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HomeCDC RecommendationAbout RSVAbout ABRYSVO

About ABRYSVO

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Prescribing InformationIndicationsPatient SiteMaternal
ABRYSVO® is the only RSV vaccine approved for adults 18-59 at increased risk of RSV-LRTD1ABRYSVO demonstrated non-inferior immunogenicity in adults 18-59 (MONeT study), compared to adults 60 and older (RENOIR study)1ReferencesNoninferiority was met if the lower bound of the 2-sided CI of adjusted GMR (MONeT/RENOIR) was >0.667 (1.5-fold noninferiority criterion) for both RSV-A and RSV-B. Neutralizing geometric mean titers for RSV-A were 41,097 in MONeT and 26,225 in RENOIR; for RSV-B they were 37,416 in MONeT and 24,680 in RENOIR.Analysis of covariance model was used as per protocol with sex and baseline titer (in logarithm scale) adjusted.Noninferiority was met if the lower bound of the 2-sided CI for the percentage difference (MONeT minus RENOIR) was >-10% for both RSV-A and RSV-B. The neutralizing titer seroresponse rates for RSV-A were 93% in MONeT and 88% in RENOIR; for RSV-B they were 93% in MONeT and 85% in RENOIR.Seroresponse is defined as achieving a ≥4-fold rise from baseline if the baseline measurement is above the LLOQ. If the baseline measurement is below the LLOQ, a post-vaccination assay result ≥4 × LLOQ is considered to be a seroresponse.CI=confidence interval; GMR=geometric mean ratio; GMT=geometric mean titer; LB=lower bound; LLOQ=lower limit of quantitation; RSV=respiratory syncytial virus; SRR=seroresponse rate.Full study designPhase 3 study of adults 18-59: MONeT
  • Multicenter, randomized, double-blind, placebo-controlled study to assess the safety and immunogenicity of ABRYSVO1
  • Adults aged 18-59 (median age, 49 years) who were considered to be at increased risk of RSV-LRTD due to certain chronic medical conditions1
  • Enrolled patients had the following chronic conditions: cardiovascular (excluding isolated hypertension), hematologic, hepatic, metabolic (including diabetes
mellitus and hyper/hypothyroidism), neurologic, pulmonary (including asthma), or renal disorders1
  • ~675 patients were randomized to receive ABRYSVO (n=453) or placebo (n=225)1
  • The vaccine and placebo groups were also similar with regard to the prevalence 
of underlying medical conditions, which included 52% with ≥1 chronic pulmonary condition, 43% with diabetes, 31% with ≥1 other disease (liver, renal, neurologic, hematologic, or other metabolic disease), and 8% with ≥1 cardiovascular condition1
  • Participants were followed for safety for up to 6 months1
Noninferiority criteria1
  • Effectiveness was assessed by comparison of the RSV neutralizing GMTs and seroresponse rates of the evaluable immunogenicity population in MONeT who received ABRYSVO (n=437) to those of a subgroup of individuals 60+ from select sites in the U.S. and Japan in RENOIR (n=410)1
  • Noninferiority was demonstrated for the ratio of neutralizing GMTs for RSV-A and RSV-B (MONeT/RENOIR subgroup; lower bounds of the 2-sided 95% CIs >0.667),
and the percentage difference in neutralizing titer seroresponse rates for RSV-A and RSV-B (MONeT minus RENOIR; lower bounds of the 2-sided 95% CIs >-10%1)
CI=confidence interval; GMT=geometric mean titers; LRTD=lower respiratory tract disease; 
RSV=respiratory syncytial virus; RT-PCR=reverse transcription-polymerase chain reaction.References:ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; January 2025.ClinicalTrials.gov. A study to assess the safety, tolerability, and immunogenicity of RSVpreF in adults at high risk of severe RSV disease (MONET). Updated April 9, 2024. Accessed October 28, 2024. https://clinicaltrials.gov/study/NCT05842967#contacts-and-locationsAbout ABRYSVO
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References:ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; January 2025.ClinicalTrials.gov. A study to assess the safety, tolerability, and immunogenicity of RSVpreF in adults at high risk of severe RSV disease (MONET). Updated April 9, 2024. Accessed October 28, 2024. https://clinicaltrials.gov/study/NCT05842967#contacts-and-locations

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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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