Respiratory syncytial virus (RSV) vaccine is a recombinant adjuvant vaccine for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years and older. Additionally, Abrysvo is FDA-approved in pregnant individuals 32 to 36 weeks gestational age for the prevention of LRTD and severe LRTD caused by RSV in infants from birth to 6 months of age. RSV-associated LRTD, including pneumonia and bronchiolitis, disproportionately affects older adults and leads to increased risk of hospitalization and death. Arexvy significantly reduced the risk of developing first episode RSV-associated LRTD by 82.6% (96.95% CI, 57.9% to 94.1%) compared with placebo in patients 60 years and older. Abrysvo significantly reduced the risk of developing first episode RSV-associated LRTD by 66.7% (96.66% CI, 28.8% to 85.8%) for LRTD with 2 or more symptoms, and by 85.7% (96.66% CI, 32% to 98.7%) for LRTD with 3 or more symptoms. In pregnant individuals, Abrysvo reduced the risk of severe LRTD by 81.8% within 90 days after birth and 69.4% within 180 days after birth. Within a subgroup of pregnant individuals who were 32 to 36 weeks gestational age, Abrysvo reduced the risk of LRTD by 34.7% and reduced the risk of severe LRTD by 91.1% within 90 days after birth when compared to placebo. Within 180 days after birth, Abrysvo reduced the risk of LRTD by 57.3% and by 76.5% for severe LRTD, when compared to placebo. The most commonly reported adverse drug reactions in clinical trials include injection site pain, fatigue, muscle pain, headache, and joint pain.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Injectable Administration
-Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. Reconstituted Arexvy vaccine should be an opalescent, colorless to pale brownish liquid. Reconstituted Abrysvo vaccine should be a clear and colorless solution. If discoloration or visible particulate matter are present, discard the vaccine dose.
-Do not mix with any other vaccine or product in the same syringe.
-Due to the potential for errors, establish a process to keep vaccines and their corresponding prefilled diluent syringe together if storage requirements do not differ. Prepare only 1 vaccine at a time and relabel the diluent syringe with the vaccine name after reconstitution.
-Establish a process to prevent infants from erroneously receiving the respiratory syncytial virus (RSV) vaccine and to prevent pregnant patients from erroneously receiving the wrong RSV vaccine. This may include noting or highlighting the vaccine's intended patient population(s) on vaccine packages and storage locations.
Intramuscular Administration
Reconstitution (Arexvy)
-Prepare respiratory syncytial virus vaccine by reconstituting the lyophilized antigen component (a sterile white powder) with the accompanying adjuvant suspension component (an opalescent, colorless to pale brownish sterile liquid). Use only the supplied adjuvant suspension component for reconstitution.
-Using a sterile needle and sterile syringe, withdraw the entire contents of the vial of the adjuvant suspension component (vial 1 of 2) by slightly tilting the vial.
-Slowly transfer entire contents of syringe into the lyophilized antigen component vial (vial 2 of 2).
-Gently swirl the vial until powder is completely dissolved. Do not shake vigorously.
-Withdraw 0.5 mL of reconstituted product for the dose.
-Storage of reconstituted Arexvy vaccine: If possible, administer immediately after reconstitution; however, reconstituted vaccine may be stored refrigerated between 36 and 46 degrees F (2 and 8 degrees C) or at room temperature [up to 25 degrees C (77 degrees F)] for up to 4 hours. Protect from light; do not store frozen.
Reconstitution (Abrysvo Vial and Prefilled Syringe)
-Supplied in a kit that includes a vial of Lyophilized Antigen Component (sterile white powder), a prefilled syringe containing the Sterile Water Diluent Component, and a vial adapter.
-Remove the flip top cap from the vial of Lyophilized Antigen Component.
-Peel off the top cover from the vial adapter packaging.
-While keeping the vial adapter in it packaging, center the adapter over the vial's stopper and attach to the vial with a straight downward push. Remove the packaging.
-Hold the syringe of Sterile Water Diluent Component by the Luer lock adapter. Twist the syringe cap. Connect the syringe to the vial adapter by turning the Luer lock.
