Categories: Drugs & Medications

The Hepatitis B Vaccine: What the Manufacturer’s Insert Tells Us

“There is a great deal of evidence to prove that immunization of children does more harm than good.” – Dr. J. Anthony Morris, former Chief Vaccine Control Officer and Research Virologist, US FDA

About Hepatitis B
Within a few hours of a hospital birth, newborn infants are injected with the Hepatitis B vaccine. The theory behind this procedure is that, this way, almost all children are caught and inoculated. It is interesting that of all the options available, including the HiB vaccine which would help prevent a disease that young infants can actually catch, the United States Centers for Disease Control have chosen to mandate this particular vaccine at birth, since it is rare and not very contagious.

All forms of Hepatitis are infections that attack the liver. The primary differences between Hep A, Hep B, Hep C, Hep D and Hep B are how they are transmitted.

There is a lot of fear surrounding this disease, with mothers sharing the horror stories of children catching hepatitis by running around barefoot or being bit by a child with hepatitis at a park. The benefits of the vaccine are equally startling and impressive – the Hepatitis B Foundation happily exclaims that “The hepatitis B vaccine is the first anti-cancer vaccine because it can prevent liver cancer. Worldwide, chronic hepatitis B causes 80% of all liver cancer, which is the 9th leading cause of death. Therefore, a vaccine that protects against a hepatitis B infection can also help prevent liver cancer.

Incidentally, the highest numbers of liver cancer in the United States are caused by alcoholic cirrhosis, not chronic Hepatitis B infection (Blumberg, B.S. and London, W.T. 1980. In Essex, M. et al. (eds) “Viruses in Naturally Occurring Cancer, Book A, Cold Spring Harbour Conferences on Cell Proliferation.”)

Hepatitis B Is Very Rare, Even Without The Vaccine
Hepatitis B is actually a rare sexually transmitted disease that can also be passed through sharing dirty needles or among people exposed to infected blood. It is a “lifestyle” disease that is primarily found among drug addicts, sexually promiscuous adults, and heath care workers exposed to blood in their line of work. An infected mother CAN pass the disease onto her newborn infant, however, according to Harrison’s Principles of Internal Medicine (1994), mother to infant transmission is “uncommon in North America and Western Europe.”

The disease has a less than 1% fatality rate, and those who recover develop a lifetime immunity. For more information on the disease, visit the National Vaccine Information Center.

In her book “Just A Little Prick,” Hillary Butler quotes an Australian news article that puts the risk of this disease into perspective:

“…of all people who contract Hepatitis B nearly:

75% will only develop mild symptoms,

20% will develop ‘moderate’ symptoms,

5% will develop severe illness,

Fewer than 1% will die from the disease or associated symptoms such as liver cancer…

From this we can ascertain that, all things being equal, you and your children run approximately a 105 in 16 million chance of contracting Hepatitis B and getting very ill or possibly even dying. That is, less than a one in 150,000 chance. All things being equal, you run about HALF the risk of dying from Hepatitis B as you do of contracting leprosy.

…Put into perspective, the chances of a ‘normal’ person contracting and dying from Hepatitis are just slightly higher than getting kicked to death by a horse.” (Butler, Peter and Hilary. Just A Little Prick. Auckland: Robert Reisinger Memorial Trust, 2006, 186).

GlaxoSmithKline’s Hepatitis B Vaccine
Before making a final decision on whether or not to permit a newborn to receive the Hepatitis B Vaccine, parents may want to review the manufacturer’s package insert. This information is included in each package of the vaccine and includes such information as ingredients, intended use, contraindications (circumstances under which the vaccine should NOT be administered, side effects, and dosage.

Hepatitis B Vaccine Ingredients
Distributed under the brand name Engerix-B, the Hepatitis B Vaccine contains as much as 5% yeast protein and aluminum hydroxide. According to the National Institutes of health, aluminum hydroxide is used “for the relief of heartburn, sour stomach, and peptic ulcer pain and to promote the healing of peptic ulcers.” Side effects include constipation, loss of appetite, confusion, tiredness, or muscle weakness.

