Hepatitis B Vaccine...aluminium....thimerosal (mercury)....yeast...but don't worry, it's gluten free!
"For over 20 years, one-day-old US infants have routinely been injected with hepatitis B vaccine. Parents never get to see their babies at a normal, un-medicated baseline" - Janet Levatin MD, Pediatrician.
Merck Sharp & Dohme (Aust.) Pty Ltd
Ingredients of the children's vaccine:
Hepatitis B vaccine (recombinant). Hepatitis B surface antigen; aluminium hydroxide 0.5 mg (adsorbant), thiomersal 1:20,000; vaccine; Gluten free.
Adult vaccine: ach 1 mL dose of vaccine contains 10 microgram of hepatitis B surface antigen adsorbed onto approximately 0.5 mg aluminium hydroxide; thiomersal (mercury derivative) 1:20,000 added as a preservative.
H-B-Vax II hepatitis B vaccine (recombinant) is a noninfectious subunit viral vaccine derived from surface antigen (HBsAg or Australia antigen) of hepatitis B virus produced in yeast cells.
The antigen is harvested and purified from fermentation cultures of a recombinant strain of the yeast Saccharomyces cerevisiae containing the gene for the adw subtype of HBsAg. The vaccine contains no detectable yeast DNA but may contain up to 1% yeast protein.
Adverse Reactions: Local pain and reactions; fatigue, headache, fever, GI upset; pharyngitis, URTI.
No adverse experiences were reported during clinical trials which could be related to changes in the titres 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.
The following adverse reactions were reported in clinical studies in healthy adults.
More common reactions.
(greater than or equal to 1% of injections.) Local reaction (injection site).
Injection site reactions (26% of doses) consisting principally of local pain, soreness, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, and nodule formation.
Body as a whole.
The most frequent systemic complaints include fatigue/asthenia (4.2%), fever greater than or equal to 37.8 deg. C (3.2%), malaise (1.2%).
Nausea (1.8%), diarrhoea (1.1%).
Pharyngitis (1.2%), upper respiratory infection (1.0%).
Less common reactions.
(< 1% of injections.) Body as a whole.
Sweating, achiness, sensation of warmth, lightheadedness, chills, flushing.
Vomiting, abdominal pains/cramps, dyspepsia, diminished appetite.
Rhinitis, influenza, cough.
Pruritus, rash (nonspecified), angioedema, urticaria.
Arthralgia including monoarticular, myalgia, back pain, neck pain, shoulder pain, neck stiffness.
The following additional adverse reactions have been reported with use of the marketed vaccine; however, in many instances a causal relationship to the vaccine has not been established.
Anaphylaxis and symptoms of immediate hypersensitivity reactions including oedema, dyspnoea, chest discomfort, bronchial spasm, or palpitation 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 arthritis (usually transient) and dermatological reactions such as erythema multiforme, ecchymoses and erythema nodosum (see Precautions).
Peripheral neuropathy including Bell's palsy; Guillain-Barre syndrome, optic neuritis.
Increased erythrocyte sedimentation rate.
Infants and young children.
The nature and incidence of systemic adverse reactions is different in infants and young children. In clinical studies, in infants up to one year of age and children one to ten years of age, reactions reported greater than or equal to 1% of doses given in studies were as follows.
Ages 0 to 1 years: irritability (3.2%), fever greater than or equal to 38.3 deg. C (2.8%), diminished appetite (2.8%), diarrhoea (2.5%), vomiting (1.8%), cough (1.4%), cold symptoms (1.1%).
Ages 1 to 10 years: cold symptoms (2.7%), viral infection (2.7%), fever greater than or equal to 38.3 deg. C (2.1%), cough (2.1%), injection site reactions (1.6%), diarrhoea (1.1%), rhinitis (1.1%), headache (1.1%).
Potential adverse effects.
In addition, a variety of adverse effects not observed in clinical trials with H-B-Vax II have been reported with H-B-Vax (plasma derived hepatitis B vaccine). Those listed below are to serve as alerting information to doctors.