-Inject the entire contents of the syringe into the vial.
-Hold the plunger rod down and gently swirl the vial until the powder is completely dissolved (less than 1 minute). Do not shake.
-Invert the vial completely and slowly withdraw the entire contents into the syringe for an approximately 0.5 mL dose.
-Twist to disconnect the syringe from the vial adapter.
-Attach a sterile needle for intramuscular injection.
-Storage of reconstituted Abrysvo vaccine: Administer vaccine immediately after reconstitution or store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) and use within 4 hours.
Reconstitution (Abrysvo Vial and Vial)
-Supplied in cartons that include vials of Lyophilized Antigen Component (sterile white powder) and vials containing the Sterile Water Diluent Component.
-Using a sterile needle and sterile syringe, withdraw the entire contents of the vial containing the Sterile Water Diluent Component.
-Inject the entire contents in the vial containing the Lyophilized Antigen Component (white powder). Do not remove syringe.
-Gently swirl the vial in a circular motion until the powder is completely dissolved. Do not shake.
-Withdraw 0.5 mL from the vial containing the reconstituted vaccine.
-Storage of reconstituted Abrysvo vaccine: Administer vaccine immediately after reconstitution or store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) and use within 4 hours.
Intramuscular Injection
-After preparation of the dose, administer immediately as an intramuscular injection.
The safety of respiratory syncytial virus (RSV) vaccine was evaluated in two trials. The safety of Arexvy was evaluated in 15,845 vaccine recipients. Solicited adverse reactions were monitored during the 4 days following vaccination in a subset of patients aged 60 years and older who received a dose of Arexvy (n = 879) or placebo (n = 874). In the solicited safety data set, local adverse reactions had a median duration of 2 days and systemic adverse reactions had a median duration of 1 to 2 days. Unsolicited adverse reactions were monitored during the 30 days following vaccination, and serious adverse events were monitored during the 6 months following vaccination, in adults aged 60 years and older who received Arexvy (n = 12,467) and placebo (n = 12,499). The safety of Abrysvo was evaluated in 17,215 vaccine recipients. Solicited adverse reactions were monitored during the 7 days following vaccination in a subset of patients ages 60 and older who received a dose of Abrysvo (n = 3,630) or placebo (n = 3,539). In the solicited safety set, local and systemic adverse reactions had a median duration of 1 to 2 days. Unsolicited adverse reactions and serious adverse reactions were monitored during the one month following vaccination, in adults aged 60 years and older who received a dose of Abrysvo (n = 17,215) and placebo (n = 17,069).
Injection site reaction was commonly reported during clinical trials for respiratory syncytial virus vaccine. The most frequent solicited local adverse reactions reported during the 4 days after a dose of Arexvy (n = 879) were pain (overall incidence, 60.9%; grade 3 incidence, 1%), erythema (greater than 20 mm, 7.5%; erythema greater than 100 mm, 0.2%), and edema or swelling (greater than 20 mm, 5.5%; swelling greater than 100 mm, 0.2%). The most frequent solicited local adverse reactions reported during the 7 days after a dose of Abrysvo (n = 3,619 to 3,663) were pain (overall incidence, 10.5% to 40.6%; mild, 9.4% to 36.1%; moderate, 1.1% to 4.4%; severe, up to 0.1%), redness or erythema (overall incidence, 2.7% to 7.2%; mild, 1.5% to 5%; moderate, 1.1% to 2.1%; severe, 0.1%), and edema or swelling (overall incidence, 2.4% to 6.2%; mild or 2.5 cm to 5 cm, 1.5% to 4.1%; moderate or 5 cm to 10 cm, 0.9% to 2%; severe or greater than 10 cm, up to 0.1%).
