COVID-19 mRNA vaccines: Drug information

For additional information see "COVID-19 mRNA vaccines: Pediatric drug information" and "COVID-19 mRNA vaccines: Patient drug information"

For abbreviations, symbols, and age group definitions show table

Brand Names: US

Comirnaty;
Moderna COVID-19 Vac 6m-11y;
Pfizer COVID-19 Vac-TriS 5-11y;
Pfizer COVID-19 Vac-TriS 6m-4y;
Spikevax

Brand Names: Canada

Comirnaty Omicron KP.2;
Spikevax Omicron KP.2

Pharmacologic Category

Vaccine;
Vaccine, COVID-19;
Vaccine, mRNA

Dosing: Adult

COVID-19, prevention

COVID-19, prevention:

Note: The mRNA COVID-19 vaccines approved for use in the United States are based on the SARS-CoV-2 Omicron variant KP.2 and labeled "2024-2025 Formula."

**COVID-19 Vaccine (mRNA) 2024-2025 Formulation Dose Recommendations for Patients ≥18 Years of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2024)**
Manufacturer (Brand name)	COVID-19 vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated (administer IM)	Interval between doses
Moderna products (Spikevax)	No prior COVID-19 vaccine	50 mcg per 0.5 mL	1 dose	N/A
	≥1 dose of any previous mRNA COVID-19 vaccine formulation	50 mcg per 0.5 mL	1 dose	Administer the current formulation dose ≥8 weeks after the last dose of previous formulation.
	≥2 doses of any previous Novavax COVID-19 vaccine formulation	50 mcg per 0.5 mL	1 dose	Administer the current formulation dose ≥8 weeks after the last dose of previous formulation.
	≥1 dose of Janssen COVID-19 vaccine	50 mcg per 0.5 mL	1 dose	N/A
Pfizer-BioNTech products (Comirnaty)	No prior COVID-19 vaccine	30 mcg per 0.3 mL	1 dose	N/A
	≥1 dose of any previous mRNA COVID-19 vaccine formulation	30 mcg per 0.3 mL	1 dose	Administer the dose ≥8 weeks after the last dose of previous formulation.
	≥2 doses of any previous Novavax COVID-19 vaccine formulation	30 mcg per 0.3 mL	1 dose	Administer the current formulation dose ≥8 weeks after the last dose of previous formulation.
	≥1 dose of Janssen COVID-19 vaccine	30 mcg per 0.3 mL	1 dose	N/A

**COVID-19 Vaccine (mRNA) 2024-2025 Formulation Dose Recommendations for Patients ≥18 Years of Age WITH Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2024)**
Manufacturer (Brand name)	COVID-19 vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated (administer IM)	Interval between doses
^a Persons ≥18 years of age who are moderately or severely immunocompromised may receive additional age-appropriate doses of a 2024-2025 formulation COVID-19 vaccine ≥2 months following the last 2024-2025 formulation COVID-19 vaccine dose per shared clinical decision-making.
Moderna products (Spikevax)	No prior COVID-19 vaccine	50 mcg per 0.5 mL	4 doses^a	Dose 1: Day 0 Dose 2: Administer 4 weeks after Dose 1 Dose 3: Administer ≥4 weeks after Dose 2 Dose 4: Administer 6 months after Dose 3 (minimum interval 2 months)
	1 dose of any previous Moderna formulation	50 mcg per 0.5 mL	3 doses^a	Dose 1: Administer 4 weeks after last dose of previous formulation Dose 2: Administer ≥4 weeks after Dose 1 Dose 3: Administer 6 months after Dose 2 (minimum interval 2 months)
	2 doses of any previous Moderna formulation	50 mcg per 0.5 mL	2 doses^a	Dose 1: Administer ≥4 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥3 doses of any previous mRNA COVID-19 vaccine formulation	50 mcg per 0.5 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥2 doses of any previous Novavax COVID-19 vaccine formulation	50 mcg per 0.5 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥1 dose of Janssen COVID-19 vaccine	50 mcg per 0.5 mL	2 doses^a	Dose 1: Day 0 Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
Pfizer-BioNTech products (Comirnaty)	No prior COVID-19 vaccine	30 mcg per 0.3 mL	4 doses^a	Dose 1: Day 0 Dose 2: Administer 3 weeks after Dose 1 Dose 3: Administer ≥4 weeks after Dose 2 Dose 4: Administer 6 months after Dose 3 (minimum interval 2 months)
	1 dose of any previous Pfizer-BioNTech formulation	30 mcg per 0.3 mL	3 doses^a	Dose 1: Administer 3 weeks after last dose of previous formulation Dose 2: Administer ≥4 weeks after Dose 1 Dose 3: Administer 6 months after Dose 2 (minimum interval 2 months)
	2 doses of any previous Pfizer-BioNTech formulation	30 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥4 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥3 doses of any previous mRNA COVID-19 vaccine formulation	30 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥2 doses of any previous Novavax COVID-19 vaccine formulation	30 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥1 dose of Janssen COVID-19 vaccine	30 mcg per 0.3 mL	2 doses^a	Dose 1: Day 0 Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)

Canadian and international recommendations: Preparations of COVID-19 mRNA vaccines containing different components may be available. Recommendations related to use of these preparations and approved ages may vary per country; consult local product labeling. The Canadian National Advisory Committee on Immunization (NACI) provides different recommendations as compared to the CDC, including longer intervals; see NACI recommendations for details. The NACI recommends that beginning in Fall 2024, persons who were previously vaccinated or unvaccinated and at increased risk for severe disease receive a dose of an age-appropriate updated COVID-19 vaccine; the recommended interval is ≥6 months (minimum 3 months) from the previous COVID-19 vaccine dose or known SARS-CoV-2 infection (whichever is later) (Ref).

Interchangeability: Vaccination series should be from the same manufacturer if possible. A different age-appropriate COVID-19 vaccine may be administered in some circumstances (ie, same vaccine not available at the vaccination site at the time of the clinic visit, previous dose unknown, person would otherwise not receive a recommended vaccine dose, or person starts but is unable to complete a vaccination series with the same COVID-19 vaccine due to a contraindication) (Ref).

If mRNA COVID-19 vaccines (2024-2025 formulation) administered from different manufacturers to previously unvaccinated persons as part of an initial vaccination series:

If moderately or severely immunocompromised, administer a 3-dose schedule with the second dose administered 4 weeks following the first dose, and the third dose (either Moderna or Pfizer-BioNTech COVID-19 vaccine) administered ≥4 weeks after the second dose (Ref).

If one dose of mRNA COVID-19 vaccine (2024-2025 formulation) and 1 dose of Novavax (2024-2025 formulation) administered to previously unvaccinated persons as part of an initial vaccination series:

If not moderately or severely immunocompromised, then no further doses needed (Ref).

If moderately or severely immunocompromised, administer 1 dose of any COVID-19 vaccine (2024-2025 formulation) ≥4 weeks after the last dose to complete initial vaccination series. Then, administer another dose 6 months later (minimum interval 2 months) (total of 4 doses); additional doses may be administered ≥2 months following the last dose under shared clinical decision-making (Ref).

Revaccination: Note: For patients who received ≥1 doses of COVID-19 vaccine prior to or while receiving a hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)–T-cell therapy, revaccination is recommended; revaccinate when ≥3 months post HCT or CAR-T-cell therapy. In patients who received ≥1 doses of COVID-19 vaccine during treatment with B-cell–depleting therapies (eg, rituximab, ocrelizumab) that were administered over a limited period (eg, as part of a treatment regimen for certain malignancies), revaccination may be considered ~6 months after completion of B-cell–depleting therapy (Ref).

Dosing recommendations for deviations in administration, preparation, or storage:

**Recommendations for Deviations in COVID-19 Vaccine Usage^a**
Deviation	Adjustment
^a CDC 2024; refer to CDC guidance documents for additional information.
^b Unless patient experiences significant or prolonged adverse reactions (assess on a case-by-case basis).
^c A longer interval (8 weeks) after the invalid dose may be optimal for some patients who are not moderately or severely immunocompromised as it may reduce the potential for increased reactogenicity and rare risk of myocarditis and pericarditis; consider patient benefit versus risk.
*Product and dosage*
Dose too high (due to incorrect product or dosage administered, including dose volume too high)	Do not repeat dose; administer subsequent dose(s) at appropriate interval(s).^b
Dose too low (due to incorrect product or dosage administered, including dose volume too low)	Repeat dose immediately (no minimum interval) with age-appropriate product and dosage.^c
Half-dose volume or formulation administered inadvertently	If same clinic day, administer another half dose (2 half doses counted as one full dose). If different day, administer full dose.
*Dosing interval*
Any dose administered too early (ie, more than 4 days prior to the recommended interval)	Repeat dose at the minimum recommended interval from dose given in error.^c
*Storage*
Improper storage or handling of vaccine (eg, temperature excursion)	Contact manufacturer; if no stability data, repeat dose immediately (no minimum interval).^c
Dose administered past expiration/beyond-use date	Repeat dose immediately (no minimum interval).^c

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

**COVID-19 Vaccine (mRNA) 2024-2025 Formulation Dose Recommendations for Patients ≥65 Years of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2024)**
Manufacturer (Brand name)	COVID-19 vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated (administer IM)	Interval between doses
Moderna products (Spikevax)	No prior COVID-19 vaccine	50 mcg per 0.5 mL	2 doses	Dose 1: Day 0 Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥1 dose of any previous mRNA COVID-19 vaccine formulation	50 mcg per 0.5 mL	2 doses	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥2 doses of any previous Novavax COVID-19 vaccine formulation	50 mcg per 0.5 mL	2 doses	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥1 dose of Janssen COVID-19 vaccine	50 mcg per 0.5 mL	2 doses	Dose 1: Day 0 Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
Pfizer-BioNTech products (Comirnaty)	No prior COVID-19 vaccine	30 mcg per 0.3 mL	2 doses	Dose 1: Day 0 Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥1 dose of any previous mRNA COVID-19 vaccine formulation	30 mcg per 0.3 mL	2 doses	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥2 doses of any previous Novavax COVID-19 vaccine formulation	30 mcg per 0.3 mL	2 doses	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥1 dose of Janssen COVID-19 vaccine	30 mcg per 0.3 mL	2 doses	Dose 1: Day 0 Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)

**COVID-19 Vaccine (mRNA) 2024-2025 Formulation Dose Recommendations for Patients ≥65 Years of Age WITH Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2024)**
Manufacturer (Brand name)	COVID-19 vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated (administer IM)	Interval between doses
^a Persons ≥65 years of age who are moderately or severely immunocompromised may receive additional age-appropriate doses of a 2024-2025 formulation COVID-19 vaccine ≥2 months following the last 2024-2025 formulation COVID-19 vaccine dose per shared clinical decision-making.
Moderna products (Spikevax)	No prior COVID-19 vaccine	50 mcg per 0.5 mL	4 doses^a	Dose 1: Day 0 Dose 2: Administer 4 weeks after Dose 1 Dose 3: Administer ≥4 weeks after Dose 2 Dose 4: Administer 6 months after Dose 3 (minimum interval 2 months)
	1 dose of any previous Moderna formulation	50 mcg per 0.5 mL	3 doses^a	Dose 1: Administer 4 weeks after last dose of previous formulation Dose 2: Administer ≥4 weeks after Dose 1 Dose 3: Administer 6 months after Dose 2 (minimum interval 2 months)
	2 doses of any previous Moderna formulation	50 mcg per 0.5 mL	2 doses^a	Dose 1: Administer ≥4 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥3 doses of any previous mRNA COVID-19 vaccine formulation	50 mcg per 0.5 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥2 doses of any previous Novavax COVID-19 vaccine formulation	50 mcg per 0.5 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
	≥1 dose of Janssen COVID-19 vaccine	50 mcg per 0.5 mL	1 dose^a	Dose 1: Day 0 Dose 2: Administer 6 months after Dose 1 (minimum interval 2 months)
Pfizer-BioNTech products (Comirnaty)	No prior COVID-19 vaccine	30 mcg per 0.3 mL	4 doses^a	Dose 1: Day 0 Dose 2: Administer 3 weeks after Dose 1 Dose 3: Administer ≥4 weeks after Dose 2 Dose 4: Administer 6 months after Dose 3 (minimum interval 2 months)
	1 dose of any previous Pfizer-BioNTech formulation	30 mcg per 0.3 mL	3 doses^a	Dose 1: Administer 3 weeks after last dose of previous formulation Dose 2: Administer ≥4 weeks after Dose 1 Dose 3: Administer 6 months after Dose 2 (minimum interval 2 months)
	2 doses of any previous Pfizer-BioNTech formulation	30 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥4 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 2 (minimum interval 2 months)
	≥3 doses of any previous mRNA COVID-19 vaccine formulation	30 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 2 (minimum interval 2 months)
	≥2 doses of any previous Novavax COVID-19 vaccine formulation	30 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation Dose 2: Administer 6 months after Dose 2 (minimum interval 2 months)
	≥1 dose of Janssen COVID-19 vaccine	30 mcg per 0.3 mL	2 doses^a	Dose 1: Day 0 Dose 2: Administer 6 months after Dose 2 (minimum interval 2 months)

Dosing: Pediatric

(For additional information see "COVID-19 mRNA vaccines: Pediatric drug information")

COVID-19, prevention

COVID-19, prevention:

Note: The 2024-2025 mRNA COVID-19 vaccines approved for use in the United States are based on the SARS-CoV-2 Omicron variant KP.2.

