From:
To:
Subject:
Date:
Attachments:
Christina Abel
*OAH_RuleComments.OAH
Immunization Rules docket 0900-30570
Thursday, June 27, 2013 9:51:07 AM
Hepatitis A MN 1.docx
Attachment is my letter
Hepatitis A Vaccine
Requiring Hepatitis A vaccine for daycare is neither needed nor reasonable. The disease is very rare in Minnesota, especially in Minnesota
children.
70% of young children who contract hepatitis A are usually without symptoms. “A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions.”
Minnesota children have been hospitalized after receiving the Hepatitis A vaccine.
Day care providers are not recommended by the ACIP to be routinely vaccinated against hepatitis A.
It is already on the Child Care Immunization form as a recommended vaccine, hepatitis A vaccine, 2 doses.
http://www.health.state.mn.us/divs/idepc/immunize/laws/childcareimzrec.pdf
Thank you,
Chris Abel
National Vaccine Injury Compensation Program
For easy access to links:
Joint Stipulation on Damages; Hepatitis A (hep A) vaccine; Prevnar vaccine; idiopathic thrombocytopenic purpura (ITP) D.P.M., by and through MICHAEL
and HEATHER MULLEN, as parents and natural guardians, December 11, 2012
Decision by Stipulation; Hepatitis A Vaccine; Seizure Disorder; Postural Orthostatic Tachycardia Syndrome JADA TOLSON November 26, 2012
Stipulation; DTap; Hep A; Serum Sickness ROBERT SMITH and AMY SMITH, as the parents and natural guardians of, L.S., an infant 11/13/2012
Damages decision based on stipulation;Hepatitis A vaccine; tetanus vaccine; polio vaccine; influenza vaccine; acute disseminated encephalomyelitis
WHITNEY MANCINO PHEND,
10/11/2012
Damages decision based on stipulation; meningococcal vaccine; Hepatitis A vaccine; Varicella vaccine; Human Papillomavirus vaccine; Guillain-Barre
syndrome; chronic headache TANYA L. STEWART, as parent and natural guardian of A.A.S., 10/02/2012
Stipulation; hepatitis A; tetanue, diphtheria, acellular pertussis vaccines; Toxic Epidermal Necrolysis LATIA GRAHAM (OK) 06/25/2012
Stipulation; hepatitis A vaccine; anaphylactic shock; seizures; cardiac arrest; irreversible brain damage; death (175,000)DEBORAH and JAMEY McBEE, Individually, and
DEBORAH McBEE, as the Court appointed personal administrator of the Estate of KENNETH BLAKE McBEE 06/22/2012
Damages; decision based on proffer; varicella, tetanus-diphtheria-acellular pertussis (Tdap) vaccine; meningococcal vaccine (MCV), hepatitis A. KAITLYN
E. AHOLT 06/18/2012 she experienced an episode of syncope immediately after receiving these vaccinations on July 15, 2012, which caused her to suffer
various injuries to her face, jaw and teeth.
Stipulation; Hepatitis A (Hep A) vaccine; neuropsychiatric impairment; fibromyalgia FREDDIE GRIGSBY 04/04/2013
Hepatitis A; Gardasil; Menactra; Influenza vaccines; Acute Disseminated Encephalomyelitis, Transverse Myelitis; Decision; Stipulation.TIANA TOCIO
03/28/2013
Stipulation; Influenza; Meningococcal; Inactivated polio; DTaP; Hepatitis A; Hepatitis B; MMR; Splenic rupture WILLIAM JEFFREY BISHOP, March 27, 2013
Damages decision based on stipulation; measles-mumps-rubella vaccine; hepatitis A vaccine; varicella vaccine; opsoclonus-myoclonus syndrome JOHN
VALUCKAS and CYNDI VALUCKAS, parents of P.V.,a minor, January 29, 2013
Stipulation; hepatitis A vaccine; Guillain-Barré Syndrome. Alexis Campbel, January 22, 2013
Vaccine Adverse Reporting System / Minnesota
This is a passive reporting system with unknown percent not reported. The hepatitis A vaccine may be given with other vaccines. The adverse event may
be coincidental or causal. Minnesota Children less than 6 years of age
Found 137 events where Age is under-6 and Location is Minnesota and Vaccine is HEP A http://www.medalerts.org/vaersdb/findfield.php?
