- What is hepatitis B
- Hepatitis B Symptoms
- Who Was the Vaccine Initially For and Why is it Given to Newborns
- Conventional Treatment for hepatitis B
- When is the hepatitis B Vaccine Given
- Efficacy of the hepatitis B Vaccine
- How Long Does hepatitis B Vaccine Protection Last
- Ingredients in the hepatitis B Vaccine
- FDA Package Inserts
- Controversy and the hepatitis B Vaccine
- Hepatitis B Vaccine Reactions
- The Bottom Line and the hepatitis B Vaccine
- Who Should Not Get the hepatitis B Vaccine
- Studies/ Reviews
What is Hepatitis B?
- Hepatitis B (HBV) is a sexually transmitted virus that causes liver damage and sometimes liver failure and cancer. It can be fatal. 
- Hepatitis B is not a common childhood illness in the US, but it can be passed on from an infected mother to her child. 
- Hepatitis B is also passed on by the sharing of IV drug needles, the use of improperly sterilized tattoo needles, or an accidental stick with an infected needle, and very rarely from a blood transfusion. 
- Hepatitis B is diagnosed with a blood test. 
- The hepatitis B virus can survive outside a person, such as on a toothbrush or razor, for one week (the virus is killed by disinfectant cleaning solutions with at least 10 percent bleach). 
Hepatitis B Symptoms
Teens and Adults who Become Infected with hep B:
- Acute symptoms of hepatitis B are nausea, vomiting, abdominal pain, diarrhea, fatigue, and jaundice. Onset usually occurs within 120 days of exposure to the virus.
- About 5 percent of teens and adults will become chronic, asymptomatic carriers. They can be treated with a medication similar to chemotherapy. About one-third of people treated are cured. Those who are not cured will develop varying degrees of chronic liver damage. Some of these will develop liver failure and/ or liver cancer, which leads to about four thousand adult deaths each year in the United States.
Stephanie Cave, MD, FAAFP (excerpt from her book): 
The CDC estimates that between 140,000 and 200,000 adults contract hepatitis B annually in the United States. Individuals who get hepatitis B can expect one of three things to happen:
- They recover. Nearly 95 percent of all cases of hepatitis B recover completely. Some experience three to four weeks of fatigue, headache, arthritis, jaundice, loss of appetite, tender liver, and nausea; others have no symptoms. People who recover completely from hepatitis B infection have lifelong immunity.
- They develop a chronic infection that eventually, over twenty to forty years, becomes liver cancer or cirrhosis. Hepatitis B is the most common cause of liver cancer.
- They die quickly from an acute infection. This occurs in about two-tenths of 1 percent of all adults who get hepatitis B.
Infants and Children who Become Infected with hep B:
- Approximately 90 percent of babies who catch hepatitis B during birth become chronically infected, with little to no sign of infection. Approximately 25 percent of infected infants will eventually develop liver cancer or liver failure later during childhood. Liver transplant is generally the only means of survival.
- Children who catch hep B during the toddler or preschool years have about a 35 percent chance of becoming chronically infected, and kids five years and older have a 10 percent chance.
Who Was the Vaccine Initially For and Why is it Given to Newborns?
- The hepatitis B vaccine was created for intravenous drug users, sexually promiscuous men and women, and mothers infected with hepatitis B. [1,3]
- No infants fall into the first two categories above, and less than 1 percent are born to those who fall into the third. Yet the practice of giving hepatitis B vaccine, a compound that often contains toxic substances such as aluminum and allergens like baker’s yeast, to infants within hours of their birth continues.
- Further, the decision was made by the CDC to vaccinate all newborns because too few adults in the high-risk groups were being immunized. 
- “It is really hard to get a teenager to come into a doctor’s office for a shot, states a CDC representative, in a debate with Dr. Tenpenny in Texas, 2009.”
Conventional Treatment for Hepatitis B
There is no specific therapy for acute HBV infection. Treatment is supportive. Interferon is the most effective treatment for chronic HBV infection and is successful in 25% to 50% of cases.
Persons with acute or chronic HBV infections should prevent their blood and other potentially infective body fluids from contacting other persons. They should not donate blood or share toothbrushes or razors with household members.
In the hospital setting, patients with HBV infection should be managed with standard precautions. 
When is the Hepatitis B Vaccine Given?
The hepatitis B vaccine is given at birth, one month, and six months of age.
VERY IMPORTANT TO NOTE: Children do not need the hepatitis B vaccine at birth unless they are born to a mother infected with hepatitis B. It is an unnecessary practice. Be very sure that your doctor understands your wishes and follows through if your decision is to forgo this vaccine at birth. You can always vaccinate your child at a later date if that is your decision.
ALSO: If you choose to vaccinate for hepatitis B, there are combination vaccines that contain the hepatitis B vaccine (Pediarix, Comvax, and Twinrix), so please make sure that your doctor is not double dosing your child with the solo Hepatitis B vaccine as well as a combination vaccine.
- For more information: CDC/Alternative Vaccine Schedules
Efficacy of the Hepatitis B Vaccine
How Long Does Vaccine Protection Last?
