What are the Hepatitis B vaccines?

Hepatitis B

The hepatitis B vaccine contains only one of the proteins of the virus. Its action is supported by an aluminum salt. The vaccine exists both single and combined with hexavalents for infants

Monocomponent vaccines

Engerix B - GlaxoSmithKline (click to open)

Hepatitis B (HBV) vaccine (adsorbed) (rDNA).

Engerix B is a vaccine used to prevent hepatitis B infection. It is indicated that it can also help prevent hepatitis D infection. This vaccine can be given to infants, children and adolescents up to the age of 15. years included.

Dosage declared by the manufacturer

One vaccination course includes three to four injections.
The primary vaccination consists of 3 or 4 doses and the cycle for children includes doses at intervals:

0,1, 6 months from the first
0,1,2,12 months from the first

Adverse events declared by the manufacturer

Lymphadenopathy
Loss of appetite
Irritability
Headache
Common Somnolence Dizziness Paraesthesia
Gastrointestinal symptoms (such as nausea, vomiting, diarrhea, abdominal pain)
Urticaria, itching and rash
Myalgia, Arthralgia
Pain and redness at the injection site, fatigue
Fever (≥37.5°C), malaise, injection site swelling, injection site reaction (such as induration)
Influenza-like illnesses
Meningitis
Thrombocytopenia
Anaphylaxis, allergic reactions including anaphylactoid reactions and serum sickness-like syndrome
Encephalitis, encephalopathy, seizure, paralysis, neuritis (including Guillain-Barre syndrome, optic neuritis and multiple sclerosis), neuropathy, hypoaesthesia
Vasculitis, hypotension
Freediving
Erythema multiforme, angioneurotic oedema, lichen planus
Arthritis, muscle weakness

Composition declared by the manufacturer

Hepatitis B virus surface antigen Produced by recombinant DNA technology in yeast cells (Saccharomyces Cerevisiae)
Adsorbed on aluminum hydroxide, hydrate
Sodium chloride
Disodium phosphate dihydrate
Sodium dihydrogen phosphate
Water for injections.

Curiosity

Clinical trials of Engerix B conducted by the manufacturer prior to FDA approval involved 5.071 healthy infants, children, and adults with no evidence of prior hepatitis B infection. Adverse events in trial participants were monitored for only 4 days after each dose of vaccine and, according to the vaccine manufacturer, no long-term safety studies were conducted in trial participants.

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HBVAXPRO - Merck (click to open)

PreHevbri-VBI Vaccines (click to open)

Hexavalent vaccines (Tetanus, Diphtheria, Pertussis, Hepatitis B, Poliomyelitis and Haemophilus influenzae type b)

Hexyon - Sanofi Pasteur MSD (click to open)

Hexyon (Diphtheria Tetanus Pertussis (DTaP), Poliomyelitis (IPV), Hepatitis B (HB), Haemophilus influenzae type b (Hib) is indicated for the primary and booster vaccination of infants and toddlers from six weeks of age against diphtheria , tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b.

Dosage declared by the manufacturer

The primary vaccination consists of 2 or 3, to which a booster dose is added. Hexyon comes given to children from six weeks of age elsafe for children over the age of 24 months it has not been studied in clinical trials.

Adverse events declared by the manufacturer

Hypersensitivity reactions
Anaphylactic reaction*
Inappetence (decreased appetite)
Crying, drowsiness
Abnormal crying (prolonged)
Seizures with or without fever*
Hypotonic reactions or episodes of hypotonia-hyporesponsiveness (HHE)
Threw up
Diarrhea
Raro Skin rash
Injection site pain, injection site erythema injection, swelling at the injection site
Irritability
Pyrexia (body temperature ≥ 38,0°C)
Induration at the injection site
Injection site lump
Pyrexia (body temperature ≥ 39,6°C)
Extensive swelling of the limbs
Brachial neuritis and Guillain-Barré syndrome
Peripheral neuropathy, optic neuritis e central nervous system demyelination (multiple sclerosis)
Apnea in very preterm infants (≤ 28 weeks gestation)
Roedematous actions involving one or both lower limbs

