ﺑﺎﺯﮔﺸﺖ ﺑﻪ ﺻﻔﺤﻪ ﻗﺒﻠﯽ
خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده : 3 مورد
نسخه الکترونیک
medimedia.ir

COVID-19 mRNA vaccines: Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (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;
  • Comirnaty (Gray Cap);
  • Comirnaty (Purple Cap);
  • Comirnaty Omicron XBB.1.5;
  • Comirnaty Original & Omicron;
  • Spikevax;
  • Spikevax Bivalent;
  • Spikevax Orig & Omicron BA.4/5;
  • Spikevax XBB.1.5
Pharmacologic Category
  • Vaccine;
  • Vaccine, COVID-19;
  • Vaccine, mRNA
Dosing: Adult
COVID-19 prevention

COVID-19 prevention:

Note: The only mRNA COVID-19 vaccines approved for use in the United States are based on the SARS-CoV-2 Omicron variant XBB.1.5 and labeled "2023-2024 Formula." EUA is no longer available for previous formulations (Ref).

COVID-19 Vaccine (mRNA) 2023-2024 Formulation Dose Recommendations for Patients ≥18 Years of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2023)

Manufacturer

COVID-19 mRNA vaccine history (prior to 2023-2024 formulation)

Vial description

Total amount of mRNA per dose

Number of 2023-2024 formulation doses indicated (administer IM)

Interval between doses

Moderna products

No prior COVID-19 vaccine

Blue label and dark blue cap

50 mcg per 0.5 mL

1 dose

N/A

≥1 dose of any previous COVID-19 vaccine formulation

Blue label and dark blue cap

50 mcg per 0.5 mL

1 dose

Administer the 2023-2024 formulation dose ≥8 weeks after the last dose of previous formulation.

Pfizer-BioNTech products

No prior COVID-19 vaccine

Gray label and cap

30 mcg per 0.3 mL

1 dose

N/A

≥1 dose of any previous COVID-19 vaccine formulation

Gray label and cap

30 mcg per 0.3 mL

1 dose

Administer the 2023-2024 formulation dose ≥8 weeks after the last dose of previous formulation.

COVID-19 Vaccine (mRNA) 2023-2024 Formulation Dose Recommendations for Patients ≥18 Years of Age WITH Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2023)

Manufacturer

COVID-19 mRNA vaccine history (prior to 2023-2024 formulation)

Vial description

Total amount of mRNA per dose

Number of 2023-2024 formulation doses indicated (administer IM)

Interval between doses

a Persons ≥18 years of age who are moderately or severely immunocompromised may receive an additional age-appropriate dose of a 2023-2024 formulation mRNA vaccine ≥2 months following the last recommended 2023-2024 formulation mRNA COVID-19 dose. Further additional doses may be administered, informed by the clinical judgment of a health care provider and personal preference and circumstances, ≥2 months after the last COVID-19 vaccine dose.

b Initial 3-dose 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).

Moderna products

No prior COVID-19 vaccine

Blue label and dark blue cap

50 mcg per 0.5 mL

3 dosesa, b

Administer second dose 4 weeks following the first dose, and administer the third dose ≥4 weeks after the second.

1 dose of any previous Moderna formulation

Blue label and dark blue cap

50 mcg per 0.5 mL

2 dosesa

Administer first dose 4 weeks following the dose of previous formulation, and administer second dose ≥4 weeks after the first 2023-2024 formulation.

2 doses of any previous Moderna formulation

Blue label and dark blue cap

50 mcg per 0.5 mL

1 dosea

Administer dose ≥4 weeks after last dose of previous formulation.

≥3 doses of any previous mRNA COVID-19 vaccine formulation

Blue label and dark blue cap

50 mcg per 0.5 mL

1 dosea

Administer dose ≥8 weeks after the last dose of previous formulation.

≥1 dose of Novavax or Janssen, including in combination with any mRNA COVID-19 vaccine dose(s)

Blue label and dark blue cap

50 mcg per 0.5 mL

1 dosea

Administer dose ≥8 weeks after the last dose of previous formulation.

Pfizer-BioNTech products

No prior COVID-19 vaccine

Gray label and cap

30 mcg per 0.3 mL

3 dosesa, b

Administer second dose 3 weeks following the first dose, and administer third dose ≥4 weeks after the second.

1 dose of any previous Pfizer-BioNTech formulation

Gray label and cap

30 mcg per 0.3 mL

2 dosesa

Administer the first dose 3 weeks after the dose of previous formulation, and administer the second dose ≥4 weeks after the first 2023-2024 formulation dose.

2 doses of any previous Pfizer-BioNTech formulation

Gray label and cap

30 mcg per 0.3 mL

1 dosea

Administer the dose ≥4 weeks after the last dose of previous formulation.

≥3 doses of any previous mRNA COVID-19 vaccine formulation

Gray label and cap

30 mcg per 0.3 mL

1 dosea

Administer the dose ≥8 weeks after the last dose of previous formulation.

≥1 dose of Novavax or Janssen, including in combination with any mRNA COVID-19 vaccine dose(s)

Gray label and cap

30 mcg per 0.3 mL

1 dosea

Administer the dose ≥8 weeks after the last dose of previous formulation.

Canadian and international recommendations: Preparations of COVID-19 mRNA vaccines containing different components (eg, SARS-CoV-2 Original strain, Omicron BA.1, BA.4/BA.5, and XBB.1.5 variants) 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 2023, persons who were previously vaccinated against COVID-19 receive a dose of an age-appropriate XBB.1.5 variant-containing COVID-19 vaccine if it has been ≥6 months from the previous COVID-19 vaccine dose or known SARS-CoV-2 infection (whichever is later) (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 Usagea

Deviation

Adjustment

a CDC 2023; 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 because of 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.

Bivalent mRNA COVID-19 vaccine (Original and Omicron BA.4/5) administered instead of 2023-2024 formula

Repeat dose using age-appropriate updated 2023-2024 formulation mRNA COVID-19 vaccine. If dose given in error was the first dose, then administer repeat dose ≥4 weeks later.c For other doses, administer repeat dose by at least the minimum interval.

2023-2024 formulation COVID-19 vaccines from different manufacturers inadvertently administered as part of a 2- or 3-dose initial vaccination series

No further doses needed for persons not moderately or severely immunocompromised.

If moderately or severely immunocompromised, administer 1 dose of any COVID-19 vaccine (2023-2024 formulation) ≥4 weeks after the last dose (total of 3 doses).

Dosing interval

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, dose administered past expiration date)

Contact manufacturer; if no stability data, repeat dose immediately (no minimum interval).c

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

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

COVID-19 prevention

COVID-19 prevention:

Note: The only mRNA COVID-19 vaccines approved for use in the United States are based on the SARS-CoV-2 Omicron variant XBB.1.5 and labeled "2023-2024 Formula". Emergency use authorization is no longer available for previous formulations (Ref).

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 (CDC 2023).

Pediatric COVID-19 Vaccine (mRNA) 2023-2024 Formulation Dose Recommendations for Patients 6 Months to <5 Years of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2023)

Manufacturer

COVID-19 mRNA vaccine history (prior to 2023-2024 formulation)

Vial description

Total amount of mRNA per dose

Number of 2023-2024 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).

b An 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.

c For 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 supplied with blue caps and blue label borders for 5 to <12 years (10 mcg per 0.3 mL); alternatively, the series may be completed with the product supplied with yellow caps and yellow label borders.

Moderna producta

No prior COVID-19 vaccine

Green label and dark blue cap

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

Green label and dark blue cap

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

Green label and dark blue cap

25 mcg per 0.25 mL

1 dose

Administer the dose ≥8 weeks after last dose of previous formulation.

