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Jerri Johnson
*OAH_RuleComments.OAH
Immunization Rules docket 0900-30570
Wednesday, June 26, 2013 1:29:09 PM
Hepatitis B vaccine - Not needed, Not reasonable.docx
Document on why the hepatitis B vaccine is not needed and is not reasonable.
Jerri Johnson
Jerri Johnson
Public Relations Coordinator
National Health Freedom Coalition'
651 688 6515
[email protected]
Hepatitis B Vaccine
Jerri Johnson, Vaccine Safety Council of MN
Requiring hepatitis B vaccine for infants instead of Kindergartners is not
needed, and is not reasonable.
The Minnesota Department of Health has a goal to stop the transmission of hepatitis B in the state in
order to eliminate hepatitis B entirely. This is a noble goal and worthy of much resources to attain.
However, even that goal must always be superceded by an even greater goal: the best possible
overall health of all people in the state. The goal to eliminate hepatitis B must not be accomplished at
the expense of the health of the people. Sometimes focusing on eliminating a specific disease using
vaccination results in harming people in the process.
Requiring this vaccine is not reasonable because the hepatitis B vaccine carries risk of injury. A
vaccine is not a treatment, but a preventive intervention. It could harm healthy people that never
would have gotten the disease it intended to prevent. Therefore, it requires a very high standard of
safety to utilize. And making it a mandate by the state (even with an exemption option) requires an
even higher standard of safety. If the state requires parents to agree to a vaccination unless they
utilize exemption, and then the baby is killed or disabled by the vaccine, (when the baby would likely
have never been exposed to the disease, especially in childhood) then the state bears responsibility
for that death or disability.
This is not needed because hepatitis B infection is exceedingly rare in Minnesota infants and
preschoolers; the rate of incidence in preschoolers is only 0.01%. One in 10,000 infants in MN
contracts the infection, so it would require vaccinating 10,000 babies to prevent one case.
Requiring vaccination for all babies in child care is not reasonable, because
of the risk of Serious Adverse Reactions to the Vaccine
Documented harm from the hepatitis B vaccine
The Vaccine Adverse Event Reporting System (VAERS) has been set up by the federal government to receive
reports from individuals who believe that a vaccine caused an adverse event. Critics of VAERS data point out
that VAERS does not establish causality between a vaccine and a death or injury, but collects reports that may
point to causality. But other scientists point out that reports in VAERS usually grossly underestimate vaccine
injuries. The CDC has admitted that probably only 5-10% of events are reported because it is a passive
reporting system, not required. Parents of vaccine injured children report frequently that their doctor refused
to report the injury because of fear of admitting that the vaccine caused harm. And parents usually are not
aware they can report it themselves.
Reports of harm from hepatitis B vaccine (VAERS)
As of March 2012, there were a total of 66,654 hepatitis B vaccine-related adverse events reported to the
federal Vaccine Adverse Events Reporting System (VAERS), including reports of headache, irritability, extreme
fatigue, brain inflammation, convulsions, rheumatoid arthritis, optic neuritis, multiple sclerosis, lupus, Guillain
Barre Syndrome (GBS) and neuropathy. There have been more than 1500 hepatitis B vaccine-related deaths
reported, including deaths in infants classified as sudden infant death syndrome (SIDS). [13]
http://www.cdc.gov/hepatitis/Statistics/SurveillanceGuidelines.htm
VAERS reports on Minnesota children 0 to 5 years of age following hep B vaccine
Found 240 events where Age is under-5 and Location is Minnesota and Vaccine is HEP B
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=on&PAGENO=2&PERPAGE=10&ESORT=NONE&REVERSESORT=&LOWAGE=%280%29&HIG
HAGE=%285%29&WhichAge=range&STATE=%28MN%29&VAX=%28HEP%29
Note: this is about 12 reports per year of adverse reactions to the hepatitis B vaccine in children in Minnesota.
That is more than the number of new cases of hepatitis B in children every year in Minnesota. That means that
a child is more likely to have an adverse reaction to the hepatitis B vaccine than to contract the disease.
Found 90 events requiring Emergency Room Visit
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=on&PAGENO=2&PERPAGE=10&ESORT=NONE&REVERSESORT=&LOWAGE=%280%29&HIG
HAGE=%285%29&WhichAge=range&STATE=%28MN%29&VAX=%28HEP%29&ER_VISIT=Yes
Found 25 events requiring hospitalization
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=on&PAGENO=2&PERPAGE=10&ESORT=NONE&REVERSESORT=&LOWAGE=%280%29&HIG
HAGE=%285%29&WhichAge=range&STATE=%28MN%29&VAX=%28HEP%29&HOSPITAL=Yes
Found 6 events where child died
Examples of write-ups on the VAERS reports: (“Days after vaccination: 0” means onset of
symptoms on same day as vaccine given)
Example of one write-up where a Minnesota baby died the same day as the vaccine was given:
Write-up: baby died in car ride home, no preceding symptoms or signs; EMS called @ 942AM
Days after vaccination: 0 Write-up: Unresponsiveness in a 9 month old male who received hep B vaccine
recombinant (Engerix-B). the vaccinee reportedly was "pale and lifeless, would not respond to us at all" and
had a "bright red rash on face." The mother reportedly sought ER attention on 04/29/2002 because of her
son''s unresponsiveness.
Days after vaccination: 0 Write-up: Child screamed a high pitched squeal, went pale and then a gray/blue
color. Was lethargic and glazed over eyes, slow breathing. Called 9-1-1. Took child to Hospital--and they
performed every test to rule out everything. (Episode happened again while in Emergency room.) Monitored
for 2 days in hospital with cause documented as reaction to immunization shots.
Days after vaccination: 0 Write-up: pt recvd vax 31OCT95 & given APAP;630PM mom heard a high pitched
weak cry ;pt color was pale ashen & bubbles of saliva noted @ mouth; grunty respiration; lethargic &
unresponsive requiring stimulation; to ER
Days after vaccination: 0 Write-up: Nurse administered hepatitis B vaccine to baby at 1010 on 4/8/10 -baby
developed bilateral pneumothorax, neck swelling. Pt transferred emergently to another facility.
