Paediatric population The safety and efficacy of Abrysvo in children (from birth to less than 18 years of age) have not yet been established. Limited data are available in pregnant adolescents and their infants (see section 5.1). Method of administration Abrysvo is for intramuscular injection into the deltoid region of the upper arm. The vaccine should not be mixed with any other vaccines or medicinal products. For instructions on reconstitution and handling of the medicinal product before administration, see section 6.6. 4.3 Contraindications Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use 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 Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of the vaccine. 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.
It is important that procedures are in place to avoid injury from fainting. Concurrent illness Vaccination should be postponed in individuals suffering from an acute febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination. Thrombocytopenia and coagulation disorders Abrysvo should be given with caution to individuals with thrombocytopenia or any coagulation disorder since bleeding or bruising may occur following an intramuscular administration to these individuals.
Immunocompromised individuals The efficacy and safety of the vaccine have not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Abrysvo may be lower in immunosuppressed individuals. Individuals less than 24 weeks of gestation Abrysvo has not been studied in pregnant individuals less than 24 weeks of gestation. 3