For some time now, vaccine researchers around the world have been on the prowl to create the perfect swine and bird flu vaccines that are both effective and safe, but have come up far short of perfection. In the process, they have added squalene-type “oil-in-water” adjuvants to some influenza vaccines, only to find that it can be risky business.
Squalene Adjuvants Never Licensed Before in U.S.
Squalene adjuvants, which ramp up the immune response, have never been licensed for use in the U.S. However, the Food and Drug Administration (FDA) paved the way for a squalene adjuvant to be included in U.S. vaccines with its November 2013 approval of the first influenza A (H5N1) monovalent “bird flu” vaccine: GlaxoSmithKline’s Q-Pan vaccine that contains the controversial oil-in-water emulsion adjuvant AS03.
Q-Pan vaccine will be added to the U.S. pandemic emergency vaccine stockpile. Although there is no H5N1 influenza pandemic underway to justify fast-tracked approval of the experimental AS03-adjuvanted bird flu vaccine, the speedy FDA approval comes amid mounting evidence that AS03 adjuvants are associated with development of serious autoimmune and neurological disorders like narcolepsy.
GSK’s Squalene-Adjuvanted H5N1 Bird Flu Vaccine: Federally Funded
Approved for adults aged 18 years or older, right now GSK’s Q-Pan H5N1 influenza vaccine is only included in the U.S. vaccine stockpile and is not commercially available for widespread public use … yet.
The U.S. Department of Health and Human Services (DHHS) purchased the vaccine from GSK to stockpile it for a potential future H5N1 pandemic emergency, in the event the bird flu virus develops the ability to spread easily from human to human. GSK will make the vaccine commercially available if directed by the Biomedical Advanced Development and Research Authority (BARDA), which financially supported the vaccine development program through a federally funded contract. 1
[In March 2013, GSK and Texas A&M announced that DHHS had approved the establishment of a $91 million influenza vaccine manufacturing plant facility in Texas that would eventually enable GSK to manufacture influenza vaccine based on the Vivalis novel EB66 duck embryonic stem cell line 2
The FDA cited one study as the basis for their approval of Q-Pan, but reported very few details. The study compared 3,400 adults who were given the vaccine to 1,100 adults who were given a placebo. Out of 2,000 evaluated study subjects, 91 percent of vaccinated adults aged 18 to 64 years “developed a level of antibodies expected to reduce the risk for influenza.” Additionally, 74 percent of vaccinated adults aged 65 years or older also developed this level of immune response.
Vaccine side effects included injection site pain as the most common, but also muscle aches, headache and fatigue. The FDA said it would collaborate with GSK to conduct additional safety and effectiveness studies, “in the event the vaccine is released for public use during an H5N1 influenza virus pandemic.” 3
Controversial H5N1 Lethal Virus Research Hit Roadblocks
There are a couple of things wrong with this picture. First and foremost, research surrounding H5N1 “bird flu” viruses has been rooted in controversy. Remember the two scientists, who were asked to temporarily halt their research projects on the H5N1 strain of the bird flu virus because they were deliberately creating a genetically engineered and more lethal version of the virus in airborne transmissible form that could infect humans? 4
After a firestorm of contentious debate with some scientists calling for an end to the research because it was too risky (the research was later resumed), in March 2013 the FDA delayed its decision regarding approval of GSK’s Q-Pan H5N1 vaccine.
The decision to delay approval came despite a unanimous vote in November 2012 by the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) to recommend Q-Pan H5N1 vaccine be licensed for inclusion in the national stockpile. Even though a delayed FDA staff decision usually indicates that additional review time is needed for the product, GSK claimed the delay was simply because of an administrative matter. 5
Squalene in Anthrax Vaccines Linked to Gulf War Syndrome
The FDA is well aware that squalene-type vaccine adjuvants like AS03 are controversial and have been linked to a series of anthrax vaccinations given to healthy American soldiers during the Gulf War that were followed by brain and immune system problems in some soldiers. Risks associated with experimental squalene-adjuvanted anthrax vaccines surfaced in the late 1990s when U.S. soldiers in the Gulf War developed brain and immune disorders and tested positive for squalene antibodies. 6 7
The FDA declined to license squalene adjuvants for use in 2009 pandemic H1N1 vaccines released for public use in the U.S. 8 9 10
GSK Pandemic ”Swine Flu” Vaccine & Narcolepsy
However, squalene adjuvants were included in pandemic H1N1 “swine flu” vaccines released in Europe during 2009-2010. In the past few years, a series of studies have produced evidence for an association between GSK’s Pandemrix, which contains AS03, and development of a serious autoimmune and neurological sleep disorder, narcolepsy.
