By Theresa Wrangham
The February 2019 meeting of the Advisory Committee on Immunization Practices (ACIP) saw new committee members introduced and changes to public comment enacted.
New Code of Conduct for ACIP Public Comment Sessions
ACIP changed their public comment rules for public meetings,1 due to the recent increase in individuals with concerns about vaccine safety and vaccine policies traveling to ACIP meetings to make a public comment. These changes include an increase to 75 minutes for public comment sessions noted on the agenda, and instituting a blind lottery when there are more individuals signed up to give comment than there is time. Written public comments will also now be published on the Regulations.gov website.
Influenza Vaccine Only 44 Percent Effective
CDC reported to ACIP that influenza infection activity during the U.S. 2018-2019 influenza season has been average with the 2009 H1N1 influenza A virus continuing to cause most lab confirmed cases. Across many U.S. states, currently there is a very high rate of influenza-like-illness (ILI). However, typically about 80 percent of ILI during the flu season is due to respiratory infections caused by other types of viruses and bacteria.
CDC interim estimates on the overall effectiveness of this season's influenza vaccine is approximately 44 percent for all age groups.2 This means that, for the estimated 20 percent 3 of Americans likely to become infected by type A or B influenza, the vaccine is only 44 percent effective.
The CDC reported that the 2018-2019 influenza vaccine appears to have a higher protective rate of 61 percent for children aged 6 months to 17 years of age. The CDC also noted that H3N2 strains of influenza were becoming more active in the Southeast portions of the U.S. This H3N2 activity delayed strain identification of next season's influenza vaccine and may impact future influenza vaccine supply.4
New Data for Afluria for Babies and Toddlers
Seqirus, the maker of Afluria Quadrivalent (QIV) influenza vaccine, presented Phase 3 trial data on Afluria for children six months to 59 months old. The data was generated using a non-inferiority model that compared Fluzone vaccine with Afluria vaccine. The Seqirus data provided to ACIP demonstrated that Afluria had similar safety and tolerability to the Fluzone comparator.5 Afluria QIV was given FDA approval in 2018 for use in this population based on this Phase 3 trial data.
New Study Claims Flu Shot Doesn't Cause Miscarriage
In an attempt to reassure pregnant women that it is safe for a flu shot to be given during every pregnancy in any trimester, a new study was presented to ACIP that found influenza vaccine did not cause miscarriages in the women evaluated in the study. This new study contradicts previous studies funded by the CDC that evaluated miscarriages among pregnant women given influenza vaccinations during the 2010-11 and 2011-12 flu seasons, which found an increased risk of miscarriage within 28 days of vaccine administration and a significant association with miscarriage in women who had received a flu shot in the previous flu season.
The study conducted by Marshfield Clinic Research Institute examined data from the CDC's Vaccine Safety Datalink (VSD) for three flu seasons (2012-13, 2013-14 and 2014-15) with the objective of determining whether there was an increased risk of miscarriage in the 28 day window noted in the previous studies and included whether the women had received a flu shot the previous season. Miscarriages were adjudicated by an obstetrician co-investigator blinded to the vaccination status of the pregnant woman.
This study differed from the previous studies in that it was three times larger than previous studies and looked at different flu seasons. These new findings are likely to result in increased pressure being placed on pregnant women by doctors to receive a flu shot during any trimester of every pregnancy, despite data from the federal vaccine injury compensation program (VICP) showing that vaccine injuries from influenza vaccines are now the leading compensated claim.6
Additionally, a 2018 Cochrane review of influenza vaccination in healthy adults found that the flu vaccine may have only a modest impact on reducing the number of cases of influenza and influenza-like illness. The data was insufficient to determine whether vaccination had any impact on lost work days or reducing serious complications of influenza during the flu season, and study authors went on to state7
We were uncertain of the protection provided to pregnant women against ILI and influenza by the inactivated influenza vaccine, or this was at least very limited.
Learn more about influenza and influenza vaccine at NVIC's influenza webpages.
CDC Investigating Possible Safety Signal for Shingrix Vaccine
After months of high demand and short supply for Shingrix (RZV) vaccine, the CDC's Dr. Tom Shimabukuro of the Immunization Safety Office (ISO) reported potential safety concerns about the shingles vaccine manufactured by GlaxoSmithKline (GSK) and licensed by the FDA in October 2017.
Reaction reports that Shingrix is causing Guillain Barre Syndrome (GBS) have been filed in both the federal vaccine adverse event vaccine system (VAERS) database and the CDC's Vaccine Safety Datalink (VSD) database. GBS involves inflammation of the peripheral nerves that can cause varying degrees of temporary or chronic paralysis of different parts of the body, including full body paralysis. According the U.S. National Institutes of Health (NIH) GBS is thought to occur at a rate of one in one million individuals.8
So far, two cases out of the four reported GBS cases following Shingrix vaccination in the VSD have been confirmed to be plausibly related to the vaccine, based on the established risk window of 0 to 42 days post vaccination.9 There have been 35 reports of GBS developing after Shingrix vaccinations filed with VAERS, 19 of which met established criteria under the Brighton Collaboration definition for GBS. There were an additional 6 VAERS reports of GBS following Shingrix vaccinations that were diagnosed by physicians.10
Using Proportional Reporting Ratio (PRR) analysis, the CDC stated that these GBS reports when compared against Pneumovax 23, Zostvax and Influenza vaccines indicates that the rate of GBS is not disproportional. Based on the data presented, CDC estimates that GBS is occurring at a rate of 2.8 cases per million doses of Shingrix vaccine.11
Monitoring of Potential Shingrix Safety Signal to Continue
The FDA is currently exploring options for analyzing Medicare and Medicaid records for a potential safety signal with the Shingrix vaccine and the CDC is conducting a clinical review of the 28 GBS cases diagnosed after Shingrix vaccination by a physician or those cases meeting pre-set criteria.
The CDC reported that, so far, there is no other safety signal in play for Shingrix based on their analysis but monitoring will continue. Representatives from GSK also stated that their post-licensure data has not detected a safety signal, but that monitoring will continue.
No policy change for use of Shingrix was made and additional data is likely to be reported to ACIP at their upcoming June meeting.
Shringrix Preference and Pending Zostavax Lawsuits
Shingrix was given preference over Zostavax by ACIP in October of 2017.12 This latest shingles vaccine safety concern comes in the midst of hundreds of injury and failure lawsuits filed against Merck, the maker of Zostavax, a live virus shingles vaccine and the first one licensed in the U.S. in 2006 that ACIP recommended for adults over age 60. In 2011, the FDA expanded the Zostavax license for use by adults over age 50.13
Individuals injured by Shingrix or Zostavax are exempt from using the federal vaccine injury compensation program (VICP) and can sue vaccine manufacturers directly because these vaccines are not routinely recommended by ACIP for children or pregnant women.
ACIP May Reconsider PCV13 Recommendation for Seniors
As part of its routine evaluation of recommendations, ACIP continued to consider data presented by its workgroup on the value of recommending that PCV13 pneumococcal vaccine be given to healthy 65+ seniors. There is a long standing recommendation for all seniors to get PPSV23 and PCV13. However, data presented on PCV13 demonstrated that to date it is not effective against pneumococcal serotype 3 (ST3),14 which represents the majority of the disease in seniors. There was discussion about whether continuing the recommendation for PCV13 has public health value for those over 65 years old.
A representative from Pfizer, the manufacturer of PCV13, argued that the CDC workgroup data was too conservative and stated that PCV13 had a direct effect on ST3. ACIP is expected to vote on this issue at the June meeting. Removal of the PCV13 recommendation would simplify standard of care administration of pneumococcal vaccine for seniors by confining it to PPSV23 vaccine.
ACIP members expressed concern that discontinuing the current PCV13 recommendation for seniors would dismantle the investment already made and that a reinvestment would be required in the near future due to new pneumococcal vaccines currently in phase II trials, (PCV15 and PCV20), which are designed to provide broader protection from the disease for adults.
Vaxelis Combination Vaccine
The newly FDA approved pediatric hexavalent Vaxelis vaccine is a joint venture between Sanofi and Merck and contains antigens for diphtheria, tetanus, pertussis, polio, hepatitis B, and Haemophilus influenzae type b (Hib). ACIP is currently considering whether Vaxelis should be preferentially recommended for use in the American Indian/Alaska Native (AI/AN) populations and if it should be included as an option in the Vaccines for Children program for infants at two, four and six months of age.
