OVID-19 Vaccine, mRNA (Moderna) (2024-2025 Formula) (Monograph)

Drug class: Vaccines

Medically reviewed by Drugs.com on Oct 10, 2024. Written by ASHP.

Introduction

Nucleoside-modified mRNA vaccine used to stimulate active immunity to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).^{1 2}

Uses for OVID-19 Vaccine, mRNA (Moderna) (2024-2025 Formula)

Prevention of Coronavirus Disease 2019 (COVID-19)

Used for active immunization to prevent COVID-19 caused by SARS-CoV-2.¹

The vaccine preparation labeled as Spikevax is FDA-approved for prevention of COVID-19 in individuals ≥12 years of age.¹

Although efficacy and safety not definitely established, COVID-19 vaccine, mRNA (Moderna) is also available under an FDA emergency use authorization (EUA) for prevention of COVID-19 in individuals 6 months through 11 years of age.^{2 501}

The current COVID-19 vaccine, mRNA (Moderna) has been specifically formulated for the 2024-2025 season and is a monovalent vaccine based on the Omicron JN.1 lineage of SARS-CoV-2, KP.2.² Previous vaccine presentations, which included the initial monovalent formulation (Original strain), the bivalent vaccines, and the subsequent monovalent 2023-2024 formulation are no longer approved or authorized for use in the US; however, evidence of effectiveness and safety of the current vaccine are based principally on data from these previous formulations.^{1 2 6 17 19 61 88 89 91 501 503}

Consult the CDC's Advisory Committee on Immunization Practices (ACIP) interim recommendations and clinical considerations for use of COVID-19 vaccines, including dosage and administration, specific populations and situations, and cautionary information.¹³

ACIP recommends COVID-19 vaccination in all individuals ≥6 months of age in the US for prevention of COVID-19.¹³ There is currently no FDA-approved or FDA-authorized COVID-19 vaccine for children <6 months of age.¹³ CDC recommends that people receive all recommended COVID-19 vaccine doses.¹³ Vaccination is especially important for people at highest risk of severe COVID-19, including people ≥65 years of age; people with underlying medical conditions, including immune compromise; people living in long-term care facilities; and pregnant people to protect themselves and their infants.¹³ The current ACIP recommendations for COVID-19 vaccinations are available at [Web]

OVID-19 Vaccine, mRNA (Moderna) (2024-2025 Formula) Dosage and Administration

General

Pretreatment Screening

• Screen all individuals for contraindications and precautions prior to vaccination.

Patient Monitoring

• Monitor all individuals who receive a COVID-19 vaccine for immediate adverse reactions according to CDC (ACIP) guidelines.¹ ACIP states that vaccination providers should consider observing the following individuals for 30 minutes after receiving the vaccine: those with a history of a non-severe, immediate (onset less than 4 hours) allergic reaction to a previous dose of COVID-19 vaccine, and those with a history of a diagnosed non-severe allergy to a component of the COVID-19 vaccine.¹³ Vaccination providers should consider observing all other individuals for 15 minutes after vaccination.¹³

Premedication and Prophylaxis

• Antipyretics or analgesics (e.g., acetaminophen, nonsteroidal anti-inflammatory agents) may be taken for the treatment of postvaccination local or systemic symptoms, if medically appropriate.¹³ However, these medications should not be used prophylactically for the purposes of prevention of post-vaccination symptoms.¹³

Dispensing and Administration Precautions

• Appropriate medications and supplies for managing immediate allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of COVID-19 vaccines.^{1 13}

• Syncope may occur following administration of parenteral vaccines, especially in adolescents.¹³ Patients should be seated or lying down during vaccination.^{13 20} Vaccination providers should consider observing vaccine recipients (especially adolescents) for 15 minutes after vaccination.¹³ If syncope develops, patients should be observed until symptoms resolve.¹³