Pandemrix was administered to 30.8 million people in 47 European countries. A total of 795 vaccine adverse event reports have linked Pandemrix with the development of narcolepsy, especially among children. 11
Finnish researchers conducted an epidemiological study to assess the narcolepsy risk among 915,854 people. Approximately 70 percent had been vaccinated. They concluded that there was more than a 12-fold increased risk of developing narcolepsy after vaccination.
In Sweden, researchers compared the incidence of narcolepsy among vaccinated and unvaccinated individuals and found a 6.6-fold increased risk of narcolepsy after vaccination. 12
Even though European health officials said evidence was insufficient to prove a causal relationship between Pandemrix and narcolepsy, the European Union changed its recommendation for the vaccine’s use in individuals younger than 20 years. The European Medicines Agency also said it expects GSK “to take into account the hypothesis generated by the Finnish research in their experimental research programme into the root cause for the association between Pandemrix and narcolepsy.” 13
More Research Connects AS03 Adjuvanted Flu Vaccines to Narcolepsy
Since the preliminary reports out of Finland and Sweden, more studies have drawn similar conclusions. In one 2013 retrospective analysis, UK researchers evaluated narcolepsy cases among 245 children aged 4 to 18 years in England. The study authors noted that there was low overall pandemic H1N1 swine flu vaccine coverage in England.
In total, 75 study patients developed narcolepsy after Jan. 1, 2008 and 11 of those patients had received AS03 adjuvanted Pandemrix vaccine before the onset of the debilitating disorder. In fact, for seven patients, narcolepsy presented within six months.
Based on these results, the researchers estimated at least a 14-fold increase in risk of narcolepsy among children who received GSK’s Pandemrix compared with age-matched children in England who didn’t receive the vaccine. Though Finland estimated that 1 in 16,000 doses could lead to narcolepsy, the English study estimated that 1 in 57,500 and 52,000 doses could lead to the disorder. 14
A second 2013 study assessed the narcolepsy diagnosis rates from 2000 to 2010 in six European countries, identifying 2,608 cases of narcolepsy. Finland and Sweden were the only two countries that recommended Pandemrix for the entire population. The researchers found an increase in narcolepsy diagnoses among children aged 5 to 19 years after the pandemic vaccine campaigns began in Finland and Sweden. There was also an increase in narcolepsy cases in Denmark, although the country had relatively low vaccine coverage. 15
Finland’s National Institute for Health and Welfare analyzed hospital and primary care data and reported that 23 of the 25 adults who developed narcolepsy in Finland during 2009 to 2011 were aged younger than 40 years. None of the patients were aged older than 64 years. Researchers concluded that Pandemrix-vaccinated adults aged from 20 years to 64 years had three to five times the risk of developing narcolepsy as compared with unvaccinated age-matched individuals. 16
Narcolepsy: A Life-Altering Disorder
Narcolepsy, which is sometimes referred to as “sleeping sickness,” is characterized as either an autoimmune or neurological disorder marked by excessive daytime sleepiness, sudden loss of muscle tone and collapse, vivid hallucinations, brief periods of total paralysis and other disabling symptoms. Researchers say genetic factors alone are not sufficient to cause the disease but genes on the HLA antigen immune complex are thought to predispose some individuals to develop narcolepsy. 17 18
Many previously healthy children who have developed Pandemrix-related narcolepsy are unable to go to school or participate in daily activities because they are unable to stay awake or concentrate long enough to participate in normal daily activities. 19
AS03 Pinpointed as Dangerous Vaccine Adjuvant
Vaccine risks often come down to vaccine ingredients and individual biological susceptibilities that place some people at increased risk for vaccine-induced injury and death. The AS03 adjuvanted pandemic H1N1 vaccine is no exception.