Pfizer-BioNTech productsa

No prior COVID-19 vaccine

Yellow label and cap

3 mcg per 0.3 mL

3 dosesc

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

Yellow label and cap

3 mcg per 0.3 mL

2 dosesc

Administer first dose 3 to 8 weeks after dose of previous formulation, then administer second dose ≥8 weeks after first 2023-2024 formulation dose.b

≥2 doses of any previous Pfizer-BioNTech formulation

Yellow label and cap

3 mcg per 0.3 mL

1 dose

Administer dose ≥8 weeks after last dose of previous formulation.

Pediatric COVID-19 Vaccine (mRNA) 2023-2024 Formulation Dose Recommendations for Patients 6 Months to <5 Years of Age WITH Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2023)

Manufacturer

COVID-19 mRNA vaccine history (prior to 2023-2024 formulation)

Vial description

Total amount of mRNA per dose

Number of 2023-2024 formulation doses indicateda (administer IM)

Interval between doses

a Persons 6 months to <5 years of age who are moderately or severely immunocompromised may receive an additional age- and product-appropriate dose of a 2023-2024 formulation mRNA vaccine ≥2 months following the last recommended 2023-2024 formulation mRNA COVID-19 dose. Further additional doses may be administered, informed by the clinical judgment of a health care provider and personal preference and circumstances.

b 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).

c For 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 supplied with blue caps and blue label borders for 5 to <12 years (10 mcg per 0.3 mL); alternatively, the series may be completed with the product supplied with yellow caps and yellow label borders.

Moderna productsb

No prior COVID-19 vaccine

Green label and dark blue cap

25 mcg per 0.25 mL

3 dosesa

Administer second dose 4 weeks following the first dose, and third dose ≥4 weeks following the second.

1 dose of any previous Moderna formulation

Green label and dark blue cap

25 mcg per 0.25 mL

2 dosesa

Administer first dose 4 weeks following the dose of previous formulation, then administer second dose ≥4 weeks after the first 2023-2024 formulation dose.

2 doses of any previous Moderna formulation

Green label and dark blue cap

25 mcg per 0.25 mL

1 dosea

Administer dose ≥4 weeks after the last dose of previous formulation.

≥3 doses of any previous Moderna formulation

Green label and dark blue cap

25 mcg per 0.25 mL

1 dosea

Administer the dose ≥8 weeks after the last dose of previous formulation.

Pfizer-BioNTech productsb

No prior COVID-19 vaccine

Yellow label and cap

3 mcg per 0.3 mL

3 dosesa,c

Administer second dose 3 weeks after first, then administer third dose ≥8 weeks after second.

1 dose of any previous Pfizer-BioNTech formulation

Yellow label and cap

3 mcg per 0.3 mL

2 dosesa,c

Administer first dose 3 weeks after dose of previous formulation, then administer second dose ≥8 weeks after first 2023-2024 formulation dose.

≥2 doses of any previous Pfizer-BioNTech formulation

Yellow label and cap

3 mcg per 0.3 mL

1 dosea

Administer dose ≥8 weeks after last dose of previous formulation.

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 (CDC 2023).

Pediatric COVID-19 Vaccine (mRNA) 2023-2024 Formulation Dose Recommendations for Patients 5 to <12 Years of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2023)

Manufacturer

COVID-19 mRNA vaccine history (prior to 2023-2024 formulation)

Vial description

Total amount of mRNA per dose

Number of 2023-2024 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 the Pfizer-BioNTech product supplied with blue caps and blue label borders; alternatively, the series may be completed with the product supplied with yellow caps and yellow label borders (for patients 6 months to <5 years; 3 mcg per 0.3 mL).

Moderna products

No prior COVID-19 vaccine

Green label and dark blue cap

25 mcg per 0.25 mL

1 dose

N/A

≥1 dose of any previous vaccine formulation

Green label and dark blue cap

25 mcg per 0.25 mL

1 dose

Administer the dose ≥8 weeks after last dose of previous formulation.

Pfizer-BioNTech productsa

No prior COVID-19 vaccine

Blue label and cap

10 mcg per 0.3 mL

1 dose

N/A

≥1 dose of any previous mRNA vaccine formulation

Blue label and cap

10 mcg per 0.3 mL

1 dose

Administer the dose ≥8 weeks after last dose of previous formulation.

Pediatric COVID-19 Vaccine (mRNA) 2023-2024 Formulation Dose Recommendations for Patients 5 to <12 Years of Age WITH Moderate to Severe Immunocompromising Conditions or Treatmenta (CDC 2023)

Manufacturer

COVID-19 mRNA vaccine history (prior to 2023-2024 formulation)

Vial description

Total amount of mRNA per dose

Number of 2023-2024 formulation doses indicateda (administer IM)

Interval between doses

a Persons 5 to <12 years of age who are moderately or severely immunocompromised may receive an additional age-appropriate dose of a 2023-2024 formulation mRNA vaccine ≥2 months following the last recommended 2023-2024 mRNA COVID-19 dose. Further additional 2023-2024 formulation doses may be administered, informed by the clinical judgment of a health care provider and personal preference and circumstances.

b Individuals transitioning from age 11 to 12 years during the initial vaccination series are recommended to receive the dose for ≥12 years of age for all doses after turning 12 years of age; however, they may also complete series with the dose for 5 to <12 years of age.

c 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 with the Pfizer-BioNTech product supplied with blue caps and blue label borders; alternatively, the series may be completed with the product supplied with yellow caps and yellow label borders (for patients 6 months to <5 years; 3 mcg per 0.3 mL).

Moderna productsb

No prior COVID-19 vaccine

Green label and dark blue cap

25 mcg per 0.25 mL

3 dosesa,c

Administer second dose 4 weeks following the first dose, and third dose ≥4 weeks following the second.

1 dose of any previous Moderna formulation

Green label and dark blue cap

25 mcg per 0.25 mL

2 dosesa,c

Administer first dose 4 weeks following the dose of previous formulation, and administer second dose ≥4 weeks after the first 2023-2024 formulation dose.

2 doses of any previous Moderna formulation

Green label and dark blue cap

25 mcg per 0.25 mL

1 dosea,c

Administer dose ≥4 weeks after the last dose of previous formulation.

≥3 doses of any previous mRNA COVID-19 vaccine

Green label and dark blue cap

25 mcg per 0.25 mL

1 dosea

Administer the dose ≥8 weeks after the last dose of previous formulation.

Pfizer-BioNTech productsb,d

No prior COVID-19 vaccine

Blue label and cap

10 mcg per 0.3 mL

3 dosesa,c

Administer second dose 3 weeks following the first dose, and administer third dose ≥4 weeks after the second.

1 dose of any previous Pfizer-BioNTech formulation

Blue label and cap

10 mcg per 0.3 mL

2 dosesa,c

Administer the first dose 3 weeks after the dose of previous formulation, and administer the second dose ≥4 weeks after the first 2023-2024 formulation dose.

2 doses of any previous Pfizer-BioNTech formulation

Blue label and cap

10 mcg per 0.3 mL

1 dosea,c

Administer the dose ≥4 weeks after the last dose of previous formulation.

≥3 doses of any previous mRNA COVID-19 vaccine formulation

Blue label and cap

10 mcg per 0.3 mL

1 dosea

Administer the dose ≥8 weeks after the last dose of previous formulation.

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 (CDC 2023).

Pediatric COVID-19 Vaccine (mRNA) 2023-2024 Formulation Dose Recommendations for Patients ≥12 Years of Age WITHOUT Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2023)

Manufacturer

COVID-19 mRNA vaccine history (prior to 2023-2024 formulation)

Vial description

Total amount of mRNA per dose

Number of 2023-2024 formulation doses indicated (administer IM)

Interval between doses

Moderna products

No prior COVID-19 vaccine

Blue label and dark blue cap

50 mcg per 0.5 mL

1 dose

N/A

≥1 dose of any previous COVID-19 vaccine formulation

Blue label and dark blue cap

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

Gray label and cap

30 mcg per 0.3 mL

1 dose

N/A

≥1 dose of any previous mRNA vaccine formulation

Gray label and cap

30 mcg per 0.3 mL

1 dose

Administer the dose ≥8 weeks after last dose of previous formulation.