Most of the data presented to ACIP on the 5 in 1 combination shot was based on noninferiority models. There were two immunogenicity endpoint failures and high fevers noted for Vaxelis. However, this did not appear to concern the ACIP workgroup as the majority of endpoints were met and there were no medically related events from fever reported. Serious adverse event data noted two cases of SIDS, one case of asphyxia, one case of hydrocephalus, and one case of Group A strep, which were all judged by researchers to not be related to the vaccine.
The data presented also noted that there is no immunogenicity data for Vaxelis vaccine following the first dose given at two months. If the immune response to Hib antigen between the first and second dose of Vaxelis is low, that may put AI/AN infants at an increased risk for HIB meningitis, if ACIP were to give Vaxelis a preferred recommendation for infants. As a result, ACIP's work group has requested immunogenicity data about Vaxelis induced immunogenicity after the first dose.
A Merck representative argued that Vaxelis would decrease the number of injections received by children, which would increase parental compliance. Currently Vaxelis is approved by the FDA for use in infants two, four and six months old. However, production is limited and Merck is ramping up Vaxelis production to make the 5 in 1 combination vaccine widely available in the U.S. in 2020.15
ACIP may vote on this issue at its June meeting.
ACIP Recommends Booster Dose of Anthrax Vaccine for First Responders
During the February meeting, ACIP voted that individuals who are not at a current high risk for anthrax exposure, but who may be at risk in the future, such as health care workers and other first responders to bioterrorism attack, may want to receive a dose of anthrax vaccine every three years. This is a Category B recommendation, meaning that it is optional for individuals who fall into this type of risk group.
The older stockpiled anthrax vaccine would be used until the supply runs out and then the new anthrax vaccine (AV7909) would be used. The U.S. is currently the only country making a switch to AV7909 as part of its stockpile in the event of a bioterrorism attack.
Hepatitis A Vaccine Likely to be Routinely Recommended for Individuals with HIV
Data was also presented by the ACIP’s workgroup for consideration of HIV positive individuals as a risk group to routinely receive the hepatitis A vaccine. This policy consideration is due to studies that suggest that hepatitis A infection in HIV positive individuals increases HIV replication,16 making it harder to treat HIV.
This potential change, which would impact approximately 400,000 Americans who have been diagnosed HIV positive, will be voted on at a future ACIP meeting.
Conflicts of Interest Declarations
Newly appointed ACIP member Dr. Stefan Gravenstein of Brown University declared that he had a conflict of interest due to his association with vaccine makers Sanofi Pasteur, Seqirus and Merck. Last year, Dr. Gravenstein also declared conflicts of interest with vaccine makers Pfizer, Novartis, Janssen and GlaxoSmithKline. Dr. Gravenstein has worked with the influenza, RSV, e coli, pneumococcal and shingles vaccines.17
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1 CDC. ACIP Public Comment. Feb. 25, 2019.
2 CDC. ACIP Influenza Presentation – Summary. Feb. 25, 2019.
3 WebMD. What Are Your Odds of Getting the Flu? 2017.
4 L. Schnirring. WHO reveals delayed pick for H3N2 flu vaccine strain. CIDRAP News. Mar. 21, 2019.
5 CDC. ACIP Meeting Presentation - Seqirus Afluria QIV Phase III Data. Feb. 25, 2019.
6 HRSA. Data & Statistics - National Vaccine Injury Compensation Program. Mar. 1, 2019.
7 Demicheli V, Jefferson T et al. Vaccines for preventing influenza in healthy adults. Cochrane Database of Systematic Reviews. Feb. 1, 2018
8 NIH. Guillian-Barré Syndrome Fact Sheet. Jul. 6, 2018.
9 CDC. ACIP Presentation - CDC ISO Update on post-licensure safety monitoring of recombinant zoster vaccine (RZV, Shingrix). Feb. 28, 2019.
10 CDC. February 2019 ACIP Meeting - Zoster & Hepatitis vaccines. Mar. 20, 2019.
13 I. Jackson. Shingles Lawsuit Filed Over Failure of Zostavax Vaccine. AboutLawsuits.com. Feb. 28, 2018.
14 CDC. ACIP Presentation - PCV13 Direct and Indirect Effects on Serotype 3 Disease. Feb. 25, 2019.
15 E. Sgonowsky. Sanofi, Merck win FDA nod for 6-in-1 pediatric vaccine Vaxelis. FiercePharma. Jan. 2, 2019.
16 CDC. ACIP Meeting Presentation – Hepatitis Vaccines. Feb. 28, 2019.
17 CDC. University Hospitals Presentation - Fluzone HD vs SDs cluster randomized trial in US NHs. S. Gravenstein, M.D. Feb. 18, 2017.
By Barbara Loe Fisher
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On a cold winter morning in November 2007, I watched hundreds of parents line up with their children in front of a Maryland county courthouse. The children had been kicked out of school by state officials and were truant. The mothers and fathers were holding letters threatening them with imprisonment or fines of $50 a day for failing to show proof their children had gotten a chickenpox or hepatitis B shot. 1
Confused, angry and frightened, but mostly resigned, they were working Moms and Dads trudging toward the courthouse on a Saturday morning to face a judge ordering them to vaccinate their children or go to jail.
Patrolling the scene was an armed SWAT team of policemen with dogs.
The U.S. media turned out that day, but they and other members of the public were kept behind barricades and denied access into the building. I was there with my son, who brought his camera. We were there to witness what was going on with parents whose children had been injured by vaccines.
There was no transparency, no public oversight on what was happening to the parents and children inside the building.
I spoke with several mothers leaving the building with their children and learned the sad truth. They were not being asked questions about their child’s medical history or whether the children had experienced health problems after previous vaccinations. No information was given about vaccine side effects or how to monitor their children for signs of vaccine reactions. 2 They were not made aware of exemptions to vaccination.
Clearly, preventing vaccine reactions was not a priority for those in charge that day.
The children were being injected with not just the two new vaccines added to the state’s school requirement list - hepatitis B and chickenpox - but also with other required vaccines if the public school system could find no record. One mother told me her children were up-to-date on their shots but the school system lost the records. She agreed to have her children receive the required vaccines all over again on the spot to avoid being fined or, worse, being sent to jail.
This mother and I were talking hundreds of yards from the front of the Courthouse door. We were standing about 12 inches inside a row of large cement stones that had been put there as a barrier to prevent terrorist attacks.
Suddenly, out of the corner of my eye I saw an armed guard with a dog emerge from the Courthouse. He was walking straight toward us.
I got this sick feeling in the pit of my stomach. It was the surge of shock and dread that any citizen of any country in any century has felt when an armed guard with a dog starts advancing.
As if we were criminals or terrorists, he yelled and gestured to us to move behind the stones. I looked at the mother and my son, who was filming our conversation, and we moved without a word.
We were being shown the power of the State wielded by that guard armed with a dog and a gun, just as parents inside the courthouse were being shown the power of the State wielded by doctors with syringes.
U.S. Constitution Protects Freedom To Dissent
When a government policy is unjust and people resist, the last resort is always a show of force. Use of fear, intimidation, discrimination and punishment of dissenting minorities is the hallmark of authoritarian governments and so is censorship and propaganda.
None of these tactics have a place in America, where our Constitution protects civil liberties, including freedom of thought, speech, conscience, religious belief and the right to dissent and petition the government. 3 4 5
Twelve years after I watched a state health department flex its muscle at a county courthouse, this year the whole world is watching the multi-billion dollar vaccine industrial complex flex its muscle in America. 6 7 8 Declaring a “take no prisoners” war on parents who decline to give their children every dose of every government recommended vaccine, the vaccine industry has been emboldened by the lucrative public-private business partnerships that have been forged over the past four decades with governments and the World Health Organization. 9 10
Vaccine Industry Wants Forced Use of All Vaccines by All People
The win that industry is looking for is a complete shut down of the public conversation about health and vaccination followed by a mandate by every government to force every child and adult to use every vaccine that drug companies develop and sell.
