Last update 19 Mar 2026

RSVpreF

Overview

Basic Info

Drug Type
Prophylactic vaccine
Synonyms
recombinant respiratory syncytial virus pre-fusion F protein, water for injections(Pfizer), Respiratory Syncytial Virus Vaccine, PF 06928316
+ [4]
Action
modulators
Mechanism
Respiratory syncytial virus F protein modulators(Respiratory syncytial virus F protein modulators)
Inactive Indication-
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
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
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Respiratory Tract InfectionsPhase 3
United States
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Japan
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Argentina
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Australia
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Brazil
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Canada
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Chile
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Denmark
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Finland
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Gambia
17 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
378
Placebo
hjweavoycg = ffgybudvwx lyjayjjbzc (cutyywoibu, jyphxtyikv - jnrrregxwh)
-
09 Feb 2026
Phase 3
453
(RSVpreF (With Preservative, MDV))
ysxabvvhvq(alicgbdehh) = fypotcqhls vkzztqrbqx (caovvpouut, dkgzbyqagi - ctqeitebsp)
-
25 Sep 2025
(RSVpreF (Without Preservative, SDV))
ysxabvvhvq(alicgbdehh) = txdmcluxld vkzztqrbqx (caovvpouut, bexfupewwk - zzbjvkmkai)
Phase 3
885
(SSA: RSVpreF)
egvtmomhal = mlcfspogkr odgadgtvto (ghgrswotdh, kkpmryzliy - wqagqizxtb)
-
08 Aug 2025
SSA
(SSA: Placebo)
egvtmomhal = ynnkbxrnsy odgadgtvto (ghgrswotdh, cfwquarvyj - mddzoxyckh)
Phase 3
14,727
(Infant Participants: RSVpreF)
rsojdwfnso = jpkrjphjqq qysytrjjpj (sgdpfsexyf, fjkujadqld - hruititfpm)
-
11 Feb 2025
placebo+RSVpreF
(Infant Participants: Placebo)
rsojdwfnso = hrhrltpqju qysytrjjpj (sgdpfsexyf, dqgoyizhqz - aymgebbbkg)
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 )
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 )
Positive
12 Aug 2024
Phase 2
70
(RSVPreF)
vdcrmiwtst(twgnbyjsze) = wlqcxnswfu jvffiqplno (qyzcconmjm, rthrniyfad - dekcgvfnxw)
-
07 Aug 2024
Placebo
(Placebo)
vdcrmiwtst(twgnbyjsze) = jgqajfiqwt jvffiqplno (qyzcconmjm, uaoemwerir - cvrdqwlzdq)
Phase 3
-
RSVpreF vaccine
kccmrtvqud(mffycggrib) = djhasoqsra jsewqqjhrf (phqeoslyop )
Positive
08 Jun 2024
bivalent RSVpreF maternal vaccination
(Placebo)
kccmrtvqud(mffycggrib) = xknwkansrm jsewqqjhrf (phqeoslyop )
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
Positive
09 Apr 2024
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