Body as a whole.
Neurological disorders such as myelitis, including transverse myelitis; acute radiculoneuropathy and Herpes zoster.
Contraindications (people who shouldn't have the vaccine):
Hypersensitivity to any component of the vaccine.
Hypersensitivity to yeast (Saccharomyces cerevisiae). Patients who develop symptoms suggestive of hypersensitivity after an injection should not receive further injections of H-B-Vax II.
Persons with immunodeficiency or those receiving immunosuppressive therapy require larger vaccine doses and respond less well than healthy individuals. Included in this group are haemodialysis patients for whom 40 microgram doses are recommended. (See Pharmacology.)
Because of the long incubation period for hepatitis B, it is possible for unrecognised infection to be present at the time H-B-Vax II is given. H-B-Vax II may not prevent hepatitis B in such patients.
Further study is required to determine the effectiveness of H-B-Vax II in preventing hepatitis when the vaccine regimen is begun after an exposure to the hepatitis B virus has already occurred (i.e. use for postexposure prophylaxis). Information available so far suggests that efficacy is reduced in such cases.
As with any parenteral vaccine, adrenaline should be available for immediate use should anaphylaxis or an anaphylactoid reaction occur.
Any serious active infection is reason for delaying use of H-B-Vax II except when, in the opinion of the doctor, withholding the vaccine entails a greater risk.
Caution and appropriate care should be exercised in administering H-B-Vax II to individuals with severely compromised cardiopulmonary status or to others in whom a febrile or systemic reaction could pose a significant risk.
Use in pregnancy.
Animal reproduction studies have not been conducted with H-B-Vax II. It is not known whether H-B-Vax II can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. H-B-Vax II should be given to a pregnant woman only if clearly needed.
Use in lactation.
It is not known whether H-B-Vax II is excreted in human milk. However, studies with H-B-Vax II in 12 lactating women have failed to reveal evidence of this vaccine being secreted.
Hepatitis B vaccines now don't contain any human or animal blood products, but up until the early 1990's they were manufactured using the blood of Hepatitis B infected homosexual males.
Although thimerosal in children's vaccines was phased out in America in 2001, I have found Aventis Pasteur data sheets dated 2003 which list thimerosal in countries other than America.
Thimerosal is also used in the manufacturing process of most vaccinations and according to the manufacturer's, may still contain trace elements of the mercury derivative, even if it is labelled as mercury free.
Court Rules Hepatitis B Vaccine Caused Victims MS And Subsequent Death
Entitlement; Hep B vaccine;
two months later, Devic’s Disease
(a variant of MS) then 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.
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.
IT IS SO ORDERED
January 16, 2009 s/Laura D. Millman
DATE Laura D. Millman.
This was made by the US Court of Federal Claims.
18 Children Hospitalised After Hepatitis B Vaccination
Report by Orissadiary correspondent; Bhubaneswar: At least 18 children were hospitalised on Saturday after being administered the Hepatitis B vaccine at a health camp in Totapada village near Khurda by an NGO 'Naibedya'. Around 50 children were given the injection. 18 of them suddenly fell ill and were admitted to the district headquarter hospital after complaints of head reeling and vomiting. Secretary, Health and Family Welfare Anu Garg said an inquiry has been ordered.
These children were Papuna Kandi( nine months), Chitta Ranjan Muduli( 11 months), Achyuta Dehuri( 10 months), Lipi Begum ( 2 years), Hiddautula Khan ( 6 years), Masina Bibi ( 6 years), Afril Begum ( 6 years), Sunil Kandi ( 8 years), Sukanti Muduli ( 8 years), Khalida Begum ( 9 years), Khallim Khan ( 10 years), Alam Khan ( 6 years), Emran Khan ( 6 years), Chiita Muduli ( 14 months), Zaheed Begum ( 8 years), Mahamad Khan ( Nine years), Rasuda Begum ( 11 years) and Dayan Khan ( 6 years). After the police got a tip off, it raided the places and detained four people Dipak Kumar Mangaraj, Bholeswar Parida, Braja Kishore Rout, Trinath Sahu.
