mRESVIA Dispersion for injection Ref.[115162] 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 a severe hypersensitivity reaction, including anaphylaxis, following 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 precautions are in place to avoid injury from fainting.

Concurrent illness

Vaccination should be postponed in individuals suffering from acute infection or febrile illness. The presence of a minor infection, such as a cold, 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

Safety and immunogenicity data on mRESVIA are not available for immunocompromised individuals. Individuals receiving immunosuppressant therapy or patients with immunodeficiency may have a diminished immune response to this vaccine.

Limitations of vaccine effectiveness

As with all vaccines, vaccination with mRESVIA may not protect all vaccine recipients.

Excipient – sodium

This vaccine contains less than 1 mmol sodium (23 mg) per 0.5 mL dose, that is to say essentially 'sodium-free.'

No interaction studies with other medicinal products have been performed.

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

Women of childbearing potential

This vaccine is not indicated in women of childbearing potential (see section 4.1). It is not to be used in women who are or may be pregnant or breast-feeding.

Pregnancy

There are no or limited amount of data from the use of mRESVIA in pregnant women. Animal studies with mRESVIA do not indicate direct or indirect harmful effects with respect to pregnancy (see section 5.3).

Breast-feeding

It is unknown whether mRESVIA is excreted in human milk.

Fertility

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

Animal studies with mRESVIA do not indicate direct or indirect harmful effects with respect to female reproductive toxicity. Animal studies are insufficient to assess male reproductive toxicity (see section 5.3).

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

However, some of the effects mentioned under section 4.8 (e.g., fatigue, dizziness) may temporarily affect the ability to drive or use machines.

Summary of the safety profile

The most commonly reported adverse reactions were injection site pain (55.9%), fatigue (30.8%), headache (26.7%), myalgia (26.6%) and arthralgia (21.7%). The onset of most solicited local and systemic adverse reactions was within 1 to 2 days after injection and resolved within 1 to 2 days after onset. The majority of local and systemic solicited adverse reactions were mild in intensity.

Tabulated list of adverse reactions

The safety profile and the frequencies of adverse reactions presented below are based on data generated in a global placebo-controlled phase ⅔ clinical study (EUDRA CT number 2021-005026-20) with a total of 18 245 participants aged ≥60 years who received one injection of 50 micrograms of mRESVIA. The clinical study was conducted in 22 countries in Central and Latin America, Africa, Asia Pacific, North America and Europe.

For information on the main characteristics of the patient population in the phase ⅔ clinical study, see section 5.1.

Adverse reactions reported are listed according to the following frequency convention: 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).

Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness (Table 1).

Table 1. Adverse reactions following administration of mRESVIA:

^* Lymphadenopathy was collected as “Axillary (underarm) swelling or tenderness ipsilateral to the side of injection”.
^† One participant in the vaccine group had a serious adverse event of facial paralysis with onset on Day 5 assessed by the investigator as related to injection. Within the 42-day risk window following injection, Bell’s palsy and/or facial paralysis was reported by 2 participants in the mRESVIA group and 2 participants in the placebo group. All 4 of these participants had risk factors for Bell’s palsy.
^‡ Urticaria has been observed with either acute onset (within a few days after vaccination) or delayed onset (up to approximately two weeks after vaccination) and may be acute or chronic (≥6 weeks) in duration.

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.