COVID-19 Vaccine (Moderna) Monograph for Professionals - Drugs.com

Skip to main content
Print
Save

# COVID-19 Vaccine (Moderna)

Drug class: Vaccines

Medically reviewed by Drugs.com on Nov 28, 2022. Written by ASHP.

### Warning

Special Alerts:

National Alert Network (NAN) Alert Regarding Influenza and COVID-19 Vaccine Mix-ups: On October 15, 2021, the National Alert Network (NAN) issued an alert to make vaccine providers aware of reports of accidental mix-ups between the influenza (flu) and COVID-19 vaccines. The alert is based on 16 cases reported to the Institute for Safe Medication Practices (ISMP) error reporting programs. Most of the reports ISMP has received involve administration of one of the COVID-19 vaccines instead of an influenza vaccine; in 3 cases, patients received an influenza vaccine instead of a COVID-19 vaccine. Because most of the errors were reported by consumers, details about the contributing factors were not provided in many cases. However, possible contributing factors include increased demand for vaccination services, the ability to administer the flu and COVID-19 vaccines during the same visit, syringes located next to each other, unlabeled syringes, distractions, and staffing shortages. The alert provides recommendations for preventing such vaccine mix-ups. For additional information, consult the NAN alert at [Web].

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 cautioned that COVID-19 Vaccine (Moderna) is being investigated for and is currently available under an FDA emergency use authorization (EUA) for active immunization to prevent COVID-19. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to the information contained in the accompanying monograph, and specifically disclaims all such warranties. Readers of this information are advised that ASHP is not responsible for the continued currency of the information, for any errors or omissions, and/or for any consequences arising from the use of the information contained in the monograph in any and all practice settings. 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 entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. 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.

## Related/similar drugs

Paxlovid, molnupiravir, remdesivir, Actemra, Lagevrio, nirmatrelvir / ritonavir

## 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.

Monovalent COVID-19 vaccine (Moderna) is also available under an FDA emergency use authorization (EUA) as a 2-dose primary vaccination series in individuals 6 months through 17 years of age† [off-label]. The EUA also authorizes use of the vaccine as an additional (third) primary dose† [off-label] in certain immunocompromised individuals ≥6 months of age.

FDA has also authorized the use of Spikevax under an EUA for certain uses not included in the approved biologics license application (BLA). The EUA authorizes use of this formulation as a 2-dose primary vaccination series in individuals 12–17 years of age† [off-label] and as an additional (third) primary dose† [off-label] in individuals 12–17 years of age with certain immunocompromising conditions.

In the previous FDA EUA, the monovalent Moderna COVID-19 vaccine was authorized for use as a homologous or heterologous booster dose or as 2 booster doses in certain populations. However, due to changes in the predominance of the Omicron variant of the SARS-CoV-2 virus, FDA authorized an updated bivalent booster product containing two mRNA components of the SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the Omicron variant. The updated booster is referred to as Moderna COVID-19 vaccine, bivalent.

Moderna COVID-19 vaccine, bivalent is used as a booster dose for prevention of COVID-19. The vaccine is authorized for use under an FDA EUA as a single booster dose† [off-label] in individuals ≥6 years of age after completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or after receipt of the most recent booster dose with any FDA authorized or approved monovalent COVID-19 vaccine.

On December 18, 2020, FDA issued the initial EUA that permitted use of the Moderna COVID-19 vaccine. The EUA was amended and reissued multiple times since then as the scope of authorization changed. For the most current version, consult the Moderna COVID-19 vaccine EUA letter of authorization at [Web].

The EUA includes certain mandatory requirements such as providing the recipient or caregiver with information consistent with the EUA fact sheet.

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.

