines didn’t do it; the doctor giving the vaccines didn’t do it – you and your child’s spontaneously defective genes did it.

So you and your child are on your own.

Pertussis Vaccine Injured Children Denied VICP Awards

And this is already happening. Normally developing children who have experienced seizures and other signs of encephalopathy within hours or days of vaccination, especially after being injected with pertussis containing vaccines (DTaP), 61 are being denied vaccine injury compensation because government officials argue that vaccinations simply “triggered” the brain deterioration process and the child’s spontaneously defective genes are solely to blame. 62 63 64 65 66 67 And now when a special master in the U.S. Court of Claims does award compensation for a pertussis vaccine injury, it is appealed by the government so that financial assistance is taken away from the child and parents raising their vaccine handicapped child. 68

Vaccine Injured Children Denied AwardsBut not all children with de novo genetic mutations go on to develop seizure disorders and brain dysfunction. A normally developing child might have continued to develop normally for many years if the pertussis vaccine or other vaccines had not been given, but doctors do not screen children for genetic susceptibility before vaccinating them. 69

NCVIA of 1986 Says Susceptible Children Should Be Compensated

The National Childhood Vaccine Injury Act specifies that children with pre-existing conditions made worse after vaccination are not disqualified from receiving vaccine injury compensation. 70 71 That is because susceptible children with underlying health conditions, who develop catastrophic brain injuries after receiving government recommended and mandated vaccines, are precisely the ones who should be the first to be awarded uncontested federal vaccine injury compensation!

We All Have Unique Genetic, Biological, Environmental Differences

Public health officials are well aware that we are all unique individuals and that there are genetic, biological and environmental differences among us, including those that increase our susceptibility to prescription drug and vaccine reactions. 72 73 74 75 76 77 Scientists do not know how, why or when genetic mutations spontaneously occur and cause harm. 78 79 80

Environmental exposures are thought to play a key role in “de novo” genetic mutations, but they are still unexplained in part because the complex science of epigenetics is still in its infancy. Scientists are just beginning to understand that our health is not only affected by the genes we inherit from our parents; our genes are turned on and off and mutate due to environmental exposures and health choices our parents and grandparents made and that we are exposed to our make during our own life. 81 82 83 84 85

Dravet Syndrome: Susceptibility to Seizures After Vaccination

Dravet Syndrome: susceptibility to seizures after vaccinationChildren diagnosed with Dravet syndrome, 86 87 for example, have a rare de novo genetic mutation that predisposes them to develop medication resistant seizures and subsequent brain damage and an estimated 2.5 percent of children who develop seizures after vaccination carry the mutation. 88 89 90 Those children are often perfectly healthy until they experience their first seizure – with or without fever – after a round of vaccinations. 91 92

And yet, children in the U.S. are not being screened for Dravet or any other genetic susceptibility that can trigger seizures and other reactions before doctors give them vaccines. 93 In fact, some doctors insisting on “no exceptions” vaccine use policies have insisted that children with Dravet continue to be vaccinated on schedule even after they develop vaccine-related seizure disorders. 94 They are the same doctors alleging that vaccines do not cause brain damage just because a small percentage of children with de novo mutations associated with Dravet syndrome develop seizures after vaccination! 95

No Science Evaluating the Vaccine Schedule Or Genetic Mutations After Vaccination

The 1986 law requires the Secretary of DHHS to:

(1) “promote the development of childhood vaccines that result in fewer and less serious adverse reactions than those on the market on Dec. 22, 1987, and promote the refinement of such vaccines;” and

(2) “to make or assure improvements in, and otherwise use the authorities of the Secretary with respect to, the licensing, manufacturing, processing, testing, labeling, warning, use instructions, distribution, storage, administration, field surveillance, adverse reaction reporting, and recall of reactogenic lots or batches, of vaccines, and research on vaccines, in order to reduce the risks of adverse reactions to vaccines.” 96

After 30 years, why has Congress failed to enforce that clarion call for research to reduce the risks of adverse reactions to vaccines?

Why the National Childhood Vaccine Injury Act of 1986 has become a betrayal of public trustWhere is the biological mechanism research measuring changes in immune and brain function at the cellular and molecular level when vaccines cause injury and death?

Where are the pathological profiles to help doctors and coroners separate “coincidence” from vaccine induced brain injury and death? 

Where are the studies investigating whether genetic mutations are occurring in a fetus or a pregnant woman after four vaccines are given during the first trimester; or after newborns are given a dose of hepatitis B vaccine on the first day of life; or after a baby has been given 24 vaccinations by age six months; or after a two year old has been given a total of 45 government recommended vaccinations?

