COVID-19 Vaccine (Moderna)

Drug class: Antineoplastic Agents

Usage of COVID-19 Vaccine (Moderna)

Prevention of Coronavirus Disease 2019 (COVID-19)

Used for active immunization to prevent COVID-19 caused by SARS-CoV-2.

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

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.

The current COVID-19 vaccine, mRNA (Moderna) has been specifically formulated for the 2023-2024 season. Previous vaccine presentations, which included the intial monovalent formulation (Original strain) and the subsequent bivalent vaccines, are no longer 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.

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.

ACIP recommends COVID-19 vaccination in all individuals ≥6 months of age in the US for prevention of COVID-19. There is currently no FDA-approved or FDA-authorized COVID-19 vaccine for children <6 months of age. The current ACIP recommendations for COVID-19 vaccinations are available at [Web]

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How to use COVID-19 Vaccine (Moderna)

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. ACIP states that vaccination providers should consider observing the following individuals for 30 minutes after receiving the vaccine: those with a history of anaphylaxis to a non-COVID-19 vaccine or injectable therapy; those with an allergy-related contraindication to a different type of COVID-19 vaccine; those with a history of a non-severe, immediate (onset within 4 hours) allergic reaction to a previous dose of COVID-19 vaccine. Vaccination providers should consider observing all other individuals for 15 minutes because of the risk of syncope.

    • 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. However, these medications should not be used prophylactically for the purposes of prevention of post-vaccination symptoms.
  • Premedication with antihistamines prior to vaccination to prevent allergic reactions is generally not recommended; however, while antihistamines will not prevent anaphylaxis, some experts advise antihistamine use as a means of preventing milder allergic reactions in patients who might be at higher risk for allergic reactions.

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

    • Administration

    IM Administration

    Administer by IM injection only. Do not dilute the vaccine.

    The Moderna COVID-19 vaccine, mRNA is supplied in various formulations and presentations; consult the manufacturer's labeling (for the Spikevax product) or the FDA EUA fact sheet (for the product authorized under the FDA EUA). As of September 11, 2023, the initial (Original strain) monovalent and the bivalent Moderna COVID-19 vaccine formulations are no longer authorized for use in US.

    COVID-19 vaccine (Moderna) must be shipped, stored, and handled under specific conditions. Consult the prescribing information or the EUA fact sheet for additional information.

    Spikevax

    Spikevax vaccine (2023-2024 Formula) is supplied in single- or multiple-dose vials and prefilled syringes for use in individuals ≥12 years of age.

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

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

    Moderna COVID-19 Vaccine, mRNA (2023-2024 Formula)

    Moderna COVID-19 vaccine (2023-2024 Formula) is available as a single-dose vial for use in individuals 6 months through 11 years of age.

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

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

    Vaccine does not contain preservatives; discard vial after single use.

    Dosage

    Pediatric Patients

    Prevention of COVID-19 Individuals ≥12 Years of Age IM

    Unvaccinated: Administer a single 0.5 mL dose.

    Previously vaccinated with 1 or more doses of any mRNA vaccine or Novavax or Janssen COVID-19 vaccine (including in combination with any original monovalent or bivalent COVID-19 vaccine doses): Administer a single 0.5 mL dose.

    Administer the updated 2023-2024 vaccine at least 2 months after the last dose of a COVID-19 vaccine for previously vaccinated individuals.

    Individuals 5-11 Years of Age IM

    Unvaccinated: Administer a single 0.25 mL dose.

    Previously vaccinated with 1 or more doses of any mRNA vaccine: Administer a single 0.25 mL dose.

    Administer the updated 2023-2024 vaccine at least 2 months after the last dose of a COVID-19 vaccine for previously vaccinated individuals.

    Individuals 6 Months through 4 Years of Age IM

    Unvaccinated: Administer 2 doses, 0.25 mL each, at month 0 and month 1. Individuals turning from 4 to 5 years of age during the initial vaccination series are recommended to receive both doses with the Moderna COVID-19 vaccine (2023-2024 Formula).

    Previously vaccinated with 1 dose of original monovalent or bivalent Moderna COVID-19 vaccine: Administer a single 0.25 mL dose 1 month after receipt of a previous dose of Moderna COVID-19 vaccine.