Various COVID-19 vaccine types are available in the US, including a viral-vectored vaccine (Janssen COVID-19 vaccine), 2 nucleoside-modified mRNA vaccines (Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine), and a protein subunit adjuvanted vaccine (Novavax COVID-19 vaccine). The mRNA vaccines are available as monovalent vaccines (Moderna COVID-19 vaccine/Spikevax and Pfizer BioNTech COVID-19 vaccine/Comirnaty) or bivalent vaccines (Moderna COVID-19 vaccine, bivalent and Pfizer BioNTech COVID-19 vaccine, bivalent). ACIP recommends COVID-19 primary series vaccination (with one of the mRNA COVID-19 vaccines or Novavax COVID-19 vaccine) in all individuals ≥6 months of age in the US for prevention of COVID-19; individuals ≥5 years of age should also receive one bivalent mRNA booster dose after completion of any FDA-approved or FDA-authorized monovalent primary series or previously received monovalent booster dose(s). A monovalent Novavax booster dose (instead of a bivalent mRNA booster dose) may be used in limited situations in individuals ≥ 18 years of age who completed any FDA-approved or FDA-authorized monovalent primary series, have not received any previous booster dose(s), and are unable to receive an mRNA vaccine (i.e., mRNA vaccine contraindicated or not available) or unwilling to receive an mRNA vaccine and would otherwise not receive a booster dose. 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].

## 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.

The Moderna COVID-19 vaccine should not be diluted.

Vials of vaccine should be swirled gently after thawing and between withdrawal of each dose; the vials should not be shaken.

##### Spikevax© and Moderna COVID-19 Vaccine Vials with Red Cap and Light Blue Label Border

Spikevax© is the FDA-approved COVID-19 vaccine indicated in individuals ≥18 years of age; it is also authorized for emergency use to provide a primary vaccination series to individuals 12–17 years of age or a third primary series dose to such individuals with certain immunocompromising conditions. The Spikevax© and Moderna COVID-19 vaccines (red cap and light blue label border) are supplied as a frozen suspension in 5.5 mL or 7.5 mL multiple-dose vials that must be thawed prior to administration.

Thawing in a refrigerator (2–8°C): Multiple-dose vials of frozen Spikevax© or Moderna COVID-19 vaccine containing 5.5 mL or 7.5 mL should be thawed for 2.5 or 3 hours, respectively, in a refrigerator. Unopened vials of the vaccine may be stored in a refrigerator (2–8°C) for up to 30 days prior to first use. If the vials are thawed in the refrigerator, allow each vial to stand at room temperature (25°C) for 15 minutes before administering.

Thawing at room temperature (15–25°C): Multiple-dose vials of frozen Spikevax© or Moderna COVID-19 vaccine containing 5.5 mL or 7.5 mL may be allowed to sit at room temperature for 1 or 1.5 hours, respectively, to thaw. Unopened vials of the vaccine may be stored for up to 24 hours at 8–25°C.

For primary series doses of Spikevax© and Moderna COVID-19 vaccine (red cap and light blue label border), 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© and Moderna COVID-19 vaccine 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.

Spikevax© and Moderna COVID-19 vaccine is supplied in 2 different multiple-dose vial presentations (5.5 mL vial and 7.5 mL vial); doses used for the primary vaccination series or for the additional (third) primary series dose may be extracted from either vial presentation.

Because the vaccine does not contain preservatives, it is critical that any vaccine remaining in the vial that does not constitute a full 0.5-mL dose should be discarded and should not be pooled with vaccine from other vials to obtain a dose.

Spikevax and Moderna COVID-19 vaccine supplied in multiple-dose vials with a red cap and a label with a light blue border intended for use in individuals 12 years of age and older should not be used in individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors.

##### Moderna COVID-19 Vaccine Vials with Dark Blue Cap and Purple Label Border

Moderna COVID-19 vaccine with a dark blue cap and purple label border is authorized under an FDA EUA for the primary vaccination series in individuals 6–11 years of age or for a third primary series dose in such individuals who have certain immunocompromising conditions; the vaccine is supplied as a frozen suspension in multiple-dose vials that must be thawed prior to administration. Although the cartons and vial labels may state “booster doses only,” the Moderna COVID-19 vaccine is currently not authorized to provide booster doses, and this presentation may be used to provide primary series doses to individuals 6–11 years of age.

Thawing in a refrigerator (2–8°C): Multiple-dose vials of frozen Moderna COVID-19 vaccine with dark blue cap and purple label border containing 2.5 mL should be thawed for 2 hours in a refrigerator. Unopened vials of the vaccine may be stored in a refrigerator (2–8°C) for up to 30 days prior to first use. If the vials are thawed in the refrigerator, allow each vial to stand at room temperature (25°C) for 15 minutes before administering.

Thawing at room temperature (15–25°C): Multiple-dose vials of frozen Moderna COVID-19 vaccine with a dark blue cap and purple label border containing 2.5 mL may be allowed to sit at room temperature for 45 minutes to thaw. Unopened vials of the vaccine may be stored for up to 24 hours at 8–25°C.

