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Get to know ABRYSVO®

Choose ABRYSVO to help protect your adult patients aged 60 years and older from the threat of RSV.1

Efficacy Profile

Additional Data

Safety Profile

Primary endpoints in an RSV clinical trial of ~34,000 adults aged 60 years and older1*

Symptoms include cough, wheezing, sputum production, shortness of breath, and tachypnea.1

Evaluable efficacy population: ABRYSVO, n=16,306; placebo, n=16,308. At the interim analysis, median duration of efficacy follow-up was 7 months.1

Study design1,2

Pivotal phase 3 study: RENOIR

  • Ongoing multinational, multicenter, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of ABRYSVO1
 
  • Adults aged 60 years and older (median age, 67 years) who were healthy or had stable chronic diseases1,2
​​​​​​​
  • 34,383 participants were randomized 1:1 to receive ABRYSVO (120 μg, n=17,197) or placebo (n=17,186)1,2
​​​​​​​
  • Randomization was stratified by age group: 60-69 years (n=21,499), 70-79 years (n=10,948), and ≥80 years (n=1,934)1
​​​​​​​
  • Prespecified underlying medical conditions included heart disease, lung disease, having ≥1 chronic cardiopulmonary conditions (asthma, COPD, or CHF), diabetes, liver disease, renal disease, or current tobacco use2
​​​​​​​​​​​​​​
  • Participants are planned to be followed for up to 2 RSV seasons (approximately 25 months)1

Primary efficacy endpoint2

  • Relative risk reduction (vs placebo) of first episode of RSV-associated lower respiratory tract disease (RSV-LRTD) in the first RSV season†
  • Endpoint was stratified by ≥2 and ≥3 lower respiratory symptoms (new or worsened, including: cough, wheezing, sputum production, shortness of breath, tachypnea)
ReferencesAs determined by positive RT-PCR test within 7 days of symptom onset and lasting more than 1 day during the same illness.1HIGH-RISK POPULATIONS WERE INCLUDED IN THE RENOIR STUDY1,2CDC=Centers for Disease Control and Prevention; CHF=congestive heart failure; CI=confidence interval; COPD=chronic obstructive pulmonary disease; LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus; RT-PCR=reverse transcription-polymerase chain reaction.
Clinical data included in the CDC’s MMWR publication3ADDITIONAL EFFICACY, SAFETY AND TOLERABILITY DATA FROM RENOIR STUDY3Additional interim season 2 and RSV-associated medically attended LRTD data are not included in the USPI3ReferencesSeason 2 interim analysis underpowered to estimate efficacy.3Combined season 1 and season 2 (interim) vaccine efficacy estimates reflect efficacy against first events occurring any time during season 1 or season 2.3
Season 1 and season 2 vaccine efficacy estimates reflect efficacy data from 2 RSV seasons, from August 2021 through January 2023.3

The data presented are based on RSV-LRTD with ≥3 lower respiratory signs or symptoms. Medically attended RSV-associated LRTD was defined as LRTD prompting any healthcare visit, such as hospitalization, visits to the emergency room or urgent care, primary care or specialist office visit, telehealth contact, or other visit.3
  • In patients who received ABRYSVO, 4.3% experienced a serious AE, 1% experienced severe reactogenicity, and 3 patients experienced inflammatory neurologic events3
  • In patients who received placebo, 4.1% experienced a serious AE and 0.7% experienced severe reactogenicity3
Evidence regarding safety of the Pfizer vaccine consisted of data from 2 randomized, double-blind, placebo-controlled clinical trials, including the same ongoing phase 3 trial, and a phase 1/2 trial with 91 participants aged ≥65 years who received either the vaccine formulation used in phase 3 or placebo.3
Please see the complete publication in Morbidity and Mortality Weekly Report for details.ReferencesAE=adverse event; CDC=Centers for Disease Control and Prevention; CI=confidence interval; LRTD=lower respiratory tract disease; MMWR=Morbidity and Mortality Weekly Report; RSV=respiratory syncytial virus.
Similar rates of systemic AEs observed between ABRYSVO and placebo groups1SYSTEMIC ADVERSE REACTIONS (ANY) WITHIN 7 DAYS AFTER VACCINATION1

The same rate of SAEs (2.3%) was reported in both the ABRYSVO and placebo arms. Three participants reported SAEs (Guillain-Barré syndrome, Miller Fisher syndrome, and hypersensitivity) that were assessed as possibly related to ABRYSVO

88% of patients 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 days1LOCAL ADVERSE REACTIONS1 A US 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 vaccine4References
AE=adverse event; CDC=Centers for Disease Control and Prevention; RSV=respiratory syncytial virus; SAE=serious adverse event.
Solicited local and systemic reactions were monitored in 7,169 participants from a subset of sites who provided e-diary data for a specific reaction after vaccination.1
“Any” includes all participants who reported a reaction as mild, moderate, or severe during day 1 to day 7 after vaccination.2
Severe is defined as preventing daily activity.

Dosing, Storage, &
Reconstitution

Administered with Pfizer’s convenient, needle-free# reconstitution kit1CLICK, MIX, PREP HIGHLIGHTS ABRYSVO Reconstitution

For step-by-step instructions, watch this ABRYSVO reconstitution video.

 Watch NowLoadingABRYSVO: Just click, mix, and prep in the same single-dose vial1

Single-dose administration
 

  • Administered as a single-dose intramuscular injection1
  • Each vial of ABRYSVO contains a single, 120-μg dose of RSV stabilized PreF proteins per approximate 0.5 mL3

Needle-free# reconstitution
 

  • ABRYSVO is reconstituted with a vial adapter that eliminates needles during the reconstitution process1#

Refrigeration and storage
 

  • Before reconstitution, store refrigerated at 2°C to 8°C (36°F to 46°F)1
  • Do not freeze (discard if carton has been frozen)1
  • After reconstitution, administer ABRYSVO immediately or store at room temperature (15°C to 30°C [59°F to 86°F]) and use within 4 hours1
ReferencesRSV=respiratory syncytial virus.Needle required for intramuscular injection is not included.1
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References:ABRYSVO (Respiratory Syncytial Virus Vaccine) Prescribing Information. Pfizer Inc; August 2023.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.Melgar M, Britton A, Roper LE, et al. Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023. MMWR Morb Mortal Wkly Rep. 2023;72(29):793-801.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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PP-A1G-USA-0936
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
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PP-MCL-USA-0367