    Previously vaccinated with 2 or more doses of original monovalent or bivalent Moderna COVID-19 vaccine: Administer a single 0.25 mL dose at least 2 months after receipt of a previous dose of Moderna COVID-19 vaccine.

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

    Immunocompromised Individuals 6 months through 4 Years of age IM

    Unvaccinated: Administer three 0.25 mL doses. 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. Individuals turning from 4 to 5 years of age during the initial vaccination series are recommended to receive Moderna COVID-19 vaccine (2023-2024 Formula) for all doses.

    Previously vaccinated with 1 or 2 doses of original monovalent or bivalent 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.

    Previously vaccinated with 3 or more doses of original monovalent or bivalent Moderna COVID-19 vaccine: Administer a single 0.25 mL dose at least 8 weeks after the last COVID-19 vaccine dose.

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

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

    Immunocompromised Individuals 5-11 Years of Age IM

    Unvaccinated: Administer three 0.25 mL doses; all doses should ideally be from the same manufacturer. 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. Children who transition from 11 to 12 years of age during the initial vaccination series are recommended to receive Moderna COVID-19 vaccine (2023-2024 Formula) 0.5 mL for all doses received on or after turning 12 years of age. Alternatively, these children may complete the 3-dose series with 0.25 mL doses.

    Previously vaccinated with 1 or 2 doses of original monovalent or bivalent 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; all doses should ideally be from the same manufacturer.

    Previously vaccinated with 3 or more doses of any mRNA vaccine: Administer a single 0.25 mL dose at least 8 weeks after the last COVID-19 vaccine dose.

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

    Immunocompromised Individuals ≥12 Years of Age IM

    Unvaccinated: Administer three 0.5 mL doses; all doses should ideally be from the same manufactuer. 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.

    Previously vaccinatedwith 1 or 2 doses of original monovalent or bivalent 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; all doses should ideally be from the same manufacturer.

    Previously vaccinated with 3 or more doses of any mRNA vccine or 1 or more doses of Novavax or Janssen COVID-19 vaccine (including in combination with any original monovalent or bivalent COVID-19 vaccine doses): Administer a single 0.5 mL dose at least 8 weeks after the last COVID-19 vaccine dose.

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

    Adults

    Prevention of COVID-19 IM

    Unvaccinated: Administer a single 0.5 mL dose.

    Previously vaccinated with 1 or more doses of any mRNA vaccine or Novavax or Janssen COVID-19 vaccine (including in combination with any original monovalent or bivalent COVID-19 vaccine doses): Administer a single 0.5 mL dose.

    Administer the updated 2023-2024 vaccine at least 2 months after the last dose of a COVID-19 vaccine for previously vaccinated individuals.

    Immunocompromised Adults:

    Unvaccinated: Administer three 0.5 mL doses; all doses should ideally be from the same manufactuer. 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.

    Previously vaccinatedwith 1 or 2 doses of original monovalent or bivalent 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; all doses should ideally be from the same manufacturer.

    Previously vaccinated with 3 or more doses of any mRNA vccine or 1 or more doses of Novavax or Janssen COVID-19 vaccine (including in combination with any original monovalent or bivalent COVID-19 vaccine doses): Administer a single 0.5 mL dose at least 8 weeks after the last COVID-19 vaccine dose.

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

    Warnings

    Contraindications

  • Known history of severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine.

    • ACIP considers the following to be contraindications to vaccination with both mRNA COVID-19 vaccines (Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine):

  • Severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or severe allergic reaction to a component of the vaccine (e.g., polyethylene glycol [PEG]).
  • Known (diagnosed) allergy to a component of the vaccine (e.g., PEG).

    • Warnings/Precautions

    Hypersensitivity Reactions

    Hypersensitivity reactions, including anaphylaxis, reported.

    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.

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

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

    History of severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mRNA COVID-19 vaccine or any of its components (e.g., PEG): ACIP considers this a contraindication to vaccination with the mRNA COVID-19 vaccines. Consideration may be given to using an alternative COVID-19 vaccine (Novavax COVID-19 vaccine) in such individuals.

    Known (diagnosed) allergy to a component of the vaccine (e.g., PEG): ACIP considers this a contraindication to vaccination with the mRNA COVID-19 vaccines. Consideration may be given to using an alternative COVID-19 vaccine (Novavax COVID-19 vaccine) in such individuals.