Meanwhile, the police detained four persons of the NGO in this regard. We are questioning the NGO personnel. The conditions of the infants were stable, Bikram Keshari Jena, the inspector-in-charge of Khurda police station said.
Source: Orissa Diary.com, 25th April 2009.
Hepatitis B Vaccination of Male Newborns Causes Autism! Boys Vaccinated At Birth With Hep B Have 3 Times Greater Risk.
Universal newborn immunization with hepatitis
B vaccine was recommended in 1991; however, safety
findings are mixed. The Vaccine Safety Datalink Workgroup reported no association between hepatitis B vaccination at birth and febrile episodes or neurological adverse
events. Other studies found positive hepatitis B vaccination and ear infection, pharyngitis, and
chronic arthritis; as well as receipt of early intervention/special education services (EIS); in probability samples of U.S. children. Children with autistic spectrum disorder(ASD) comprise a growing caseload for EIS. We evaluated
the association between hepatitis B vaccination of male neonates and parental report of ASD.
METHODS: This cross-sectional study used U.S. probability samples obtained from National Health Interview Survey 1997–2002 datasets. Logistic regression modeling was used to estimate the effect of neonatal hepatitis B vaccination on
ASDrisk amongboys age 3–17 years with shot records, adjusted for race, maternal education, and two-parent household.
RESULTS:Boys who received the hepatitis B vaccine during the first month of life had 2.94 greater odds for ASD (nZ31 of 7,486; OR Z 2.94; p Z 0.03; 95% CI Z 1.10, 7.90)compared to later- or unvaccinated boys.Non-Hispanic white
boys were 61% less likely to have ASD(ORZ0.39; pZ0.04;95% CIZ0.16, 0.94) relative to non-white boys.
CONCLUSION: Findings suggest that U.S. male neonates vaccinated with hepatitis B vaccine had a 3-fold greater risk of ASD; risk was greatest for non-white boys.
Source: Annals of Epidemiology, vol.19, no. 9, September 2009: 651-680.
At Birth Hepatitis B Vaccine Causes Developmental Delay in Baby Monkeys
A new research study published today in a leading scientific journal, NeuroToxicology, found that a Hepatitis B vaccine containing the mercury-based preservative thimerosal caused significant delays in the acquisition of critical survival reflexes in newborn rhesus macaque monkeys. In this first-ever study comparing vaccinated animals with unvaccinated controls, thirteen of the animals were given a Hepatitis B vaccine containing a standardized amount of thimerosal to match that given to babies; four received a saline placebo, and three were not given any shots. The unvaccinated animals developed normally. Delays in vaccinated infants involved three critical reflexes associated with feeding, which are essential for survival in the wild.
"Infants of lower birth weight and gestational age were at greater risk" explained Dr. Laura Hewitson of the University of Pittsburgh, one of the principal investigators of the study. "The reflexes affected in this study are controlled by the brainstem, which regulates functions like heart rate, breathing, and intestinal activity, so these findings give us cause for concern, especially for low birth weight and pre-term infants who might be more susceptible to functional brain injury from this vaccine."
According to Hewitson, the study was not designed to determine whether it was the thimerosal preservative or another component of the vaccine that caused the observed delays. Although the FDA and American Academy of Pediatrics recommended in 1999 that thimerosal be removed as soon as possible from vaccines in the US, it is still used as a preservative in flu shots, including the recently licensed H1N1 vaccines. Flu shots are currently recommended for pregnant women and children 6 months of age and older.
