Adverse reactions : תופעות לוואי

4.8     Undesirable effects
 a. Summary of the safety profile
Adverse event information is based on data coming from two clinical trial with Efluelda and on the clinical and post-marketing experience of Trivalent Influenza Vaccine (Split Virion, Inactivated) High-Dose (TIV-HD).

The safety of Efluelda was assessed in a pooled analysis of two clinical trials (QHD00013 and QHD00011) in which 2549 adults from 60 years of age and older (378 adults from 60 to 64 years of age and 2171 adults 65 years of age and older) received Efluelda.
The most frequently reported adverse reaction occurring after vaccination was injection site pain reported by 42.6% of study participants followed by myalgia (23.8%), headache (17.3%) and malaise (15.6%). Most of these reactions occurred and resolved within three days of vaccination. The intensity of most of these reactions was mild to moderate.

Overall, adverse reactions were generally less frequent in participants aged 65 years and older than in participants aged 60 to 64 years.

Reactogenicity of the vaccine was slightly increased as compared to the standard dose vaccine, but no major difference in intensity was observed.
The safety of Efluelda was evaluated in a descriptive study (QHD00028) in which subjects received Efluelda together with an investigational booster 100 mcg dose of COVID- 19 mRNA vaccine (nucleoside modified) (n=100), Efluelda only (n=92) or an investigational booster 100 mcg dose of COVID-19 mRNA vaccine (nucleoside modified) only (n=104). The frequency and severity of local and systemic adverse reactions was similar in subjects who were co-administered with Efluelda and licensed COVID-19 mRNA vaccine and subjects administered with a booster dose of licensed COVID-19 mRNA vaccine.
b. Tabulated list of adverse reactions
The data below summarizes the frequencies of adverse reactions that were recorded following vaccination with Efluelda and adverse reactions reported during clinical development and post-marketing experience with TIV-HD (marked with * in the table below).

Adverse events are ranked under headings of frequency using the following convention: Very common (≥1/10);
Common (≥1/100 to <1/10);
Uncommon (≥1/1,000 to <1/100);
Rare (≥1/10,000 to <1/1,000);
Very rare (<1/10,000);
Not known (cannot be estimated from available data).

ADVERSE REACTIONS                                   FREQUENCY
General Disorders and Administration Site Conditions
Injection site pain, injection site erythema, malaise                          Very common Injection site swelling, injection site induration, injection site bruising,   Common Fever (≥37.5°C), shivering
Injection site pruritis, fatigue                                               Uncommon Asthenia                                                                       Rare Chest pain                                                                     Not known* Musculoskeletal and Connective Tissue Disorders
Myalgia                                                                        Very common Muscle weaknessa                                                               Uncommon Arthralgia, pain in extremities                                                Rare Nervous System Disorders
Headache                                                                       Very common Lethargya                                                                      Uncommon Dizziness, paraesthesia                                                        Rare Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis      Not known* (including encephalomyelitis and transverse myelitis), facial palsy (Bell’s palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination)

Blood and Lymphatic System Disorders
Thrombocytopenia, lymphadenopathy                                              Not known* ADVERSE REACTIONS                                     FREQUENC
Y
Respiratory, Thoracic and Mediastinal Disorders
Cough, oropharyngeal pain                                                       Uncommon Rhinorrhea                                                                      Rare Dyspnea, wheezing, throat tightness                                             Not known* Gastrointestinal Disorders
Nausea, vomiting, dyspepsiaa, diarrhoea                                         Uncommon Immune System Disorders
Pruritus, urticaria, night sweats, rash                                         Rare Anaphylaxis, other allergic/hypersensitivity reactions (including               Not known* angioedema)
Vascular Disorders
Flushing                                                                        Rare Vasculitis, vasodilatation                                                      Not known* Ear and Labyrinth Disorders
Vertigo                                                                         Rare Eye Disorders
Ocular hyperemia                                                                Rare a
Dyspepsia, lethargy, and muscular weakness were observed with TIV-HD in the QHD00013 trial 

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 (www.health.gov.il) according to the National Regulation by using an online form https://sideeffects.health.gov.il.