For children born in America in 1983, the federal government recommended 23 doses of seven vaccines given between two months and six years old. 11 Today, the child vaccination schedule is 69 doses of 16 vaccines given between the day of birth and age 18, with 50 doses administered before age six, at a current price tag of more than $3,000 per child. 12 13
Child Vaccine Schedule Could Double or Triple in Future
For children born in America in the years to come, that vaccine list and cost could double or triple. The World Health Organization is encouraging drug companies to fast track more than a dozen new “priority” vaccines to market for children, pregnant women and adults - and you can be sure industry will lobby governments to mandate all of them - respiratory syncytial virus (RSV), streptococcus A & B, HIV, herpes simplex virus, gonorrhea, e-coli, shigella, salmonella, tuberculosis, malaria and more. 14
Where is the scientific evidence to support the assumption that forcing everyone to use more and more vaccines to atypically manipulate our immune systems and repeatedly provoke inflammatory responses in our bodies throughout life will produce better health for all? 15 16 17 18 19 20
The Real Public Health Emergency Is Not About Measles
The signs are everywhere that people are trying to throw off the chains binding them to failed medical and public health policies that cost Americans more than three trillion dollars a year in health care costs. 21 Americans are beginning to understand that trusting blindly and saluting doctors smartly for the past 40 years has not prevented 1 child in 6 from becoming learning disabled, 22 23 or 1 in 9 from suffering with asthma, 24 or 1 in 10 from struggling with mental and behavior disorders 25 or 1 in 40 from developing autism. 26
America now has the worst infant mortality rates, 27 28 and worst maternal mortality rates, 29 30 and worst life expectancy 31 32 of all developed nations. Highly vaccinated and medicated Americans are very sick, with millions of children and adults suffering with immune and brain dysfunction marked by chronic inflammation in their brains and bodies 33 34 that confines too many of them to special education classrooms and frequent trips to doctors’ offices to try to deal with a lifetime of chronic illness and disability. 35 36
No public health official, professor or legislator in America can explain why millions and millions of children and more than 1 in 2 adults are chronically ill or disabled. 37
This is the real public health emergency that mothers and fathers want to talk about, but Congress and medical trade groups do not want to talk about. This is the elephant in the room at every public hearing on bills proposing to take away or expand vaccine informed consent rights being held in state legislatures today.
No Exception Vaccine Laws Guarantee Denial of Vaccine Casualties
The pharmaceutical industry, which was handed a partial liability shield from vaccine injury lawsuits by the U.S. Congress in 1986 38 that was turned into a total liability shield by the Supreme Court in 2011,39 40 41 is fighting to keep an economic stranglehold on a crumbling U.S. health care system. 42 43 44 45 With the government having paid vaccine victims more than $4 billion dollars in federal vaccine injury compensation since 1988 under the National Childhood Vaccine Injury Act, 46 47 pharmaceutical corporations do not want to give up the no-risk, stable income stream they get from selling mandated vaccines. 48
“No exception” vaccine laws guarantee that the good vaccine science will never be done so vaccine casualties can continue to be swept under the rug by denying they exist, 49 50 51 52 53 and nobody has to care about the crippled and dead bodies lying on the ground except the mothers and fathers grieving endlessly for what could have been. 54
Today, everybody knows somebody who was healthy, got vaccinated and was never healthy again. 55 56 This inconvenient truth is why the vaccine industry must find a way to shut down all public conversation about vaccination and eliminate all vaccine exemptions - and do it now.
Vaccine Risks Not Being Shared Equally By All
In January 2019, the World Health Organization announced that “vaccine hesitant” people, especially parents, are one of the top 10 threats to global health. 57 This ominous warning was quickly followed by the declaration of a state of emergency in Washington after a handful of measles cases were confirmed in primarily unvaccinated children. 58 Immediately, the media shifted into overdrive just like in January 2015 when measles cases were reported in Disneyland and the California legislature quickly removed the personal belief vaccine exemption for school children, 59 60 61 despite the biggest public protests the state Capitol had seen since the Viet Nam War.
In the first two months of 2019, we have watched thousands of brave parents and health care professionals travel to state Capitols and line up with their children at public hearings in Washington, 62 63 Arizona, 64 Nevada, 65 Oregon 66 and on Capitol Hill. 67 They are taking time off their jobs and spending their own money to make the journey to beg lawmakers to protect the legal right for children to get a school education and for parents to exercise voluntary informed consent to vaccine risk taking for their minor children. 68
With almost no vaccine contraindications today that qualify for a medical exemption under narrow CDC guidelines, 69 70 vaccine risks are not being shared equally by all. One-size-fits-all vaccine laws place an unequal risk burden on, and discriminate against, a vulnerable minority of children, who have genetic, biological and environmental susceptibility to suffering vaccine reactions. 71 72 73 74
Why are the lives of vaccine vulnerable children, who public health officials do not want to acknowledge, valued less than the lives of immune compromised children they will acknowledge?
Calls for Forced Vaccination and Censorship
Since 2015, no state legislature has removed a vaccine exemption. 75 76 This year, while 11 states are proposing to restrict or eliminate vaccine exemptions, NVIC is supporting 61 bills that expand exemptions or protect vaccine informed consent rights (as of Mar.1, 2019), the largest number of bills we have ever supported in a legislative session. 77
This pushback against forced vaccination is being met with fury by doctors and lawyers inside and outside of government and by multi-media corporations demanding that parental rights and vaccine exemptions be stripped from state laws and that all information criticizing government vaccine policy be removed from the web. 78 79 80
In the past few weeks, high ranking federal health officials have made false statements in Congress in an effort to mislead lawmakers into believing childhood vaccines like MMR do not carry serious risks. 81
The FDA Commissioner has threatened state legislators with federal government intervention if they do not eliminate vaccine exemptions. 82 83 84
The Chair of the U.S. House Intelligence Committee has pressured Facebook to block conversations about vaccination and Amazon to censor books and videos containing information about vaccine risks and failures. 85 86 87
Amazon immediately bowed to that government pressure and removed the movie Vaxxed from Amazon Prime and similar videos critical of vaccine safety. 88 However, CNN is urging Amazon to go further and burn all the books, too. 89 90
A Washington DC lawmaker reacted to the hype by asking, “What if you take parents out of the equation?” and introduced a bill to allow minor children of any age to get vaccines in the city without a parent’s knowledge or consent after a doctor says the child is “mature” enough to make the decision. 91
What is the justification for burning the books and clearing the way for doctors to persuade very young children to get vaccinated without their parents’ knowledge or consent?
The media would have you believe that calls for censorship and the elimination of state vaccine exemptions and parental rights is based on 206 reported cases of measles identified in 11 states between January and March in our population of 328 million people. According to the CDC, “three or more cases” of measles is considered to be an “outbreak.” 92
All the blame for measles outbreaks is being put on parents of the less than two percent of unvaccinated children attending U.S. schools, where nearly 95 percent of children nationwide have received two doses of measles containing MMR vaccine. 93
Aside from the illogical premise that children only catch measles or other infections in school buildings, is the call for censorship and “no exceptions” vaccine laws only about a few hundred cases of measles?
I don’t think so.
The Human Right to Autonomy Limits the Power of the State
The demonization of parents and enlightened doctors, who criticize vaccine science and government policy, is the tip of the spear in a larger culture war going on in this and other countries where economically stable, well educated populations are beginning to understand they are being exploited by corporations that have made business deals with governments. 94 95 96 97 98
The culture wars in the 21st century are about whether the first human right, individual autonomy, 99 will survive or an authoritarian State will own our children and have the power to eliminate civil liberties and sacrifice the lives of certain people for what those in control of the State consider the greater good of society. 100
The human right to autonomy protects individuals and vulnerable minorities from being discriminated against and exploited by the State. Who has the moral right, or should have the legal authority, to demand that mothers and fathers violate their conscience and risk their children’s lives or face punishment for refusing to do it?
What kind of government policy demands that kind of involuntary sacrifice?
And what kind of government demands that information about the risks and failures of a liability free pharmaceutical product be censored and withheld from the people being forced to use it?
There is no more important freedom than the freedom to decide when and for what reason you are willing to risk your life or your child’s life. We give up the human right to autonomy at our peril, no matter where or in what century we live.
The outcome of the Vaccine Culture War will determine what it means to be free. 101 Because if the State can tag, track down and force individuals against their will to be injected with biologicals of known and unknown toxicity today, then there will be no limit on which individual freedoms the State can take away in the name of the greater good tomorrow.