Days after vaccination: 0 Write-up: pt recvd 1st dose of Hep B on 9FEB93 & 4 hrs following vax devel apneic
episode, limpness & paleness; pt was admitted to a hosp;
Days after vaccination: 0
Acute pancreatitis (broad), Pseudomembranous colitis (broad), Gastrointestinal nonspecific symptoms and
therapeutic procedures (narrow)
Days after vaccination: 0 Write-up: pt seen in clinic in AM & later had apnea, spell & turned blue in face
The National Vaccine Injury Compensation Program (NVICP) has
compensated many individuals severely injured by the hepatitis B Vaccine
The NVICP was set up by the federal government to receive complaints of vaccine injury, investigate to
determine whether individuals should be compensated. Unlike the VAERS system, which does not determine
causality, this investigation is detailed and strenuous.
Multiple court rulings by the Vaccine Court have awarded financial compensation to individuals claiming
autoimmune diseases and death following receipt of the hep B vaccine. Diseases included inflammatory
disorders of the brain and nervous system, including multiple sclerosis, acute disseminating encephalomyelitis,
Guillian Barre’ Syndrome, and other autoimmune diseases such as rheumatoid arthritis, lupus, and
fibromyalgia.
Claims Filed and Compensated or Dismissed by Vaccine 1 June 4, 2013
Vaccines Listed in Claims as Reported by Petitioners
Vaccine(s)
Filed
Injury
DTaP-Hep B-IPV
Compensated
Death
Dismissed
Total
30
16
46
23
23
Injuries 535
Deaths 45
Total 580
Compensated
228
Dismissed
352
Hep A- Hep B
9
0
9
8
1
Hep B-HIB
6
0
6
3
3
4,678
6
4,684
4
4.679
11,873
1,042
12,915
3,295
9,620
Hepatitis B (Hep B)
Unspecified3
TOTAL
1
The number of claims filed by vaccine as reported by petitioners in claims since the VICP
began on October 1, 1988, which have been compensated or dismissed by the U.S. Court of
Federal Claims (Court). Claims can be compensated by a settlement between parties or a
decision by the Court.
2
Claims filed for vaccines which are not covered under the VICP.
3
Insufficient information submitted to make a determination. The majority of these claims
were part of the Omnibus Autism Proceedings.
Example of Federal Vaccine Court compensation following death
Petitioner has prevailed on the issue of entitlement. The medical records during decedent's final
hospitalization reflect that she died from demyelinating disease. Not only did decedent have a
vaccine injury, but also her death was vaccine-related.
CONCLUSION
Petitioner is entitled to reasonable compensation. The undersigned hopes that the parties may reach
an amicable settlement and will have a telephonic status conference soon with the parties to discuss
further proceedings.
http://www.uscfc.uscourts.gov/sites/default/files/MILLMAN.DOE012109B_0.pdf
The hepatitis B vaccine has too many documented cases of vaccine injury and death for the State of
Minnesota to be requiring it for babies.
Clinical Studies Identify Harm from the hepatitis B vaccine
A wide variety of neurological and auto-immune disorders, including multiple sclerosis, rheumatoid
arthritis, optic neuritis, Bell's Palsy, Guillian-Barre' Syndrome and diabetes, have been reported in
peer-reviewed journals following administration of hepatitis B vaccine. Here are just a few:
Autoimmune Hazards of the hepatitis B Vaccine A French study looking at research on the hep B
vaccine concluded: “According to Hippocratic tradition, the safety level of a preventive medicine must
be very high, as it is aimed at protecting people against diseases that they may not contract. This
paper points out that information on the safety of hepatitis B vaccine (HBV) is biased as compared to
classical requirements of evidence-based medicine (EBM), as exemplified by a documented selectivity
in the presentation or even publication of available clinical or epidemiological data. Then, a review is
made of data suggesting that HBV is remarkable by the frequency, the severity and the variety of its
complications, some of them probably related to a mechanism of molecular mimicry leading to
demyelinating diseases, and the others reproducing the spectrum of non-hepatic manifestations of
natural hepatitis B. To be explained, this unusual spectrum of toxicity requires additional
investigations based upon complete release of available data.”
Autoimmunity Reviews 4 (2005) 96– 100
http://www.ncbi.nlm.nih.gov/pubmed/15722255
Marc Girard* 1 bd de la Re´publique 78000-Versailles, France
"Recombinant hepatitis B vaccine and risk of multiple sclerosis: a prospective study." A Harvard
study found that: When researchers analyzed hepatitis B vaccination statistics from 163 individuals
with multiple sclerosis and 1,604 "controls," they found a correlation between getting the hepatitis B
vaccine and developing multiple sclerosis. Specifically, the results indicated that the risk of developing
multiple sclerosis was three times higher in the group that was vaccinated against hepatitis B than in
the group that wasn't vaccinated.
Neurology 2004 Sep 14;63(5):838-42
Hepatitis B Immunization Linked to Autoimmune Rheumatic Diseases
Two abstracts being presented at the 62nd Annual Meeting of the American College of
Rheumatology (held November 8-12, 1998, in San Diego, California) link the development of
autoimmune rheumatic diseases to immunization with hepatitis B vaccine. A recently published paper
from Canada also links the development of rheumatic diseases to immunization with hepatitis
B vaccine. In all cases immunization starting after 2 months of life was associated with autoimmunity
while immunization starting at birth has not been linked to the development of autoimmunity.
The development of rheumatoid arthritis after recombinant hepatitis B vaccination.
OBJECTIVE: Hepatitis B vaccination has been associated with reactive arthritis and rarely rheumatoid
arthritis (RA). We defined the clinical, serologic, and immunogenetic background of patients
developing RA, soon after recombinant hepatitis B vaccination.
CONCLUSION: Recombinant hepatitis B vaccine may trigger the development of RA in MHC
class II genetically susceptible individuals.
Pope JE, Stevens A, Howson W, Bell DA
Department of Medicine, the University of Western Ontario, London, Canada.
J Rheumatol 1998 Sep;25(9):1687-93
SEVERE RHEUMATIC DISORDERS ASSOCIATED WITH HEPATITIS B VIRUS (HBV) VACCINATION
HBV vaccination may induce hypersensitivity and autoimmune reactions in susceptible individuals
and healthy Subjects.
