Introduction

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

Uses for COVID-19 Vaccine (Moderna)

Prevention of Coronavirus Disease 2019 (COVID-19)

COVID-19 vaccine, mRNA (Spikevax) is used for prevention of COVID-19 caused by SARS-CoV-2 in individuals ≥18 years of age as a 2-dose primary vaccination series. Spikevax is the FDA-approved monovalent Moderna COVID-19 vaccine labeled for prevention of COVID-19 in individuals ≥18 years of age.

Although efficacy and safety have not been established, the Moderna COVID-19 vaccine is also available under an FDA emergency use authorization (EUA) for active immunization to prevent COVID-19 in individuals 6 months of age or older as the bivalent vaccine (Moderna COVID-19 vaccine, bivalent).

There are 2 formulations of the Moderna COVID-19 vaccine, a monovalent vaccine (Moderna COVID-19 vaccine/Spikevax) and a bivalent vaccine (Moderna COVID-19 vaccine, bivalent). The monovalent form was the initial vaccine presentation; a bivalent vaccine was later authorized for improving protection against the circulating Omicron variant of SARS-CoV-2.

On April 18, 2023, FDA amended the EUA of Moderna COVID-19 vaccine, bivalent to simplify the vaccination schedule. Current EUA authorizes use of the bivalent vaccine for all doses administered to individuals ≥6 months of age. The monovalent Moderna COVID-19 vaccine is no longer authorized for use in the US.

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.

COVID-19 Vaccine (Moderna) 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. 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. Confirm dosing volume prior to administration based on age of the recipient, product used, and if primary series dose or a booster dose.

The Moderna COVID-19 vaccine is supplied in various formulations and vial presentations. There are important differences between these formulations in concentration and dose volume; consult the manufacturer's labeling (for the Spikevax product) or the FDA EUA Fact Sheets for Healthcare Providers for specific instructions on each formulation. The various formulations and vial presentations are distinguished by different color vial caps and labels. Verify that the appropriate formulation is used. As of April 18, 2023, the monovalent Moderna COVID-19 vaccine is no longer authorized for use in US.

The Moderna COVID-19 vaccine should not be diluted.

There are 2 presentations of Moderna COVID-19 vaccine, bivalent. The bivalent vaccine supplied in multiple dose vials with a dark blue cap and label with a gray border is authorized to provide doses for individuals ≥6 months of age. The bivalent vaccine supplied in multiple dose vials with a dark pink cap and label with a yellow box is authorized to provide certain doses for individuals 6 months through 5 years of age

Spikevax©

The Spikevax^© vaccine is supplied as a frozen suspension in 5.5 mL or 7.5 mL multiple-dose vials that must be thawed prior to administration. See manufacturer's prescribing information for specific instructions for thawing.

For primary series doses of Spikevax^©, 0.5 mL of the vaccine should be withdrawn from the vial using aseptic technique and an appropriate syringe and needle (preferably with a low dead-volume syringe and/or needle); the vaccine should be administered immediately following preparation.

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

Moderna COVID-19 Vaccine, Bivalent (Omicron BA.4/BA.5) Vials with Dark Blue Cap and Gray Label Border

Moderna COVID-19 vaccine, bivalent (dark blue cap and gray label border) is supplied as a frozen suspension in multiple-dose vials that must be thawed prior to administration. See manufacturer's prescribing information for specific instructions for thawing.

Thawed Moderna COVID-19 vaccine, bivalent should appear as a white to off-white suspension and may contain white or translucent product-related particles. The thawed vaccine should not be used if it is discolored or contains other particles. Vaccine that has been thawed must not be refrozen.

Moderna COVID-19 vaccine, bivalent vials with dark blue cap and gray label border is supplied in 2.5 mL multiple-dose vials. Both 0.5-mL doses and 0.25-mL doses may be withdrawn from the same vial. When extracting only 0.5-mL doses from the vial, the maximum number of doses that may be extracted is 5 doses per vial. When extracting only 0.25-mL doses, each multiple-dose vial contains 10 doses.

Vaccine does not contain preservatives; discard any remaining vaccine and do not pool excess vaccine from multiple vials.

Moderna COVID-19 Vaccine, Bivalent (Omicron BA.4/BA.5) Vials with Dark Pink Cap and Label with a Yellow Box

Moderna COVID-19 vaccine, bivalent (dark pink cap and label with a yellow box) is supplied as a frozen suspension in multiple-dose vials that must be thawed prior to administration. See manufacturer's prescribing information for specific instructions for thawing.

Thawed Moderna COVID-19 vaccine, bivalent should appear as a white to off-white suspension and may contain white or translucent product-related particles. The thawed vaccine should not be used if it is discolored or contains other particles. Vaccine that has been thawed must not be refrozen.

Each multiple-dose vial of COVID-19 vaccine, bivalent vials with dark pink cap and label with a yellow box contains 2 doses of 0.2 mL.

Vaccine does not contain preservatives; discard any remaining vaccine and do not pool excess vaccine from multiple vials.