AS03, GSK’s proprietary squalene adjuvant, contains a combination of three “oil in water” ingredients, including oil derived from shark livers. Its role in the vaccine is to stimulate a super-charged immune response, in addition to the immune response stimulated by lab-altered, inactivated influenza virus in the vaccine. Yet, there has been little scientific investigation into the individual genetic and biological susceptibilities that could increase risks for some people given squalene-adjuvanted vaccines. 20
MF-59: Another Squalene Adjuvant
MF59 is another squalene adjuvant,21
which has been used for years by another vaccine manufacturer, Novartis, in vaccines used in Europe and other countries. The FDA has not approved vaccines using MF59 for use in the United States, even though drug companies have been lobbying for years to get the FDA to approve MF59 adjuvanted vaccines. 22
The issue with squalene adjuvants could lie in the method of entry. While squalene is an organic compound found in plants, animals and humans,23
and has antioxidant properties when consumed, injecting squalene directly into the body appears to cause the body to react differently. 24
In one 2000 study, injecting squalene into rats led to chronic arthritis, prompting the idea that these molecules could have “wide pathogenetic implications in humans” and may play a role in chronic inflammatory diseases. 25
NVIC Historically Wary of Untested Squalene Adjuvants
NVIC has been cautious of oil-based adjuvants since reports in the 1990s that some experimental anthrax vaccines given to U.S. soldiers in the Gulf War Gulf War included squalene adjuvants that left the soldiers with severe brain and immune system dysfunction. Understanding that vaccine risks can be greater for some individuals than others, NVIC continues to be concerned that squalene adjuvants may increase the risk for vaccine-induced chronic inflammation and autoimmunity in some children and adults, who are genetically predisposed to atypical inflammatory responses and autoimmunity.
NVIC has argued that squalene adjuvants have not been tested compared to placebos in large trials published in scientific journals. In addition, there are no studies specifically evaluating cellular, molecular and DNA changes in the body after squalene-adjuvanted vaccines have been administered to children and adults.
Under Emergency Use Authorization approved by Congress, the FDA has the legal authority to approve and release experimental vaccines for public use whenever federal health officials declare a national “public health emergency.” In 2009, NVIC expressed concern that normal FDA licensing procedures would be by-passed to include squalene adjuvants in pandemic influenza vaccines without adequate testing, which it seems now has been done four years later. 26 27
H5N1 Bird Flu Pandemic Threat Low
FDA’s approval of GSK’s Q-Pan H5N1 squalene-adjuvanted vaccine raises eyebrows because H5N1 bird flu virus infections and related deaths in humans have been confined to those working in the bird farming industry in Asia and the Middle East, who have direct contact with infected birds. Thus far, the H5N1 bird virus does not efficiently transmit among humans.
There is no looming H5N1 pandemic threat in the United States!
Cases of H5N1 reported from 2010 through October 2013 to the World Health Organization have been identified mostly in Indonesia, Egypt, Vietnam, China and Cambodia. 28
Even the FDA admitted the low likelihood of a pandemic H5N1 outbreak in the U.S. in their statement announcing approval of the H5N1 vaccine for national stockpiles: “Most avian influenza A viruses do not infect people,” they stated. However, “H5N1 is an influenza virus with pandemic potential because it continues to infect wild birds with occasional outbreaks of influenza disease in poultry populations, and most humans have no immunity to it.” 29
Squalene adjuvants have never been licensed in the U.S. and legitimate questions are being raised about why there has been a rush to approve an experimental AS03-adjuvanted H5N1 bird flu vaccine for national stockpiling without requiring GSK to produce data demonstrating that the controversial AS03 squalene adjuvant included in the vaccine is safe for everyone. This move by FDA in the absence of a true public health emergency suggests that drug companies put pressure on the regulatory agency to pave the way for future no-hassle “grandfathered” licensing of experimental vaccines containing untested squalene adjuvants.
Only time will tell but, so far, it looks like the scoreboard is Pharma - 1, Public Health Safety - 0.
Asa PB, Wilson RB, Garry GF.
Stephanie Christner, DO, has been appointed to a four year term as the voting consumer representative on the Vaccines & Related Biological Products Advisory Committee (VRBPAC)
of the Food & Drug Administration (FDA). On Nov. 13, 2013, she will participate in her first meeting as a member of VRBPAC, a 12-member FDA committee that reviews and evaluates vaccine safety, effectiveness and appropriate use of vaccines and biological products intended for public use, including clinical trial and other data submitted by drug companies seeking licensure of new vaccines.