How long does protection from Hepatitis B vaccine last?
Studies indicate that immunologic memory remains intact for at least 20 years among healthy vaccinated individuals who initiated Hepatitis B vaccination >6 months of age. The vaccine confers long-term protection against clinical illness and chronic Hepatitis B virus infection. Cellular immunity appears to persist even though antibody levels might become low or decline below detectable levels.
Among vaccinated cohorts who initiated Hepatitis B vaccination at birth, long-term follow-up studies are ongoing to determine the duration of vaccine-induced immunity.
Translation: Among children receiving the hepatitis B vaccine before 6 months of age, the CDC does not yet know how long the child has protection from the hepatitis B virus.
Ingredients in the Hepatitis B Vaccine
The Recombivax HB brand (Merck) contains:
- hepatitis B surface antigen (that’s what the protein is called)
- Aluminum— 250 micrograms per dose
- Saline solution
- Yeast proteins
- Formaldehyde— a residual amount
The Engerix-B brand (GlaxoSmithKline) contains:
- hepatitis B surface antigen
- Aluminum— 250 micrograms per dose
- Saline solution
- Phosphate buffers (to keep the solution stable)
- Yeast proteins
Note: Adults receive a double dose of hepatitis B vaccine, so each adult dose contains 500 micrograms of aluminum. 
If you would like specific information regarding each ingredient, including studies:
FDA Package Inserts
- Recombivax HB (Merck) Recombivax FDA Package Insert
- Engerix-B (GlaxoSmithKline) Engerix-B FDA Package Insert
- Pediarix (GlaxoSmithKline) DTaP, hep B, and polio combo. Pediarix FDA Package Insert
- Comvax (Merck) Hep B and HIB combo. Comvax FDA Package Insert
- Twinrix (GlaxoSmithKline) Hep B and hep A combo. Twinrix FDA Package Insert
Controversy and the Hepatitis B Vaccine
- Michael Belkin is a father, businessman, former quantitative strategist at Salomon Brothers. Read his testimony here.
- Bonnie S. Dunbar, Ph.D., a professor at Baylor College of Medicine in Houston and a pioneer in vaccine research, is one of a growing number of scientists, parents, and health professionals who believe that the hepatitis B vaccine is a serious, perhaps even deadly threat to a portion of the population that may have a genetic makeup that makes them react negatively to the vaccine. Read her testimony here.
Hepatitis B Vaccine, May 18, 1999 The House Reform Committee
Hepatitis B Vaccine Reactions
According to the CDC, moderate or severe reactions to hepatitis B vaccine should be reported to and checked by a doctor immediately. If any of these reactions were to occur, they would happen within a few minutes to a few hours after receiving the shot.
Recombivax HB Clinical Trials reported the following adverse reactions:
FDA Package Insert: 
Incidence Equal To or Greater Than 1% of Injections
- GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Injection site reactions consisting principally of soreness, and including pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth, nodule formation. The most frequent systemic complaints include fatigue/weakness; headache; fever (≥100°F); malaise.
- GASTROINTESTINAL DISORDERS: Nausea; diarrhea
- RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Pharyngitis; upper respiratory infection
Incidence Less Than 1% of Injections
- GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS: Sweating; achiness; sensation of warmth; lightheadedness; chills; flushing
- GASTROINTESTINAL DISORDERS: Vomiting; abdominal pains/cramps; dyspepsia; diminished appetite
- RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS: Rhinitis; influenza; cough
- NERVOUS SYSTEM DISORDERS: Vertigo/dizziness; paresthesia
- SKIN AND SUBCUTANEOUS TISSUE DISORDERS: Pruritus; rash (non-specified); angioedema; urticaria
- MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS: Arthralgia including monoarticular; myalgia; back pain; neck pain; shoulder pain; neck stiffness
- BLOOD AND LYMPHATIC DISORDERS: Lymphadenopathy
- PSYCHIATRIC DISORDERS: Insomnia/disturbed sleep
- EAR AND LABYRINTH DISORDERS: Earache
- RENAL AND URINARY DISORDERS: Dysuria
- CARDIAC DISORDERS: Hypotension
Recombivax HB Postmarketing Surveillance:
FDA Package Insert: 
(this means the adverse reactions that have been reported by the public since the introduction of the vaccine)
- Immune System Disorders: Hypersensitivity reactions including anaphylactic/anaphylactoid reactions, bronchospasm, and urticaria 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. Autoimmune diseases including systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, and polyarteritis nodosa have also been reported.
- Gastrointestinal Disorders: Elevation of liver enzymes; constipation
- Nervous System Disorders: 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
- Skin and Subcutaneous Disorders: Stevens-Johnson syndrome; alopecia; petechiae; eczema
- Musculoskeletal and Connective Tissue Disorders: Arthritis, Pain in extremity
- Blood and Lymphatic System Disorders: Increased erythrocyte sedimentation rate; thrombocytopenia
- Psychiatric Disorders: Irritability; agitation; somnolence
- Eye Disorders: Optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis
- Cardiac Disorders: Syncope; tachycardia
Note: All adverse reactions should also be reported to the Vaccine Adverse Events Reporting System (VAERS).