Solicited systemic adverse reactions reported during the 4 days after a dose of Arexvy (n = 879) included fatigue (overall incidence, 33.6%; grade 3 incidence, 1.7%), myalgia (overall incidence, 28.9%; grade 3 incidence, 1.4%), headache (overall incidence, 27.2%; grade 3 incidence, 1.3%), arthralgia (overall incidence, 18.1%; grade 3 incidence, 1.3%), fever more than 100.4 degrees F (38 degrees C) (2%), and fever more than 102.2 degrees F (39 degrees C) (0.1%). Systemic adverse reactions reported during the 7 days after a dose of Abrysvo (n = 3,619 to 3,663) included fatigue (overall incidence, 15.5% to 46.1%; severe, 0.3% to 1.3%), muscle pain or myalgia (overall incidence, 10.1% to 26.5%; severe, 0.2% to 0.4%), headache (overall incidence, 12.8% to 31%; severe, 0.1% to 0.4%), joint pain or arthralgia (overall incidence, 7.5% to 11.6%; severe, up to 0.2%), fever more than 100.4 degrees F (38 degrees C) (1.4% to 2.6%), and fever more than 102 degrees F (38.9 degrees C) (less than 0.1%).
There is insufficient data to determine a causal relationship of atrial fibrillation to respiratory syncytial virus (RSV) vaccine. Atrial fibrillation was reported within 30 days of Arexvy administration in 10 patients (7 serious events) who received respiratory syncytial virus vaccine (n = 12,467), compared to 4 patients (1 serious event) who received placebo (n = 12,499). Within 6 months of administration, serious events of atrial fibrillation were reported in 13 patients who received Arexvy, compared to 15 participants who received placebo. Atrial fibrillation was reported in 10 vaccine recipients (4 serious events) with 30 days of Abrysvo administration (n = 17,215), compared to 4 patients (3 serious events) who received placebo (n = 17,069).
In clinical trials, Guillain-Barre syndrome was reported in 1 participant beginning 9 days after receiving Arexvy, and in 1 participant 7 days after receiving Abrysvo. Miller Fisher syndrome was reported in 1 participant 7 days after receiving Abrysvo.
Acute disseminated encephalomyelitis was reported in 2 participants who received respiratory syncytial virus vaccine with Fluarix quadrivalent in clinical trials; 1 event was fatal. The onset of symptoms was 7 and 22 days post vaccination, respectively.
Nausea (overall incidence, 3.4% to 20%; severe, 0.2%), vomiting (overall incidence, 0.9% to 7.8%; severe, 0.2%), and diarrhea (overall incidence, 5.9% to 11.2%; severe, 0.1%) were reported during the 7 days after Abrysvo administration in clinical trials (n = 3,619 to 3,663).
Hypersensitivity/serious hypersensitivity reactions or anaphylaxis was reported in 1 patient 8 hours after receiving Abrysvo in clinical trials (n = 17,215).
In clinical trials, there was an increased incidence of preterm birth in pregnant individuals 24 to 36 weeks gestation who received respiratory syncytial virus vaccine compared to those who received placebo (5.3% to 6.8% vs. 2.6% to 4.95%). To avoid the potential risk of preterm birth, administer respiratory syncytial virus vaccine (Abrysvo) after 32 weeks gestation. Serious pregnancy-related outcomes occurring in individuals who received Abrysvo included pre-eclampsia (1.8% vs. 1.4%, placebo), gestational hypertension (1.1% vs. 1%, placebo), premature rupture of membranes (0.4% vs. 0.4%, placebo), preterm premature rupture of membranes (0.4% vs. 0.3%, placebo), hypertension (0.4% vs. 0.2%, placebo), and fetal death (0.3% vs. 0.2%, placebo). Additionally, low birth weight (5.1% vs. 4.4%, placebo) and jaundice (7.2% vs. 6.7%, placebo) were observed more frequently in infants born to individuals receiving Abrysvo.
The respiratory syncytial virus vaccine is contraindicated in patients with a history of a severe allergic reaction to any component of the vaccine. As with any biologic product, procedures should be in place to manage allergic reactions. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy. The respiratory syncytial virus vaccine may not protect all vaccine recipients.
Injectable vaccines, including the respiratory syncytial virus vaccine, have been associated with episodes of syncope and fainting. Prior to administration, ensure procedures are in place to prevent falls and manage syncopal reactions.