Honoring Her Daughter & Advocating for Vaccine Education
Stephanie Christner, DO, is a Board Member of the National Vaccine Information Center (NVIC). Her infant daughter, Victoria, died on Valentine’s Day 2009 after reactions to a series of vaccinations she received at two and four months old. In honor of her daughter, Dr. Christner founded “Valentine’s for Victoria,” educational fundraisers held in 2010 and 2011 supporting NVIC’s charitable public education and advocacy work. Dr. Christner’s personal experience and professional perspective on the need for greater physician and parent vaccine education was featured in the award winning 2011 film documentary The Greater Good.
Mom, Doctor, Businesswoman & Volunteer
Dr. Christner graduated from Southern Methodist University with a BA in Business Administration and a BS in Economics. In 2000, she received her medical degree from Oklahoma State College of Osteopathic Medicine. She completed her internship in Family Medicine and her residency in Psychiatry at the University of Oklahoma. She received the Microbiology Award in medical school, the Resident Research Award during residency and was co-author of a HIPPA journal article.
Dr. Christner practiced outpatient and emergency psychiatry until 2010, when she co-founded a company specializing in allergy, GMO and preservative-free foods. She recently returned to clinical practice in outpatient psychiatry and neurofeedback. Married with five children, she is actively involved in church and community service work.
by Barbara Loe Fisher
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It was 1977 when I found out I was going to become a Mom. I instinctively knew I needed to be careful while I was pregnant, especially during the first two trimesters when the major organ systems of the fetus develop at a rapid rate. In the 1960’s there had been a lot of publicity about babies dying or being born without arms or legs because women had taken a drug (Thalidomide) for morning sickness in the first or second trimester of pregnancy1
and I wanted to make sure I did everything I could to protect my health and the health of my baby before and after he was born.
Mothers to be in my generation were told to take extra vitamins and eat nutritious food but, most of all, to avoid anything that could harm the developing fetus like alcohol, cigarette smoke, medications, radiation, household cleaning products and other toxic exposures. Some of us were aware of the risks of heavy anesthesia during delivery and signed up for Lamaze classes to prepare for a drug-free birth, which many obstetricians discouraged, and we chose to breastfeed, even though a lot of pediatricians were pushing formula and bottles back then.
Today, pregnant women face a different set of difficult questions and choices about keeping themselves and their babies healthy. Among them are whether or not to get vaccinations during pregnancy that public health officials, obstetricians and pediatricians say will protect pregnant women and their newborns from getting sick with influenza and B. pertussis whooping cough.
Toxic Exposures & Assumption of Safety - Is It A Good Idea?
Although since the 1970’s public health officials have recommended influenza vaccinations for pregnant women in the second or third trimester,2
relatively few obstetricians promoted the vaccine until the past decade when, in 2006, the Centers for Disease Control (CDC) strengthened recommendations that all pregnant women, healthy or not, should get a flu shot in any trimester.3
Then, in 2011, a pertussis containing Tdap shot was recommended for all pregnant women, preferably after 20 weeks gestation.4
Both current vaccine recommendations5 6 7
are endorsed by the American College of Obstetricians and Gynecologists (ACOG)8 9
the American Academy of Pediatrics (AAP) and other medical trade associations.10 11
With these recommendations, the time-honored rule of avoiding any potential toxic exposure that might interfere with the normal development of the fetus has been suspended and replaced with an assumption that vaccination during pregnancy is safe. But what is the scientific evidence documenting that this assumption is a well-informed one?
Glaring Lack of Safety Testing
You have to look no further than information in the vaccine manufacturer product inserts and posted online by the U.S. Food and Drug Administration (FDA) and Centers for Disease Control (CDC) to quickly answer that question.