The Bottom Line and the Hepatitis B Vaccine
There has never been any actual evidence that this is a childhood disease, outside of mom-to-baby transmission during birth or through blood transfusions or accidental blood exposure. The CDC website makes it very clear that hep B is not transmitted by casual day-to-day contact. With better prenatal diagnosis and newborn treatment, there are now only about 130 infant cases each year, 0.001% of children under one year and less than 1% of the entire population.
- Children don’t actually need the protection until their teen years (unless child is exposed to high risk individuals, or the dirty needle on the playground incident?)
- Anyone who is exposed to hep B– infected blood can be given an HBIG injection, which is made of hepatitis B antibodies filtered out of donated blood units from volunteers who have high antibody levels. This blood product is sterilized and filtered through various techniques. The injection contains the antibodies in a saline solution with polysorbate 80.
- If the mother is not hepatitis B positive, there is a very good chance that the hepatitis B vaccine will not be needed for a child who will not be exposed to high risk individuals.
- Hepatitis B Vaccine– 657 claims (604 injuries/53 deaths) have been filed with the Vaccine Injury Compensation Program (“vaccine court”). Of the 657 filed, 234 were compensated, 354 dismissed, 69 unsettled (April 2014)
- Hep A- Hep B Vaccine– 14 claims filed with the Vaccine Injury Compensation Program (“vaccine court”). Of the 14 filed, 8 compensated, 1 dismissed, 6 unsettled (April 2014)
- Hep B- HIB Vaccine– 8 claims filed with the Vaccine Injury Compensation Program (“vaccine court”). Of the 8 filed, 4 compensated, 3 dismissed, 1 unsettled (April 2014)
- If you would like up to date information on how many Hepatitis B Injury Compensation Claims have been filed with the Vaccine Injury Compensation Program (VICP) and the number of families compensated, please see the charts here: VICP Statistics Report (provided by The Department of Health and Human Services) 
- Epidemiology and Prevention of Vaccine-Preventable Diseases, 12th Edition (The Pink Book) (CDC) (PDF Version) (Web Version)
- CDC:MMWR. Hepatitis B Virus: A Comprehensive Strategy for Eliminating Transmission in the United States through Universal Childhood Vaccination. Recommendations of the Immunization Practices Advisory Committee (ACIP). Sept. 1991. Online.
- CDC.gov. Hepatitis Statistics. Disease Burden from Viral Hepatitis A, B, and C in the United States. Sept. 13, 2011. Online.
- What Your Doctor May Not Tell You About(TM) Children’s Vaccinations
- The Vaccine Book: Making the Right Decision for Your Child (Sears Parenting Library)
- Make an Informed Vaccine Decision for the Health of Your Child: A Parent’s Guide to Childhood Shots
- Vaccinations: A Thoughtful Parent’s Guide: How to Make Safe, Sensible Decisions about the Risks, Benefits, and Alternatives
- Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children
- Vaccine Ingredient Summary (CDC)
- Federal Vaccine Compensation Statistics (US Department of Health and Human Services)
- The changing epidemiology of hepatitis B in the United States. Need for alternative vaccination strategies, Alter M. J. et al., Journal of the American Medical Association 1990; 263: 1218 –1222.
- Recombivax FDA Package Insert
- CDC Hep B Vaccine Info
- Hepatitis B Foundation- Cause for a Cure
- Mercola- 60 Things that Can Go Terribly Wrong with Hepatitis B Vaccination (2011)
- World Health Organization (WHO) – Hepatitis B
- Immunization Action Coalition – Hepatitis B Vaccine Information Statement
- Vaccine Book List (with approximately 100 resource books)
- World Health Organization (WHO)
- Center for Disease Control (CDC)
- Vaccination Information Network
- New Study: Hepatitis B Vaccine Damages The Liver – Healthy Home Economist
- Isolated abducens nerve palsy following neonatal hepatitis B vaccination
- Purification of HBV antigens for use in vaccines
- Reports to the Vaccine Adverse Event Reporting System after hepatitis A and hepatitis AB vaccines in pregnant women
- Hepatitis B vaccination with or without hepatitis B immunoglobulin at birth to babies born of HBsAg-positive mothers prevents overt HBV transmission but may not prevent occult HBV infection in babies: a randomized controlled trial
- In the United States Court of Federal Claims Office of Special Masters Damages– “A lump sum payment of $1,076,412.15 representing compensation for life care expenses , in the form of a check payable to petitioner.”
- Hepatitis B vaccination at three months of age: A successful strategy?
- Chronic hepatitis B infection in adolescents who received primary infantile vaccination
- Autoimmunity following hepatitis B vaccine as part of the spectrum of ‘Autoimmune (Auto-inflammatory) Syndrome induced by Adjuvants’ (ASIA): analysis of 93 cases.
- Adverse Effects of Vaccines– Institute of Medicine
- Chronic fatigue after hepatitis B vaccination
Content Created: 04/14