Immunocompromised patients, including patients with immunosuppression or receiving immunosuppressive therapy, may not have an adequate immune response to the respiratory syncytial virus vaccine. Efficacy studies excluded persons who were immunocompromised.
Safety and efficacy of respiratory syncytial virus (RSV) vaccine have not been established in neonates, infants, children, or adolescents; however, evidence from an animal model strongly suggests that the RSV vaccine would be unsafe in patients younger than 2 years of age due to an increased risk of enhanced respiratory disease. The RSV vaccine is not indicated for use in pediatric patients.
In clinical trials, there was an increased incidence of preterm birth in patients who received respiratory syncytial virus vaccine compared to those who received placebo. Data are insufficient to establish or exclude a causal relationship between preterm birth and respiratory syncytial virus vaccine. To avoid the potential risk of preterm birth, administer respiratory syncytial virus vaccine (Abrysvo) after 32 weeks gestation. Abrysvo has not been studied in pregnant individuals less than 24 weeks gestation or those at increased risk for preterm birth. Additionally, pre-eclampsia and gestational hypertension occurred more frequently in pregnant individuals receiving Abrysvo compared to placebo while low birth weight and jaundice occurred more frequently in infants born to individuals who received Abrysvo compared to placebo. There was no evidence of increased vaccine-associated risk of congenital anomalies or fetal deaths. A pregnancy exposure registry is available; encourage individuals who received Abrysvo during pregnancy to enroll in the registry by calling 1-800-616-3791.
There are no data on the presence of respiratory syncytial virus vaccine in human milk, the effects on a breast-fed infant, or the effects on milk production. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Ensure correct formulation selection for respiratory syncytial virus (RSV) vaccine use. Errors have been reported involving infants and young children who received the RSV vaccine and pregnant individuals administered Arexvy instead of Abrysvo. It is important to be familiar with each vaccine, indication, and FDA-approved age range to avoid dosing errors. Pregnant individuals who erroneously received Arexvy do not need to receive a dose of Abrysvo; however, nirsevimab is recommended in the infant (if younger than 8 months). Administer nirsevimab to infants who erroneously received the RSV vaccine instead of nirsevimab.
General Dosing Information
-The respiratory syncytial virus (RSV) vaccine is recommended for pregnant individuals at 32 to 36 weeks' gestation using seasonal administration to prevent RSV-associated lower respiratory tract infection (LRTI) in patients younger than 6 months. The RSV season is usually September through January in most of the United States. In individuals not receiving vaccination with the RSV vaccine, nirsevimab administration is recommended in patients younger than 8 months. All infants should be protected against RSV-associated LRTI through the use of 1 of these products; both are not usually needed. There is currently no ACIP recommendation for RSV vaccination in subsequent pregnancies.
-Pregnant patients who erroneously received Arexvy do not need to receive a dose of Abrysvo; however, nirsevimab is recommended for the infant (if younger than 8 months).
-Administer nirsevimab to infants who erroneously received the RSV vaccine instead of nirsevimab.
-Due to the potential for increased inflammatory neurologic events (6 cases of Guillain-Barre syndrome, acute disseminated encephalomyelitis, and others), shared clinical decision-making between the patient and health care provider is recommended in patients 60 years and older.
-Until additional information is available from postmarketing data clarifying the existence of any potential risk, target RSV vaccination in older adults to those who are at highest risk for severe RSV disease and would be most likely to benefit from vaccination.
--Chronic underlying medical conditions associated with increased risk include lung disease, cardiovascular diseases, moderate or severe immune compromise, diabetes mellitus, neurologic or neuromuscular conditions, kidney disorders, liver disorders, and hematologic disorders.
-Other factors associated with increased risk include frailty, advanced age, or residence in a nursing home or other long-term care facility.
For respiratory syncytial virus (RSV) infection prophylaxis for the prevention of lower respiratory tract disease (LRTD):
Intramuscular dosage (Arexvy):
Adults 60 years and older: 0.5 mL IM as a single dose.
Intramuscular dosage (Abrysvo):
Adults 60 years and older: 0.5 mL IM as a single dose.
Pregnant Persons 32 to 36 weeks gestation: 0.5 mL IM as a single dose.