Seven patients (4 F, 3 M; mean age 35 ± 10 yrs), developed severe rheumatic disorders after the first
(4) or the third (3) injection of HBV vaccine. Before HBV vaccination, one was a healthy subject and 6
were previously suffering from: eosinophilic fasciitis (1), systemic lupus (1), HLA B27 positive axial
ankylosing spondylitis (2), sickle cell disease (1) and idiopathic cutaneous urticaria (1).
Fourteen days (mean) after vaccine injection, they developed rheumatic disorders including: 3 severe
symetric polyarthritis fulfilling ARA RA criteria, associated in one case with vasculitis and 2 monoclonal
IgM cryoglobulins. Two cases of oligoarthritis (one associated with palatine and laryngeal oedema,
ocular sicca syndrome, hypereosinophilia, positive ANA, and C4 defect), 1 case of Sjögren syndrome, 1
severe systemic flare of lupus with arthritis, pleural effusion, vasculitis and a grade IIIa
glomerulonephritis.
Conclusion: Hepatitis B virus vaccination may induce severe reactions requiring the use of a long
term treatment (mean period of time of 32.5 ± 24.8 months) in healthy subjects and in patients who
suffer from autoimmune diseases and from ankylosing spondylitis or reactive arthritis, even if a
complete remission has been already obtained.
S. Laoussadi, V. Sayag-Boukris, C.-J. Menkes, André Kahan
Department of Rheumatology A, Cochin Hospital, Paris V University, Paris,
France
RHEUMATIC DISORDERS DEVELOPED AFTER HEPATITIS B VACCINATION
Aim: to obtain an overview of rheumatic disorders occurring after hepatitis B vaccination.
Methods: a questionnaire was sent to rheumatology departments in nine French hospitals. Criteria for
entry were rheumatic complaints of one-week duration or more, occurrence during the 2 months
following hepatitis B vaccination, no previously diagnosed rheumatic disease, exclusion of bacterial or
viral reactive arthritis.
Results: 21 patients (18 women, 3 men; mean age = 30.7 years +/- 12.6 SD) were included. All
received recombinant hepatitis B vaccine. The time interval between the vaccination and occurrence
of complaints was one week or less for 10 patients, between one week and one month for 8 patients,
between one and two months for 3 patients. In 9 patients, the next vaccinal dose was inoculated
despite the complaints. The symptomatology worsened in 7 cases, and was not modified in one case
(effects unknown for the last patient). The observed disorders were as follows: rheumatoid arthritis
for 6 patients, systemic lupus erythematosus for 2, reactive arthritis for 5, polyarthralgia-myalgiafatigue for 3, suspected or biopsy-proved vasculitis for 3, miscellaneous for 2.
Conclusion: hepatitis B vaccination might be followed by various rheumatic conditions, and might
trigger the onset of underlying inflammatory and/or auto-immune rheumatic diseases. However, a
causal relation between hepatitis B vaccination and the observed rheumatic manifestations cannot
be easily established. Further epidemiological works are needed to establish whether hepatitis B
vaccination is associated or not with an incidence of rheumatic disorders higher than normal.
J.F. Maillefert1, J. Sibilia2, E. Toussirot3, E. Vignon4, R. Juvin5, C. Piroth1, D. Wendling3, J.L. Kuntz2,
C. Tavernier1, P. Gaudin5 Departments of Rheumatology; 1Dijon; 2Strasbourg; 3Besançon; 4Lyon; 5Grenoble, France
HepB Vaccine Causes Liver Disease
Hepatitis B vaccine and liver problems in U.S. children less than 6 years old, 1993 and 1994:
Children given hepatitis B vaccinations are 2.57 times more likely to suffer from liver problems.
Abstract: Data to assess the benefits and risks of hepatitis B vaccine for the general population of
U.S. children are sparse. This study addressed the problem of external validity found in previous
studies of high risk populations by evaluating the benefit of hepatitis B vaccination for the general
population of American children. We calculated the risk of liver problems among hepatitis B
vaccinated and non-hepatitis B vaccinated children using logistic regression. Hepatitis B vaccinated
children had an unadjusted odds ratio of 2.94 and age-adjusted odds ratio of 2.35 for liver problems
compared with non-hepatitis B vaccinated children in the 1993 National Health Interview Survey.
Hepatitis B vaccinated children had an unadjusted odds ratio of 2.57 and age-adjusted odds ratio of
1.53 for liver problems compared with non-hepatitis B vaccinated children in the 1994 National
Health Interview Survey dataset.
Epidemiology. 1999 May;10(3):337-9. PMID: 10230847 M A Fisher, S A Eklund
Department of Epidemiology, University of Michigan, Ann Arbor 48109, USA.
Autoimmunity following Hepatitis B vaccine as part of the spectrum of ‘Autoimmune (Autoinflammatory) Syndrome induced by Adjuvants’ (ASIA): analysis of 93 cases
1.
2.
Objectives: In this study we analyzed the clinical and demographic manifestations among patients diagnosed with
immune/autoimmune-mediated diseases post-hepatitis B vaccination. We aimed to find common denominators for all
patients, regardless of different diagnosed diseases, as well as the correlation to the criteria of Autoimmune (Autoinflammatory) Syndrome induced by Adjuvants (ASIA).
Patients and methods: We have retrospectively analyzed the medical records of 114 patients, from different centers in
the USA, diagnosed with immune-mediated diseases following immunization with hepatitis-B vaccine (HBVv). All
patients in this cohort sought legal consultation. Of these, 93/114 patients diagnosed with disease before applying for
legal consultation were included in the study. All medical records were evaluated for demographics, medical history,
number of vaccine doses, peri-immunization adverse events and clinical manifestations of diseases. In addition,
available blood tests, imaging results, treatments and outcomes were recorded. Signs and symptoms of the different
immune-mediated diseases were grouped according to the organ or system involved. ASIA criteria were applied to all
patients.
3.
4.
Results: The mean age of 93 patients was 26.5 ± 15 years; 69.2% were female and 21% were considered autoimmune
susceptible. The mean latency period from the last dose of HBVv and onset of symptoms was 43.2 days. Of note, 47% of
patients continued with the immunization program despite experiencing adverse events. Manifestations that were
commonly reported included neuro-psychiatric (70%), fatigue (42%) mucocutaneous (30%), musculoskeletal (59%) and
gastrointestinal (50%) complaints. Elevated titers of autoantibodies were documented in 80% of sera tested. In this
cohort 80/93 patients (86%), comprising 57/59 (96%) adults and 23/34 (68%) children, fulfilled the required criteria for
ASIA.
