COVID-19 vaccine, mRNA-Moderna

Dosage Forms & Strengths injection, suspension

100mcg/0.5mL per dose
Each multiple-dose vial contains 10 doses

COVID-19 Disease Prevention

December 18, 2020: 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

Dosing Considerations

Limitations of effectiveness: May not protect all vaccine recipients

There are no data available on interchangeability of this vaccine with other COVID-19 vaccines; individuals who have received 1 dose should receive a second dose with the same vaccine to complete vaccination series

Adverse Effects

Mandatory for vaccination providers to report to the vaccine adverse events reporting system (VAERS) all vaccine administration errors, serious adverse events, multisystem inflammatory syndrome, and hospitalized or fatal cases of COVID-19 following vaccination >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%)

Warnings

Contraindications Known history of severe allergic reaction (eg, anaphylaxis) to any component in vaccine CDC listed contraindications

CDC has listed the following contraindications
Severe allergic reaction after previously receiving mRNA COVID-19 vaccine or its components
Allergic reaction (of any severity) immediately after receiving mRNA COVID-19 vaccine or its components, including polyethylene glycol (PEG)
Immediate allergic reaction (of any severity) to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient PEG)

Cautions Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have diminished immune response to the vaccine Vaccine may not protect all vaccine recipients Allergic reactions Appropriate medical treatment used to manage immediate allergic reactions must be immediately available following vaccination Do not administer second dose to anyone experiencing a severe reaction (ie, requiring epinephrine or hospitalization) to the first dose Individuals with histories of severe allergic reaction to vaccines should consult their doctors about the COVID-19 vaccine People with severe allergies to food, pets, latex, oral medications, or environmental conditions may be vaccinated according to interim CDC clinical considerations for mRNA COVID-19 vaccines Drug interaction overview

Data are not available to assess concomitant administration with other vaccines

Pregnancy & Lactation

Pregnancy Data are insufficient to inform of vaccine-associated risks in pregnancy Pregnancy registry: Women who are vaccinated with Moderna COVID-19 vaccine during pregnancy are encouraged to enroll in the registry by calling 1-866-MODERNA (1-866-663-3762) 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 Pregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.

Pharmacology

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

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 Storage Does not contain preservatives Vial stoppers are not made with natural rubber latex Unopened vials Store in original carton to protect from light