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HomeCDC RecommendationAbout RSVAbout ABRYSVO

About ABRYSVO

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Prescribing InformationIndicationsPatient SiteMaternal
Generally similar rates of systemic AEs observed between ABRYSVO® and placebo groups1


For patients aged 60+


For patients aged 18-59

Tab Number 3

Systemic adverse reactions (any) within 7 days after vaccination1SAEs were reported by 3.3% of participants in the ABRYSVO group and 3.2% in the placebo group. Three participants reported SAEs (Guillain-Barré syndrome, Miller Fisher syndrome, and hypersensitivity) that were assessed as possibly related to ABRYSVO1Solicited local and systemic reactions were monitored in 7,073 participants (3,627 ABRYSVO participants and 3,446 placebo recipients) from a subset of sites who provided e-diary data for a specific reaction after vaccination.1AE=adverse event; SAE=serious adverse event.Local adverse reactions1References
"Severe" is defined as preventing daily activity.1
“Any” includes all participants who reported a reaction as mild, moderate, or severe during day 1 to day 7 after vaccination.2
88% of patients aged 60 or older reported no local reactions with ABRYSVO2The majority of local reactions after ABRYSVO vaccination were mostly mild or moderate and had a median duration of 1-2 days1A U.S. survey of more than 55,000 adults in April/May 2021 evaluating respiratory vaccines showed that more than half of patients cite side effects as the key concern when getting a vaccine3Postmarketing Experience
  • The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with ABRYSVO
     
  • The FDA conducted a self-controlled case series analysis, using CMS data, in adults 65 and older. The study identified patients who received ABRYSVO and experienced GBS (confirmed via medical records)
     
  • While the results suggest an increased risk of GBS, available evidence is insufficient to establish a causal relationship
     
Systemic adverse reactions (any) within 7 days after vaccination1SAEs were reported by 1.1% of participants in the ABRYSVO group and 3.1% in the placebo group. No SAEs were assessed as related to study vaccination.1
  • One unsolicited case of urticaria occurred on the same day as ABRYSVO administration and was considered to be related1
ReferencesSolicited local and systemic reactions that occurred within 7 days following study vaccination were self-reported in electronic diaries or were reported to an investigator by 676 participants (451 ABRYSVO participants and 225 placebo
recipients). For all participants, unsolicited adverse events were collected for 1 month after study vaccination; SAEs were collected for 6 months throughout study participation.1AE=adverse event; C=Celsius; SAE=serious adverse event.The majority of local reactions after ABRYSVO vaccination were mild or moderate and
had a median duration of 1-2 days1Local adverse reactions1Solicited local and systemic adverse reactions that occurred within 7 days following study vaccination were self-reported in electronic diaries or were reported to an investigator by 676 participants (451 ABRYSVO participants and 225 placebo recipients). For all participants, unsolicited adverse events were collected for 1 month after study vaccination; SAEs were collected for 6 months after study vaccination.1“Any” includes all participants who reported a reaction as mild, moderate, or severe during day 1 to day 7 after vaccination.3
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References:ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; January 2025.  Walsh EE, Pérez Marc G, Zareba AM, et al; for the RENOIR Clinical Trial Group. Efficacy and safety of a bivalent RSV prefusion F vaccine in older adults. N Engl J Med. 2023;388(16):1465-1477.Joyce MC, Mountjoy NJ, Johnson JA, et al. From trial to practice: incidence and severity of COVID-19 vaccine side effects in a medically at-risk and vaccine-hesitant community. BMC Public Health. 2022;22(1):2351.

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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
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