Conclusions: Common clinical characteristics were observed among 93 patients diagnosed with immune-mediated
conditions post-HBVv, suggesting a common denominator in these diseases. In addition, risk factors such as history of
autoimmune diseases and the appearance of adverse event(s) during immunization may serve to predict the risk of
post-immunization diseases. The ASIA criteria were found to be very useful among adults with post-vaccination events.
The application of the ASIA criteria to pediatric populations requires further study.
http://www.ncbi.nlm.nih.gov/pubmed/22235045
Lupus February 2012 vol. 21 no. 2 146-152
The Zabludowicz Center for Autoimmune Diseases, Sheba Medical Center, Tel-Hashomer, Israel
Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel
Yehuda Shoenfeld, MD, FRCP, Zabludowicz Center for Autoimmune Diseases, Chaim Sheba Medical Center, TelHashomer 52621, Israel Email: [email protected]
1
2
HEPATITIS B TRIPLE SERIES VACCINE AND DEVELOPMENTAL DISABILITY IN US CHILDREN AGED 1–9 YEARS
This study investigated the association between vaccination with the Hepatitis B triple series vaccine
prior to 2000 and developmental disability in children aged 1–9 years (n¼1824), proxied by parental
report that their child receives early intervention or special education services (EIS). National Health
and Nutrition Examination Survey 1999–2000 data were analyzed and adjusted for survey design by
Taylor Linearization using SAS version 9.1 software, with SAS callable SUDAAN version 9.0.1. The odds
of receiving EIS were approximately nine times as great for vaccinated boys (n¼46) as for
unvaccinated boys (n¼7), after adjustment for confounders. This study found statistically significant
evidence to suggest that boys in United States who were vaccinated with the triple series Hepatitis B
vaccine, during the time period in which vaccines were manufactured with thimerosal, were more
susceptible to developmental disability than were unvaccinated boys.
Carolyn Gallagher* and Melody Goodman
Toxicological & Environmental Chemistry
Vol. 90, No. 5, September–October 2008, 997–1008
Given the overwhelming evidence of long-term damage from this vaccine, one wonders how it was
ever approved by the FDA. Here’s one answer: The pharmaceutical company making the vaccine did
its own safety testing, and it did not follow up its subjects for longer than 5 days. So it made no effort
to see whether subjects developed auto-immune diseases over time.
No vaccine should be approved, let alone required, until long-term safety studies have been
completed.
Package inserts for hepatitis B vaccines outline adverse reactions, and
show that in the safety studies for FDA approval, individuals were only
monitored for 5 days.
RECOMBIVAX HB®
HEPATITIS B VACCINE (RECOMBINANT)
ADVERSE REACTIONS
RECOMBIVAX HB and RECOMBIVAX HB Dialysis Formulation are generally well-tolerated. No
adverse experiences were reported during clinical trials which could be related to changes in the titers of
antibodies to yeast. As with any vaccine, there is the possibility that broad use of the vaccine could reveal
adverse reactions not observed in clinical trials.
In three clinical studies, 434 doses of RECOMBIVAX HB, 5 mcg, were administered to 147 healthy
infants and children (up to 10 years of age) who were monitored for 5 days after each dose. Injection site
reactions and systemic complaints were reported following 0.2% and 10.4% of the injections,
respectively. The most frequently reported systemic adverse reactions (>1% injections), in decreasing
order of frequency, were irritability, fever (≥101°F oral equivalent), diarrhea, fatigue/weakness, diminished
appetite, and rhinitis.10
In a study that compared the three-dose regimen (5 mcg) with the two-dose regimen (10 mcg) of
RECOMBIVAX HB in adolescents, the overall frequency of adverse reactions was generally similar.
In a group of studies, 3258 doses of RECOMBIVAX HB, 10 mcg, were administered to 1252 healthy
adults who were monitored for 5 days after each dose. Injection site reactions and systemic complaints
were reported following 17% and 15% of the injections, respectively. The following adverse reactions
were reported:
LOCAL REACTION (INJECTION SITE)
Injection site reactions consisting principally of soreness,
and including pain, tenderness, pruritus,
erythema, ecchymosis, swelling, warmth, and nodule
formation.
BODY AS A WHOLE
The most frequent systemic complaints include
fatigue/weakness; headache; fever (≥100°F); and
malaise.
DIGESTIVE SYSTEM
Nausea; and diarrhea
RESPIRATORY SYSTEM
Pharyngitis; and upper respiratory infection
Incidence Less Than 1% of Injections
BODY AS A WHOLE
Sweating; achiness; sensation of warmth;
lightheadedness; chills; and flushing
DIGESTIVE SYSTEM
Vomiting; abdominal pains/cramps; dyspepsia; and
diminished appetite
RESPIRATORY SYSTEM
Rhinitis; influenza; and cough
NERVOUS SYSTEM
Vertigo/dizziness; and paresthesia
INTEGUMENTARY SYSTEM
Pruritus; rash (non-specified); angioedema; and urticaria
MUSCULOSKELETAL SYSTEM
Arthralgia including monoarticular; myalgia; back pain;
neck pain; shoulder pain; and neck stiffness
HEMIC/LYMPHATIC SYSTEM
Lymphadenopathy
PSYCHIATRIC/BEHAVIORAL
RECOMBIVAX HB®
Hepatitis B Vaccine (Recombinant) 9987435
8
Insomnia/disturbed sleep
SPECIAL SENSES
Earache
UROGENITAL SYSTEM
Dysuria
CARDIOVASCULAR SYSTEM
Hypotension
Marketed Experience
The following additional adverse reactions have been
reported with use of the marketed vaccine. In
many instances, the relationship to the vaccine was
unclear.