Warnings and Precautions
Parts of the syringe are made of latex and may cause a reaction in those sensitive to latex.

The package insert specifically states that “Epinephrine injection (1:1,000) and other appropriate agents used for the control of immediate allergic reactions must be immediately available should an acute anaphylactic reaction occur.

In some cases, those with Multiple Sclerosis who receive the vaccine find their condition worsens after administration of the Hepatitis B vaccine.

As one will find on other vaccine package inserts, Engerix-B “has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.” This means no one knows if Engerix-B causes cancer or interferes with fertility, and no studies have been conducted to find out.

Adverse Reactions to The Hepatitis B Vaccine
The following adverse reactions, or side effects, are listed on GlaxoSmithKline’s package insert. Swelling
Fever
Headache
Dizziness
Pain
Pruritis
Ecchymosis
Sweating
Malaise
Chills
Weakness
Flushing
Tingling
Hypotension
Influenza-type symptoms
Upper respiratory tract illnesses
Nausea
Anorexia
Abdominal pain/cramps
Vomiting
Constipation
Diarrhea
Lymphadenopathy
Pain/stiffness in the arm, shoulder or neck
Arthralgia
Myalgia
Back pain
Rash
Urticaria
Petechiae
Erythema
Somnolence
Insomnia
Irritability
Agitation
Anaphylaxis
Stevens-Johnson Syndrome
Angioedema
Arthritis
Tachycardia/palpitations
Bronchospasms including asthma-like symptoms
Abnormal liver-function tests
Dyspepsia
Migraine
Syncope
Paresis
Hypoesthesia
Paresthesia
Guillain-Barre Syndrome
Bell’s Palsy
Transverse myelitis
Optic neuritis
Multiple Sclerosis
Seizures
Thrombocytopenia
Eczema
Purpura
Herpes Zoster
Alopecia
Conjunctivitis
Keratitis
Visual Disturbances
Vertigo
Tinnitus
Earache

The National Vaccine Information Center Reviews The “Safety Studies”
The NVIC notes the following with regards to safety studies performed for the Hepatitis B vaccine:

“In 1986, the FDA gave Merck & Co. a license to market the first recombinant DNA hepatitis B vaccine, which replaced the old hepatitis B vaccines made from blood taken from human chronic hepatitis B virus carriers. In awarding Merck & Co. and, later, SmithKline Beecham Pharmaceuticals, licenses to market their genetically engineered hepatitis B vaccines in the U.S., the FDA allowed both drug companies to use “safety” studies which only included a few thousand children monitored for only four or five days after vaccination to check for reactions. As “proof” their hepatitis B vaccine is safe to be used in children, Merck & Co. stated in their 1993 product insert that “In a group of studies, 1636 doses of RECOMBIVAX HB were administered to 653 healthy infants and children (up to 10 years of age) who were monitored for 5 days after each dose.”

Merck & Co. found that injection site and systemic complaints, such as fatigue and weakness, fever, headache and arthralgia (joint pain), were reported following up to 17 percent of all hepatitis B injections. Because the FDA did not require drug companies to provide scientific evidence that hepatitis B vaccine does not compromise the immune and neurological systems of children and adults over weeks, months or years post-vaccination, Merck & Co. warns in the 1996 product insert that “As with any vaccine, there is the possibility that broad use of the vaccine could reveal adverse reactions not observed in clinical trials” and SmithKline Beecham (1993) has a similar warning that “it is possible that expanded commercial use of the vaccine could reveal rare adverse reactions.”

Note: SmithKline Beechem is now GlaxoSmithKline.

A Possible AIDS Connection
Some experts have concluded that the Hepatitis B vaccine has contributed to the spread of AIDS. Readers can review the evidence by clicking here and draw their own conclusions.

For Additional Information
Interested readers should visit the government’s online Vaccine Adverse Event Reporting System for the quantity and nature of adverse reactions reported each year, keeping in mind that the government itself estimates that only 10% of adverse reactions are actually reported.