Abrysvo

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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
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  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Abrysvo Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Respiratory syncytial virus vaccine; soln for IM inj after reconstitution; preservative-free.

    Pharmacological Class

    RSV vaccine.

    How Supplied

    Kits—1, 5, 10 (w. supplies)

    How Supplied

    Abrysvo is supplied in a kit containing a vial of lyophilized antigen component, a prefilled syringe containing diluent and a vial adapter. Abrysvo is supplied in cartons of 1, 5, and 10 kits. The vial stopper and the tip cap and rubber plunger of the prefilled syringe are not made with natural rubber latex.

    Storage

    Before Reconstitution:

    • Refrigerate at 2°C to 8°C (36°F to 46°F) in the original carton.

    After Reconstitution:

    • After reconstitution, administer immediately or store at room temperature [15ºC to 30ºC (59ºF to 86ºF)] and use within 4 hours. Do not store reconstituted vaccine under refrigerated conditions [2ºC to 8ºC (36ºF to 46ºF)]. 

    Manufacturer

    Pfizer Inc.

    Generic Availability

    NO

    Mechanism of Action

    Abrysvo induces an immune response against RSV pre F that protects against lower respiratory tract disease caused by RSV.

    Abrysvo Indications

    Indications

    Active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age. Active immunization for the prevention of LRTD caused by RSV in adults aged ≥60yrs.

    Abrysvo Dosage and Administration

    Adult

    Pregnant individuals (32–36 weeks gestational age) or Adults (≥60yrs): one single dose (0.5mL) by IM inj.

    Children

    <18yrs: not established.

    Administration

    To form Abrysvo, reconstitute the lyophilized antigen component with the sterile water diluent component.

    • Step 1: While keeping the vial adapter in its packaging, center over the vial’s stopper and connect with a straight downward push. Remove the packaging.

    • Step 2: Hold the syringe only by the Luer lock adapter. Twist to remove the syringe cap, then twist to connect the syringe to the vial adapter. Inject the entire contents of the syringe into the vial, then gently swirl the vial until the powder is completely dissolved (less than 1 minute).

    • Step 3: Invert the vial and slowly withdraw the entire contents into the syringe. Attach sterile needle suitable for intramuscular injection.

    Administer the reconstituted Abrysvo immediately or store at room temperature and use within 4 hours.

    Abrysvo Contraindications

    Not Applicable

    Abrysvo Boxed Warnings

    Not Applicable

    Abrysvo Warnings/Precautions

    Warnings/Precautions

    Potential risk for preterm birth; use only as indicated. Have appropriate medical treatment available. Syncope. Immunocompromised. Vaccination may not protect all recipients. Pregnancy. Nursing mothers. 

    Pregnancy Considerations

    Pregnancy Exposure Registry

    • There is a pregnancy exposure registry that monitors pregnancy outcomes in individuals exposed to Abrysvo during pregnancy. Individuals who received Abrysvo during pregnancy are encouraged to contact, or have their healthcare provider contact, 1-800-616-3791 to enroll in or obtain information about the registry.

    Risk Summary

    • A developmental toxicity study was performed in female rabbits administered a vaccine formulation containing two times the antigen content of a single human dose of Abrysvo prior to and during gestation. The study showed no evidence of harm to the fetus or to postnatal survival, growth, or development.

    Clinical Considerations

    • Abrysvo has not been studied in pregnant individuals less than 24 weeks gestational age, and those at increased risk for preterm birth.

    • Available data are insufficient to establish or exclude a causal relationship between preterm birth and Abrysvo. To avoid the potential risk of preterm birth with use of Abrysvo before 32 weeks of gestation, administer Abrysvo as indicated in pregnant individuals at 32 through 36 weeks gestational age.

    Nursing Mother Considerations

    Risk Summary

    • Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for Abrysvo and any potential adverse effects on the breastfed child from Abrysvo or from the underlying maternal condition. For preventative vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.

    Pediatric Considerations

    • The safety and effectiveness of Abrysvo to prevent RSV LRTD and severe RSV LRTD in infants born to individuals vaccinated at younger than 10 years of age have not been established.

    • The safety and effectiveness of Abrysvo to prevent RSV LRTD in non-pregnant individuals younger than 18 years of age via active immunization have not been established.

    Abrysvo Pharmacokinetics

    See Literature

    Abrysvo Interactions

    Interactions

    Concomitant immunosuppressants: may get suboptimal response.

    Abrysvo Adverse Reactions

    Adverse Reactions

    Fatigue, headache, inj site pain, muscle pain; anaphylaxis. 