EVENTS=on&PAGENO=2&PERPAGE=10&ESORT=NONE&REVERSESORT=&LOWAGE=%280%29&HIGHAGE=%286%29&WhichAge=range&STATE=%28MN%29&VAX=%28HEPA%29
Found 63 events where Age is under-6 and Location is Minnesota and Vaccine is HEP A and ER Visit or Dr visit
http://www.medalerts.org/vaersdb/findfield.php?
EVENTS=on&PAGENO=2&PERPAGE=10&ESORT=NONE&REVERSESORT=&LOWAGE=%280%29&HIGHAGE=%286%29&WhichAge=range&STATE=%28MN%29&VAX=%28HEPA%29&ER_VISIT=Yes
Hepatitis A
Requiring hepatitis A vaccination for a child enrolling in child care or a school-based early childhood
program is neither reasonable nor needed because there are so few cases and the disease is not serious
in this age group.
From SOAR, P 33 “Childhood Risk Historically, children 2 through 18 years of age have had the highest
rates of hepatitis A disease, with children under five having the highest incidence of infection.”
The U.S. information seems to show children today, less than 5, have the lowest rate for hepatitis A.
The number of acute cases in Minnesota is rare with the median age 25 to 40 years of age.
Number of Acute Hepatitis A Cases and Per 100,000 Population, 2006-2011
2011, 27 cases of hepatitis A (HAV) (0.5 / 100,000 population) 3 to 86 years (median, 27 years)
2010, 37 cases of hepatitis A (HAV) (0.7/ 100,000 population) 3 to 74 years (median, 38 years).
2009, 30 cases of hepatitis A (HAV) (0.6 / 100,000 population) 10 months to 71 years (median, 41 years)
2008, 49 cases of hepatitis A (0.9 p/100,000 population) 5 to 84 years (median, 40 years).
2007, 94 cases of hepatitis A (1.8 / 100,000 population) 1 to 89 years (median, 40 years).
2006, 31 cases of hepatitis A (0.6 /100,000 population) 3 to 76 years (median, 25 years).
http://www.health.state.mn.us/divs/idepc/newsletters/dcn/index.html
P 30 “The ACIP urged that its recommendation for hepatitis A vaccine be implemented in states,
counties or communities where there was Moderate incidence of hepatitis A disease. As a result, the
largest declines in disease incidence were in areas in which routine vaccination of children was
occurring.”
Yes it worked in Minnesota when the incidence rate of hepatitis A in American Indians declined steadily
from 10.4 per 100,000 in 1999 to 6.0, 3.7, and 2.5 per 100,000, in 2000, 2001, and 2002 respectively,
demonstrating the success of targeted immunization. Minnesota Viral Hepatitis A, 2007
http://www.health.state.mn.us/divs/idepc/newsletters/dcn/sum07/vhepa.html
But it does not mean all Minnesota children should be required to be vaccinated to attend daycare
when their risk for both contracting and complications of hepatitis A infection is very rare.
P 30 “Currently, 16 states require the Hepatitis A vaccine for children in child care.”
Most states do not require the Hepatitis A vaccine for children in child care.
The Hepatitis A vaccine requirement for children in daycare will be targeting a low risk group (70%
without symptoms) but who would benefit from an infection if contracted at this age developing lifelong
immunity. Natural immunity will protect the person later in life without boosters when the
complications, including hospitalization, increases.
From the SONAR p 31,“Among older children and adults, infection is usually symptomatic, with jaundice
occurring in more than 70% of cases. Hepatitis A disease can be quite serious. Among reported cases of
hepatitis A, eleven to twenty-two percent required hospitalization, with people age 60 and over more
likely to be hospitalized”.
P 38 “Young children often show no signs of Hepatitis A disease, but they can be the major disease
reservoir for older children and adults.”
If there was a concern for children spreading hepatitis A in daycare maybe daycare workers should also
be required to be vaccinated. But no, daycare workers (or Healthcare workers or sewage and solid
waste disposal workers) are not even recommended by the ACIP to be routinely vaccinated against
hepatitis A. “Although child care centers might have been the source of outbreaks of hepatitis A in
certain communities, disease in child care centers more commonly reflects extended transmission from
the community.”
CDC’s Ask the Expert: http://www.immunize.org/askexperts/experts_hepa.asp
United States, 2004–2008, death from Hepatitis A in person 0-34 years of age is extremely small, it is
statistically 0 per 100,000 population. Centers for Disease Control and Prevention Viral Hepatitis Statistiscs and
Surveillance. http://www.cdc.gov/hepatitis/Statistics/2010Surveillance/Table2.3.htm
“A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions.
