Hepatitis B Vaccine...aluminium....thimerosal (mercury)....yeast...but don't worry, it's gluten free!

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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%).

Gastrointestinal.

Nausea (1.8%), diarrhoea (1.1%).

Nervous system.

Headache (4.1%).

Respiratory.

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.

Gastrointestinal.

Vomiting, abdominal pains/cramps, dyspepsia, diminished appetite.

Respiratory.

Rhinitis, influenza, cough.

Nervous system.

Vertigo/dizziness, paraesthesia.

Dermatological.

Pruritus, rash (nonspecified), angioedema, urticaria.

Musculoskeletal.

Arthralgia including monoarticular, myalgia, back pain, neck pain, shoulder pain, neck stiffness.

Lymphatic.

Lymphadenopathy.

Psychiatric/behavioural.

Insomnia/disturbed sleep.

Special senses.

Earache.

Genitourinary.

Dysuria.

Cardiovascular.

Hypotension.

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.

Hypersensitivity.

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).

Nervous system.

Peripheral neuropathy including Bell's palsy; Guillain-Barre syndrome, optic neuritis.

Special senses.

Tinnitus.

Haematological.

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.

Hypersensitivity. Irritability.

Nervous system.

Neurological disorders such as myelitis, including transverse myelitis; acute radiculoneuropathy and Herpes zoster.

Haematological.

Thrombocytopenia.

Special senses.

Visual disturbances.

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.

Precautions

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.