    Abrysvo Clinical Trials

    Clinical Trials

    Study in Pregnant Individuals For Efficacy in Their Infants from Birth Through 6 Months of Age

    • The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 MATISSE trial (ClinicalTrials.gov Identifier: NCT04424316), which evaluated the efficacy of Abrysvo in preventing RSV-associated LRTD in infants born to individuals vaccinated during pregnancy.

    • Maternal participants were randomly assigned to receive either Abrysvo (n=3695) or placebo (n=3697). Vaccine efficacy, defined as the relative risk reduction of RSV-associated LRTD and severe RSV-LRTD in infants born to individuals who received Abrysvo vs those who received placebo, was evaluated within 90, 120, 150, and 180 days after birth.

    • Results showed vaccine efficacy of 81.8% (99.5% CI, 40.6-96.3) against severe LRTD caused by RSV in infants from birth through the first 90 days of life (6 cases in the vaccine group and 33 cases in the placebo group). Efficacy of 69.4% (97.58% CI, 44.3-84.1) was observed over the 6-month follow-up period (19 cases in the vaccine group and 62 cases in the placebo group).

    • While the second primary endpoint did not meet statistical significance, vaccine efficacy against RSV-associated LRTD was reported to be 57.1% (99.5% CI, 14.7-79.8) in infants from birth through the first 90 days of life and 51.3% (97.58% CI, 29.4-66.8) over the 6-month follow up period.

    • Among individuals who were 32 through 36 weeks gestational age, 1572 participants received Abrysvo and 1539 received placebo. Findings showed Abrysvo reduced the risk of severe LRTD by 91.1% (95% CI, 38.8-99.8) within 90 days after birth and by 76.5% (95% CI, 41.3-92.1) within 180 days after birth compared with placebo. Vaccine efficacy against LRTD was reported to be 34.7% (95% CI, -34.6, 69.3) within 90 days after birth and 57.3% (95% CI, 29.8-74.7) within 180 days after birth.

     

    Efficacy in Individuals 60 Years of Age and Older

    • The approval was based on data from the randomized, double-blind, placebo-controlled phase 3 RENOIR study (ClinicalTrials.gov Identifier: NCT05035212), which assessed the efficacy and safety of Abrysvo in the prevention of RSV-associated LRTD in adults 60 years of age and older. Patients were randomly assigned to receive Abrysvo (n=17,197) or placebo (n=17,186).

    • The coprimary endpoints were vaccine efficacy against the first episode of RSV-associated LRTD with at least 2 or at least 3 symptoms. The median duration of follow-up for efficacy was 7 months.

    • Vaccine efficacy for Abrysvo was reported to be 66.7% (96.66% CI, 28.8-85.8) against RSV-associated LRTD with at least 2 symptoms (11 cases in the vaccine group vs 33 cases in the placebo arm). 

    • Vaccine efficacy was reported to be 85.7% (96.66% CI, 32.0-98.7) against RSV-associated LRTD with at least 3 symptoms (2 cases in the vaccine group vs 14 cases in the placebo arm). 

     

    Concomitant Vaccine Administration with Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed

    •  The phase 2, placebo-controlled, randomized, observer-blind study (ClinicalTrials.gov Identifier: NCT04071158) evaluated the safety, tolerability, and immunogenicity of Abrysvo (at dose levels 120mcg and 24mcg, with or without Al(OH)3) when administered concomitantly with Tdap in non-pregnant women 18 through 49 years of age.

    • Antibody responses to antigens contained in Abrysvo and Tdap were assessed 1 month after vaccination in a population of non-pregnant adult individuals. 

    • Lower geometric mean antibody concentrations (GMCs) to the acellular pertussis antigens (pertussis toxin [PT], filamentous hemagglutinin (FHA), and pertactin [PRN]) were observed when Abrysvo was administered concomitantly with a tetanus, diphtheria and acellular pertussis vaccine (Tdap) compared to pertussis GMCs when Tdap was administered alone. 

    • The lower limit of the 2-sided 95% confidence interval of the GMC ratio (GMC Abrysvo+Tdap /GMC Tdap) was 0.64 for PT, 0.50 for FHA, and 0.48 for PRN, which did not meet the pre-specified non-inferiority criterion (lower limit of the 95% confidence interval for the GMC ratio is >0.67). The clinical relevance of this finding is unknown. The non-inferiority criteria for tetanus, diphtheria and RSV vaccine antigens were met.

    Abrysvo Note

    Not Applicable

    Abrysvo Patient Counseling

    Patient Counseling

    Prior to administration of this vaccine:

    • Inform vaccine recipient of the potential benefits and risks of vaccination with Abrysvo.

    • Advise vaccine recipient to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967 and www.vaers.hhs.gov.

    Cost Savings Program

    Abrysvo Savings and Support

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