    History of any immediate allergic reaction to any other vaccine or injectable therapy (i.e., IM, IV, or sub-Q vaccines or therapies): ACIP considers this a precaution, but not a contraindication, to COVID-19 vaccination.

    History of immediate allergic reaction to a vaccine or injectable therapy that contains multiple components (one or more of which is a component of a COVID-19 vaccine), but it is not known which component elicited the reaction: ACIP considers this a precaution, but not a contraindication, to the COVID-19 vaccine.

    History of allergic reactions (including severe allergic reactions) not related to COVID-19 vaccines, other vaccines, or injectable therapies: ACIP states that food, pet, insect, venom, or environmental allergies and allergic reactions to oral medications (including the oral equivalents of injectable medications) are not a contraindication or precaution to COVID-19 vaccination. Latex allergy is not a contraindication or precaution since vial stoppers of COVID-19 vaccines are not made with natural rubber latex. Allergies to eggs or gelatin are not a contraindication or precaution since COVID-19 vaccines do not contain eggs or gelatin. In addition, a family history of allergies is not a contraindication or precaution to COVID-19 vaccination.

    ACIP states to observe the following individuals for 30 minutes after vaccination: those with a history of an immediate allergic reaction of any severity to any other vaccine or injectable therapy, those with a contraindication to a different type of COVID-19 vaccine (i.e., viral vector), 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 anaphylaxis due to any cause not considered a contraindication; observe all other individuals for 15 minutes. Instruct vaccine recipients to seek immediate medical care if they develop signs or symptoms of an allergic reaction after their observation period ends and they have left the vaccination site.

    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.

    ACIP interim guidance regarding management of anaphylaxis are available at the CDC website at [Web].

    Lymphadenopathy

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

    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. 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.

    Myocarditis and Pericarditis

    Rare reports of acute myocarditis or pericarditis in recipients of mRNA COVID-19 vaccines. Symptom onset typically within 0–7 days (range: 0–40 days) after receipt of a dose of an mRNA COVID-19 vaccine.

    Has occurred predominantly in males <40 years of age. In some cases, patients were hospitalized and responded to medications and rest with rapid improvement or resolution of symptoms. Additional data needed regarding potential for long-term sequelae.

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

    If myocarditis or pericarditis occurs after receipt of a COVID-19 vaccine, report the case to VAERS.

    Syncope

    Syncope (fainting) may occur in association with administration of injectable vaccines, including Moderna COVID-19 vaccine (2023-2024 Formula). Procedures should be in place to avoid injury from fainting.cluding Moderna COVID-19 vaccine (2023-2024 Formula). ACIP states to consider observing individuals receiving the vaccine, especially adolescents, for 15 minutes after vaccination.

    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.

    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. 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.

    Data not available to date regarding safety and efficacy of COVID-19 vaccines in adults or children with a history of multisystem inflammatory syndrome). ACIP recommends weighing theoretical concerns about a dysregulated immune response against the known risks of COVID-19 following reinfection and the benefits of protection following COVID-19 vaccination.

    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. Current FDA-approved or FDA-authorized COVID-19 vaccines are not live vaccines, so they may be safely administered to immunocompromised individuals.

    US healthcare providers and health departments can request a clinical consultation from the Clinical Immunization Safety Assessment COVIDvax project ([Web]) if they have concerns about vaccinating individuals with certain underlying medical conditions.

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

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

    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.

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

    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.

    FDA states that pregnancy is not a contraindication to use of the Moderna COVID-19 vaccine, and pregnant women should discuss potential benefits and risks of vaccination with their healthcare providers.

    ACIP states vaccination against COVID-19 is recommended for pregnant women. Evidence indicates that benefits of vaccination against COVID-19 during pregnancy outweigh any known or potential risks.

    ACOG recommends that pregnant women be vaccinated against COVID-19. 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.

    Pregnancy exposure registry established to monitor pregnancy outcomes in women exposed to the Moderna COVID-19 vaccine during pregnancy. Encourage women who are vaccinated with the Moderna COVID-19 vaccine during pregnancy to enroll in the registry by calling 866-663-3762.

    Encourage women who receive a COVID-19 vaccine during pregnancy and those who become pregnant within 30 days after receiving a COVID-19 vaccine to participate in CDC's v-safe program.

