Pharmaceutical Name

Trade (marketing or proprietary) name: MRESVIA, ABRYSVO, AREXVY

Generic (nonproprietary or active ingredient) name: Respiratory Syncytial Virus Vaccine, and Respiratory Syncytial Virus Vaccine, Adjuvanted

Indication and Usage

Reason the product has been approved for sale on the market.

MRESVIA: 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.

ABRYSVO is an active immunization for the prevention of LRTD caused by 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 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 individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV.

AREXVY 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;
• Individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV

Manufacturer Insert

Ingredients

Also known as “excipients” for vaccines.

MRESVIA: Each 0.5 mL dose of MRESVIA contains 50 mcg of nucleoside modified mRNA encoding the RSV F glycoprotein stabilized in the prefusion conformation (pre-F protein). Each 0.5 mL dose of MRESVIA also contains the following ingredients: a total lipid content of 1.02 mg (SM-102 (heptadecan-9-yl 8-((2-hydroxyethyl) (6-oxo-6-(undecyloxy) hexyl) amino) octanoate), polyethylene glycol 2000 dimyristoyl glycerol [PEG2000-DMG], cholesterol, and 1,2-distearoyl-sn-glycero3-phosphocholine [DSPC]), 0.25 mg tromethamine, 1.2 mg tromethamine hydrochloride, 0.021 mg acetic acid, 0.10 mg sodium acetate trihydrate, 44 mg sucrose, and water for injection.

ABRYSVO: After reconstitution, a single dose of ABRYSVO is formulated to contain 120 mcg of RSV stabilized prefusion F proteins (60 mcg RSV preF A and 60 mcg RSV preF B) per 0.5 mL. ABRYSVO also contains the following buffer ingredients: 0.11 mg tromethamine, 1.04 mg tromethamine hydrochloride, 11.3 mg sucrose, 22.5 mg mannitol, 0.08 mg polysorbate 80, and 1.1 mg sodium chloride per 0.5 mL. ABRYSVO is a sterile, clear, and colorless solution. ABRYSVO contains no preservatives. Each dose may also contain residual amounts of host cell proteins (≤0.1% w/w) and DNA (<0.4 ng/mg of total protein) from the manufacturing process.

AREXVY: After reconstitution, each 0.5 mL dose is formulated to contain 120 mcg of the recombinant RSVPreF3 antigen, 25 mcg of MPL, and 25 mcg of QS-21. Each dose also contains 14.7 mg of Trehalose, 4.4 mg of sodium chloride, 0.83 mg of potassium dihydrogen phosphate, 0.26 mg of dipotassium phosphate, 0.18 mg of polysorbate 80, 0.15 mg of disodium phosphate anhydrous, 0.5 mg of DOPC, and 0.125 mg of cholesterol. AREXVY ontains no preservative. Each dose may also contain residual amounts of host cell proteins (≤2.0%) and DNA (≤0.80 ng/mg) from the manufacturing process.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

Do not administer AREXVY/ABRYSVO/MRESVIA to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of AREXVY/ABRYSVO/MRESVIA.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

MRESVIA

Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of MRESVIA.

Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines, including MRESVIA. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence: Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to MRESVIA.

ABRYSVO

Guillain-Barré Syndrome: The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome (GBS) during the 42 days following vaccination with ABRYSVO.

Potential Risk of Preterm Birth: A numerical imbalance in preterm births in ABRYSVO recipients was observed compared to placebo recipients in two clinical studies. 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. Pregnant individuals who were at increased risk of preterm birth were generally excluded from clinical studies of ABRYSVO.

Management of Acute Allergic Reactions: Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an anaphylactic reaction occurs following administration of ABRYSVO.

Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines, including ABRYSVO. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence: Immunocompromised individuals, including those receiving immunosuppressive therapy, may have a diminished immune response to ABRYSVO.

Limitations of Vaccine Effectiveness: Vaccination with ABRYSVO may not protect all vaccine recipients.

AREXVY

Guillain-Barré Syndrome: The results of a postmarketing observational study suggest an increased risk of Guillain-Barré syndrome during the 42 days following vaccination with AREXVY.