Infants ≥6 months and Children <5 years: IM: Dosing based on vaccine product and mRNA COVID-19 vaccination history; tables for patients with and without moderate to severe immunocompromising conditions are separate; use caution. It is recommended that patients in this age group receive all doses from the same manufacturer (Ref).

Pediatric COVID-19 Vaccine (mRNA) 2024-2025 Formulation Dose Recommendations for Patients **6 Months to <5 Years** of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2024)
Manufacturer	COVID-19 mRNA vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated (administer IM)	Interval between doses
^a Vaccination series should be from the same manufacturer if possible. A different age-appropriate COVID-19 vaccine may be administered in some circumstances (ie, same vaccine not available at the vaccination site at the time of the clinic visit, previous dose unknown, person would otherwise not receive a recommended vaccine dose, or person starts but is unable to complete a vaccination series with the same COVID-19 vaccine due to a contraindication).
^bAn 8-week interval between the first and second doses might be optimal for some people, as it might reduce the small risk of myocarditis and pericarditis associated with these vaccines. The minimum interval is recommended in situations when the fullest possible protection needs to be achieved sooner (eg, increased concern about an individual's higher risk for severe disease).
^cFor children who transition from age 4 to 5 years during the Pfizer-BioNTech vaccination series, it is recommended to complete the series with the Pfizer-BioNTech product (10 mcg per 0.3 mL) for persons 5 to <12 years of age. If the 10 mcg per 0.3 mL dose is the second dose, administer 3 to 8 weeks after the first dose; if it is the third dose, administer ≥8 weeks after the second dose.
Moderna product^a	No prior COVID-19 vaccine	25 mcg per 0.25 mL	2 doses	Administer second dose 4 to 8 weeks following the first dose.^b
	1 dose of any previous Moderna formulation	25 mcg per 0.25 mL	1 dose	Administer dose 4 to 8 weeks after last dose of previous formulation.^b
	≥2 doses of any previous Moderna formulation	25 mcg per 0.25 mL	1 dose	Administer the dose ≥8 weeks after last dose of previous formulation.
Pfizer-BioNTech products^a	No prior COVID-19 vaccine	3 mcg per 0.3 mL	3 doses^c	Administer second dose 3 to 8 weeks after first, then administer third dose ≥8 weeks after second.^b
	1 dose of any previous Pfizer-BioNTech formulation	3 mcg per 0.3 mL	2 doses^c	Administer first dose 3 to 8 weeks after dose of previous formulation, then administer second dose ≥8 weeks after first 2024-2025 formulation dose.^b
	≥2 doses of any previous Pfizer-BioNTech formulation	3 mcg per 0.3 mL	1 dose	Administer dose ≥8 weeks after last dose of previous formulation.

Pediatric COVID-19 Vaccine (mRNA) **2024-2025 Formulation** Dose Recommendations for Patients **6 Months to <5 Years** of Age WITH Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2024)
Manufacturer	COVID-19 mRNA vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated^a (administer IM)	Interval between doses
^a Persons 6 months to <5 years of age who are moderately or severely immunocompromised may receive additional age- and product-appropriate doses of 2024-2025 formulation COVID-19 mRNA vaccine ≥2 months following the last 2024-2025 formulation COVID-19 mRNA vaccine dose per shared clinical decision-making.
^b All doses should be from the same manufacturer if possible. A different age-appropriate COVID-19 vaccine may be administered in some circumstances (ie, same vaccine not available at the vaccination site at the time of the clinic visit, previous dose unknown, person would otherwise not receive a recommended vaccine dose, or person starts but is unable to complete a vaccination series with the same COVID-19 vaccine due to a contraindication).
^c For children who transition from age 4 to 5 years during the Pfizer-BioNTech vaccination series, it is recommended to complete the series, at the intervals provided in the table above, with the Pfizer-BioNTech product (10 mcg per 0.3 mL) for persons 5 to <12 years of age administered for all doses received on or after the 5th birthday.
Moderna products^b	No prior COVID-19 vaccine	25 mcg per 0.25 mL	4 doses^a	Dose 1: Day 0 Dose 2: Administer 4 weeks after dose 1. Dose 3: Administer ≥4 weeks after dose 2. Dose 4: Administer 6 months after dose 3 (minimum interval: 2 months).
	1 dose of any previous Moderna formulation	25 mcg per 0.25 mL	3 doses^a	Dose 1: Administer 4 weeks after last dose of previous formulation. Dose 2: Administer ≥4 weeks after dose 1. Dose 3: Administer 6 months after dose 2 (minimum interval: 2 months).
	2 doses of any previous Moderna formulation	25 mcg per 0.25 mL	2 doses^a	Dose 1: Administer ≥4 weeks after last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).
	≥3 doses of any previous Moderna formulation	25 mcg per 0.25 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).
Pfizer-BioNTech products^b	No prior COVID-19 vaccine	3 mcg per 0.3 mL	4 doses^a,c	Dose 1: Day 0 Dose 2: Administer 3 weeks after dose 1. Dose 3: Administer ≥8 weeks after dose 2. Dose 4: Administer 6 months after dose 3 (minimum interval: 2 months).
	1 dose of any previous Pfizer-BioNTech formulation	3 mcg per 0.3 mL	3 doses^a,c	Dose 1: Administer 3 weeks after last dose of previous formulation. Dose 2: Administer ≥8 weeks after dose 1. Dose 3: Administer 6 months after dose 2 (minimum interval: 2 months).
	≥2 doses of any previous Pfizer-BioNTech formulation	3 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).

Children 5 to <12 years: IM: Dosing based on vaccine product and mRNA COVID-19 vaccination history; tables for patients with and without moderate to severe immunocompromising conditions are separate; use caution. For patients with moderate to severe immunocompromising conditions, the first 3 doses are recommended to be from the same manufacturer (Ref).

Pediatric COVID-19 Vaccine (mRNA) **2024-2025 Formulation** Dose Recommendations for Patients 5 to <12 Years of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2024)
Manufacturer	COVID-19 mRNA vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated (administer IM)	Interval between doses
^a For children who transition from age 4 to 5 years during the Pfizer-BioNTech vaccination series, it is recommended to complete the series with one dose of the Pfizer-BioNTech product (10 mcg per 0.3 mL) for persons 5 to <12 years of age. If the 10 mcg per 0.3 mL dose is the second dose, administer 3 to 8 weeks after the first dose; if it is the third dose, administer ≥8 weeks after the second dose.
Moderna products	No prior COVID-19 vaccine	25 mcg per 0.25 mL	1 dose	N/A
Moderna products	≥1 dose of any previous vaccine formulation	25 mcg per 0.25 mL	1 dose	Administer the dose ≥8 weeks after last dose of previous formulation.
Pfizer-BioNTech products^a	No prior COVID-19 vaccine	10 mcg per 0.3 mL	1 dose	N/A
Pfizer-BioNTech products^a	≥1 dose of any previous mRNA vaccine formulation	10 mcg per 0.3 mL	1 dose	Administer the dose ≥8 weeks after last dose of previous formulation.

Pediatric COVID-19 Vaccine (mRNA) **2024-2025 Formulation** Dose Recommendations for Patients 5 to <12 Years of Age WITH Moderate to Severe Immunocompromising Conditions or Treatment^a (CDC 2024)
Manufacturer	COVID-19 mRNA vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated^a (administer IM)	Interval between doses
^a Persons 5 to <12 years of age who are moderately or severely immunocompromised may receive additional age-appropriate doses of 2024-2025 formulation COVID-19 mRNA vaccine ≥2 months following the last 2024-2025 mRNA COVID-19 vaccine dose per shared clinical decision-making.
^b Individuals transitioning from age 11 to 12 years during the initial vaccination series are recommended to complete the series, at the intervals provided in the table above, using the dosage for persons ≥12 years of age for all doses received on or after the 12th birthday.
^c The first 3 doses of the vaccination series should be from the same manufacturer if possible. A different age-appropriate COVID-19 vaccine may be administered in some circumstances (ie, same vaccine not available at the vaccination site at the time of the clinic visit, previous dose unknown, person would otherwise not receive a recommended vaccine dose, or person starts but is unable to complete a vaccination series with the same COVID-19 vaccine due to a contraindication).
^d For children who transition from age 4 to 5 years during the Pfizer-BioNTech vaccination series, it is recommended to complete the series, at the intervals provided in the table above, with the Pfizer-BioNTech product (10 mcg per 0.3 mL) for persons 5 to <12 years of age used for all doses administered on or after the 5th birthday.
Moderna products^b	No prior COVID-19 vaccine	25 mcg per 0.25 mL	4 doses^a,c	Dose 1: Day 0 Dose 2: Administer 4 weeks after dose 1. Dose 3: Administer ≥4 weeks after dose 2. Dose 4: Administer 6 months after dose 3 (minimum interval: 2 months).
	1 dose of any previous Moderna formulation	25 mcg per 0.25 mL	3 doses^a,c	Dose 1: Administer 4 weeks after last dose of previous formulation. Dose 2: Administer ≥4 weeks after dose 1. Dose 3: Administer 6 months after dose 2 (minimum interval: 2 months).
	2 doses of any previous Moderna formulation	25 mcg per 0.25 mL	2 doses^a,c	Dose 1: Administer ≥4 weeks after the last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).
	≥3 doses of any previous mRNA COVID-19 vaccine	25 mcg per 0.25 mL	2 doses^a	Dose 1: Administer ≥8 weeks after the last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).
Pfizer-BioNTech products^b,d	No prior COVID-19 vaccine	10 mcg per 0.3 mL	4 doses^a,c	Dose 1: Day 0 Dose 2: Administer 3 weeks after dose 1. Dose 3: Administer ≥4 weeks after dose 2. Dose 4: Administer 6 months after dose 3 (minimum interval: 2 months).
	1 dose of any previous Pfizer-BioNTech formulation	10 mcg per 0.3 mL	3 doses^a,c	Dose 1: Administer 3 weeks after last dose of previous formulation. Dose 2: Administer ≥4 weeks after dose 1. Dose 3: Administer 6 months after dose 2 (minimum interval: 2 months).
	2 doses of any previous Pfizer-BioNTech formulation	10 mcg per 0.3 mL	2 doses^a,c	Dose 1: Administer ≥4 weeks after last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).
	≥3 doses of any previous mRNA COVID-19 vaccine formulation	10 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥8 weeks after the last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).

Children ≥12 years and Adolescents: IM: Dosing based on vaccine product and mRNA COVID-19 vaccination history; tables for patients with and without moderate to severe immunocompromising conditions are separate; use caution. For patients with moderate to severe immunocompromising conditions, the first 3 doses are recommended to be from the same manufacturer (Ref).

**Pediatric COVID-19 Vaccine (mRNA) 2024-2025 Formulation Dose Recommendations for Patients ≥12 Years of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2024)**
Manufacturer	COVID-19 mRNA vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated (administer IM)	Interval between doses
Moderna products	No prior COVID-19 vaccine	50 mcg per 0.5 mL	1 dose	N/A
Moderna products	≥1 dose of any previous COVID-19 vaccine formulation	50 mcg per 0.5 mL	1 dose	Administer the dose ≥8 weeks after last dose of previous formulation.
Pfizer-BioNTech products	No prior COVID-19 vaccine	30 mcg per 0.3 mL	1 dose	N/A
Pfizer-BioNTech products	≥1 dose of any previous mRNA vaccine formulation	30 mcg per 0.3 mL	1 dose	Administer the dose ≥8 weeks after last dose of previous formulation.