The risk of hepatitis A vaccine causing serious harm, or death, is extremely small.” VIS/hep A vaccine
http://www.immunize.org/vis/hepatitis-a.pdf
The National Vaccine Injury Compensation Program has compensated a family for a hepatitis A vaccine
reaction resulting in the death of their daughter. She suffered an anaphylactic shock, seizures, cardiac
arrest, irreversible brain damage and death after her Hepatitis A vaccine. Stipulation; hepatitis A vaccine;
anaphylactic shock; seizures; cardiac arrest; irreversible brain damage; death
Hepatitis A Vaccine Information
It seems the Clinical trial included different potency of Havrix or was given alone or concomitantly with
other routine childhood vaccinations. No Placebo
Vaccine ingredient:
Hep A (Havrix) - aluminum hydroxide, amino acid supplement, polysorbate 20, formalin, neomycin
sulfate, MRC-5 cellular proteins
Havrix http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM224555.pdf
Some of the adverse events after vaccination:
Of solicited adverse events in clinical trials of adults, who received HAVRIX 1440 EL.U., and children (2
years of age and older), who received eitherHAVRIX 360 EL.U. or 720 EL.U., the most frequently
reported was injection-site soreness (56% of adults and 21% of children); less than 0.5% of soreness was
reported as severe.
Headache was reported by 14% of 3adults and less than 9% of children. Other solicited and unsolicited
events occurring during clinical trials are listed below.
Incidence 1% to 10% of Injections:
Metabolism and Nutrition Disorders: Anorexia.
Gastrointestinal Disorders: Nausea.
General Disorders and Administration Site Conditions: Fatigue, fever >99.5°F (37.5°C), induration,
redness, and swelling of the injection site; malaise.
Incidence <1% of Injections:
Infections and Infestations: Pharyngitis, upper respiratory tract infections.
Blood and Lymphatic System Disorders: Lymphadenopathy.
Psychiatric Disorders: Insomnia.
Nervous System Disorders: Dysgeusia, hypertonia.
Eye Disorders: Photophobia.
Ear and Labyrinth Disorders: Vertigo.
Gastrointestinal Disorders: Abdominal pain, diarrhea, vomiting.
Skin and Subcutaneous Tissue Disorders: Pruritus, rash, urticaria.
Musculoskeletal and Connective Tissue Disorders: Arthralgia, myalgia.
General Disorders and Administration Site Conditions: Injection site hematoma.
Investigations: Creatine phosphokinase increased.
In clinical trials, it seems children received VAQTA alone (no placebo) or with other vaccines (no placebo)
or children received either VAQTA or an alum diluents = amorphous aluminum hydroxyphosphate sulfate
as the placebo.
Hep A (Vaqta) - amorphous aluminum hydroxyphosphate sulfate, bovine albumin, formaldehyde,
neomycin, sodium borate, MRC-5 (human diploid) cells
Hepatitis A Vaqta http://www.merck.com/product/usa/pi_circulars/v/vaqta/vaqta_pi.pdf
The most common local adverse reactions and systemic adverse events (≥15%) reported in different
clinical trials across different age groups when VAQTA was administered alone or concomitantly were:
•Children — 12 through 23 months of age: injection-site pain/tenderness (37.0%), injection-site
erythema (21.2%), fever (16.4% when administered alone, and 27.0% when administered
concomitantly).
•Children/Adolescents — 2 through 18 years of age: injection-site pain (18.7%)
The following additional unsolicited local adverse reactions and systemic adverse events were observed
at a common frequency of ≥1% to <10% in any individual clinical study. This listing includes only the
adverse reactions not reported elsewhere in the label. These local adverse reactions and systemic
adverse events occurred among recipients of VAQTA alone or VAQTA given concomitantly within 14
days following any dose of VAQTA across four clinical studies
•
•
•
•
•
•
•
•
Eye disorders: Conjunctivitis
Gastrointestinal disorders: Constipation; vomiting
General disorders and administration site conditions: Injection-site bruising; injection-site
ecchymosis
Infections and infestations: Otitis media; nasopharyngitis; rhinitis; viral infection; croup;
pharyngitis streptococcal; laryngotracheobronchitis; viral exanthema; gastroenteritis viral;
roseola
Metabolism and nutrition disorders: Anorexia
Psychiatric disorders: Insomnia; crying
Respiratory, thoracic and mediastinal disorders: Cough; nasal congestion; respiratory congestion
Skin and subcutaneous tissue disorders:Rash vesicular; measles-like/rubella-like rash; varicellalike rash; rash morbilliform
6.2 Post-Marketing Experience
Blood and lymphatic disorders: Thrombocytopenia.