Qualitative composition declared by the manufacturer

Diphtheria toxoid
Tetanus toxoid
Bordetella pertussis antigens
Pertussis toxoid
Filamentous hemagglutinin
Poliovirus produced on Vero cells
- Type 1 (Mahoney)
- Type 2 (MEF-1)
- Type 3 (Saukett)
Hepatitis B surface antigen produced in Hansenula polymorpha yeast cells by recombinant DNA technology
Polysaccharide of Haemophilus influenzae type b
aluminum hydroxide, hydrate
glutaraldehyde,
formaldehyde,
neomycin,
streptomycin and polymyxin B
Excipient with known effect
Phenylalanine
Dibasic sodium phosphate
Potassium dihydrogen phosphate
Trometamol
Sucrose
Essential amino acids including L-phenylalanine
Sodium hydroxide, acetic acid or hydrochloric acid

Curiosity

On 29 July 2017, two days before the publication in the Official Gazette of the so-called Lorenzin Decree, the Italian Medicines Agency (AIFA) updated the texts of the summary of product characteristics (Rcp) and the package leaflet (Fi) of the vaccine Hexyon. The SPC published by AIFA before 29 July 2017 reported in paragraph 4.8 that "The safety of Hexyon in children older than 24 months has not been studied in clinical trials" and in paragraph 5.1 that "The immunogenicity of Hexyon in children older than 24 months has not been studied in clinical trials." On 29 July 2017 the prescription of 24 months of age disappeared, thus guaranteeing the possibility of administering that vaccine in accordance with the political needs dictated and regulated by the Lorenzin Decree. The same change was also found on the same day on the European Medicines Agency (EMA) website.
Since that torrid July 2017, our questions have remained unanswered: which studies have been presented in order to guarantee safety and efficacy after 24 months of age?

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Infanrix Hexa - GlaxoSmithKline (click to open)

Diphtheria (D), Tetanus (T), Pertussis (acellular component) (Pa), Hepatitis B (rDNA) (HBV), Polio (inactivated) (IPV), and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed) and is indicated for primary and booster vaccination of infants and young children

Dosage declared by the manufacturer

The primary immunization schedule consists of two or three doses which should be administered based on official recommendations.
The safety and efficacy of Infanrix hexa in children older than 36 months have not been established. No data available.

Adverse events declared by the manufacturer

Upper respiratory tract infection
Lymphadenopathy
Thrombocytopenia
Anaphylactic reactions
Anaphylactoid reactions (including urticaria)
Allergic reactions (including itching)
Loss of appetite
Abnormal crying, irritability, restlessness
Nervousness
Drowsiness
Collapse or shock-like state (hypotonic-hyporesponsive episode) 2
Seizures (with or without fever)
Tosse
Bronchitis
Freediving
Diarrhea
Threw up
Rash
angioedema
Dermatitis
Fever ≥ 38°C
Pain
Redness
Injection site swelling (≤ 50 mm)
Fever >39,5°C
Injection site reactions, including induration, local swelling at the injection site
Diffuse swelling of the injected limb, sometimes extending to the adjacent joint
Fatigue
Swelling of the entire injected limb
Extensive swelling reactions
Injection site mass
Blisters at the injection site
Paralysis
Neuropathy
Neuritis
Hypotension
Vasculitis
lichen planus
erythema multiforme
Arthritis
Muscle weakness
Guillain-Barre syndrome
encephalopathy
Encephalitis
Meningitis

Qualitative composition declared by the manufacturer

Diphtheria toxoid
Tetanus toxoid
Bordetella pertussis antigens: Pertussis toxoid
Filamentous hemagglutinin
Pertactin
Hepatitis B surface antigen (HBs)
Polio virus (inactivated) (IPV): type 1 (Mahoney strain), type 2 (MEF-1 strain), type 3 (Saukett strain)
Haemophilus influenzae type b polysaccharide (polyribosylribitol phosphate, PRP)
Adsorbed on aluminum hydroxide, hydrate (Al(OH)3) produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
Adsorbed on aluminum phosphate (AlPO4) propagated in VERO cells
Formaldehyde
Neomycin
Polymyxin
Para-aminobenzoic acid
Phenylalanine
Hib Powder: Anhydrous lactose
Sodium chloride
medium 199
mineral salts (including sodium and potassium)
vitamins (including para-aminobenzoic acid) and other substances
Water for injections

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Vaxelis - MCM Vaccine BV (click to open)

IMPORTANT NOTE: Corvelva invites you to get in-depth information by reading all the sections and links, as well as the manufacturer's product leaflets and technical data sheets, and to speak with one or more trusted professionals before deciding to vaccinate yourself or your child. This information is for informational purposes only and is not intended as medical advice.

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