FACT: Drug companies did not test the safety and effectiveness of giving influenza or Tdap vaccine to pregnant women before the vaccines were licensed in the U.S.12 13 and there is almost no data on inflammatory or other biological responses to these vaccines that could affect pregnancy and birth outcomes.14
FACT: The Food and Drug Administration (FDA) lists influenza and Tdap vaccines as either Pregnancy Category B or C biologicals15 which means that adequate testing has not been done in humans to demonstrate safety for pregnant women and it is not known whether the vaccines can cause fetal harm or affect reproduction capacity. The manufacturers of influenza and Tdap vaccines state that human toxicity and fertility studies are inadequate and warn that the influenza and Tdap vaccines should “be given to a pregnant woman only if clearly needed.”16 17 18
FACT: There are ingredients in influenza and pertussis containing Tdap vaccines that have not been fully evaluated for potential genotoxic19 or other adverse effects on the human fetus developing in the womb that may negatively affect health after birth, including aluminum adjuvants, mercury containing (Thimerosal) preservatives and many more bioactive and potentially toxic ingredients.20 21 22 23 24 25 26 27 28 29
FACT: There are serious problems with outdated testing procedures for determining the potency and toxicity of pertussis vaccines and some scientists are calling for limits to be established for specific toxin content of pertussis-containing vaccines
FACT: There are no published biological mechanism studies that assess pre-vaccination health status and measure changes in brain and immune function and chromosomal integrity after vaccination of pregnant women or their babies developing in the womb.31
FACT: Since licensure of influenza and Tdap vaccines in the U.S., there have been no well designed prospective case controlled studies comparing the health outcomes of large groups of women who get influenza and pertussis containing Tdap vaccines during pregnancy either separately or simultaneously compared to those who do not get the vaccines, and no similar health outcome comparisons of their newborns at birth or in the first year of life have been conducted. Safety and effectiveness evaluations that have been conducted are either small,32 retrospective,33 34 compare vaccinated women to vaccinated women35 or have been performed by drug company or government health officials using unpublished data.36
FACT: The FDA has licensed Tdap vaccines to be given once as a single dose pertussis booster shot to individuals over 10 or 11 years old. The CDC’s recommendation that doctors give every pregnant woman a Tdap vaccination during every pregnancy - regardless of whether a woman has already received one dose of Tdap - is an off-label use of the vaccine.37
FACT: Injuries and deaths from pertussis-containing vaccines are the most compensated claims in the federal Vaccine Injury Compensation Program (VICP) and influenza vaccine injuries and deaths are the second most compensated claim.38
FACT: A 2013 published study evaluating reports of acute disseminated encephalomyelitis (ADEM) following vaccination in the U. S. Vaccine Adverse Events Reporting System (VAERS) and in a European vaccine reaction reporting system found that seasonal influenza vaccine was the most frequently suspected cause of brain inflammation after 18 years old, representing 32 percent of the total cases reported, and pertussis containing DTaP was among the vaccines most frequently associated with brain inflammation in children between birth and age five.39
FACT: When a pregnant woman is harmed by an influenza or Tdap vaccine, drug companies selling the vaccines in the U.S., doctors and other vaccine providers are shielded from vaccine injury lawsuits40 but it is unclear whether vaccine injuries sustained by an unborn child in the womb will qualify for federal vaccine injury compensation.41
Rush to Vaccinate: Policy Preceding Science
In addition to lack of credible scientific evidence to demonstrate safety,42 43
there is not enough credible epidemiological and biological mechanism evidence to demonstrate it is effective
or necessary 44 45 46 47
pregnant woman to get an influenza and Tdap shot during every
pregnancy. The rush to vaccinate pregnant women and reach into the womb to try to passively vaccinate the developing fetus48 49
is a clear case of policy preceding science.
An experimental genetically engineered nanoparticle vaccine for respiratory syncytial virus (RSV) and another one for Group B Streptococcus are in advanced clinical trials and reportedly likely will be exclusively recommended for pregnant women after they are licensed.50 With new vaccines on the horizon that will target pregnant women, it is critically important that more bad vaccine policy does not precede good vaccine science.
Pregnant women today need to take a long, hard look at the well advertised but theoretical benefits and unknown risks of getting vaccinated during pregnancy before making a vaccine decision. It is especially important when there are so many warning signs that America’s highly vaccinated child and adult population in the 21st century is not very healthy.
Maternal and infant mortality statistics are a classic measure of a nation’s public health status and, in this country, here are red flags that cannot be ignored any longer.
Maternal and Infant Mortality Rates High in America
How many young couples of child bearing age know that women getting pregnant and delivering babies in America today have more than twice
the risk of dying during pregnancy, childbirth or after giving birth than they did three decades ago?51 52
Women having babies are dying of heart failure, high blood pressure and stroke, infection of the blood, diabetes and blood clots in greater numbers because the maternal death rate in America has been climbing since 1987.53
We now rank a dismal number 50 in maternal mortality in the world, which is worse than that of most European countries and some countries in Asia and the Middle East.54
Equally shocking is the fact that the U.S. now has the highest first day infant death rate
of all industrialized countries55
and ranks number 31 among nations in infant mortality.56
Preterm birth rates have increased 36% since the early 1980’s57
and 6 out of every 1,000 babies born alive in America die before their first birthday.58
Birth defects, chromosomal damage, premature birth, low birth weight and sudden infant death syndrome are the leading causes of death for about 23,000 newborn infants every year,59
with half of those deaths occurring on the first day of life. A baby born in America is twice as likely to die within the first 24 hours as babies born in the European Union.60
Why Is Health in the U.S. on Such A Steep Decline?