Preventing and Managing Allergic Vaccine Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of AREXVY.

Syncope: Syncope (fainting) may occur in association with administration of injectable vaccines, including AREXVY. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence: Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AREXVY.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

MRESVIA: In a clinical trial (NCT05127434), the most commonly reported (≥10%) adverse reactions were injection-site pain (55.9%), fatigue (30.8%), headache (26.7%), myalgia (25.6%), arthralgia (21.7%), axillary (underarm) swelling or tenderness (15.2%), and chills (11.6%). The insert does not have a post-marketing section.

ABRYSVO can cause: Guillain-Barré Syndrome.

• In 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 individuals 60 years of age and older, 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 individuals 18 through 59 years of age with chronic medical conditions, the most commonly reported (≥10%) adverse reactions and for which the rate for ABRYSVO exceeds the rate for placebo were pain at the injection site (35.3%), muscle pain (24.4%), joint pain (12.4%), and nausea (11.8%).

AREXVY can cause: Guillain-Barré Syndrome, injection site pain, fatigue, myalgia, headache, arthralgia, erythema, and swelling.

Limitations of Vaccine Effectiveness

Vaccination with ABRYSVO may not protect all vaccine recipients.

Specific Populations

Pregnancy

MRESVIA is not approved for use in persons younger than 60 years of age. There are no human data to establish whether there is a vaccine-associated risk with use of MRESVIA in pregnancy.

A numerical imbalance in preterm births in ABRYSVO recipients was observed compared to placebo recipients in these two clinical studies. Available data are insufficient to establish or exclude a causal relationship between preterm birth and ABRYSVO. Serious adverse reactions observed in pregnant individuals at a higher rate in the ABRYSVO group compared to the placebo group included preeclampsia (1.8% versus 1.4%) and gestational hypertension (1.1% versus 1.0%). ABRYSVO has not been studied in pregnant individuals less than 24 weeks gestational age, and those at increased risk for preterm birth.

AREXVY is not approved for use in persons <50 years of age. In a clinical study that enrolled pregnant individuals who received an investigational unadjuvanted RSV vaccine that contained the same RSVPreF3 antigen as AREXVY, an increase in preterm births was observed compared to pregnant individuals who received placebo (sucrose reconstituted with saline).

Breastfeeding

It is not known whether MRESVIA is excreted in human milk. MRESVIA is not approved for use in persons younger than 60 years of age. No human or animal data are available to assess the effects of MRESVIA on the breastfed infant or on milk production/excretion

It is not known whether ABRYSVO is excreted in human milk. Data are not available to assess the effects of ABRYSVO on the breastfed infant or on milk production/excretion.

It is not known whether AREXVY is excreted in human milk. AREXVY is not approved for use in persons <50 years of age. No human or animal data are available to assess the effects of AREXVY on the breastfed infant or on milk production/excretion.

Fertility

ABRYSVO has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.

MRESVIA/AREXVY have not been evaluated for carcinogenic or mutagenic potential or for impairment of male fertility.

Pediatric

Safety and effectiveness of MRESVIA in individuals younger than 18 years of age have not been established.

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.

Evidence from an animal model strongly suggests that AREXVY would be unsafe in individuals younger than 2 years of age because of an increased risk of enhanced respiratory disease. Safety and effectiveness in individuals 2 years through 17 years of age have not been established.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

MRESVIA induces an immune response against RSV pre-F protein that protects against LRTD caused by RSV.

ABRYSVO

• Active Immunization: ABRYSVO induces an immune response against RSVpreF that protects against lower respiratory tract disease caused by RSV.
• Passive Immunization: Antibodies to RSV antigens from individuals vaccinated in pregnancy are transferred transplacentally to protect infants younger than 6 months of age against LRTD and severe LRTD caused by RSV.

AREXVY induces an immune response against RSVpreF3 that protects against LRTD caused by RSV.

Analytical Deep Dive

Contains research on the Maternal Vaccine (ABRYSVO) and Monoclonal Antibody (Nirsevimab/Beyfortus).

What is informed consent?

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