Kostaive · 4.5 Interaction with other medicinal products and other forms of interaction · 1

HOS-100692 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile Primary vaccination series The most frequent adverse reactions (≥ 10%) after dose 1 or dose 2 are pain at the injection site (49.1%), tenderness at the injection site (49.0%), fatigue (42.3%), headache (35.4%), myalgia (30.1%), chills (28.5%), arthralgia (27.2%), dizziness (20.1%), and pyrexia (10.8%). The majority of adverse reactions were mild in intensity and resolved within a few days of vaccination. One case of anaphylaxis was reported as related to Kostaive (see section 4.4). Booster dose The overall safety profile for participants who received a booster dose of Kostaive was similar to that seen after 2 doses (primary vaccination series). Tabulated list of adverse reactions The safety profile presented below is based on data from 2 clinical studies: • Study ARCT-154-01, conducted to evaluate the safety, immunogenicity, and efficacy of a 2- dose regimen of Kostaive, involving participants 18 years of age and older who received at least one dose of Kostaive (N=8 807). • Study ARCT-154-J01, conducted to evaluate the safety and immunogenicity for booster immunisation. In this study, a single dose of Kostaive was administered to participants aged 18 years or older (N=420) who had previously received 3 doses of authorised COVID-19 mRNA vaccines at least 3 months prior to enrollment. Adverse reactions observed during clinical studies are listed according to the following frequency categories: 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 the available data) 5  Table 1 Adverse reactions MedDRA System Organ Adverse reactions Frequency Class Immune system disorders Immediate and delayed Uncommon hypersensitivity reactions (e.g., rash, urticaria, allergic dermatitis) Anaphylaxis Very rare Nervous system disorders Headache Very common Dizziness Very common Gastrointestinal disorders Diarrhoea

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HOS-100688 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-100687 · has-indication-information · PDF-Seite 2

Kostaive is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The use of this vaccine should be in accordance with official recommendations.

HOS-100690 · has-interaction-information · PDF-Seite 4

Kostaive may be administered concomitantly with seasonal influenza vaccine. Different injectable vaccines should be given at different injection sites.

HOS-100691 · has-pregnancy-information · PDF-Seite 4

Pregnancy There are limited data from the use of Kostaive in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3). Administration of Kostaive in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. 4 Breast-feeding No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast- feeding woman to Kostaive is negligible. Kostaive can be used during breast-feeding. Fertility Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

HOS-100689 · has-warning-information · PDF-Seite 3

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hypersensitivity and anaphylaxis Cases of hypersensitivity, including anaphylaxis, have been reported with Kostaive (see section 4.8). Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Kostaive. Myocarditis and pericarditis An increased risk of myocarditis and pericarditis has been observed following vaccination with some other COVID-19 vaccines. These conditions can develop within a few days and primarily occur within 14 days. They have been observed more often in younger males. Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccine recipients (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis. 3 Anxiety-related reactions Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress-related reactions, may occur in association with vaccination as a psychogenic response to the needle injection. Procedures should be in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Thrombocytopenia and coagulation disorders As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. Immunocompromised individuals The efficacy and safety of the vaccine have not been assessed in immunocompromised individuals, including those with a known diagnosis of the human immunodeficiency virus (HIV) or those receiving immunosuppressant therapy (see section 5.1). The efficacy of Kostaive may be lower in immunocompromi

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