ABRYSVO Powder and solvent for solution for injection Ref.[51247] Active ingredients: Respiratory syncytial virus vaccine

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. Since protection of the infant against RSV depends on transfer of maternal antibodies across the placenta, Abrysvo should be administered between weeks 24 and 36 of gestation (see sections 4.2 and 5.1).

Limitations of vaccine effectiveness

As with any vaccine, a protective immune response may not be elicited after vaccination.

Excipient

This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially 'sodium-free'.

Abrysvo contains polysorbate 80. Polysorbate 80 may cause hypersensitivity reactions.

Abrysvo can be administered concomitantly with:

• seasonal influenza vaccines, either standard dose adjuvanted or high dose unadjuvanted
• COVID-19 mRNA vaccines, with or without high dose unadjuvanted influenza vaccine administered concomitantly.

A minimum interval of two weeks is recommended between administration of Abrysvo and administration of a tetanus, diphtheria and acellular pertussis vaccine (Tdap). There were no safety concerns when Abrysvo was co-administered with Tdap in healthy non-pregnant women. Immune responses to RSV A, RSV B, diphtheria and tetanus on co-administration were non-inferior to those after separate administration. However, the immune responses to the pertussis components were lower on co-administration compared to separate administration and did not meet the criteria for non- inferiority. The clinical relevance of this finding is unknown.

Pregnancy

Data on pregnant women (more than 4 000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity.

Results from animal studies with Abrysvo do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).

In a phase 3 study (Study 1), maternal adverse events reported within 1 month after vaccination were similar in the Abrysvo group (14%) and the placebo group (13%).

No safety signals were detected in infants up to 24 months of age. The incidences of adverse events reported within 1 month after birth in infants were similar in the Abrysvo group (37%) and the placebo group (35%). Major birth outcomes assessed in the Abrysvo group compared to placebo included premature birth (201 (6%) and 169 (5%), respectively), low birth weight (181 (5%) and 155 (4%), respectively) and congenital anomalies (174 (5%) and 203 (6%), respectively).

Breast-feeding

It is unknown whether Abrysvo is excreted in human milk. No adverse effects of Abrysvo have been shown in breastfed newborns of vaccinated mothers.

Fertility

No human data on the effect of Abrysvo on fertility are available.

Animal studies do not indicate direct or indirect harmful effects with respect to female fertility (see section 5.3).

Abrysvo has no or negligible influence on the ability to drive and use machines.

Summary of the safety profile

Pregnant individuals

In pregnant women at 24-36 weeks of gestation the most frequently reported adverse reactions were vaccination site pain (41%), headache (31%) and myalgia (27%). The majority of local and systemic reactions in maternal participants were mild to moderate in severity and resolved within 2-3 days of onset.

Individuals 18 years of age and older

In individuals 18 years of age and older the most frequently reported adverse reactions were fatigue (23%), headache (20%), vaccination site pain (19%) and myalgia (16%). The majority of reactions were mild to moderate in severity and resolved within 1-2 days of onset.

Tabulated list of adverse reactions

The safety of administering a single dose of Abrysvo to pregnant women at 24-36 weeks of gestation (n=3 682) and to individuals 18 years of age and older (n=20 275) was evaluated in clinical trials.

Adverse reactions 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 reported are listed per system organ class, in decreasing order of seriousness.

Table 1. Adverse reactions following administration of Abrysvo:

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 medicinal product must not be mixed with other medicinal products.