mRESVIA (mRNA-1345)

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  • Product Details

    Description

    mRESVIA is an mRNA-based vaccine developed by Moderna, designed to protect adults aged 60 years and older from lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV). Utilizing the same lipid nanoparticle (LNP) delivery system as Moderna's COVID-19 vaccines, mRESVIA delivers nucleoside-modified mRNA encoding the stabilized prefusion F glycoprotein of RSV, eliciting a robust immune response against both RSV-A and RSV-B subtypes. For individuals seeking to buy mRESVIA, it's essential to consult healthcare providers to understand its benefits and suitability.

    Fact Table

    Formula

    N/A (mRNA-based)

    License

    US FDA (2024)

    Bioavailability

    Not applicable (vaccine)

    Legal status

    Prescription only (Rx)

    Chemical Name

    Respiratory Syncytial Virus Vaccine, mRNA (mRNA-1345)

    Elimination half-life

    Short (mRNA degraded rapidly in vivo)

    Dosage (Strength)

    One 0.5 mL intramuscular injection (containing 50 µg mRNA)

    Pregnancy

    Not recommended without medical consultation

    Brands

    mRESVIA

    Protein binding

    Not applicable

    PubChem CID

    Not listed

    MedlinePlus

    a621035

    ChEBI

    Not listed

    ATC code

    J07BH06

    DrugBank

    DB17975

    KEGG

    D12572

    Routes of administration

    Intramuscular injection

    Directions

    Administered as a single 0.5 mL intramuscular injection, mRESVIA is supplied in prefilled syringes for ease of use. The vaccine should be stored frozen between -40°C to -15°C and thawed prior to administration. Once thawed, it can be stored refrigerated at 2°C to 8°C for up to 30 days. Healthcare professionals should follow proper storage and handling protocols to maintain vaccine efficacy.

    Ingredients

    Each 0.5 mL dose of mRESVIA contains:

    • 50 micrograms of nucleoside-modified mRNA encoding the RSV prefusion F glycoprotein
    • Lipid nanoparticles (LNPs) for mRNA delivery
    • Excipients including SM-102, cholesterol, DSPC, PEG2000-DMG, tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose

    The formulation is preservative-free and appears as a white to off-white suspension.

    Cautions

    Before administering the mRESVIA vaccine, healthcare providers should assess individuals for potential hypersensitivity reactions. The vaccine's safety and efficacy have not been established in populations under 60 years of age. As with all vaccines, immunization with mRESVIA may not protect all recipients. Monitoring for adverse reactions post-vaccination is recommended.

    Contraindications

    mRESVIA is contraindicated in individuals with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine.

    Side Effects

    Common side effects observed in clinical trials include:

    • Injection-site pain (55.9%)
    • Fatigue (30.8%)
    • Headache (26.7%)
    • Myalgia (25.6%)
    • Arthralgia (21.7%)
    • Axillary swelling or tenderness (15.2%)
    • Chills (11.6%)

    These reactions are generally mild to moderate in intensity and resolve within a few days post-vaccination.

    Frequently Asked Questions about mRESVIA (mRNA-1345)


    What is mRESVIA (mRNA-1345)?

    mRESVIA (mRNA-1345) is an mRNA vaccine developed for the prevention of respiratory syncytial virus (RSV) infection in older adults. It uses messenger RNA technology to help the body recognize and fight RSV infections.


    How does mRESVIA work?

    mRESVIA works by delivering messenger RNA (mRNA) that instructs cells to produce a protein that resembles a key protein on the surface of the RSV virus. This triggers an immune response, teaching your body to recognize and fight the actual virus if exposed in the future, without causing disease.


    Who is the manufacturer of mRESVIA?

    mRESVIA (mRNA-1345) is manufactured by Moderna, a biotechnology company known for its mRNA vaccine technology.


    Is mRESVIA FDA approved?

    Yes, mRESVIA received FDA approval for use in adults 60 years and older to prevent RSV-associated lower respiratory tract disease.


    Who should receive the mRESVIA vaccine?

    mRESVIA is recommended for adults 60 years of age and older to protect against RSV-associated lower respiratory tract disease.