Martin Niemoller prophetically warned that incremental oppression by those in control of an authoritarian State is facilitated by denial, apathy and fear. He said, "In Germany, they came first for the Communists, and I didn't speak up because I wasn't a Communist. Then they came for the Jews, and I didn't speak up because I wasn't a Jew. Then they came for the trade unionists, and I didn't speak up because I wasn't a trade unionist. Then they came for the Catholics, and I didn't speak up because I was a Protestant. Then they came for me, and by that time no one was left to speak up." 102
Americans, this is our moment to help determine the outcome of a very real culture war that threatens to destroy long held values and beliefs that are embodied in the Bill of Rights of the U.S. Constitution to protect us from tyranny. The Bill of Rights affirms that we have God given natural rights, known today as civil liberties or human rights, which belong to each one of us and should never be taken away for any reason.
You Will Make the Choice
You and you alone will make the choice to live free or die as a slave. Do not let anyone take away your freedom to think and speak and obey the certain judgment of your conscience.
Use the NVIC Advocacy Portal to contact your state and federal legislators. Defend freedom and educate your family, friends and leaders in your community. Go to NVIC.org and sign up for our newsletter, so that no matter what happens in the weeks and months to come, you will not lose contact with us.
Be the one who never has to regret that you did not do today what you could have done to change tomorrow.
It’s your health. Your family. Your choice.
And our mission continues: No forced vaccination. Not in America.
Note: This commentary provides referenced information and perspective on a topic related to vaccine science, policy, law or ethics being discussed in public forums and by U.S. lawmakers. The websites of the U.S. Department of Health and Human Services (DHHS) provide information and perspective of federal agencies responsible for vaccine research, development, regulation and policymaking.
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38 National Vaccine Information Center. NVIC Position Statement on National Childhood Vaccine Injury Act of 1986. May 2018.
39 Supreme Court of the United States. Bruesewitz v. Wyeth No. 09-152. Justice Sotomayor with whom Justice Ginsberg joins, dissenting Feb. 22, 2011.
40 National Vaccine Information Center. National Vaccine Information Center Cites “Betrayal” of Consumers by U.S. Supreme Court Giving Total Liability Shield to Big Pharma. Business Wire Feb. 23, 2011.
41 Fisher BL, Williams K, Wrangham TK. NVIC response to an inquiry from the Government Accountability Office (GAO) on the implementation of the federal vaccine injury compensation program (VICP) after passage of the 1986 National Childhood Vaccine Injury Act. National Vaccine Information Center July 11, 2014.
42 Irving P. Chronic Conditions in America: Price and Prevalence. RAND Corp. July 12, 2017.
43 Sawyer B, Cox C. How does health care spending in the U.S. compare to other countries? Kaiser Family Foundation Dec. 7, 2018.
44 Hilzik M. The 21st Century Cures Act: A huge handout to the drug industry disguised as a pro-research bounty. Los Angeles Times Dec. 5, 2016.
45 Parpia R. Big Pharma Pays Universities for Most Medical Research in the U.S. Today. The Vaccine Reaction Apr. 15, 2018.
46 Health Resources and Services Administration (HRSA). Vaccine Injury Compensation Data from the Vaccine Injury Compensation Program (VICP). Mar. 1, 2019.
47 Fisher BL. The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform? Advisory Commission on Childhood Vaccines Nov. 18, 2008.
48 LaVigne P. Global Vaccines Market Projected to Surge to $58 Billion by 2025. The Vaccine Reaction Jan. 3, 2019.
49 Fisher BL. What’s Old Is New: Vaccine Safety Concerns of Parents in 1996 (presented to Institute of Medicine). NVIC Newsletter May 22, 2018.
50 Fisher BL. Vaccine Safety Concerns of Parents in 2001. Institute of Medicine Jan. 11, 2001.
51 Fisher BL. Public Perspective on Studies of Health Outcomes Related to the Federal Childhood Immunization Schedule. Institute of Medicine Feb. 9, 2012.
52 National Vaccine Information Center. NVIC Supports Three of Five Recommendations of New IOM Report on US Childhood Immunization Schedule and Calls for Transparency. Business Wire Jan. 16, 2013.
53 Informed Consent Action Network. Letter to Secretary of HHS and National Vaccine Program Office on Vaccine Safety Responsibilities under the National Childhood Vaccine Injury Act of 1986. Dec. 18, 2018.
54 Vaxxed.com. Vaccine Injury Stories Submitted (by state).
55 National Vaccine Information Center. International Memorial for Vaccine Victims.
56 MedAlerts. Search the Vaccine Adverse Events Reporting System (VAERS) Database.
57 World Health Organization (WHO). Ten Threats to Global Health in 2019. Jan. 16, 2019.
58 Gstalger MM. Washington declare public health emergency as measles hits anti-vaccination community. The Hill Jan. 23, 2019.
59 Fisher BL. Measles in Disneyland: Third MMR Shot and Vaccine Exemption Ban? NVIC Newsletter Jan. 28, 2015.
60 Parpia R. Pharma Cash Raises Question of Undue Influence on SB277. The Vaccine Reaction July 9, 2015.
61 Richardson D. The Fallout from California SB277: What Happens Next? NVIC Newsletter Aug. 5, 2015.
62 Evans C. Hundreds rally to preserve right not to vaccinate children amid measles outbreak. CBS News Feb. 8, 2019.
63 LaCorte R. Washington Lawmakers Weigh 2 Vaccine Exemption Bills. Associated Press/US News & World Report Feb. 20, 2019.
64 Fischer H. Bills that critics fear would lead to dip in vaccinations advance. Arizona Capitol Times Feb. 21, 2019.
65 Solis J. ‘Vaccine hesitancy’ hindering Nevada’s response to outbreaks. Nevada Current Feb. 20, 2019.
66 Visser A. Controversial Vaccine Bill Draws Crowd, Slurs and Tears at Hearing. The Lund Report Feb. 28, 2019.
67 Sun L. Senate panel warns of dangers of anti-vaccine movement. Washington Post/Stars & Stripes Mar. 5, 2019.
68 Bennett L. Senate vaccine hearings spark anti-vaccine protest in Utah. Deseret News Mar. 5, 2019.
69 CDC. Recommendations and Guidelines of the Advisory Committee on Immunization Practices (ACIP): Contraindications and Precautions. Table 4-2. Conditions incorrectly perceived as contraindications or precautions to vaccination (i.e., vaccines may be given under these conditions). Jan. 10, 2019.
70 Rubin LG, Levin MJ, Lyungman P et al. 2013 Infectious Diseases Society of America (IDSA) Clinical Practice Guideline for Vaccination of the Immunocompromised Host. Clin Infect Dis Dec. 4, 2013; 58(3).
71 Crowe JE. Genetic predisposition for adverse events after vaccination. J Infect Dis 2007; 196(2): 176-177.
72 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Adverse Effects of Vaccines: Evidence and Causality: Evaluating Biological Mechanisms of Adverse Events (p. 57-102), Increased Susceptibility (p. 82). Washington, DC: The National Academies Press 2012.
73 Institute of Medicine Committee on the Assessment of Studies of Health Outcomes Related to the Recommended Childhood Immunization Schedule. Summary: Health Outcomes (p. 5-6) and Conclusions About Scientific Findings (p. 11) and Review of Scientific Findings (p. 75-98). The Childhood Immunization Schedule and Safety Stakeholder Concerns, Scientific Evidence and Future Studies; Washington, D.C. The National Academies Press 2013.
74 U.S. Court of Federal Claims. Vaccine Injury Claims: Opinions and Orders.
75 National Vaccine Information Center. State Vaccine Legislation in America 2015-2017 Oct. 25, 2017.
76 National Vaccine Information Center. US Vaccine Exemptions Remain Secure in 2018. Sept. 12, 2018.
77 National Vaccine Information Center. Public Hearings on Measles Outbreaks and Vaccine Laws Provide Opportunities for Americans to Voice Concerns. Business Wire Feb. 25, 2019.
78 Einbinder N. As more parents join the anti-vax movement, states are scrambling to make it harder to opt out of vaccinating your child. Insider Feb. 28, 2019.