Nervous system disorders: Guillain-Barré syndrome; cerebellar ataxia; encephalitis.
Your will find some of the above adverse events and more in both the National Vaccine Injury
Compensation Program and Vaccine Adverse Reporting System web sites after Hepatitis A vaccination.
National Vaccine Injury Compensation Program
Some of the National Vaccine Injury Compensation Program rulings include “Respondent (the
government) denies injury/death was caused-in-fact by vaccination, nonetheless, the parties agreed
informally to resolve this matter ...
Most petitioners received multiple vaccines. Highlighted the diagnosed injuries in green
Definitions:
idiopathic thrombocytopenic purpura (ITP)"of unknown cause the immune system malfunctions and
begins attacking platelets as if they were foreign substances (causing bleeding or brusing).
Acute Disseminated Encephalomyelitis (ADEM) is a rare inflammatory demyelinating disease of the
central nervous system. ADEM is thought to be an autoimmune disorder in which the body’s immune
system mistakenly attacks its own brain tissue, triggered by an environmental stimulus in genetically
susceptible individuals.
Guillain-Barre Syndrome disorder in which your body's immune system attacks your nerves.
transverse myelitis inflammation of the spinal cord
opsoclonus myoclonus rare neurological disorder characterized by an unsteady, trembling gait,
myoclonus (brief, shock-like muscle spasms), and opsoclonus (irregular, rapid eye movements). Other
symptoms may include difficulty speaking, poorly articulated speech, or an inability to speak. A decrease
in muscle tone, lethargy, irritability, and malaise (a vague feeling of bodily discomfort) may also be
present.
Joint Stipulation on Damages; Hepatitis A (hep A) vaccine; Prevnar vaccine; idiopathic
thrombocytopenic purpura (ITP) D.P.M., by and through MICHAEL and HEATHER MULLEN, as parents
and natural guardians, December 11, 2012
Decision by Stipulation; Hepatitis A Vaccine; Seizure Disorder; Postural Orthostatic Tachycardia
Syndrome JADA TOLSON November 26, 2012
Stipulation; DTap; Hep A; Serum Sickness ROBERT SMITH and AMY SMITH, as the parents and natural
guardians of, L.S., an infant 11/13/2012
Damages decision based on stipulation;Hepatitis A vaccine; tetanus vaccine; polio vaccine; influenza
vaccine; acute disseminated encephalomyelitis WHITNEY MANCINO PHEND,
10/11/2012
Damages decision based on stipulation; meningococcal vaccine; Hepatitis A vaccine; Varicella vaccine;
Human Papillomavirus vaccine; Guillain-Barre syndrome; chronic headache TANYA L. STEWART, as
parent and natural guardian of A.A.S., 10/02/2012
Stipulation; hepatitis A; tetanue, diphtheria, acellular pertussis vaccines; Toxic Epidermal
Necrolysis LATIA GRAHAM (OK) 06/25/2012
Stipulation; hepatitis A vaccine; anaphylactic shock; seizures; cardiac arrest; irreversible brain damage;
death (175,000)DEBORAH and JAMEY McBEE, Individually, and DEBORAH McBEE, as the Court appointed
personal administrator of the Estate of KENNETH BLAKE McBEE 06/22/2012
Damages; decision based on proffer; varicella, tetanus-diphtheria-acellular pertussis (Tdap) vaccine;
meningococcal vaccine (MCV), hepatitis A. KAITLYN E. AHOLT 06/18/2012 she experienced an episode
of syncope immediately after receiving these vaccinations on July 15, 2012, which caused her to suffer
various injuries to her face, jaw and teeth.
Stipulation; Hepatitis A (Hep A) vaccine; neuropsychiatric impairment; fibromyalgia FREDDIE GRIGSBY
04/04/2013
Hepatitis A; Gardasil; Menactra; Influenza vaccines; Acute Disseminated Encephalomyelitis, Transverse
Myelitis; Decision; Stipulation.TIANA TOCIO 03/28/2013
Stipulation; Influenza; Meningococcal; Inactivated polio; DTaP; Hepatitis A; Hepatitis B; MMR; Splenic
rupture WILLIAM JEFFREY BISHOP, March 27, 2013
Damages decision based on stipulation; measles-mumps-rubella vaccine; hepatitis A vaccine; varicella
vaccine; opsoclonus-myoclonus syndrome JOHN VALUCKAS and CYNDI VALUCKAS, parents of P.V.,a
minor, January 29, 2013
Stipulation; hepatitis A vaccine; Guillain-Barré Syndrome. Alexis Campbel, January 22, 2013
Vaccine Adverse Reporting System / Minnesota
This is a passive reporting system with unknown percent not reported. The hepatitis A vaccine
may be given with other vaccines. The adverse event may be coincidental or causal.