Dosage

Moderna COVID-19 vaccine is available in various formulations and vial presentations. Ensure the correct age-appropriate formulation is selected for administration. The monovalent Moderna COVID-19 vaccine is no longer authorized for use in US; therefore, dosing recommendations are provided only for the bivalent vaccine below.

See the following tables for recommended doses and dosing intervals for the Moderna COVID-19 vaccine, bivalent.

For immunocompromised individuals (e.g., those who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise) 6 months through 5 years of age who have received two 0.25-mL doses of the Moderna COVID-19 vaccine or Moderna COVID-19 vaccine, bivalent, an additional 0.25-mL dose of Moderna COVID-19 vaccine, bivalent (vial with a dark blue cap and a label with a gray border) may be administered at least 1 month following the most recent dose; additional doses of the bivalent vaccine may be administered at clinician's discretion.

For immunocompromised individuals (e.g., those who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise) 6 years of age and older, a single additional age-appropriate dose of Moderna COVID-19 vaccine, bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine; additional age-appropriate doses of Moderna COVID-19 vaccine, bivalent may be administered at clinician's discretion.

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 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

Sensitivity Reactions

Hypersensitivity Reactions

Hypersensitivity reactions reported in 1.5% of vaccine recipients and 1.1% of placebo recipients in the ongoing phase 3 trial evaluating the Moderna COVID-19 vaccine; hypersensitivity events reported in the vaccine group and likely related to vaccination included injection site rash and injection site urticaria.

Although immediate allergic reactions not reported to date in clinical trials evaluating the Moderna COVID-19 vaccine, severe allergic reactions, including anaphylaxis, reported rarely following administration of mRNA COVID-19 vaccines outside of clinical trials.

Following issuance of the FDA EUA for the Moderna COVID-19 vaccine, safety monitoring data identified 10 cases of anaphylaxis among 4,041,396 individuals in the US who received the first dose of the vaccine (2.5 cases per million vaccine doses administered).

From December 21, 2020 to January 10, 2021, safety monitoring data identified 43 cases of nonanaphylactic allergic reactions in individuals who received the first dose of the Moderna COVID-19 vaccine.

Delayed-onset local reactions (e.g., erythema, induration, pruritus, tenderness) around the injection site area reported in some vaccine recipients. ACIP states that delayed-onset local reaction after the first dose of an mRNA COVID-19 vaccine is not a contraindication or precaution to administration of the second vaccine dose. Therefore, individuals with such injection site reactions after the first dose of an mRNA COVID-19 vaccine should receive the second dose of the same vaccine at the recommended interval, preferably in the opposite arm.

If a hypersensitivity reaction, including anaphylaxis, occurs following COVID-19 vaccination, report the case to VAERS. (See EUA Requirements for Postvaccination Monitoring and Mandatory Vaccine Adverse Event Reporting under Cautions.)

Because anaphylactic reactions reported rarely following administration of COVID-19 vaccines, ACIP issued interim guidance with contraindications and precautions for use of COVID-19 vaccines pending further investigation.

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. ACIP states consideration may be given to using an alternative COVID-19 vaccine (Janssen COVID-19 vaccine) in such individuals. However, because of potential cross-reactive hypersensitivity between ingredients in mRNA COVID-19 vaccines and the Janssen COVID-19 vaccine (including PEG and polysorbate 80, respectively), consider consultation with an allergist-immunologist to help determine if the individual can safely receive the Janssen COVID-19 vaccine.

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. ACIP states consideration may be given to using an alternative COVID-19 vaccine (Janssen COVID-19 vaccine) in such individuals. However, because of potential cross-reactive hypersensitivity between ingredients in mRNA COVID-19 vaccines and the Janssen COVID-19 vaccine (including PEG and polysorbate 80, respectively), consider consultation with an allergist-immunologist to help determine if the individual can safely receive the Janssen COVID-19 vaccine.

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. ACIP states that history of allergic reaction to sub-Q immunotherapy for allergies (i.e., allergy shots) is not a contraindication or precaution 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.

History of delayed-onset local reactions (e.g., erythema, induration, pruritus) around the injection site area after first dose of an mRNA COVID-19 vaccine: ACIP states that these local reactions are not a contraindication or precaution for administration of second dose of mRNA COVID-19 vaccine. Such individuals should receive second dose using the same mRNA COVID-19 vaccine used for first dose at the recommended interval, preferably in the opposite arm.

If a precaution for COVID-19 vaccination is identified, ACIP recommends performing a risk assessment to help decide whether the individual should be vaccinated.

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].

When confronted with a complex COVID-19 vaccine safety question that is not readily addressed by ACIP guidance, US healthcare personnel or health departments can request a clinical consultation from the Clinical Immunization Safety Assessment COVIDvax project ([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. Some experts suggest scheduling routine screening mammography or ultrasound prior to first dose of an mRNA COVID-19 vaccine or 4–6 weeks following second dose of the vaccine, if possible, and if this would not unduly delay appropriate care.

