Help protect 2 populations at risk of RSV with 1 vaccine 2
INFANTS via maternal immunisation 1 , 2
RSV is a leading cause of hospitalisation due to LRTDs , such as bronchiolitis and pneumonia , in infants under 6 months old . 3 , 4
ADULTS aged ≥60 years 1 , 2
Older adults § hospitalised with RSV are more likely to have longer hospital stays compared with younger individuals . 3
LRTD , lower respiratory tract disease . §
Adults aged ≥65 years . 3
ABRYSVO helps protect against RSV-LRTD in infants from birth to 6 months , and in adults aged ≥60 years across two RSV seasons 5 – 8
Phase 3 MATISSE study 5 , 6
Vaccine efficacy against severe MA RSV-LRTD
Phase 3 RENOIR study 1 , 7 , 8
Vaccine efficacy against RSV-LRTD with ≥3 symptoms
At
82 % 3 months
89 %
95 % CI : 57.5 , 93.9
Across
Season 1
95 % CI : 53.6 , 98.7 Mean follow-up : 7.05 months
70 % |
|
|
|
At
6 months
95 % CI : 50.6 , 82.5
|
78 % |
|
Across
Season 2
95 % CI : 51.4 , 91.1 Total mean follow-up : 17.6 months
|
MA , medically attended ; RSV-LRTD , RSV-associated LRTD .
No safety concerns have been identified in Phase 3 studies evaluating ABRYSVO in pregnant women , infants and older adults . ¶ 5 – 7
¶
In Phase 3 studies , no adverse events leading to study withdrawal were reported in pregnant women ( n = 3,698 ) or adults aged ≥60 years ( n = 17,215 ) who received ABRYSVO . No safety signals were detected in infants to 2 years after birth . 5 – 7
ABRYSVO can be given : 2
Year-round
Co-administered with certain other vaccines
Pregnant women ( ABRYSVO only )
Between 28 – 36 weeks gestation , regardless of expected delivery date
At the same time , or separately to dTpa , influenza and COVID-19
Adults aged ≥60 years ( ABRYSVO or Arexvy )
But should be offered before the start of the RSV season , where possible
Including influenza , COVID-19 , zoster and pneumococcal
MATISSE study primary efficacy endpoints : vaccine efficacy within 90 , 120 , 150 and 180 days after birth , against : 1 ) Severe MA RSV-LRTD , and 2 ) MA RSV-LRTD . 5 , 6
RENOIR study primary efficacy endpoints : vaccine efficacy through Season 1 against RSV-LRTD with : ≥2 symptoms , or ≥3 symptoms ( including cough , wheezing , sputum production , shortness of breath and tachypnoea ); analysis continued through Season 2 to assess duration of protection . 7 , 8
References : 1 . ABRYSVO Approved Product Information . 2 . Australian Immunisation Handbook . Respiratory syncytial virus ( RSV ). Available at : https :// immunisationhandbook . health . gov . au / contents / vaccine-preventable-diseases / respiratory-syncytial-virus-rsv . Accessed February 2025 . 3 . Saravanos GL , et al . Med J Aust . 2019 ; 210:447 – 453 . 4 . Self A , et al . BMC Public Health . 2023 ; 23:2560 . 5 . Kampmann B , et al . N Engl J Med . 2023 ; 388:1451 – 1464 . 6 . Simões EAF , et al . Obstet Gynecol . 2025 ; 145:157 – 167 . 7 . Walsh EE , et al . N Engl J Med . 2023 ; 388:1465 – 1477 . 8 . Walsh EE , et al . N Engl J Med . 2024 ; 391:1459 – 1460 . Abrysvo ® is a registered trademark . Pfizer Australia Pty Limited , Sydney , Australia . www . pfizer . com . au . Pfizer Medical Information : 1800 675 229 . PP-A1G-AUS-0268 . ABR-003335-01 . February 2025 .