Minnesota Children less than 6 years of age
Found 137 events where Age is under-6 and Location is Minnesota and Vaccine is HEP A
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=on&PAGENO=2&PERPAGE=10&ESORT=NONE&REVERSESORT=&LOWAG
E=%280%29&HIGHAGE=%286%29&WhichAge=range&STATE=%28MN%29&VAX=%28HEPA%29
Found 63 events where Age is under-6 and Location is Minnesota and Vaccine is HEP A and ER Visit or Dr
visit
http://www.medalerts.org/vaersdb/findfield.php?EVENTS=on&PAGENO=2&PERPAGE=10&ESORT=NONE&REVERSESORT=&
LOWAGE=%280%29&HIGHAGE=%286%29&WhichAge=range&STATE=%28MN%29&VAX=%28HEPA%29&ER_VISIT=Yes
Found 3 events, Age under-6, in Minnesota, Vaccine is HEP A and Hospitalized
1-year-old developed symptoms one day after the Influenza, MMRV and Hep A vaccines:
Write-up: Erythema Multiforme Fever DC DX: erythema multiforme without mucositis or mucosal
involvement. Febrile viral upper respiratory illness. HX: presented with 2 day hx of progressive rash,
began on Friday evening 10/6/06. Seen in urgent care on 10/7/06. Had been receiving amoxicillin for
sinus infection had taken for approximately 1 week. Instructed to discontinue medication and begin
Benadryl. At time of presentation ot urgent care the rash was mild in appearance, however, over 12-24
hours rash spread and now involves ears and remainder of body surface. Not febrile during this
time.Sinus symptoms had resolved. PMX includes strep throat once and sinus infection once. Febrile
during hospitalization temp max of 104.
2-year-old developed symptoms 9 days after Hep A vaccine
Write-up: Patient had sudden onset of ataxia and right sided strabismus on 10-26-06, nine days after
hep A vaccine was administered. No other illness preceded or proceeded these symptoms. No history of
any such symptoms. She was transferred to the hospital. Symptoms resolved within 24 hours. No other
cause of symptoms was identified. We do not know if the vaccine was responsible for the reaction, but
with no other prodromal symptoms, we felt we should at least alert VAERS in case similar effects were
being observed elsewhere.
Medical record documents a healthy 2 year old at well child exam of 10/17/2006. Only c/o by mother is
right eye tearing greater than left. MD impression: Plugged right tear duct. Hep A vax given. Child
presented to ER on 10/26/2006 with balance problems, difficulty walking and strabismus. H&P
Impression: acute episode of stabismus and ataxia, somewhat improved. Hospital Opthamology Consult
for Right 6th nerve palsy reveals the following impression: Probable viral syndrome with secondary very
focal encephalitis with secondary posterior fossa symptoms and brain stem symptoms. Follow up with
PCP on 11/1/2006 reveals child has been well without problems since discharge from the hospital.
Impression: "Acute cerebellar ataxia of unknown etiology",
5 –year-old developed symptoms 11 days after receiving DTaP, Hep A, polio, MMR, and chickenpox
vaccines
Symptoms: Acute disseminated encephalomyelitis
SMQs:, Noninfectious encephalitis (narrow), Demyelination (narrow)
Write-up: Three hospitalizations; diagnosed with ADEM and treated with high-dose IV steroids.
Summary
Requiring Hepatitis A vaccine for daycare is neither needed nor reasonable. The disease is very rare in
Minnesota, especially in Minnesota children.
70% of young children who contract hepatitis A are usually without symptoms.
“A vaccine, like any medicine, could possibly cause serious problems, such as severe allergic reactions.”
Minnesota children have been hospitalized after receiving the Hepatitis A vaccine.
Day care providers are not recommended by the ACIP to be routinely vaccinated against hepatitis A.
It is already on the Child Care Immunization form as a recommended vaccine, hepatitis A vaccine, 2
doses. http://www.health.state.mn.us/divs/idepc/immunize/laws/childcareimzrec.pdf
Thank you,
Christina Abel, RN
3411 Winnetka Ave N
Crystal MN 55427
763-546-1708
Vaccine Awareness Minnesota