Consider that increased axillary lymph node or deltoid uptake has been detected on positron emission tomography (PET) or other imaging performed in individuals who recently received an mRNA 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. Reported more frequently after the second vaccine dose than the first dose. Increased risk observed with the Moderna COVID-19 vaccine as compared to other authorized or approved COVID-19 vaccines. Risk of myocarditis with booster doses has been relatively lower than the second dose of the primary series based on limited evidence.

Data to date indicate myocarditis and pericarditis following vaccination with an mRNA COVID-19 vaccine occurred predominantly in males <40 years of age; the risk is highest among males 18–24 years of age. In some reported 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 the possibility of myocarditis and pericarditis in the differential diagnosis for any individual, particularly males 12–29 years of age, who develop acute chest pain, shortness of breath, or palpitations after receipt of an mRNA COVID-19 vaccine. During initial evaluation of suspected cases, query the individual about prior COVID-19 vaccination and pertinent medical, travel, and social history; in addition, consider assessing ECG, troponin levels, and inflammatory markers such as C-reactive protein and erythrocyte sedimentation rate. Consider expert consultation regarding diagnosis, management, and follow-up.

Inform individuals receiving an mRNA COVID-19 vaccine, especially males 12–29 years of age, about the possibility of myocarditis or pericarditis after receiving the vaccine and the possibility of myocarditis or pericarditis occurring following SARS-CoV-2 infection and advise them to seek medical care if symptoms of myocarditis or pericarditis occur after vaccination.

If myocarditis or pericarditis occurs after receipt of a COVID-19 vaccine, report the case to VAERS. (See EUA Requirements for Postvaccination Monitoring and Mandatory Vaccine Adverse Event Reporting under Cautions.)

Individuals who developed myocarditis or pericarditis after a dose of an mRNA COVID-19 vaccine: Because it is unclear whether such individuals are at increased risk of further adverse cardiac effects following a subsequent dose of the vaccine, experts recommend deferring subsequent doses until additional safety data are available. ACIP states there may be certain circumstances when administration of a subsequent dose can be considered, taking into account the individual's personal risk of severe acute COVID-19 (e.g., age, underlying conditions), level of COVID-19 in the community and personal risk of infection, availability of additional data on risk of myocarditis or pericarditis in such situations, and availability of additional data on long-term outcomes. Those who choose to receive a subsequent dose should wait until their episode of myocarditis or pericarditis has completely resolved, including resolution of symptoms attributed to myocarditis or pericarditis with no evidence of ongoing heart inflammation or sequelae as determined by the individual’s clinical team, which may include a cardiologist, and special testing to assess cardiac recovery.

Individuals with a history of myocarditis or pericarditis unrelated to mRNA COVID-19 vaccination (e.g., prior to COVID-19 vaccination): Data are limited regarding the safety and efficacy of COVID-19 vaccines in such individuals. FDA states that a decision to administer the Moderna COVID-19 vaccine to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances. ACIP states that any COVID-19 vaccine approved or authorized by FDA can be administered after the episode of myocarditis or pericarditis unrelated to COVID-19 vaccination has completely resolved, including resolution of symptoms attributed to myocarditis or pericarditis with no evidence of ongoing heart inflammation or sequelae as determined by the individual’s clinical team, which may include a cardiologist, and special testing to assess cardiac recovery.

Thrombocytopenia

Very rare reports of thrombocytopenia, including immune thrombocytopenia (ITP), in recipients of mRNA COVID-19 vaccines (Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine) during post-authorization surveillance. As of February 4, 2021, >18 million doses of the Pfizer-BioNTech COVID-19 vaccine and >16 million doses of the Moderna COVID-19 vaccine had been administered in the US, and FDA had identified 15 cases of thrombocytopenia in recipients of the Pfizer-BioNTech COVID-19 vaccine and 13 cases in recipients of the Moderna COVID-19 vaccine (reporting rates of 0.8 per million doses for both mRNA vaccines). FDA stated that this number of post-vaccination cases of thrombocytopenia does not suggest a safety concern attributable to mRNA COVID-19 vaccines.

As of April 24, 2021, data from the Vaccine Safety Datalink (VSD) regarding reports of cerebral venous sinus thrombosis (CVST) in recipients of mRNA COVID-19 vaccines identified 11 CVST cases (3 in recipients of the Pfizer-BioNTech vaccine and 8 in recipients of the Moderna vaccine). However, only 6 were considered to be potential incident cases of CVST since 5 of the cases were ruled out based on patient history (e.g., history of head injury, history of cavernous sinus syndrome); thrombocytopenia was not reported in any of these patients. At the time of this analysis, 6.3 million doses of mRNA COVID-19 vaccines had been administered at the healthcare organizations included in the VSD network, and there were no confirmed cases of CVST with thrombocytopenia in recipients of the Pfizer-BioNTech COVID-19 vaccine or Moderna COVID-19 vaccine.

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.

