Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Summary of safety profile
Pediatric Use: Sci-B-Vac has been shown to be well tolerated and highly immunogenic in infants and children of all ages. Newborns also respond well; maternally transferred antibodies do not interfere with the active immune response to the vaccine.

The clinical trial safety profile of Sci-B-Vac is based on two Phase 3 controlled clinical trials (Sci-B-Vac-001 and Sci-B-Vac-002) in which 2 920 adults received at least one dose of Hepatitis B vaccine (recombinant, adsorbed) 10µg/1 ml.
Local and systemic post-injection reactions were monitored using diary cards for a 7-day period starting on the day of each vaccination (solicited adverse events).
The most common solicited local reactions were injection-site pain (72.2%), tenderness (71.2%) and local pruritus/itching (12.2%). Most common solicited systemic reactions were myalgia (41.7%), fatigue (37.5%), and headache (36.3%).

The frequency and severity of solicited adverse events generally declined or remained similar with successive vaccinations.

Tabulated list of adverse reactions
The information in the table below is taken from data from the two pivotal studies and includes both solicited and spontaneously reported adverse reactions.

The frequency of adverse reactions is defined as follows:
Very common: (≥1/10)
Common: (≥1/100 to <1/10)
Uncommon: (≥1/1000 to <1/100)
Rare: (≥1/10,000 to <1/1000)
Very rare: (<1/10,000)

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Table 1:        Adverse Reactions by System Organ Class and Frequency System Organ Class             Adverse Reaction                                            Frequency Blood and Lymphatic System
Lymphadenopathy                                             Uncommon
Disorders
Diarrhoea1, nausea/vomiting1                                Common
Gastrointestinal Disorders
Abdominal pain                                              Common
Injection site pain1, injection site tenderness1,
Very Common injection site pruritus1, fatigue1,
General Disorders and
Injection site swelling1, injection site redness1           Common
Administration Site Conditions
Injection site bruising                                     Common
Fever1                                                      Common
Headache1                                                   Very Common Nervous System Disorders
Dizziness                                                   Common
Musculoskeletal and Connective Myalgia1                                                    Very Common Tissue Disorder                Arthralgia                                                  Common Skin and Subcutaneous Tissue Urticaria, pruritus                                           Uncommon Disorders                      Rash                                                        Common Vascular disorders             Flushing, hot flush                                         Uncommon 1
Local and systemic adverse reactions collected using diary cards. Adverse events collected on the diary cards included local (pain, tenderness, erythema/redness, pruritus/itchiness and oedema/swelling) and systemic (nausea/vomiting, diarrhoea, headache, fever, fatigue and myalgia) solicited adverse events.


In a series of studies, 2313 doses of Sci-B-Vac were administered to 771 healthy adults who were monitored for 5 days after each dose. The following adverse reactions were reported: 
Incidence Equal to or Greater Than 1% of Injections:
Local Reaction (Injection Site): Injection site reactions consist of soreness and include pain, tenderness, pruritus, erythema, ecchymosis, swelling, warmth and nodule formation. These reactions were mild and resolved within two days after vaccination.
Additional complaints included fatigue/weakness, headache, fever (37.8ºC), malaise, nausea, diarrhoea pharyngitis and upper respiratory infection.

Incidence Less Than 1% of Injections:
Sweating, aching, sensation of warmth, light-headedness, chills, flushing, vomiting, abdominal pains/cramps, dyspepsia, diminished appetite, rhinitis, influenza, cough, vertigo/dizziness, paresthesia, pruritus, rash (non-specified), angioedema, urticaria, arthralgia including monarticular, myalgia, back pain, neck pain, shoulder pain, neck stiffness, lymphadenopathy, insomnia/disturbed sleep, earache, dysuria and hypotension.

Additional information in special populations
Safety data are limited in immunocompromised adults, in adults previously vaccinated for hepatitis B and in adults with chronic renal failure, including patients on haemodialysis.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il