"We undertook these experiments largely because we were unable to find any safety studies comparing vaccinated and unvaccinated animals," said Dr. Andrew Wakefield, Executive Director of Thoughtful House and a co-investigator of the project. "This study is part of a larger research program looking at the safety of the vaccine schedule from birth to age four years. What is particularly concerning is that in spite of the recommendation to remove thimerosal from vaccines a decade ago, millions of people, many of them children and pregnant mothers, are about to get mercury in their flu shots."
Thimerosal is also still routinely used in Hepatitis B and numerous other vaccines world-wide.
About Thoughtful House:
Thoughtful House advocates and provides multi-disciplinary treatment for autism and related developmental delays and disorders. The Thoughtful House research program is dedicated to understanding the biological origins of childhood developmental disorders and establishing best practices in treating children affected by these disorders; Thoughtful House supports a ‘safety-first’ vaccination policy.
Delayed Acquisition of Neonatal Reflexes in Newborn Primates Receiving a Thimerosal-Containing Hepatitis B Vaccine: Influence of Gestational Age and Birth Weight.
Hewitson L, Houser LA, Stott C, Sackett G, Tomko JL, Atwood D, Blue L, White ER and Wakefield AJ.
NeuroToxicology, In Press, Accepted Manuscript, Available online 30 September 2009. DOI: 10.1016/j.neuro.2009.09.008.
Taken from press release from Thoughtful House.
Hep B Vaccine Doesn't Work in Patients with Celiac Disease. 50% of Sufferers were Unresponsive to Vaccination
Human leukocyte antigen (HLA) phenotype DQ2 is considered the most important genetic marker for un-responsiveness to hepatitis B vaccine. Since celiac disease (CD) is also strongly associated with the same haplo-type it may be hypothesized that celiac patients are less able to respond to the vaccine. We report a retrospective study on celiac patients vaccinated with three doses of 10 μg at 3, 5 and 11 months of age by an intramuscular injection of a recombinant hepatitis B vaccine (Engerix B).
We found 30 of 60 celiac patients (50%) unresponsive to vaccination and a significant higher number of responders among patients younger than 18 months at the time of celiac disease diagnosis.
Our study confirms that celiac patients have a lower percentage of response to hepatitis B vaccination than healthy subjects.
Volume 27, Issue 43, 9 October 2009, Pages 6030-6033.
Lupus After Hep B Vaccination
The objective of this article is to identify common and atypical features of systemic lupus erythematosus diagnosed following hepatitis B vaccination. We analyzed retrospectively the medical records of 10 systemic lupus erythematosus patients from different centers, who developed the disease following hepatitis B vaccination and determined the prevalence of different manifestations and the time association to vaccination. In this case series, 80% of the patients were female, mean age 35 ± 9 years, of which 20% received one inoculation, 20% received two doses and 60% received all three inoculations. The mean latency period from the first hepatitis B virus immunization and onset of autoimmune symptoms was 56.3 days. All patients were diagnosed with systemic lupus erythematosus, according to the American College of Rheumatology revised criteria within 1 year. The prevalence of some systemic lupus erythematosus manifestations was typical and included involvement of the joints (100%), skin (80%), muscles (60%) and photosensitivity (30%). Other symptoms differed in this unique group of systemic lupus erythematosus patients such as low rate of kidney and hematologic involvement, and a relatively high rate of hepatitis (20%). Neurological (80%) and pulmonary (70%) symptoms were also common in this group. Data from this case-series, and previously documented cases in the literature could only show a temporal relation between hepatitis B vaccination and the appearance of systemic lupus erythematosus. Systemic lupus erythematosus related to vaccine may differ from idiopathic systemic lupus erythematosus in its clinical presentation and may resemble drug-induced systemic lupus erythematosus. Thus, physicians should be alerted to this potential association, its possible long latency period and unique presentations, and be encouraged to report and analyze these cases. Lupus (2009) 18, 1192—1197.