Individuals with Current SARS-CoV-2 Infection

ACIP recommends deferring COVID-19 vaccination in individuals with known current SARS-CoV-2 infection until they have recovered from the acute illness (if symptomatic) and until criteria for discontinuance of isolation have been met.

Individuals with Prior SARS-CoV-2 Infection

Available data suggest that COVID-19 vaccines can be given safely to individuals with evidence of prior SARS-CoV-2 infection.

Data not available to date regarding safety and efficacy of administering COVID-19 vaccines to individuals who have received passive antibody therapy with investigational SARS-CoV-2-specific monoclonal antibodies or investigational COVID-19 convalescent plasma as part of treatment of COVID-19. (See Specific Drugs under Drug Interactions.)

Individuals with a History of Multisystem Inflammatory Syndrome

Data not available to date regarding safety and efficacy of COVID-19 vaccines in adults or children with a history of multisystem inflammatory syndrome (MIS-A or MIS-C, respectively). 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.

ACIP states that individuals with a history of MIS-A or MIS-C may choose to be vaccinated. The benefits of COVID-19 vaccination are thought to outweigh the risks in those with a history of MIS-C, if the following criteria are met: achievement of clinical recovery (including return to normal cardiac function), 90 days have passed since the diagnosis of MIS-C, individual resides in an area of high or substantial community transmission of SARS-CoV-2 (or otherwise have an increased risk for exposure and transmission), and onset of MIS-C preceded any COVID-19 vaccination.

ACIP states that individuals with a history of MIS-A or MIS-C should consider deferring COVID-19 vaccination until they have recovered from their illness and for 90 days after the date MIS-A or MIS-C was diagnosed, recognizing that the risk of reinfection and, therefore, the benefit from vaccination might increase with time following the initial infection.

If MIS-A or MIS-C associated with a confirmed SARS-CoV-2 infection develops after receipt of a COVID-19 vaccine, consider referral to a specialist in infectious diseases, rheumatology, or cardiology. US healthcare providers and health departments can also request a clinical consultation from the Clinical Immunization Safety Assessment COVIDvax project ([Web]).

If MIS-A or MIS-C occurs following COVID-19 vaccination, report the case to VAERS. (See EUA Requirements for Postvaccination Monitoring and Mandatory Vaccine Adverse Event Reporting under Cautions.)

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.

Individuals with Altered Immunocompetence

Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have diminished immune responses to vaccines. Counsel such individuals regarding the potential for reduced immune response to COVID-19 vaccines and the need to continue to follow public health preventive measures such as wearing a mask and social distancing.

Moderately or severely immunocompromised individuals (e.g., solid organ transplant recipients taking immunosuppressive therapy, those with solid tumor or hematologic malignancies undergoing active treatment) may have reduced immune responses following a 2-dose vaccination series with an mRNA COVID-19 vaccine compared with those who are not immunocompromised.

Administration of an additional dose of mRNA COVID-19 vaccine after the initial 2-dose vaccination series may enhance immune responses to the vaccine in some immunocompromised individuals.

ACIP recommends that individuals who are moderately or severely immunocompromised follow booster recommendations for the general population.

Individuals with Autoimmune Conditions

ACIP states that individuals with autoimmune conditions may receive any COVID-19 vaccine approved or authorized by FDA, unless they have a contraindication.

Recommendations for individuals with altered immunocompetence apply to individuals with autoimmune conditions who are immunocompromised because of drug therapy (e.g., high-dose corticosteroids, biologic agents). (See Individuals with Altered Immunocompetence under Cautions.)

Individuals with a History of Guillain-Barré Syndrome (GBS)

To date, GBS not reported in clinical trials evaluating mRNA COVID-19 vaccines.

ACIP states that individuals with a history of GBS may receive any COVID-19 vaccine approved or authorized by FDA, unless they have a contraindication.

If GBS occurs following COVID-19 vaccination, report the case to VAERS. (See EUA Requirements for Postvaccination Monitoring and Mandatory Vaccine Adverse Event Reporting under Cautions.)

Individuals with a History of Bell's Palsy

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

Cases of Bell's palsy (facial paralysis) reported in the ongoing phase 3 trial evaluating the Moderna COVID-19 vaccine. FDA states that available data are insufficient to determine a causal relationship with the vaccine.

ACIP states that individuals with a history of Bell’s palsy may receive COVID-19 vaccination, unless they have a contraindication.

If Bell’s palsy occurs following COVID-19 vaccination, report the case to VAERS. (See EUA Requirements for Postvaccination Monitoring and Mandatory Vaccine Adverse Event Reporting under Cautions.)

Individuals with Increased Bleeding Risk

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

ACIP states that IM vaccines may be given to individuals who have bleeding disorders if a clinician familiar with the patient’s bleeding risk determines that the preparation can be administered IM with reasonable safety. In these cases, use a fine needle (23 gauge or smaller) to administer the vaccine and apply firm pressure to the injection site (without rubbing) for ≥2 minutes. In individuals receiving therapy for hemophilia, schedule IM vaccines for administration shortly after a dose of such therapy.