Where is the basic science research to compare de novo mutations and chromosomal damage in children and adults before and after vaccination?

Clearly, that knowledge is not important to public health officials and doctors, who have not conducted methodologically sound studies proving that the federal childhood vaccine schedule of 69 doses of 16 vaccines is safe. 97 The refusal by government to compare long-term health outcomes of vaccinated and unvaccinated children to find out exactly who is genetically more susceptible to suffering vaccine harm and if there are differences in the numbers of de novo genetic mutations experienced by vaccinated and unvaccinated children, is indefensible.

NVIC Submits Statements on VICP to GAO and ACCV

In November 2014, the Government Accountability Office (GAO) published a report for Congress that affirmed what parents of vaccine injured children have been saying for years. 98 Part of that GAO report included information provided by the National Vaccine Information Center in a July 2014 referenced statement submitted to GAO. 99

In September 2014, NVIC additionally submitted a referenced statement to the Advisory Commission on Childhood Vaccines (ACCV) protesting the systematic gutting of the definition of encephalopathy and Vaccine Injury Table by CDC officials using rule making authority for the express purpose of denying vaccine injured children federal compensation. 100

NVIC Provides Evidence to GAO and ACCV for Betrayal of Trust

In NVIC’s statements to GAO and ACCV, we reviewed the history of the National Childhood Vaccine Injury Act of 1986 and provided evidence for why that law has become a betrayal of public trust:

FACT: By 2015, over $3 billion in federal compensation had been awarded to more than 4,000 child and adult vaccine victims but two out of three children applying for federal vaccine injury compensation have been turned down, even though there is a $3 billion dollar surplus in the Vaccine Injury Trust Fund; 101 102

FACT: Between 1988 and 1995, vaccine injured children were receiving awards through an administrative procedure. However, when CDC officials changed the rules for obtaining compensation in 1995, including rewriting the definition of encephalopathy, the system became highly adversarial. Today, almost no vaccine injured child can qualify for an uncontested award, especially if they exhibited signs of brain inflammation after vaccination and were permanently brain injured.

FACT: Today, 80 percent of vaccine injury compensation awards are given to adults disabled by flu shots and only 20 percent of awards are given to children legally required to get vaccinated to attend daycare or school;

FACT: Most vaccine injury claims take many years to adjudicate because the Departments of Health and Justice use taxpayer dollars to fight against awarding compensation for the majority of children and adults who apply;

FACT: Parents are not being informed by government officials or doctors about the very short two to three year deadlines for filing a vaccine injury compensation claim for their child, so most parents don’t even know they can file a claim and often miss the filing deadline. On NVIC.org, you can read two outside consultant reports (Banyan 103 and Altarum 104 ) that have independently confirmed that federal health officials have failed to publicize the existence of a vaccine injury compensation program;

FACT: Federal officials are not transparent with the public about details of vaccine injury awards, even though this is a requirement in the law;

FACT: Many pediatricians and other vaccine providers refuse to comply with the informing, recording and reporting vaccine safety provisions in the law. In fact, pediatrician members of the American Academy of Pediatrics and other medical trade industry groups are refusing to give children medical care if their parents do not get them vaccinated according to the CDC schedule.

The VICP Failed Experiment in Tort Reform Should Be Repealed

The vaccine injury compensation program has been a failed experiment in tort reform for many years and it is long past time for a congressional investigation. 105 Years of neglect and failure to provide oversight on a law that parents were promised would be “simple justice for children” has allowed government with the help of industry to break the program apart to the point where it cannot – and should not - be salvaged. Protecting profit-making corporations from product liability, especially when they partner with government to mandate use of their products, is a bad idea.

It is time to repeal the 1986 law and again hold pharmaceutical corporations accountable for the risks and failures of vaccine products in a civil court of law.

Informed ConsentWithout a legal check and balance on companies whose products are mandated by government, vaccines that cause harm and fail to work can stay on the market and people can be exploited, especially when government vaccine policies fail to respect biodiversity and end up selecting the genetically vulnerable for sacrifice.

Defend the Human Right to Informed Consent to Vaccine Risk Taking

The broken social contract with parents by government that at its core is a profound betrayal of public trust, is one more reason why it is so important for Americans to defend the human right to exercise voluntary informed consent to medical risk taking, especially vaccine risk taking. If we don’t protect our legal right to know and freedom to choose now, we will be held captive by corporations and government throwing the most vaccine vulnerable among us under the bus.

Explore NVIC's website and go to NVICAdvocacy.org today and find out how you can work with others in your state to secure and protect flexible medical, religious and conscientious belief exemptions in vaccine laws.

It’s your health. Your family. Your choice.



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