79 Simmons T. Faith is no excuse for skipping vaccines, says med school professor. Religion News Feb. 28, 2019.
80 Colliver V. State lawmakers pushing for laxer vaccine rules despite measles outbreaks. Politico Mar. 3, 2019.
81 Fisher BL. Dr. Fauci, It’s Not Nice to Fool Congress About Vaccine Reactions. The Vaccine Reaction Feb. 28, 2019.
82 O’Reilly ED. Measles outbreak is bringing vaccine exemptions into spotlight. Axios Feb. 14, 2019.
83 Hoyt R, Pittman T. Health officials reacts to FDA chief comment on vaccine exemptions. THV 11 Feb. 22, 2019.
84 Parmet W. Gottlieb’s threat of federal vaccine mandates: questionable legality, poor policy. Stat News Feb. 28, 2019.
85 Congressman Adam Schiff News Release. Schiff Sends Letter to Google, Facebook Regarding Anti-Vaccine Misinformation. Feb. 14, 2019.
86 Congressman Adam Schiff News Release. Schiff Sends Letter to Amazon CEO Regarding Anti-Vaccine Misinformation. Mar. 1, 2019.
87 Carbone C. Facebook cracks down on vaccine misinformation. Fox News Mar. 11, 2019.
88 O’Donovan C. You Can No Longer Stream Anti-Vax Documentaries on Amazon Prime. Buzz Feed Mar. 1, 2019.
89 Sarlin J. Anti-vaccine movies disappear from Amazon after CNN Business Report. CNN Mar. 1, 2019.
90 O’Kane C. Amazon removes books promoting autism “cures” and vaccine misinformation. CBS News Mar. 13, 2019
91 Austermuhle M. Vaccines for Kids? New DC Bill Would Allow Minors to Get Shots Without Parental Consent. WAMU 9 Mar. 6, 2019.
92 CDC. Measles Cases and Outbreaks. Mar. 11, 2019.
93 CDC. Vaccination Coverage for Selected Vaccines and Exemption Rates Among Children in Kindergarten — United States, 2017–18 School Year. MMWR Oct. 12, 2018; 67(4)): 1115-1122.
94 National Institute of Allergy and Infectious Diseases. Public Private Partnerships.
95 Parpia R. Legislator Joins Big Pharma Via “Revolving Door.” The Vaccine Reaction Feb. 21, 2016.
96 Fisher BL. Here Comes the 21st Century Cures At: Say Goodbye to Vaccine Safety Science. NVIC Newsletter July 21, 2015.
97 Drug Companies Pay FDA and NIH to Fast Track and Market Vaccines. The Vaccine Reaction Sept. 28, 2018.
98 National Vaccine Advisory Committee. Strengthening the Effectiveness of State, and Local Efforts to Improve HPV Vaccine Coverage in the United States: Recommendations of the National Vaccine Advisory Committee. Public Health Reports Aug. 9, 2018.
99 Fagan A. Human Rights. Internet Encyclopedia of Philosophy.
100 Fisher BL. Forced Vaccination: The Tragic Legacy of Jacobson v. Massachusetts. NVIC Newsletter Nov. 2, 2016.
101 Fisher BL. The Vaccine Culture War in America: Are You Ready? NVIC Newsletter Mar. 8, 2019.
102 Martin Niemoller, German Theologian and Lutheran Pastor. New World Encyclopedia Aug. 24, 2018.
Parents and their children line up at a Feb. 8, 2019 legislative hearing in Washington state to oppose a vaccine bill eliminating personal belief exemption.
As of Feb. 18, 2019, the National Vaccine Information Center (NVIC) is monitoring more than 100 bills filed in 30 states proposing to expand, restrict or eliminate vaccine informed consent rights. Over President’s Day weekend, the NVIC Advocacy Portal team issued Action Alerts for vaccine bills introduced in the states of Connecticut, Nevada and Florida that threaten voluntary vaccine decision making, and also issued Action Alerts for the states of Oregon and Arizona that expand the ability to make informed voluntary decisions about vaccination. Additional bills may be filed during the next few weeks and more Action Alerts will be sent to registered users of the Portal.
Washington, Arizona, Connecticut, Maine, New Jersey, New York, Vermont, Oregon and Colorado are among the states that have either introduced bills to restrict or eliminate vaccine exemptions or there have been confirmed reports that similar legislation is under consideration. However, there are also a number of bills proposing to expand vaccine informed consent rights, including in Hawaii, Iowa, Idaho, Maryland, Minnesota, Mississippi, Montana, Oklahoma, Oregon, Pennsylvania, Rhode Island and West Virginia. As of Feb. 18, NVIC has indicated support for 50 of the more than 100 vaccine-related bills introduced so far this legislative session.
Since 1982, NVIC has advocated for voluntary vaccine decision-making in the U.S. and the inclusion of flexible medical, religious and conscientious belief vaccine exemptions in public health policies and laws. In 2010, the free online communications network, the NVIC Advocacy Portal was launched to inform the public about proposed vaccine-related bills and to email Action Alerts to registered Portal users and put them in direct electronic contact with their own legislators.
NVIC monitors and reports on vaccine-related legislation that affects children and adults living in the U.S., including parents of minor children; foster parents; college students; health care providers and other adults whose lives are impacted by vaccination policies and laws.
Among the vaccine bills that NVIC is tracking this year include ones that propose to:
Compromise Vaccine Informed Consent Rights
- Mandate use of new vaccines by children and adults;
- Restrict or eliminate vaccine exemptions;
- Restrict the list of persons who can approve vaccine exemptions
- Allow vaccine providers to administer HPV and hepatitis B vaccines to minors without parental consent;
- Allow forced vaccination and medical treatment under certain circumstances;
- Allow state health officials to mandate all federally recommended vaccines;
- Mandate that doctors and other vaccine providers track and report the vaccination status of all children and adults in electronic medical records;
- Require schools to publicly post vaccination rates or vaccine exemption rates;
- Require a physician signature for a religious or conscientious belief exemption to vaccination;
- Require school districts to conduct health and safety visits for children under private instruction;
- Require vaccines for college students based on CDC (ACIP) vaccine recommendations;
- Require long term care facilities to track vaccination status of employees and residents;
- Expand the release of information in the state vaccine tracking registry (such as to insurance companies);
- Mandate vaccines for vendors serving hospitals and other medical facilities;
- Require all insurance plans to cover all CDC recommended vaccines without copays or deductibles;
- Allow pharmacists, dentists or optometrists to administer vaccines.
Expand Vaccine Informed Consent Rights
- Require vaccine administrators to provide certain kinds of vaccine information to adults or parents of minor children before vaccination;
- Require schools to inform parents of their right to exemptions from vaccine requirements;
- Expand the list of persons who can approve vaccine exemptions;
- Require legislature approval for changes to the list of vaccines required for school attendance;
- Protect employees who refuse vaccination from discipline or discharge;
- Clarify that refusal to vaccinate or delay vaccines is not child abuse;
- Allow serologic (blood titer) proof of immunity in lieu of vaccination;
- Prohibit vaccine mandates for non-communicable diseases;
- Eliminate the ability of state health officials to mandate all federally recommended vaccines;
- Establish that it is unlawful for an employer to mandate vaccines for healthcare employees;
- Require information and notification of vaccines derived from aborted fetal tissue;
- Prohibit managed care entities from imposing requirements relating to vaccination protocol;
- Require parental consent before a child in protective custody can be vaccinated;
- Establish a state database to monitor adverse effects of vaccinations.
Parents and their children demonstrate on the steps of the Washington state Capitol Feb. 8, 2019 in opposition to a vaccine bill that would remove personal belief exemption.
Check the NVIC Advocacy Portal Often
The federal government makes vaccine use recommendations and state governments make vaccine use laws. NVIC primarily focuses on reviewing state bills and making bill updates to the Portal on a daily basis, including creating more detailed background information on bills for Portal users.
Registered users of the NVIC Advocacy Portal are emailed Action Alerts with talking points when there are major calls for action, such as submission of personal testimony or attendance at a legislative hearing in a state Capitol, or the need to immediately contact legislators by phone, fax, email or in-person visits.
Because a bill’s status can change quickly, NVIC Portal users are encouraged to log into the Portal every day to check their own state pages for:
- Vaccine bill descriptions
- NVIC’s position (or changes) on the bill;
- Bill information posted by state legislatures
- Where the bill is in the legislative process
- Talking points and NVIC’s recommendations for action
COMMINICATING WITH YOUR LEGISLATORS
NVIC provides information about proposed vaccine legislation to help Americans become educated about vaccine policymaking and participate in the democratic process when laws are proposed that violates the human right to informed consent to medical risk taking or threatens exercise of freedom of thought, speech and conscience when it comes to making vaccine choices. If you want to have input into the public health law making process, you must establish personal relationships with your elected representatives and voice your concerns.