    Lactation

    Limited data are available to assess whether COVID-19 vaccines have any effects on the breast-fed infant or on milk production. FDA states that breast-feeding is not a contraindication to use of the Moderna COVID-19 vaccine; breast-feeding women should discuss benefits and risks of vaccination with their healthcare providers.

    ACIP states that vaccination against COVID-19 recommended for lactating women. FDA-authorized COVID-19 vaccines administered to breast-feeding women cannot cause SARS-CoV-2 infection in women or their infants; therefore, breast-feeding women can receive COVID-19 vaccination.

    ACOG recommends that lactating women be vaccinated against COVID-19. ACOG also states that theoretical concerns regarding safety of vaccinating lactating women do not outweigh potential benefits of the vaccine; there is no need for individuals who receive a COVID-19 vaccine to avoid initiating breast-feeding or to discontinue breast-feeding.

    Females and Males of Reproductive Potential

    ACIP recommends vaccination against COVID-19 in women currently trying to become pregnant and those who might become pregnant in the future. Women trying to become pregnant do not need to avoid pregnancy after COVID-19 vaccination. There is no evidence that any FDA-approved or FDA-authorized COVID-19 vaccines affect current or future fertility.

    ACOG recommends vaccination for all eligible individuals, including those who may consider future pregnancy.

    Pediatric Use

    Moderna COVID-19 vaccine (2023-2024 Formula) is authorized for use in children 6 months through 11 years of age.

    The Spikevax COVID-19 vaccine (2023-2024 Formula) is FDA-labeled for use in adolescents ≥12 years of age.

    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.

    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 2023-2024 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.

    Most common adverse reactions following administration of Spikevax or Moderna COVID-19 vaccine, bivalent containing the same amount of mRNA as the Spikevax 2023-2024 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.

    Most common adverse reactions following administration of Spikevax or Moderna COVID-19 vaccine, bivalent containing the same amount of mRNA as the Spikevax 2023-2024 Formula (≥10%) in participants ≥65 years of age: pain at injection site, fatigue, myalgia, headache, arthralgia, chills, and axillary swelling/tenderness.

    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.

    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.

    What other drugs will affect COVID-19 Vaccine (Moderna)

    Vaccines

    Data not available to date to assess safety and immunogenicity of concomitant administration of COVID-19 vaccine (Moderna) with other vaccines. Immunogenicity and adverse event profiles are generally similar whether vaccines are administered concomitantly or alone. Base decisions to administer a COVID-19 vaccine concomitantly with other vaccine(s) on whether routine immunizations with the other vaccines have been delayed or missed, the individual's risk of vaccine-preventable disease (e.g., during an outbreak or occupational exposures), and reactogenicity profiles of the vaccines.

    ACIP states that COVID-19 vaccines may be administered without regard to timing of other vaccines, including simultaneous administration on the same day. If a COVID-19 vaccine is administered concomitantly with other vaccines, administer at a different injection site and, if possible, separate injection sites by ≥1 inch.

    Specific Drugs

    Drug

    Interaction

    Comments

    Antithrombotic agents

    ACIP does not recommend taking aspirin or an anticoagulant before vaccination with any currently FDA-approved or FDA-authorized COVID-19 vaccination, unless patient istaking these drugs as part of their routine medications

    Antiviral agents

    Antiviral agents given at any interval before or after COVID-19 vaccination unlikely to impair development of vaccine-induced protective antibody responses

    Immune globulin and antibody therapies not specific for SARS-CoV-2 (e.g., immune globulin IV [IGIV], Rho[D] immune globulin)

    May administer COVID-19 vaccine concurrently with or at any interval before or after immune globulin or antibody therapies not specific for SARS-CoV-2; ACIP states there is no recommended minimum interval between receipt of antibody therapies not specific for SARS-CoV-2 and COVID-19 vaccination

    Immunosuppressive agents (e.g., cancer chemotherapy, corticosteroids, radiation)

    Possible decreased or suboptimal antibody responses to vaccines, including the Moderna COVID-19 vaccine

    Data insufficient to date to inform optimal timing of COVID-19 vaccination for individuals planning to receive immunosuppressive therapies

    ACIP states that individuals receiving immunosuppressive therapy may receive COVID-19 vaccination if they have no contraindications to the vaccine

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