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HomeCDC RecommendationAbout RSVAbout ABRYSVOAbout ABRYSVOEfficacy ProfileSafety ProfileDosing, Storage, ReconstitutionOrder ABRYSVOResourcesResourcesMaternal RSV Vaccine PlannerHealth Plan CoverageRequest A RepEventsMaterialsVideos
Prescribing InformationIndications Older AdultPatient Site
ACOG supports the CDC recommendation for ABRYSVO®1The CDC recommends ABRYSVO for pregnant persons as a one-time dose at 32 weeks and 0 days’ through 36 weeks and 6 days’ gestation, using seasonal administration (September through January in most of the continental US), for prevention of RSV-associated LRTI in infants aged <6 months2Supported by1:

ACOG • American Academy of Family Physicians • American College of Nurse-Midwives • AWHONN • NPWH • The Society for Maternal-Fetal Medicine

View the full press releaseLoadingCDC Clinical Guidance on ABRYSVO
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Seasonal administration

  • ABRYSVO should be administered to pregnant persons at 32 through 36 weeks gestation during September – January in most of the continental US2
​​​​​​​
  • In jurisdictions with RSV seasonality that differs from most of the continental US, providers should follow state, local, or territorial guidance on timing of maternal vaccination with ABRYSVO2

Coadministration

  • The CDC provided clinical guidance to healthcare providers stating that they can coadminister those vaccines for which a patient is eligible in the same visit, such as Tdap, influenza, and COVID-19 vaccines2
 
  • In the ABRYSVO clinical trials, coadministration of ABRYSVO and Tdap was studied in non-pregnant women 18 to 49 years old and no safety concerns were identified3
 
  • Available data on immunogenicity of coadministration of RSV vaccines and other vaccines are currently limited3

Additional dose in subsequent pregnancies

  • ​​​​​​Currently, no data are available on either the efficacy of the first lifetime dose to protect infants born after subsequent pregnancies or the safety of additional doses given during subsequent pregnancies2
 
  • Additional data are needed to determine whether additional seasonal doses during subsequent pregnancies are indicated, and ACIP might update recommendations in the future, as data become available2
ACIP=Advisory Committee on Immunization Practices; ACOG=American College of Obstetricians and Gynecologists; AWHONN=Association of Women's Health, Obstetric and Neonatal Nurses; CDC=Centers for Disease Control and Prevention; LRTI=lower respiratory tract infection; MMWR=Morbidity and Mortality Weekly Report; NPWH=National Association of Nurse Practitioners in Women's Health; RSV=respiratory syncytial virus; Tdap=tetanus, diphtheria, and pertussis. Maternal RSV Vaccine Planner

For eligible patients, this tool estimates the ABRYSVO vaccination window based upon estimated pregnancy due date, season, and location, consistent with the approved ABRYSVO indication and CDC recommendation.

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Learn more about coverage for this RSV vaccine for eligible pregnant patients.

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Discover the common virus that's particularly dangerous in infants.4

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References:

American Academy of Family Physicians (AAFP). Obstetric care professionals recommend RSV vaccine for pregnant individuals. October 13, 2023. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccinationFleming-Dutra KE, Jones JM, Roper LE, et al. Use of the Pfizer Respiratory Syncytial Virus Vaccine During Pregnancy for the Prevention of Respiratory Syncytial Virus–Associated Lower Respiratory Tract Disease in Infants: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72:1115-1122.
doi:10.15585/mmwr.mm7241e1ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; October 2024.Parikh RC, McLaurin KK, Margulis AV, et al. Chronologic age at hospitalization for respiratory syncytial virus among preterm and term infants in the United States. Infect Dis Ther. 2017;6(4):477-486. doi:10.1007/s40121-017-0167-9

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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 in association 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 vaccine 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 (10.7%), 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 versus 4.4% placebo) and neonatal jaundice (7.2% ABRYSVO versus 6.7% 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