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HomeCDC RecommendationAbout RSVAbout ABRYSVOHeading

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Efficacy ProfileSafety ProfileDosing, Storage, Reconstitution
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Prescribing InformationIndications Older AdultPatient Site
For eligible patients, ABRYSVO® is the first opportunity to help protect infants against RSV from birth through 6 months via maternal immunization1 View Efficacy DataLoading View Safety DataLoading View Efficacy DataLoading View Safety DataLoadingABRYSVO: the only maternal RSV vaccine recommended by the CDC for immunization of pregnant people at 32 weeks and 0 days’ through 36 weeks and 6 days’ gestation from September to January in most regions.1-3


In jurisdictions with RSV seasonality that differs (Alaska, southern Florida, Guam, Hawaii, Puerto Rico, US-affiliated Pacific Islands, and US Virgin Islands), providers should follow state, local, or territorial guidance on timing of ABRYSVO.

ACOG supports the CDC
recommendation for ABRYSVO4

ABRYSVO: the only maternal RSV vaccine recommended by the CDC for immunization of pregnant people at 32 weeks and 0 days’ through 36 weeks and 6 days’ gestation from September to January in most regions.1-3


In jurisdictions with RSV seasonality that differs (Alaska, southern Florida, Guam, Hawaii, Puerto Rico, US-affiliated Pacific Islands, and US Virgin Islands), providers should follow state, local, or territorial guidance on timing of ABRYSVO.

ACOG supports the CDC recommendation for ABRYSVO4

Talk to your eligible pregnant patients about maternal vaccination with ABRYSVO to reduce their newborns' risk of RSV from birth through 6 months.1
Order ABRYSVOLoading Find ABRYSVOLoading Order ABRYSVOLoading Find ABRYSVOLoadingMaternal 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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Respiratory Syncytial Virus

Learn about RSV, a common virus that’s particularly dangerous for infants.7

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ABRYSVO Reconstitution

Learn about Pfizer’s needle-free reconstitution options.

ReferencesNeedle required for intramuscular injection is not included. Learn MoreLoading
Broad Coverage

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

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Resources

Discover helpful ABRYSVO resources and patient materials.

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ACOG=American College of Obstetricians and Gynecologists; CDC=Centers for Disease Control and Prevention; RSV=respiratory syncytial virus.ACOG=American College of Obstetricians and Gynecologists; CDC=Centers for Disease Control and Prevention; RSV=respiratory syncytial virus.
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References:

ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; August 2024.Fleming-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.mm7241e1CDC recommends new vaccine to help protect babies against severe respiratory syncytial virus (RSV) illness after birth. Press Release. Centers for Disease Control and Prevention. Published September 22, 2023. Accessed August 9, 2024. https://www.cdc.gov/media/releases/2023/p0922-RSV-maternal-vaccine.htmlAmerican College of Obstetricians and Gynecologists. Maternal Respiratory Syncytial Virus Vaccination. Practice Advisory. September 2023. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2023/09/maternal-respiratory-syncytial-virus-vaccinationGreen LJ, Mackillop LH, Salvi D, et al. Gestation-specific vital sign reference ranges in pregnancy. Obstet Gynecol. 2020;135(3):653-664.Data on file. Pfizer Inc.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

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
  • 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 older adults, the most commonly reported (≥10%) adverse reactions were fatigue (15.5%), headache (12.8%), pain at the injection site (10.5%), and muscle pain (10.1%)
  • 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