Source: Lupus, Vol. 18, No. 13, 1192-1197 (2009)
Anaphylactic shock due to hepatitis B immunoglobulin in a newborn
Hepatitis B immunoglobulin (HBIG) is administered for the passive immunisation of all infants born to HBsAg-positive mothers within 12h of birth. Adverse effects of HBIG are very rare. In this study, we report a newborn (a female, 33 weeks' gestation and 2030g birth weight) developing anaphylaxis after HBIG administration. The mother was a Hepatitis B virus (HBV) carrier. Hypotension and erythematous rash developed 7min after HBIG administration. Reporting the first anaphylaxis case in newborns due to HBIG in literature, we suggest the condition be taken into account, and requisite precautions should be taken against this probable complication in the newborn.
44 Pupils Sick and Hospitalised after Hepatitis B Vaccine
A total of 44 pupils became sick and was taken to the hospital after receiving the hepatitis B vaccine at school on Thursday in Huilai county, in Jieyang of Guangdong province, the Guangzhou Daily reported Friday.
On Thursday morning, 84 pupils got the injection, and some felt ill half an hour later, and 44 had been taken to the hospital as of 5:00 pm, the newspaper said.
The disease control center of Huilai county said they have used more than 90,000 doses of the same batch of hepatitis B vaccine but did not have any abnormal reactions. The rest of the vaccine has been sealed up.
"The vaccine was transported here by the special refrigerated truck of Jieyang's disease control center," said Wu Junqiu, head of the disease control center of Huilai county. He said it was impossible that there were any problems in the storage and transportation process of the vaccine, he said.
The newspaper said the vaccine was produced by a Shenzhen-based biological product company and was valid until Sept 1, 2012. And the syringes, which are valid until October 2012, were produced by a Shanghai-based company.
Babies of Hep B Positive Mothers Still Getting Hep B Despite Vaccination
About 10 percent of babies born to mothers with the hepatitis B e antigen (HBeAg) will become HB carriers, even with vaccination, a pediatrician said Saturday.
Since the HB vaccine does not guarantee full protection against infection, it is important to keep track of high risk children, said Chen Hui-ling, a pediatrician at National Taiwan University Hospital.
Citing a study of some 2,000 some children, Chen said that infants born to HBeAg mothers have a higher chance of becoming carriers, even if a rigorous vaccination scheme is implemented 24 hours after birth.
Source: Focus Taiwan News Channel, 21st July 2012.
FDA does not endorse the safety of a new hepatitis b vaccine
In Maryland, a federal advisory panel has voted not to support the safety of a novel hepatitis B vaccine for adults aged 18 to 70 years according to Medscape.com's Medical News. At a meeting on Thursday, the United States Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee voted 8 to 5 with 1 abstention that the safety data presented by Dynavax Technologies Corporation were not adequate to support safety of Heplisav.
The committee's three main concerns were:
1. That the safety database was too small to detect rare adverse events
2. That the vaccine hadn't been studied in sufficient numbers of ethnic minority populations
3. That it hadn't been studied in combination with the administration of other adult vaccines.
There were numerically greater numbers of Heplisav patients with evidence of autoimmunity including thyroid disorders, and some rare serious events among Heplisav recipients, including 1 case each of Wegener's granulomatosis, Tolosa-Hunt syndrome, and Guillain-Barre syndrome. Melinda Wharton, deputy director of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, Atlanta, Georgia, voted no for safety. She said, "...I don't think the safety database is sufficiently large to support a recommendation for use in the general adult population, given that this vaccine contains a new adjuvant."
Committee chairman and professor of pediatrics and microbiology and molecular medicine at the University of Chicago, Illinois, Robert Daum, MD, voted no on both efficacy and safety. "I'm concerned that there are not enough data in different ethnic groups to be sure that the immunogenic responses are adequate. I'm also concerned that there were no data presented about giving other vaccines simultaneously.... If this were a pediatric vaccine we'd be jumping up and down about that.... I don't see this as a separate visit vaccine," said Dr. Daum. Bruce Gellin, MD, MPH, director of the National Vaccine Program Office of the US Department of Health and Human Services, also voted no for safety.