Drugs / RSVpreF
RSVpreF
also known as
Abrysvo · Respiratory Syncytial Virus Prefusion F Vaccine · RSV prefusion F · RSVpreF vaccine
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | Japan (PMDA) | — | RSV prevention in infants | — | “application was filed with the Ministry of Health, Labor and Welfare for RSVPreF as a maternal immunization to help protect infants against RSV.” pfizer.com ↗ “In February 2023, Pfizer Japan announced an application was filed with the Ministry of Health, Labor and Welfare for RSVpreF” pfizer.com ↗ |
| Filed | Other | — | RSV prevention in older adults and infants | — | “In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for review for both individuals ages 60 and older and as a maternal immunization” pfizer.com ↗ “In April 2023, Pfizer Canada announced Health Canada accepted RSVpreF for review for both individuals ages 60 and older and as a maternal immunization” pfizer.com ↗ |
Trials 23
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT05900154 | Jun 2023 → Feb 2024 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05788237 | Mar → Sep 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 25 trials · 2 met primary | ||||||
| Phase 2 | NCT05886777 | Jun 2023 → Jan 2024 | — | Pfizer | Completed | Met primary |
| Phase 2 | NCT04785612 | Nov 2020 → Apr 2021 | respiratory syncytial virus infectious disease | Hvivo | Completed | Met primary |
| Phase 2 | NCT04071158 | Oct → Dec 2019 | respiratory tract infectious disorder | Pfizer | Completed | Mixed |
| Phase 2 | NCT04032093 | Aug 2019 → Sep 2021 | respiratory tract infectious disorder | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT03529773 | Apr 2018 → Nov 2019 | respiratory tract infectious disorder | Pfizer | Completed | No outcome recorded |
| Phase 314 trials · 5 met primary | ||||||
| Phase 3 | NCT07839871 | Sep 2026 → Apr 2031 expected | respiratory syncytial virus infectious disease | Pfizer | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07768345 | Aug 2026 → Feb 2028 expected | respiratory syncytial virus infectious disease | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT07653100 | Jun 2026 → Jan 2027 expected | respiratory syncytial virus infectious disease | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT07543380 | May → Aug 2026 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT06866405 | Apr 2025 → Feb 2028 expected | respiratory syncytial virus infectious disease | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT06890416 | Apr → Sep 2025 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT06593587 | Oct 2024 → Feb 2025 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT06473519 | Jun → Sep 2024 | respiratory syncytial virus infectious disease | Pfizer | Completed | Met primary |
| Phase 3 | NCT06325657 | Mar 2024 → Jun 2025 | respiratory syncytial virus infectious disease | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT05842967 | May 2023 → Mar 2024 | respiratory syncytial virus infectious disease | Pfizer | Completed | Met primary |
| Phase 3 | NCT05301322 | Apr → Oct 2022 | respiratory syncytial virus infectious disease | Pfizer | Completed | Met primary |
| Phase 3 | NCT05096208 | Oct 2021 → Apr 2022 | respiratory syncytial virus infectious disease | Pfizer | Completed | Met primary |
| Phase 3 | NCT05035212 | Aug 2021 → Jan 2027 expected | lower respiratory tract disorder | Pfizer | Active not recruiting | Met primary |
| Phase 3 | NCT04424316 | Jun 2020 → Oct 2023 | respiratory tract infectious disorder | Pfizer | Completed | Mixed |
| Phase 42 trials | ||||||
| Phase 4 | NCT07693166 | Sep 2026 → Sep 2027 expected | HIV infectious disease, respiratory syncytial virus infectious disease | University of British Columbia | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07296120 | Jan 2026 → Jan 2027 expected | respiratory syncytial virus infectious disease | The Cooper Health System | Not yet recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT07819097 Comparator | Sep 2026 → May 2027 expected | — | Pfizer | Recruiting | No outcome recorded |
