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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
Explore the safety profile of ABRYSVO®

Choose ABRYSVO to help protect your pregnant patients’ babies from the threat of RSV.1

Maternal Safety

Infant Safety

Tab Number 3

The majority of solicited local and systemic reactions resolved within 2-3 days of onset1

Solicited adverse reactions within 7 days of vaccination1

 ReferencesReferencesANY includes all participants who reported a reaction as mild, moderate, or severe during day 1 to day 7 after vaccination.The presented results are based on the participants with solicited reactogenicity at the time of the data cutoff date for the primary analysis.1

Individuals who received ABRYSVO during pregnancy are encouraged to contact 1-800-616-3791 to enroll in a Pregnancy Exposure Registry.

Serious adverse events were generally similar between ABRYSVO and placebo arms1

Select pregnancy-related serious adverse events in pregnant individuals occurring at any time following vaccination1†

 Most SAEs were related to pregnancy complications and occurred more than 1 month after vaccination1Postmarketing observational study in adults aged 65+: Risk of Guillain-Barré syndrome (GBS) following vaccination with ABRYSVOStudy Design
  • The FDA conducted a self-controlled case series analysis (using CMS data) in adults 65 and older to determine if there was an increased risk of GBS following administration of protein subunit RSV vaccines1,2
  • Using Medicare claims data, this study was able to identify patients who received ABRYSVO and experienced GBS (confirmed via medical records)1
  • The risk of GBS following vaccination was assessed using a risk window of 1 to 42 days post vaccination and a control window of 43 to 90 days post vaccination1
Study Results
  • The results suggest an increased risk of GBS during the 42 days following vaccination with ABRYSVO1
While the results of this observational study suggest an increased risk of GBS during the 42 days following ABRYSVO, available evidence is insufficient to establish a causal relationship.1ReferencesIncludes all SAEs from vaccination to 6 months post-delivery (up to approximately 10 months, depending on the gestational age at the time of vaccination). HELLP syndrome occurred in 5 participants (2 in the ABRYSVO group and 3 in the placebo group).1There was 1 maternal death in the ABRYSVO group due to postpartum hemorrhage that was not likely to be associated with vaccination.1A total of 19 intrauterine deaths were reported for the index pregnancy: 10 intrauterine deaths in the ABRYSVO group (0.3%) and 9 intrauterine deaths in the placebo group (0.2%). The intrauterine deaths represented various clinical conditions and presentations resulting in fetal demise without clear evidence of a common pathophysiology.1CI=confidence interval; CMS=Centers for Medicare and Medicaid Services; FDA=U.S. Food and Drug Administration; HELLP=hemolysis, elevated liver enzymes, and low platelets; RSV=respiratory syncytial virus; SAE=serious adverse event.
Preterm births and additional safety outcomes1,3Explore the safety profile of ABRYSVO®ReferencesAdditional low birth weight and neonatal jaundice data (when vaccine was administered 32-36 weeks gestation) are shown above. These data are derived from the October 13, 2023 MMWR.3
  • Within the trial dosing interval of the phase 3 ABRYSVO trial, there was an ~1% higher rate of preterm birth observed vs placebo3
  • Available data are insufficient to establish or exclude a causal relationship between preterm birth and ABRYSVO1
To avoid the potential risk of preterm birth before 32 weeks of gestation, administer ABRYSVO to pregnant individuals at 32 through 36 weeks gestational age1
Incidence of adverse events in infants1

Fetal/neonatal serious adverse events1
This study revealed no evidence for a vaccine-associated increase in the risk of congenital anomalies or fetal deaths1
  • Any adverse events in infants from birth to 1 month of age were observed in 38.0% in the ABRYSVO group compared to 35.4% in the placebo group1
  • Safety was monitored up to 24 months1
CI=confidence interval; MMWR=Morbidity and Mortality Weekly Report; RSV=respiratory syncytial virus.

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References:

ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; July 2025.Centers for Disease Control and Prevention. Respiratory syncytial virus (RSV) vaccine safety. Published July 11, 2025. Accessed October 23, 2025.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(41):1115-1122.

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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.