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 and include batch/lot number, if available. 4.9 Overdose 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. 5. PHARMACOLOGICAL PROPERTIES 5.1 Pharmacodynamic properties Pharmacotherapeutic group: Vaccines, other viral vaccines; ATC code:
J07BX05 Mechanism of action Abrysvo contains two recombinant stabilised RSV prefusion F antigens representing subgroups RSV-A and RSV-B. Prefusion F is the primary target of neutralising antibodies that block RSV infection. Following intramuscular administration, the prefusion F antigens elicit an immune response, which protects against RSV-associated lower respiratory tract disease (LRTD). In infants born to mothers who were vaccinated with Abrysvo, protection against RSV-associated LRTD is due to transplacental transfer of RSV neutralising antibodies. Adults 18 years of age and older are protected by active immunisation.
Clinical efficacy Infants from birth through 6 months of age by active immunisation of pregnant individuals Study 1 was a phase 3, multicentre, randomised (1:1), double-blind, placebo-controlled study to assess the efficacy of a single dose of Abrysvo in the prevention of RSV-associated LRTD in infants born to pregnant individuals vaccinated between weeks 24 and 36 of gestation. The need for revaccination with subsequent pregnancies has not been established. RSV-associated LRTD was defined as a medically attended visit in individuals with a reverse transcription-polymerase chain reaction (RT-PCR) confirmation of RSV and with one or more of the following respiratory symptoms:
fast breathing, low oxygen saturation (SpO 2 indrawing. Severe RSV-associated LRTD was defined as RSV-associated LRTD that additionally met 6 System organ class Adverse reactions pregnant individuals ≤49 years Adverse reactions individuals ≥18 years Vaccination site redness Common Common Vaccination site swelling Common Common Pyrexia Uncommon Vaccination site pruritus Rare Vaccination site bruising Rare Vaccination site haematoma Rare