ABRYSVO Powder and solvent for solution for injection Ref.[51247] Active ingredients: RSV glycoprotein F antigen

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 can be administered concomitantly with seasonal influenza vaccine (QIV, surface antigen, inactivated, adjuvanted). In a randomised study in adults 65 years of age and older, the criteria for non-inferiority of the immune responses in the co-administration versus the separate administration group were met. However, numerically lower RSV A and B neutralising titres and numerically lower influenza A and B haemagglutination inhibition titres were observed when Abrysvo and inactivated adjuvanted seasonal influenza vaccine were co-administered than when they were administered separately. The clinical relevance of this finding is unknown.

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 noninferiority. The clinical relevance of this finding is unknown.

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 60 years of age and older

In individuals 60 years of age and older the most frequently reported adverse reaction was vaccination site pain (11%). 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 60 years of age and older (n=18 575) was evaluated in phase 3 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:

^a In a study in individuals 60 years of age and older, one case of Guillain-Barré syndrome and one case of Miller Fisher syndrome were reported with onset of 7 and 8 days, respectively, after receiving Abrysvo and assessed by the investigator as possibly related to the administered vaccine. Both cases had either confounding factors or an alternative aetiology. One additional case, with onset 8 months after receiving Abrysvo, was assessed as not related to the administered vaccine by the investigator. One case of Guillain-Barré syndrome was reported in the placebo group 14 months after administration.

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.