KOSTAIVE Powder for dispersion for injection Ref.[114806] Active ingredients: Zapomeran

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.

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 immunocompromised individuals.

Limitations of vaccine effectiveness

As with any vaccine, vaccination with Kostaive may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their vaccination.

Excipients with known effect

Potassium

This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially “potassium-free”.

Sodium

This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially “sodium-free”.

No interaction studies have been performed.

Concomitant administration of Kostaive with other vaccines has not been studied.

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.

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).

Kostaive has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions mentioned under section 4.8 may temporarily affect the ability to drive or use machines.

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).

Table 1. Adverse reactions:

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. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products.