Pediatric COVID-19 Vaccine (mRNA) 2023-2024 Formulation Dose Recommendations for Patients ≥12 Years of Age WITH Moderate to Severe Immunocompromising Conditions or Treatment (CDC 2023)

Manufacturer

COVID-19 mRNA vaccine history (prior to 2023-2024 formulation)

Vial description

Total amount of mRNA per dose

Number of 2023-2024 formulation doses indicateda (administer IM)

Interval between doses

a Persons ≥12 years of age who are moderately or severely immunocompromised may receive an additional age-appropriate dose of a 2023-2024 formulation mRNA vaccine ≥2 months following the last recommended 2023-2024 mRNA COVID-19 dose. Further additional 2023-2024 formulation doses may be administered, informed by the clinical judgment of a health care provider and personal preference and circumstances.

b Individuals transitioning from age 11 to 12 years during the initial vaccination series are recommended to receive the dose for ≥12 years of age for all doses after turning 12 years of age; however, they may also complete series with the dose for 5 to <12 years of age.

c Initial 3-dose 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 productsb

No prior COVID-19 vaccine

Blue label and dark blue cap

50 mcg per 0.5 mL

3 dosesa,c

Administer second dose 4 weeks following the first dose, and third dose ≥4 weeks following the second.

1 dose of any previous Moderna formulation

Blue label and dark blue cap

50 mcg per 0.5 mL

2 dosesa,c

Administer first dose 4 weeks following the dose of previous formulation, and administer second dose ≥4 weeks after the first 2023-2024 formulation dose.

2 doses of any previous Moderna formulation

Blue label and dark blue cap

50 mcg per 0.5 mL

1 dosea

Administer dose ≥4 weeks after the last dose of previous formulation.

≥3 doses of any previous mRNA COVID-19 vaccine

Blue label and dark blue cap

50 mcg per 0.5 mL

1 dosea

Administer the dose ≥8 weeks after the last dose of previous formulation.

Pfizer-BioNTech productsb

No prior COVID-19 vaccine

Gray label and cap

30 mcg per 0.3 mL

3 dosesa,c

Administer second dose 3 weeks following the first dose, and administer third dose ≥4 weeks after the second.

1 dose of any previous Pfizer-BioNTech formulation

Gray label and cap

30 mcg per 0.3 mL

2 dosesa,c

Administer the first dose 3 weeks after the dose of previous formulation, and administer the second dose ≥4 weeks after the first 2023-2024 formulation dose.

2 doses of any previous Pfizer-BioNTech formulation

Gray label and cap

30 mcg per 0.3 mL

1 dosea

Administer the dose ≥4 weeks after the last dose of previous formulation.

≥3 doses of any previous mRNA COVID-19 vaccine formulation

Gray label and cap

30 mcg per 0.3 mL

1 dosea

Administer the dose ≥8 weeks after the last dose of previous formulation.

Canadian and international recommendations: Preparations of COVID-19 mRNA vaccines containing different components (eg, SARS-CoV-2 Original strain, Omicron BA.1, BA.4/BA.5, and XBB.1.5 variants) 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 2023, persons who were previously vaccinated against COVID-19 receive a dose of an age-appropriate XBB.1.5 variant-containing COVID-19 vaccine if it has been ≥6 months from the previous COVID-19 vaccine dose or known SARS-CoV-2 infection (whichever is later) (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 (Ref).

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

Recommendations for Deviations in COVID-19 Vaccine Usage (CDC 2023)

Deviation

Adjustment

a Some experts suggest a longer interval (8 weeks) after the invalid dose because of the potential for increased reactogenicity and rare risk of myocarditis and pericarditis; consider patient benefit versus risk.

b Unless patient experiences significant or prolonged adverse reactions (assess on a case-by-case basis).

Age

Person <6 months of age received any 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.a

Person 6 months to <5 years of age received initial 2 doses with products from different manufacturers (ie, 1 dose from Moderna and 1 dose from Pfizer-BioNTech; any previous or current formulation).

Administer an age-appropriate third dose of either 2023-2024 formulation Moderna or Pfizer-BioNTech COVID-19 mRNA vaccine ≥8 weeks after the second dose.

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.

Bivalent mRNA COVID-19 vaccine (Original and Omicron BA.4/5) administered instead of 2023-2024 Formula

Repeat dose using age-appropriate updated 2023-2024 formulation mRNA COVID-19 vaccine. If dose given in error was the first dose, then administer repeat dose ≥4 weeks later.a For other doses, administer repeat dose by at least the minimum interval.

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

Any COVID-19 vaccine dose administered after recommended interval

Do not repeat dose; no maximum interval.

Preparation (Pfizer-BioNTech products 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 use

Contact manufacturer; if no stability data, repeat dose immediately (no minimum interval).

Diluent from single-use vial used for multiple vials

Do not repeat dose.

Storage

Improper storage or handling of vaccine (eg, temperature excursion, dose administered past expiration date)

Contact manufacturer; if no stability data, repeat dose immediately (no minimum interval).a

Dosing: Kidney Impairment: Pediatric

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

Dosing: Hepatic 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).

>10%:

Gastrointestinal: Decreased appetite (infants and children: 5% to 32%) (table 1), diarrhea (Pfizer: 4% to 11%) (table 2), nausea and vomiting (Moderna: 4% to 24%) (table 3)

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

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

9%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

4%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

9%

N/A

>55 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

2,482

1,238

Dose 1

Moderna

24%

9%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

18%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

9%

8%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

21%

7%

18 to 64 years of age

10,985

10,918

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

211

N/A

Monovalent booster dose

Moderna

13%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

5%

4%

≥65 years of age

3,762

3,748

Dose 1

Moderna

12%

4%

≥65 years of age

3,692

3,648

Dose 2

Moderna

8%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

6%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

6%

N/A

≥65 years of age

174

N/A

Bivalent booster dose

Moderna

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

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

1,746

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

14%

0.6%

12 to 17 years of age

2,482

1,238

Dose 1

Moderna

20%

0.9%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

9%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

3%

0.5%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

9%

0.5%

18 to 64 years of age

10,985

10,918

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

211

N/A

Monovalent booster dose

Moderna

8%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

2%

0.5%

≥65 years of age

3,762

3,748

Dose 1

Moderna

8%

0.4%

≥65 years of age

3,692

3,648

Dose 2

Moderna

3%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

2%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

6%

N/A

≥65 years of age

174

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

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

6%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

6%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

7%

N/A

>55 years of age

301

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

1,746

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

2,482

1,238

Dose 1

Moderna

93%

30%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

91%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

87%

19%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

90%

19%

18 to 64 years of age

10,985

10,918

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

211

N/A

Monovalent booster dose

Moderna

88%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

74%

13%

≥65 years of age

3,762

3,748

Dose 1

Moderna

83%

12%

≥65 years of age

3,692

3,648

Dose 2

Moderna

76%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

67%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

62%

N/A

≥65 years of age

174

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

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

83%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

60%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

58%

N/A

>55 years of age

301

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

1,746

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

2,482

1,238

Dose 1

Moderna

21%

1%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

13%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

7%

0.3%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

13%

0.3%

18 to 64 years of age

10,985

10,918

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

211

N/A

Monovalent booster dose

Moderna

8%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

4%

0.5%

≥65 years of age

3,762

3,748

Dose 1

Moderna

11%

0.4%

≥65 years of age

3,692

3,648

Dose 2

Moderna

3%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

6%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

5%

N/A

≥65 years of age

174

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

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

8%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

6%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

7%

N/A

>55 years of age

301

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), drowsiness (infants and children: 9% to 37%) (table 9), fatigue (25% to 68%) (table 10), headache (3% to 70%) (table 11), irritability (and/or crying; infants and children: 18% to 68%) (table 12)