**Pediatric COVID-19 Vaccine (mRNA) 2024-2025 Formulation Dose Recommendations for Patients ≥12 Years of Age WITH Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2024)**
Manufacturer	COVID-19 mRNA vaccine history (prior to 2024-2025 formulation)	Total amount of mRNA per dose	Number of 2024-2025 formulation doses indicated^a (administer IM)	Interval between doses
^a Persons ≥12 years of age who are moderately or severely immunocompromised may receive additional age-appropriate dose of 2024-2025 formulation mRNA COVID-19 vaccine ≥2 months following the last 2024-2025 mRNA COVID-19 dose per shared clinical decision making.
^b Individuals transitioning from age 11 to 12 years during the initial vaccination series are recommended to complete the series, at the intervals provided in the table above, using the dosage for people ≥12 years of age for all doses received on or after the 12th birthday.
^c The first 3 doses of the vaccination series should be from same manufacturer if possible. A different age-appropriate COVID-19 vaccine may be administered in some circumstances (ie, same vaccine not available at the vaccination site at the time of the clinic visit, previous dose unknown, person would otherwise not receive a recommended vaccine dose, or person starts but is unable to complete a vaccination series with the same COVID-19 vaccine due to a contraindication).
Moderna products^b	No prior COVID-19 vaccine	50 mcg per 0.5 mL	4 doses^a,c	Dose 1: Day 0 Dose 2: Administer 4 weeks after dose 1. Dose 3: Administer ≥4 weeks after dose 2. Dose 4: Administer 6 months after dose 3 (minimum interval: 2 months).
	1 dose of any previous Moderna formulation	50 mcg per 0.5 mL	3 doses^a,c	Dose 1: Administer 4 weeks after last dose of previous formulation. Dose 2: Administer ≥4 weeks after dose 1. Dose 3: Administer 6 months after dose 2 (minimum interval: 2 months).
	2 doses of any previous Moderna formulation	50 mcg per 0.5 mL	2 doses^a	Dose 1: Administer ≥4 weeks after last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).
	≥3 doses of any previous mRNA COVID-19 vaccine or ≥2 doses of previous Novavax formulation	50 mcg per 0.5 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).
Pfizer-BioNTech products^b	No prior COVID-19 vaccine	30 mcg per 0.3 mL	4 doses^a,c	Dose 1: Day 0 Dose 2: Administer 3 weeks after dose 1. Dose 3: Administer ≥4 weeks after dose 2. Dose 4: Administer 6 months after dose 3 (minimum interval: 2 months).
	1 dose of any previous Pfizer-BioNTech formulation	30 mcg per 0.3 mL	3 doses^a,c	Dose 1: Administer 3 weeks after last dose of previous formulation. Dose 2: Administer ≥4 weeks after dose 1. Dose 3: Administer 6 months after dose 2 (minimum interval: 2 months).
	2 doses of any previous Pfizer-BioNTech formulation	30 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥4 weeks after last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).
	≥3 doses of any previous mRNA COVID-19 vaccine formulation	30 mcg per 0.3 mL	2 doses^a	Dose 1: Administer ≥8 weeks after last dose of previous formulation. Dose 2: Administer 6 months after dose 1 (minimum interval: 2 months).

Canadian and international recommendations: Preparations of COVID-19 mRNA vaccines containing different components may be available. Recommendations related to use of these preparations and approved ages may vary per country; consult local product labeling. The Canadian National Advisory Committee on Immunization (NACI) provides different recommendations as compared to the CDC, including longer intervals; see NACI recommendations for details. The NACI recommends that beginning in fall 2024, persons at increased risk of SARS-CoV-2 infection or severe COVID-19 disease (regardless of previous vaccination status) should receive a dose of an age-appropriate updated COVID-19 vaccine. The recommended interval for patients previously vaccinated or infected is ≥6 months after the last dose or test-confirmed infection; the minimum interval is 3 months (Ref).

Revaccination: For patients who received ≥1 doses of COVID-19 vaccine prior to or while receiving a hematopoietic cell transplant (HCT) or chimeric antigen receptor (CAR)–T-cell therapy, revaccination is recommended; revaccinate when ≥3 months post HCT or CAR-T-cell therapy. In patients who received ≥1 doses of COVID-19 vaccine during treatment with B-cell–depleting therapies (eg, rituximab, ocrelizumab) that were administered over a limited period (eg, as part of a treatment regimen for certain malignancies), revaccination may be considered ~6 months after completion of B-cell–depleting therapy. Consult clinical team for patient-specific decisions (Ref).

Dosing recommendations for deviations in administration, preparation, or storage:

**Recommendations for Deviations in COVID-19 Vaccine Usage (CDC 2024)**
Deviation	Adjustment
^a Some experts suggest a longer interval (8 weeks) after the invalid dose for patients who are not moderately or severely immunocompromised because of the potential for increased reactogenicity and rare risk of myocarditis and pericarditis; consider patient benefit versus risk.
^bUnless patient experiences significant or prolonged adverse reactions (assess on a case-by-case basis).
Age
Person <6 months of age received mRNA COVID-19 vaccine product	If the first dose was administered ≥5 days before turning 6 months of age, repeat the dose when patient is ≥6 months of age and ≥4 weeks after the invalid dose.^a
Person 6 months to <12 years of age received Novavax formulation as part of a multidose initial vaccination series (ie, any person 6 months to <5 years, and persons 5 to <12 years who are moderately to severely immunocompromised)	Count the dose and complete the initial series with mRNA vaccine, spacing dose by at least the minimum interval for series.^a If last dose in the series, no further doses are needed.
Person 5 to <12 years of age who is NOT moderately or severely immunocompromised received Novavax formulation	If previously received ≥1 dose of any mRNA vaccine: No further doses needed. If has not previously received any doses of any mRNA vaccine: Administer 1 dose of mRNA vaccine ≥4 weeks after the dose given in error.^a
*Product and dosage*
Dose too high (due to incorrect product or dosage administered, including dose volume too high)	Do not repeat dose; administer subsequent dose at appropriate interval.^b
Dose too low (due to incorrect product or dosage administered, including dose volume too low)	Repeat dose immediately (no minimum interval) with age-appropriate product and dosage.^a
Half-dose volume or formulation administered inadvertently	If same clinic day, administer another half dose (2 doses counted as full dose). If different day, repeat dose.
*Interchangeability*
Person 6 months to <5 years of age (previously unvaccinated) received initial 2 mRNA vaccine doses with products from different manufacturers (ie, 1 dose from Moderna and 1 dose from Pfizer-BioNTech; any previous or current formulation)	Administer a third dose of either 2024-2025 formulation Moderna or Pfizer-BioNTech COVID-19 mRNA vaccine ≥8 weeks after the second dose. Patients who are moderately or severely immunocompromised should also receive a fourth dose 6 months later (minimum interval: 2 months).
Person ≥5 years of age (previously unvaccinated) who are moderately or severely immunocompromised received initial 2 mRNA vaccine doses with products from different manufacturers (ie, 1 dose from Moderna and 1 dose from Pfizer-BioNTech; any previous or current formulation)	Administer a third dose of either 2024-2025 formulation Moderna or Pfizer-BioNTech COVID-19 mRNA vaccine ≥4 weeks after the last dose, followed by a fourth dose 6 months after the third dose (minimum interval: 2 months).
Person ≥12 years of age (previously unvaccinated) received 1 dose of mRNA vaccine and 1 dose of Novavax vaccine	For routine vaccination, no further doses needed. For patients who are moderately to severely immunocompromised, administer any dose of 2024-2025 vaccination ≥4 weeks after the last dose, followed by another dose of any 2024-2025 vaccination 6 months later (minimum interval: 2 months).
*Dosing interval*
Any COVID-19 dose administered prior to the minimum interval	Repeat dose at the minimum recommended interval from dose given in error (see dosing tables).^a Doses administered ≤4 days before the minimum interval (ie, grace period) may be counted and do not need to be repeated.
Any COVID-19 vaccine dose administered after recommended interval	Do not repeat dose; no maximum interval.
*Preparation (Pfizer-BioNTech products that require dilution only)*
Only diluent administered	Administer the authorized dose immediately with no minimum interval.
Inappropriate dilution resultant in lower than authorized dose	Repeat dose immediately (no minimum interval).^a
Dose undiluted or inappropriate dilution resulted in higher-than-authorized dose	Do not repeat dose.
Wrong diluent used	Repeat dose immediately (no minimum interval).^a
Diluent from single-use vial used for multiple vials	Do not repeat dose.
Ready-to-use product that shouldn't be diluted is mixed with any diluent	Repeat dose immediately (no minimum interval).^a
*Storage*
Improper storage or handling of vaccine (eg, temperature excursion)	Contact manufacturer; if no stability data, repeat dose immediately (no minimum interval).^a
Dose administered past expiration/beyond-use date	Repeat dose immediately (no minimum interval).^a

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions (Significant): Considerations

Hypersensitivity reactions

Severe hypersensitivity reactions, including anaphylaxis, have been reported with both the Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) COVID-19 Vaccines (mRNA) during vaccination outside of clinical trials (Ref). Other hypersensitivity reactions that were commonly present with anaphylaxis included airway obstruction, angioedema, nausea, pruritus, skin rash, and urticaria (Ref). Immediate treatment (including epinephrine 1 mg/mL) for anaphylactoid and/or hypersensitivity reactions should be available during vaccine administration (Ref). Of importance, the polyethylene glycol (PEG) excipient in the COVID-19 mRNA vaccines was initially suspected to be the cause of severe hypersensitivity reactions; however, several case series have documented no severe reactions with COVID-19 mRNA vaccination in patients with known or probable PEG or polysorbate allergy (Ref). Data also suggest an association between the booster dose of COVID-19 mRNA vaccination, particularly Moderna, and the risk of new-onset chronic spontaneous urticaria (CSU) (Ref).

Onset: Anaphylaxis: Rapid; Pfizer: Median onset 10 minutes (range: <1 minute to 19 hours) (Ref). Moderna: Median onset 10 minutes (range: 1 to 45 minutes) (Ref). CSU: Intermediate; Median onset 10 to 11 days (range: 8 to 13 days) (Ref).

Risk factors:

Precautions (but not contraindications) include:

• History of any non-severe, immediate (onset <4 hours) allergic reaction to a previous dose (Ref)

• A history of anaphylaxis to any other vaccine or injectable therapy (eg, IM, IV, or SubQ vaccines or therapies [excluding SubQ immunotherapy for allergies]) (Ref)

• Patients with an allergy-related contraindication to another type of COVID-19 vaccine (eg, adenovirus vector) (certain measures must be taken before a different type of COVID-19 [eg, mRNA] is administered to these patients) (Ref)

Local reactions

Local reactions occur in both adult and pediatric patients (ages ≥6 months) and include erythema at injection site, pain at injection site, and swelling at injection site. In the adult population, injection site pain was reported more frequently in patients 16 to 55 years of age and was more likely to be moderate in severity compared to patients ≥56 years with the Pfizer-BioNTech (Comirnaty) COVID-19 Vaccine (mRNA) primary series. Similarly, injection site pain was reported more frequently in patients 18 to 64 years of age with the Moderna (Spikevax) COVID-19 Vaccine (mRNA). Local reactions were similar to the primary series for the Pfizer-BioNTech COVID-19 Vaccine (mRNA) and the Moderna (Spikevax) COVID-19 Vaccine (mRNA) monovalent and bivalent booster doses. In general, local reactions were mild to moderate in severity and resolved after a mean duration of ~2 to 3 days in both adult and pediatric patients. The proportion of local reactions did not increase after the second dose (Ref). Local hypersensitivity reactions (including rash at injection site and urticaria at injection site) have occurred with the Moderna (Spikevax) COVID-19 Vaccine (mRNA). Swelling at or near the site of dermal fillers (eg, face or lips) may also occur (Ref).

Delayed-onset injection-site reactions (“COVID arm”) have occurred with the Moderna (Spikevax) COVID-19 Vaccine (mRNA) and include erythema, induration, swelling, pain/tenderness, and pruritus (Ref). Delayed-onset local reactions that occur with the first dose are not a contraindication or precaution to the second dose; administer the same vaccine but preferably in the opposite arm (Ref). Delayed-onset local reactions resolved after a median duration of 4 to 6 days (range: 2 to 11 days) (Ref).

Mechanism: Delayed-onset local reactions: Non–dose-related; immunologic (T-cell mediated) (Ref).

Onset: Varied. Local reactions occur within 7 days after either injection (typically within ~1 day) (Ref). Delayed-onset local reactions occur with a median onset on day 7 or 8 after the first dose (range: 2 to 12 days) (Ref). For patients who experienced delayed-onset local reactions with the first dose, delayed-onset local reactions occur more quickly with the second dose with a median onset on day 2 after the second dose (range: 0 to 5 days) (Ref).

Myocarditis and pericarditis

Myocarditis and pericarditis have been reported rarely with both the Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) COVID-19 Vaccines (mRNA) (Ref). Evidence suggests a possible higher risk for myocarditis with the Moderna COVID-19 Vaccine (mRNA) versus the Pfizer-BioNTech (Comirnaty) Vaccine (mRNA) (Ref). The risk of myocarditis after a booster dose may be similar to or lower than the risk after the second dose of the primary series for the Pfizer-BioNTech COVID-19 and Moderna COVID-19 Vaccines (mRNA) (Ref). Symptoms may include acute chest pain, shortness of breath, or palpitations; younger children may also experience irritability, lethargy, poor feeding, and tachypnea (Ref). Most cases resolved with hospitalization, treatment, and rest within 90 days (Ref).

Mechanism: Unknown; various immune and non-immune hypotheses exist (Ref).

Onset: Varied; usually within 7 days (most often 2 to 4 days) after the second dose or booster dose (Ref).