| Phase 4 | NCT07097012 Comparator | Oct 2025 → Jul 2026 overdue | respiratory syncytial virus infectious disease | Canadian Immunization Research Network | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2025-10-13 | Pfizer | Results Pfizer to Highlight Advancements in Respiratory Health and Infectious Disease Research at IDWeek 2025 pfizer.com ↗
Bivalent RSV Prefusion F-Based Subunit Vaccine Recipients with Chronic Kidney Disease Achieved High Neutralizing Titers One Month After Vaccination |
| 2025-04-16 | Pfizer | Regulatory 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 ↗
With respect to ABRYSVO, ACIP stated: ACIP recommends adults 50–59 years of age who are at increased risk of severe RSV disease receive a single dose of RSV vaccine. |
| 2025-04-01 | Pfizer | Regulatory European Commission Approves Pfizer’s RSV Vaccine ABRYSVO® to Help Protect Adults Aged 18-59 Against RSV Lower Respiratory Tract Disease pfizer.com ↗
This expands the previous authorization for individuals aged 60 and older, and ABRYSVO now offers in the EU the broadest RSV vaccine indication, which includes: |
| 2024-10-22 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s RSV Vaccine ABRYSVO® for Adults Aged 18 to 59 at Increased Risk for Disease pfizer.com ↗ |
| 2024-04-09 | Pfizer | Results 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 ↗
Pfizer Inc. (NYSE: PFE) today announced positive top-line immunogenicity and safety data from the ongoing pivotal Phase 3 clinical trial ( NCT05842967 ) MONeT (RSV I M munizati ON Study for Adul T s at Higher Risk of Severe Illness), evaluating a single dose of ABRYSVO versus placebo in adults 18 to 59 years of age at risk of developing severe respiratory syncytial virus (RSV)-associated lower respiratory tract disease (LRTD). |
| 2023-10-05 | Pfizer | Results Pfizer Presents New Data at IDWeek 2023 Highlighting Advances in Prevention and Treatment of Certain Respiratory Illnesses and Other Infectious Diseases pfizer.com ↗
Eight abstracts have been selected for oral presentation, including data on the successful coadministration of ABRYSVO with an influenza vaccine in older adults and results from the Phase 3 REVISIT study of Pfizer’s investigational antibiotic combination aztreonam-avibactam (ATM-AVI) candidate. |
| 2023-09-22 | Pfizer | Regulatory Pfizer Broadens Portfolio of Respiratory Vaccines Recommended by CDC Advisory Committee with ABRYSVO™ for RSV pfizer.com ↗
ABRYSVO recommended by CDC Advisory Committee for pregnant persons 32 through 36 weeks gestation to help protect infants from respiratory syncytial virus (RSV) from birth through first six months of life |
| 2023-08-24 | Pfizer | Regulatory European Commission Approves Pfizer’s ABRYSVO™ to Help Protect Infants through Maternal Immunization and Older Adults from RSV pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for ABRYSVO ™ , the company’s bivalent respiratory syncytial virus (RSV) prefusion F (RSVpreF) vaccine, to help protect both infants through maternal immunization and older adults. |
| 2023-08-21 | Pfizer | Regulatory 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 ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ ( Respiratory Syncytial Virus Vaccine ), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. |
| 2023-05-31 | Pfizer | Regulatory U.S. FDA Approves ABRYSVO™, Pfizer’s Vaccine for the Prevention of Respiratory Syncytial Virus (RSV) in Older Adults pfizer.com ↗ |
| 2023-05-18 | Pfizer | Regulatory FDA Advisory Committee Votes in Support of Approval for Pfizer’s Vaccine Candidate to Help Prevent RSV in Infants Through Maternal Immunization pfizer.com ↗
The Committee voted 14 to 0 on effectiveness and 10 to 4 on safety. |
| 2023-02-28 | Pfizer | Regulatory Pfizer Receives Positive FDA Advisory Committee Votes Supporting Potential Approval for Vaccine Candidate to Help Combat RSV in Older Adults pfizer.com ↗
The Committee voted 7 to 4 on safety and 7 to 4 on effectiveness. |
