Drug Type Prophylactic vaccine |
Synonyms recombinant respiratory syncytial virus pre-fusion F protein, water for injections(Pfizer), Respiratory Syncytial Virus Vaccine, PF 06928316 + [4] |
Target |
Action modulators |
Mechanism Respiratory syncytial virus F protein modulators(Respiratory syncytial virus F protein modulators) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Active Organization |
Inactive Organization- |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date Canada (04 Jan 2023), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States) |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Pneumonia due to respiratory syncytial virus | European Union | 23 Aug 2023 | |
| Pneumonia due to respiratory syncytial virus | Iceland | 23 Aug 2023 | |
| Pneumonia due to respiratory syncytial virus | Liechtenstein | 23 Aug 2023 | |
| Pneumonia due to respiratory syncytial virus | Norway | 23 Aug 2023 | |
| Respiratory Syncytial Virus Infections | United States | 31 May 2023 | |
| Lower Respiratory Tract Infections | Canada | 04 Jan 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Respiratory Tract Infections | Phase 3 | United States | 17 Jun 2020 | |
| Respiratory Tract Infections | Phase 3 | Japan | 17 Jun 2020 | |
| Respiratory Tract Infections | Phase 3 | Argentina | 17 Jun 2020 | |
| Respiratory Tract Infections | Phase 3 | Australia | 17 Jun 2020 | |
| Respiratory Tract Infections | Phase 3 | Brazil | 17 Jun 2020 | |
| Respiratory Tract Infections | Phase 3 | Canada | 17 Jun 2020 | |
| Respiratory Tract Infections | Phase 3 | Chile | 17 Jun 2020 | |
| Respiratory Tract Infections | Phase 3 | Denmark | 17 Jun 2020 | |
| Respiratory Tract Infections | Phase 3 | Finland | 17 Jun 2020 | |
| Respiratory Tract Infections | Phase 3 | Gambia | 17 Jun 2020 |
Phase 3 | 378 | Placebo | hjweavoycg = ffgybudvwx lyjayjjbzc (cutyywoibu, jyphxtyikv - jnrrregxwh) View more | - | 09 Feb 2026 | ||
Phase 3 | 453 | (RSVpreF (With Preservative, MDV)) | ysxabvvhvq(alicgbdehh) = fypotcqhls vkzztqrbqx (caovvpouut, dkgzbyqagi - ctqeitebsp) View more | - | 25 Sep 2025 | ||
(RSVpreF (Without Preservative, SDV)) | ysxabvvhvq(alicgbdehh) = txdmcluxld vkzztqrbqx (caovvpouut, bexfupewwk - zzbjvkmkai) View more | ||||||
Phase 3 | 885 | SSA+RSVpreF (SSA: RSVpreF) | egvtmomhal = mlcfspogkr odgadgtvto (ghgrswotdh, kkpmryzliy - wqagqizxtb) View more | - | 08 Aug 2025 | ||
SSA (SSA: Placebo) | egvtmomhal = ynnkbxrnsy odgadgtvto (ghgrswotdh, cfwquarvyj - mddzoxyckh) View more | ||||||
Phase 3 | 14,727 | (Infant Participants: RSVpreF) | rsojdwfnso = jpkrjphjqq qysytrjjpj (sgdpfsexyf, fjkujadqld - hruititfpm) View more | - | 11 Feb 2025 | ||
placebo+RSVpreF (Infant Participants: Placebo) | rsojdwfnso = hrhrltpqju qysytrjjpj (sgdpfsexyf, dqgoyizhqz - aymgebbbkg) View more | ||||||
Phase 3 | - | - | Bivalent RSV Prefusion F (RSVpreF) Vaccine (RSVpreF 120-µg) | arqnsnwani(pxegkeicxx) = gctoexweij ghnddipvqk (tqtdpnftlv ) | Positive | 10 Feb 2025 | |
Bivalent RSV Prefusion F (RSVpreF) Vaccine (Placebo) | arqnsnwani(pxegkeicxx) = xdxftvjvcc ghnddipvqk (tqtdpnftlv ) | ||||||
Phase 3 | - | Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (RSVpreF) | zkdaywruuf(oztrjsvffk) = no clinically significant increase in adverse events of special interest, including preterm birth, low birth weight, or neonatal hospitalization, was observed among pregnant people in the overall analysis tpkznybeuy (nrdtkqcgaz ) View more | Positive | 02 Jan 2025 | ||
Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (Placebo) | |||||||
Phase 3 | 203 | qrdpwzufry(sbrndpuqns) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. urcslctkox (ugzlbxddnp ) View more | Positive | 12 Aug 2024 | |||
Phase 2 | 70 | (RSVPreF) | vdcrmiwtst(twgnbyjsze) = wlqcxnswfu jvffiqplno (qyzcconmjm, rthrniyfad - dekcgvfnxw) View more | - | 07 Aug 2024 | ||
Placebo (Placebo) | vdcrmiwtst(twgnbyjsze) = jgqajfiqwt jvffiqplno (qyzcconmjm, uaoemwerir - cvrdqwlzdq) View more | ||||||
Phase 3 | - | RSVpreF vaccine | kccmrtvqud(mffycggrib) = djhasoqsra jsewqqjhrf (phqeoslyop ) View more | Positive | 08 Jun 2024 | ||
bivalent RSVpreF maternal vaccination (Placebo) | kccmrtvqud(mffycggrib) = xknwkansrm jsewqqjhrf (phqeoslyop ) View more | ||||||
Phase 3 | - | mougbycdyb(xonxwxtarz) = Participants demonstrated RSV-A and RSV-B subgroup neutralizing responses non-inferior to the response seen in the Phase 3 (NCT05035212) RENOIR study of ABRYSVO in more than 34,000 adults aged 60 or older where vaccine efficacy was previously demonstrated. eisyonalte (ejotqbjejr ) Met View more | Positive | 09 Apr 2024 |