U.S. public health officials say there are “no clear” answers for why our maternal mortality rate is skyrocketing.61
They don’t know why so many of our babies are dying on the first day and within the first year of life, in stark contrast to many other nations where maternal and infant mortality rates are declining.
Public health officials also can’t figure out why so many infants and children in America are plagued with brain and immune system problems. The unprecedented, unexplained chronic disease and disability epidemic 62
has gotten worse in the past three decades – with 1 child in 6 now learning disabled; 63
1 in 9 suffering with asthma;64
1 in 50 developing autism;65
1 in 400 becoming diabetic66
and millions more suffering with severe food allergies,67
inflammatory bowel disease 68
and other chronic illness.69 70
The health of American adults has also deteriorated during the past three decades compared to other wealthy nations where health is improving71
and our life expectancy is worse than many other countries as well.72
The CDC says that today chronic diseases are the most common and costly causes of death and disability with about half of all adults living with at least one chronic illness.73
U.S. Number One Market for Drugs & Vaccines
What is not
on the list of potential causes for this failing public health report card is lack of access to drugs and vaccines. With a population of 316 million people out of 7 billion people on the earth, the U.S. spends nearly $3 trillion dollars per year on health care74
- more than any other nation in the world75 76
- and we consume 40 percent of all drugs sold globally.77 78 79
In addition, America is the leading purchaser of vaccines in the world’s $32 billion dollar vaccine market.80 81 82
Since 1981, 95 percent of all children entering kindergarten have received multiple doses of seven vaccines including pertussis and measles vaccines.83
In 1991, the CDC recommended all infants get a hepatitis B shot at 12 hours old84
and, by 2012, more than 70 percent of all newborns had received a hepatitis B shot at birth while between 80 and 90 percent of three year olds had gotten multiple doses of eleven vaccines.85
In a crusade to eliminate an expanding list of microbes, U.S. health officials currently direct pediatricians to give children 49 doses of 14 vaccines by age six starting on the day of birth with more than two dozen doses administered by an infant’s first birthday.86
More than two dozen additional vaccinations are recommended or mandated for teenagers and adults, including annual flu shots throughout life.87
Has Mandated Use of More Vaccines Compromised America’s Health?
Every state in the U.S. has laws requiring dozens of vaccinations for daycare and school attendance88
in contrast to neighboring Mexico and Canada, which recommend but do not mandate vaccines (a provision in Canada’s Constitution prohibits compulsory vaccination).89
Japan, New Zealand, Australia, Iceland and Norway recommend but do not legally require vaccines and 15 countries in the European Union, including United Kingdom, Germany, Spain, Greece, Denmark, Netherlands, Finland and Austria similarly recommend but do not mandate vaccines.90
All of these countries have lower infant mortality rates than the U.S. and do not recommend that infants under one year old get as many vaccines as American infants do.91
In fact, no other country legally requires92
the numbers of vaccinations that the U.S. does for children to attend daycare and school or for adults to keep their jobs.93
It is no wonder that more Americans are asking questions about why our children need so many vaccines and why adults need to get a flu shot every year – even during pregnancy – when our population is already the most vaccinated in the world but far less healthy than other countries that do not mandate or recommend so many vaccines.
Ask for the Science
If you are pregnant and have other children, be aware that the American Academy of Pediatrics is urging pediatricians to vaccinate parents bringing their children in for sick or well baby visits, especially pregnant women.94
If an obstetrician or pediatrician pressures you to get vaccinated while you are pregnant, ask the doctor to show you the science. If you conclude the vaccine’s benefits do not outweigh the risks for you and your baby but are threatened or sanctioned in any way for making an informed choice, you should find another doctor who will treat you with respect and honor your health care choices.
Go to NVIC.org to learn more and sign up for NVIC’s free online Advocacy Portal so you can work to protect the freedom to make voluntary vaccine decisions in your state.
It’s your health, your family, your choice.
Toxicology Data Network. 2-Phenoxyethanol
. National Library of Medicine
. Webpage last reviewed Jan. 19, 2012.
Toxicol 1993; 31(3): 183-190.