| 2023-02-21 | Pfizer | Regulatory U.S. FDA Accepts Biologics License Application for Pfizer’s Respiratory Syncytial Virus Maternal Vaccine Candidate for Priority Review pfizer.com ↗
The FDA has accepted the BLA for priority review and has set a Prescription Drug User Fee Act (PDUFA) action date of August 2023. |
| 2022-12-07 | Pfizer | Regulatory U.S. FDA Accepts for Priority Review the Biologics License Application for Pfizer’s Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV Disease in Older Adults pfizer.com ↗
Priority Review designation by the FDA reduces the standard BLA review period by four months. |
| 2022-11-01 | Pfizer | Results Pfizer Announces Positive Top-Line Data of Phase 3 Global Maternal Immunization Trial for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate pfizer.com ↗
The observed efficacy for severe medically attended lower respiratory tract illness (severe MA-LRTI) was 81.8% (CI: 40.6%, 96.3%) through the first 90 days of life. |
| 2022-08-25 | Pfizer | Results Pfizer Announces Positive Top-Line Data from Phase 3 Trial of Older Adults for its Bivalent Respiratory Syncytial Virus (RSV) Vaccine Candidate pfizer.com ↗
This positive result enabled Pfizer to look at the more severe disease primary endpoint of LRTI-RSV defined by three or more symptoms, where vaccine efficacy of 85.7% (96.66% CI: 32.0%, 98.7%) was observed. |
| 2022-03-24 | Pfizer | Regulatory Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus Vaccine Candidate for the Prevention of RSV in Older Adults pfizer.com ↗
RSVpreF received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) |
| 2022-03-02 | Pfizer | Regulatory Pfizer Granted FDA Breakthrough Therapy Designation for Respiratory Syncytial Virus (RSV) Vaccine Candidate for the Prevention of RSV in Infants from Birth up to Six Months of Age by Active Immunization of Pregnant Women pfizer.com ↗
Pfizer Inc. (NYSE:PFE) today announced that its respiratory syncytial virus (RSV) vaccine candidate, PF-06928316 or RSVpreF, received Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for prevention of RSV-associated lower respiratory tract illness in infants from birth up to six months of age by active immunization of pregnant women. |
All press releases naming this drug 20 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 27 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RSVPreF | “The efficacy, immunogenicity, and safety of a bivalent RSV prefusion F protein-based (RSVpreF) vaccine in pregnant women and their infants are uncertain.” PMID 35476650 ↗ Apr 202225“This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B.” PMID 34932102 ↗ Apr 2022 “RSVpreF and HZ/su vaccine when given together in adults 50 years of age and older” NCT06890416 ↗ “The RSVpreF vaccine will be administered according to the Product Monograph.” NCT07097012 ↗ “RSV stabilized prefusion F subunit vaccine (RSVpreF)” PMID 34637519 ↗ Jun 2022 “Biological: RSVPreF” NCT04785612 ↗ |
| Known as | Abrysvo | “Cohort 2- Pregnant participants who received the RSVpreF in a previous pregnancy, either through commercial means with Abrysvo® or as part of a Pfizer clinical trial, will be...” NCT06866405 ↗1“Participants will receive a single dose of the RSVpreF vaccine (Abrysvo®) intramuscularly between 32+0 and 36+6 weeks of gestation, consistent with Health Canada approval.” NCT07693166 ↗ |
| Known as | Respiratory Syncytial Virus Prefusion F Vaccine | “Respiratory Syncytial Virus Prefusion F Vaccine (RSVpreF)” NCT07296120 ↗ |
| Known as | RSV prefusion F | “RSV prefusion F (RSVpreF) is a bivalent stabilized prefusion F vaccine containing RSV-A and RSV-B antigens.” PMID 39928572 ↗ Feb 2026 |
| Known as | RSVpreF vaccine | “The purpose of the study is to learn about the safety and immune activity of the RSVpreF vaccine.” NCT06325657 ↗ |
| Modality | Vaccine | “This phase 1/2 study evaluated a bivalent prefusion F vaccine (RSVpreF) with antigens from RSV subgroups A and B.” PMID 34932102 ↗ Apr 2022 |
| Route | Intramuscular | “single intramuscular injection” PMID 37018474 ↗ Apr 2023 |