COVID-19 mRNA Vaccine (Moderna)
Indications
COVID-19 mRNA Vaccine (Moderna) is used for:
COVID-19 disease prevention
Adult Dose
Injection
Emergency use authorization (EUA) issued by FDA for active immunization to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals aged >18 years
0.5 mL IM x2 doses administered 1 month apart
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Administration
IM Preparation
Thaw frozen suspension before administering
Thaw in refrigerated at 2-8ºC (36-46ºF) for 2.5 hr
After thawing, let vial stand at room temperature for 15 minutes before administering
Alternatively, thaw at room temperature of 15-25ºC (59-77ºF) for 1 hr
After thawing, do not refreeze
Do not shake; swirl vial gently after thawing and between each withdrawal
Do not dilute
Suspension is white to off-white and may contain white or translucent product-related particulates
Visually inspect for other particulate matter and/or discoloration administration; if either of these conditions exists, do not administer
IM Administration
For IM injection only
Contra Indications
Known history of severe allergic reaction (eg, anaphylaxis) to any component in vaccine
Precautions
Appropriate medical treatment used to manage immediate allergic reactions must be immediately available following vaccination
Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to the vaccine
Vaccine may not protect all vaccine recipients
Pregnancy-Lactation
Pregnancy
Data are insufficient to inform of vaccine-associated risks in pregnancy
Animal data
Vaccine administered IM to female rats 28 and 14 days prior to mating, and on gestation days 1 and 13
No vaccine-related adverse effects on female fertility, fetal development, or postnatal development were reported
Lactation
Data are not available to assess effects on breastfed infants or on milk production/excretion
Interactions
Data are not available to assess concomitant administration with other vaccines
Adverse Effects
Side effects of COVID-19 mRNA Vaccine (Moderna) :
>10%
Injection site pain (86.9%)
Fatigue (38.4%)
Headache (35.3%)
Myalgia (23.7%)
Use of antipyretic/analgesic medication (23.3%)
Axillary swelling/tenderness (11.6%)
1-10%
Nausea/vomiting (9.4%)
Chills (9.2%)
Swelling (hardness), >25 mm (6.7%)
Pain, Grade 3 (3.2%)
Erythema >25 mm (3%)
Headache, Grade 3 (1.9%)
Fatigue, Grade 3 (1.1%)
<1%
Fever (0.9%)
Myalgia, Grade 3 (0.6%)
Swelling (hardness), Grade 3 (0.5%)
Arthralgia, Grade 3 (0.4%)
Axillary swelling/tenderness, Grade 3 (0.3%)
Erythema, Grade 3 (0.3%)
Chills, Grade 3 (0.1%)
Fatigue, Grade 4 (<0.1%)
Arthralgia, Grade 4 (<0.1%)
Nausea/vomiting, Grade 3 (<0.1%)
Fever, Grade 3-4 (<0.1%)
Mechanism of Action
Nucleoside-modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2; formulated in lipid particles, which enable delivery of RNA into host cells to allow expression of the SARS-CoV-2 S antigen
Elicits an immune response to the S antigen, which protects against COVID-19