By Theresa Wrangham, NVIC Executive Director
It is not often one gets to witness history, but I count myself lucky that I did while I monitored the Sept. 10-11, 2013 meeting of the National Vaccine Advisory Committee (NVAC). During that meeting I read a statement
to clarify the historic record on behalf of NVIC co-founders Barbara Loe Fisher and Kathi Williams.
The September 2013 meeting marked the 25th year Anniversary of NVAC and the Vaccines for Children program. Special guest Tim Westmoreland was invited to address1
the NVAC about the history of why Congress created the federal Vaccine Injury Compensation Program (VICP) and the federal vaccine advisory committees under the National Childhood Vaccine Injury Act of 1986.2
A Crisis of Public Trust in DPT Vaccine Safety
In the early 1980’s Mr. Westmoreland served as Counsel to the House Subcommittee on Health and the Environment.3
In his statements to NVAC, Mr. Westmoreland said his comments were his own but attributed the “perfect storm” that compelled Congress to create a federal vaccine injury compensation program in 1986 to (1) short falls and rationing of vaccines; (2) publicized vaccine injuries of children and public concern about vaccine safety; and (3) vaccine industry withdrawal from the marketplace. He added that “the crisis was always vaccine injury compensation.”
And herein lies a valuable history lesson.
NVIC Founders Worked With Congress in 1980’s
When I heard these comments during the meeting, I notified NVIC President Barbara Loe Fisher and NVIC Vice President Kathi Williams because, as co-founders of Dissatisfied Parents Together (DPT) in 1982, they worked with parents of DPT vaccine injured children and Congress and secured vaccine safety informing, recording and reporting provisions in the 1986 Vaccine Injury Act. To clarify the public record about NVIC’s standing and involvement in creation of the 1986 law, they wrote a statement for me to give on their behalf during the NVAC public comment period at the end of the day.
Read NVIC’s statement to NVAC
In their statement
, Barbara and Kathi described how DPT vaccine injury lawsuits in the early 1980’s prompted pharmaceutical companies and medical trade groups to press Congress for liability protection. They also stated that parents of vaccine injured children were told by congressional staffers on both sides of the aisle that legislation giving liability protection to vaccine manufacturers was going to be passed to “protect the vaccine supply” – with or without the participation of parents of vaccine injured children.
It was only through the efforts of parents of DPT vaccine injured children, including co-founders of Dissatisfied Parents Together (DPT) which opened the National Vaccine Information Center in 1989, that vaccine safety informing, reporting and recording provisions were secured in the 1986 law that also created a no-fault Vaccine Injury Compensation Program (VICP). The original 1986 legislation allowed petitioners to pursue civil litigation if they were turned down for compensation in the U.S. Federal Court of Claims. However, in 2011 the U.S. Supreme Court declared vaccines to be “unavoidably unsafe” and effectively shielded drug companies from all vaccine injury lawsuits.4
ACCV: Nearly $3 Billion in Compensation but Claim Dismissals High
There has been nearly $3 billion in federal compensation awarded to children and adults for vaccine injuries and deaths since the VICP began making awards in 1989. At the September meeting of the Advisory Commission for Childhood Vaccines (ACCV) the Division of Vaccine Injury Compensation (DVIC) reported that fiscal year 2013 was likely to exceed totals for compensated claims of previous years – over $216 million as of August 13. Reportedly, two large claims, one for $48 million and another for $40 million, will likely settle prior to the DVIC’s fiscal year end of September 30th. While the VICP approaches record compensations, their average dismissal rate from 2008 to 2013 is over 80 percent.5
GBS Recommended for Addition to Vaccine Injury Table
The DVIC also requested that the ACCV add Guillian-Barre’ Syndrome (GBS) related to influenza vaccinations in their recommendations to expand the Vaccine Injury Table (VIT)6
along with previously ACCV approved recommendations based on the recent findings by Institute of Medicine to the Secretary of DHHS.
GBS is an immune mediated neurological disorder that affects the nervous system and causes paralysis. The VICP has compensated just over 90 percent of adjudicated GBS/flu shot cases and the ACCV voted to include GBS as an influenza vaccine related injury in their recommendations to the DHHS Secretary.
Influenza vaccine injury is the leading vaccine injury claim submitted to the VICP.
