Hep B (Hepatitis B)

What you need to know about the Hepatitis B vaccine.

CDC schedule recommendation: For ages: Day of birth, 2 months, 6-15 months

How bad is the disease?

Hepatitis B is a contagious disease in which the hepatitis B virus, or HBV, infects and inflames the liver, causing permanent damage in less than 5% of those infected. It is not highly contagious—you cannot get hepatitis B through casual contact, such as sharing a glass, sneezing, or coughing. The virus is transmitted through exchange of infected body fluids such as blood or semen. It can enter the body through a cut in the skin, through the exchange of needles used by drug addicts, or through a body cavity. A pregnant woman can pass the disease along to her infant at birth.

How common is the disease?

According to the CDC, an estimated 350 million people worldwide have Hepatitis B, with only 1.2 million of those cases occurring in the U.S. The vast majority of Hepatitis B cases are in Asia and Africa.

Who is at risk of becoming infected with Hepatitis B?

According to HHS, IV drug users and men who have unprotected sex with men are the most at-risk groups of being infected with the virus. The highest rates of chronic hepatitis B infection in the U.S. occur in foreign-born individuals, especially people born in Asia, the Pacific Islands, or Africa. Over half of the cases in the U.S. are among people who were born elsewhere.

Does getting the vaccine help protect others from getting the same illness?

Theoretically, it should as Hepatitis B is communicable. However, the vaccine doesn’t always confer immunity to the disease and according to the Physicians’ Desk Reference, the duration of the protective effect of the vaccine when it does work is unknown. Since the main routes of transmission are through unprotected sex with Hep B-positive individuals and using dirty needles for injecting drugs, avoiding those activities provides protection.

What is the risk of getting the illness?

Nearly 95% of all people infected with Hepatitis B recover completely. People who recover have lifelong immunity to the virus. For those who don’t recover, the infection, over 20 to 40 years, can lead to liver cancer or cirrhosis. In about two-tenths of 1 percent of total cases, people die quickly from an acute infection.

What are the symptoms and treatment for the illness?

Symptoms can range from none to mild or severe and include loss of appetite, nausea, vomiting, fever, fatigue, flu-like symptoms, dark urine, jaundice, pale stools, itching and an enlarged liver. Treatment includes rest, avoidance of alcohol, interferon, and hyperimmune globulin.

What are the risks of complications from the illness?

Cancer of the liver, cirrhosis, and death.

How effective is the vaccine?

According to the CDC, the vaccine is 95% effective in preventing Hepatitis B. However, some studies (see below) indicate that level of efficacy may be inflated, and, according to the Physicians’ Desk Reference for both Recombivax and Engerix, “Routine booster doses are generally not recommended as the duration of protective effect is unknown.”

What are the benefits of getting the vaccine?

Hepatitis B is transmitted to others via blood products from those already infected. If you are an IV drug user or having unsafe, unprotected sex with multiple partners, you should weigh the risks and benefits of having a Hep B vaccination.

Who should not get the vaccine?

The CDC recommends that people talk with the vaccine provider if they’ve had an allergic reaction after a previous dose of the Hepatitis B vaccine, if they have any severe, life-threatening allergies, or if they are moderately or severely ill. People should consider the likelihood of being exposed to the Hepatitis B virus based on lifestyle. Newborns, for example, are not IV drug users or having unprotected sex with Hep B-infected individuals. Considering that all medical procedures—including vaccination—carry risks, newborns are not good candidates for this vaccine.

What are the vaccine side effects according to the package insert?

The package insert for Merck’s Recombivax lists the following: Anaphylactic/anaphylactoid reactions, bronchospasm, urticarial, arthralgia/arthritis (usually transient), fever, urticaria, erythema multiforme, ecchymoses, erythema nodosum, systemic lupus erythematosus (SLE), lupus-like syndrome, vasculitis, polyarteritis nodosa, gastrointestinal disorders, elevation of liver enzymes; constipation, 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, Stevens-Johnson syndrome; alopecia; petechiae; eczema, arthritis, pain in extremities, increased erythrocyte sedimentation rate; thrombocytopenia, irritability; agitation; somnolence. optic neuritis; tinnitus; conjunctivitis; visual disturbances; uveitis, syncope; tachycardia.