Hypersensitivity
Anaphylaxis and symptoms of immediate
hypersensitivity reactions including rash, pruritus,
urticaria,
edema, angioedema, dyspnea, chest discomfort,
bronchial spasm, palpitation, or symptoms consistent
with a hypotensive episode have been reported within
the first few hours after vaccination. An apparent
hypersensitivity syndrome (serum-sickness-like) of
delayed onset has been reported days to weeks after
vaccination, including: arthralgia/arthritis (usually
transient), fever, and dermatologic reactions such as
urticaria, erythema multiforme, ecchymoses and
erythema nodosum (see WARNINGS and
PRECAUTIONS).
Digestive System
Elevation of liver enzymes; constipation
Nervous System
Guillain-Barré Syndrome; multiple sclerosis;
exacerbation of multiple sclerosis; myelitis including
transverse myelitis; seizure; febrile seizure; peripheral
neuropathy including Bell's Palsy; radiculopathy;
herpes zoster; migraine; muscle weakness; hypesthesia;
encephalitis
Integumentary System
Stevens-Johnson Syndrome; alopecia; petechiae; eczema
Musculoskeletal System
Arthritis
Pain in extremity
Hematologic
Increased erythrocyte sedimentation rate;
thrombocytopenia
Immune System
Systemic lupus erythematosus (SLE); lupus-like
syndrome; vasculitis; polyarteritis nodosa
Psychiatric/Behavioral
Irritability; agitation; somnolence
Special Senses
Optic neuritis; tinnitus; conjunctivitis; visual
disturbances; uveitis
Cardiovascular System
Syncope; tachycardia.
Patients, parents and guardians should be instructed to
report any serious adverse reactions to their
healthcare provider, who in turn should report such
events to the U.S. Department of Health and Human
Services through the Vaccine Adverse Event Reporting
System (VAERS), 1-800-822-7967.31
Engerix
6.2 Postmarketing Experience
In addition to reports in clinical trials, worldwide voluntary reports of adverse events received for
ENGERIX-B since market introduction (1990) are listed below. This list includes serious adverse events or
events which have a suspected causal connection to components of ENGERIX-B.
The following adverse events have been identified during postapproval use of ENGERIX-B. Because these
events are reported voluntarily from a population of unknown size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to the vaccine.
Infections and Infestations: Herpes zoster, meningitis.
Blood and Lymphatic System Disorders: Thrombocytopenia.
Immune System Disorders: Allergic reaction, anaphylactoid reaction, anaphylaxis. An apparent
hypersensitivity syndrome (serum sickness-like) of delayed onset has been reported days to weeks after
vaccination, including: arthralgia/arthritis (usually transient), fever, and dermatologic reactions such as
urticaria, erythema multiforme, ecchymoses, and erythema nodosum.
Nervous System Disorders: Encephalitis, encephalopathy, migraine, multiple sclerosis, neuritis, neuropathy
including hypoesthesia, paresthesia, Guillain-Barré syndrome and Bell’s palsy, optic neuritis, paralysis,
paresis, seizures, syncope, transverse myelitis.
Eye Disorders: Conjunctivitis, keratitis, visual disturbances.
Ear and Labyrinth Disorders: Earache, tinnitus, vertigo.
Cardiac Disorders: Palpitations, tachycardia.
Vascular Disorders: Vasculitis.
Respiratory, Thoracic and Mediastinal Disorders: Apnea, bronchospasm including asthma-like symptoms.
Given the level of harm from this vaccine, it is absolutely unreasonable for
the government to require it.
A vaccine with this safety profile should never be given without giving
parents truthful information on the risks and benefits. But parents are not
informed of the true risks of the hepatitis B vaccine
Despite the numerous studies documenting harm from this vaccine, and the large number of cases
where the Vaccine Court has awarded compensation to individuals harmed or killed by the vaccine,
the Vaccine Information Statement (VIS) federally mandated to be given to parents, says: “Hepatitis
B is a very safe vaccine. Most people do not have any problems with it. Severe problems are
extremely rare.”
This is similar to the statement in the MDH SONAR: “Studies have found that the hepatitis B vaccine is
safe. It has been in use for over 25 years and few serious side effects have been noted.”
This denial of risk to parents renders the exemption meaningless, because parents are not made
aware that they should consider an exemption due to possible harm.
With the government wanting to require a vaccine with so many documented injuries
and deaths, one would think that there must be a severe epidemic threatening a
large portion of the population. On the contrary, the disease is extremely rare, can
only be spread by contact with blood or bodily fluids, and is declining rapidly.
Requiring the hepatitis B vaccine is not needed because the incidence of
the disease is so low and is consistently dropping.
Incidence of acute hepatitis B (new cases) nation-wide has decreased from a high of 11.5 per
hundred thousand population in 1985 to 1.3 per hundred thousand in 2008.
Table 1a. Reported number and rate per 100,000 population of cases of acute, symptomatic, viral hepatitis,
by type and year, United States, 1966-2008
Hepatitis A
Year
Hepatitis B
No.
Hepatitis C
No.
Rate
Rate
No.
Rate
1985¶
23257
10.0
26654
11.5
4,192§
1.8§
1986¶
23430
10.0
26107
11.2
3,634§
1.6§
1987
25280
10.4
25916
10.7
2,999§
1.2§
1988
28507
11.6
23177
9.4
2,619§
1.1§
1989
35821
14.4
23419
9.4
2,529§
1.0§
1990
31441
12.6
21102
8.5
2,553§
1.0§
1991
24378
9.7
18003
7.1
3,582§
1.4§
1992
23112
9.1
16126
6.3
6010
2.4
1993
24238
9.4
13361
5.2
4786
1.9
1994
26796
10.3
12517
4.8
4470
1.8
1995
31582
12.0
10805
4.1
4576
1.7
1996
31032
11.7
10637
4.0
3716
1.4
1997
30021
11.2
10416
3.9
3816
1.4
1998
23229
8.6
10258
3.8
3518
1.3
1999
17047
6.3
7694
2.8
3111
1.1
2000
13397
4.8
8036
2.9
3197
1.1
2001
10615
3.7
7844
2.8
1,640**
0.7**
2002
8795
3.1
8064
2.8
1,223 ††
0.5 ††
2003
7653
2.6
7526
2.6
891††
0.3 ††
2004
5683
1.9
6212
2.1
758
0.3
2005
4488
1.5
5494
1.8
694
0.2
2006
3579
1.2
4,713§§
1.6§§
802
0.3
2007¶¶
2979
1.0
4519
1.5
849
0.3
2008¶¶
2585
0.9
4,033***
1.3***
878***
0.3
Source: National Notifiable Diseases Surveillance System, 1966-2008.