Individuals receiving anticoagulation therapy presumably have the same bleeding risk as those with clotting factor disorders and should follow the same guidelines for IM administration. If possible, schedule IM vaccines prior to use of an anticoagulant so that the patient's risk of bleeding is not increased by the drug's therapeutic action.

History of Dermal Filler Use

Administration of an mRNA COVID-19 vaccine to individuals who have received injectable dermal fillers (e.g., hyaluronic acid dermal fillers) has infrequently resulted in swelling at or near the site of dermal filler injection (usually face or lips) starting 1–2 days after vaccination.

ACIP states that individuals who have received injectable dermal fillers may receive COVID-19 vaccination, unless they have a contraindication to the vaccine. Advise such individuals to contact their healthcare provider for evaluation if they develop swelling at or near site of dermal filler injection following vaccination.

Limitations of Vaccine Effectiveness

May not protect all vaccine recipients against COVID-19. The risk of SARS-CoV-2 infection cannot be fully eliminated in fully vaccinated individuals while there is continued widespread community transmission of COVID-19.

Use of COVID-19 vaccines for outbreak management or for postexposure prophylaxis to prevent SARS-CoV-2 infection in individuals with a specific known exposure to the virus is unlikely to be effective and is not currently recommended.

FDA-approved or FDA-authorized COVID-19 vaccines are both efficacious and effective against symptomatic SARS-CoV-2 infection, including severe forms of disease. A substantial amount of data is available that has evaluated the effectiveness of COVID-19 vaccines in real world conditions.

Based on the unknown duration of vaccine-induced protection and unknown extent of protection against emerging SARS-CoV-2 variants, counsel individuals who receive COVID-19 vaccination and are considered fully vaccinated and those who have received a third primary dose or a booster dose of the vaccine to continue to follow current CDC interim guidance to protect themselves and others. Consult the CDC website at [Web].

Duration of Immunity

Duration of protection against SARS-CoV-2 infection following completion of the 2-dose vaccination series of COVID-19 vaccine (Moderna) not fully evaluated. The immunogenicity of COVID-19 vaccines has been demonstrated through 6 to 8 months after completion of the primary vaccine series. However, waning antibody levels and reduced neutralization of variants have been documented, which has contributed to current ACIP recommendations for single booster doses.

Improper Storage and Handling

Improper storage or handling of vaccines may reduce or destroy vaccine potency resulting in inadequate or no immune response in vaccinees. Inspect all vaccines on delivery and monitor during storage to ensure that recommended storage temperatures are maintained.

The Moderna COVID-19 vaccine must be shipped, stored, and handled under specific conditions at all times, including maintaining cold chain conditions and chain of custody, according to specifications in the EUA fact sheet for healthcare providers and guidance from the manufacturer and CDC. Do not administer vaccine that has been mishandled or has not been stored at the recommended temperatures. (See Storage under Stability.)

Contact the manufacturer at 866-663-3762 for guidance if there are concerns about mishandling or defective or damaged vaccine.

EUA Requirements for Postvaccination Monitoring and Mandatory Vaccine Adverse Event Reporting

Monitor all vaccine recipients for immediate adverse reactions according to CDC (ACIP) guidelines.

Provide vaccine recipients or their caregivers with information on, and encourage participation in, CDC's voluntary smartphone-based tool (v-safe). Information on v-safe is available at [Web].

It is mandatory that vaccination providers administering the Moderna COVID-19 vaccine report all vaccine administration errors (even if not associated with an adverse event) and serious adverse events (irrespective of attribution to vaccination) that occur following vaccination and also report all cases of multisystem inflammatory syndrome (MIS) and COVID-19 that result in hospitalization or death in vaccine recipients to VAERS. Obtain information on submitting a VAERS report by calling 800-822-7967.

Consult FDA fact sheet for healthcare providers for the Moderna COVID-19 vaccine available at the FDA website and at [Web] for requirements and instructions regarding reporting of adverse reactions and vaccination errors.

Interpretation of SARS-CoV-2 Testing in Vaccinated Individuals

Results of SARS-CoV-2 viral tests (nucleic acid amplification or antigen tests) not affected by prior COVID-19 vaccination.

Use a test that specifically evaluates IgM/IgG to the nucleocapsid protein to assess for evidence of prior infection in an individual with a history of COVID-19 vaccination (e.g., for public health surveillance or diagnosis of MIS-C or MIS-A).

Interpretation of Tuberculosis Tests in Vaccinated Individuals

ACIP states do not delay COVID-19 vaccination in situations when an immune-based method of tuberculosis testing (i.e., intradermal tuberculin skin test [TST] or serum interferon gamma release assay [IGRA]) is required or indicated.

ACIP states that TST or IGRA testing can be administered without regard to timing of COVID-19 vaccination.

Specific Populations

Pregnancy

Data insufficient to date regarding use of the Moderna COVID-19 vaccine in pregnant women to inform vaccine-associated risks during pregnancy.

