ABRYSVO

/ Pfizer

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.
Pregnant individuals
A single dose of 0.5 mL should be administered between weeks 24 and 36 of gestation.
Individuals 60 years of age and older
A single dose of 0.5 mL should be administered.
See prescribing information for full details.

* Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy.
* Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV.

Hypersensitivity to the active substances or to any of the excipients

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.
Limitations of vaccine effectiveness
A protective immune response may not be elicited after vaccination.
See prescribing information for full details.

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, vaccination site pain and myalgia. The majority of reactions were mild to moderate in severity and resolved within 1-2 days of onset.
See prescribing information for full details.

This medical product 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 this medical product and administration of a tetanus, diphtheria and acellular pertussis vaccine (Tdap). There were no safety concerns when this medical product 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.
See prescribing information for full details.

Pregnancy: Data on pregnant women (more than 4,000 exposed outcomes) indicate no malformative nor feto/neonatal toxicity.
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 medicinal product group (37%) and the placebo group (35%). Major birth outcomes assessed in the treatment group compared to placebo included premature birth (207 (6%) and 172 (5%), respectively), low birth weight (186 (5%) and 158 (4%), respectively) and congenital anomalies (205 (6%) and 245 (7%), respectively).
See prescribing information for full details.
Lactation: It is unknown whether this medicinal product is excreted in human milk. No adverse effects of this medicinal product have been shown in breastfed newborns of vaccinated mothers.

Overdose with Abrysvo is unlikely due to its single dose presentation.
There is no specific treatment for an overdose with Abrysvo. In the event of an overdose, the individual should be monitored and provided with symptomatic treatment as appropriate.