Administration

IM Administration

Administer by IM injection only.^{1 501}

The Moderna COVID-19 vaccine, mRNA is available as the FDA-approved Spikevax preparation or as an EUA-authorized vaccine presentation; consult the manufacturer's labeling (for the Spikevax product) or the FDA EUA fact sheet (for the product authorized under the FDA EUA).^{1 501} As of August 22, 2024, the initial (Original strain) monovalent, the bivalent, and the monovalent 2023-24 Moderna COVID-19 vaccine formulations are no longer approved or authorized for use in the US.²

COVID-19 vaccine (Moderna) must be shipped, stored, and handled under specific conditions.^{1 14 18 20} Consult the prescribing information or the EUA fact sheet for additional information.^{1 501}

Spikevax

Spikevax vaccine (2024-2025 Formula) is supplied in single-dose vials and prefilled syringes for use in individuals ≥12 years of age.¹

The vaccine is supplied as a frozen suspension that must be thawed prior to administration.¹ See manufacturer's prescribing information for specific instructions.¹

The thawed vaccine should appear as a white to off-white suspension and may contain white or translucent product-related particles.¹ Do not use if it is discolored or contains other particles.¹ Vaccine that has been thawed must not be refrozen.¹

Moderna COVID-19 Vaccine, mRNA (2024-2025 Formula)

Moderna COVID-19 vaccine (2024-2025 Formula) is available as single-dose pre-filled syringes for use in individuals 6 months through 11 years of age.⁵⁰¹

The vaccine is supplied as a frozen suspension that must be thawed prior to administration.⁵⁰¹ See the EUA Fact Sheet for specific instructions.⁵⁰¹

The thawed vaccine should appear as a white to off-white suspension and may contain white or translucent product-related particles.⁵⁰¹ Do not use if it is discolored or contains other particles. ⁵⁰¹ Vaccine that has been thawed must not be refrozen.⁵⁰¹

Dosage

The recommended number of doses of Moderna COVID-19 vaccine, mRNA (2024-2025 Formula) and interval between doses are based on age and vaccination history as follows in the dosage sections below.^{1 13}

Pediatric Patients

Prevention of COVID-19

Individuals ≥12 Years of Age Who are Not Immunocompromised

IM

Unvaccinated: Administer a single 0.5 mL dose.^{1 13}

Previously vaccinated with 1 or more doses of any mRNA COVID-19 vaccine NOT including 1 dose of any 2024-2025 COVID-19 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.^{1 13}

Previously vaccinated with 2 or more doses of any Novavax COVID-19 vaccine NOT including 1 dose of any COVID-19 2024-2025 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.¹³

Individuals 5-11 Years of Age Who are Not Immunocompromised

IM

Unvaccinated: Administer a single 0.25 mL dose.^{13 501}

Previously vaccinated with 1 or more doses of any COVID-19 mRNA vaccine NOT including 1 dose of any 2024-2025 mRNA vaccine: Administer a single 0.25 mL dose at least 8 weeks after the last dose.^{13 501}

Individuals 6 Months through 4 Years of Age Who are Not Immunocompromised

IM

Unvaccinated: Administer 2 doses, 0.25 mL each (dose 1 on day 0 and dose 2 at 4–8 weeks after dose 1).^{13 501} CDC states that an 8-week interval between the first and second doses might be optimal for some people as it might reduce the rare risk of myocarditis and pericarditis.¹³

Previously vaccinated with 1 dose of any Moderna COVID-19 vaccine: Administer a single 0.25 mL dose 4–8 weeks after receipt of the previous dose of Moderna COVID-19 vaccine.^{13 501}

Previously vaccinated with 2 or more doses of any Moderna COVID-19 vaccine NOT including at least 1 dose of 2024-2025 Moderna vaccine: Administer a single 0.25 mL dose at least 8 weeks after receipt of the last dose.^{13 501}

Per FDA authorization, all COVID-19 vaccine doses in this age group should ideally be from the same manufacturer.¹³