    How is mRESVIA administered?

    mRESVIA is administered as a single intramuscular injection, typically in the upper arm (deltoid muscle).


    Will I need booster doses of mRESVIA?

    Current recommendations are for a single dose. The need for booster doses will be determined based on ongoing research into the duration of protection.


    Can I receive mRESVIA at the same time as other vaccines?

    Generally, mRESVIA can be administered at the same visit as other vaccines, including influenza and COVID-19 vaccines. Consult with your healthcare provider about your specific situation.


    What if I have already had RSV?

    Prior RSV infection does not provide long-lasting immunity. The vaccine is still recommended even if you've previously had RSV.


    How effective is mRESVIA in preventing RSV?

    Clinical trials demonstrated that mRESVIA is highly effective in preventing RSV-associated lower respiratory tract disease in older adults, with efficacy rates of approximately 83-94% against RSV-associated lower respiratory tract disease.


    Is mRESVIA safe?

    Yes, mRESVIA has been evaluated in large clinical trials and demonstrated a favorable safety profile. Like all vaccines, it underwent rigorous testing before receiving FDA approval.


    Can mRESVIA cause RSV infection?

    No, mRESVIA cannot cause RSV infection. The vaccine contains mRNA that instructs cells to produce a protein similar to one found on the RSV virus, but it does not contain the live virus or even the whole virus.


    What are the contraindications for receiving mRESVIA?

    mRESVIA should not be administered to individuals with a history of severe allergic reaction (anaphylaxis) to any component of the vaccine. Those with allergies to components of the vaccine should consult their healthcare provider.


    How does mRNA technology in mRESVIA differ from traditional vaccines?

    Unlike traditional vaccines that use weakened or inactivated viruses, mRESVIA uses mRNA technology. The mRNA instructs cells to produce a specific protein from the RSV virus, which triggers an immune response without exposing the body to the actual virus.


    What clinical trials were conducted for mRESVIA?

    mRESVIA underwent comprehensive clinical trials, including the Phase 3 ConquerRSV study, which evaluated safety and efficacy in adults 60 years and older. The trials demonstrated significant protection against RSV-associated lower respiratory tract disease.


    What is the storage requirement for mRESVIA?

    mRESVIA requires cold storage, similar to other mRNA vaccines. Healthcare providers are equipped with proper storage facilities to maintain the vaccine's efficacy.


    What is Respiratory Syncytial Virus (RSV)?

    RSV is a common respiratory virus that usually causes mild, cold-like symptoms. However, it can be serious for infants, young children, and older adults, potentially causing bronchiolitis and pneumonia.


    Why is RSV vaccination important for older adults?

    RSV can cause severe respiratory illness in older adults, especially those with compromised immune systems or underlying medical conditions. RSV infections in older adults can lead to hospitalization and, in some cases, death.


    What is the season for RSV?

    RSV season typically runs from fall through spring in temperate climates, with peak activity usually occurring between December and February in the Northern Hemisphere.


    Can I receive mRESVIA if I'm immunocompromised?

    Immunocompromised individuals should consult with their healthcare provider. While the vaccine does not contain live virus and is generally considered safe, individual health conditions may affect recommendations.


    Is mRESVIA recommended for pregnant women?

    mRESVIA is currently approved for adults 60 years and older. Pregnant women should consult with their healthcare provider regarding RSV prevention strategies appropriate for their situation.


    How long does protection from mRESVIA last?

    Studies indicate protection lasts at least through one RSV season. Ongoing research is evaluating the duration of protection and whether booster doses may be needed in subsequent years.


    What should I do if I experience side effects after receiving mRESVIA?

    Mild side effects like injection site pain or fatigue typically resolve within a few days. For severe or persistent side effects, contact your healthcare provider. You or your provider can also report adverse events to the Vaccine Adverse Event Reporting System (VAERS).


    Can I get RSV after receiving mRESVIA?

    While mRESVIA significantly reduces the risk of RSV infection, no vaccine is 100% effective. However, if you do contract RSV after vaccination, symptoms are likely to be less severe.

    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 15329

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