NVIC encourages that positive action be taken to oppose a bill that places any restriction on medical vaccine exemptions or restricts or eliminates personal, religious or conscientious belief vaccine exemptions or compromises the legal right to make informed, voluntary decisions about vaccination without being coerced or punished for the decision made. Although emails and faxes are important, personal calls and visits to legislators are even more important.
Use the NVIC Advocacy Portal to Contact Your Legislator
Contact information for your state representatives and senators can be obtained by becoming a registered user of the free NVIC Advocacy Portal, logging into the Portal and clicking on the “State Teams” tab and then “My State,” where there is a list of elected officials automatically posted on the right hand side of the page. There is a request for an address when you register for the Portal in order to provide you with personally customized legislator contact information.
Forced vaccination proponents have tried to create an environment in the media and in communities that minimizes the reality of vaccine injuries and deaths. The VAXXED Website, has thousands of video clips of people in different states sharing their vaccine reaction experiences. There is a state map on the VAXXED website where visitors can click on a state and view vaccine injury testimonials. These can be shared on social media and with legislators and staff.
Your legislator should also be aware of the suffering of Americans, who are being threatened and punished when they do not comply with physician, school or employer requirements to receive federally recommended vaccines. NVIC’s Cry for Vaccine Freedom Wall contains first person descriptions of parents and adult workers who have been coerced and sanctioned for attempting to make voluntary vaccine decisions for themselves or their children.
NVIC’s fully referenced and illustrated Guide to Reforming Vaccine Policy and Law provides an overview summary of the major issues related to vaccine science, policy, law and ethics and is an excellent information resource for legislators.
Click the plus sign at the bottom of this page to view and/or post comments on our commentary.
By Barbara Loe Fisher
There have been 101 cases of measles that have been reported in 10 states since the beginning of 2019, 1 hardly a public health emergency in a U.S. population of more than 320 million people where 94 percent of school children have received two doses of MMR vaccine and only two percent of children have a vaccine exemption for any reason. 2 In what looks like a repeat of the “measles in Disneyland” media feeding frenzy that stampeded California state legislators into eliminating the personal belief vaccine exemption in 2015, 3 4 the tiny minority of parents who have made a conscious choice not to give their children every one of the dozens of doses of federally recommended and state mandated vaccines are being once again relentlessly stereotyped, demonized and bullied. 5 6 7 8
In what appears to be another well-orchestrated campaign to pressure state legislatures to remove all personal belief vaccine exemptions in the U.S. and further restrict already narrow medical exemptions to vaccination, 9 10 11 12 13 forced vaccination proponents are whipping up irrational fear to justify attacking human rights, including freedom of thought, speech, religious belief and conscience.14 15 16 17 18 19 It is a spectacle unworthy of a nation where human rights 20 and civil liberties have been valued since the ratification of the Bill of Rights in the U.S. Constitution in 1789 21 and the informed consent principle became the anchor for medical ethics after World War II. 222324
During this time of discrimination and oppression, the nonprofit educational charity, the National Vaccine Information Center (NVIC), is back up in Times Square with NVIC's “Vaccinations: Know the Risks and Failures” and “No Forced Vaccination” animated digital message. Displayed on a giant 56 foot by 29 foot electronic screen in the heart of New York City’s Times Square Plaza at 1500 Broadway (where the ball drops on New Year’s Eve), NVIC’s 10-second spot celebrating the human right to freedom of thought and conscience will be broadcast a minimum of three times per hour for 20 hours per day from 6 a.m. to 2 a.m. through April 2019. More than one million people pass through Times Square daily. View the digital ad on NVIC’s referenced Vaccinations: Know the Risks and Failures page on NVIC’s website here.
During the past decade, NVIC has sponsored national vaccine education campaigns to encourage well-informed, voluntary vaccine decisionmaking. In 2011, NVIC sponsored a digital vaccine education billboard in New York City’s Times Square on New Year’s Eve 25 and produced a flu prevention video for Delta Airline’s in-flight programming. 26 In 2013, NVIC launched a national vaccine education billboard and ad campaign that featured billboards on highways and buses New Jersey, Pennsylvania, Oregon, Washington, Arizona, Illinois, Texas, Georgia and Colorado, Vermont and other states. 27 In 2015 and 2016, NVIC’s message advocating for vaccine education and choice was up in Times Square, as well. 28 29
Founded by parents of DPT vaccine injured children in 1982 to prevent vaccine injuries and deaths through public education, NVIC has steadfastly defended respect for the informed consent principle and its protection in vaccine policies and laws because vaccines are pharmaceutical products that carry a risk of injury or death. More than $4 billion has been paid by the government since 1988 to children and adults who have been harmed by FDA licensed and CDC recommended vaccines under the National Childhood Vaccine Injury Act of 1986. 30 Some people are biologically more susceptible to suffering vaccine reactions but doctors are unable to reliability predict who will be harmed before vaccination. 31 This fact makes protection of personal belief vaccine exemptions even more important, as does the fact that Congress and the U.S. Supreme Court have shielded vaccine companies and vaccine administrators from liability for vaccine injuries and deaths. 32 33
In a population of more than 320 million people, a few hundred cases of measles is not a public health emergency and should not be used to justify eliminating the legal right to exercise informed consent to vaccination, which is protected by the inclusion of flexible medical, religious and conscientious belief vaccine exemptions in public health laws. 34 35
The human right to freedom of thought, speech, religious belief, conscience and informed consent will be preserved if Americans stand up for human rights that protect against tyranny. Only if we elect and support lawmakers who protect human rights will human rights be protected in government policy and law.
Whether it is in the states, on Capitol Hill or in Times Square, our mission continues: No forced vaccination. Not in America.
Click the plus sign at the bottom of this page to view and/or post comments on our commentary.
1 CDC. Measles Cases in 2019. Feb. 1, 2019.
2 CDC. Vaccination Coverage for Selected Vaccines and Exemption Rates Among Children in Kindergarten — United States, 2017–18 School Year. MMWR Oct. 12, 2018; 67(4)): 1115-1122.
3 Fisher BL. The Vaccine Culture War in America: Are You Ready? National Vaccine Information Center Mar. 8, 2015.
4 Richardson D. Fallout from California SB277: What Happens Next? NVIC Newsletter Aug. 5, 2015.
5 Editorial Board. How to Inoculate Against Anti-Vaxxers. New York Times Jan. 11, 2019.
6 Cohen E, Bonifield J. Some states allow parents to get out of vaccinations. Then this happens. CNN Jan. 29, 2019.
7 Keneally M. Parents who don't vaccinate kids tend to be affluent, better educated, experts say. ABC News Jan. 29, 2019.
8 Caceres M. Media Takes Low Road by Pitting Children Against Their Parents To Promote Vaccines. The Vaccine Reaction Feb. 13, 2019.
9 National Vaccine Information Center. NVIC Advocacy Portal: 2019 State Legislative Session Vaccine-Related Bills.
10 CBS. Hundreds rally to preserve right not to vaccinate children amid measles outbreak. Feb. 8, 2019.
11 Douglass J. Oregon lawmaker wants to end non-medical exemptions to school vaccine requirements. KATU2 Feb. 11, 2019.
12 MacReady N. Questionable Medical Exemptions for Vaccines Up After New Law in California. Emedicine health Oct. 29, 2018.
13 CDC. Recommendations and Guidelines of the Advisory Committee on Immunization Practices (ACIP): Contraindications and Precautions. Table 4-2. Conditions incorrectly perceived as contraindications or precautions to vaccination (i.e., vaccines may be given under these conditions). Jan. 10, 2019.
14 Fisher BL. The New Internet Police Protecting You From Freedom of Thought and Speech. NVIC Newsletter Dec. 3, 2018.
15 CBS News. Measles Outbreak Fueled by Anti-Vaccination Movement, Infectious Disease Expert Says. Jan. 30, 201.
16 Ad Age. Google, Facebook Queried on Anti-Vaccine Information by Democrat. Feb. 14, 2019.
17 Najera RF. Measles Epidemic Continues and Grows in Washington State, New Cases in Houston, Texas. History of Vaccines Feb. 6, 2019.