For primary series doses for individuals 6 through 11 years of age, 0.5 mL of the vaccine should be withdrawn.

Thawed Moderna COVID-19 vaccine 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.

Because the vaccine does not contain preservatives, it is critical that any vaccine remaining in the vial that does not constitute a full 0.5-mL dose should be discarded and should not be pooled with vaccine from other vials to obtain a dose.

##### Moderna COVID-19 Vaccine Vials with Dark Blue Cap and Magenta Label Border

Moderna COVID-19 vaccine (dark blue cap and magenta label border) is authorized under an FDA EUA for the primary vaccination series in individuals 6 months through 5 years of age or for a third primary series dose in such individuals who have certain immunocompromising conditions; the vaccine is supplied as a frozen suspension in multiple-dose vials that must be thawed prior to administration.

Thawing in a refrigerator (2–8°C): Multiple-dose vials of frozen Moderna COVID-19 vaccine with a dark blue cap and magenta label border containing 2.5 mL should be thawed for 2 hours in a refrigerator. Unopened vials of the vaccine may be stored in a refrigerator (2–8°C) for up to 30 days prior to first use. If the vials are thawed in the refrigerator, allow each vial to stand at room temperature (25°C) for 15 minutes before administering.

Thawing at room temperature (15–25°C): Multiple-dose vials of frozen Moderna COVID-19 vaccine with a dark blue cap and magenta label border containing 2.5 mL may be allowed to sit at room temperature for 45 minutes to thaw. Unopened vials of the vaccine may be stored for up to 24 hours at 8–25°C.

For primary series doses for individuals 6 months through 5 years of age, 0.25 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 Moderna COVID-19 vaccine 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 vials with dark blue cap and magenta label border is supplied in a 2.5 mL multiple-dose vials.

Because the vaccine does not contain preservatives, it is critical that any vaccine remaining in the vial that does not constitute a full 0.25-mL dose should be discarded and should not be pooled with vaccine from other vials to obtain a dose.

##### 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 authorized under an FDA EUA for use in individuals ≥6 years of age as a single booster dose administered at least 2 months after either completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine, or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.

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.

Thawing in a refrigerator (2–8°C): Multiple-dose vials of frozen Moderna COVID-19 vaccine, bivalent should be thawed for 2 hours in a refrigerator. Unopened vials of the vaccine may be stored in a refrigerator (2–8°C) for up to 30 days prior to first use. If vials are thawed in the refrigerator, allow each vial to stand at room temperature (25°C) for 15 minutes before administering.

Thawing at room temperature (15–25°C): Multiple-dose vials of frozen Moderna COVID-19 vaccine, bivalent may be allowed to sit at room temperature for 45 minutes to thaw. Unopened vials of the vaccine may be stored for up to 24 hours at 8–25°C.

For individuals ≥12 years of age, a single booster dose is 0.5 mL. For individuals 6–11 years of age, a single booster dose is 0.25 mL.

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. When extracting doses from the vial, the maximum number of doses that may be extracted is 5 doses per vial.

Because the vaccine does not contain preservatives, it is critical that any vaccine remaining in the vial that does not constitute a full 0.5-mL dose should be discarded and should not be pooled with vaccine from other vials to obtain a dose.

### Dosage

Moderna COVID-19 vaccine is available in various formulations and vial presentations. Ensure the correct age-appropriate formulation is selected for administration. Spikevax and the EUA authorized formulations are for specific age groups, and for primary series or booster doses.

ACIP states that in general, the same monovalent vaccine product should be used for all doses in the primary series.

ACIP states that children 6 months through 4 years of age who receive different mRNA products for the first 2 doses of an mRNA COVID-19 vaccine series should follow a 3-dose schedule. A third dose of either mRNA vaccine should be administered at least 8 weeks after the second dose to complete the 3-dose primary series.

ACIP states that in exceptional situations when the mRNA COVID-19 vaccine used for the first dose cannot be determined or is not available, may administer any available age-appropriate mRNA COVID-19 vaccine approved or authorized by FDA with a minimum interval of 28 days between doses to complete the mRNA COVID-19 vaccination series.