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

2,482

1,238

Dose 1

Moderna

43%

8%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

30%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

9%

6%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

49%

6%

18 to 64 years of age

10,985

10,918

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

211

N/A

Monovalent booster dose

Moderna

24%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

5%

4%

≥65 years of age

3,762

3,748

Dose 1

Moderna

31%

4%

≥65 years of age

3,692

3,648

Dose 2

Moderna

18%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

14%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

23%

N/A

≥65 years of age

174

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

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

29%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

16%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

13%

N/A

>55 years of age

301

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

2,482

1,238

Dose 1

Moderna

68%

29%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

59%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

39%

29%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

68%

25%

18 to 64 years of age

10,985

10,918

Dose 2

Moderna

62%

N/A

18 to 64 years of age

129

N/A

Monovalent booster dose

Moderna

55%

N/A

18 to 64 years of age

211

N/A

Monovalent booster dose

Moderna

59%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

33%

23%

≥65 years of age

3,762

3,748

Dose 1

Moderna

58%

20%

≥65 years of age

3,692

3,648

Dose 2

Moderna

47%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

47%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

49%

N/A

≥65 years of age

174

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

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

64%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

45%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

49%

N/A

>55 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

2,482

1,238

Dose 1

Moderna

70%

30%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

57%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

35%

29%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

63%

25%

18 to 64 years of age

10,985

10,918

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

211

N/A

Monovalent booster dose

Moderna

49%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

25%

19%

≥65 years of age

3,762

3,748

Dose 1

Moderna

46%

18%

≥65 years of age

3,692

3,648

Dose 2

Moderna

42%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

32%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

36%

N/A

≥65 years of age

174

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

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

48%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

27%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

34%

N/A

>55 years of age

301

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: ≤25%) (table 13), axillary swelling (Moderna: Including axillary tenderness; 4% to 28%), myalgia (Moderna: 10% to 62%; Pfizer: 2% to 39%) (table 14)

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

2,482

1,238

Dose 1

Moderna

29%

9%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

24%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

17%

12%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

46%

11%

18 to 64 years of age

10,985

10,918

Dose 2

Moderna

42%

N/A

18 to 64 years of age

129

N/A

Monovalent booster dose

Moderna

33%

N/A

18 to 64 years of age

211

N/A

Monovalent booster dose

Moderna

33%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

16%

12%

≥65 years of age

3,762

3,748

Dose 1

Moderna

35%

11%

≥65 years of age

3,692

3,648

Dose 2

Moderna

40%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

30%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

28%

N/A

≥65 years of age

174

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%

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

25%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

9%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

11%

N/A

>55 years of age

301

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

2,482

1,238

Dose 1

Moderna

47%

13%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

40%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

24%

14%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

62%

13%

18 to 64 years of age

10,985

10,918

Dose 2

Moderna

50%

N/A

18 to 64 years of age

129

N/A

Monovalent booster dose

Moderna

43%

N/A

18 to 64 years of age

211

N/A

Monovalent booster dose

Moderna

43%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

20%

12%

≥65 years of age

3,762

3,748

Dose 1

Moderna

47%

11%

≥65 years of age

3,692

3,648

Dose 2

Moderna

47%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

32%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

35%

N/A

≥65 years of age

174

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

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

39%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

20%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

22%

N/A

>55 years of age

301

N/A

Bivalent booster dose

Pfizer

Miscellaneous: Fever (≤24%) (table 15)

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

1,746

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

3%

1%

12 to 17 years of age

2,482

1,238

Dose 1

Moderna

12%

1%

12 to 17 years of age

2,478

1,220

Dose 2

Moderna

6%

N/A

12 to 17 years of age

1,312

N/A

Monovalent booster dose

Moderna

0.9%

0.3%

18 to 64 years of age

11,406

11,407

Dose 1

Moderna

17%

0.3%

18 to 64 years of age

10,985

10,918

Dose 2

Moderna

7%

N/A

18 to 64 years of age

129

N/A

Monovalent booster dose

Moderna

5%

N/A

18 to 64 years of age

211

N/A

Monovalent booster dose

Moderna

4%

N/A

18 to 64 years of age

263

N/A

Bivalent booster dose

Moderna

0.3%

0.2%

≥65 years of age

3,762

3,748

Dose 1

Moderna

10%

0.1%

≥65 years of age

3,692

3,648

Dose 2

Moderna

5%

N/A

≥65 years of age

38

N/A

Monovalent booster dose

Moderna

1%

N/A

≥65 years of age

140

N/A

Monovalent booster dose

Moderna

5%

N/A

≥65 years of age

174

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

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

9%

N/A

18 to 55 years of age

289

N/A

Monovalent 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

4%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

5%

N/A

>55 years of age

301

N/A

Bivalent booster dose

Pfizer

1% to 10%:

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

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

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

289

N/A

Monovalent 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

1%

N/A

>55 years of age

298

N/A

Monovalent booster dose

Pfizer

2%

N/A

>55 years of age

301

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, and severe hypersensitivity reaction) (table 17)

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)

Hypersensitivity: Angioedema (Shimabukuro 2021a)

Infection: Herpes zoster infection (Moderna)

Local: Local swelling (at or near the site of dermal fillers [eg, face or lips]) (CDC 2022c)

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

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

Post-authorization/postmarketing:

Cardiovascular: Myocarditis, pericarditis, syncope (adolescents in particular)

Dermatologic: Bullous pemphigoid (Washrawirul 2022), contact dermatitis (Washrawirul 2022), cutaneous lupus erythematous (Washrawirul 2022), ecchymoses (Washrawirul 2022), eczema (Washrawirul 2022), erythema multiforme (Washrawirul 2022), fixed drug eruption (Washrawirul 2022), lichen planus (Washrawirul 2022), maculopapular rash (Washrawirul 2022), pruritus (Shimabukuro 2021a), psoriasis (Washrawirul 2022), skin rash (Shimabukuro 2021a), Sweet syndrome (Washrawirul 2022), urticaria (Shimabukuro 2021a)

Endocrine & metabolic: Graves disease (new onset or exacerbation) (Chee 2022)

Hematologic & oncologic: Immune thrombocytopenia (Washrawirul 2022), petechia (Washrawirul 2022), purpuric disease (Washrawirul 2022)

Hypersensitivity: Anaphylaxis (Washrawirul 2022), hypersensitivity reaction (Pfizer: Including severe hypersensitivity reactions)

Nervous system: Dizziness (CDC 2021a)

Neuromuscular & skeletal: Joint injury (shoulder; unsolicited) (Polack 2020), upper extremity pain (arm) (Pfizer)

Respiratory: Airway obstruction (Shimabukuro 2021a)

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 Hemophilia 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 2023).

• Myocarditis/pericarditis (CDC 2023):

- 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 2023):

- 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.

- Persons with current SARS-CoV-2 infection (including asymptomatic): In persons with known current SARS-CoV-2 infection, defer vaccination until the person has recovered from acute illness (if symptomatic) and no longer requires isolation.

- Persons with known SARS-CoV-2 exposure: Persons with recent known exposure may be vaccinated if they do not have symptoms consistent with COVID-19 infection; follow CDC's postexposure guidance. Vaccination for postexposure prophylaxis is not recommended.

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 2023). 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 2023; 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 2023; NACI 2023). 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 2023).