Risk factors:

• Males <40 years of age (median age of 20 to 30 years of age in most cases) (Ref)

Systemic reactions (excluding hypersensitivity)

Systemic reactions occur in both adult and pediatric patients (ages ≥6 months) and include arthralgia, chills, diarrhea, fatigue, fever, headache, myalgia, nausea, and vomiting. Younger children, especially those <3 years of age, may also experience irritability/crying, drowsiness, and decreased appetite (Ref). In both adult and pediatric patients in general, the frequency and severity of systemic reactions were higher after the second dose with the Pfizer-BioNTech (Comirnaty) COVID-19 Vaccine (mRNA) primary series. In the adult population, frequency and severity of systemic reactions were also higher in patients 16 to 55 years of age than patients ≥56 years with the primary series. Similarly, the frequency and severity of systemic reactions were higher after the second dose and in patients 18 to 64 years of age with the Moderna (Spikevax) COVID-19 Vaccine (mRNA). Systemic reactions were similar to the primary series for the Pfizer-BioNTech COVID-19 Vaccine (mRNA) and the Moderna COVID-19 Vaccine (mRNA) monovalent and bivalent booster doses. Most systemic reactions were mild to moderate in severity and resolved within 1 to 3 days of onset (Ref). Reactions (eg, chills, fever, myalgia) may occur more frequently with the first dose in patients with prior SARS-CoV-2 infection (Ref). An unsolicited systemic reaction possibly attributed to vaccine was lymphadenopathy.

Onset: Rapid; within 3 days after either injection (Ref)

Adverse Reactions

The following adverse reactions and incidences are derived from product labeling and the FDA issued emergency use authorizations (EUAs) for the Pfizer BioNTech COVID-19 Vaccine mRNA (Comirnaty) (ages ≥6 months) (primary series, monovalent booster doses, and bivalent booster doses), and the Moderna COVID-19 Vaccine (Spikevax) (ages ≥6 months) (primary series, monovalent booster doses, and bivalent booster doses), unless otherwise specified. Refer to product labeling and EUAs for specific vaccines for information regarding reporting adverse reactions (FDA 2022b, FDA 2022c, FDA 2022d, FDA 2022i, FDA 2022j, FDA 2024a, FDA 2024b).

>10%:

Gastrointestinal: Decreased appetite (infants, children: 5% to 32%; including anorexia) (table 1)Decreased Appetite, diarrhea (Pfizer: 4% to 11%) (table 2)Diarrhea, nausea and vomiting (Moderna: 4% to 24%) (table 3)Nausea and Vomiting

**COVID-19 Vaccine (mRNA): Adverse Reaction: Decreased Appetite**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
30%	26%	6 to 23 months of age	1,746	582	Dose 1	Moderna
32%	25%	6 to 23 months of age	1,596	526	Dose 2	Moderna
24%	22%	2 to 3 years of age	944	320	Dose 1	Moderna
31%	21%	2 to 3 years of age	963	330	Dose 2	Moderna
23%	N/A	17 months to 3 years of age	120	N/A	Monovalent booster dose	Moderna
22%	21%	6 to 23 months of age	1,159 to 1,173	591 to 595	Dose 1	Pfizer
22%	18%	6 to 23 months of age	1,137 to 1,147	590 to 591	Dose 2	Pfizer
20%	14%	6 to 23 months of age	362 to 365	170	Dose 3	Pfizer
5%	N/A	6 to 23 months of age	24	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Diarrhea**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
8%	8%	2 to 4 years of age	1,813 to 1,824	905 to 909	Dose 1	Pfizer
7%	7%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
5%	5%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
6%	N/A	2 to 4 years of age	36	N/A	Bivalent booster dose	Pfizer
6%	4%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
5%	5%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
5%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
8%	7%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
6%	4%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
7%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
11%	11%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
10%	8%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
11%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
8%	7%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
8%	6%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
10%	N/A	≥56 years of age	301	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Nausea and Vomiting**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
7%	8%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
10%	5%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
4%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
11%	11%	6 to 11 years of age	3,004	993	Dose 1	Moderna
24%	10%	6 to 11 years of age	2,988	969	Dose 2	Moderna
13%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
11%	9%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
24%	9%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
18%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
9%	8%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
21%	7%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
12%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
13%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
17%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
5%	5%	≥65 years of age	3,760	3,749	Dose 1	Moderna
12%	4%	≥65 years of age	3,691	3,649	Dose 2	Moderna
8%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
6%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
4%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna

Local: Erythema at injection site (2% to 20%) (table 4)Erythema at Injection Site, pain at injection site (27% to 95%) (table 5)Pain at Injection Site, swelling at injection site (3% to 21%) (table 6)Swelling at Injection Site, tenderness at injection site (infants, children: Pfizer: 4% to 17%) (table 7)Tenderness at Injection Site

**COVID-19 Vaccine (mRNA): Adverse Reaction: Erythema at Injection Site**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
9%	4%	6 to 23 months of age	1,056	582	Dose 1	Moderna
14%	4%	6 to 23 months of age	1,596	526	Dose 2	Moderna
10%	4%	2 to 3 years of age	944	320	Dose 1	Moderna
12%	3%	2 to 3 years of age	963	330	Dose 2	Moderna
11%	N/A	17 months to 3 years of age	120	N/A	Monovalent booster dose	Moderna
4%	0.2%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
7%	0.8%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
4%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
12%	1%	6 to 11 years of age	3,004	993	Dose 1	Moderna
19%	1%	6 to 11 years of age	2,988	969	Dose 2	Moderna
11%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
13%	0.6%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
20%	0.9%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
9%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
3%	0.5%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
9%	0.5%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
5%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
5%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
4%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
2%	0.6%	≥65 years of age	3,760	3,749	Dose 1	Moderna
8%	0.4%	≥65 years of age	3,691	3,649	Dose 2	Moderna
3%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
2%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
6%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna
11%	7%	6 to 23 months of age	1,159 to 1,173	591 to 595	Dose 1	Pfizer
9%	7%	6 to 23 months of age	1,137 to 1,147	590 to 591	Dose 2	Pfizer
7%	5%	6 to 23 months of age	362 to 365	170	Dose 3	Pfizer
8%	N/A	6 to 23 months of age	24	N/A	Bivalent booster dose	Pfizer
9%	9%	2 to 4 years of age	1,814 to 1,825	905 to 909	Dose 1	Pfizer
11%	6%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
11%	3%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
8%	N/A	2 to 4 years of age	36	N/A	Bivalent booster dose	Pfizer
15%	6%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
19%	5%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
16%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
6%	1%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
5%	0.9%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
6%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
5%	1%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
6%	0.7%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
7%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
5%	1%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
7%	0.8%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
4%	N/A	≥56 years of age	300	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Pain at Injection Site**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
37%	30%	6 to 23 months of age	1,056	582	Dose 1	Moderna
46%	26%	6 to 23 months of age	1,596	526	Dose 2	Moderna
53%	37%	2 to 3 years of age	944	320	Dose 1	Moderna
68%	44%	2 to 3 years of age	963	330	Dose 2	Moderna
42%	N/A	17 months to 3 years of age	120	N/A	Monovalent booster dose	Moderna
65%	41%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
73%	40%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
56%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
93%	47%	6 to 11 years of age	3,004	993	Dose 1	Moderna
95%	50%	6 to 11 years of age	2,988	969	Dose 2	Moderna
90%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
93%	35%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
92%	30%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
91%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
87%	19%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
90%	19%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
86%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
83%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
86%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
74%	13%	≥65 years of age	3,760	3,749	Dose 1	Moderna
83%	12%	≥65 years of age	3,691	3,649	Dose 2	Moderna
76%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
67%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
68%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna
31%	21%	2 to 4 years of age	1,814 to 1,825	905 to 909	Dose 1	Pfizer
31%	20%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
27%	13%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
28%	N/A	2 to 4 years of age	36	N/A	Bivalent booster dose	Pfizer
74%	31%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
71%	30%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
74%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
86%	23%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
79%	18%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
70%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
84%	14%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
78%	12%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
76%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
70%	9%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
66%	8%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
57%	N/A	≥56 years of age	300	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Swelling at Injection Site**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
8%	3%	6 to 23 months of age	1,056	582	Dose 1	Moderna
15%	2%	6 to 23 months of age	1,596	526	Dose 2	Moderna
8%	3%	2 to 3 years of age	944	320	Dose 1	Moderna
12%	2%	2 to 3 years of age	963	330	Dose 2	Moderna
11%	N/A	17 months to 3 years of age	120	N/A	Monovalent booster dose	Moderna
3%	0.9%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
7%	0.6%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
12%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
12%	1%	6 to 11 years of age	3,004	993	Dose 1	Moderna
17%	1%	6 to 11 years of age	2,988	969	Dose 2	Moderna
11%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
16%	1%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
21%	1%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
13%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
7%	0.4%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
13%	0.4%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
6%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
7%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
8%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
5%	0.6%	≥65 years of age	3,760	3,749	Dose 1	Moderna
11%	0.4%	≥65 years of age	3,691	3,649	Dose 2	Moderna
3%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
6%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
8%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna
4%	3%	6 to 23 months of age	1,159 to 1,173	591 to 595	Dose 1	Pfizer
4%	2%	6 to 23 months of age	1,137 to 1,147	590 to 591	Dose 2	Pfizer
3%	2%	6 to 23 months of age	362 to 365	170	Dose 3	Pfizer
4%	N/A	6 to 23 months of age	24	N/A	Bivalent booster dose	Pfizer
4%	3%	2 to 4 years of age	1,814 to 1,825	905 to 909	Dose 1	Pfizer
6%	2%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
3%	1%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
3%	N/A	2 to 4 years of age	36	N/A	Bivalent booster dose	Pfizer
11%	3%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
15%	3%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
16%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
7%	1%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
5%	0.6%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
8%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
6%	0.6%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
7%	0.2%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
7%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
7%	1%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
8%	0.7%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
3%	N/A	≥56 years of age	300	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Tenderness at Injection Site**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
17%	11%	6 to 23 months of age	1,159 to 1,173	591 to 595	Dose 1	Pfizer
15%	9%	6 to 23 months of age	1,137 to 1,147	590 to 591	Dose 2	Pfizer
16%	12%	6 to 23 months of age	362 to 365	170	Dose 3	Pfizer
4%	N/A	6 to 23 months of age	24	N/A	Bivalent booster dose	Pfizer

Nervous system: Chills (2% to 49%) (table 8)Chills, drowsiness (infants, children: 9% to 37%) (table 9)Drowsiness, fatigue (25% to 68%) (table 10)Fatigue, headache (3% to 70%) (table 11)Headache, irritability (and/or crying; infants, children: 18% to 68%) (table 12)Irritability