For booster vaccination, bivalent mRNA vaccines are recommended. Any homologous or heterologous bivalent mRNA vaccine can be used if a booster dose is FDA-authorized for use in that age group.

See Table 1 for recommended doses and dosing intervals for the Moderna COVID-19 vaccine and Table 2 for recommended dose and dosing interval for the Moderna COVID-19 vaccine, bivalent.

Table 1. Moderna COVID-19 Vaccine Primary Series and Additional Primary Dose2
| PRIMARY SERIES | PRIMARY SERIES | PRIMARY SERIES
Indicated population | Individuals ≥12 years of age | Individuals 6–11 years of age | Individuals 6 months through 5 years of age
Vial cap and label | Red caps and light blue label borders | Dark blue caps and purple label borders | Dark blue caps and magenta label borders
Dose | 100 mcg | 50 mcg | 25 mcg
Injection volume | 0.5 mL | 0.5 mL | 0.25 mL
Recommended doses and interval | 2 doses, administered 1 month apart Immunocompromised individuals: Additional (third) primary dose recommended ≥ 1 month after the second dose of the primary series | 2 doses, administered 1 month apart Immunocompromised individuals: Additional (third) primary dose recommended ≥ 1 month after the second dose of the primary series | 2 doses, administered 1 month apart Immunocompromised individuals: Additional (third) primary dose recommended ≥ 1 month after the second dose of the primary series

Table 2. Moderna COVID-19 Vaccine, Bivalent Booster Dose Recommendations2
| BIVALENT BOOSTER DOSE | BIVALENT BOOSTER DOSE
Indicated population | Individuals 6–11 years of age | Individuals ≥12 years of age
Vial cap and label | Dark blue caps and gray label borders | Dark blue caps and gray label borders
Dose | 25 mcg | 50 mcg
Injection volume | 0.25 mL | 0.5 mL
Recommended doses and interval | Single dose administered at least 2 months after completion of primary vaccination with any FDA authorized or approved monovalent COVID-19 vaccine OR a single dose administered at least 2 months after receipt of the most recent booster dose with any FDA authorized or approved monovalent COVID-19 vaccine | Single dose administered at least 2 months after completion of primary vaccination with any FDA authorized or approved monovalent COVID-19 vaccine OR a single dose administered at least 2 months after receipt of the most recent booster dose with any FDA authorized or approved monovalent COVID-19 vaccine

#### Pediatric Patients

##### Primary Vaccination Series

###### Children 6 months –5 years of age†

IM

For primary vaccination in this age group, the FDA EUA authorizes two 0.25-mL doses of the Moderna COVID-19 vaccine 25 mcg/0.25 mL (dark blue cap with magenta label border) formulation administered 1 month apart.

###### Adolescents 6–11 years of age†

IM

For primary vaccination in this age group, the FDA EUA authorizes two 0.5-mL doses of the Moderna COVID-19 vaccine 50 mcg/0.5 mL (dark blue cap with purple label border) formulation administered 1 month apart.

###### Adolescents 12–17 years of age†

IM

For primary vaccination in this age group, the FDA EUA authorizes two 0.5-mL doses of the Moderna COVID-19 vaccine 100 mcg/0.5 mL (red cap with light blue label border) formulation 1 month apart.

##### Individuals Who Move Between Age Groups During the Primary Vaccination Series

ACIP recommendations state that people should receive the recommended age-appropriate vaccine product and dosage based on their age on the day of vaccination. If a person moves from a younger age group to an older age group during the primary series or between the primary series and the booster dose, they should receive the vaccine product and dosage for the older age group for all subsequent doses. However, FDA authorization allows for individuals who will turn 6 from 5 years of age between doses in the primary series to receive, for any primary dose: (1) the Moderna COVID-19 vaccine product authorized for individuals ages 6 months–5 years of age or (2) the Moderna COVID-19 vaccine product authorized for individuals 6–11 years of age. The FDA also allows for individuals who will turn 12 from 11 years of age between doses in the primary series to receive, for any primary dose: (1) the Moderna COVID-19 vaccine product authorized for individuals 6–11 years of age or (2) the Spikevax or Moderna COVID-19 vaccine product authorized for individuals ≥12 years of age.

