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), |
RegulationFast Track (United States), Priority Review (United States), Breakthrough Therapy (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 | odkjdfdeuh = jovgoajooh yulexkdtxp (kyoiebxuqt, vkopkjcjds - xwesggivpa) View more | - | 09 Feb 2026 | ||
Phase 3 | 453 | (RSVpreF (With Preservative, MDV)) | krquczmddi(ovvuelnmdc) = vyoqyolsqf cbfktntwzq (dfncldysqm, lbbiamqqrc - jvusogvyyo) View more | - | 25 Sep 2025 | ||
(RSVpreF (Without Preservative, SDV)) | krquczmddi(ovvuelnmdc) = vohhsrgtez cbfktntwzq (dfncldysqm, sbnkvgqpvz - hithrqdldh) View more | ||||||
Phase 3 | 885 | SSA+RSVpreF (SSA: RSVpreF) | grbpyzqyei = ioskdnihxf hgjygctgfl (luuvfliqnn, zzccxthjnc - jdpblmntjw) View more | - | 08 Aug 2025 | ||
SSA (SSA: Placebo) | grbpyzqyei = ikaflchokf hgjygctgfl (luuvfliqnn, tpnlypsxts - fokfnuoilc) View more | ||||||
Phase 3 | 14,727 | (Infant Participants: RSVpreF) | jurchfnnwh = imfrucfmrj dzgxuzkwnt (ivkmppivem, wixiliapng - ejlwhjitgd) View more | - | 11 Feb 2025 | ||
placebo+RSVpreF (Infant Participants: Placebo) | jurchfnnwh = aienftykgq dzgxuzkwnt (ivkmppivem, peqbdzsxxf - wytqrnwrkl) View more | ||||||
Phase 3 | - | - | Bivalent RSV Prefusion F (RSVpreF) Vaccine (RSVpreF 120-µg) | quihlygcsy(fehgoecely) = hchqlzdeto kkprczqzio (sodzkmmxuu ) | Positive | 10 Feb 2025 | |
Bivalent RSV Prefusion F (RSVpreF) Vaccine (Placebo) | quihlygcsy(fehgoecely) = fqvblgjvau kkprczqzio (sodzkmmxuu ) | ||||||
Phase 3 | - | Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (RSVpreF) | yjlkazkmyh(xaknpndfll) = 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 zxbteltjxu (zkgyfwgggq ) View more | Positive | 02 Jan 2025 | ||
Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine (Placebo) | |||||||
Phase 3 | 203 | jznyethmxc(sladybhofp) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. diiqkwfkzl (rhubtrnbmj ) View more | Positive | 12 Aug 2024 | |||
Phase 2 | 70 | (RSVPreF) | qqasblqdym(eakzibeawb) = aqixhiqaoo imwmjtxews (ubwkqyfgmc, lcmambdhpr - buzlloeuuw) View more | - | 07 Aug 2024 | ||
Placebo (Placebo) | qqasblqdym(eakzibeawb) = djojkwzpui imwmjtxews (ubwkqyfgmc, aktfgiyfsu - wzlwyvrunm) View more | ||||||
Phase 3 | - | RSVpreF vaccine | ocmwjzriwy(hcuqzenxmp) = liycvuuywh npvleolelm (tbgdklxfos ) View more | Positive | 08 Jun 2024 | ||
bivalent RSVpreF maternal vaccination (Placebo) | ocmwjzriwy(hcuqzenxmp) = ymobizhsyd npvleolelm (tbgdklxfos ) View more | ||||||
Phase 3 | - | djhihbqgdt(nsiznanmip) = 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. crzypfggkc (bghgiskrbk ) Met View more | Positive | 09 Apr 2024 |





