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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
For eligible patients, ABRYSVO® is the first opportunity to help protect infants from RSV via maternal immunization1

Study Design

RSV-LRTD
Primary Endpoint

Hospitalizations
Secondary Endpoint

ABRYSVO was studied in a phase 3 clinical study: MATISSE1,2

MATISSE PHASE 3 BASELINE CHARACTERISTICS1,2

  • Maternal participants were randomized 1:1 to receive ABRYSVO (n=3,695) or placebo (n=3,697)
  • Demographic characteristics in regard to age, race, and ethnicity were balanced between ABRYSVO and placebo arms
  • Median maternal age at vaccination: 29 years
  • Median gestational age at vaccination was 31 weeks and 2 days (range 24-36.9 weeks)
  • Pregnant individuals with high-risk pregnancies were excluded from the study
VACCINE EFFICACY WITHIN MATISSE WAS ANALYZED BASED ON 2 DOSING INTERVALS1: Trial Dosing Interval1

Gestational age at vaccination: 24-36.9 weeks


Vaccine efficacy in the prevention of RSV-LRTD and severe RSV-LRTD within 3, 4, 5, and 6 months after birth*

 Approved Dosing Interval1✝

Gestational age at vaccination: 32-36 weeks

Descriptive subgroup analysis in line with the indication, showing vaccine efficacy in prevention of RSV-LRTD and severe RSV-LRTD within 3 and 6 months after birth*

RSV-associated lower respiratory tract disease (RSV-LRTD) defined in MATISSE1,3 ReferencesVaccine efficacy was defined as the relative risk reduction of severe RSV-LRTD and RSV-LRTD in infants born to pregnant women who received ABRYSVO compared to placebo.1This descriptive subgroup analysis was not controlled for multiple comparisons.1RSV-associated LRTD in infants was defined as a medically attended visit with a RT-PCR–confirmed RSV illness with 1 or more of the respiratory symptoms shown in this table.1In severe LRTD, tachypnea was defined as respiratory rate ≥70 breaths/minute (<age 2 months), ≥60 breaths/minute (age ≥2 to 12 months), or ≥50 breaths/minute (age ≥12 to 24 months). In LRTD, tachypnea was defined as respiratory rate ≥60 breaths/minute (age <2 months), ≥50 breaths/minute (age ≥2 to 12 months), or ≥40 breaths/minute (age ≥12 to 24 months).1Invasive or noninvasive.1ER=emergency room; ICU=intensive care unit; LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus; RSV-LRTD=respiratory syncytial virus lower respiratory tract disease; RT-PCR=reverse transcriptase-polymerase chain reaction; SpO2=oxygen saturation.
ABRYSVO: powerful protection from RSV-LRTD during the most vulnerable months of an infant’s life1,4REDUCTION IN THE RISK OF SEVERE RSV-LRTD AND RSV-LRTD IN INFANTS FROM BIRTH THROUGH 6 MONTHS1The trial dosing interval included pregnant women vaccinated from gestational weeks 24 through 36.91Trial Dosing Interval Vaccine Efficacy (24-36.9 Week Gestational Period) (%)1 ReferencesThe prespecified success criterion (a CI lower bound >20%) was not met for this endpoint evaluation at 90 days.1A descriptive subgroup analysis included pregnant women vaccinated from gestational weeks 32 through 36 (in line with the approved dosing interval)1Approved Dosing Interval Vaccine Efficacy (32-36 Week Gestational Period) (%)1† ReferencesThis descriptive subgroup analysis was not controlled for multiple comparisons; results from 90 days and 180 days are presented.1CI=confidence interval; LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.
ABRYSVO helped protect infants from RSV-associated hospitalizations1*REDUCTION IN RSV-ASSOCIATED INFANT HOSPITALIZATION FROM BIRTH THROUGH 6 MONTHS1*Trial Dosing Interval (24-36.9 Week Gestational Period) Vaccine Efficacy (%)  ReferencesSuccess criterion for the secondary endpoint was defined as having a CI lower bound >0.5

CI=confidence interval; RSV=respiratory syncytial virus.
 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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References:

ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; October 2024.Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 2023;388(16):1451-1464.Kampmann B, Madhi SA, Munjal I, et al. Bivalent prefusion F vaccine in pregnancy to prevent RSV illness in infants. N Engl J Med. 2023;388(Supp16):S1-38.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/s40121-017-0167-9Data on file. Pfizer Inc.

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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