##### Third Primary Dose in Immunocompromised Individuals ≥6 months of age†

The FDA EUA permits administration of an additional (third) primary dose† of the Moderna COVID-19 vaccine at least 1 month after the second dose in individuals 6 months through 18 years of age who are solid organ transplant recipients or diagnosed with conditions considered to have an equivalent level of immunocompromise. The additional primary dose is 0.25 mL of the Moderna COVID-19 vaccine 25 mcg/0.25 mL (dark blue cap with magenta label border) in children 6 months through 5 years of age, a 0.5-mL dose of the Moderna COVID-19 vaccine 50 mcg/0.5 mL (dark blue cap with purple label border) in children 5 through 11 years of age, or a 0.5-mL dose of the Moderna COVID-19 vaccine 100 mcg/0.5 mL (red cap with light blue label border) in adolescents12 through 17 years of age.

##### Booster Dose†

In children ≥12 years of age, a single booster dose of 0.5 mL of the Moderna COVID-19 vaccine, bivalent should be administered at least 2 months after completion of the primary vaccination series or receipt of the most recent booster dose with any FDA authorized or approved COVID-19 monovalent vaccine.

In children 6–11 years of age, a single booster dose of 0.25 mL of the Moderna COVID-19 vaccine, bivalent should be administered at least 2 months after completion of the primary vaccination series or receipt of the most recent booster dose with any FDA authorized or approved COVID-19 monovalent vaccine.

#### Adults

##### Primary Vaccination Series

###### IM

Adults ≥18 years of age should receive two 0.5-mL doses of the 100 mcg/0.5 mL (red cap with light blue label border) vaccine administered 1 month (28 days) apart.

###### Additional Primary Dose in Immunocompromised Adults

IM

FDA EUA permits administration of an additional primary dose† of 0.5-mL of the 100 mcg/0.5 mL (red cap with light blue label border) vaccine at least 28 days after the second dose in solid organ transplant recipients or those diagnosed with conditions considered to have an equivalent level of immunocompromise.

###### Booster Dose†

IM

The FDA EUA permits administration of a single booster dose of 0.5 mL of the Moderna COVID-19 vaccine, bivalent (dark blue cap with gray label border) at least 2 months after completion of the primary vaccination series or receipt of the most recent booster dose with any FDA authorized or approved COVID-19 monovalent vaccine in individuals ≥18 years of age.

Detailed Sars-cov-2 (covid-19) mrna-1273 vaccine dosage information

## Cautions for COVID-19 Vaccine (Moderna)

### 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 Liver Disease

American Association for the Study of Liver Diseases (AASLD) released a consensus statement regarding use of COVID-19 vaccines in individuals with chronic liver disease or a liver transplant. These experts state vaccination against COVID-19 is strongly recommended because of increased risk of morbidity and mortality in adults with chronic liver disease, especially those with cirrhosis.

AASLD also recommends that those with chronic liver disease receiving treatment with prednisone, antimetabolites, or biologic therapies and those with hepatocellular carcinoma who receive an mRNA COVID-19 vaccine should receive a third (additional) dose of the vaccine administered ≥28 days after the 2-dose primary series.

Consult AASLD consensus statement for additional guidance on use of COVID-19 vaccines in individuals with chronic liver disease.

##### 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.

#### Individuals Vaccinated Outside the US

Some individuals in the US may have previously received vaccination against COVID-19 in another country using a vaccine not approved or authorized by FDA and/or not listed for emergency use by WHO. ACIP provides guidance on COVID-19 vaccination in such patients

#### 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 Rho(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

Safety and effectiveness of the Moderna COVID-19 vaccine for prevention of COVID-19 in individuals ≥ 6 months of age is based on safety and effectiveness from ongoing clinical trials.

FDA EUA permits use of the Moderna COVID-19 vaccine for the 2-dose primary series and third primary dose in immunocompromised individuals for the prevention of COVID-19 in adolescents ≥12 years of age† based on safety and efficacy in adolescents and in adults. The FDA EUA further permits use of the COVID-19 vaccine (Moderna) 50 mcg/0.5 mL formulation for the 2-dose primary series and third primary dose in immunocompromised individuals for prevention of COVID-19 in children 6–11 years of age† and in children 6 months through 5 years of age† based on safety and effectiveness in these age groups in addition to data from the adolescent and adult populations.