CDC states that children who transition from 4 to 5 years of age during the initial vaccine series should receive 1 dose of the 2024-2025 vaccine from the same manufacturer at the dosage authorized for children 5-11 years of age on or after turning 5 years of age.¹³

Immunocompromised Individuals 6 months through 4 Years of age

IM

Unvaccinated: Administer three 0.25 mL doses.^{13 501} There should be a 4 week interval between dose 1 and dose 2 and at least a 4 week interval between dose 2 and dose 3.^{13 501}

Previously vaccinated with 1 or 2 doses of any Moderna COVID-19 vaccine: Complete the 3-dose series with two or one 0.25 mL dose(s), respectively, using the same dosing interval as above.^{13 501}

Previously vaccinated with 3 or more doses of any Moderna COVID-19 vaccine NOT including at least 1 dose of 2024-2025 Moderna: Administer a single 0.25 mL dose at least 8 weeks after the last dose.^{13 501}

One or more additional doses may be administered based on clinician discretion.¹³

Per CDC recommendations, all COVID-19 vaccine doses in immunocompromised individuals of all age groups should ideally be from the same manufacturer.¹³

CDC states that children who transition from 4 to 5 years of age during the initial vaccine series should complete the 3-dose series using the dosage for children ages 5-11 years for all doses received on or after turning 5 years of age.¹³

Immunocompromised Individuals 5-11 Years of Age

IM

Unvaccinated: Administer three 0.25 mL doses.^{13 501} There should be a 4 week interval between dose 1 and dose 2 and at least a 4 week interval between dose 2 and dose 3.^{13 501}

Previously vaccinated with 1 or 2 doses of any Moderna COVID-19 vaccine: Complete the 3-dose series with two or one 0.25 mL dose(s), respectively, using the same dosing interval as above.^{13 501}

Previously vaccinated with 3 or more doses of any mRNA vaccine NOT including at least 1 dose of any 2024-2025 mRNA vaccine: Administer a single 0.25 mL dose at least 8 weeks after the last dose.^{13 501}

One or more additional doses may be administered based on clinician discretion.¹³

Per CDC recommendations, all COVID-19 vaccine doses in immunocompromised individuals of all age groups should ideally be from the same manufacturer.¹³

CDC states that children who transition from 11 to 12 years of age during the initial vaccine series should complete the 3-dose series using the dosage approved for people 12 years of age or older for all doses received on or after turning 12 years of age.¹³

Immunocompromised Individuals ≥12 Years of Age

IM

Unvaccinated: Administer three 0.5 mL doses.¹³ There should be a 4 week interval between dose 1 and dose 2 and at least a 4 week interval between dose 2 and dose 3.^{13 501}

Previously vaccinatedwith 1 or 2 doses of any Moderna COVID-19 vaccine: Complete the 3-dose series with two or one 0.5 mL dose(s), respectively, using the same dosing interval as above.^{13 501}

Previously vaccinated with 3 or more doses of any COVID-19 mRNA vaccine NOT including at least 1 dose of any 2024-2025 COVID-19 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.^{13 501}

Previously vaccinated with 2 or more doses of any Novavax COVID-19 vaccine NOT including 1 dose of any 2024-2025 COVID-19 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.¹³

One or more additional doses may be administered based on clinician discretion.¹³

Per CDC recommendations, all COVID-19 vaccine doses in immunocompromised individuals of all age groups should ideally be from the same manufacturer.¹³

Adults

Prevention of COVID-19

IM

Adults Who are Not Immunocompromised:

Unvaccinated: Administer a single 0.5 mL dose.^{1 13}

Previously vaccinated with 1 or more doses of any mRNA COVID-19 vaccine NOT including 1 dose of any 2024-2025 COVID-19 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.^{1 13}

Previously vaccinated with 2 or more doses of any Novavax COVID-19 vaccine NOT including 1 dose of any 2024-2025 COVID-19 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.¹³

Immunocompromised Adults:

Unvaccinated: Administer three 0.5 mL doses.¹³ There should be a 4 week interval between dose 1 and dose 2 and at least a 4 week interval between dose 2 and dose 3.¹³

Previously vaccinatedwith 1 or 2 doses of any Moderna COVID-19 vaccine: Complete the 3-dose series with two or one 0.5 mL dose(s), respectively, using the same dosing interval as above.¹³

Previously vaccinated with 3 or more doses of any COVID-19 mRNA vaccine NOT including at least 1 dose of any COVID-19 2024-2025 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.¹³

Previously vaccinated with 2 or more doses of any Novavax COVID-19 vaccine NOT including at least 1 dose of any COVID-19 2024-2025 vaccine: Administer a single 0.5 mL dose at least 8 weeks after the last dose.¹³

One or more additional doses may be administered based on clinician discretion.¹³

Per CDC recommendations, all COVID-19 vaccine doses in immunocompromised individuals of all age groups should ideally be from the same manufacturer.¹³

Cautions for OVID-19 Vaccine, mRNA (Moderna) (2024-2025 Formula)

Contraindications

• Individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine or individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Moderna COVID-19 vaccine.^{1 2}

Warnings/Precautions

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, reported.^{1 2 17 29}

Although immediate allergic reactions not reported to date in clinical trials evaluating the Moderna COVID-19 vaccine, severe allergic reactions including anaphylaxis reported rarely outside of clinical trials.^{1 17}

Delayed-onset local reactions around injection site reported in some vaccine recipients.¹ ACIP states that such reaction after one dose is not a contraindication or precaution to administration of a second vaccine dose.^{1 11 13 19 38}

If a hypersensitivity reaction occurs following COVID-19 vaccination, report the case to VAERS.¹³

History of severe allergic reaction (e.g., anaphylaxis) after a previous dose or to a component (e.g., PEG) of a COVID-19 vaccine: ACIP considers this a contraindication to vaccination with the mRNA COVID-19 vaccines.¹³ Consideration can be given to using an alternate COVID-19 vaccine type in such individuals provided certain measures are taken.¹³ Consultation with an allergist-immunologist is encouraged to provide expert evaluation of the original allergic reaction, and reassess if administration of additional doses of the same vaccine type may be possible.¹³

ACIP states to consider monitoring the following individuals for 30 minutes after vaccination: those with a history of a non-severe, immediate allergic reaction to a previous dose of COVID-19 vaccine, and those with a history of a diagnosed non-severe allergy to a component of the COVID-19 vaccine.¹³ In all other individuals, particularly in adolescents, consider monitoring for 15 minutes after vaccination.¹³

Appropriate medications and supplies to manage immediate allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of a COVID-19 vaccine.^{1 23}

Lymphadenopathy

Lymphadenopathy, lymphadenitis, lymph node pain, injection-site lymphadenopathy, axillary swelling/tenderness, and axillary mass reported in clinical trials evaluating COVID-19 vaccine (Moderna).^{1 10}

Unilateral axillary adenopathy, including palpable axillary mass, identified through self-detection or incidentally on breast imaging in individuals who received an mRNA COVID-19 vaccine outside of clinical trials.^{30 44} Consider vaccine-induced hyperplastic axillary adenopathy in differential diagnosis if unilateral axillary adenopathy identified on breast imaging in individuals who recently received an mRNA COVID-19 vaccine.^{30 44}

Myocarditis and Pericarditis

Rare reports of acute myocarditis or pericarditis in recipients of COVID-19 vaccines.¹ Symptom onset typically within 0–7 days (range: 0–40 days) after receipt of the second dose of an mRNA COVID-19 vaccine.^{13 53 54 55 56 57 58}

Has occurred predominantly in adolescent and young males, but cases also reported in females.¹ In some cases, patients were hospitalized and responded to medications and rest with rapid improvement or resolution of symptoms.^{13 53 54 55 56 58}