In infants, incidence of hepatitis B is extremely low
This chart of acute hepatitis B in the US by age group shows that in 0 – 19 year olds, the rate has
essentially been near zero since 2004. And all other age groups have been steadily dropping.
NIH reports that the rate of acute hepatitis in children is now 0.1 per 100,000. (0.0001%)
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3290915/
Incidence of hepatitis B has dropped particularly sharply in children
Incidence of hepatitis B in the US has dropped precipitously since From 1990 to 2004, and especially in children.
“Incidence among children aged <12 years declined 94%, from 1.1 to 0.36 per 100,000 population.” CDC: A
comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States. Recommendations of
the Advisory Committee on Immunization Practices (ACIP).
Author’s note: 0.36 per 100,000 equals 0.00036%
The strategy of testing pregnant women and treating and vaccinating their infants, along with offering
voluntary vaccinations to infants, is having spectacular success, and adding a rule to require
vaccination is not needed.
In Minnesota, a very rare disease is even more rare
In Minnesota, rates are some of the lowest in the nation and consistently dropping. Where the
national average for acute hepatitis B has dropped from 11.5 per hundred thousand down to 1.3, in
Minnesota, our rate has dropped down to 0.4 per hundred thousand in 2010, (almost all of them
adults). This is 0.0004% for acute cases.
Reported cases of acute hepatitis B, by state ― 2006–2010 (per hundred thousand)
State
2006
Rate*
2007
(No.)
Rate
2008
(No.)
Rate
2009
(No.)
Rate
2010
(No.)
Rate
(No.)
Alabama
2.1
(95)
2.8
(128)
2.3
(109)
1.9
(89)
1.4
Alaska
1.2
(8)
1.3
(9)
1.5
(10)
0.6
(4)
0.7
(5)
Arizona
U†
U
1.3
(81)
1.2
(80)
0.6
(42)
0.4
(26)
Arkansas
3.1
(87)
2.5
(72)
2.3
(67)
2.2
(65)
2.3
(66)
California
1.2
(427)
1.1
(402)
0.8
(303)
0.7
(258)
0.7
(252)
Colorado
0.7
(34)
0.7
(35)
0.7
(33)
0.5
(27)
0.9
(46)
Connecticut
1.4
(49)
1.1
(38)
0.9
(30)
0.5
(16)
0.6
(22)
Delaware
5.5
(47)
1.7
(15)
U
U
U
U
U
U
District of Columbia
1.5
(9)
U
U
U
U
1.7
(10)
0.5
(3)
Florida
2.3
(42)0
1.8
(337)
1.9
(344)
1.6
(299)
1.6
(297)
Georgia
2.2
(205)
1.6
(155)
1.9
(187)
1.5
(144)
1.7
(165)
Hawaii
0.6
(8)
1.3
(17)
0.5
(7)
0.5
(6)
0.4
(6)
Idaho
1
(15)
1
(15)
0.8
(12)
0.7
(11)
0.4
(6)
Illinois
1
(132)
1
(129)
1.4
(184)
0.9
(118)
1.1
(135)
Indiana
1.3
(80)
1
(64)
1
(67)
1.2
(74)
1.2
(75)
Iowa
0.7
(21)
0.9
(26)
0.8
(24)
1.2
(37)
0.5
(15)
Kansas
0.4
(11)
0.3
(9)
0.3
(9)
0.2
(6)
0.4
(11)
Kentucky
1.6
(69)
1.8
(76)
2.4
(101)
2.1
(90)
3.1
(136)
Louisiana
1.5
(63)
2.3
(100)
2.1
(94)
1.6
(73)
1.2
(55)
2
(26)
1.4
(19)
1.1
(15)
1.1
(15)
1.0
(13)
Maryland
2.6
(148)
2
(113)
1.5
(85)
1.3
(72)
1.2
(67)
Massachusetts
0.3
(19)
0.6
(42)
0.3
(21)
0.3
(17)
0.2
(13)
Michigan
1.4
(141)
1.2
(120)
1.5
(149)
1.3
(132)
1.2
(122)
Minnesota
0.6
(32)
0.5
(25)
0.5
(25)
0.7
(38)
0.4
(23)
Mississippi
0.4
(13)
1.3
(37)
1.7
(50)
1.1
(33)
1.1
(33)
Missouri
1.1
(62)
0.7
(39)
0.6
(38)
0.8
(47)
1.1
(67)
Montana
0.5
(5)
0.1
(1)
0.2
(2)
0.1
(1)
0
(0)
Nebraska
1.1
(20)
0.7
(13)
0.5
(9)
1.2
(22)
0.7
(12)
Nevada
1.7
(42)
1.9
(49)
1.6
(43)
1.3
(34)
1.5
(41)
New Hampshire
0.8
(11)
0.4
(5)
0.6
(8)
0.5
(6)
0.4
(5)
New Jersey
1.9
(164)
1.9
(162)
1.4
(118)
1.1
(93)
0.9
(77)
New Mexico
1.2
(24)
0.7
(13)
0.6
(12)
0.4
(8)
0.2
(5)
1
(202)
1.1
(211)
0.9
(173)
0.7
(129)
0.7
(139)
North Carolina
1.8
(159)
1.4
(128)
0.9
(81)
1.1
(104)
1.2
(113)
North Dakota
0.2
(1)
0.3
(2)
0.3
(2)
U
U
U
U
Ohio
1.1
(123)
1.1
(124)
1
(118)
0.8
(88)
0.8
(95)
Oklahoma
2.7
(96)
4.2
(152)
3.5
(129)
3.3
(122)
3.1
(115)
Oregon
2.2
(82)
1.6
(59)
1.1
(41)
1.2
(44)
1.1
(42)
Pennsylvania
1.4
(172)
1.5
(188)
1.2
(157)
0.8
(106)
0.6
(72)
Rhode Island
1
(11)
1.5
(16)
U
U
U
U
U
U
South Carolina
2.2
(97)
1.5
(65)
1.6
(71)
1.2
(56)
1.3
(59)
South Dakota
0.6
(5)
0.9
(7)
U
U
0.5
(4)
0.2
(2)
Maine
New York
(68)
Tennessee
2.5
(155)
2.3
(144)
2.4
(149)
2.2
(136)
2.4
(150)
Texas
3.6
(833)
3.1
(741)
2.3
(562)
1.7
(420)
1.6
(394)
1
(26)
0.6
(15)
0.5
(14)
0.2
(5)
0.3
(8)
0.6
(4)
0.8
(5)
0.5
(3)
U
U
0.3
(2)
1
(78)
1.9
(144)
1.7
(130)
1.4
(110)
1.2
(97)
Washington
1.2
(74)
1
(65)
0.9
(56)
0.7
(48)
0.7
(50)
West Virginia
4.1
(74)
4.5
(82)
4.6
(83)
4.6
(84)
4.7
(88)
Wisconsin
0.6
(33)
0.4
(20)
0.3
(18)
0.4
(24)
0.9
(54)
Wyoming
0.2
(1)
1
(5)
1.1
(6)
0.7
(4)
0.5
(3)
Total
1.6
(4,713)
1.5
(4,519)
1.3
(4,029)
1.1
(3,371)
1.1
(3,350)
Utah
Vermont
Virginia
Acute Hepatitis B Statistics in Minnesota
Number of Acute Cases per Year, 1998 – 2012
Acute hepatitis B is defined as persons who are symptomatic and newly infected.