FDA EUA permits use of the Moderna COVID-19 vaccine, bivalent as a booster dose in individuals 6–17 years of age. Authorization of the bivalent vaccine in this pediatric age group is based on immune response and safety data used for authorization of this vaccine formulation in individuals ≥18 years of age as well as experience with the monovalent Moderna COVID-19 vaccine in individuals 6–17 years 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†: 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†: 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†: 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†: 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†: 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%).

## Interactions for 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.

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

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 they are taking 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 |

COVID-19 convalescent plasma

Limited data are available; not known whether prior receipt of such antibody therapy interferes with immune response to the vaccine

To avoid potential interference with vaccine immune response, ACIP recommends deferring COVID-19 vaccination for ≥90 days after such antibody therapy if received for treatment and ≥30 days if received for post-exposure prophylaxis based on estimated half-life of SARS-CoV-2 antibody therapies and evidence suggesting reinfection uncommon in first 90 days after initial infection; however, COVID-19 vaccination not contraindicated in those who received passive antibody therapy within the past 90 days and COVID-19 vaccine doses received <90 days after receipt of passive antibody therapy do not need to be repeated

If COVID-19 subsequently develops in a vaccinated individual, ACIP states prior receipt of COVID-19 vaccine should not affect treatment decisions, including use of SARS-CoV-2 antibody therapies, or timing of such treatment

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

Based on general best practices for vaccination of immunocompromised individuals, ACIP states COVID-19 vaccination should ideally be completed ≥2 weeks before initiation or resumption of immunosuppressive therapies, whenever possible; consider individual's risks related to their underlying condition and response to the vaccine if making decisions to delay immunosuppressive therapy to complete COVID-19 vaccination

Revaccination with a primary vaccine series at least 3 months (12 weeks) after hematopoietic stem cell transplantation or CAR-T-cell therapy in individuals who previously received doses of COVID-19 vaccine prior to these treatments is recommended; an additional primary dose is recommended if the individual was revaccinated with an mRNA COVID-19 vaccine and continues to have moderate or severe immune compromise

Corticosteroids given topically or by local injection (e.g., intra-articular, intrabursal, or tendon injection): COVID-19 vaccines may be administered without regard to timing of corticosteroid administration

If COVID-19 subsequently develops in a vaccinated individual, ACIP states prior receipt of COVID-19 vaccine should not affect treatment decisions, including use of corticosteroids, or timing of such treatment

SARS-CoV-2-specific monoclonal antibodies (bamlanivimab and etesevimab, casirivimab and imdevimab, sotrovimab)

Data not available; not known whether prior receipt of such antibody therapy interferes with immune response to the vaccine

To avoid potential interference with vaccine immune response, ACIP recommends deferring COVID-19 vaccination for ≥90 days after such antibody therapy if received for treatment and ≥30 days if received for post-exposure prophylaxis based on estimated half-life of SARS-CoV-2 antibody therapies and evidence suggesting reinfection uncommon in first 90 days after initial infection; however, COVID-19 vaccination not contraindicated in those who received passive antibody therapy within the past 90 days and COVID-19 vaccine doses received <90 days after receipt of passive antibody therapy do not need to be repeated

If COVID-19 subsequently develops in a vaccinated individual, ACIP states prior receipt of COVID-19 vaccine should not affect treatment decisions, including use of SARS-CoV-2 antibody therapies, or timing of such treatment

Sars-cov-2 (covid-19) mrna-1273 vaccine drug interactions (more detail)

## Stability

### Storage

Prescribing information or the EUA fact sheet for healthcare providers and information provided by CDC and the manufacturer should be consulted for additional information on storage, handling, and stability of the vaccine. Various documents that describe the shipping, storage, and handling requirements and procedures for the Moderna COVID-19 vaccine, including specifics about temperature requirements and temperature monitoring, thermal shipping containers, ultra-low-temperature freezers, and safe handling of dry ice, are available at [Web]

## Actions

- Nucleoside-modified mRNA vaccine formulated in lipid nanoparticles (LNPs).

- 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). 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. The S antigen elicits an immune response to provide protection against SARS-CoV-2.

- Data from clinical trials in healthy adults indicate dose-dependent antibody responses to a 2-dose regimen of the Moderna COVID-19 vaccine, with antibody responses boosted after the second dose. The vaccine induces both binding and neutralizing antibodies at levels comparable to or higher than those reported in convalescent serum obtained from individuals who have recovered from COVID-19; antibody responses in adults ≥56 years of age are similar to those reported in adults 18–55 years of age. The vaccine also directly activates T-cells, which eliminate infected cells and support B-cell responses; the T-cell response is predominantly type 1 helper (Th1).