Consider possibility of myocarditis and pericarditis in the differential diagnosis for any individual who develops acute chest pain, shortness of breath, or palpitations after receipt of a COVID-19 vaccine.⁵³ Consider expert consultation regarding diagnosis, management, and follow-up.⁵³

If myocarditis or pericarditis occurs after receipt of a COVID-19 vaccine, report the case to VAERS.^{13 53} CDC has published recommendations for vaccination in individuals with a history of myocarditis or pericarditis.¹³

Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines.^{1 501} Procedures should be in place to avoid injury from fainting.¹ ACIP states to consider observing individuals receiving the vaccine, especially adolescents, for 15 minutes after vaccination.¹³

Concomitant Illness

Base decision to administer or delay vaccination in an individual with a current or recent febrile illness on the severity of symptoms and etiology of the illness.²⁰

ACIP states that a moderate or severe acute illness is a precaution for administration of vaccines and recommends that a risk assessment be performed with potential deferral of vaccination.¹³ Deferring vaccination until an individual has recovered avoids superimposing adverse effects of the vaccine on the underlying illness or mistakenly concluding that a manifestation of the underlying illness resulted from vaccination.²⁰

ACIP states that the benefits of COVID-19 vaccination for individuals with a history of multisystem inflammatory syndrome in adults (MIS-A) or in children (MIS-C) outweigh the risks.¹³ ACIP has published considerations for initiating COVID-19 vaccination in such individuals.¹³

Individuals with Underlying Medical Conditions

ACIP states that individuals with altered immunocompetence or certain underlying medical conditions may receive any COVID-19 vaccine approved or authorized by FDA, unless they have a contraindication to the vaccine.¹³ Current FDA-approved or FDA-authorized COVID-19 vaccines are not live vaccines, so they may be safely administered to immunocompromised individuals.¹³

Although a causal relationship not established, several cases of Bell's palsy reported in COVID-19 vaccine trials.¹

Advise individuals who have bleeding disorders or are receiving anticoagulant therapy about the risk of hematoma from IM injections.²⁰

Specific Populations

Pregnancy

Data insufficient to date regarding use of COVID-19 vaccine, mRNA (Moderna) in pregnant women to inform vaccine-associated risks during pregnancy.¹

Developmental toxicity study in rats did not reveal evidence of vaccine-related adverse effects on female fertility, fetal development, or postnatal development.¹

Available data suggest that, while absolute risk is low, pregnant women with COVID-19 are at increased risk of severe illness, preterm birth, and possibly increased risk of adverse pregnancy complications and outcomes.^{13 16 34}

ACIP and ACOG recommend COVID-19 vaccination in pregnant women.^{13 16} Evidence indicates that benefits of vaccination against COVID-19 during pregnancy outweigh any known or potential risks.¹³

ACOG recommends that pregnant women be vaccinated against COVID-19.¹⁶ ACOG suggests that clinicians review available data on risks and benefits of vaccination, including risks of not getting vaccinated, in the context of the individual's current health status and risk of exposure.¹⁶

Lactation

Limited data are available to assess whether COVID-19 vaccines have any effects on the breast-fed infant or on milk production.¹

ACIP and ACOG recommends COVID-19 vaccination in people who are breastfeeding.^{13 16}

Females and Males of Reproductive Potential

ACIP recommends vaccination against COVID-19 in people who are pregnant, trying to get pregnant, or might become pregnant in the future.^{13 13}

Pediatric Use

Moderna COVID-19 vaccine (2024-2025 Formula) is authorized for use in children 6 months through 11 years of age.⁵⁰¹

The Spikevax COVID-19 vaccine (2024-2025 Formula) is FDA-labeled for use in adolescents ≥12 years of age.¹

Geriatric Use

Individuals ≥65 years of age have been included in clinical trials evaluating the original Moderna COVID-19 monovalent vaccine (no longer authorized for use in the US), and data from such individuals contribute to the overall assessment of safety and efficacy of the vaccine.^{1 2}