18 Newsday. End the religious exemption for vaccines in New York. Editorial Feb 8, 2019.
19 Fisher BL. Forced Vaccination: The Tragic Legacy of Jacobson v. Massachusetts. National Vaccine Information Center Nov. 2, 2016.
20 Universal Declaration of Human Rights. United Nations General Assembly Dec. 10, 1948.
21 National Archives. America’s Founding Documents: The Bill of Rights.
22 Annas GJ, Grodin MA. The Nazi Doctors and the Nuremberg Code. Oxford University Press 1992.
23 U.S. Library of Medicine. Informed Consent – Adults. Medline Plus Jan. 28, 2019.
24 Fisher BL. Why Is Informed Consent to Vaccination a Human Right? National Vaccine Information Center June 28, 2017.
25 National Vaccine Information Center. NVIC Educates One Million Plus in Times Square on New Year’s Eve. NVIC Newsletter Dec. 26, 2011.
26 National Vaccine Information Center. Flu Prevention Video. November 2011.
27 National Vaccine Information Center. NVIC Launches National “Know the Risks” Billboard Vaccine Education Campaign. Mar. 12, 2013.
28 National Vaccine Information Center. NVIC’s “No Forced Vaccination” Message in Times Square, Philadelphia and New Jersey. Apr. 13, 2015.
29 National Vaccine Information Center. NVIC Back in Times Square for Christmas and New Year’s Eve. Dec. 17, 2015.
30 DHHS. National Vaccine Injury Compensation Program: Vaccine Injury Compensation Data. Health Resources Services Administration (HRSA) Feb. 1, 2019.
31 Institute of Medicine Committee to Review Adverse Effects of Vaccines. Evaluation of Biologic Mechanisms of Adverse Effects: Increased Susceptibility. Chapter 3 (p. 82). Washington, D.C. The National Academies Press 2012.
32 NVIC. National Vaccine Information Center Cites “Betrayal” of Consumers by U.S. Supreme Court Giving Total Liability Shield to Big Pharma. NVIC Press Release Feb. 23, 2011.
33 National Vaccine Information Center. NVIC Position Statement on National Childhood Vaccine Injury Act of 1986. May 2018.
34 O’Reilly ED. Measles Outbreak Is Bringing Vaccine Exemptions Into Spotlight. Axios Feb. 14, 2019.
35 Fisher BL. Guide to Reforming Vaccine Policy and Law. National Vaccine Information Center 2014, Revised 2017.
Report on Vaccine Related Federal Advisory Committee Activities
By Theresa Wrangham
After the U.S. Food and Drug Administration’s (FDA) approved Merck’s HPV-9 Gardasil vaccine for use in adults age 27 to 45 in 2018, the Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) of the Department of Health and Human Services (HHS) is evaluating whether to expand their current HPV vaccine recommendation to include this new age group.
ACIP’s current recommendation is that boys and girls ages 9 through 15 should get two-doses of HPV-9. The “catch-up” vaccine schedule is a three- dose series for females above age 15 through age 27 and males above 15 years of age to 21 years of age, if not previously vaccinated with HPV vaccine.1
CDC to Step Up HPV Vaccine Marketing Strategies
Should ACIP expand their recommendations for use of HPV-9 vaccine in the newly approved age group, the CDC won’t be alone in the push to increase the use of the HPV vaccine by children and adults in the U.S. During the September meeting of the National Vaccine Advisory Committee (NVAC), a federal advisory committee that makes recommendations to the National Vaccine Program Office (NVPO), the HHS Assistant Secretary ADM Brett Giroir M.D. emphasized that HHS supported the NVAC’s HPV vaccine recommendations 2 published in June 2018. Dr. Giroir stated that increasing HPV vaccination in America would be a focus for HHS in 2019.
The federal government’s focus on increasing the use recommendations for the HPV vaccine may result in a renewed effort by state legislators to introduce legislation in many states to mandate HPV vaccine for school entry.
HPV-9 Use in Older Adults Considered by ACIP
During the October 2018 ACIP meeting, the HPV workgroup presented preliminary information for discussion purposes. Cost data, though incomplete, showed that increasing use recommendations of the HPV-9 vaccine is not likely to be cost effective. In addition, preliminary data showed that receiving the vaccine would not likely have a significant positive impact on those who may have chronic HPV infections that go on to become HPV associated cancers.3
As this discussion unfolds and finalized data is presented to ACIP during 2019, reportedly a permissive use recommendation is more likely than a routine use recommendation.4 A permissive use recommendation would mean that consumers would be advised of the vaccine’s approval for use in 27 to 45 year olds, while a routine use recommendation would mean that vaccine providers would more strongly recommend use of the vaccine in this older age group.
Any recommendation by ACIP to expand the use recommendation of the HPV vaccine in this age group will result in providing a liability shield to vaccine providers and require anyone in this age group who is injured by this vaccine to petition the federal vaccine injury compensation program (VICP) for injury compensation.
ACIP may vote on this issue as early as their next meeting in February 2019. However, ACIP’s February agenda has not yet been published. Notably, during the February 2018 ACIP meeting, the CDC presented data indicating that it may be decades before it is known whether HPV vaccine has impact on HPV associated cancers.5
ACIP Recommends Routine Hepatitis A Vaccination for the Homeless
Votes carried out during October’s ACIP meeting included the passage of a routine recommendation of Hepatitis A vaccine for the homeless to prevent outbreaks in this at risk group;6 and formatting and language clean up of the CDC recommended childhood7 and adult8 vaccine schedules (routine, catch-up and medical indication tables). The CDC’s website will be updated with these vaccine schedules with the goal of making the new schedules clearer to vaccine administrators and the public.
Vaccine Access A Key Factor in Rise in Unvaccinated Children
At the October ACIP meeting, the CDC set forth the latest MMWR reports on childhood vaccine coverage. Dr. Nancy Messonnier, Director of the National Center for Immunization and Respiratory Diseases (NCIRD) commented on the slight increase in the number of unvaccinated children. Dr. Messonnier stated,
“Parental choice may play some role, but CDC’s data really suggests that many of these parents do want to vaccinate their children, but they may not be able to get vaccines for them. They may face hurdles like not having a health care professional near by, not having time to get their children to a doctor, and thinking that they cannot afford vaccines.”9
New Anthrax Vaccine Likely to be Stockpiled
A presentation was made on the new anthrax vaccine AV7909, which is manufactured by Emergent Biosolutions, and uses the novel CpG 7909 adjuvant. The new adjuvant CpG oligodeoxynucleotide (CpG ODN) is a synthetic oligodeoxynucleotide derived from bacterial DNA that accelerates the pro-inflammatory response of the immune system to stimulate immunity.10 11 This vaccine, once approved, will be stockpiled in the Strategic National Stockpile, to be used in the event of a bioterrorism attack.12 13
Pneumococcal Vaccine May Provide Little Benefit To Seniors
ACIP is also conducting a routine review of their use recommendation for PVC 13 pneumococcal vaccine in adults. Data was presented suggesting that the vaccine has little direct benefit to seniors. Additional data will be presented during February’s ACIP meeting with a possible vote in February or June that may result in a change to the routine use recommendation of the PCV 13 vaccine in 65+ adults.14
Change in Tetanus Revaccination Considered
Data was presented on the use of Tdap in place of Td vaccine for the 10-year booster vaccination recommended by the CDC.15 It appears a key reason behind this possible substitution has to do with vaccine providers opting to keep little to no Td vaccine supplies on hand. ACIP has formed a workgroup to evaluate a possible change in this policy and will present data and recommendations to ACIP for additional consideration.
Infant Dose of Influenza Vaccine May Change
Sanofi Pasteur presented data on the initial use of a full dose (.5-ml) of the Fluzone Quadrivalent vaccine in infants six months of age compared to the current half dose recommended for this age group.16 Additional information will be presented at future ACIP meetings as the committee considers a possible change in recommendations.
CDC Removes Many Pertussis Vaccine Contraindications
The CDC removed four DTaP precautions to receipt of pertussis containing vaccines, including
- Fever over 105 F within 48 hours following DTaP;
- Persistent, inconsolable crying lasting more than 3 hours within 48 hours following a dose of DTaP;
- Collapse or shock-like state within 48 hours following a dose of DTaP;
- Seizure within 72 hours following a dose of DTaP.
from their Best Practice Guidelines webpage.17 18 The reason provided for this change was that these precautions were associated with the DTP vaccine, which is no longer licensed for use in the U.S. due to its higher reactivity and risk for vaccine injury, and not the DTaP vaccine.