The package insert for Glaxo Smith Klein’s Engerix lists the following: Dizziness, headache, injection site erythema, injection site induration, injection site swelling, upper respiratory tract illnesses, lymphadenopathy, anorexia, agitation, insomnia, somnolence, tingling, flushing, hypotension, abdominal pain/cramps, constipation, diarrhea, nausea, vomiting, erythema, petechiae, pruritus, rash, sweating, urticarial, arthralgia, back pain, myalgia, pain/stiffness in arm, shoulder, or neck, chills, influenza-like symptoms, injection site ecchymosis, injection site pain, injection site pruritus, irritability, malaise, weakness., herpes zoster, meningitis, and thrombocytopenia. 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. 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. Conjunctivitis, keratitis, visual disturbances. Earache, tinnitus, vertigo. Palpitations, tachycardia, Vasculitis. Apnea, bronchospasm including asthma-like symptoms. Dyspepsia. Alopecia, angioedema, eczema, erythema multiforme including Stevens-Johnson syndrome, erythema nodosum, lichen planus, purpura. Arthritis, muscular weakness. Injection site reaction. Abnormal liver function tests.

Adverse Events reported to the Vaccine Adverse Event Reporting System (VAERS):

Winning vaccine injury lawsuits:

Vaccines are liability free. However, there is a National Vaccine Injury Compensation Program, a one-sided “claims program” for vaccine injuries. There is no judge nor jury of peers. The injured are on their own against government paid “Special Masters” acting as judges (sometimes with no legal background), government attorneys, government science and government owned/oversight of the Program. Only 33% of claims are ever awarded. The rest are dismissed or lost. Cases can drag on for years. Despite the high burden of proof in VICA, 279 lawsuits regarding this vaccine have won since 1988.

What are the ingredients in the vaccine?

Engerix–B (GSK): Each 0.5-mL pediatric/adolescent dose contains 10 mcg of HBsAg adsorbed on 0.25 mg aluminum as aluminum hydroxide. Each 1-mL adult dose contains 20 mcg of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide, yeast. ENGERIX-B contains the following excipients: Sodium chloride (9 mg/mL) and phosphate buffers (disodium phosphate dihydrate, 0.98 mg/mL; sodium dihydrogen phosphate dihydrate, 0.71 mg/mL).

Recombivax (Merck): All formulations contain approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate, previously referred to as aluminum hydroxide) per mL of vaccine. In each formulation, hepatitis B surface antigen is absorbed onto approximately 0.5 mg of aluminum (provided as amorphous aluminum hydroxyphosphate sulfate) per mL of vaccine. Yeast. The vaccine contains <15mcg/mL residual formaldehyde.

Which ingredients are known to be toxic?
  • Formaldehyde: According to the Agency for Toxic Substances and Disease Registry (ATSDR), formaldehyde is highly toxic and is an eye, skin, and respiratory tract irritant. Children may be more susceptible than adults to the respiratory effects of formaldehyde. Formaldehyde solution (formalin) causes corrosive injury to the gastrointestinal tract, especially the pharynx, epiglottis, esophagus, and stomach. The systemic effects of formaldehyde are due primarily to its metabolic conversion to formate, and may include metabolic acidosis, circulatory shock, respiratory insufficiency, and acute renal failure. Formaldehyde is a potent sensitizer and a probable human carcinogen.
  • Aluminum: Aluminum is well known as a neurotoxin and may be associated with Alzheimer’s disease according to ATSDR. Brain and bone disease caused by high levels of aluminum in the body have been seen in children with kidney disease.
Research Evidence of Vaccine Failure:

This study found that 36% of hospital workers vaccinated against Hepatitis B did not develop immunity to the disease.

Research Evidence of Vaccine Shedding
Since the Hep B vaccine does not use a live virus, shedding should not be an issue.

What are the complications of using this vaccine in combination with other vaccines?
The safety of giving vaccines, including the Hep B vaccine, with other vaccines at the same time has never been studied. When injuries and deaths occur following the use of two or more vaccines at the same time, the source of those injuries and deaths will be more difficult to identify.

Are there ways to protect against the disease without getting the vaccine?
Yes, by avoiding contaminated needles during drug use and by avoiding sex with infected individuals.

Essential facts you should know before vaccinating:
Only newborns of mothers infected with Hepatitis B are at risk of contracting the disease. The Hep B vaccine would not be effective for an infant who already has the virus. Avoiding the use of dirty needles for injecting drugs and not having unprotected sex are more effective than vaccinating especially since the vaccine is not always effective. Even when it does confer immunity, the duration of the protective effect is unknown.

Resources/Articles to read before vaccinating:
Helpful videos: