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HomeCDC RecommendationAbout RSVAbout ABRYSVOAbout ABRYSVOStudy Design & Efficacy ProfileSafety ProfileDosing, Storage, ReconstitutionOrder ABRYSVOResourcesResourcesMaternal RSV Vaccine PlannerHealth Plan CoverageRequest A RepEventsMaterialsVideos
Prescribing InformationIndications AdultPatient Site
ABRYSVO® ACT-O-VIAL®: two-step, needle-free,* reconstitutionReferences

*Needle required for intramuscular injection is not included.

ACT-O-VIAL® Instructions for Use Video Email Video Loading Email Video Loading

View the video above or see full Prescribing Information for complete instructions on reconstituting and storing ABRYSVO.

See the ACT-O-VIAL® two-step process: press and swirl for reconstitution, then prep for administration1Single-dose administration1
  • Administered as an intramuscular injection (at 32-36 weeks gestational age)1
  • Contains no adjuvant or preservatives1
  • Each vial of ABRYSVO contains a single, 120-mcg dose of RSV-stabilized preF proteins per approximately 0.5 mL1
Needle-free* reconstitution1
  • ACT-O-VIAL® is a dual-compartment vial system that allows reconstitution of ABRYSVO by combining the diluent and lyophilized antigen all in one vial1
Storage and handling
  • Storage before reconstitution: ABRYSVO should be stored refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton1
DO NOT FREEZE. Discard if the carton has been frozen.
  • Storage after reconstitution: Administer ABRYSVO immediately or store at room temperature between 15°C and 30°C (59°F and 86°F) and use within 4 hours1
DO NOT FREEZE RECONSTITUTED VACCINE.1
  • The ACT-O-VIAL® package's space-saving design lets HCPs store 5 times the doses in the same amount of space compared with the original needle-free reconstitution* kit2
As of the 2025-2026 RSV season and going forward, the Pfizer Reconstitution Kit is no longer available to purchase. Any remaining stock in refrigerator storage can be used before it expires.ReferencesNeedle required for intramuscular injection is not included.HCP=healthcare professional; PreF=prefusion F; RSV=respiratory syncytial virus.About ABRYSVO Stock ABRYSVO

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References:

ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; July 2025.Data on file. Pfizer Inc.

To report an adverse event, please call 1-800-438-1985

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IndicationsABRYSVO is a vaccine indicated for:
  • active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older
  • active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age
  • active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV

Please click here for full Prescribing Information.
Important Safety Information
  • Do not administer ABRYSVO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of ABRYSVO
  • The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with ABRYSVO
  • A numerical imbalance in preterm births was observed compared to placebo in 2 clinical studies. Data are insufficient to establish or exclude a causal relationship between preterm birth and ABRYSVO. To avoid potential risk of preterm birth with use of ABRYSVO before 32 weeks of gestation, administer to pregnant individuals at 32 through 36 weeks gestational age
  • Appropriate medical treatment must be available in case of an anaphylactic reaction
  • Syncope (fainting) may occur with administration of injectable vaccines, including ABRYSVO. Procedures should be in place to avoid injury from fainting
  • Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to ABRYSVO
  • Vaccination with ABRYSVO may not protect all recipients
  • In clinical trials with adults aged 60+, the most commonly reported (≥10%) adverse reactions were fatigue (15.7%), headache (12.9%), pain at the injection site (10.6%), and muscle pain (10.2%)  
  • In clinical trials with adults aged 18-59, the most commonly reported (≥10%) adverse reactions were pain at the injection site (35.3%), muscle pain (24.4%), joint pain (12.4%), and nausea (11.8%)
  • In clinical trials with pregnant individuals, the most commonly reported (≥10%) adverse reactions were pain at the injection site (40.6%), headache (31.0%), muscle pain (26.5%), and nausea (20.0%)  
  • In clinical trials with infants born to pregnant individuals, low birth weight (5.1% ABRYSVO vs 4.3% placebo) and neonatal jaundice (7.3% ABRYSVO vs 6.9% placebo) were observed
Individuals who received ABRYSVO during pregnancy are encouraged to contact 1-800-616-3791 to enroll in a Pregnancy Exposure Registry.

Patients should always ask their healthcare providers for medical advice about adverse events. You are encouraged to report negative side effects of vaccines to the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). Visit http://www.vaers.hhs.gov or call 1-800-822-7967.

Please see full Prescribing Information for ABRYSVO. IndicationsABRYSVO is a vaccine indicated for:
  • active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older
     
  • active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through 6 months of age
     
  • active immunization for the prevention of LRTD caused by RSV in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV
You are now leaving PfizerProBy clicking Go to VaxAssist.com, you will be redirected to VaxAssist by Pfizer, where your patients can check eligibility and vaccine options. For additional information on ABRYSVO, please see Important Safety Information.