• Pediatric: Multiple formulations from both 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]:

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

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

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]

Spikevax: 50 mcg/0.5 mL (0.5 mL)

Suspension Prefilled Syringe, Intramuscular:

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

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)

Generic Equivalent Available: US

May be product dependent

Pricing: US

Suspension (Comirnaty Intramuscular)

30 mcg/0.3 ml (per 0.3 mL): $138.00

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

25MCG/0.25ML (per 0.25 mL): $153.60

Suspension (Pfizer COVID-19 Vac-TriS 5-11y Intramuscular)

10 mcg/0.3 ml (per 0.3 mL): $92.40

Suspension (Spikevax Intramuscular)

50 mcg/0.5 mL (per 0.5 mL): $153.60

Suspension Prefilled Syringe (Comirnaty Intramuscular)

30 mcg/0.3 ml (per 0.3 mL): $144.00

Suspension Prefilled Syringe (Spikevax Intramuscular)

50 mcg/0.5 mL (per 0.5 mL): $155.40

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: 3 mcg/0.2 mL (2.2 mL); 10 mcg/0.2 mL (1 ea) [contains 2-((peg)-2000)-n,n-ditetradecylacetamide]

Comirnaty (Gray Cap): 30 mcg/0.3 mL (1.8 mL) [contains 2-((peg)-2000)-n,n-ditetradecylacetamide]

Comirnaty (Purple Cap): 30 mcg/0.3 mL (1.8 mL) [contains 2-((peg)-2000)-n,n-ditetradecylacetamide]

Comirnaty Omicron XBB.1.5: 3 mcg/0.2 mL (2 mL); 10 mcg/0.3 mL (0.3 mL, 1.8 mL); 30 mcg/0.3 mL (0.3 mL, 1.8 mL, 2 mL)

Comirnaty Original & Omicron: 10 mcg/0.2 mL (1.3 mL); 30 mcg/0.3 mL (0.48 mL, 2.25 mL) [contains 2-((peg)-2000)-n,n-ditetradecylacetamide]

Spikevax: 50 mcg/0.5 mL (2.5 mL); 100 mcg/0.5 mL (5 mL) [contains dmg-peg 2000]

Spikevax Bivalent: 50 mcg/0.5 mL (Original/Omicron BA.1) (2.5 mL) [contains dmg-peg 2000]

Spikevax Orig & Omicron BA.4/5: 50 mcg/0.5 mL (2.5 mL) [contains dmg-peg 2000]

Spikevax XBB.1.5: 0.1 mg/mL (2.5 mL)

Prescribing and Access Restrictions

The US federal government, in conjunction with state health departments, allocates vaccine supply to individual sites of care across the United States.

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 and provide a paper record card as a backup.

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) in adults and children

  • cases of myocarditis or pericarditis

  • cases of COVID-19 that result in hospitalization or death

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).

Moderna vaccine: Prior to use, gently swirl vial; do not shake. Do not pool partial doses remaining in vials into a full dose (Ref).

Pfizer-BioNTech vaccine (vials for ≥12 years of age [no dilution required]): Prior to use, gently invert vial; do not shake. Do not pool partial doses remaining in vials into a full dose (Ref).

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 Hemophilia 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).

Moderna vaccine: Prior to use, gently swirl vial; do not shake. Do not pool partial doses remaining in vials into a full dose (Ref). The 2023-2024 formulation single-dose vial for ages 6 months to <12 years (with a green label and dark blue cap) may contain significant overfill; ensure that correct amount (0.25 mL) is withdrawn for patient dose and discard any excess volume (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. Do not pool partial doses remaining in vials into a full dose.

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).

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 Hemophilia Foundation, World Federation of Hemophilia).

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/vis/vis-statements/covid-19.html.

Use: Labeled Indications

US labeling:

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

Note: As of September 11, 2023, the only mRNA COVID-19 vaccines now available in the United States are based on the SARS-CoV-2 Omicron variant XBB.1.5 and labeled "2023-2024 Formula". Pfizer-BioNTech COVID-19 Vaccine, 2023-2024 Formula and Moderna COVID-19 Vaccine, 2023-2024 Formula are available under emergency use authorization (EUA) for persons 6 months to <12 years of age and are FDA approved for persons ≥12 years of age. EUA is no longer available for older monovalent and bivalent products. 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 2023-2024 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 containing different components (eg, SARS-CoV-2 Original strain, Omicron BA.1, BA.4/BA.5, and XBB.1.5 variants) may be available; 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 2023a; FDA 2023b; ISMP [Smetzer 2022a]).

The Moderna 2023-2024 formulation vials (green label and dark blue cap) have significant overfill in the single-use vial. Ensure accurate mL volume before administration to avoid overdose (ISMP 2023).

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Abatacept: May diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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

AzaTHIOprine: May diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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 enhance the adverse/toxic effect of CloZAPine. COVID-19 Vaccines may increase the serum concentration of CloZAPine. Risk C: Monitor therapy

Corticosteroids (Systemic): May diminish the therapeutic effect 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 diminish the therapeutic effect 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 enhance the adverse/toxic effect 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 therapy

Elivaldogene Autotemcel: May enhance the adverse/toxic effect of Vaccines. Specifically, there may be a greater risk for contracting an infection from any live vaccine. Elivaldogene Autotemcel may diminish the therapeutic effect 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 combination

Immunosuppressants (Cytotoxic Chemotherapy): May diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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 diminish the therapeutic effect 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

Propacetamol: May diminish the therapeutic effect 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

Smallpox and Monkeypox Vaccine (Live): May enhance the adverse/toxic effect of COVID-19 Vaccine (mRNA). Specifically, the risk of myocarditis may be increased. Risk C: Monitor therapy

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

SulfaSALAzine: May diminish the therapeutic effect 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 diminish the therapeutic effect 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

Tixagevimab and Cilgavimab: May diminish the therapeutic effect of COVID-19 Vaccines. Management: Wait at least 2 weeks after receipt of a COVID-19 vaccine before administering tixagevimab and cilgavimab for pre-exposure prophylaxis. Risk D: Consider therapy modification

Tofacitinib: May diminish the therapeutic effect 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 diminish the therapeutic effect 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 2023). 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).

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 pregnant patients (ACOG 2023; CDC 2023). Refer to current CDC guidelines for vaccination of adults.

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 2023). 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 2023). 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 2023). 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 2023).