- COVID-19 vaccine (Moderna) available for use under the FDA EUA is provided as a frozen suspension in multiple-dose vials. Following thawing as directed by the manufacturer, each 0.5-mL dose of COVID-19 vaccine (Moderna) labeled as Spikevax or without a trade name with the red cap and light blue label border contains 100 mcg of mRNA encoding the S glycoprotein of SARS-CoV-2. Each 0.5-mL dose of COVID-19 vaccine (Moderna) with a dark blue cap and purple label border contains 50 mcg of mRNA encoding the S glycoprotein of SARS-CoV-2. Each 0.25-mL dose of COVID-19 vaccine (Moderna) with a dark blue cap and magenta label border contains 25 mcg of mRNA encoding the S glycoprotein of SARS-CoV-2. Each 0.5-mL dose of the Moderna COVID-19 vaccine, bivalent (Original and Omicron BA.4/BA.5) with a dark blue cap and gray label border contains 25 mcg nucleoside-modified messenger RNA (mRNA) encoding the prefusion stabilized Spike glycoprotein (S) of the SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 25 mcg mRNA encoding the pre-fusion stabilized S-protein of the SARS-CoV-2 Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5). The vaccine also contains 4 different lipids (SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine [DSPC]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate, and sucrose.

- Does not contain preservatives; vial stoppers are not made with natural rubber latex.

## Advice to Patients

- Prior to administration of COVID-19 vaccine (Moderna) labeled as Spikevax or without a trade name, provide the vaccine recipient or their caregiver with information consistent with the Fact Sheet for Recipients and Caregivers.

- Importance of the vaccination provider including vaccination information in the state/local jurisdiction’s Immunization Information System (IIS) or other designated system. Advise recipient or caregiver that more information about IISs can be found at [Web]

- Importance of vaccine recipient informing vaccination provider if they previously received any other COVID-19 vaccine, have any medical conditions (e.g., bleeding disorders, myocarditis or pericarditis, immunocompromising diseases), or are receiving anticoagulants or immunosuppressive therapy.

- Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. Encourage women who receive a COVID-19 vaccine around the time of conception or during pregnancy to enroll in the pregnancy registry at [Web].

## 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.

Allocation of the Moderna COVID-19 vaccine (with or without a trade name) is being directed by the US government. The vaccine will be supplied directly from the manufacturer or authorized US distributor(s) and distributed to emergency response stakeholders as directed by the US government, including the CDC and/or other designee.

COVID-19 Vaccine, mRNA (Moderna)
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer
--- | --- | --- | --- | ---
Parenteral | Suspension, for IM use | 25 mcg (of mRNA) per 0.25-mL dose | Moderna COVID-19 Vaccine (available in multiple dose vials with dark blue caps and magenta label borders) | ModernaTX
|  | 50 mcg (of mRNA) per 0.5-mL dose | Moderna COVID-19 Vaccine (available in multiple dose vials with dark blue caps and purple label borders) | ModernaTX
|  | 100 mcg (of mRNA) per 0.5-mL dose | Spikevax (available in multiple dose vials with red caps and light blue label borders) | ModernaTX
|  |  | Moderna COVID-19 Vaccine (available in multiple dose vials with red caps and light blue label borders) | ModernaTX

COVID-19 Vaccine, mRNA (Moderna), Bivalent
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer
--- | --- | --- | --- | ---
Parenteral | Suspension, for IM use | 50 mcg (of mRNA; 25 mcg Original and 25 mcg BA.4/BA.5) per 0.5-mL dose | Moderna COVID-19 Vaccine, Bivalent (available in multiple dose vials with dark blue caps and gray label borders) | ModernaTX

AHFS DI Essentials™. © Copyright 2023, Selected Revisions November 28, 2022. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.

Reload page with references included

## More about sars-cov-2 (covid-19) mrna-1273 vaccine

- Check interactions
- Reviews (28)
- Side effects
- Dosage information
- Drug class: viral vaccines
- En español

### Patient resources

- Advanced Reading

### Professional resources

#### Other brands

Spikevax

### Related treatment guides

- COVID-19

Medical Disclaimer