**COVID-19 Vaccine (mRNA): Adverse Reaction: Chills**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
6%	6%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
12%	5%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
8%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
10%	7%	6 to 11 years of age	3,004	993	Dose 1	Moderna
30%	8%	6 to 11 years of age	2,988	969	Dose 2	Moderna
14%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
18%	11%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
43%	8%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
30%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
9%	6%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
49%	6%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
40%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
26%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
24%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
5%	4%	≥65 years of age	3,760	3,749	Dose 1	Moderna
31%	4%	≥65 years of age	3,691	3,649	Dose 2	Moderna
18%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
14%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
15%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna
2%	2%	2 to 4 years of age	1,813 to 1,824	905 to 909	Dose 1	Pfizer
3%	3%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
3%	3%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
3%	N/A	2 to 4 years of age	36	N/A	Bivalent booster dose	Pfizer
5%	5%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
10%	4%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
11%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
28%	10%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
42%	7%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
23%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
17%	7%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
38%	4%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
22%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
7%	4%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
23%	3%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
12%	N/A	≥56 years of age	300	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Drowsiness**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
37%	37%	6 to 23 months of age	1,746	582	Dose 1	Moderna
35%	33%	6 to 23 months of age	1,596	526	Dose 2	Moderna
30%	29%	2 to 3 years of age	944	320	Dose 1	Moderna
36%	27%	2 to 3 years of age	963	330	Dose 2	Moderna
27%	N/A	17 months to 3 years of age	120	N/A	Monovalent booster dose	Moderna
27%	29%	6 to 23 months of age	1,159 to 1,173	591 to 595	Dose 1	Pfizer
24%	21%	6 to 23 months of age	1,137 to 1,147	590 to 591	Dose 2	Pfizer
20%	13%	6 to 23 months of age	362 to 365	170	Dose 3	Pfizer
9%	N/A	6 to 23 months of age	24	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Fatigue**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
40%	36%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
48%	29%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
32%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
43%	34%	6 to 11 years of age	3,004	993	Dose 1	Moderna
65%	35%	6 to 11 years of age	2,988	969	Dose 2	Moderna
49%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
48%	37%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
68%	29%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
58%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
39%	29%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
68%	25%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
62%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
54%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
60%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
33%	23%	≥65 years of age	3,760	3,749	Dose 1	Moderna
58%	20%	≥65 years of age	3,691	3,649	Dose 2	Moderna
47%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
47%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
58%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna
30%	31%	2 to 4 years of age	1,813 to 1,824	905 to 909	Dose 1	Pfizer
26%	23%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
25%	22%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
31%	N/A	2 to 4 years of age	36	N/A	Bivalent booster dose	Pfizer
34%	31%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
39%	24%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
46%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
60%	41%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
66%	25%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
67%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
49%	33%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
62%	23%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
61%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
34%	23%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
51%	17%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
39%	N/A	≥56 years of age	301	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Headache**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
12%	12%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
16%	8%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
20%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
31%	31%	6 to 11 years of age	3,004	993	Dose 1	Moderna
54%	28%	6 to 11 years of age	2,988	969	Dose 2	Moderna
38%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
45%	39%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
70%	30%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
57%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
35%	29%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
63%	25%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
59%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
47%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
52%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
25%	19%	≥65 years of age	3,760	3,749	Dose 1	Moderna
46%	18%	≥65 years of age	3,691	3,649	Dose 2	Moderna
42%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
32%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
37%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna
5%	5%	2 to 4 years of age	1,813 to 1,824	905 to 909	Dose 1	Pfizer
5%	4%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
5%	4%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
3%	N/A	2 to 4 years of age	36	N/A	Bivalent booster dose	Pfizer
22%	24%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
28%	19%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
34%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
55%	35%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
65%	24%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
51%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
44%	34%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
54%	24%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
47%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
25%	18%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
39%	14%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
31%	N/A	≥56 years of age	300	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Irritability**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer	Comments
68%	62%	6 to 23 months of age	1,746	582	Dose 1	Moderna	Described as "irritability/crying"
64%	59%	6 to 23 months of age	1,596	526	Dose 2	Moderna
55%	51%	2 to 3 years of age	944	320	Dose 1	Moderna
54%	45%	2 to 3 years of age	963	330	Dose 2	Moderna
53%	N/A	17 months to 3 years of age	120	N/A	Monovalent booster dose	Moderna
51%	47%	6 to 23 months of age	1,159 to 1,173	591 to 595	Dose 1	Pfizer	N/A
47%	41%	6 to 23 months of age	1,137 to 1,147	590 to 591	Dose 2	Pfizer
44%	38%	6 to 23 months of age	362 to 365	170	Dose 3	Pfizer
18%	N/A	6 to 23 months of age	24	N/A	Bivalent booster dose	Pfizer

Neuromuscular & skeletal: Arthralgia (Moderna: 6% to 46%; Pfizer: 0.8% to 25%) (table 13)Arthralgia, axillary swelling (Moderna: including axillary tenderness; 4% to 28%), myalgia (Moderna: 10% to 62%; Pfizer: 2% to 39%) (table 14)Myalgia

**COVID-19 Vaccine (mRNA): Adverse Reaction: Arthralgia**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
6%	5%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
9%	5%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
8%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
9%	8%	6 to 11 years of age	3,004	993	Dose 1	Moderna
16%	9%	6 to 11 years of age	2,988	969	Dose 2	Moderna
13%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
15%	12%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
29%	9%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
24%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
17%	12%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
46%	11%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
42%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
32%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
36%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
16%	12%	≥65 years of age	3,760	3,749	Dose 1	Moderna
35%	11%	≥65 years of age	3,691	3,649	Dose 2	Moderna
40%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
30%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
31%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna
0.8%	2%	2 to 4 years of age	1,813 to 1,824	905 to 909	Dose 1	Pfizer
1%	1%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
1%	0.8%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
3%	N/A	2 to 4 years of age	36	N/A	Bivalent booster dose	Pfizer
3%	6%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
5%	4%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
7%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
10%	7%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
16%	5%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
12%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
12%	6%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
24%	6%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
15%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
9%	6%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
19%	4%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
12%	N/A	≥56 years of age	300	N/A	Bivalent booster dose	Pfizer

**COVID-19 Vaccine (mRNA): Adverse Reaction: Myalgia**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
10%	9%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
16%	8%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
12%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
15%	10%	6 to 11 years of age	3,004	993	Dose 1	Moderna
28%	11%	6 to 11 years of age	2,988	969	Dose 2	Moderna
21%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
27%	17%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
47%	13%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
40%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
24%	14%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
62%	13%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
50%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
42%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
49%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
20%	12%	≥65 years of age	3,760	3,749	Dose 1	Moderna
47%	11%	≥65 years of age	3,691	3,649	Dose 2	Moderna
47%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
32%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
36%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna
2%	2%	2 to 4 years of age	1,813 to 1,824	905 to 909	Dose 1	Pfizer
3%	2%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
2%	2%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
9%	7%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
12%	7%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
18%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
24%	13%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
32%	8%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
26%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
23%	11%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
39%	9%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
30%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
14%	8%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
29%	5%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
18%	N/A	≥56 years of age	300	N/A	Bivalent booster dose	Pfizer

Miscellaneous: Fever (0.3% to 24%) (table 15)Fever

**COVID-19 Vaccine (mRNA): Adverse Reaction: Fever**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
11%	8%	6 to 23 months of age	1,056	582	Dose 1	Moderna
15%	8%	6 to 23 months of age	1,596	526	Dose 2	Moderna
11%	8%	2 to 3 years of age	944	320	Dose 1	Moderna
19%	11%	2 to 3 years of age	963	330	Dose 2	Moderna
10%	N/A	17 months to 3 years of age	120	N/A	Monovalent booster dose	Moderna
8%	5%	37 months to 5 years of age	2,013	650	Dose 1	Moderna
16%	5%	37 months to 5 years of age	1,975	629	Dose 2	Moderna
4%	N/A	37 months to 5 years of age	25	N/A	Monovalent booster dose	Moderna
3%	2%	6 to 11 years of age	3,004	993	Dose 1	Moderna
24%	2%	6 to 11 years of age	2,988	969	Dose 2	Moderna
9%	N/A	6 to 11 years of age	1,280	N/A	Monovalent booster dose	Moderna
2%	0.9%	12 to 17 years of age	2,480 to 2,482	1,238	Dose 1	Moderna
12%	1%	12 to 17 years of age	2,477 to 2,478	1,219 to 1,220	Dose 2	Moderna
6%	N/A	12 to 17 years of age	1,335 to 1,351	N/A	Monovalent booster dose	Moderna
0.9%	0.3%	18 to 64 years of age	11,406	11,402	Dose 1	Moderna
17%	0.3%	18 to 64 years of age	11,000	10,929	Dose 2	Moderna
7%	N/A	18 to 64 years of age	129	N/A	Monovalent booster dose	Moderna
4%	N/A	18 to 64 years of age	210	N/A	Monovalent booster dose	Moderna
4%	N/A	18 to 64 years of age	402 to 403	N/A	Bivalent booster dose	Moderna
0.3%	0.2%	≥65 years of age	3,760	3,749	Dose 1	Moderna
10%	0.1%	≥65 years of age	3,691	3,649	Dose 2	Moderna
5%	N/A	≥65 years of age	38	N/A	Monovalent booster dose	Moderna
1%	N/A	≥65 years of age	139 to 140	N/A	Monovalent booster dose	Moderna
4%	N/A	≥65 years of age	105	N/A	Bivalent booster dose	Moderna
7%	7%	6 to 23 months of age	1,159 to 1,173	591 to 595	Dose 1	Pfizer
7%	6%	6 to 23 months of age	1,137 to 1,147	590 to 591	Dose 2	Pfizer
7%	6%	6 to 23 months of age	362 to 365	170	Dose 3	Pfizer
4%	N/A	6 to 23 months of age	24	N/A	Bivalent booster dose	Pfizer
5%	5%	2 to 4 years of age	1,813 to 1,824	905 to 909	Dose 1	Pfizer
5%	5%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
5%	4%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
3%	1%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
7%	1%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
7%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
10%	1%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
20%	0.6%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
9%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
4%	0.9%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
16%	0.4%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
5%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
1%	0.4%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
12%	0.2%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
5%	N/A	≥56 years of age	301	N/A	Bivalent booster dose	Pfizer

1% to 10%:

Gastrointestinal: Abdominal pain (Moderna: 1%), nausea (Pfizer: ≤1%), vomiting (Pfizer: 0.5% to 3%) (table 16)Vomiting

**COVID-19 Vaccine (mRNA): Adverse Reaction: Vomiting**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Number of Patients (COVID-19 Vaccine [mRNA])	Number of Patients (Placebo)	Comments	Manufacturer
3%	3%	2 to 4 years of age	1,813 to 1,824	905 to 909	Dose 1	Pfizer
3%	3%	2 to 4 years of age	1,772 to 1,779	877 to 878	Dose 2	Pfizer
2%	4%	2 to 4 years of age	547 to 552	262	Dose 3	Pfizer
3%	N/A	2 to 4 years of age	36	N/A	Bivalent booster dose	Pfizer
2%	2%	5 to 11 years of age	1,511	748	Dose 1	Pfizer
2%	0.8%	5 to 11 years of age	1,501	740	Dose 2	Pfizer
2%	N/A	5 to 11 years of age	371	N/A	Monovalent booster dose	Pfizer
3%	0.9%	12 to 15 years of age	1,127	1,127	Dose 1	Pfizer
3%	1%	12 to 15 years of age	1,097	1,078	Dose 2	Pfizer
3%	N/A	12 to 17 years of age	107	N/A	Bivalent booster dose	Pfizer
1%	1%	16 to 55 years of age	2,899	2,908	Dose 1	Pfizer
2%	1%	16 to 55 years of age	2,682	2,684	Dose 2	Pfizer
2%	N/A	18 to 55 years of age	309	N/A	Bivalent booster dose	Pfizer
0.5%	0.5%	≥56 years of age	2,008	1,989	Dose 1	Pfizer
0.7%	0.3%	≥56 years of age	1,860	1,833	Dose 2	Pfizer
0.7%	N/A	≥56 years of age	300	N/A	Bivalent booster dose	Pfizer

Hematologic & oncologic: Lymphadenopathy (≤5%; unsolicited)

Hypersensitivity: Hypersensitivity reaction (Moderna: 2% to 5%; including rash at injection site, urticaria at injection site, severe hypersensitivity reaction) (table 17)Hypersensitivity Reaction

**COVID-19 Vaccine (mRNA): Adverse Reaction: Hypersensitivity Reaction**
Drug (COVID-19 Vaccine [mRNA])	Placebo	Population	Manufacturer
4%	5%	6 to 23 months of age	Moderna
4%	2%	6 to 11 years of age	Moderna
5%	3%	6 to 11 years of age	Moderna
2%	0.6%	12 to 17 years of age	Moderna
2%	1%	≥18 years of age	Moderna

Local: Injection-site reaction (Moderna: Delayed-onset: 1% to 3%)

<1%:

Dermatologic: Hyperhidrosis (Pfizer), night sweats (Pfizer), skin rash (Pfizer; unsolicited)

Hypersensitivity: Angioedema, serum sickness-like reaction (Moderna)

Infection: Herpes zoster infection (Moderna; data insufficient to determine causal relationship)

Local: Local swelling (at or near the site of dermal fillers [eg, face or lips]) (CDC 2024)

Nervous system: Asthenia (Pfizer), facial nerve paralysis (including Bell palsy, hypoesthesia, paresthesia; unsolicited, data insufficient to determine causal relationship), febrile seizure, lethargy (Pfizer), malaise (Pfizer)

Neuromuscular & skeletal: Limb pain (including upper extremity pain [arm]) (Pfizer)

Frequency not defined: Gastrointestinal: Appendicitis (Pfizer; unsolicited; data insufficient to determine causal relationship)

Post-authorization/postmarketing:

Cardiovascular: Cardiac tamponade (Kaimori 2024), eosinophilic granulomatosis with polyangiitis (Hwang 2023), myocarditis (Pillay 2022), pericarditis (Pillay 2022), syncope

Dermatologic: Bullous pemphigoid (Washrawirul 2022), contact dermatitis (Washrawirul 2022), cutaneous lupus erythematous (Washrawirul 2022), ecchymoses (Washrawirul 2022), eczema (Washrawirul 2022), erythema multiforme (Washrawirul 2022), erythema nodosum (Chahed 2023), fixed drug eruption (Washrawirul 2022), lichen planus (Washrawirul 2022), maculopapular rash (Washrawirul 2022), pemphigus vulgaris (Khalayli 2023), pruritus (Shimabukuro 2021a), psoriasis (Washrawirul 2022), Stevens-Johnson syndrome (Padniewski 2022), Sweet syndrome (Washrawirul 2022), toxic epidermal necrolysis (Padniewski 2022), urticaria (Shimabukuro 2021a)

Endocrine & metabolic: Graves disease (new onset or exacerbation) (Chee 2022), subacute thyroiditis (Tomic 2023)

Gastrointestinal: Colitis (including ischemic colitis) (Doman 2023, Mönkemüller 2022), gastroenteritis (subserosal eosinophilic) (Lee 2022)