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

Available data suggest that, while the absolute risk is low, pregnant and recently pregnant women with COVID-19 are at increased risk of severe illness, including illness resulting in hospitalization, admission to an intensive care unit (ICU), mechanical ventilation, extracorporeal membrane oxygenation (ECMO), or death compared with women who are not pregnant. Pregnant and recently pregnant women with comorbidities such as obesity and diabetes mellitus may be at even higher risk of severe COVID-19. Additionally, pregnant women with COVID-19 are at increased risk of preterm birth and may be at an increased risk of adverse pregnancy complications or outcomes, such as preeclampsia, coagulopathy, and stillbirth.

Post-authorization surveillance safety data are accumulating regarding COVID-19 vaccination during pregnancy and clinical trials evaluating safety and efficacy of COVID-19 vaccines in pregnant women are underway or planned. Early data from VAERS, v-safe active surveillance, and v-safe pregnancy registry have not identified any safety concerns in pregnant women who were vaccinated late in their pregnancy or in their infants; additional evidence has not found an increased risk for miscarriage with receipt of a mRNA vaccine before 20 weeks gestation. There is some evidence that pregnant women who receive an mRNA vaccine (Moderna COVID-19 vaccine or Pfizer-BioNTech COVID-19 vaccine) during pregnancy have immune responses comparable to those observed in nonpregnant individuals and may develop anti-SARS-CoV-2 antibody titers greater than those observed in women diagnosed with SARS-CoV-2 infection during pregnancy. The Moderna COVID-19 vaccine cannot cause SARS-CoV-2 infection in the pregnant woman or her fetus.

ACIP states vaccination against COVID-19 is recommended for pregnant women. These experts state that evidence regarding safety and efficacy of COVID-19 vaccines available from both animal and human studies indicates that benefits of vaccination against COVID-19 during pregnancy outweigh any known or potential risks. For purposes of decisions regarding administration of the primary vaccination series, ACIP states consider pregnant and recently pregnant women (up until at least 42 days following the end of pregnancy) in the same group as individuals with underlying medical conditions.

ACIP states that pregnant women are eligible for and can receive COVID-19 vaccination; based on current knowledge, COVID-19 vaccines unlikely to pose a risk to pregnant women or the fetus. ACIP does not state a preference for any specific COVID-19 vaccine in such women.

ACOG recommends that pregnant women be vaccinated against COVID-19. When recommending the COVID-19 vaccine to pregnant women, 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 (e.g., possibility for exposure at work or home) and possibility for exposing high-risk household members. In addition, take into account the individual's values and perceived risk of various outcomes; autonomous decision-making should be respected and supported.

ACIP and ACOG state that a conversation between the pregnant woman and her clinical team may assist with decisions regarding use of COVID-19 vaccines; however, such a conversation is not required and written permission is not needed prior to vaccination.

ACIP and ACOG recommend that women who become pregnant after receiving the first dose of an mRNA COVID-19 vaccination series should receive the second dose according to the usual schedule, unless contraindicated.

ACOG states do not withhold Rh_o(D) immune globulin when indicated in an individual who is planning to receive or recently received a COVID-19 vaccine. (See Specific Drugs under Interactions.)

Adverse effects similar to those reported in non-pregnant individuals can occur following COVID-19 vaccination in pregnant women. Advise pregnant women who experience fever following COVID-19 vaccination to take acetaminophen; may also offer acetaminophen as an option for pregnant women experiencing other postvaccination symptoms.

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. (See EUA Requirements for Postvaccination Monitoring and Mandatory Vaccine Adverse Event Reporting under Cautions.)

Females and Males of Reproductive Capacity

Routine pregnancy testing not recommended before receiving a COVID-19 vaccine.

ACIP states vaccination against COVID-19 recommended for 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.

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

There is no evidence that any FDA-approved or FDA-authorized COVID-19 vaccines affect current or future fertility. FDA states there is no scientific evidence to suggest that Moderna COVID-19 vaccine could cause infertility in women. In addition, infertility not known to occur as a result of natural COVID-19 disease, further demonstrating that immune responses to the virus, whether induced by infection or a vaccine, are not a cause of infertility.

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.

Although there is some evidence that antibodies that develop following vaccination with mRNA COVID-19 vaccines are present in breast milk, additional data needed to determine if these antibodies convey protection against SARS-CoV-2 infection in breast-fed infants.

Pediatric Use

Moderna COVID-19 vaccine, bivalent is authorized for use in pediatric patients 6 months through 17 years of age. The bivalent vaccine is not authorized for use in individuals <6 months of age.

Geriatric Use

Individuals ≥65 years of age were included in clinical trials evaluating the Moderna COVID-19 vaccine and data from such individuals contribute to overall assessment of safety and efficacy of the vaccine.

