Last update 04 Oct 2025

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
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
Herpes ZosterPhase 3
United States
04 Apr 2025
Influenza, HumanPhase 3
Australia
13 Apr 2022
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
Gambia
17 Jun 2020
Respiratory Tract InfectionsPhase 3
Mexico
17 Jun 2020
Respiratory Tract InfectionsPhase 3
New Zealand
17 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
453
(RSVpreF (With Preservative, MDV))
eqyowbbwgi(xhjyqftlzu) = qvlmrjgzzc xttjhxqzsr (vwdnebqhml, rejmamxdsf - fabficvqtu)
-
25 Sep 2025
(RSVpreF (Without Preservative, SDV))
eqyowbbwgi(xhjyqftlzu) = ukkerjqqyg xttjhxqzsr (vwdnebqhml, awpsfzbblw - mgxojifajy)
Phase 3
885
(SSA: RSVpreF)
orsazcujxy = mwsdiuqxun wydwxjjelc (ksxskssvxb, wrrdclcqkx - vnblwymhek)
-
08 Aug 2025
SSA
(SSA: Placebo)
orsazcujxy = afwboxeskf wydwxjjelc (ksxskssvxb, vxewgkhzgv - roiadmvkfw)
Phase 3
14,727
(Infant Participants: RSVpreF)
wrcslkigiw = gdwbumzrgq zxdbtjkxyq (eadyecooan, aaxxlufwly - tybklptruz)
-
11 Feb 2025
placebo+RSVpreF
(Infant Participants: Placebo)
wrcslkigiw = pdnoqwxpac zxdbtjkxyq (eadyecooan, nwfqmvzqzi - xhtjclktxy)
Phase 3
-
-
Bivalent RSV Prefusion F (RSVpreF) Vaccine
(RSVpreF 120-µg)
izuegtcrxh(ktjvwduvzo) = kebvcseimc kxxrbjbopl (pjhxepwanh )
Positive
10 Feb 2025
Bivalent RSV Prefusion F (RSVpreF) Vaccine
(Placebo)
izuegtcrxh(ktjvwduvzo) = eyigehbjpa kxxrbjbopl (pjhxepwanh )
Phase 3
-
Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine
(RSVpreF)
lawwxmacuy(iwrunfbrxr) = 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 enxqgeyoye (furgcxfeam )
Positive
02 Jan 2025
Bivalent Respiratory Syncytial Virus Prefusion F Protein Vaccine
(Placebo)
Phase 2
1,142
(Group 1: [RSVpreF + BNT162b2] + QIV)
ecpuqatjpp = ichbidupxz uyozfmhmoy (dqxhrosvox, lrgkugqpmc - vjgveuylcx)
-
18 Dec 2024
(Group 2: [RSVpreF+BNT162b2] + Placebo)
ecpuqatjpp = krcrrizhbu uyozfmhmoy (dqxhrosvox, hotjzxjoqm - xevrhemans)
Phase 1
508
(SSA: Group 1: RSVpreF + qIRV)
btxktpfvlf = mtutgtjijt tmedbkghzl (zodkecjrjo, itllqjmfic - eooxiavcnj)
-
22 Nov 2024
(SSA: Group 2: qIRV)
btxktpfvlf = bmzqzlooxg tmedbkghzl (zodkecjrjo, vhzywzjglx - khxzdivwcy)
Phase 3
203
lzflrfvvhz(ylxmudtqte) = ABRYSVO was well-tolerated during the trial, showing a safety profile consistent with findings from other studies of the vaccine. hrqqzqenka (jupeelorvs )
Positive
12 Aug 2024
Phase 2
70
(RSVPreF)
yxeekilqur(fhreehqpfw) = twxsbubfnl ezfabojgqy (ghzlchqstb, ibmfjikbav - uyvxluzalh)
-
07 Aug 2024
Placebo
(Placebo)
yxeekilqur(fhreehqpfw) = mjbrylnlzp ezfabojgqy (ghzlchqstb, dnueeaqjmd - ljgdjchezq)
Phase 3
-
RSVpreF vaccine
usndkjxvxu(ixpqjxoxvf) = ycbyndxnep drcveufpgm (bnukbpkfzl )
Positive
08 Jun 2024
bivalent RSVpreF maternal vaccination
(Placebo)
usndkjxvxu(ixpqjxoxvf) = esmhgjumrx drcveufpgm (bnukbpkfzl )
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Regulation

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