Hematologic & oncologic: Eosinophilia (Doman 2023), hemophagocytic lymphohistiocytosis (Hieber 2022), Henoch-Schönlein purpura (Nakatani 2022), immune thrombocytopenia (Washrawirul 2022), petechia (Washrawirul 2022), purpuric disease (Washrawirul 2022)

Hepatic: Autoimmune hepatitis (Kim 2023), hepatotoxicity (Rivera-Tenorio 2022)

Hypersensitivity: Hypersensitivity angiitis (Abdelmaksoud 2022), hypersensitivity reaction (Pfizer: including anaphylaxis) (Washrawirul 2022)

Nervous system: Acute disseminated encephalomyelitis (Miyamoto 2022), complex regional pain syndrome (Horisawa 2023), dizziness (CDC 2021a), Guillain-Barré syndrome (Algahtani 2023), status epilepticus (Dasara 2024), vocal cord paralysis (Son 2022)

Neuromuscular & skeletal: Joint injury (shoulder; unsolicited) (Polack 2020), myositis (Tosunoğlu 2023), polymyalgia rheumatica (Yokote 2022), rhabdomyolysis (Pucchio 2023)

Ophthalmic: Exacerbation of ocular herpes simplex (acute retinal necrosis) (Shoji 2024), optic neuritis (Etemadifar 2024), retinopathy (central serous) (Mechleb 2022)

Respiratory: Airway obstruction (Shimabukuro 2021a), exacerbation of asthma (Ando 2022)

Miscellaneous: Vogt-Koyanagi-Harada disease (Ikuno 2024)

Contraindications

History of a severe allergic reaction (eg, anaphylaxis) after a previous dose or to a component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Shoulder injury related to vaccine administration: Vaccine administration that is too high on the upper arm may cause shoulder injury (eg, shoulder bursitis, tendinopathy) resulting in shoulder pain and reduced range of motion following injection. Use proper injection technique for vaccines administered in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Cross 2016; Foster 2013).

• Syncope: Syncope has been reported with use of injectable vaccines and may result in serious secondary injury (eg, skull fracture, cerebral hemorrhage); typically reported in adolescents and young adults and within 15 minutes after vaccination. Procedures should be in place to avoid injuries from falling and to restore cerebral perfusion if syncope occurs (ACIP [Kroger 2023]).

Disease-related concerns:

• Acute illness: The decision to administer or delay vaccination because of current or recent febrile illness depends on the severity of symptoms and the etiology of the disease. In general, it is recommended to defer vaccine administration in patients with moderate or severe acute febrile illness (with or without fever) and to provide vaccination in patients with mild acute illness (with or without fever) (ACIP [Kroger 2023]). Although not included in the Pfizer or Moderna documentation from the FDA, the Canadian product information for the Pfizer vaccine recommends postponing vaccination in patients with acute severe febrile illness. In addition, the Canadian product information for the Moderna vaccine states to consider postponing vaccination in patients with acute severe febrile illness or severe acute infection.

• Bleeding disorders: Use with caution in patients with bleeding disorders (including thrombocytopenia); bleeding or hematoma may occur from IM administration; if the patient receives antihemophilia or other similar therapy, IM injection can be scheduled shortly after such therapy is administered (ACIP [Kroger 2023]). For more information on administering the COVID-19 vaccine in patients with bleeding disorders, see society recommendations (eg, US National Bleeding Disorders Foundation, World Federation of Hemophilia).

• Multisystem inflammatory syndrome: In patients with a history of multisystem inflammatory syndrome (MIS), the benefits of vaccination are thought to outweigh the risks in patients who meet 2 recovery criteria: 1) clinical recovery from MIS (including return to baseline cardiac function) and 2) ≥90 days have passed since diagnosis. Vaccination can be considered in patients who do not meet both criteria on a case-by-case basis. In patients who developed MIS within 60 days following a dose of COVID-19 vaccine, decisions about subsequent doses should be made on a case-by-case basis. In patients who developed MIS >60 days after a previous dose of COVID-19 vaccine, subsequent doses should be considered ≥90 days after MIS diagnosis for patients who have clinically recovered (including return to baseline cardiac function) (CDC 2024).

• Myocarditis/pericarditis (CDC 2024):

- Persons who experience myocarditis/pericarditis after a dose of the vaccine: For persons who developed myocarditis or pericarditis within 3 weeks after any dose of a COVID-19 vaccine, subsequent doses of any COVID-19 vaccine are generally not recommended. If after risk assessment a decision is made to administer subsequent dose(s), wait until complete resolution of signs/symptoms of myocarditis or pericarditis with no evidence of ongoing heart inflammation or sequelae as determined by clinical team.

- Persons with history of myocarditis or pericarditis that occurred prior to vaccination or >3 weeks after a COVID-19 vaccine dose: Persons with history of myocarditis or pericarditis that occurred prior to COVID-19 vaccination or >3 weeks after a COVID-19 vaccine dose may receive any FDA-approved or FDA-authorized COVID-19 vaccine after complete resolution of signs/symptoms of myocarditis or pericarditis with no evidence of ongoing heart inflammation or sequelae as determined by clinical team. This also applies to persons who had myocarditis or pericarditis due to SARS-CoV-2 or other viruses.

• SARS-CoV-2 infection or exposure (CDC 2024): Persons with history of COVID-19 or asymptomatic SARS-CoV-2 infection: Vaccination is recommended for everyone ≥6 months of age (with an age-appropriate COVID-19 vaccine), regardless of history of symptomatic or asymptomatic SARS-CoV-2 infection. Persons who recently had SARS-CoV-2 infection may consider delaying vaccine doses by 3 months from symptom onset or positive test (if asymptomatic); increased time between infection and vaccination may improve vaccination immune response.

Concurrent drug therapy issues:

• Anticoagulant therapy: Clinicians administering vaccine should be aware of potential bleeding or hematoma that could occur due to IM administration (ACIP [Kroger 2023]).

• Vaccines: The CDC and American Academy of Pediatrics recommend simultaneous administration of the COVID-19 vaccine with other vaccines or administration in the days before and after receipt of other vaccines (AAP 2022; CDC 2024). There is no minimum interval between administration of a COVID-19 vaccine and an orthopoxvirus vaccine (Jynneos or ACAM2000). Because of the risk for myocarditis and pericarditis related to the COVID-19 vaccine and smallpox vaccine (ACAM2000) and the unknown myocarditis and pericarditis risk related to smallpox and monkeypox vaccine (Jynneos or Imvamune), consider waiting 4 weeks between administering an orthopoxvirus vaccine (ACAM2000; Jynneos or Imvamune) and COVID-19 vaccine (especially for adolescent/young adult males). However, vaccination with either agent should not be delayed if the patient is at increased risk for mpox or severe COVID-19. The CDC recommends prioritizing the use of Jynneos over ACAM2000 when coadministering with a COVID-19 vaccine (CDC 2024; CDC/ACIP [Rao 2022]).

Dosage form specific issues:

• Traceability: The vaccine name, batch/lot number, expiration date, and other administration details must be recorded for each patient in order to improve traceability.

Special populations:

• Altered immunocompetence: COVID-19 vaccines can be safely administered to immunocompromised persons (including those with HIV or receiving immunosuppressant therapy) if no contraindications exist. Immunocompromised persons may have a diminished immune response to the vaccine, but the potential benefit of the vaccine outweighs the uncertainties. If possible, complete COVID-19 vaccination ≥2 weeks prior to initiation or resumption of immunosuppressive therapy (CDC 2024; NACI 2024). For more information on administering the COVID-19 vaccine in specific disease states, see society recommendations (eg, American Cancer Society, National Multiple Sclerosis Society).

• Persons who had received dermal fillers: Temporary swelling at or near the site of filler injection has been infrequently reported after COVID-19 (mRNA) vaccination (CDC 2024).

• Pediatric: Multiple formulations from two manufacturers (Pfizer-BioNTech and Moderna) are available and the ages for which each product is authorized differs. Additionally, the recommended number of doses for some age groups may differ. Use extra caution when selecting formulation, dosage, and preparation prior to administration (ISMP [Smetzer 2022b]).

Other warnings/precautions:

• Effective immunity: Vaccination may not result in effective immunity in all patients. Response depends upon multiple factors (eg, type of vaccine, age of patient) (ACIP [Kroger 2023]).

• Mammograms: Temporary contralateral or ipsilateral lymphadenopathy after a COVID-19 vaccination has been reported. To avoid possible misinterpretation of mammogram screening, mammograms are recommended prior to vaccination or 4 to 6 weeks after the second dose. When this is not possible, the mammogram technologist or radiologist should be informed when and which vaccine was administered, and what arm the injection was given (ACOG 2023). Imaging needed for acute symptoms, or urgent treatment planning or complications, should not be delayed (Becker 2021).

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intramuscular [preservative free]:

Pfizer COVID-19 Vac-TriS 5-11y: 10 mcg/0.3 mL (0.3 mL) [contains 2-((peg)-2000)-n,n-ditetradecylacetamide]

Pfizer COVID-19 Vac-TriS 6m-4y: 3 mcg/0.3 mL (0.9 mL) [contains 2-((peg)-2000)-n,n-ditetradecylacetamide]

Suspension Prefilled Syringe, Intramuscular:

Moderna COVID-19 Vac 6m-11y: 25 mcg/0.25 mL (0.25 mL) [contains dmg-peg 2000]

Suspension Prefilled Syringe, Intramuscular [preservative free]:

Comirnaty: 30 mcg/0.3 mL (0.3 mL) [contains 2-((peg)-2000)-n,n-ditetradecylacetamide]

Spikevax: 50 mcg/0.5 mL (0.5 mL) [contains dmg-peg 2000]

Generic Equivalent Available: US

May be product dependent

Pricing: US

Suspension Prefilled Syringe (Comirnaty Intramuscular)

30 mcg/0.3 ml (per 0.3 mL): $164.10

Suspension Prefilled Syringe (Moderna COVID-19 Vac 6m-11y Intramuscular)

25MCG/0.25ML (per 0.25 mL): $154.80

Suspension Prefilled Syringe (Spikevax Intramuscular)

50 mcg/0.5 mL (per 0.5 mL): $170.16

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Intramuscular:

Comirnaty Omicron KP.2: 10 mcg/0.3 mL (0.3 mL, 1.8 mL); 30 mcg/0.3 mL (0.3 mL) [contains 2-((peg)-2000)-n,n-ditetradecylacetamide]

Spikevax Omicron KP.2: 0.1 mg/mL (2.5 mL) [contains dmg-peg 2000]

Prescribing and Access Restrictions

As part of the emergency use authorization (EUA), information consistent with fact sheets pertaining to emergency use of the COVID-19 vaccines must be provided to health care providers and recipients/caregivers, and certain mandatory requirements for administration under the EUA must be met as outlined in the FDA EUA letter. Currently, EUAs are used for vaccination in individuals 6 months to <12 years of age. Use in ages ≥12 years has received full approval (no fact sheets are provided).

Moderna COVID-19 Vaccine:

The health care provider fact sheets are located at: https://www.fda.gov/media/167208/download.

The patient fact sheets for recipients and caregivers are located at: https://www.fda.gov/media/167209/download.

Pfizer-BioNTech COVID-19 Vaccine:

The health care provider fact sheets are located at: https://www.fda.gov/media/167211/download.

The patient fact sheets for recipients and caregivers are located at: https://www.fda.gov/media/167212/download.

The vaccine provider should include vaccination information in the state/local jurisdiction Immunization Information System (IIS) or other designated system.

Additionally, the vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS) (https://vaers.hhs.gov/reportevent.html or 1-800-822-7967):

vaccine administration errors whether or not associated with an adverse event
serious adverse events (irrespective of attribution to vaccination)
cases of multisystem inflammatory syndrome (MIS)
cases of myocarditis or pericarditis
cases of COVID-19 that result in hospitalization or death following administration of COVID-19 vaccine

The vaccination provider is also responsible for responding to FDA requests for more information. Additional adverse events may be reported to VAERS and the manufacturer. Adverse events related to the Pfizer-BioNTech vaccine may be reported to Pfizer via https://www.pfizersafetyreporting.com, 1-800-438-1985, or via fax at 1-866-635-8337. Adverse events related to the Moderna vaccine may be reported to ModernaTx, Inc. via https://report.moderna.convergehealthsafety.com, 1-866-663-3762, or via fax at 1-866-599-1342.

Administration: Adult

IM: Administer IM in the deltoid muscle or anterolateral thigh (Ref). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not inject intravascularly, SUBQ, or intradermally. To prevent syncope-related injuries, adolescents and adults should be vaccinated while seated or lying down. If administering simultaneously with other vaccines, administer each vaccine at a different injection site (Ref). US recipients or caregivers should be given a vaccination card that includes the name of the vaccine, lot number, the vaccination date, and name of the health care site or person where the vaccine was administered (Ref).