Influenza and Healthy People 2020 Goals
‘Tis the season and as I reported earlier this year,7
adults are increasingly being pressured by doctors and public health officials to comply with the federally recommended adult vaccination schedule.8
DHHS officials set adult flu shot coverage targets based on Healthy People 2020 Goals. The objective of Healthy People in terms of vaccination is to increase vaccine uptake rates and reduce infectious diseases for which vaccines are licensed and recommended by federal health officials. 9
These goals were designed to be aspirational but are now being treated by CDC officials as hard targets that must be reached within certain time limits.
Though influenza vaccine injuries and deaths are now leading compensation awards in the VICP, and effectiveness of the vaccine is variable, influenza vaccine uptake targets among children and adults are relentlessly pursued. CDC’s Dr. Anne Schuchat briefed the NVAC on Healthy People 2020 Goals for influenza vaccine:
- 70% of children age 6 months to 17 years;
- 70% for adults 18 and over;
- 90% for Health Care Providers (HCP)
- TBA for Pregnant women – waiting for data to set goal
The “Horrors of HPV Vaccine Coverage”
With the exception of HPV vaccine coverage, Dr. Schuchat also briefed the NVAC on other vaccination coverage objectives related to the Healthy People 2020 goals. She presented data that demonstrated vaccine coverage goals of 90% or more had been mostly reached for DTaP, hep B, MMR, polio, varicella and HiB vaccines. 10
However, Dr. Schuchat was not happy with HPV vaccine coverage in the U.S., which she said was experiencing a “pathetic plateau.” She stated during the NVAC meeting that the “horrors of HPV vaccine coverage” would be presented in greater detail to the NVAC in a separate presentation that was largely the same information we reported in August.11
HPV vaccine coverage is not a Healthy People 2020 goal.
Healthy People 2020 Extends Reach
New to Healthy People 2020 vaccine coverage goals for children 19-35 months are hep B birth dose (85%), rotavirus (80%) and hep A (85%), so it is likely that there will be more publicity generated by public health officials and medical trade groups to promote use of these vaccines. Currently coverage is estimated to be approximately 70% for hep B and rotavirus and 55% for hep A.
The Unvaccinated and Measles
There has been increased media coverage about “pockets” and “clusters” of unvaccinated individuals where measles cases are occurring among communities of vaccinated children and adults. Within the Healthy People 2020 goals there is a tracking measure to sustain levels of unvaccinated children ages 19 to 35 months at less than one percent. Data used for this measure is from the National Immunization Survey, which showed that for 2012 that rate is 0.8 percent. Should it reach 1 percent, a tracking goal will be put into place.
With all the media focus on 159 cases reported in the U.S. by the end of August, Dr. Schuchat noted that measles incidence in the U.S. is still well below 1 case per million. In fact, in her presentation the incidence was noted as 0.18 per million and showed that all states had at least a 92 percent MMR vaccine coverage rate.
For more information on measles, view or read an analysis
published by NVIC in September with more than 80 references on reported measles outbreaks in the U.S. Please forward this analysis to your friends to increase public awareness about measles and measles vaccine.
Making Exemptions Harder to Get in the Works
With Healthy People goals being used as hard measurement for the success of CDC operated public health programs, it is doubtful that anyone reading this post will be surprised to learn that the NVAC is struggling to find creative ways to change the behavior of those who refuse vaccines and to neutralize the concerns of the numbers of parents and health care professionals growing more hesitant to comply with expanding vaccine schedules.
A new working group has been formed in NVAC to examine vaccine hesitancy and suggest ways to change behaviors. If our experience in advocating for protection of vaccine exemptions at the state level is any example of what to expect, this federal working group is likely to recommend further restriction of vaccine exemptions and government-operated behavior modification programs for those declining one or more federally recommended vaccines.
When recommendations of this nature have been made in the past by the NVAC, they hit with lightening speed in terms of affecting vaccine mandates at the state level.12
Time will tell, but we anticipate that the fight to preserve vaccine choice and exemptions at a state level will become more aggressive in 2014.
Be Ready to Act
Be ready to act to protect vaccine exemptions in your state by signing up to use NVIC’s Advocacy Portal
. You will receive real-time email alerts about legislative efforts to expand, eliminate or restrict vaccine exemptions in your state. NVIC’s Advocacy Portal makes it easy to contact your legislator by smart phone or computer and make your voice heard. This informed consent issue affects every individual’s ability to voluntarily decide whether or not to accept or decline the use of one or more vaccines.
Please forward our articles, brochures and website address to your friends and family and encourage them to support informed consent to medical and vaccine risk-taking.