Year
HAV
HBV
HCV
1998
145
53
19
1999
128
63
25
2000
197
39
13
2001
47
34
20
2002
53
45
10
2003
52
43
16
2004
59
42
16
2005
36
40
12
2006
31
32
11
2007
94
25
28
2008
49
25
22
2009
30
39
15
2010
37
24
15
2011
27
20
18
2012*
29
16
29
* In 2012 the case definition for acute hepatitis B and C changed to include asymptomatic cases with a positive test for hepatitis C six months or
less after a negative antibody test (seroconversion). Of the 29 acute hepatitis C cases, six were asymptomatic seroconverters and of the 16 acute
hepatitis B cases, two were asymptomatic seroconverters.
Hepatitis B in infants in Minnesota, the group affected by the proposed rule
Hepatitis B is transmitted only by exchange of bodily fluids such as blood. The disease exists primarily
in adults and is transmitted most commonly through sexual contact, through sharing of needles
during injected drug use, or in accidental needle sticks in health care workers.
Persons with Chronic HBV in MN by Age, 2012
Incidence of chronic hepatitis B infection in children (defined as persons infected for longer than six
months)
MDH reported that there are actually zero cases of acute hepatitis in Minnesota children and a total
of 27 cases of recorded chronic hepatitis in Minnesota children between the ages of 0 and 4. That
includes all children who have ever had evidence of infection (they may not be ill or symptomatic, but
have had laboratory evidence from blood tests.) Twenty-seven cases in four years equates to an
average of 7 cases per year, or 7 cases per birth cohort of 70,000 babies born each year. Seven out of
70,000 is 1 in 10,000, or 0.01% of Minnesota preschoolers that are known to be infected.
Minnesota children are already required to receive the hepatitis B vaccine for entrance to
Kindergarten and again in 7th grade. So those existing vaccinations are intended to provide protection
for the time when they might become sexually active, or use illegal injectable drugs.
This new proposed rule is ostensibly to protect children between the time of their birth and entrance
to Kindergarten. Yet, in Minnesota, as in the rest of the nation, hepatitis B infection in childhood is so
rare as to be nearly zero. Vaccinating Minnesotans in infancy is not needed.
Most cases of hepatitis B in children are from perinatal infection (childbirth)
Further study of the epidemiology of hepatitis B in infants reveals that the major route for infants to
be infected is perinatal infection, or transmission from an infected mother to her baby at childbirth.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3290915/
Screening of women in pregnancy has been extremely successful. The SONAR statement mentioned
that since vaccination for hepatitis B for infants was introduced in 1991, the incidence of the disease
in infants has plummeted. But SONAR did not mention that screening of pregnant women for
hepatitis B began at nearly the same time - in 1988. Virtually all women receiving medical care in
pregnancy are now checked for hep B. If they are found to be positive for HsAg (infected) then their
infant, when born, is treated immediately with immunoglobulin, and also receives three doses of hep
B vaccine. Once a women has been identified to be positive for hep B, all of her family members and
contacts can be tested and treated.
This program has proven to be extremely effective, and is stopping the disease at the very place
where it is most commonly transmitted to infants. These infants are all retested at 9 to 15 months.
Almost all of the children thus treated do not develop hepatitis. A few every year do develop it, and
most of the children in the 27 cases of hepatitis in preschoolers come from this group.
This paragraph from the MDH Infection Control Newsletter describes the program and the results for
2009:
In addition to the 39 hepatitis B cases, 4 perinatal infections were identified in infants who tested positive for
HBsAg during post-vaccination screening performed between 9 and 15 months of age. The infants were born in
2008. The perinatal infections were identified through a public health program that works to ensure appropriate
prophylactic treatment of infants born to HBV-infected mothers. All four infants were born in the United States
and had received hepatitis B immune globulin and 3 doses of hepatitis B vaccine in accordance with the
recommended schedule and were therefore considered treatment failures. Despite these treatment failures, the
success of the public health prevention program is demonstrated by the fact that an additional 321 infants born
to HBV-infected women during 2008 had post-serologic testing demonstrating no infection.
This approach, which concentrates on high-risk individuals, is reasonable and is working well. Since
the advent in 1988 of comprehensive testing of all pregnant women for HBsAg, including followup of
those positive for hep B, and offering post-exposure immunoprophylaxis, as well as in 1991 of offering
vaccination of some babies, the incidence of hepatitis B in infants has dropped by 95% and appears to
be continuing to drop.
These infants make up a major share (at least 15) of the 27 cases counted as chronic hepatitis B in
preschoolers. Vaccinating all the healthy babies in Minnesota would not prevent these cases.
How many cases in infants would be prevented by this rule?
In the last four years of statistics in Minnesota infants thus treated, at least 15 were known to be
perinatal cases. So out of 27 current preschoolers with chronic hep B, 15 were detected at birth,
treated, and vaccinated. That leaves 12 cases in four years, or about 3 cases per year, of unknown
origin of infection. So with an estimated 280,000 preschoolers age 0 – 4, there are 12 or fewer total
cases (3 per year) where the infection was not from birth, not identified right away.
