Zapomeran

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. The efficacy of zapomeran may be lower in immunocompromised individuals.

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.

There are limited data from the use of zapomeran in pregnant women.

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Administration of zapomeran in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.

No effects on the breast-fed newborn/infant are anticipated since the systemic exposure of the breast-feeding woman to zapomeran is negligible. Zapomeran can be used during breast-feeding.

Fertility

Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.

Zapomeran has no or negligible influence on the ability to drive and use machines. However, some of the adverse reactions 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 zapomeran.

Booster dose

The overall safety profile for participants who received a booster dose of zapomeran 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 zapomeran, involving participants 18 years of age and older who received at least one dose of zapomeran (N=8 807).
• Study ARCT-154-J01, conducted to evaluate the safety and immunogenicity for booster immunisation. In this study, a single dose of zapomeran 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).

Adverse reactions: