What are the Hepatitis B vaccines?
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.
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.
HBVAXPRO - Merck (click to open)
Hepatitis B vaccine (recombinant DNA)
This vaccine is indicated for active immunization against hepatitis B virus infection caused by all known subtypes in individuals from birth to 15 years of age. It is possible that vaccination with HBVAXPRO may also prevent infection with the hepatitis B virus of hepatitis D
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
- Transient irritation, erythema, induration
- Fatigue, fever, malaise, flu-like symptoms
- Thrombocytopenia
- Lymphadenopathy
- Serum sickness
- Anaphylaxis
- Polyarteritis nodosa
- Paraesthesia
- Paralysis (including Bell's palsy, facial paralysis)
- Peripheral neuropathies (polyradiculoneuritis, Guillain-Barré syndrome)
- Neuritis (including optic neuritis)
- Myelitis (including transverse myelitis)
- Encephalitis
- Demyelinating disease of the central nervous system
- Exacerbation of multiple sclerosis
- Multiple sclerosis
- Convulsions
- Headache
- Dizziness
- Syncope
- Uveitis
- Hypotension
- Vasculitis
- Bronchospasm-like symptoms
- Threw up
- Nausea
- Diarrhea
- Abdominal pain
- Rash
- Alopecia
- itch
- Urticaria
- erythema multiforme
- angioedema
- Eczema
- Arthralgia
- Arthritis
- Myalgia
- Pain in extremities
- Increased liver enzymes
- Freediving
Composition declared by the manufacturer
- Hepatitis B virus surface antigen, recombinant (HbsAg) produced in yeast Saccharomyces cerevisiae (strain 2150-2-3) by recombinant DNA technology
- Adsorbed on amorphous aluminum hydroxyphosphate sulfate
- Formaldehyde
- Potassium thiocyanate
- Sodium chloride
- Sodium borate
- Water for injections
PreHevbri-VBI Vaccines (click to open)
Hepatitis B vaccine (recombinant, adsorbed)
PreHevbri is a vaccine for the prevention of infection with the hepatitis B virus. It is used in adults to provide protection against all known types of hepatitis B virus and may also provide protection against hepatitis D.
NB: This vaccine is subject to additional monitoring. Healthcare professionals are asked to report any suspected adverse reactions.
Dosage declared by the manufacturer
The vaccination schedule consists of 3 doses administered 0, 1, 6 months after the first. There are no recalls.
NB Pediatric population The safety and efficacy of PreHevbri in children have not yet been established
Adverse events declared by the manufacturer
- Lymphadenopathy
- Diarrhea
- Nausea / vomiting
- Abdominal pain
- Injection site pain, injection site tenderness, injection site pruritus, tiredness
- Injection site swelling, injection site redness
- Injection site bruising
- Temperature
- Headache
- Dizziness
- Myalgia
- Arthralgia
- Urticaria
- itch
- Rash
- Redness
Hot flush
Composition declared by the manufacturer
- Hepatitis B surface antigens produced in Chinese hamster ovary cells by recombinant DNA technology
- Adsorbed on 500 micrograms Al3+ as aluminum hydroxide, hydrate
- Sodium chloride
- Potassium chloride
- Disodium phosphate dodecahydrate
- Potassium dihydrogen phosphate
- Sodium hydroxide
- Hydrochloric acid
- Water for injections
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?
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)
- Cough
- 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
Vaxelis - MCM Vaccine BV (click to open)
Diphtheria, tetanus, pertussis (acellular component), hepatitis B (rDNA), polio (inactivated), and Haemophilus type b conjugate vaccine (adsorbed).
Dosage declared by the manufacturer
The primary vaccination consists of two or three doses, to be administered with an interval of at least 1 month between one dose and the next, and can be carried out starting from 6 weeks of age.
Adverse events declared by the manufacturer
- Rhinitis
- Lymphadenopathy
- Reduced appetite
- Increased appetite
- Sleep disorders including insomnia, restlessness
- Drowsiness
- Hypotonia
- Pallor
- Cough
- Threw up
- Diarrhea
- Abdominal pain
- Rash, hyperhidrosis
- Crying, irritability
- crisis (convulsions ) with or without fever
- status type episodes shock
- extensive swelling of the vaccinated limb
- Erythema at the injection site, pain in the injection, injection site swelling
- Pyrexia
- Injection site lividuria, injection site induration, injection site nodule
- Injection site rash, injection site warmth, tiredness
- Apnea in very preborn infantsripe (≤ 28 weeks gestation)
Qualitative composition declared by the manufacturer
- Diphtheria toxoid adsorbed on aluminum phosphate
- Tetanus toxoid adsorbed on aluminum phosphate
- Bordetella pertussis antigens adsorbed on aluminum phosphate
- Pertussis toxoid
- Filamentous hemagglutinin (FHA)
- Pertactin (PRN)
- Type 2 and 3 fimbriae (FIM)
- Hepatitis B surface antigen (HbsAg) adsorbed on amorphous aluminum hydroxyphosphate sulfate produced in yeast cells (Saccharomyces cerevisiae) by recombinant DNA technology
- Poliovirus (Inactivated) produced in Vero cells
- Type 1 (Mahoney)
- Type 2 (MEF-1)
- Type 3 (Saukett)
- Polysaccharide of Haemophilus influenzae type b
- glutaraldehyde
- formaldehyde
- neomycin
- streptomycin, polymyxin B
- bovine serum albumin
- Sodium phosphate