Maximum Dosage Limits:
-Adults
Adults 60 years and older: 0.5 mL/dose IM.
Adults 50 to 59 years: Safety and efficacy have not been established.
Adults 18 to 49 years: 0.5 mL/dose IM.
-Geriatric
0.5 mL/dose IM.
-Adolescents
0.5 mL/dose IM.
-Children
Safety and efficacy have not been established.
-Infants
Safety and efficacy have not been established.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Albuterol; Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Betamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Bimekizumab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Budesonide; Glycopyrrolate; Formoterol: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticosteroids (systemic): (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Corticotropin, ACTH: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Cortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deflazacort: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Deucravacitinib: (Moderate) Patients receiving immunosuppressant medications may have a diminished vaccine response. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Dexamethasone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Elivaldogene Autotemcel: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least six weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Hydrocortisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Methylprednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ocrelizumab: (Moderate) Administer all non-live vaccines at least 2 weeks before ocrelizumab initiation, whenever possible. Ocrelizumab may interfere with the effectiveness of non-live virus vaccines. Attenuated antibody responses to tetanus toxoid-containing vaccine, pneumococcal polysaccharide and pneumococcal conjugate vaccines, and seasonal influenza vaccine were observed in patients exposed to ocrelizumab at the time of vaccination during an open-label study. Infants born to mothers exposed to ocrelizumab during pregnancy may receive non-live vaccines as indicated before B-cell recovery; however, consider assessing the immune response to the vaccine. ACIP recommends that patients receiving any vaccination during immunosuppressive therapy or in the 2 weeks prior to starting therapy should be considered unimmunized and should be revaccinated a minimum of 3 months after discontinuation of therapy. Passive immunoprophylaxis with immune globulins may be indicated for immunocompromised persons instead of, or in addition to, vaccination.
Ofatumumab: (Major) Administer all needed non-live vaccines according to immunization guidelines at least 2 weeks before initiation of ofatumumab. Ofatumumab may interfere with the effectiveness of inactivated vaccines due to its actions, which cause B-cell depletion.
Prednisolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Prednisone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Satralizumab: (Major) Administer all non-live vaccines according to immunization guidelines at least 2 weeks before initiation of satralizumab.
Siponimod: (Moderate) Administer all non-live vaccines at least 2 weeks before siponimod initiation, whenever possible. Vaccines may be less effective if given during siponimod treatment. Patients should be considered unimmunized if vaccinated within a 14-day period before starting immunosuppresive therapy or during immunosuppressive therapy, and should they be revaccinated at least 3 months after therapy is discontinued if immune competence is restored.
Triamcinolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Ublituximab: (Moderate) Patients receiving immunosuppressant medications may have a diminished response to non-live vaccines. When feasible, administer indicated vaccines at least two weeks prior to initiating immunosuppressant medications. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving immunosuppressant medications about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Vamorolone: (Moderate) Patients receiving high-dose corticosteroid therapy may have a diminished response to vaccines. High-dose corticosteroid therapy is generally defined as a dose of at least 20 mg/day of prednisone or equivalent (or 2 mg/kg/day for patients weighing less than 10 kg) for at least 14 consecutive days. When feasible, administer indicated vaccines at least 4 weeks before planned high-dose corticosteroid therapy or wait at least 2 weeks after discontinuation. If vaccine administration is necessary, consider revaccination following restoration of immune competence. Counsel patients receiving high-dose corticosteroids about the possibility of a diminished vaccine response and to continue to follow precautions to avoid exposure after receiving the vaccine.
Respiratory syncytial virus vaccine induces an immune response against recombinant respiratory syncytial virus glycoprotein F stabilized in pre-fusion conformation (Arexvy, RSVPreF3; Abrysvo, recombinant RSV preF A and RSV preF B) that protects against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV). When Abrysvo is administered to pregnant individuals, antibodies to RSV antigens are transferred transplacentally to protect infants younger than 6 months of age.
Respiratory syncytial virus vaccine is administered intramuscularly.
Affected cytochrome P450 isoenzymes: none