At the time of FDA's safety and efficacy analysis of data from the ongoing phase 3 trial for the EUA, 24.8% of participants were ≥65 years of age and 4.6% were ≥75 years of age. Subgroup efficacy analysis based on age indicated that vaccine efficacy in those ≥65 years of age was 86.4% compared with 95.6% in those 18 to <65 years of age. No overall notable differences in safety profiles between participants ≥65 years of age and younger adults.

In an ongoing Phase 2 clinical study of a single booster dose, 22.2% (n=38) of participants were ≥65 years of age. This study did not include sufficient numbers of participants ≥65 years of age to determine whether they respond differently than younger participants. However, some local and systemic adverse reactions were reported in a lower proportion of participants ≥65 years of age compared to participants 18 through 64 years of age.

Common Adverse Effects

Adverse effects following administration of the Moderna COVID-19 primary vaccination series in adults ≥18 years through 64 years of age in clinical trials: Pain at injection site (93.3%), fatigue (71.9%), headache (68.7%), myalgia (64.8%), chills (49.7%), arthralgia (48.6%), nausea/vomiting (25.7%), axillary swelling/tenderness (22.2%), fever (17.3%), swelling at the injection site (15.4%), and erythema at the injection site (10.5%).

Adverse effects following administration of the Moderna COVID-19 primary vaccination series in adults ≥65 years of age in clinical trials: Pain at injection site (88.3%), fatigue (64.8%), headache (53.3%), myalgia (51.8%), arthralgia (40.2%), chills (32.7%), nausea/vomiting (15.0%), swelling at the injection site (13.0%), and axillary swelling/tenderness (12.7%).

Local and systemic adverse effects were usually reported within the first 1–2 days after a vaccine dose, had a median duration of 2–3 days, and were reported more frequently after the second dose of the 2-dose vaccination series. Use of antipyretic or pain medication within 7 days after receiving the first or second vaccine dose reported in 23.3 or 57.3%, respectively, of those 18–64 years of age and in 17.9 or 41.9%, respectively, of those ≥65 years of age.

Adverse effects following administration of the Moderna COVID-19 primary vaccination series in adolescents 12 through 17 years of age^{† [off-label]}: Pain at the injection site (97.2%), headache (78.4%), fatigue (75.2%), myalgia (54.3%), chills (49.1%), arthralgia (34.6%), axillary swelling/tenderness (34.6%), nausea/vomiting (29.3%), swelling at the injection site (27.7%), erythema at the injection site (25.8%), and fever (13.7%).

Adverse effects following administration of the Moderna COVID-19 primary vaccination series in children 6 through 11 years of age^{† [off-label]}: Pain at the injection site (98.4%), fatigue (73.1%), headache (62.1%), myalgia (35.3%), chills (34.6%), nausea/vomiting (29.3%), axillary swelling/tenderness (27.0%), fever (25.7%), erythema at the injection site (24.0%), swelling at the injection site (22.3%), and arthralgia (21.3%).

Adverse effects following administration of the Moderna COVID-19 primary vaccination series in children 37 months through 5 years of age^{† [off-label]}: Injection site pain (83.8%), fatigue (61.9%), headache (22.9%), myalgia (22.1%), fever (20.9%), chills (16.8%), nausea/vomiting (15.2%), axillary (or groin) swelling/tenderness (14.3%), arthralgia (12.8%), erythema at the injection site (9.5%), and swelling at the injection site (8.2%).

Adverse effects following administration of the Moderna COVID-19 primary vaccination series in children 24–36 months of age^{† [off-label]}: Pain at the injection site (76.8%), irritability/crying (71.0%), sleepiness (49.7%), loss of appetite (42.4%), fever (26.1%), erythema at the injection site (17.9%), swelling at the injection site (15.7%), and axillary (or groin) swelling/tenderness (11.5%).

Adverse effects following administration of the Moderna COVID-19 primary vaccination series in children 6 through 23 months of age^{† [off-label]}: Irritability/crying (81.5%), pain at the injection site (56.2%), sleepiness (51.1%), loss of appetite (45.7%), fever (21.8%), swelling at the injection site (18.4%), erythema at the injection site (17.9%), and axillary (or groin) swelling/tenderness (12.2%).

Adverse effects following administration of bivalent booster (Original and Omicron BA.1) dose in individuals ≥18 years of age clinical trials: pain at the injection site (77.3%), fatigue (54.9%), headache (43.9%), myalgia (39.6%), arthralgia (31.1%), chills (23.8%), axillary swelling/tenderness (17.4%), nausea/vomiting (10.3%), erythema at the injection site (6.9%), swelling at the injection site (6.9%), and fever (4.4%).

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. Confirm dosing volume prior to administration based on age of the recipient, product used, and if primary series dose or a booster dose.

The Moderna COVID-19 vaccine is supplied in various formulations and vial presentations. There are important differences between these formulations in concentration and dose volume; consult the manufacturer's labeling (for the Spikevax product) or the FDA EUA Fact Sheets for Healthcare Providers for specific instructions on each formulation. The various formulations and vial presentations are distinguished by different color vial caps and labels. Verify that the appropriate formulation is used. As of April 18, 2023, the monovalent Moderna COVID-19 vaccine is no longer authorized for use in US.