Pfizer-BioNTech vaccine (Comirnaty) (vials for ≥12 years of age [no dilution required]): Prior to use, gently invert vial; do not shake.

Inappropriate administration technique: If administered SUBQ or into a muscle other than the deltoid or anterolateral thigh (alternate administration site), do not repeat dose. If additional doses are needed, administer at the recommended interval(s) (Ref).

Patients at risk for hemorrhage: For patients at risk of hemorrhage following IM injection, the vaccine should be administered IM if, in the opinion of the physician familiar with the patient's bleeding risk, the vaccine can be administered by this route with reasonable safety. If the patient receives antihemophilia or other similar therapy, IM vaccination can be scheduled shortly after such therapy is administered. A fine needle (23-gauge or smaller) can be used for the vaccination and firm pressure applied to the site (without rubbing) for at least 2 minutes. The patient should be instructed concerning the risk of hematoma from the injection. Patients on anticoagulant therapy should be considered to have the same bleeding risks and treated as those with clotting factor disorders (Ref). For patients with bleeding disorders, specific recommendations are available (eg, US National Bleeding Disorders Foundation, World Federation of Hemophilia).

Administration: Pediatric

Parenteral: IM: Administer IM in the deltoid muscle or anterolateral thigh as appropriate for age (Ref). Use proper injection technique in the deltoid muscle (eg, injecting in the central, thickest part of the muscle) to reduce the risk of shoulder injury related to vaccine administration (Ref). Do not inject intravascularly, SUBQ, or intradermally. To prevent syncope-related injuries, adolescents should be vaccinated while seated or lying down. If administering simultaneously with other vaccines, administer each vaccine at a different injection site (Ref). US recipients or caregivers should be given a vaccination card that includes the name of the vaccine, lot number, the vaccination date, and name of the health care site or person where the vaccine was administered (Ref).

Pfizer-BioNTech vaccine: Vials with yellow caps must be diluted prior to use; vials with blue cap, and vials and prefilled syringes for patients ≥12 years of age must NOT be diluted. Discard after single use (Ref).

Inappropriate administration technique: If administered SUBQ or into a muscle other than the deltoid or anterolateral thigh, do not repeat dose. If additional doses are needed, administer at the recommended interval (Ref).

Medication Guide and/or Vaccine Information Statement (VIS)

In the United States, the appropriate CDC-approved Vaccine Information Statement (VIS) must be provided to the patient/caregiver before administering each dose of this vaccine; the VIS edition date and date it was provided to the patient/caregiver should be recorded as required by US law; VIS is available at https://www.cdc.gov/vaccines/hcp/current-vis/covid-19.html.

Use: Labeled Indications

US labeling:

COVID-19 prevention: Active immunization to prevent COVID-19.

Note: Pfizer-BioNTech COVID-19 Vaccine, 2024-2025 Formula and Moderna COVID-19 Vaccine, 2024-2025 Formula are FDA approved for persons ≥12 years of age and available under emergency use authorization (EUA) for persons 6 months to <12 years of age. Approved/authorized ages vary by product; see EUA or product labeling for details (Ref).

CDC recommendations:

The CDC recommends that all persons ≥6 months of age receive at least one age-appropriate 2024-2025 COVID-19 vaccine. The CDC does not have a preferential recommendation as to which vaccine is used. The specific number of doses depends on the person's age, COVID-19 vaccination history, immune status, and vaccine product (Ref).

Moderate and severe immunocompromising conditions and treatments include but are not limited to (Ref):

• Active treatment for solid tumor and hematologic malignancies

• Hematologic malignancies associated with poor responses to COVID-19 vaccines (eg, chronic lymphocytic leukemia, non-Hodgkin lymphoma, multiple myeloma, acute leukemia) regardless of current treatment status

• Receipt of solid-organ or islet transplant and taking immunosuppressive therapy

• Receipt of CAR-T-cell or hematopoietic cell transplant (within 2 years of transplantation or taking immunosuppressive therapy)

• Moderate or severe primary immunodeficiency (eg, common variable immunodeficiency disease, severe combined immunodeficiency, DiGeorge syndrome, Wiskott-Aldrich syndrome)

• HIV infection (advanced or untreated)

• Active treatment with any of the following: High-dose corticosteroids (ie, prednisone ≥20 mg/day or equivalent for ≥2 weeks); alkylating agents; antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive, tumor necrosis blockers, and other biologic agents that are immunosuppressive or immunomodulatory.

Canadian and international labeling:

COVID-19 prevention (Comirnaty [Pfizer-BioNTech vaccine] and Spikevax [Moderna vaccine]): Active immunization to prevent COVID-19. Approved ages vary by product; see product labeling for details.

Note: Preparations of COVID-19 vaccines in Canada and internationally may contain different components; use caution.

Canadian guidance: The National Advisory Committee on Immunization has made recommendations on the use of COVID-19 vaccines; see recommendations for details (Ref).

Medication Safety Issues

Sound-alike/look-alike issues:

Multiple formulations (Pfizer-BioNTech and Moderna) are available; errors related to use of the incorrect formulation have been reported (ISMP [Smetzer 2022a]). Concentrations, dilution requirements, and ingredients vary. Ensure correct formulation, dosage, and preparation prior to administration.

COVID-19 vaccine may be confused with influenza virus vaccine. Medication errors have occurred when COVID-19 vaccine was inadvertently administered instead of influenza virus vaccine (and vice versa). These products may be stored in close proximity to each other. Confirm the correct vaccine has been selected prior to administration (ISMP/NAN 2021).

COVID-19 vaccine may be confused with epinephrine injection. Medication errors have occurred when epinephrine injection was inadvertently administered instead of COVID-19 vaccine. Most mix-ups were due to look-alike, predrawn syringes of epinephrine and the vaccine, which were stored in close proximity (ISMP [Smetzer 2022a]).

Other safety concerns:

Errors related to inaccurate dilution of the Pfizer-BioNTech vaccine formulations have occurred; use caution when diluting the vaccine (Pfizer-BioNTech vaccine with yellow vial cap and label requires dilution; other formulations do not) (FDA 2024a; FDA 2024b; ISMP [Smetzer 2022a]).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Abatacept: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding SQ abatacept for 1 to 2 weeks after each vaccine dose and timing vaccine dose so that it is given 1 week prior to the next IV abatacept dose. Risk D: Consider Therapy Modification

Acetaminophen: May decrease therapeutic effects of Vaccines. Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider Therapy Modification

Anti-CD20 B-Cell Depleting Therapies: May decrease therapeutic effects of COVID-19 Vaccines. Management: Administer COVID-19 vaccine 2 to 4 weeks prior to the next scheduled dose of anti-CD20 therapy, if used chronically for the treatment of autoimmune disease. Revaccinate 6 months after completion of anti-CD20 therapy if used over a limited period. Risk D: Consider Therapy Modification

Apremilast: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding apremilast for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. These guidelines consider apremilast to be an immunomodulatory or immunosuppressive medication. Risk D: Consider Therapy Modification

Atidarsagene Autotemcel: May increase adverse/toxic effects of Vaccines. Atidarsagene Autotemcel may decrease therapeutic effects of Vaccines. Risk X: Avoid

AzaTHIOprine: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding azathioprine for 1 to 2 weeks after each vaccine dose as permitted by the underlying disease. This recommendation is specific to patients using azathioprine for rheumatic and musculoskeletal disease. Risk D: Consider Therapy Modification

Baricitinib: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding baricitinib, tofactinib, or upadacitinib for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider Therapy Modification

Belimumab: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding subcutaneous belimumab doses for 1 to 2 weeks after each COVID-19 vaccine dose as disease activity permits. The recommendation specifies subcutaneous belimumab and does not mention intravenous belimumab. Risk D: Consider Therapy Modification

Calcineurin Inhibitors (Systemic): May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding calcineurin inhibitors for 1 to 2 weeks after each vaccine dose as permitted by the underlying disease. This is specific to the use of calcineurin inhibitors for rheumatologic or musculoskeletal disease. Risk D: Consider Therapy Modification

CAR-T Cell Immunotherapy: May decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: The CDC recommends that CAR-T-cell recipients who received COVID-19 vaccine prior to or during treatment with CAR-T-cell therapy should be revaccinated with a primary vaccine series at least 3 months (12 weeks) after CAR-T-cell therapy. Risk D: Consider Therapy Modification

CloZAPine: COVID-19 Vaccines may increase adverse/toxic effects of CloZAPine. COVID-19 Vaccines may increase serum concentration of CloZAPine. Risk C: Monitor

Corticosteroids (Systemic): May decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

CycloPHOSphamide: May decrease therapeutic effects of COVID-19 Vaccines. Management: Adjust timing of intravenous cyclophosphamide so that administration occurs 1 week after each vaccine dose, if feasible; hold oral cyclophosphamide for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider Therapy Modification

Dermal Fillers: COVID-19 Vaccine (mRNA) may increase adverse/toxic effects of Dermal Fillers. Specifically, the risk for swelling at or near the site of dermal filler injection (usually face or lips) may be increased. Risk C: Monitor

Elivaldogene Autotemcel: May increase adverse/toxic effects of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may decrease therapeutic effects of Vaccines. Management: Administration of vaccines is not recommended in the 6 weeks before myeloablative conditioning, and until hematologic recovery after elivaldogene autotemcel treatment. Risk X: Avoid

Immunosuppressants (Cytotoxic Chemotherapy): May decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

Immunosuppressants (Miscellaneous Oncologic Agents): May decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

Immunosuppressants (Therapeutic Immunosuppressant Agents): May decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

Leflunomide: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding leflunomide for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider Therapy Modification

Methotrexate: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding methotrexate for 1 to 2 weeks after vaccine administration as permitted by underlying disease. This is specific to patients using methotrexate for rheumatic and musculoskeletal disease. Risk D: Consider Therapy Modification

Mycophenolate: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding mycophenolate for 1 to 2 weeks after each vaccine dose as permitted by the underlying disease. This recommendation is specific to patients using mycophenolate for rheumatic and musculoskeletal diseases. Risk D: Consider Therapy Modification

Pemivibart: May decrease therapeutic effects of COVID-19 Vaccines. Management: Do not administer pemivibart for at least 2 weeks after receipt of COVID-19 vaccination. Risk D: Consider Therapy Modification

Propacetamol: May decrease therapeutic effects of Vaccines. Management: Consider avoiding routine prophylactic use of propacetamol before or during vaccine administration when possible. Propacetamol is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider Therapy Modification

Sipavibart: May decrease therapeutic effects of COVID-19 Vaccines. Management: Consider waiting at least 2 weeks after receipt of a COVID-19 vaccine to initiate sipavibart. Risk D: Consider Therapy Modification

Smallpox and Mpox Vaccine (Live): May increase adverse/toxic effects of COVID-19 Vaccine (mRNA). Specifically, the risk for myocarditis may be increased. Risk C: Monitor

Smallpox and Mpox Vaccine (Live/Attenuated): May increase adverse/toxic effects of COVID-19 Vaccine (mRNA). Specifically, the risk of myocarditis may be increased. Risk C: Monitor

SulfaSALAzine: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding sulfasalazine for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. These guidelines consider sulfasalazine to be an immunomodulatory or immunosuppressive medication. Risk D: Consider Therapy Modification

Teplizumab: May decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: mRNA vaccines are not recommended during the 2 weeks before teplizumab, during treatment, or for 6 weeks afterward. The CDC recommends a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Risk D: Consider Therapy Modification

Tofacitinib: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding baricitinib, tofactinib, or upadacitinib for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider Therapy Modification

Upadacitinib: May decrease therapeutic effects of COVID-19 Vaccines. Management: Rheumatology guidelines recommend holding baricitinib, tofactinib, or upadacitinib for 1 to 2 weeks after vaccine administration as permitted by the underlying disease. Risk D: Consider Therapy Modification

Reproductive Considerations

Pregnancy testing is not required prior to vaccination. Pregnancy does not need to be delayed following vaccination. mRNA COVID-19 vaccines are not a cause of infertility (ACOG 2023).

There have been anecdotal reports of temporary menstrual changes following vaccination. Vaccines have not previously been associated with menstrual disturbances; however, environmental stresses can temporarily impact menses. Based on available data, any changes in the length of menstrual cycle following COVID-19 vaccination are <1 day, and changes in duration or quantity of bleeding resolve within 1 to 2 menstrual cycles. COVID-19 vaccines may be given to patients who are menstruating, and vaccination does not need to be scheduled based on menstrual cycle. Potential changes in menstrual bleeding are not a reason to avoid vaccination (ACOG 2023).

Due to the risk of severe illness, pregnancy complications, and death from COVID-19 infection during pregnancy, staying current with COVID-19 vaccination is strongly recommended for all patients planning a pregnancy, patients trying to become pregnant now, and patients who might become pregnant in the future, including those patients previously diagnosed with COVID-19 infection (ACOG 2023; CDC 2024). Refer to current CDC guidelines for vaccination of adults.