Parents Describe Vaccine Injury and Death During ACIP Public Comment Period
During ACIP’s public comment session, the majority of comments were made by individuals reporting vaccine injuries and deaths and those concerned about lack of informed consent protections in vaccine policies and laws. Health care professionals provided public comments that were critical of data presented to ACIP and of current ACIP vaccine recommendations. Many parents echoed these concerns and shared their heart breaking stories of vaccine injury and death.19 20
Destiny Maynard tearfully shared with the committee the story of her son, Christopher, who died in the summer of 2018 following complications from Acute Disseminated Encephalomyelitis (ADEM) shortly after receiving an HPV vaccination. She read a statement from her son’s neurologist explaining that cases of ADEM can be triggered by vaccines and that the HPV vaccine, specifically, has been implicated in cases of ADEM within one month of vaccination. The statement concluded that strong consideration must be given to the HPV vaccine causing ADEM, which resulted in the death of Christopher.21
ACCV Requests Funding for More Special Masters But Ignores Vaccine Safety Gaps
On December 6, 2018, The Advisory Committee on Childhood Vaccines (ACCV) met and passed a resolution to request that the Secretary of Health provide additional funding to hire more special masters for the U.S. Court of Federal Claims to adjudicate vaccine injury claims in the federal vaccine injury compensation program (VICP). When the Secretary of HHS opposes awarding compensation, the special masters make determinations about whether plaintiffs will or will not receive an award from the federal vaccine injury compensation program (VICP). Noting a serious backlog in pending compensation claims, ACCV expressed hope that providing funding for hiring more special masters will accelerate to processing of claims.
The Government Accountability Office published a report in 2014 critical of the length of time it takes to process VICP claims, 22 one of many criticisms of the implementation of the VICP created by Congress in the 1986 National Childhood Vaccine Injury Act.23 The Secretary of Health still has not fulfilled NVIC’s long-standing request for funding of research to address acknowledged vaccine safety science gaps identified in over 25 years of reports issued by the National Academy of Medicine (NAM), formerly the Institute of Medicine (IOM).
Vaccine Administrators Get Liability Shield for Causing Shoulder Injuries
According to reports by federal officials during ACCV’s meeting, the leading injury claim in the VICP by adults is shoulder injury (SIRVA) from improperly administered vaccines, followed by Guillian-Barre Syndrome (GBS) caused by from influenza vaccine. Notably, during the June 4, 2015 meeting of ACCV, HRSA noted that SIRVA was not an adverse reaction to the vaccine itself, rather it was an injury resulting from incorrect administration of the vaccine too high in the shoulder muscle causing shoulder injury. NVIC provided public comment opposing the addition of SIRVA to the Vaccine Injury Table (VIT) due to the fact that this injury is not a vaccine adverse event, rather it is the result of a lack of professional training and/or misadministration by the vaccine provider.24
Despite these comments, ACCV recommended adding SIRVA to the VIT to provide healthcare professionals with a liability shield if they incorrectly administer any routinely recommended childhood vaccine in the shoulder and cause a shoulder injury. SIRVA injuries can range from mild to severe, can cause temporary or permanent injury that limits movement and results in pain from bursitis and tendinitis.25 26
ACCV Considers Survey to Assess VICP Experience and Awareness
ACCV’s process workgroup presented initial discussion results on their review of a survey of petitioners rating their experience with VICP, the outcome of their claim, and how they found out about the VICP. This survey is, in part, the result of the acknowledged lack of public awareness of the VICP and how it might be improved. NVIC has requested that ACCV amend the survey to include questions relating to the satisfaction and adequacy of awards from VICP based on recommendations from federally commissioned reports on VICP.
Upcoming Federal Advisory Committee Meetings.
For more than three decades, NVIC has monitored and reported on federal vaccine advisory committee meetings that shape federal vaccine policy and influence state vaccine laws. These meetings are open to the public and most are streamed live. All meetings allow for public comment and have different requirements on registering to make a public comment. A selection of NVIC’s previous public comments can be read here. We encourage our supporters to make their voice heard and to voice their concerns to these federal committees. Upcoming committee meetings in 2019 are:
ACIP - February 27-28, 2019, learn more and register here.
ACCV – March 7-8, 2019, learn more and register here.
NVAC – March 25, 2019, learn more and register here.
Click the plus sign at the bottom of this page to view and/or post comments on our commentary.
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2 NVAC. Strengthening the Effectiveness of National, State, and Local Efforts to Improve HPV Vaccination Coverage in the United States. ASPPH Public Health Reports. Aug. 9, 2018.
3 CDC . ACIP Meeting Presentation - Impact and economic analysis – Summary of three models of 9-valent HPV vaccination among adults up to age 45 years in the United States. Chesson, H., CDC. Oct. 25, 2018.
4 CDC. ACIP Meeting Presentation – Expanded age range for 9-valent HPV vaccine: Work Group plans and policy considerations. Markowitz, L. Oct. 25, 2018.
5 CDC. ACIP Meeting Presentation – Trends in HPV-associated cancers in the United States. Dr. Elizabeth VanDyne, CDC/NCIRD. Feb. 12, 2018.
6 CDC. ACIP Presentations – Hepatitis A Vaccines. Oct. 24, 2018.
7 CDC. ACIP Presentations – 2019 Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger. Bernstein, H. Robinson, C. Oct. 24, 2018.
8 CDC. ACIP Presentation – Recommended Adult Immunization Schedule, 2018. Hunter, P. Kim, D. Oct. 24, 2018.
9 CDC. ACIP Video Recording – October 2018 ACIP Meeting – Agency Updates & HPV. Nov. 14, 2018.
10 Hopkins RJ, Daczkowski NF et al. Randomized, Double Blind, Placebo Controlled, Safety and Immunogenicity Study of 4 Formulations of Anthrax Vaccine Adsorbed Plus CPG7909 (AV7909) in Health Adult Volunteers. Vaccine 2013; 31(30): 3051-3058.
11 Coherent Market Insights. CpG Oliogodeoxynucleotide Market. January 2019.
12 CDC. ACIP Meeting Presentations – Anthrax. Oct. 24, 2018.
13 Hackett DW. Anthrax Vaccine Stockpile is Reloading. Precision Vaccines Dec. 28, 2017.
14 CDC. ACIP Meeting Presentation – Preliminary Evidence to Recommendations for the ongoing review of the PCV 13 recommendation for adults >65 years old. Matanock, A. Oct 24, 2018.
15 CDC. ACIP Meeting Presentation – Background: Repeat Tdap vaccination. Havers, F. Oct. 25, 2018.
16 Sanofi Pasteur. ACIP Meeting Presentation - Study GRC88, Safety and Immunogenicity of Fluzone Quadrivalent Vaccine 0.5-mL Dose for Children 6 through 35 Months of Age. Mercer, M. Oct. 25, 2018.
17 CDC. Recommendations and Guidelines of the ACIP – General Best Practice Guidelines. Table 4.2. Sep. 14, 2018.
18 CDC. ACIP Video Recording – October 2018 ACIP Meeting – General Recommendations; Influenza; Rabies; Meningococcal; Pertussis. Nov. 14, 2018.
19 CDC. ACIP Video Recording – Japanese Encephalitis. Nov. 14, 2018.
20 CDC. ACIP Video Recording –Pertussis. Nov. 14, 2018.
21 CDC. ACIP Video Recording –Pertussis. Nov. 14, 2018.
22 Government Accountability Office (GAO). Vaccine Injury Compensation: Most Claims Took Multiple Years and Many Were Settled Through Negotiation. U.S. Government Accountability Office Nov. 21, 2014.
23 Fisher BL, Williams K, Wrangham TK. NVIC response to an inquiry from the Government Accountability Office (GAO) on the implementation of the federal vaccine injury compensation program (VICP) after passage of the 1986 National Childhood Vaccine Injury Act. National Vaccine Information Center July 11, 2014.
24 HRSA. ACCV Certified Minutes. Pg 5. Jun. 4, 2015.
25 CDC. Intramuscular Influenza (Flu) Vaccination Infographic. Jun. 4, 2018.
26 Llamas, M. Shoulder Injury Related to Vaccine Administration: SIRVA. Drugwatch.