The Moderna COVID-19 vaccine should not be diluted.

There are 2 presentations of Moderna COVID-19 vaccine, bivalent. The bivalent vaccine supplied in multiple dose vials with a dark blue cap and label with a gray border is authorized to provide doses for individuals ≥6 months of age. The bivalent vaccine supplied in multiple dose vials with a dark pink cap and label with a yellow box is authorized to provide certain doses for individuals 6 months through 5 years of age

Spikevax©

The Spikevax^© vaccine is supplied as a frozen suspension in 5.5 mL or 7.5 mL multiple-dose vials that must be thawed prior to administration. See manufacturer's prescribing information for specific instructions for thawing.

For primary series doses of Spikevax^©, 0.5 mL of the vaccine should be withdrawn from the vial using aseptic technique and an appropriate syringe and needle (preferably with a low dead-volume syringe and/or needle); the vaccine should be administered immediately following preparation.

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

Moderna COVID-19 Vaccine, Bivalent (Omicron BA.4/BA.5) Vials with Dark Blue Cap and Gray Label Border

Moderna COVID-19 vaccine, bivalent (dark blue cap and gray label border) is supplied as a frozen suspension in multiple-dose vials that must be thawed prior to administration. See manufacturer's prescribing information for specific instructions for thawing.

Thawed Moderna COVID-19 vaccine, bivalent should appear as a white to off-white suspension and may contain white or translucent product-related particles. The thawed vaccine should not be used if it is discolored or contains other particles. Vaccine that has been thawed must not be refrozen.

Moderna COVID-19 vaccine, bivalent vials with dark blue cap and gray label border is supplied in 2.5 mL multiple-dose vials. Both 0.5-mL doses and 0.25-mL doses may be withdrawn from the same vial. When extracting only 0.5-mL doses from the vial, the maximum number of doses that may be extracted is 5 doses per vial. When extracting only 0.25-mL doses, each multiple-dose vial contains 10 doses.

Vaccine does not contain preservatives; discard any remaining vaccine and do not pool excess vaccine from multiple vials.

Moderna COVID-19 Vaccine, Bivalent (Omicron BA.4/BA.5) Vials with Dark Pink Cap and Label with a Yellow Box

Moderna COVID-19 vaccine, bivalent (dark pink cap and label with a yellow box) is supplied as a frozen suspension in multiple-dose vials that must be thawed prior to administration. See manufacturer's prescribing information for specific instructions for thawing.

Thawed Moderna COVID-19 vaccine, bivalent should appear as a white to off-white suspension and may contain white or translucent product-related particles. The thawed vaccine should not be used if it is discolored or contains other particles. Vaccine that has been thawed must not be refrozen.

Each multiple-dose vial of COVID-19 vaccine, bivalent vials with dark pink cap and label with a yellow box contains 2 doses of 0.2 mL.

Vaccine does not contain preservatives; discard any remaining vaccine and do not pool excess vaccine from multiple vials.

Dosage

Moderna COVID-19 vaccine is available in various formulations and vial presentations. Ensure the correct age-appropriate formulation is selected for administration. The monovalent Moderna COVID-19 vaccine is no longer authorized for use in US; therefore, dosing recommendations are provided only for the bivalent vaccine below.

See the following tables for recommended doses and dosing intervals for the Moderna COVID-19 vaccine, bivalent.

For immunocompromised individuals (e.g., those who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise) 6 months through 5 years of age who have received two 0.25-mL doses of the Moderna COVID-19 vaccine or Moderna COVID-19 vaccine, bivalent, an additional 0.25-mL dose of Moderna COVID-19 vaccine, bivalent (vial with a dark blue cap and a label with a gray border) may be administered at least 1 month following the most recent dose; additional doses of the bivalent vaccine may be administered at clinician's discretion.

For immunocompromised individuals (e.g., those who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise) 6 years of age and older, a single additional age-appropriate dose of Moderna COVID-19 vaccine, bivalent may be administered at least 2 months following the initial dose of a bivalent COVID-19 vaccine; additional age-appropriate doses of Moderna COVID-19 vaccine, bivalent may be administered at clinician's discretion.

Vaccines

Data not available to date to assess safety and immunogenicity of concomitant administration of COVID-19 vaccine (Moderna) with other vaccines.

Extensive experience with non-COVID-19 vaccines demonstrated that immunogenicity and adverse event profiles are generally similar whether vaccines are administered concomitantly or alone. However, it is not known whether reactogenicity of COVID-19 vaccines is increased when administered concomitantly with other vaccines, including those known to be more reactogenic (e.g., adjuvanted vaccines). 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, give each parenteral vaccine at a different injection site and, if possible, separate injection sites by ≥1 inch. ACIP states that, although >1 vaccine can be given IM into the deltoid muscle in adolescents and adults, give COVID-19 vaccines and vaccines likely to cause a local reaction in different limbs, if possible.

Specific Drugs