Common Adverse Effects

Most common adverse reactions following administration of Spikevax or Moderna COVID-19 vaccine, bivalent containing the same amount of mRNA as the Spikevax 2024-2025 Formula (≥10%) in participants 12– 17 years of age: pain at the injection site, fatigue, headache, myalgia, chills, axillary swelling/tenderness, arthralgia, nausea/vomiting, swelling at the injection site.¹

Most common adverse reactions following administration of Spikevax or Moderna COVID-19 vaccine, bivalent containing the same amount of mRNA as the Spikevax 2024-2025 Formula (≥10%) in participants 18–64 years of age: pain at injection site, fatigue, headache, myalgia, arthralgia, chills, axillary swelling/tenderness, and nausea/vomiting, pain at the injection site, fatigue, headache, myalgia, chills, axillary swelling/tenderness, arthralgia, nausea/vomiting, and swelling at the injection site.¹

Most common adverse reactions following administration of Spikevax or Moderna COVID-19 vaccine, bivalent containing the same amount of mRNA as the Spikevax 2024-2025 Formula (≥10%) in participants ≥65 years of age: pain at injection site, fatigue, myalgia, headache, arthralgia, chills, and axillary swelling/tenderness.¹

Solicited adverse effects in individuals 6–36 months of age receiving the COVID-19 vaccine, mRNA (Moderna): Injection site erythema, pain and swelling; axillary (or groin) swelling/tenderness, fever, irritability/crying, loss of appetite and sleepiness.⁵⁰¹

Solicited adverse effects in individuals 37 months through 11 years of age receiving the COVID-19 vaccine, mRNA (Moderna): Injection site erythema, pain and swelling; arthralgia, axillary (or groin) swelling/tenderness, chills, fatigue, fever, headache, myalgia and nausea/vomiting.⁵⁰¹

Drug Interactions

Vaccines

No data to assess concomitant administration of Moderna COVID-19 vaccine with other vaccines; ACIP states that COVID-19, influenza, and respiratory syncytial virus (RSV) vaccines may be simultaneously administered to eligible patients.¹³

Simultaneous administration of COVID-19 vaccine and nirsevimab is recommended.¹³ There are additional considerations for simultaneous administration of an orthopoxvirus vaccine and COVID-19 vaccine.¹³ See ACIP recommendations for additional information.¹³

Specific Drugs

Stability

Storage

Suspension for Injection

Consult prescribing information or FDA EUA fact sheet for information on storage, handling, and stability of the vaccine.^{1 501}

Actions

• Nucleoside-modified mRNA vaccine formulated in lipid nanoparticles (LNPs).^{1 2 10 11 12 25}

• The mRNA contained in the Moderna COVID-19 vaccine encodes a full-length spike (S) glycoprotein of SARS-CoV-2 stabilized in a prefusion conformation with 2 proline substitutions (S-2P).^{1 2 10 11} The 2024-2025 Formula contains nucleoside-modified mRNA encoding the prefusion stabilized spike glycoprotein of the SARS-CoV-2 Omicron variant lineage KP.2.¹ Following IM injection, the LNPs in the vaccine enable delivery of the mRNA into host cells where it is released and translated to the encoded S antigen of SARS-CoV-2.^{1 2 11} The S antigen elicits an immune response to provide protection against SARS-CoV-2.^{1 2 11}

Advice to Patients

• Advise the vaccine recipient or caregiver to read the FDA-approved patient labeling or FDA Fact Sheet.^{1 501}

• Inform the vaccine recipient or caregiver of the potential benefits and risks of vaccination.¹

• Instruct the vaccine recipient or caregiver to report any adverse events to their healthcare provider or to the Vaccine Adverse Event Reporting System at 1-800-822-7967 and [Web].¹

• Advise patients to inform their clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.^{1 501}

• Advise women to inform their clinician if they are or plan to become pregnant or plan to breast-feed.^{1 501}

• Inform patients of other important precautionary information.^{1 501}

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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