The MDH goal of vaccinating all infants in order to wipe out transmission of hepatitis B would
require vaccinating 70,000 children every year to prevent 3 cases, or vaccinating 23,000 children to
prevent each case. This is not a reasonable or needed strategy, especially given that those 69,997
children that would not be exposed would be put at risk of injury from the vaccine.
Requiring the hepatitis B vaccine is not needed because the incidence is so
low, and is already declining significantly. Strategies to eliminate this
disease are working.
The existence of an exemption option in MN does not justify requiring any
and all vaccines
One could argue that because Minnesota has exemption available to parents, then it is reasonable to
require a vaccine if there is any need. But using this argument, one could impose any vaccine
requirement desired on the populace, even if there is little to any occurrence of a disease, and even if
the vaccine clearly causes a severe risk of injury to a high percentage of recipients.
So the existence of an exemption can not justify adding any and all vaccines to the immunization
schedule. Consideration must be given to the actual need for the intervention, safety of the vaccine,
and the risk/benefit ratio. In the case of this disease, the risk of harm from the vaccine may be
greater than the risk of contracting the disease.
The exemption option becomes meaningless if parents have not been truthfully informed of the
actual risks of the vaccine.
The Vaccine Information Statement (VIS) federally mandated to be given to parents, says only:
“Hepatitis B is a very safe vaccine. Most people do not have any problems with it.
The vaccine contains non-infectious material, and cannot cause hepatitis B infection. Some mild
problems have been reported:
• Soreness where the shot was given (up to about 1 person in 4).
• Temperature of 99.9°F or higher (up to about 1 person in 15).
Severe problems are extremely rare. Severe allergic reactions are believed to occur about once in 1.1
million doses. A vaccine, like any medicine, could cause a serious reaction. But the risk of a vaccine
causing serious harm, or death, is extremely small.”
Parents of vaccine-injured children often comment that they were led to believe that no serious harm
would come, nothing worse than a fever and sore arm, from a vaccine. If the government requires a
dangerous vaccine, while denying its danger, it is betraying the trust of its citizens, and bears
responsibility for the devastation that is caused in many lives.
Reasonable strategies instead of requiring the hepatitis B vaccine
Current strategy is working. Incidence of hepatitis B has been reduced by 95% and is still dropping.
Automatically exempt from vaccination requirements all babies born to mothers who tested
negative in pregnancy.
Many leading European countries do not require hepatitis B vaccine for all infants, even though it
has been available for 18 years.
•
•
•
•
•
Finland: “Hepatitis B vaccine is given only to infants of HbsAg carrier mothers or fathers at the age of 0, 1, 2 and
12 months.”
Denmark: “Vaccination against hepatitis B is recommended to children of HBsAg-positive mothers starting at birth
with both hepatitis B immunoglobulin and one dose of HepB.”
Norway: “HepB is recommended for risk groups only.”
Sweden: “HepB is only recommended to children considered high-risk groups. Vaccination is given at birth to
infants of mothers positive for hepatitis B.”
The Netherlands: “Only for children born to HBsAg positive mothers.”
Continue to screen pregnant women and follow up with their infants and all close
contacts.
Continue to focus on the adult groups where transmission is highest.
Summary
The goal to eliminate a particular infectious disease must not be pursued at the expense of causing
chronic disease in the population.
The standard of safety for a preventive medical procedure must be extremely high. For the state to
require it, it must be even higher. The state should not require any vaccine until it has been tested
against a placebo group with no vaccine (in most studies the placebo is a different vaccine), the
subjects are followed long –term to observe for chronic disease (not done except in very small
numbers), and the data from the original large scale safety studies are made available to the public.
The hepatitis B vaccine does not meet this standard of safety. On the contrary, there is voluminous
evidence that it has harmed many people.
Vaccination of all infants with hepatitis B vaccine is unreasonable because the documentation of
risk of death and chronic disease and disability from the vaccine is clear.
In the case of this disease, the risk of harm from the vaccine may be greater than the risk of
contracting the disease.
Vaccination of all infants for hepatitis B is not needed because incidence in infants and children is
extremely low, and incidence in babies is primarily from perinatal (birth) infection, which is already
being detected and treated at birth. As shown above, it would be required to vaccinate 23,000
babies to prevent each case of chronic hepatitis in infants.
We already have in place an effective tool for addressing this transmission and it is working well: all
mothers are tested for hepatitis B in pregnancy. If the mother is infected, then her baby is given
immunoglobulin and hepatitis B vaccine at birth. Families and close contacts are notified and
offered vaccination. This approach is extremely effective, and efficiently targets the primary mode
of transmission of hepatitis B to infants in Minnesota. Since the introduction of this program, and
at the same time, offering hepatitis B vaccine to infants (parents) on a voluntary basis, the incidence
of hepatitis B in small children has declined by 94% and it is continuing to drop every year.
It is not reasonable to require hepatitis B vaccine for babies whose
mothers tested negative for hepatitis B in pregnancy
All pregnant women are tested for hepatitis B in pregnancy.
It is not reasonable to require a mother who already tested negative for hepatitis B during
pregnancy to submit her infant to the risk of a hepatitis B vaccine because:
We know her baby was not exposed to hepatitis B in childbirth.
We know her baby’s chances of being exposed to hepatitis B until old enough to engage in
adult risky behavior of sexuality or drug use are miniscule
The Hep B vaccine is well-documented to have adverse, including death.
The parents have not been truthfully informed of the actual risks of the vaccine and so the
exemption is meaningless.
In an effort to eliminate an infectious disease, we are creating chronic diseases in our children.
Health care should be individualized to meet the needs of each patient. Public health programs, on
the other hand, target epidemics, or diseases. Their goal is to eliminate a disease. The SONAR
stated, “If we continue with this strategy, we have a chance of eliminating or greatly reducing the
incidence of this disease in the United States in one or two generations.”
Unfortunately, in order to do so, it may require seriously harming some individuals. We should not
put at risk hundreds of thousands of children who are never going to be exposed to this disease.
It is absolutely unreasonable for the State of MN to require this vaccine under the above
circumstances.