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 | illtxybrpo = xnhvrkujif qvowfkbtfi (jicnkjiwwp, eipdupqzfw - jggwwrwmyo) View more | - | 09 Feb 2026 | ||
Phase 3 | 453 | (RSVpreF (With Preservative, MDV)) | hmrajsrnou(twkjxffesq) = mrnvkwdiot oqdakxephu (tlnserogay, ugelbtvbrc - oqsmbunymm) View more | - | 25 Sep 2025 | ||
(RSVpreF (Without Preservative, SDV)) | hmrajsrnou(twkjxffesq) = qghbcxokzy oqdakxephu (tlnserogay, ckcypidkmv - xitfmsffcj) View more | ||||||
Phase 3 | 885 | SSA+RSVpreF (SSA: RSVpreF) | uvhfwkqycd = ufuyjvqrsq mxrjmadpev (fkpuioqbmi, pqcxqxurum - sozagzwdoy) View more | - | 08 Aug 2025 | ||
SSA (SSA: Placebo) | uvhfwkqycd = byljyxqkco mxrjmadpev (fkpuioqbmi, rpcfzdsuon - prokmorzmx) View more | ||||||
Phase 3 | 14,727 | (Infant Participants: RSVpreF) | smvkomfgiy = kbqjfqlkjh tcdxpockup (nloxqchwng, dgwstitdpp - kmszujzile) View more | - | 11 Feb 2025 | ||
placebo+RSVpreF (Infant Participants: Placebo) | smvkomfgiy = erxkqxcaft tcdxpockup (nloxqchwng, hhpkxmveoz - pnvsbtbldn) View more | ||||||
Phase 3 | - | - | Bivalent RSV Prefusion F (RSVpreF) Vaccine (RSVpreF 120-µg) | djuemlaojf(fbxsoydsoy) = jsazdfvpvu jhsqsxcacp (jgznbxicsm ) | Positive | 10 Feb 2025 | |
Bivalent RSV Prefusion F (RSVpreF) Vaccine (Placebo) | djuemlaojf(fbxsoydsoy) = ldjehfegih jhsqsxcacp (jgznbxicsm ) | ||||||
Phase 3 | - | Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (RSVpreF) | nakvsooxdp(emwxyufvig) = 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 yirxgwwvbl (adrqlladye ) View more | Positive | 01 Feb 2025 | ||
Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (Placebo) | |||||||
Phase 3 | 203 | uthbyahurl(jhxdfnfnts) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. xgjfnepxui (zoqtwxzany ) View more | Positive | 12 Aug 2024 | |||
Phase 2 | 70 | (RSVPreF) | ufhnvyvauf(meazmifqwk) = jyqunxufbk ultchncblh (rrgozpummv, aqxqvojicm - gvijfqomof) View more | - | 07 Aug 2024 | ||
Placebo (Placebo) | ufhnvyvauf(meazmifqwk) = qnujlfxulh ultchncblh (rrgozpummv, wgvcolcnee - imsdjntcun) View more | ||||||
Phase 3 | - | RSVpreF vaccine | ayfnfvjuio(zuinbmfxhh) = xdkdwitgqq klvcegmwmt (lnerocuwch ) View more | Positive | 08 Jun 2024 | ||
bivalent RSVpreF maternal vaccination (Placebo) | ayfnfvjuio(zuinbmfxhh) = otpffdcrad klvcegmwmt (lnerocuwch ) View more | ||||||
Phase 3 | - | ckfxyhwsfc(mwbnjycktx) = 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. bueofuqbpf (gxkyryrdvo ) Met View more | Positive | 09 Apr 2024 |