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: Moderna COVID-19 vaccine | Pfizer BioNTech COVID-19 vaccine;
  • (PT) Portugal: Comirnaty | COVID-19 vaccine Moderna | Spikevax;
  • (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
  1. Aharon D, Lederman M, Ghofranian A, et al. In vitro fertilization and early pregnancy outcomes after coronavirus disease 2019 (COVID-19) vaccination. Obstet Gynecol. Published online January 25, 2022. doi:10.1097/AOG.0000000000004713 [PubMed 35080199]
  2. American Academy of Pediatrics (AAP) Committee on Infectious Diseases. COVID-19 vaccines in infants, children, and adolescents. Pediatrics. Published online June 18, 2022. doi:10.1542/peds.2022-058700. https://publications.aap.org/pediatrics/article/doi/10.1542/peds.2022-058700/188297/COVID-19-Vaccines-in-Infants-Children-and [PubMed 35716376]
  3. American College of Obstetricians and Gynecologists (ACOG). COVID-19 vaccination considerations for obstetric–gynecologic care. https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2020/12/vaccinating-pregnant-and-lactating-patients-against-covid-19. Updated September 25, 2023. Accessed September 26, 2023.
  4. American College of Obstetricians and Gynecologists (ACOG). COVID-19 FAQs for obstetricians-gynecologists, obstetrics. https://www.acog.org/clinical-information/physician-faqs/covid-19-faqs-for-ob-gyns-obstetrics. Accessed September 21, 2023.
  5. Baden LR, El Sahly HM, Essink B, et al; COVE Study Group. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. Published online December 30, 2020. doi:10.1056/NEJMoa2035389 [PubMed 33378609]
  6. Becker AS, Perez-Johnston R, Chikarmane SA, et al. Multidisciplinary recommendations regarding post-vaccine adenopathy and radiologic imaging: Radiology Scientific Expert Panel. Radiology. Published online February 24, 2021. doi:10.1148/radiol.2021210436 [PubMed 33625298]
  7. Blumenthal KG, Freeman EE, Saff RR, et al. Delayed large local reactions to mRNA-1273 vaccine against SARS-CoV-2 [published online ahead of print, 2021 Mar 3]. N Engl J Med. 2021;10.1056/NEJMc2102131. doi:10.1056/NEJMc2102131 [PubMed 33657292]
  8. Canadian National Advisory Committee on Immunization (NACI). COVID-19 vaccines: Canadian Immunization Guide. https://www.canada.ca/en/public-health/services/publications/healthy-living/canadian-immunization-guide-part-4-active-vaccines/page-26-covid-19-vaccine.html. Updated June 27, 2023. Accessed September 19, 2023.
  9. Canadian National Advisory Committee on Immunization (NACI). Addendum to the guidance on the use of COVID-19 vaccines in the fall of 2023. https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-addendum-guidance-use-covid-19-vaccines-fall-2023.html. Updated September 12, 2023a. Accessed September 19, 2023.
  10. Canadian National Advisory Committee on Immunization (NACI). Guidance on the use of COVID-19 vaccines in the fall of 2023. https://www.canada.ca/en/public-health/services/publications/vaccines-immunization/national-advisory-committee-immunization-guidance-use-covid-19-vaccines-fall-2023.html. Updated July 11, 2023b. Accessed September 19, 2023.
  11. Canadian National Advisory Committee on Immunization (NACI). Recommendations on the use of bivalent Omicron-containing mRNA COVID-19 vaccines. https://www.canada.ca/content/dam/phac-aspc/documents/services/immunization/national-advisory-committee-on-immunization-naci/recommendations-use-bivalent-Omicron-containing-mrna-covid-19-vaccines.pdf. Updated September 1, 2022. Accessed September 8, 2022.
  12. Centers for Disease Control and Prevention (CDC) COVID-19 Response Team; Food and Drug Administration (FDA): First month of COVID-19 vaccine safety monitoring – United States, December 14, 2020-January 13, 2021. MMWR Morb Mortal Wkly Rep. 2021a;70(8): 283-288. doi:10.15585/mmwr.mm7008e3
  13. Centers for Disease Control and Prevention (CDC). Clinical considerations: myocarditis and pericarditis after receipt of mRNA COVID-19 vaccines among adolescents and young adults. https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html. Updated May 28, 2021b. Accessed June 30, 2021.
  14. Centers for Disease Control and Prevention (CDC). Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html. Updated October 24, 2023. Accessed October 31, 2023.
  15. Centers for Disease Control and Prevention (CDC). Interim clinical considerations for use of COVID-19 vaccines currently approved or authorized in the United States. https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html. Updated December 8, 2022c. Accessed December 12, 2022.
  16. Chee YJ, Liew H, Hoi WH, et al. SARS-CoV-2 mRNA vaccination and Graves' disease: a report of 12 cases and review of the literature. J Clin Endocrinol Metab. Published online March 2, 2022. doi:10.1210/clinem/dgac119 [PubMed 35235663]
  17. Ciapponi A, Berrueta M, P K Parker E, et al. Safety of COVID-19 vaccines during pregnancy: a systematic review and meta-analysis. Vaccine. Published online March 27, 2023. doi:10.1016/j.vaccine.2023.03.038 [PubMed 37012114]
  18. Comirnaty (COVID-19 Vaccine [mRNA]) [prescribing information]. New York, NY: Pfizer; October 2023.
  19. Comirnaty (COVID-19 Vaccine [mRNA]) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada ULC; March 2023.
  20. Comirnaty Omicron XBB.1.5 (COVID-19 Vaccine [mRNA], Monovalent [Omicron XBB.1.5]) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada ULC; September 2023.
  21. Comirnaty Original and Omicron BA.4/BA.5 (COVID-19 Vaccine [mRNA], Bivalent [original and Omicron BA.4/BA.5]) [product monograph]. Kirkland, Quebec, Canada: Pfizer Canada ULC; September 2023.
  22. Cross GB, Moghaddas J, Buttery J, Ayoub S, Korman TM. Don't aim too high: avoiding shoulder injury related to vaccine administration. Aust Fam Physician. 2016;45(5):303-306. [PubMed 27166466]
  23. de Freitas Paganoti C, Alkmin da Costa R, Papageorghiou AT, et al. COVID-19 vaccines confer protection in hospitalized pregnant and postpartum women with severe COVID-19: a retrospective cohort study. Vaccines (Basel). 2022;10(5):749. doi:10.3390/vaccines10050749 [PubMed 35632505]
  24. DeSilva M, Haapala J, Vazquez-Benitez G, et al. Evaluation of acute adverse events after Covid-19 vaccination during pregnancy. N Engl J Med. 2022;387(2):187-189. doi:10.1056/NEJMc2205276 [PubMed 35731916]
  25. Dick A, Rosenbloom JI, Karavani G, Gutman-Ido E, Lessans N, Chill HH. Safety of third SARS-CoV-2 vaccine (booster dose) during pregnancy. Am J Obstet Gynecol MFM. 2022;4(4):100637. doi:10.1016/j.ajogmf.2022.100637 [PubMed 35398583]
  26. Duperrex O, Tommasini F, Muller YD. Incidence of chronic spontaneous urticaria following receipt of the COVID-19 vaccine booster in Switzerland. JAMA Netw Open. 2023;6(2):e2254298. doi:10.1001/jamanetworkopen.2022.54298 [PubMed 36723944]
  27. Foster SL, Davis MV. Vaccine administration: preventing serious shoulder injuries. J Am Pharm Assoc (2003). 2013;53(1):102-103. doi:10.1331/JAPhA.2013.13503 [PubMed 23636163]
  28. Fu W, Sivajohan B, McClymont E, et al. Systematic review of the safety, immunogenicity, and effectiveness of COVID-19 vaccines in pregnant and lactating individuals and their infants. Int J Gynaecol Obstet. 2022;156(3):406-417. doi:10.1002/ijgo.14008 [PubMed 34735722]
  29. Golan Y, Prahl M, Cassidy AG, et al. COVID-19 mRNA vaccination in lactation: assessment of adverse events and vaccine related antibodies in mother-infant dyads. Front Immunol. 2021;12:777103. doi:10.3389/fimmu.2021.777103 [PubMed 34804068]
  30. Greenhawt M, Abrams EM, Shaker M, et al. The risk of allergic reaction to SARS-CoV-2 Vaccines and recommended evaluation and management: a systematic review, Meta-Analysis, GRADE Assessment, and International Consensus Approach. J Allergy Clin Immunol Pract. 2021;9(10):3546-3567. doi:10.1016/j.jaip.2021.06.006 [PubMed 34153517]