Pregnancy Considerations

Antibodies generated following vaccination of pregnant patients can be detected in cord blood. Placental transfer of IgG antibodies to the neonate increases from time of vaccination to delivery following administration of an mRNA COVID-19 vaccine during pregnancy (Fu 2022; Rawal 2022). Antibodies generated in response to the vaccine persist in the infant serum for up to 6 months of age and are higher than those in infants born to infected mothers (Rawal 2022; Shook 2022). Administration of the mRNA vaccine during pregnancy decreases hospitalization due to COVID-19 infection in infants <6 months of age (Halasa 2022a; Halasa 2022b).

There was no increased risk of congenital fetal anomalies (identified via ultrasonography) based on data collected from 1,149 pregnant patients vaccinated within 30 days prior to conception until 14 weeks' gestation when compared to nonvaccinated pregnant patients (n=534) or pregnant patients vaccinated outside of this time period (n=1,473) (ACOG 2023; Ruderman 2022). Meta-analyses, one which included data from the V-safe Surveillance System and pregnancy registry and the Vaccine Adverse Event Reporting System (VAERS), found the rates of small for gestational age, stillbirth, preterm birth, miscarriage, and congenital anomalies to be similar following COVID-19 vaccination when compared to the general population (Ma 2022; Rawal 2022). The rates of gestational diabetes, gestational hypertension, preeclampsia, or eclampsia following COVID-19 vaccination are also within the known background rate (ACOG 2023; Ma 2022; Rawal 2022). In addition, no safety concerns were detected in a meta-analysis of studies following maternal vaccination with an mRNA COVID-19 vaccine (ACOG 2023; Ciapponi 2023).

The immune response generated by the COVID-19 (mRNA) vaccine in pregnant patients is comparable to the immune response in patients who are not pregnant (ACOG 2023). Meta-analyses of available studies have found the antibody response in pregnant patients provided by vaccination to be higher than that following natural infection (Fu 2022; Rawal 2022). The rates of injection-site pain, injection-site soreness, and fatigue occurred at rates similar to nonpregnant patients (Fu 2022; Rawal 2022). Using data from the VAERS, reports of acute adverse events requiring medical attention following vaccination during pregnancy are uncommon (DeSilva 2022). A large observational cohort study evaluating the COVID-19 (mRNA) vaccine found the incidence of significant adverse health events to be lower in vaccinated pregnant patients compared to age-matched unvaccinated pregnant persons (Sadarangani 2022). COVID-19 vaccination effectively prevents COVID-19 infection and hospitalization in pregnant patients (Ma 2022; Rawal 2022). If severe infection and hospitalization occur, pregnant patients who are vaccinated are significantly less likely to require ICU admission, intubation, or die (de Freitas Paganoti 2022). Based on available data, mRNA vaccines are likely to have the same safety and efficacy in pregnant and nonpregnant patients (ACOG 2023).

The risk of severe illness from COVID-19 infection is increased in symptomatic pregnant patients compared to nonpregnant patients. Pregnant and recently pregnant patients with moderate or severe infection are at increased risk of complications such as hypertensive disorders of pregnancy, postpartum hemorrhage, or other infections compared to pregnant patients without COVID-19. Pregnant patients with symptoms may require ICU admission, mechanical ventilation, or ventilatory support (ECMO) compared to symptomatic nonpregnant patients. Other adverse pregnancy outcomes include preterm birth and stillbirth. The risk of coagulopathy, cesarean delivery, and maternal death may be increased; neonates have an increased risk for NICU admission. Maternal age and comorbidities such as diabetes, hypertension, lung disease, and obesity may also increase the risk of severe illness in pregnant and recently pregnant patients (ACOG FAQ 2023; NIH 2023).

Vaccination of pregnant patients may be done in any setting authorized to administer the vaccine. The COVID-19 vaccine may be administered in any trimester and should be given as soon as possible to maximize maternal and fetal health. COVID-19 vaccines may be administered simultaneously with other vaccines routinely administered during pregnancy. Vaccination status should be documented for all pregnant patients; for patients who do not receive the COVID-19 vaccine, the discussion should be documented in the medical record and vaccination offered again at subsequent visits (ACOG 2023).

Rho(D) immune globulin is not expected to interfere with an immune response to the COVID-19 vaccine. Treatment should not be withheld in patients planning to be vaccinated or who recently received the COVID-19 vaccine (ACOG 2023).

Information related to COVID-19 vaccines continues to emerge; refer to current guidelines for vaccinating pregnant patients.

Data collection to monitor maternal and infant outcomes following exposure to COVID-19 vaccines during pregnancy is ongoing:

- Health care providers are encouraged to enroll patients exposed to the Moderna COVID-19 Vaccine during pregnancy in the Moderna Pregnancy Registry (1-866-663-3762).

- Health care providers are encouraged to enroll patients exposed to COVID-19 mRNA vaccines during the last 2 months of pregnancy in the Organization of Teratology Information Specialists (OTIS) pregnancy registry (1-877-311-8972; https://mothertobaby.org/join-study/).

Breastfeeding Considerations

mRNA from the COVID-19 (mRNA) vaccines may be present in breast milk.

- Breast milk was sampled in 14 lactating patients (~9 months postpartum) following administration of 2 doses of the Pfizer-BioNTech COVID-19 Vaccine. Sampling occurred prior to and at intervals up to 4 to 6 weeks after the second dose. Among 40 samples, 36 (90%) showed no traces of vaccine mRNA. Negligible vaccine mRNA at levels of 2 ng/mL were measurable only within the first week of either dose. Authors of this study calculated the estimated exposure to a breastfed infant would be 0.667% of the vaccine dose in 100 mL of breast milk. Any vaccine mRNA would be readily destroyed by enzymes in the infant GI tract. There were no adverse events observed in the breastfed infants (Low 2021).

- Trace amounts of vaccine mRNA were found in the breast milk of lactating patients who were administered the Pfizer-BioNTech COVID-19 Vaccine (n=6) or the Moderna COVID-19 Vaccine (n=5) within 6 months of delivery. Breast milk was collected for 5 days after vaccination. Five participants had COVID-19 vaccine mRNA present in a breast milk sample, all within 45 hours of receiving the vaccine. There was no vaccine mRNA present in breast milk collected 48 hours after vaccination (Hanna 2022).

- COVID-19 (mRNA) vaccines contain PEGylated proteins. In a study of 13 lactating patients who received a COVID-19 (mRNA) vaccine, breast milk was sampled prior to the first vaccination and up to 2 weeks after the second dose. The level of PEGylated proteins in breast milk was not significantly different following vaccination (Golan 2021).

SARS-CoV-2-specific antibodies are present in breast milk following vaccination as well as natural infection. Meta-analyses of data obtained following administration of the COVID-19 (mRNA) vaccine to lactating women show breast milk contains IgG and IgA, with the greatest concentrations achieved after the second dose (Fu 2022; Muyldermans 2022; Whited 2022). The degree of clinical benefit of maternal vaccination to the breastfed infant is not yet known (ACOG 2023).

Meta-analyses of data obtained following administration of the COVID-19 (mRNA) vaccine show adverse reactions following vaccination are not significantly different in lactating patients compared to pregnant or nonpregnant patients. The most common side effects are fatigue, fever, headache, chills, muscle pain, and pain at the injection site. Reactions were more common following the second dose (Fu 2022; Muyldermans 2022). Transient changes in milk supply (both increases and decreases) have been reported following COVID-19 (mRNA) vaccine administration (Lamers 2022; Muyldermans 2022). A few mothers have also noted a transient change of breast milk to a blue-green color following the first or second dose (Muyldermans 2022).

Lactating patients produce immune responses to vaccination comparable to nonlactating persons (ACOG 2023).

The risk of severe illness from COVID-19 infection is increased in recently pregnant patients compared to nonpregnant patients (ACOG FAQ 2023). Staying current with COVID-19 vaccination is recommended for all lactating patients who do not otherwise have contraindications to the vaccine (CDC 2024). Refer to current CDC guidelines for vaccination of adults. The initiation of breastfeeding does not need to be avoided, and breastfeeding does not need to be discontinued in patients who are vaccinated (ACOG 2023).

Monitoring Parameters

Monitor for hypersensitivity and syncope for 15 minutes following administration (ACIP [Kroger 2023]; CDC 2024). Observe patients for 30 minutes after vaccination in those patients with the following: a history of nonsevere, immediate (within 4 hours) allergic reaction after receipt of a COVID-19 vaccine; a history of anaphylaxis following receipt of a non–COVID-19 vaccine or injectable therapy; or a person with an allergy-related contraindication to a different type of COVID-19 vaccine (CDC 2024). If seizure-like activity associated with syncope occurs, maintain patient in supine or Trendelenburg position to reestablish adequate cerebral perfusion.

Antibody testing to assess for SARS-CoV-2 immunity before or following vaccination is not currently recommended (CDC 2024).

Mechanism of Action

Promotes active immunization against COVID-19 caused by SARS-CoV-2 virus. The modified messenger RNA (mRNA) in the vaccine is formulated in lipid particles that enable delivery of the RNA into host cells to allow expression of the SARS-CoV-2 spike (S) antigen. The vaccine elicits both neutralizing antibody and cellular immune responses to the S antigen, which protects against COVID-19 disease.

Pharmacokinetics (Adult Data Unless Noted)

Onset of action:

Moderna vaccine: Vaccine efficacy assessment was based on disease cases occurring 14 days or more after dose 2 (Baden 2020). Virus-neutralizing antibody activity was detected in all patients by day 15 following the second dose (Jackson 2020).

Pfizer-BioNTech vaccine: Vaccine efficacy assessment was based on disease cases occurring 7 days or more after dose 2 (Polack 2020). Virus-neutralizing antibody activity peaked 7 to 14 days following the second dose (Walsh 2020).

Brand Names: International

International Brand Names by Country

For country code abbreviations (show table)

(AE) United Arab Emirates: COVID-19 vaccine Moderna | Pfizer BioNTech COVID-19 vaccine;
(AR) Argentina: Comirnaty;
(AT) Austria: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(AU) Australia: Comirnaty | Spikevax;
(BE) Belgium: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(BG) Bulgaria: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(BO) Bolivia, Plurinational State of: Comirnaty;
(BR) Brazil: Comirnaty;
(CH) Switzerland: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(CL) Chile: Spikevax;
(CO) Colombia: COVID-19 vaccine Moderna | Pfizer BioNTech COVID-19 vaccine | Spikevax;
(CY) Cyprus: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(CZ) Czech Republic: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(DE) Germany: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(DK) Denmark: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(EE) Estonia: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(ES) Spain: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(ET) Ethiopia: Pfizer BioNTech COVID-19 vaccine;
(FI) Finland: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(FR) France: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(GB) United Kingdom: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(GR) Greece: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(HR) Croatia: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(HU) Hungary: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(ID) Indonesia: Comirnaty | Moderna COVID-19 vaccine;
(IE) Ireland: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(IL) Israel: Comirnaty | Moderna COVID-19 vaccine | Pfizer BioNTech COVID-19 vaccine;
(IS) Iceland: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(IT) Italy: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(JP) Japan: Comirnaty | COVID-19 vaccine Moderna;
(KR) Korea, Republic of: Comirnaty | Spikevax;
(LI) Liechtenstein: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(LT) Lithuania: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(LU) Luxembourg: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(LV) Latvia: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(MT) Malta: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(MX) Mexico: Comirnaty | Spikevax;
(MY) Malaysia: Comirnaty;
(NG) Nigeria: Moderna COVID-19 vaccine | Pfizer BioNTech COVID-19 vaccine;
(NL) Netherlands: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(NO) Norway: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(NZ) New Zealand: Comirnaty;
(PA) Panama: Vacuna Pfizer-BioNTech COVID-19;
(PE) Peru: Comirnaty;
(PH) Philippines: COVID-19 vaccine Moderna | Pfizer BioNTech COVID-19 vaccine;
(PL) Poland: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(PR) Puerto Rico: Comirnaty | Moderna COVID-19 vaccine | Pfizer BioNTech COVID-19 vaccine;
(PT) Portugal: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(QA) Qatar: Comirnaty | Spikevax | Spikevax XBB.1.5;
(RO) Romania: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(SA) Saudi Arabia: Pfizer BioNTech COVID-19 vaccine;
(SE) Sweden: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(SG) Singapore: Comirnaty | Moderna COVID-19 vaccine | Pfizer BioNTech COVID-19 vaccine;
(SI) Slovenia: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(SK) Slovakia: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(TH) Thailand: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
(TN) Tunisia: COVID-19 vaccine Moderna | Pfizer BioNTech COVID-19 vaccine;
(TW) Taiwan: Spikevax;
(UA) Ukraine: Comirnaty;
(ZA) South Africa: Comirnaty

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Refer to manufacturer's labeling.
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COVID-19 mRNA vaccines: Drug information