Comirnaty Generic Name & Formulations
Legal Class
Rx
General Description
COVID-19 vaccine (mRNA); contains 30mcg of nucleoside-modified mRNA encoding the viral spike S glycoprotein of SARS-CoV-2; per 0.3mL; susp for IM inj after dilution; preservative-free.
Pharmacological Class
COVID-19 vaccine.
How Supplied
Multiple-dose vials—25, 195 (w. diluent; shipped separately)
Manufacturer
Generic Availability
NO
Mechanism of Action
The nucleoside-modified mRNA in Comirnaty is formulated in lipid particles, which enable delivery of the mRNA into host cells to allow expression of the SARS-CoV-2 S antigen. The vaccine elicits an immune response to the S antigen, which protects against COVID-19.
Comirnaty Indications
Indications
Active immunization to prevent COVID-19 in individuals ≥12yrs of age.
Comirnaty Dosage and Administration
Adults and Children
<12yrs: not established. Give by IM inj only. ≥12yrs: 0.3mL given as a 2-dose series 3 weeks apart.
Administration
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DO NOT DILUTE prior to use for Comirnaty multiple dose vials with gray caps and labels with gray borders.
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Visually inspect parenteral drug products for particulate matter and discoloration prior to administration. The vaccine will be a white to white-off suspension.
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Give a single 0.3mL dose of Comirnaty intramuscularly.
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May use dead-volume syringes and/or needles to extract 6 doses from a single vial.
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Do not pool excess vaccine from multiple vials.
Comirnaty Contraindications
Not Applicable
Comirnaty Boxed Warnings
Not Applicable
Comirnaty Warnings/Precautions
Warnings/Precautions
Have epinephrine inj available. Increased risks of myocarditis and pericarditis (esp. within 7 days after the second dose); higher risk among males <40yrs of age, and highest among males 12–17yrs of age. Syncope. Immunocompromised. Pregnancy. Nursing mothers.
Comirnaty Pharmacokinetics
See Literature
Comirnaty Interactions
Interactions
Immunosuppressants: may get suboptimal response.
Comirnaty Adverse Reactions
Adverse Reactions
Inj site reactions (eg, pain, swelling, redness), fatigue, headache, muscle pain, chills, joint pain, fever.
Comirnaty Clinical Trials
Comirnaty Note
Not Applicable