drugset

Drugs / ABRYSVO

Follow last change Aug 2026 re-read 3 minutes ago

ABRYSVO

also known as Pfizer RSV vaccine · RSVpreF

Developed for: respiratory syncytial virus infectious disease · respiratory syncytial virus bronchiolitis
Investigated by: Centre Hospitalier Annecy Genevois · National Heart, Lung, and Blood Institute (NHLBI) · National Institute of Allergy and Infectious Diseases (NIAID) · PENTA Foundation · Pfizer · Tor Biering-Sørensen
+1 more
· University of Rochester

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Approved	EU (EMA)	Abrysvo	—	2023-08-23	europa.eu ↗

Trials 6

today

EU approved 2023

NCT07232706 · Ph 3 NCT07041190 · Ph 3 NCT06684743 · Ph 4 NCT06551506 · Ph 4 NCT06077149 · Ph 4 NCT05170399 · Ph 4

2023202420252026202720282029

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 32 trials
Phase 3	NCT07232706	May 2026 → May 2029 expected	respiratory syncytial virus infectious disease	Centre Hospitalier Annecy Genevois	Recruiting	No outcome recorded
Phase 3	NCT07041190	Sep 2025 → Nov 2028 expected	respiratory syncytial virus infectious disease	PENTA Foundation	Not yet recruiting	No outcome recorded
Phase 44 trials · 1 met primary
Phase 4	NCT06684743	Nov 2024 → May 2028 expected	respiratory syncytial virus infectious disease	Tor Biering-Sørensen	Active not recruiting	Met primary
Phase 4	NCT06551506	Sep 2024 → May 2026	respiratory syncytial virus infectious disease	National Institute of Allergy and Infectious Diseases (NIAID)	Completed	No outcome recorded
Phase 4	NCT06077149	Nov 2023 → Nov 2024	respiratory syncytial virus infectious disease	University of Rochester	Completed	No outcome recorded
Phase 4	NCT05170399	Sep 2022 → Aug 2026 overdue	lymphoma	National Heart, Lung, and Blood Institute (NHLBI)	Recruiting	No outcome recorded
Comparator or background therapy2 trials
Phase 1	NCT07492706 Comparator	Apr 2026 overdue	respiratory syncytial virus infectious disease	MAXVAX Biotechnology Limited Liability Company	Not yet recruiting	No outcome recorded
Phase 3	NCT06955728 Comparator	Sep 2025 → Feb 2028 expected	preterm premature rupture of the membranes, respiratory syncytial virus bronchiolitis	University of Witwatersrand, South Africa	Recruiting	No outcome recorded

Press releases naming this drug 10 releases

Date	Issuer	Release
2025-04-16	Pfizer	ACIP Votes to Expand Recommendation for Pfizer’s RSV Vaccine ABRYSVO® to Include Adults Aged 50 to 59 at Increased Risk of Disease pfizer.com ↗
2025-04-01	Pfizer	European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease pfizer.com ↗
2024-10-22	Pfizer	U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease pfizer.com ↗
2024-08-12	Pfizer	Pfizer Announces Top-Line Results of ABRYSVO® for RSV in Immunocompromised Adults pfizer.com ↗
2024-04-09	Pfizer	Pfizer Announces Positive Top-Line Results from Phase 3 Study of ABRYSVO® in Adults Aged 18 to 59 at Increased Risk for RSV Disease pfizer.com ↗
2024-02-29	Pfizer	Pfizer Announces Positive Top-Line Data for Full Season Two Efficacy of ABRYSVO® for RSV in Older Adults pfizer.com ↗
2023-09-22	Pfizer	Pfizer Broadens Portfolio of Respiratory Vaccines Recommended by CDC Advisory Committee with ABRYSVO™ for RSV pfizer.com ↗
2023-08-24	Pfizer	European Commission Approves Pfizer’s ABRYSVO™ to Help Protect Infants through Maternal Immunization and Older Adults from RSV pfizer.com ↗
2023-08-21	Pfizer	U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Infants Through Active Immunization of Pregnant Individuals 32-36 Weeks of Gestational Age pfizer.com ↗
2023-05-31	Pfizer	U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults pfizer.com ↗

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 8 sources stand behind the page.

Field	Value	Cited text
Known as	ABRYSVO	“All participants will get either the Pfizer RSV vaccine (RSVpreF (ABRYSVO)) or the GSK RSV vaccine (RSVpreF (AREXVY)) at 120 ug of the RSV prefusion F antigen intramuscularly...” NCT06077149 ↗ 8 “an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy” NCT06551506 ↗ “For this arm, the RSV prefusion F protein-based vaccine Abrysvo® will be used” NCT06684743 ↗ “ABRYSVO vaccine developed by Pfizer.” NCT06955728 ↗ NCT07492706 ↗ NCT07041190 ↗ NCT06551506 ↗ NCT07232706 ↗ NCT05170399 ↗
Known as	Pfizer RSV vaccine	“All participants will get either the Pfizer RSV vaccine (RSVpreF (ABRYSVO)) or the GSK RSV vaccine (RSVpreF (AREXVY)) at 120 ug of the RSV prefusion F antigen intramuscularly...” NCT06077149 ↗
Known as	RSVpreF	“an active RSV vaccine based on the prefusion F protein (RSVpreF, ABRYSVO, Pfizer) administered during pregnancy” NCT06551506 ↗
Modality	Vaccine	“Respiratory Syncytial Virus Vaccine” NCT05170399 ↗
Route	Intramuscular	“at 120 ug of the RSV prefusion F antigen intramuscularly in the the non-dominant deltoid muscle” NCT06077149 ↗