  31. Halasa NB, Olson SM, Staat MA, et al; Overcoming Covid-19 Investigators. Maternal vaccination and risk of hospitalization for Covid-19 among infants. N Engl J Med. 2022b;387(2):109-119. doi:10.1056/NEJMoa2204399 [PubMed 35731908]
  32. Halasa NB, Olson SM, Staat MA, et al; Overcoming COVID-19 Investigators; Overcoming COVID-19 Network. Effectiveness of maternal vaccination with mRNA COVID-19 vaccine during pregnancy against COVID-19-associated hospitalization in infants aged <6 months - 17 states, July 2021-January 2022. MMWR Morb Mortal Wkly Rep. 2022a;71(7):264-270. doi:10.15585/mmwr.mm7107e3 [PubMed 35176002]
  33. Hanna N, Heffes-Doon A, Lin X, et al. Detection of messenger RNA COVID-19 vaccines in human breast milk. JAMA Pediatr. 2022;176(12):1268-1270. doi:10.1001/jamapediatrics.2022.3581 [PubMed 36156636]
  34. Health Canada. Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-import-sale-advertising-drugs.html#a2.8. Updated September 16, 2020a. Accessed December 10, 2020.
  35. Institute for Safe Medication Practices (ISMP). COVID-19 vaccine package concerns. ISMP Medication Safety Alert. https://www.ismp.org/acute-care/medication-safety-alert-july-14-2022 Published July 14, 2022. Accessed August 16, 2022.
  36. Institute for Safe Medication Practices (ISMP). Moderna COVID-19 vaccine overfill leads to a double dose. ISMP Medication Safety Alert. https://www.ismp.org/communityambulatory/medication-safety-alert-october-2023. Published October 2023. Accessed November 1, 2023.
  37. Institute for Safe Medication Practices (ISMP); The National Alert Network (NAN). Mix-ups between the influenza (flu) vaccine and COVID-19 vaccine. https://www.ismp.org/alerts/mix-ups-between-influenza-flu-vaccine-and-covid-19-vaccines. Published October 15, 2021.
  38. Jackson LA, Anderson EJ, Rouphael NG, et al; mRNA-1273 Study Group. An mRNA vaccine against SARS-CoV-2 - preliminary report. N Engl J Med. 2020;383(20):1920-1931. doi:10.1056/NEJMoa2022483 [PubMed 32663912]
  39. Johnston MS, Galan A, Watsky KL, Little AJ. Delayed localized hypersensitivity reactions to the Moderna COVID-19 vaccine: a case series. JAMA Dermatol. Published online May 12, 2021. doi:10.1001/jamadermatol.2021.1214 [PubMed 33978670]
  40. Kashani-Ligumsky L, Lopian M, Cohen R, et al. Titers of SARS CoV-2 antibodies in cord blood of neonates whose mothers contracted SARS CoV-2 (COVID-19) during pregnancy and in those whose mothers were vaccinated with mRNA to SARS CoV-2 during pregnancy. J Perinatol. 2021;41(11):2621-2624. doi:10.1038/s41372-021-01216-1 [PubMed 34564695]
  41. Koo G, Anvari S, Friedman DL, et al. mRNA COVID-19 vaccine safety in patients with previous immediate hypersensitivity to pegaspargase. J Allergy Clin Immunol Pract. 2022;10(1):322-325. doi:10.1016/j.jaip.2021.09.051 [PubMed 34678498]
  42. Kroger A, Bahta L, Hunter P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Accessed October 10, 2022.
  43. Kroger A, Bahta L, Long S, Sanchez P. General best practice guidelines for immunization: best practices guidance of the Advisory Committee on Immunization Practices (ACIP). https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.pdf. Updated February 10, 2023. Accessed May 10, 2023.
  44. Lamers M, van der Mijle A, van Hunsel F, de Vries L, van Puijenbroek E, Ceulemans M. Letter to the editor: COVID-19 vaccination during breastfeeding and its possible negative effect on milk production and supply: a preliminary observation. Breastfeed Med. 2022. doi:10.1089/bfm.2022.0057 [PubMed 35426744]
  45. Low JM, Gu Y, Ng MSF, et al. Codominant IgG and IgA expression with minimal vaccine mRNA in milk of BNT162b2 vaccinees. NPJ Vaccines. 2021;6(1):105. doi:10.1038/s41541-021-00370-z [PubMed 34413319]
  46. Ma Y, Deng J, Liu Q, Du M, Liu M, Liu J. Effectiveness and safety of COVID-19 vaccine among pregnant women in real-world studies: a systematic review and meta-analysis. Vaccines (Basel). 2022;10(2):246. doi:10.3390/vaccines10020246 [PubMed 35214704]
  47. Magnus MC, Gjessing HK, Eide HN, Wilcox AJ, Fell DB, Håberg SE. Covid-19 vaccination during pregnancy and first-trimester miscarriage. N Engl J Med. 2021. doi:10.1056/NEJMc2114466 [PubMed 34670062]
  48. Mark C, Gupta S, Punnett A, et al. Safety of administration of BNT162b2 mRNA (Pfizer-BioNTech) COVID-19 vaccine in youths and young adults with a history of acute lymphoblastic leukemia and allergy to PEG-asparaginase. Pediatr Blood Cancer. 2021;68(11):e29295. doi:10.1002/pbc.29295 [PubMed 34398511]
  49. Moderna manufacturer communication September 14, 2022. Data on file.
  50. Moro PL, Olson CK, Zhang B, Marquez P, Strid P. Safety of booster doses of Coronavirus disease 2019 (COVID-19) vaccine in pregnancy in the vaccine adverse event reporting system. Obstet Gynecol. 2022;140(3):421-427. doi:10.1097/AOG.0000000000004889 [PubMed 35926203]
  51. Muyldermans J, De Weerdt L, De Brabandere L, Maertens K, Tommelein E. The effects of COVID-19 vaccination on lactating women: a systematic review of the literature. Front Immunol. 2022;13:852928. doi:10.3389/fimmu.2022.852928 [PubMed 35464406]
  52. National Institutes of Health. COVID-19 Treatment Guidelines Panel. Coronavirus disease 2019 (COVID-19) treatment guidelines. https://www.covid19treatmentguidelines.nih.gov/. Updated April 20, 2023. Accessed April 25, 2023.
  53. Oliver S, Gargano J, Marin M, et al. The Advisory Committee on Immunization Practices' Interim Recommendation for Use of Pfizer-BioNTech COVID-19 Vaccine — United States, December 2020. MMWR Morb Mortal Wkly Rep. 2020;69(50):1922-1924. doi:10.15585/mmwr.mm6950e2 [PubMed 33332292]
  54. Oliver SE, Gargano JW, Marin M, et al. The Advisory Committee on Immunization Practices' interim recommendation for use of Moderna COVID-19 Vaccine - United States, December 2020. MMWR Morb Mortal Wkly Rep. 2021a;69(5152):1653-1656. doi: 10.15585/mmwr.mm695152e1 [PubMed 33382675]
  55. Oliver SE, Gargano JW, Scobie H, et al. The Advisory Committee on Immunization Practices' interim recommendation for use of Janssen COVID-19 vaccine - United States, February 2021. MMWR Morb Mortal Wkly Rep. 2021b;70(9):329-332. doi:10.15585/mmwr.mm7009e4 [PubMed 33661860]
  56. Orvieto R, Noach-Hirsh M, Segev-Zahav A, Haas J, Nahum R, Aizer A. Does mRNA SARS-CoV-2 vaccine influence patients' performance during IVF-ET cycle? Reprod Biol Endocrinol. 2021;19(1):69. doi:10.1186/s12958-021-00757-6 [PubMed 33985514]
  57. Otani IM, Tsao LR, Tang M. Coronavirus disease 2019 vaccine administration in patients with reported reactions to polyethylene glycol- and polysorbate-containing therapeutics. Ann Allergy Asthma Immunol. 2022;129(1):88-94.e1. doi:10.1016/j.anai.2022.03.006 [PubMed 35288274]
  58. Picard M, Drolet JP, Masse MS, et al. Safety of COVID-19 vaccination in patients with polyethylene glycol allergy: a case series. J Allergy Clin Immunol Pract. 2022;10(2):620-625.e1. doi:10.1016/j.jaip.2021.11.021 [PubMed 34949564]
  59. Pfizer. Pfizer-BioNTech COVID-19 Vaccine - overfill volume in multi-dose vial. https://www.pfizermedicalinformation.com/en-us/document/a0r5I000001MzbtQAC. Published December 17, 2020.
  60. Pfizer manufacturer communication. Storage and Handling of Diluted Vials Outside of Recommendations in the EUA Prescribing Information During and After Dilution. January 21, 2021. Data on file.
  61. Pfizer manufacturer communication. Storage of vaccine in SYRINGE-information outside the EUA PI (for 12 years of age and older-GRAYCAP). January 14, 2022. Data on file.
  62. Pillay J, Gaudet L, Wingert A, et al. Incidence, risk factors, natural history, and hypothesised mechanisms of myocarditis and pericarditis following covid-19 vaccination: living evidence syntheses and review. BMJ. 2022;378:e069445. doi:10.1136/bmj-2021-069445 [PubMed 35830976]
  63. Polack FP, Thomas SJ, Kitchin N, et al; C4591001 Clinical Trial Group. Safety and efficacy of the BNT162b2 mRNA covid-19 vaccine. N Engl J Med. Published online December 10, 2020. doi:10.1056/NEJMoa2034577 [PubMed 33301246]
  64. Rao AK, Petersen BW, Whitehill F, et al. Use of JYNNEOS (smallpox and monkeypox vaccine, live, nonreplicating) for preexposure vaccination of persons at risk for occupational exposure to orthopoxviruses: recommendations of the Advisory Committee on Immunization Practices - United States, 2022. MMWR Morb Mortal Wkly Rep. 2022;71(22):734-742. doi:10.15585/mmwr.mm7122e1 [PubMed 35653347]
  65. Rawal S, Tackett RL, Stone RH, Young HN. COVID-19 vaccination among pregnant people in the United States: a systematic review. Am J Obstet Gynecol MFM. 2022;4(4):100616. doi:10.1016/j.ajogmf.2022.100616 [PubMed 35283351]
  66. Refer to manufacturer's labeling.
  67. Ruderman RS, Mormol J, Trawick E, et al. Association of COVID-19 vaccination during early pregnancy with risk of congenital fetal anomalies. JAMA Pediatr. 2022:e220164. doi:10.1001/jamapediatrics.2022.0164 [PubMed 35377399]
  68. Sadarangani M, Soe P, Shulha HP, et al; Canadian Immunization Research Network. Safety of COVID-19 vaccines in pregnancy: a Canadian National Vaccine Safety (CANVAS) network cohort study. Lancet Infect Dis. 2022:S1473-3099(22)00426-1. doi:10.1016/S1473-3099(22)00426-1 [PubMed 35964614]
  69. Shimabukuro TT, Cole M, Su JR. Reports of anaphylaxis after receipt of mRNA COVID-19 vaccines in the US-December 14, 2020-January 18, 2021. JAMA. 2021a;325(11):1101-1102. doi:10.1001/jama.2021.1967 [PubMed 33576785]
  70. Shook LL, Atyeo CG, Yonker LM, et al. Durability of anti-spike antibodies in infants after maternal COVID-19 vaccination or natural infection. JAMA. 2022;327(11):1087-1089. doi:10.1001/jama.2022.1206 [PubMed 35129576]
  71. Smetzer J, Cohen M, eds. EPINEPHrine administered instead of the COVID-19 vaccine. ISMP Medication Safety Alert! Acute Care Edition. 2022a;27(2):2.
  72. Smetzer J, Cohen M, eds. Additional risk of age-related mix-ups now that our youngest patients are eligible for COVID-19 vaccines. ISMP Medication Safety Alert! Acute Care Edition. 2022b;27(13):3-5.
  73. Spikevax (COVID-19 mRNA vaccine) [prescribing information]. Cambridge, MA: Moderna US Inc; September 2023.
  74. Spikevax (COVID-19 mRNA vaccine) [product monograph]. Toronto, Ontario, Canada: Moderna Biopharma Canada Corp; October 2023.
  75. Spikevax Bivalent Original/Omicron BA.1 (COVID-19 mRNA vaccine) [product monograph]. Toronto, Ontario, Canada: Moderna Biopharma Canada Corp; October 2023.
  76. Spikevax Bivalent Original/Omicron BA.4/5 (COVID-19 mRNA vaccine) [product monograph]. Toronto, Ontario, Canada: Moderna Biopharma Canada Corp; October 2023.
  77. Spikevax XBB.1.5 (COVID-19 mRNA vaccine) [product monograph]. Toronto, Ontario, Canada: Moderna Biopharma Canada Corp; September 2023.
  78. US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccine: Emergency Use Authorization (EUA) of Moderna COVID-19 Vaccine (2023-2024 Formula), for individuals 6 months through 11 years of age. https://www.fda.gov/media/167208/download. Updated September 11, 2023b. Accessed September 13, 2023.
  79. US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccine: Emergency Use Authorization of the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula), for individuals 6 months through 11 years of age. https://www.fda.gov/media/167211/download. Updated September 11, 2023a. Accessed September 13, 2023.
  80. US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19): For 5 through 11 years of age; dilute before use. https://www.fda.gov/media/153714/download. Updated October 12, 2022b. Accessed October 13, 2022.
  81. US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19): For 12 years of age and older; dilute before use. https://www.fda.gov/media/153713/download. Updated December 22, 2022c. Accessed December 23, 2022.
  82. US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccine: Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine to prevent coronavirus disease 2019 (COVID-19): For 12 years of age and older; do not dilute. https://www.fda.gov/media/153715/download. Updated August 31, 2022d. Accessed September 8, 2022.
  83. US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccine: Emergency Use Authorization (EUA) of the Moderna COVID-19 Vaccine, bivalent (original and Omicron BA.4/BA.5) to prevent coronavirus disease 2019 (COVID-19): booster dose presentation; For 6 years of age and older; dark blue cap and a label with a gray border. https://www.fda.gov/media/161318/download. Updated December 8, 2022i. Accessed December 19, 2022.
  84. US Food and Drug Administration (FDA). Fact sheet for healthcare providers administering vaccine (vaccination providers): Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 Vaccine, bivalent (original and Omicron BA.4/BA.5) to prevent coronavirus disease 2019 (COVID-19): booster dose presentation; For 12 years of age and older; do not dilute. https://www.fda.gov/media/161327/download. Updated October 12, 2022j. Accessed October 13, 2022.
  85. US Food and Drug Administration (FDA). Important information about the correct dosage and administration of Moderna COVID-19 vaccine (2023-2024 formula) for individuals 6 months through 11 years of age. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/important-information-about-correct-dosage-and-administration-moderna-covid-19-vaccine-2023-2024. Published November 1, 2023c. Accessed November 8, 2023.
  86. US Food and Drug Administration (FDA). Letters to health care providers: Possible false RPR reactivity with BioPlex 2200 syphilis total & RPR test kit following a COVID-19 vaccine - letter to clinical laboratory staff and health care providers. https://www.fda.gov/medical-devices/letters-health-care-providers/possible-false-rpr-reactivity-bioplex-2200-syphilis-total-rpr-test-kit-following-covid-19-vaccine. Published December 17, 2021. Accessed October 4, 2022.
  87. Wallace M, Woodworth KR, Gargano JW, et al. The Advisory Committee on Immunization Practices’ interim recommendation for use of Pfizer-BioNTech COVID-19 vaccine in adolescents aged 12–15 years — United States, May 2021. MMWR. 2021;70:1-4. https://www.cdc.gov/mmwr/volumes/70/wr/pdfs/mm7020e1-H.pdf.
  88. Walsh EE, Frenck RW Jr, Falsey AR, et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. N Engl J Med. 2020;383(25):2439-2450. doi:10.1056/NEJMoa2027906 [PubMed 33053279]
  89. Washrawirul C, Triwatcharikorn J, Phannajit J, Ullman M, Susantitaphong P, Rerknimitr P. Global prevalence and clinical manifestations of cutaneous adverse reactions following COVID-19 vaccination: a systematic review and meta-analysis. J Eur Acad Dermatol Venereol. 2022;36(11):1947-1968. doi:10.1111/jdv.18294 [PubMed 35666609]
  90. Whited N, Cervantes J. Antibodies against SARS-CoV-2 in human breast milk after vaccination: a systematic review and meta-analysis. Breastfeed Med. 2022;17(6):475-483. doi:10.1089/bfm.2021.0353 [PubMed 35325550]
  91. Woodworth KR, Moulia D, Collins JP, et al. The Advisory Committee on Immunization Practices' interim recommendation for use of Pfizer-BioNTech COVID-19 Vaccine in children aged 5-11 years - United States, November 2021. MMWR Morb Mortal Wkly Rep. 2021;70:1-5.
  92. Young BE, Seppo AE, Diaz N, et al. Association of human milk antibody induction, persistence, and neutralizing capacity with SARS-CoV-2 infection vs mRNA vaccination. JAMA Pediatr. 2021:e214897. doi:10.1001/jamapediatrics.2021.4897 [PubMed 34757387]
Topic 130318 Version 296.0

آیا می خواهید مدیلیب را به صفحه اصلی خود اضافه کنید؟